diff --git "a/sample_size_estimation/train.jsonl" "b/sample_size_estimation/train.jsonl" new file mode 100644--- /dev/null +++ "b/sample_size_estimation/train.jsonl" @@ -0,0 +1,1143 @@ +{"trial_id": "NCT00987688", "pmid": "29703266", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multi-centre Randomised Trial to Evaluate the Effect of Early Hypothermia on Neurological Function in Patients With Severe Traumatic Brain Injury. Including Renal Sub Study\n\nIncluded conditions:\n- Brain Injuries, Traumatic\n\nStudy Armgroups:\n- {'label': 'Hypothermia', 'type': 'EXPERIMENTAL', 'description': 'Early and sustained hypothermia.', 'interventionNames': ['Other: Hypothermia']}\n- {'label': 'Normothermia', 'type': 'NO_INTERVENTION', 'description': 'Standard management'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Hypothermia', 'description': 'exposure: Early and sustained hypothermia. Hypothermia will initially be induced by infusion of up to 2L ice cold saline. Following a safety assessment the patient will be rapidly cooled to 33C using surface temperature control equipment. They will be maintained at 33C for 72 hours. Rewarming will occur at a rate of 1C/4hrs and will be titrated to intracranial pressure (ICP) control and BP.', 'armGroupLabels': ['Hypothermia']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of favourable neurological outcomes (Glasgow Outcome Score Extended: GOSE 5 to 8)', 'description': 'The Glasgow Outcome Scale Extended (GOSE) is an ordinal rating scale. The 8 scores in the scale are: Dead (1), Vegetative State (2), Lower Severe Disability (3), Upper Severe Disability (4), Lower Moderate Disability (5), Upper Moderate Disability (6), Lower Good Recovery (7), and Upper Good Recovery (8).', 'timeFrame': '6 months post injury'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a two-sided alpha of 0.05, power of slightly >80% (82.8%), and uses an uncorrected Chi square test. It also accounts for a 5% loss to follow-up, a maximum of 12% non-compliance, and interim analyses using Haybittle-Peto 3SD group sequential boundaries. The final analysis significance level is adjusted to \u00b11.996 SD (P=0.0459) instead of \u00b11.96 SD (P=0.05).", "answer": 511, "answer_type": "ACTUAL", "explanation": "Sample size, power and interim analysis schedule\n The overall recruitment target was set at 500 participants from commencement in December 2010 and was slightly increased to 510 participants in September 2017 after blinded review of the combined proportion of patients with \u00e2\u0080\u0098consent withdrawn\u00e2\u0080\u0099 or \u00e2\u0080\u0098loss to follow-up\u00e2\u0080\u0099. A total of 511 patients were randomised before the conclusion of trial recruitment on 10 November 2017.\n A study of fixed size with full compliance and follow-up would require 364 patients (182 in each of two treatment arms) to detect a 15% absolute increase from 50% to 65% in favourable neurological outcome at six\u00c2\u00a0months following injury (equivalent to a 30% relative improvement in risk) with slightly >\u00e2\u0080\u008980% (82.8%) power, assuming a two-sided alpha of 0.05 and an uncorrected Chi square test. This postulated POLAR risk improvement from a baseline of 50% to 65% in treated patients is equivalent to an odds ratio of approximately 1.86.\n The original POLAR trial sample size of 364 fully evaluable patients was appropriately inflated to a practically required target of 500 patients to maintain 80% power to find the anticipated beneficial effect of prophylactic hypothermia while accommodating anticipated losses to follow-up (5%) and non-compliance (cross-over from cooling to control and related losses, maximum 12%). Also incorporated was a much smaller (0.7%) inflation necessary to accommodate the originally anticipated interim analyses of both mortality and the proportion of unfavourable neurological outcomes using Haybittle-Peto 3SD group sequential boundaries at two recruitment points (one-quarter [n\u00e2\u0080\u0089=\u00e2\u0080\u0089125] and one-half [n\u00e2\u0080\u0089=\u00e2\u0080\u0089250]) [7].\n Following the October 2015 publication of the EUROTHERM3235 study [6], the POLAR DSMC required a further substantial increase in interim monitoring, namely at increments of 50 patients from n\u00e2\u0080\u0089=\u00e2\u0080\u0089300 to n\u00e2\u0080\u0089=\u00e2\u0080\u0089450 inclusive. Ten of 11 planned interim analyses will be of both mortality and the proportion of unfavourable neurological outcomes, while at the penultimate (n\u00e2\u0080\u0089=\u00e2\u0080\u0089450) assessment, short-term 28-day mortality alone will be assessed due to time constraints. These extra analyses implied a sample size inflationary requirement (4% - 0.7%\u00e2\u0080\u0089=\u00e2\u0080\u00893.3% extra) [44] which may be accommodated within the originally planned sample size, provided losses to follow-up and non-compliance remained below anticipated limits.\n From calculations using East trial design software [45] based upon an approximate Chi-square test, the trial power was only slightly diminished at 82.3% (down from 83%) with 366 fully evaluable participants and 11 interim Haybittle-Peto 3SD interim analyses. In the absence of early stopping, the final analysis would be properly conducted at \u00c2\u00b1\u00e2\u0080\u00891.996 SD (P\u00c2\u00a0=\u00e2\u0080\u00890.0459) rather than \u00c2\u00b1\u00e2\u0080\u00891.96 SD (P\u00c2\u00a0=\u00e2\u0080\u00890.05). This level of significance will not be adjusted for multiplicity; however, the primary trial outcome is clearly defined and the conclusions of the study will be those based on the primary analysis conducted in the ITT full analysis patient set. Unless otherwise specified, all hypothesis tests and accompanying significance levels (that is, P values) will be two-sided, with 95% CI.", "id": 0, "split": "train"} +{"trial_id": "NCT01353313", "pmid": "39543521", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial of the Effect of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22 - 26 Months of Age in Intubated Infants < 30 Weeks Gestation Age\n\nIncluded conditions:\n- Infant, Newborn\n- Infant, Small for Gestational Age\n- Infant, Very Low Birth Weight\n- Infant, Premature\n- Bronchopulmonary Dysplasia\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Saline placebo', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Hydrocortisone', 'type': 'EXPERIMENTAL', 'description': 'hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer\u00ae, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents)', 'interventionNames': ['Drug: Hydrocortisone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Hydrocortisone', 'description': 'Hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer\u00ae, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows:\\n\\n4mg/kg/day \u00b8 q 6 hours x 2 days, then 2mg/kg/day \u00b8 q 6 hours x 3 days; then\\n\\n1mg/kg/day \u00b8 q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days', 'armGroupLabels': ['Hydrocortisone']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Saline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows:\\n\\n4mg/kg/day \u00b8 q 6 hours x 2 days, then 2mg/kg/day \u00b8 q 6 hours x 3 days; then\\n\\n1mg/kg/day \u00b8 q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD)', 'description': 'Survival without moderate or severe physiologic BPD at 36 weeks postmenstrual age. Moderate or severe physiologic BPD is defined as a requirement for supplemental oxygen and/or positive airway pressure to maintain oxygen saturation greater than 90 percent. A room air challenge was performed for infants estimated to be receiving less than 0.30 FiO2 by nasal cannula.', 'timeFrame': 'From day of randomization to 36 weeks post menstrual age'}\n- {'measure': 'Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI)', 'description': 'Survival without moderate or severe neurodevelopmental impairment (NDI) at 22-26 months corrected age. NDI is defined as defined as any of: Bayley Scales of Infant and Toddler Development-III (Bayley-III) cognitive composite score less than 85 (standardized mean 100, SD 15, range 55-145) or motor composite score less than 85 (standardized mean 100, range 45-155) (lower scores indicating greater impairment), Gross Motor Function Classification System (GMFCS) level greater than or equal to II (on a scale from level I to V; I=normal and progressively higher levels indicate greater impairment), severe vision impairment in both eyes (consistent with refraction from less than 20 to 200), or bilateral hearing impairment with or without amplification (by report).', 'timeFrame': 'From day of randomization to 22-26 months corrected age'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a two-tailed test with a Type I error set at 5% and aims for \u226580% power. It also accounts for potential difficulty in recruitment and changes in the NRN composition. For functional respiratory outcomes, the study assumes a small-sized effect f (standard deviation of the means) of 0.12 or higher, with 10 covariates accounting for 20% of the variation in the outcome. For impulse oscillometry, the study assumes a medium-sized effect f of 0.26 or higher.", "answer": 800, "answer_type": "ACTUAL", "explanation": "Sample size and power estimates\n The sample size for the HYBRiD Outcomes Study is dictated by the number of participants who were enrolled in the primary trial (n\u00e2\u0080\u0089=\u00e2\u0080\u0089800) and survived until early school age (approximate n\u00e2\u0080\u0089=\u00e2\u0080\u0089720). Based on prior NRN follow-up studies, we anticipate that about 80% of surviving children enrolled in the parent trial will be evaluated for this proposed follow-up study (n\u00e2\u0080\u0089=\u00e2\u0080\u0089575). To account for potential difficulty in recruitment of older children who are not currently being actively tracked at all sites and potential losses with changes to the composition of the NRN, we conservatively present power projections using 500 children or 250 on each arm.\n Projected power for the HYBRiD Outcomes Study composite primary outcome of functional impairment is based on estimated event rates from the neonatal literature, because no study has assessed the same composite outcome and the current study population is expected to have higher morbidity than many existing trial or population-based cohorts [8, 56]. The Victorian Infant Collaborative Study reported \u00e2\u0080\u009cclinically important neurobehavioral impairment\u00e2\u0080\u009d (mild to major neurosensory, intellectual, educational, or behavioral impairment) in 55% of extremely low birth weight infants at 8 years [57]. Based on these data, we conservatively hypothesized that at least one component of the composite (functional motor, cognitive, academic, or respiratory impairment) will be present in about 50% of the placebo group. Note that this assumption provides the most conservative estimate of power for this study.\n Assuming a two-tailed test with Type I error set at 5%, a sample size of 500 participants will provide\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008980% power to detect a difference of \u00e2\u0089\u00a5\u00e2\u0080\u008913% in the risk of functional developmental impairments between the two treatment groups. This is a clinically meaningful difference in outcome rates, with 8 being the number needed to treat to prevent one child from having functional disability. This magnitude of difference is similar to the effect size noted for trials of high-risk populations in the meta-regression of the relationship between of dexamethasone exposure and death or cerebral palsy by Doyle, et al. [18]\n In addition to the outcome of functional developmental impairment, we examined power for comparisons of functional respiratory outcomes (e.g., distance from 6-minute walk test). With N\u00e2\u0080\u0089=\u00e2\u0080\u0089500, we would have >\u00e2\u0080\u008980% power to detect differences in mean scores between the two treatment groups with a small-sized effect f expressed as the standard deviation of the means [58]. Specifically, we have >\u00e2\u0080\u008980% power to detect f\u00e2\u0080\u0089=\u00e2\u0080\u00890.12 or higher, assuming the inclusion of 10 covariates accounting for 20% of the variation in the outcome. For the subgroup receiving impulse oscillometry (N\u00e2\u0080\u0089=\u00e2\u0080\u0089100), we would have >\u00e2\u0080\u008980% power to detect differences in mean values for impulse oscillometry between the two groups for medium-sized and larger effects (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.26 or higher).", "id": 1, "split": "train"} +{"trial_id": "NCT01869413", "pmid": "29716640", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tranexamic Acid During Cystectomy Trial (TACT)\n\nIncluded conditions:\n- Bladder Cancer\n\nStudy Armgroups:\n- {'label': 'Tranexamic Acid', 'type': 'EXPERIMENTAL', 'description': 'Tranexamic acid will be administered as an intravenous infusion of 10 mg/kg over 10 minutes (loading dose) prior to surgical incision, followed by 5 mg/kg/hour continuous maintenance infusion for the length of surgery (typically 4 to 8 hours). For example, an 80 kg patient would receive 800 mg prior to incision and a 400 mg/hr infusion for the duration of surgery. For a 6 hour procedure, the total dose administered would be 3200 mg.', 'interventionNames': ['Drug: Tranexamic Acid']}\n- {'label': 'Placebo control', 'type': 'PLACEBO_COMPARATOR', 'description': 'As there is no standard of care concerning administration of anti-fibrinolytic agents in cystectomy procedures, controls will follow the same dosing and schedule as above (loading dose followed by maintenance infusion), but with 0.9% sodium chloride.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tranexamic Acid', 'description': 'Tranexamic acid will be administered as an intravenous infusion of 10 mg/kg over 10 minutes (loading dose) prior to surgical incision, followed by 5 mg/kg/hour continuous maintenance infusion for the length of surgery (typically 4 to 8 hours).', 'armGroupLabels': ['Tranexamic Acid'], 'otherNames': ['Cyklokapron (Pfizer)']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'As there is no standard of care concerning administration of anti-fibrinolytic agents in cystectomy procedures, controls will follow the same dosing and schedule as above (loading dose followed by maintenance infusion), but with 0.9% sodium chloride.', 'armGroupLabels': ['Placebo control'], 'otherNames': ['Normal Saline']}\n\nPrimary Outcomes:\n- {'measure': 'proportion of patients transfused at least one unit of packed red blood cell transfusion', 'timeFrame': 'up to 30 days post-operative'}\n\nPlease estimate the sample size based on the assumption: \nAssuming 80% power to detect a 15% absolute difference, with a two-sided alpha level of 5%, and accounting for 2% non-compliance.", "answer": 354, "answer_type": "ACTUAL", "explanation": "Sample size\n A patient record review from The Ottawa Hospital indicated that red blood cell transfusions were performed in approximately 60% of patients with bladder cancer undergoing radical cystectomy. However, we anticipate that transfusion rates are likely to decrease slightly while under the study protocol. From the results of our survey, systemic anti-fibrinolytics are rarely used during radical cystectomies; to influence practice we suggest that tranexamic acid will have to produce a substantial reduction in the proportion of patients requiring transfusion. To assist in determining the minimally important effect of tranexamic acid deemed necessary to change clinical practice, Canadian experts in the surgical treatment of bladder cancer were surveyed in February 2012. Minimally important effect sizes ranged from an absolute difference of 15% (relative risk (RR) 30%) to 30% (RR 60%) and are consistent with effects observed in many clinical trials of tranexamic acid [12]. From our systematic review of lysine analogs to prevent bleeding during pelvic surgery, the pooled estimate favored lysine analogs (RR 0.69; 95% confidence interval (CI) 0.47 to 1.00) [13].\n If 50% of placebo patients will require at least one transfusion within 30\u00c2\u00a0days of surgery, and if the use of tranexamic acid reduces the need for transfusion within 30\u00c2\u00a0days to 35% of patients (15% absolute reduction), and assuming 80% power to detect this absolute difference, with a two-sided alpha level of 5%, the required sample size is 340 people (170 per treatment group). To account for 2% non-compliance with the protocol (possibly due to intraoperative complications or protocol deviations) the total sample size required was estimated to be 354 patients (177 per arm) [15].", "id": 2, "split": "train"} +{"trial_id": "NCT01977547", "pmid": "30055634", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Age of Blood in Children in Pediatric Intensive Care Units\n\nIncluded conditions:\n- Anemia\n\nStudy Armgroups:\n- {'label': 'Short storage', 'type': 'ACTIVE_COMPARATOR', 'description': 'Red blood cells storage duration of equal to or less than 7 days.', 'interventionNames': ['Biological: Short storage RBC age']}\n- {'label': 'Standard issue', 'type': 'ACTIVE_COMPARATOR', 'description': 'Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days.', 'interventionNames': ['Biological: Short storage RBC age']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Short storage RBC age', 'description': 'IND obtained to cover the expiration date on the red blood cell unit', 'armGroupLabels': ['Short storage', 'Standard issue']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)', 'description': 'The primary outcome measure of this RCT is NPMODS defined as the proportion of patients who die during the 28 days after randomization or who develop NPMODS. For patients with no organ dysfunction at randomization, New MODS is the development of \u2265 2 concurrent organ dysfunctions during the 28 days after randomization. For patients with 1 organ dysfunction at randomization, New MODS is the development of at least 1 other concurrent organ dysfunction after randomization. Patients with MODS (ie concurrent dysfunction of \u2265 2 organ systems) at randomization can develop Progressive MODS defined as development of at least 1 additional concurrent organ dysfunction at during the 28 days after randomization. All deaths will be considered Progressive MODS. NPMODS will be monitored up to 28 days or ICU discharge because it is almost never observed beyond this time in children.', 'timeFrame': '28 days after randomization'}\n\nPlease estimate the sample size based on the assumption: \nSample size calculations are based on a two-tailed \u03b1 of 0.05, a power (1 \u2212 \u03b2) of 0.90, and an expected dropout rate of 1.7%.", "answer": 1538, "answer_type": "ACTUAL", "explanation": "Sample size\n Patient eligibility criteria and short-storage definition (7-day cutoff) in ABC PICU will be similar to those used in preliminary studies (Table\u00c2\u00a04) [1, 23]. Based on this prior work and on a large survey of North American intensivists [38], the incidence of NPMODS is expected to be 18% in the control group and 12% in the short-storage group and the relative risk is expected to be 33%. Sample size calculations based on these estimates for two independent proportions (chi-square) using a two-tailed \u00ce\u00b1 of 0.05 and a (1 \u00e2\u0088\u0092 \u00ce\u00b2) of 0.90 yield an estimate of 769 patients per arm (total: 1538) [42]. The ABC PICU Trial Steering Committee, the CCCTG (www.ccctg.ca), and the PALISI Network (www.palisi.org) support these estimates and the choice of a 33% relative risk difference because it is considered clinically important and sufficiently significant to change practice. The proportion of patients lost to follow-up is expected at 1.7% based on results of the TRIPICU study. The sample size for the ABC PICU trial is, therefore, 769 patients per arm (total: 1538) [42].Table 4Estimates for the absolute risk reduction expected in the ABC PICU trialAnalytic cohort study: Gauvin et al. [1]Descriptive cohort study: Karam et al. [2]Storage time cutoff for \u00e2\u0080\u009cfresh\u00e2\u0080\u009d RBC unit7\u00c2\u00a0days7\u00c2\u00a0daysPICU expected length of stay>\u00e2\u0080\u008924\u00c2\u00a0h>\u00e2\u0080\u008948\u00c2\u00a0hHemodynamically unstable patientsNoYesNPMODS in transfused patients15%39.2%Odds ratio for development of NPMODS in older versus fresher (confidence interval)1.39 (0.42\u00e2\u0080\u00934.61)1.54 (0.80\u00e2\u0080\u00932.96)Estimated risk in experimental group 1/OR\u00e2\u0080\u0089=\u00e2\u0080\u0089(p1/(1 \u00e2\u0088\u0092 p1))/(p0/(1 \u00e2\u0088\u0092 p0))11%22%MODS multiple organ dysfunction syndrome, NPMODS new or progressive multiple organ dysfunction syndrome, OR odds ratio, PICU pediatric intensive care unit, RBC red blood cell, RCT randomized controlled trial", "id": 3, "split": "train"} +{"trial_id": "NCT02027896", "pmid": "31551393", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial\n\nIncluded conditions:\n- Hip Fractures\n\nStudy Armgroups:\n- {'label': 'Accelerated medical clearance and surgery', 'type': 'EXPERIMENTAL', 'description': 'Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.', 'interventionNames': ['Other: Accelerated medical clearance and surgery']}\n- {'label': 'Standard surgical care', 'type': 'NO_INTERVENTION', 'description': 'Surgical hip fracture repair according to the standard timing.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Accelerated medical clearance and surgery', 'description': 'Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.', 'armGroupLabels': ['Accelerated medical clearance and surgery']}\n\nPrimary Outcomes:\n- {'measure': 'Composite - major perioperative complication', 'description': 'Composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding', 'timeFrame': '90 days'}\n- {'measure': 'Mortality', 'description': 'All-cause mortality', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (two-sided \u03b1) of 0.05, over 80% power, and accounting for 4% missing AKI status.", "answer": 3001, "answer_type": "ACTUAL", "explanation": "Sample size\n The main HIP ATTACK trial enrolled 3001 patients, and more than 90% of these patients were enrolled after the initiation of the renal substudy protocol. We expect that approximately 74% of these patients will be eligible for inclusion in the kidney substudy. A sample of 1998 patients will provide over 80% power to detect a relative risk (RR) reduction of 30% for the primary outcome of AKI (two-sided \u00ce\u00b1=0.05), comparing the accelerated approach to usual care, assuming the incidence of AKI is 14% in the usual-care group, after accounting for 4% missing AKI status. Approximately 10%\u00e2\u0080\u009312% of patients develop postoperative AKI.17 18 In hip fracture patients, AKI incidence is even higher, around 15%\u00e2\u0080\u009320%.10\u00e2\u0080\u009312 With these data in mind, we used a conservative 14% AKI incidence for the usual care group to perform the sample size calculation to ensure we would have adequate statistical power to detect a 30% RR reduction in the primary outcome, if it in truth exists.", "id": 4, "split": "train"} +{"trial_id": "NCT02033278", "pmid": "31438858", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multicenter Phase IIb Clinical Trial, Double-blind, Randomized, Controlled Placebo for to Assess the Efficacy of Intracoronary Infusion of Autologous Adult Stem Cells Mononuclear Marrow Unexpanded on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.\n\nIncluded conditions:\n- Idiopathic Dilated Cardiomyopathy\n\nStudy Armgroups:\n- {'label': 'Infusion of autologous mononuclear bone marrow cells', 'type': 'EXPERIMENTAL', 'description': 'Infusion of autologous mononuclear bone marrow cells plus conventional medical treatment (as indicated by clinician)', 'interventionNames': ['Drug: Infusion of autologous mononuclear bone marrow cells']}\n- {'label': 'Placebo infusion', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo infusion plus conventional medical treatment (as indicated by clinician)', 'interventionNames': ['Drug: Placebo infusion']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Infusion of autologous mononuclear bone marrow cells', 'description': 'Infusion of autologous mononuclear bone marrow cells plus conventional medical treatment (as indicated by clinician)', 'armGroupLabels': ['Infusion of autologous mononuclear bone marrow cells']}\n- {'type': 'DRUG', 'name': 'Placebo infusion', 'description': 'Placebo infusion plus conventional medical treatment (as indicated by clinician)', 'armGroupLabels': ['Placebo infusion']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in ventricular function measured angiographically.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, beta risk of 0.2 (power of 80%), common standard deviation of 10, correlation coefficient of 0.5, and a loss to follow-up rate of 10%.", "answer": 27, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n A sample size calculation was performed based on the clinical trial study already completed by our group [32]. In this study, a mean increase in ejection fraction of 9.4\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00899.9% was observed. At the end of the follow-up, mean values of LVEF were 38% among responders, and 27% among non-responders. The sample size calculation was done using GRANMO (v7.12) for paired or repeated measures in two groups. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided contrast, 17 subjects are required in the first group and 34 in the second one to detect a difference equal to or greater than 9\u00e2\u0080\u0089units. It is assumed a common standard deviation of 10 and a correlation coefficient between the initial and final measurement of 0.5. A loss to follow-up rate of 10% has been estimated. However, an interim analysis has been planned in order to re-calculate trial sample size based on the mean increase in ejection fraction observed in the first 20 patients that complete a 6\u00e2\u0080\u0089months\u00e2\u0080\u0099 follow-up period.", "id": 5, "split": "train"} +{"trial_id": "NCT02040272", "pmid": "32873681", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mesothelioma and Radical Surgery 2: a Multicentre Randomised Trial Comparing (Extended) Pleurectomy Decortication Versus no (Extended) Pleurectomy Decortication for Patients With Malignant Pleural Mesothelioma (Mars 2).\n\nIncluded conditions:\n- Mesothelioma\n\nStudy Armgroups:\n- {'label': 'Surgery', 'type': 'EXPERIMENTAL', 'description': '(Extended) pleurectomy decortication', 'interventionNames': ['Procedure: (Extended) pleurectomy decortication']}\n- {'label': 'no surgery', 'type': 'NO_INTERVENTION', 'description': 'no surgery'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': '(Extended) pleurectomy decortication', 'armGroupLabels': ['Surgery']}\n\nPrimary Outcomes:\n- {'measure': 'Survival', 'description': 'The time from randomisation to death will be measured and date of death will be collected on purposely designed case report forms.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed to have 80% power to detect the specified HR at a 5% significance level (two-sided). It also accounts for a 10% cross-over rate from the medical to surgery groups.", "answer": 328, "answer_type": "ESTIMATED", "explanation": "Sample size\n The total sample size has been set at 328 participants (164 per group). The patients randomised in the pilot trial will contribute to the total sample size. The study will have 80% power to detect a HR of 0.7 at 5% statistical significance (two-sided), modelled on a published assumption of a median survival time of 16.8 months in patients with mesothelioma who were fit enough to receive surgery, but did not have it17 and allowing for 10% cross-over from the medical to surgery groups (as noted in previous trials such as MARS).7 Cross-over will be minimised through instruction (ie, recruit only patients who have equipoise from the outset) and education.\n The relative difference of 30% (HR 0.7) was regarded as the minimally important difference for patients and clinicians to choose surgery given the risks of the procedure. The figure was chosen by the trial\u00e2\u0080\u0099s patient and public involvement (PPI) group. The possibility that survival could be worse with surgery was also discussed, and a relative difference of 30% was also regarded as an appropriate difference to indicate harm, therefore a two-tailed test for superiority was agreed.", "id": 6, "split": "train"} +{"trial_id": "NCT02064062", "pmid": "29764889", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Autologous Stem Cells in Achilles Tendinopathy\n\nIncluded conditions:\n- Achilles Tendinitis, Right Leg\n- Achilles Tendinitis\n- Achilles Degeneration\n- Achilles Tendon Thickening\n- Tendinopathy\n- Achilles Tendinitis, Left Leg\n\nStudy Armgroups:\n- {'label': 'Autologous Mesenchymal Stem Cells', 'type': 'EXPERIMENTAL', 'interventionNames': ['Biological: Autologous Mesenchymal Stem Cells']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Autologous Mesenchymal Stem Cells', 'armGroupLabels': ['Autologous Mesenchymal Stem Cells'], 'otherNames': ['Mesenchymal Stem Cells', 'Stromal Cells', 'Stem Cells', 'Cell Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'The primary safety outcome will be the incidence rate of Serious Adverse Reaction (SAR).', 'description': 'The primary safety outcome is the incidence rate of SARs. This will be expressed as the proportion of participants experiencing a SAR at any time over the 24 week follow-up period. Primary outcomes will be assessed by adverse events reporting, clinical assessment and ultrasound.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \n95%, 80%, and 50% confidence levels were used to rule out true SAR rates. No formal power calculation was performed as this is a proof-of-concept pilot study.", "answer": 10, "answer_type": "ESTIMATED", "explanation": "Power and sample size\n Sample size was determined to ensure a predetermined level of accuracy for the incidence of SAR\u00c2\u00a0using an exact binomial CI. With 10 participants, if no SAR is observed we can rule out a true SAR rate of 31% or greater with 95% confidence, or a true SAR rate of 21% or greater with 80% confidence, or a true SAR rate of 13% or greater with 50% confidence. With six participants for the interim analysis, if no SAR is observed we can rule out a true SAR rate of 46% or greater with 95% confidence, or a true SAR rate of 32% or greater with 80% confidence, or a true SAR rate of 21% or greater with 50% confidence. Since the study is a proof-of-concept pilot study, no formal power calculation was performed.", "id": 7, "split": "train"} +{"trial_id": "NCT02232360", "pmid": "32321551", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Comparative Analysis of the Effects on Plaque Volume and Tissue Characteristics Between Combined Therapy With STAatin Plus FENOfibrate and Statin Alone in Mild to Moderate, Non- Intervened Coronary Artery Stenosis (STAFENO Trial)\n\nIncluded conditions:\n- Coronary Artery Disease\n\nStudy Armgroups:\n- {'label': 'Rosuvastatin and fenofibrate', 'type': 'EXPERIMENTAL', 'description': 'Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day', 'interventionNames': ['Drug: Rosuvastatin and fenofibrate']}\n- {'label': 'Rosuvastatin alone', 'type': 'ACTIVE_COMPARATOR', 'description': 'Rosuvastatin 10 mg per day', 'interventionNames': ['Drug: Rosuvastatin alone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rosuvastatin and fenofibrate', 'description': 'Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day', 'armGroupLabels': ['Rosuvastatin and fenofibrate'], 'otherNames': ['Combination therapy with rosuvastatin and fenofibrate']}\n- {'type': 'DRUG', 'name': 'Rosuvastatin alone', 'description': 'Rosuvastatin 10mg per day', 'armGroupLabels': ['Rosuvastatin alone'], 'otherNames': ['Rosuvastatin alone therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions', 'description': 'Percent and Absolute changes of Necrotic Core volume in non-culprit intermediate lesions by VH-IVUS', 'timeFrame': 'After 12\u00b12 months treatment'}\n\nPlease estimate the sample size based on the assumption: \n80% power, standard deviation of 7.82, two-sided alpha level of 0.05, dropout rate of 20%.", "answer": 106, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Based on a previous study [15], a sample size of approximately 42 patients per treatment group was calculated to provide 80% power (assuming a standard deviation of 7.82) to detect a difference of 4.78 in percentage NCV and to detect the superiority of statin plus fenofibrate compared to statin alone with a two-sided alpha level of 0.05. With a statin plus fenofibrate:satin alone sampling ratio of 1:1 and a dropout rate of 20%, a final sample size of 53 patients per treatment group (total 106 patients) was specified in order to provide an adequate number of evaluable patients. To the best of the researchers\u00e2\u0080\u0099 knowledge, no study has been conducted on the change of tissue characteristics after fenofibrate treatment. We hypothesized that fenofibrate has an effect on percentage NCV as much as that of 10\u00e2\u0080\u0089mg atorvastatin [15]. In addition, a previous study [16] consisting of 100 patients with non-significant lesions demonstrated a significant decrease in NCV in the rosuvastatin (10\u00e2\u0080\u0089mg/day) treated group but not in the simvastatin treated group (20\u00e2\u0080\u0089mg/day).", "id": 8, "split": "train"} +{"trial_id": "NCT02249572", "pmid": "33737417", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vestibular Schwannoma - Radiosurgery or Expectation\n\nIncluded conditions:\n- Vestibular Schwannoma\n\nStudy Armgroups:\n- {'label': 'gamma knife radiosurgery', 'type': 'EXPERIMENTAL', 'description': 'Single fraction gamma knife radiosurgery given at 12 Gy to tumor periphery for vestibular schwannoma', 'interventionNames': ['Radiation: gamma knife radiosurgery']}\n- {'label': 'Expectation', 'type': 'NO_INTERVENTION', 'description': 'No active treatment given for vestibular schwannoma'}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'gamma knife radiosurgery', 'description': 'Leksell Perfection model gamma knife.', 'armGroupLabels': ['gamma knife radiosurgery']}\n\nPrimary Outcomes:\n- {'measure': 'Relative Tumor volume', 'description': 'Growth measured as volume ratio V4years/Vbaseline and 1/volume doubling time', 'timeFrame': '4 years'}\n\nPlease estimate the sample size based on the assumption: \nScenario 1: Significance level 0.05, power 90%; Scenario 2: Significance level 0.05, power 90%, SD 35; Scenario 3: Significance level 0.10, power 95%, SD 35; Tumor growth endpoint: Power 80%", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size\n We performed two power analyses based on data from our own VS database.\n \n Based on hearing outcomes\n In the first power analysis, we examined the number of patients needed to demonstrate if the two groups would be similar or different in hearing outcome (figures 1\u00e2\u0080\u00933).\n \n Figure 1\n \n Hearing acuity as suggested endpoint.\n \n \n \n \n Figure 2\n \n Hearing acuity as suggested endpoint.\n \n \n \n \n Figure 3\n \n Hearing acuity as suggested endpoint.\n \n \n \n Test for difference:\n \n \n \n \n Power(1\u00e2\u0080\u0094type 2 error):\n 0.8 or 0.9\n The probability of reject H0 when H0 is false\n \n \n \n \n Type 1 error:\n 0.05\n The probability of reject H0 when H0 is true\n \n \n \n \n One usually wants a power of 80% or more and a low type 1 error.\n \n \n Scenario 1\u00e2\u0080\u0094difference in proportions (Gardner-Robertson)\n We want to determine the sample size for a 5-year VS trial with Gamma Knife therapy and a control group with no treatment. The primary outcome is hearing loss, defined as useful to no useful hearing (binary outcome). We desire a 0.05-significance level test with 90% statistical power. The proportion of no useful hearing at a 5-year follow-up in a similar population is 54%. We plan to have an equal allocation to the two treatment groups.\n \n \n Scenario 2\u00e2\u0080\u0094difference in means (% of perfect hearing)\n We want to determine the sample size for a 5-year VS trial with Gamma Knife therapy and a control group with no treatment. The primary outcome is hearing loss, defined as the percentage of perfect hearing (100% excellent hearing and 0% deaf). We desire a 0.05 significance level test with 90% statistical power. The SD observed from a similar population is 35. We plan to have an equal allocation to the two treatment groups.\n Test for equivalence:\n \n \n \n \n Power(1\u00e2\u0080\u0094type 2 error):\n 0.90 or 0.95\n The probability of reject H0 when H0 is false\n \n \n \n \n Type 1 error:\n 0.10\n The probability of reject H0 when H0 is true\n \n \n \n \n One usually wants a higher power (90% or more) and a higher type 1 error.\n \n \n Scenario 3\u00e2\u0080\u0094equivalence in means (% of perfect hearing)\n We want to determine the sample size for a 5-year VS equivalence trial with Gamma Knife therapy and a control group with no treatment. The primary outcome is hearing loss, defined as the percentage of perfect hearing (100% excellent hearing and 0% deaf). We desire a 0.10-significance level test with 95% statistical power and decide that the zone of equivalence is (\u00e2\u0088\u009215%, 15%) and that the true difference in means does not exceed 0%. The SD observed from a similar population is 35. We plan to have an equal allocation to the two treatment groups (figures 1\u00e2\u0080\u00933).\n \n \n Tumour growth as the endpoint\n The second endpoint concerning changes in tumour size (figure 4). The analysis indicates that a sample of about 100 patients divided into two groups would be sufficient to demonstrate a difference in tumour size within 2\u00e2\u0080\u0089years at a power of 80.\n \n Figure 4\n \n Tumour size as the suggested endpoint.\n \n \n \n Based on the power analysis, the study seemed to be feasible only to demonstrate the effect of GKRS on tumour volume, as the number of patients needed to demonstrate difference or similarity in hearing outcomes was unrealistically high.", "id": 9, "split": "train"} +{"trial_id": "NCT02302664", "pmid": "30157940", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Pragmatic Multi-centre Blinded Randomised Placebo-controlled Trial Comparing Platelet Rich Plasma Injection (PRP) to Placebo (Imitation) Injection in Adults With Achilles Tendon Rupture\n\nIncluded conditions:\n- Achilles Tendon Rupture\n\nStudy Armgroups:\n- {'label': 'PRP Injection', 'type': 'ACTIVE_COMPARATOR', 'description': \"Intervention - PRP Injection: The injection is the intervention. A blood sample is withdrawn from patient. Away from patient part of sample is spun down in centrifuge to produce 'Platelet Rich Plasma' (PRP). Patient returns to treatment area and their own PRP is then injected into tendon rupture gap. This is carried out by a surgeon or extended scope physiotherapist, generally in the outpatient clinic, after a local anaesthetic has been applied. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Remaining blood sample sent for analysis.\", 'interventionNames': ['Procedure: PRP Injection into Achilles tendon rupture gap']}\n- {'label': 'Imitation Injection', 'type': 'SHAM_COMPARATOR', 'description': 'Sham - Imitation Injection: The injection is the intervention. A blood sample is withdrawn from patient. Treatment is prepared. Patient returns to treatment area and a needle (no syringe) is inserted and held into tendon rupture gap to mimic injection (after local anaesthetic has been applied). No active ingredient given. Carried out by surgeon or extended scope physiotherapist, generally in the outpatient clinic. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Blood sample sent for analysis.', 'interventionNames': ['Procedure: Imitation Injection into Achilles tendon rupture gap']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'PRP Injection into Achilles tendon rupture gap', 'description': \"PRP injection delivered into the tendon rupture gap Intervention - PRP Injection: The injection is the intervention. A blood sample is withdrawn from patient. Away from patient part of sample is spun down in centrifuge to produce 'Platelet Rich Plasma' (PRP). Patient returns to treatment area and their own PRP is then injected into tendon rupture gap. This is carried out by a surgeon or extended scope physiotherapist, generally in the outpatient clinic, after a local anaesthetic has been applied. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Remaining blood sample sent for analysis.\", 'armGroupLabels': ['PRP Injection']}\n- {'type': 'PROCEDURE', 'name': 'Imitation Injection into Achilles tendon rupture gap', 'description': 'Imitation injection delivered into the tendon rupture gap Sham - Imitation Injection: The injection is the intervention. A blood sample is withdrawn from patient. Treatment is prepared. Patient returns to treatment area and a needle (no syringe) is inserted and held into tendon rupture gap to mimic injection (after local anaesthetic has been applied). No active ingredient given. Carried out by surgeon or extended scope physiotherapist, generally in the outpatient clinic. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Blood sample sent for analysis.', 'armGroupLabels': ['Imitation Injection']}\n\nPrimary Outcomes:\n- {'measure': 'Heel-Rise Endurance Test (HRET)', 'description': 'Muscle-tendon function, measured objectively with the limb symmetry index (LSI) in maximal work during the heel-rise endurance test (HRET) \\\\[ Time Frame: 24 weeks following study treatment \\\\] The HRET is a validated objective performant test of calf-muscle Achilles tendon capacity to work, which is measured in the unit joules (J). The HRET involves the participant standing on one leg and raising and lowering the heel repeatedly until fatigued. The work during the HRET for each lower limb is measured. The performance of each limb is then converted into a limb symmetry index, which is the primary outcome metric from the HRET.', 'timeFrame': '24 weeks following study treatment'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 5% (two-sided) significance level, and 20% loss to follow-up. Later adjusted to a minimum of 80% power with the same significance level and loss to follow-up.", "answer": 230, "answer_type": "ACTUAL", "explanation": "Sample size\n A total number of 214 patients (107 per arm) will provide 90% power to detect a standardised difference of 0.5 in the LSI measured at 24\u00c2\u00a0weeks post treatment, with 5% (two-sided) significance and allowing 20% losses to follow-up. This is based on data from the non-surgical arm of a previous study [4], where a clinically important difference of 10% with a standard deviation (SD) of 20 was observed. This sample size will also provide 90% power and 5% (two-sided) significance to detect a standardised effect size of 0.5 in the Achilles Tendon Rupture Score (ATRS; patient reported outcome) between the two intervention groups, based on a difference of 11 and an SD of 21.4.\n However, this sample calculation was inflated as a result of a pre-specified blinded check of the assumptions for the primary outcome variability, which took place approximately halfway through recruitment using the overall population data (total sample, rather than intervention groups separately), as recommended by the Data and Safety Monitoring Committee (DSMC). As of June 2017, approximately half of the patients had reached their primary end-point and recruitment was still ongoing. Using cleaned and validated data from 75 patients, the observed SD was 24. Based on this observed SD of 24 (being aware that this could go up or down with the addition of further patient data), the sample size was recalculated.\n Therefore, based on a minimum of 80% power, and allowing for 20% loss to follow-up, a sample size of 226 patients would be required to identify a clinically important difference of 10% with an SD of 24. The DSMC advised us during this process, and it was decided that the recruitment should overshoot to a minimum of 230 patients (to account for further minimal fluctuations on sample size assumptions) as a feasible target in the remaining timelines of the trial. This approach was supported by the Trial Steering Committee (TSC).", "id": 10, "split": "train"} +{"trial_id": "NCT02320630", "pmid": "33663487", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy, Safety and Cost-effectiveness of Hydroxychloroquine, Sulfasalazine, Methotrexate Triple Therapy in Preventing Relapse Among Patients With Rheumatoid Arthritis Achieving Clinical Remission or Low Disease Activity\n\nIncluded conditions:\n- Recurrence (Disease Attribute)\n\nStudy Armgroups:\n- {'label': 'A', 'type': 'EXPERIMENTAL', 'description': 'Maintenance treatment group', 'interventionNames': ['Drug: Entanercept', 'Drug: MTX']}\n- {'label': 'B', 'type': 'EXPERIMENTAL', 'description': 'Combination treatment group', 'interventionNames': ['Drug: Entanercept', 'Drug: HCQ', 'Drug: MTX']}\n- {'label': 'C', 'type': 'EXPERIMENTAL', 'description': 'Single drug group', 'interventionNames': ['Drug: Entanercept', 'Drug: MTX']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Entanercept', 'description': 'Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).', 'armGroupLabels': ['A', 'B', 'C'], 'otherNames': ['MTX']}\n- {'type': 'DRUG', 'name': 'HCQ', 'description': 'Combination of HCQ+SSZ+MTX were given to patients for 60weeks (Week0-Week60).Entanercept was given to patients for 12 weeks (Week0-Week12).', 'armGroupLabels': ['B'], 'otherNames': ['SSZ', 'MTX', 'TFP']}\n- {'type': 'DRUG', 'name': 'MTX', 'description': 'MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).', 'armGroupLabels': ['A', 'B', 'C'], 'otherNames': ['Entanercept']}\n\nPrimary Outcomes:\n- {'measure': 'the rate of recurrence', 'timeFrame': '60 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.8 and a significance level of 0.05 (two-sided) were used. The dropout rate is estimated to be 20%.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n According to the study purposes, a superiority design was considered appropriate. Our hypothesis is that the relapse rate in group A (triple therapy group) will be lower than that in group C (MTX monotherapy group) in 60\u00c2\u00a0weeks after randomization.\n Sample size was calculated by PASS 11.0. It was reported that for patients with established RA achieving CR or LDA by TNFi combined with MTX, 24% to 85% suffered from disease relapse after discontinuation of TNFi [4\u00e2\u0080\u00937]. When combined csDMARDs preserved after TNFi removed, the rate of relapse was 51.2\u00e2\u0080\u009358% [4, 7]. We assume that adding HCQ\u00e2\u0080\u0089+\u00e2\u0080\u0089SSZ 3\u00c2\u00a0months before the removal of TNFi may somehow decrease the relapse. Accordingly, we expect the relapse rate as 50% in patients in triple therapy group, and 74% in MTX monotherapy group. With a power of 0.8 and a significance level of 0.05 (two-sides), using a 1:1:1 treatment allocation of enrollment, to detect the difference of relapse rate between the two groups, the required sample size is 61 for each group. Given the estimated dropout rate of 20%, we intend to recruit a total of 240 subjects (80 for each group).\n We assume that the relapse rate may be similar between group A and group B (TNFi maintenance therapy group), and the cost-effectiveness may be better in group A than in group B. The relapse rate and cost-effective comparison between group A and group B will be exploratory and there was no relevant research hypothesis, so the sample size was not calculated by it.", "id": 11, "split": "train"} +{"trial_id": "NCT02340026", "pmid": "30326883", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dynamic Supported Mobility for Infants and Toddlers With Cerebral Palsy\n\nIncluded conditions:\n- Cerebral Palsy\n\nStudy Armgroups:\n- {'label': 'Conventional Therapy', 'type': 'EXPERIMENTAL', 'description': 'The conventional treatment group will receive traditional, therapist-directed pediatric physical therapy. Therapy will focus on early gait training strategies and encouragement of \"normal\" movement patterns for walking and other age-appropriate movements, with manual guidance or correction of atypical movements from the therapist. This group may use assistive devices, orthoses, and may receive static body weight support for gait training. Therapy activities will be performed in blocks of practice, with the specific activities and level of therapist assistance tailored to each child.', 'interventionNames': ['Other: Conventional Therapy']}\n- {'label': 'Dynamic Supported Mobility', 'type': 'EXPERIMENTAL', 'description': \"Children will receive dynamic weight support during all DSM treatment time. The environment will be arranged to encourage active motor exploration, somewhat similar to a play gym for toddlers, to promote the motor variability, engagement, and error experiences that characterize the typical development of upright motor skills and walking. The floor area within 3 feet below either side of the overhead track for a distance of 20 feet (approximately 120 ft2 total) will be defined with colorful thin rubber interlocking mats and arranged with pediatric toys and activities, tailored to the child's interests and to encourage motor skills just beyond his/her current ability. The therapist will minimally assist the child as needed to perform the movements he/she initiates.\", 'interventionNames': ['Other: Dynamic Supported Mobility']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Dynamic Supported Mobility', 'description': \"Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance\", 'armGroupLabels': ['Dynamic Supported Mobility']}\n- {'type': 'OTHER', 'name': 'Conventional Therapy', 'description': 'No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing \"typical\" movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child', 'armGroupLabels': ['Conventional Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Gross Motor Function Measure (GMFM-66) During Treatment Phase', 'description': \"Computation of the GMFM-66 score involves statistical weighting of the raw item scores for difficulty. This score will also be used with the patient's age to determine Gross Motor Function Classification System (GMFCS) percentile rank. Scores range from 0 (no volitional movement) to 100 (gross motor function of an average 5 year old). Higher scores reflect better outcomes.\", 'timeFrame': 'Baseline and 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA uniform attrition rate of 20% is assumed, and a 2-sided 95% confidence interval for the estimated difference in GMFM-66 between the two interventions will extend +/- 6 units from the observed difference, assuming a conservative standard deviation of 9.", "answer": 42, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n Predicted change in the iMOVE group was estimated from data collected from four children (pilot study data) who would meet the proposed inclusion criteria. A mean GMFM-66 [47] increase of 5.3 was observed after 6\u00c2\u00a0weeks of treatment. We estimated that a change of 10.6 would be expected within 24\u00c2\u00a0weeks of treatment. Predicted change in the CONV group was determined from published GMFM-66 percentile scores for average change over six months\u00e2\u0080\u0099 time [48]. We are planning to recruit a total of 42 participants (21 per treatment group). We estimated a uniformed attrition rate of 20% by the end of the study, therefore, evaluable data from 34 participants (17 per group) will be available. With a sample size of 34, a 2-sided 95% confidence interval for the estimated difference in GMFM-66 between the two interventions will extend +/\u00e2\u0088\u0092\u00e2\u0080\u00896\u00c2\u00a0units from the observed difference assuming a conservative standard deviation of 9.", "id": 12, "split": "train"} +{"trial_id": "NCT02384876", "pmid": "33712076", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Determination of the Optimal Dose of Ephedrine in Intraoperative Arterial Hypotension of Newborns and Infants up to 6 Months of Age. A Randomized, Controlled, Open-label, Dose Escalation Study.\n\nIncluded conditions:\n- Intraoperative Arterial Hypotension\n- Infant, Newborn\n\nStudy Armgroups:\n- {'label': 'Ephedrine, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG', 'type': 'EXPERIMENTAL', 'description': 'Dose escalation: 6 successive cohorts with a maximal increasing dose', 'interventionNames': ['Drug: Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG']}\n- {'label': 'Ephedrine, dose : 0.1 mg/kG, reference dose', 'type': 'ACTIVE_COMPARATOR', 'description': 'Reference dose', 'interventionNames': ['Drug: Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.1 mg/kG.']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG', 'armGroupLabels': ['Ephedrine, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG']}\n- {'type': 'DRUG', 'name': 'Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.1 mg/kG.', 'armGroupLabels': ['Ephedrine, dose : 0.1 mg/kG, reference dose']}\n\nPrimary Outcomes:\n- {'measure': 'Therapeutic success is defined as a mBP superior to 55% of the basal mBP (prior to anesthesia) within 10 minutes post Ephedrine administration', 'timeFrame': 'Continuous monitoring within 10 minutes post-administration'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size was calculated to achieve a 95% confidence interval width between 0.18 and 0.29 for the probabilities of efficacy of each dose.", "answer": 120, "answer_type": "ACTUAL", "explanation": "Sample size\n A total of 120 patients will be randomized, in 6 different cohorts with a maximal increasing dose.\n The distribution of subjects as proposed in Table 1 for each dose and cohort should allow to maximizing the precision of the estimation of the differences of efficacy of each dose, taking into account the cohort effect, which could be significant in this study. This proposal is conform to the description of Bailey [10].\n The sample size was calculated in terms of 95% confidence interval width of the probabilities of efficacy of each dose. The number of 120 subjects should allow width between 0.18 and 0.29, depending on the dose. These calculations are based on simulations performed using the R software; the hypotheses regarding the efficacy depending on the dose were based on results of the retrospective cohort on 141 subjects, considering a standard deviation of the cohort effect of 0.3 on a logarithmic scale of the odds of success.", "id": 13, "split": "train"} +{"trial_id": "NCT02417662", "pmid": "29666135", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer. a Randomised Phase III Trial\n\nIncluded conditions:\n- Non-small Cell Lung Cancer\n\nStudy Armgroups:\n- {'label': 'Systemic Anti-Cancer Therapy (SACT) alone', 'type': 'ACTIVE_COMPARATOR', 'description': 'The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines.', 'interventionNames': ['Other: Non-investigational SACT']}\n- {'label': 'SACT + Radical Radiotherapy (Conventional RT and SABR)', 'type': 'EXPERIMENTAL', 'description': 'SACT followed by radical RT (conventional or SABR) to the primary and SABR to the metastatic sites.\\n\\nThe choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines.', 'interventionNames': ['Radiation: Radical Radiotherapy (Conventional RT and SABR)']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Radical Radiotherapy (Conventional RT and SABR)', 'description': 'Radical radiotherapy (conventional or SABR) to primary and SABR to the metastases', 'armGroupLabels': ['SACT + Radical Radiotherapy (Conventional RT and SABR)']}\n- {'type': 'OTHER', 'name': 'Non-investigational SACT', 'description': 'There is no intervention in the control group, patients will receive SACT. The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines.', 'armGroupLabels': ['Systemic Anti-Cancer Therapy (SACT) alone']}\n\nPrimary Outcomes:\n- {'measure': 'Overall Survival', 'description': 'The trial will investigate the impact of the addition of radical conventional and stereotactic radiotherapy to standard systemic therapy on overall survival', 'timeFrame': 'From date of randomisation to the date of death, up to 36 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided 5% alpha, 85% power, 10% dropout rate", "answer": 340, "answer_type": "ESTIMATED", "explanation": "Sample size and study duration\n In total, 340 patients are required (170 per arm) to detect an improvement in median survival from 9.9 to 14.3 months, that is, a HR of at least 0.69, with a two-sided 5% alpha and 85% power and a 10% dropout rate.\n Prior to study initiation, a survey was sent to all UK radiotherapy centres on their SABR/SRS practices. At least 26 centres replied with an average of 4.6 suitable study patients in the previous 6 months. Assuming only half of this amount would satisfy the eligibility criteria, this would equate to around 120 patients. We thus expect that the trial will take around 3 years to accrue. We hope to include more than 30 centres in our study in improve on trial participation. Nevertheless, an early feasibility study will be conducted after the first 50 patients. The study opened August 2016.", "id": 14, "split": "train"} +{"trial_id": "NCT02419482", "pmid": "32086359", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.\n\nIncluded conditions:\n- Polycystic Ovary Syndrome\n\nStudy Armgroups:\n- {'label': '4x4 minutes interval training', 'type': 'EXPERIMENTAL', 'description': '4x4 minutes high intensity interval training with 4 minute intervals', 'interventionNames': ['Behavioral: 4x4 minutes high intensity interval training']}\n- {'label': '10x1 minute interval training', 'type': 'EXPERIMENTAL', 'description': '10x1 minute high intensity interval training with 1 minute intervals', 'interventionNames': ['Behavioral: 10x1 minute high intensity interval training']}\n- {'label': 'control', 'type': 'NO_INTERVENTION', 'description': 'Physical activity recommended'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': '4x4 minutes high intensity interval training', 'description': 'Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.', 'armGroupLabels': ['4x4 minutes interval training'], 'otherNames': ['High-intensity exercise', 'Aerobic exercise']}\n- {'type': 'BEHAVIORAL', 'name': '10x1 minute high intensity interval training', 'description': 'Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.', 'armGroupLabels': ['10x1 minute interval training'], 'otherNames': ['High-intensity exercise', 'Aerobic exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Menstrual frequency', 'description': 'Electronic menstrual diary', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power is set at 80%, significance level at 0.05, and standard deviation at 2 menstrual bleedings per year. A non-parametric test may be necessary due to non-normality, requiring a 15% increase in sample size. Additionally, a dropout rate of 10%-15% is expected.", "answer": 64, "answer_type": "ACTUAL", "explanation": "Sample size and statistical analysis\n We computed the sample size for a one-way analysis of variance test with three groups. In women with PCOS, a menstrual frequency of on average 4.5 menstrual bleeding during 1\u00e2\u0080\u0089year is expected.51 With a statistical power of 80%, a significance level of 0.05 and a SD of two menstrual bleeding during a 12-month period, we calculated that 48 women will be required to detect an increase in menstrual bleeding to 7.5 in the intervention groups.26 Because of the non-normality of menstrual frequency, it may be necessary to use a non-parametric test. Non-parametric tests require more participants and we, therefore, added 15% to the required sample size. Additionally, to allow for expected dropouts of 10%\u00e2\u0080\u009315%, we aim to include 64 women in the study.\n We will perform all the statistical analyses blinded for group allocation. The primary analysis will be a comparison between groups for the number of menstrual bleeding during 12 months. We will adjust for the self-reported menstrual frequency at baseline. We will include all women who have reported menstrual frequency in the primary analysis, independent of adherence to the interventions, that is, intention-to-treat analysis. The number of pregnancies during the 16 weeks of intervention and during the 12-month follow-up will be compared between groups. Secondary outcome measures will be compared between groups after 16 weeks and after 12 months and adjusted for baseline values. We will do additional \u00e2\u0080\u0098per protocol\u00e2\u0080\u0099 analyses where we include women in the HIT groups that have completed >75% of the scheduled exercise sessions during the intervention period (for comparisons after 16 weeks) and a mean minimum of one HIT session/week during the 12-month follow-up (for comparisons at the end of follow-up).\n Results will be reported as means with 95% CIs and/or SD. We will report the effect of HIT as mean changes from baseline to 16 weeks of intervention and after 12 months of follow-up. We will use mixed models to test differences between groups. P values <0.05\u00e2\u0080\u0089will be considered significant for both primary and secondary outcomes. We will also perform subgroup analyses to investigate differences between BMI categories and compare adherence rates and enjoyment of the two HIT protocols.", "id": 15, "split": "train"} +{"trial_id": "NCT02448602", "pmid": "34918637", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect\n\nIncluded conditions:\n- Primary Insomnia\n\nStudy Armgroups:\n- {'label': 'Single point group (Shenmen)', 'type': 'OTHER', 'description': 'Patients will be acupuncture with Shenmen(HT7).', 'interventionNames': ['Other: acupuncture']}\n- {'label': 'Sancai coordinated points group', 'type': 'OTHER', 'description': 'Patients in Sancai coordinated points group, will be acupuncture with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6).', 'interventionNames': ['Other: acupuncture']}\n- {'label': 'Control group', 'type': 'OTHER', 'description': 'Patients in Control group, will be acupuncture with at the junction of deltoid and biceps.', 'interventionNames': ['Other: acupuncture']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'acupuncture', 'description': 'Patients will be treated with Shenmen(HT7), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.', 'armGroupLabels': ['Single point group (Shenmen)']}\n- {'type': 'OTHER', 'name': 'acupuncture', 'description': 'Patients in Sancai coordinated points group, will be treated with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.', 'armGroupLabels': ['Sancai coordinated points group']}\n- {'type': 'OTHER', 'name': 'acupuncture', 'description': 'Patients in Control group, will be treated with at the junction of deltoid and biceps, needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Pittsburgh sleep quality index(PSQI)', 'timeFrame': '9 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power = 90%, Dropout rate = 20%", "answer": 333, "answer_type": "ESTIMATED", "explanation": "2.8\n Sample size\n A power analysis is calculated before conducting this trial, which \u00ce\u00b1\u00e2\u0080\u008a=\u00e2\u0080\u008a0.05 and power\u00e2\u0080\u008a=\u00e2\u0080\u008a90%. According to the previous pilot study, percentages of responders for the primary endpoint are verum 87.5%, sham 25%. Therefore, the sample size in this trial can be estimated initially according to the following formula. Each group needs at least 111 patients (assuming a 20% dropout rate), 333 patients in 3 groups totally will be enrolled in the study.\n \nn=2(u\u00ce\u00b1'+u\u00ce\u00b2)2p(1\u00e2\u0088\u0092p)(p1\u00e2\u0088\u0092p2)2", "id": 16, "split": "train"} +{"trial_id": "NCT02449200", "pmid": "31153362", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Controlled Trial of Multimodal Physiotherapy for Patients With Acute / Sub-acute Cervical Radiculopathy\n\nIncluded conditions:\n- Cervical Radiculopathy\n\nStudy Armgroups:\n- {'label': 'Multimodal physiotherapy group', 'type': 'EXPERIMENTAL', 'description': '4 week multimodal physiotherapy treatment programme provided by an experienced musculoskeletal physiotherapist', 'interventionNames': ['Other: Multimodal physiotherapy']}\n- {'label': 'Advice to stay active group', 'type': 'NO_INTERVENTION', 'description': 'Advice to stay active and continue use of prescribed medication as appropriate, via weekly phone calls from a physiotherapist over a 4 week period.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Multimodal physiotherapy', 'description': 'Manual therapy, exercise and neural unloading tape provided twice weekly over 4 weeks by an experienced musculoskeletal physiotherapist', 'armGroupLabels': ['Multimodal physiotherapy group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in neck and arm pain (Numerical Pain Rating Scale)', 'description': 'Neck and arm pain levels measured with the Numerical Pain Rating Scale for current, best and worst pain levels over last 24 hours (Jensen et al 1994)', 'timeFrame': '4 weeks'}\n- {'measure': 'Change from baseline in Neck Disability Index', 'description': 'Disability resulting from the cervical radiculopathy measured with the Neck Disability Index (Vernon and Mior 1991)', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided 5% significance level, 80% power, and an additional 10% to account for anticipated dropout.", "answer": 64, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n The NDI and the NPRS are the independent primary outcome measures and sample size estimates were carried out for both outcome measures. An MCID for the NDI of 7 has been determined for cervical radiculopathy [48]. Using a reported NDI SD of 9.2 [48] for this patient group, with a two-sided 5% significance level and a power of 80%, a sample size of 29 participants per group is necessary. An MCID for the NPRS of 2 has been determined for mechanical neck pain, including cervical radiculopathy [43] and a SD of 1.85 [48]. Using these figures, with a two-sided 5% significance level and a power of 80%, a sample size of 15 per group was calculated. An online sample size calculator [49] for comparing means of 2 independent groups, that utilises reference tables [50] was used. The larger sample size per group calculated using the NDI was chosen and an additional 10% was added to account for anticipated dropout. In total, a sample size of 64 participants will be recruited.", "id": 17, "split": "train"} +{"trial_id": "NCT02459457", "pmid": "30344165", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Comparison of Paclitaxel in Combination With Cisplatin(TP), Carboplatin(TC) or Fluorouracil(TF) Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Squamous Cell Carcinoma: A Three-Arm Randomized Phase III Trial\n\nIncluded conditions:\n- Stage III Esophageal Squamous Cell Carcinoma\n\nStudy Armgroups:\n- {'label': 'Paclitaxel and Cisplatin (TP)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive TP concurrent with radiotherapy (1.8Gy/d, d1-5/week, 34Fx) Paclitaxel: 175mg/m2/d, ivgtt over 3 hours, d1; Cisplatin: 25mg/m2/d, ivgtt, d1-3, q4w\\\\*4', 'interventionNames': ['Drug: Paclitaxel and Cisplatin', 'Radiation: Radiotherapy']}\n- {'label': 'Paclitaxel and Fluorouracil (TF)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive TF concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; 5-FU 300mg/m2, civ 96h, d1-4, qw\\\\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; 5-FU 1800mg/m2, civ 72h, d1-3, q4w\\\\*2', 'interventionNames': ['Drug: Paclitaxel and Fluorouracil', 'Radiation: Radiotherapy']}\n- {'label': 'Paclitaxel and Carboplatin\uff08TC\uff09', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive TC concurrent with radiotherapy(1.8Gy/d, d1-5/week, 34Fx) Concurrent: paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=2, ivgtt, d1, qw\\\\*6; Adjuvant: paclitaxel 175 mg/m2/d, ivgtt over 3 hours, d1; carboplatin AUC=5, ivgtt, d1, q4w\\\\*2', 'interventionNames': ['Drug: Paclitaxel and Carboplatin', 'Radiation: Radiotherapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Paclitaxel and Cisplatin', 'description': 'patients get Paclitaxel and Cisplatin according to protocol', 'armGroupLabels': ['Paclitaxel and Cisplatin (TP)'], 'otherNames': ['TP']}\n- {'type': 'DRUG', 'name': 'Paclitaxel and Fluorouracil', 'description': 'patients get Paclitaxel and Fluorouracil according to protocol', 'armGroupLabels': ['Paclitaxel and Fluorouracil (TF)'], 'otherNames': ['TF']}\n- {'type': 'DRUG', 'name': 'Paclitaxel and Carboplatin', 'description': 'patients get Paclitaxel and Carboplatin according to protocol', 'armGroupLabels': ['Paclitaxel and Carboplatin\uff08TC\uff09'], 'otherNames': ['TC']}\n- {'type': 'RADIATION', 'name': 'Radiotherapy', 'description': '1.8Gy/d, d1-5/week, 34Fx', 'armGroupLabels': ['Paclitaxel and Carboplatin\uff08TC\uff09', 'Paclitaxel and Cisplatin (TP)', 'Paclitaxel and Fluorouracil (TF)']}\n\nPrimary Outcomes:\n- {'measure': 'overall survival', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-sided significance level (\u03b1) of 0.025, accrual period of 48 months, minimum follow-up period of 24 months, and dropout rate of 10%.", "answer": 321, "answer_type": "ACTUAL", "explanation": "Sample size calculation and statistical analysis\n This three-arm randomised trial is designed to confirm whether TF is superior to TP or TC concurrent with radiotherapy in terms of overall survival. According to RTOG 0113 and other reports, median survival time of TF concurrent with radiotherapy for oesophageal cancer is 28.7 months, while TP 14.9 months5and TC 17.4\u00e2\u0080\u0089months13. According to the Schoenfeld and Richter\u00e2\u0080\u0099s method, the sample size of 107 patients per arm (154 events in total) is required to warrant a power of 80% at a two-sided \u00ce\u00b1 level of 0.025 for the comparison between TP and TF with relatively smaller difference, assuming an accrual period of 48 months, a minimum follow-up period of 24 months and a dropout rate of 10%.14 15 The total sample size is planned as 321 patients (107 patients in each arm, a total of 231 events).\n The median overall survival will be estimated with Kaplan-Meier method, and log-rank test will be used to compare the overall survival among treatment arms. We will conduct a subgroup analyses to test whether the treatment effects differ among subgroups (N0, N1, M1a).", "id": 18, "split": "train"} +{"trial_id": "NCT02460588", "pmid": "30971235", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized Trial\n\nIncluded conditions:\n- Idiopathic Pulmonary Fibrosis\n\nStudy Armgroups:\n- {'label': 'Corticosteroid with placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.\\n\\nAll patients will receive non experimental medication with high dose of corticosteroid.', 'interventionNames': ['Drug: Placebo', 'Drug: Corticosteroid (prednisolone)']}\n- {'label': 'Corticosteroid associated with Cyclophosphamide', 'type': 'EXPERIMENTAL', 'description': 'Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.\\n\\nAll patients will receive non experimental medication with high dose of corticosteroid.\\n\\nIntravenous Cyclophosphamide (CYC), 600 mg/m\u00b2 (adapted to age and renal function, maximal dose of 1.2 g) at Day 0, Day 15, M1, M2', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Corticosteroid (prednisolone)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.\\n\\nIntravenous Cyclophosphamide (CYC), 600 mg/m\u00b2 (adapted to age and renal function, maximal dose of 1.2 g) at Day 0, Day 15, M1, M2', 'armGroupLabels': ['Corticosteroid associated with Cyclophosphamide']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.', 'armGroupLabels': ['Corticosteroid with placebo'], 'otherNames': ['Control group']}\n- {'type': 'DRUG', 'name': 'Corticosteroid (prednisolone)', 'description': 'All patients will receive non experimental medication with high dose of corticosteroid.', 'armGroupLabels': ['Corticosteroid associated with Cyclophosphamide', 'Corticosteroid with placebo'], 'otherNames': ['Both groups']}\n\nPrimary Outcomes:\n- {'measure': '\"Early\" survival', 'description': 'All cause of mortality at 3 months', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha = 5%, power = 80%, two-sided tests, and a dropout rate within the limit of 10% of the initial number of patients needed.", "answer": 120, "answer_type": "ACTUAL", "explanation": "Sample size\n Reviewing all the series reported between 1993 and 2006 revealed a 3-month mortality rate of 67.1% (95% confidence interval [CI]: 56.2\u00e2\u0080\u009376.5) [5].\n We thus hypothesize that the 3-month mortality rate with methylprednisolone pulse dosing will be 67%, decreasing to 42% after adding CYC. Given that alpha\u00e2\u0080\u0089=\u00e2\u0080\u00895%, power\u00e2\u0080\u0089=\u00e2\u0080\u008980%, and two-sided tests will be applied, 60 subjects per group are needed. In case of dropouts, additional patients will be included within the limit of 10% of the initial number of patients needed.\n Therefore, 120 patients should be recruited in a period of 24\u00e2\u0080\u0089months and that correspond to 13% of the expected new patients.", "id": 19, "split": "train"} +{"trial_id": "NCT02490904", "pmid": "30376884", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.\n\nIncluded conditions:\n- End-stage Renal Disease\n\nStudy Armgroups:\n- {'label': 'Eplerenone group', 'type': 'EXPERIMENTAL', 'description': 'Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation.', 'interventionNames': ['Drug: Eplerenone']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Eplerenone', 'description': 'Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours', 'armGroupLabels': ['Eplerenone group']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Double-blinded Placebo administered for 4 days at 25mg every 12 hours', 'armGroupLabels': ['Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'Iohexol clearance', 'description': 'Graft function at 3 months evaluated by GFR using iohexol clearance', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation is 14 mL/min, significance level (alpha) is 5%, power (1-beta) is 80%, and a 5% dropout or non-randomization rate is anticipated.", "answer": 132, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n According to French statistical data (https://www.agence-biomedecine.fr/annexes/bilan2016/donnees/organes/06-rein/synthese.htm), the mean eGFR at 3\u00c2\u00a0months among patients receiving a kidney graft from an ECD is 42\u00c2\u00a0mL/min. Inclusion of 126 patients will allow identifying of a difference of 7\u00c2\u00a0mL/min/1.73\u00c2\u00a0m2 between the two groups (42\u00c2\u00a0mL/min/1.73\u00c2\u00a0m2 in the placebo group and 49\u00c2\u00a0mL/min/1.73\u00c2\u00a0m2 in the eplerenone group), with a standard deviation of 14\u00c2\u00a0mL/min, a two-sided alpha risk of 5%, and a beta risk of 20% (power 80%). Since it is anticipated that 5% of patients could be included but not randomized or could withdraw their consent, we will target the inclusion of 132 patients.", "id": 20, "split": "train"} +{"trial_id": "NCT02506829", "pmid": "30463608", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Comparative Effectiveness Trial Of Financial Incentives Versus Usual Care For Smokers Hospitalized In The Veterans Affairs Hospital System\n\nIncluded conditions:\n- Smoking\n- Smoking, Tobacco\n- Tobacco Use Disorder\n\nStudy Armgroups:\n- {'label': 'Usual care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital.', 'interventionNames': ['Behavioral: Smoking cessation counseling (Quitline)', 'Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)']}\n- {'label': 'Financial Incentives', 'type': 'EXPERIMENTAL', 'description': \"Usual care in hospital, referral to a smoking cessation Quitline on discharge from hospital. Financial incentives for: a) speaking with a coach from the Smoker's Quitline ($50), b) completion of another community-based smoking-cessation program ($50), and/or c) use of pharmacotherapies for smoking cessation at 2 weeks ($50); and d) for smoking cessation, confirmed with the use of a cotinine test at 2 months ($150); and e) for smoking cessation, confirmed with the use of a cotinine test at 6 months after study enrollment ($250).\", 'interventionNames': ['Behavioral: Smoking cessation counseling (Quitline)', 'Behavioral: Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)', 'Behavioral: Financial incentives']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Smoking cessation counseling (Quitline)', 'armGroupLabels': ['Financial Incentives', 'Usual care']}\n- {'type': 'BEHAVIORAL', 'name': 'Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)', 'armGroupLabels': ['Financial Incentives', 'Usual care']}\n- {'type': 'BEHAVIORAL', 'name': 'Financial incentives', 'armGroupLabels': ['Financial Incentives']}\n\nPrimary Outcomes:\n- {'measure': 'Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine', 'description': 'Assessed by self-report questionnaire, and biochemically verified by salivary cotinine', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power = 80%, participation rate = 60%, loss to follow-up rate = 10-15%.", "answer": 182, "answer_type": "ACTUAL", "explanation": "Sample size\n We will enroll 182 smokers and expect a 60% participation rate. In addition, we expect a 10\u00e2\u0080\u009315% loss to follow-up rate at 6\u00c2\u00a0months. We consider an absolute difference of approximately 20% in smoking cessation rates to be clinically substantial, where absolute difference\u00e2\u0080\u0089=\u00e2\u0080\u0089(rate1 \u00e2\u0080\u0093 rate2). Therefore, this sample size (91 patients per arm) allows at least 80% power to detect a substantial clinical difference in smoking cessation rates between the control group (enhanced usual care alone arm) and intervention group (financial incentives plus enhanced usual care arm) with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05.", "id": 21, "split": "train"} +{"trial_id": "NCT02517827", "pmid": "38851710", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions A Prospective, Multi-centre, Randomised Study\n\nIncluded conditions:\n- Peripheral Artery Disease\n- Artery Stenosis\n\nStudy Armgroups:\n- {'label': 'Endovascular procedure', 'type': 'ACTIVE_COMPARATOR', 'description': 'Common femoral artery (target lesion) to be treated with directional atherectomy and paclitaxel-coated balloon angioplasty. Optional: stentimplantation.', 'interventionNames': ['Device: Atherectomy and paclitaxel-coated balloon angioplasty']}\n- {'label': 'Surgery', 'type': 'ACTIVE_COMPARATOR', 'description': 'Common femoral artery (target lesion) to be treated with open, surgical endarterectomy', 'interventionNames': ['Procedure: Open, surgical endarterectomy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Atherectomy and paclitaxel-coated balloon angioplasty', 'description': 'Directional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery', 'armGroupLabels': ['Endovascular procedure']}\n- {'type': 'PROCEDURE', 'name': 'Open, surgical endarterectomy', 'description': 'open, surgical endarterectomy of the common femoral artery', 'armGroupLabels': ['Surgery']}\n\nPrimary Outcomes:\n- {'measure': 'Primary patency', 'description': 'Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of \u226550%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio \\\\>2.4.', 'timeFrame': '12 month'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) = 0.05 (one-sided), power (beta) = 0.2, proportion = 0.8, margin = -0.2, and a lost-to-follow-up rate of 15%.", "answer": 306, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Based on the available data the primary patency rate at 12\u00c2\u00a0months after successful endovascular therapy with directional atherectomy and DCB is estimated at 80% [2]. Assuming a comparable primary patency of 90% after open surgery [alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (one-sided) and beta\u00e2\u0080\u0089=\u00e2\u0080\u00890.2, proportion\u00e2\u0080\u0089=\u00e2\u0080\u00890.8, margin\u00e2\u0080\u0089=\u00e2\u0080\u0089\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.2], 260 patients must be included in this trial to reveal the non-inferiority of the treatment groups. Considering a lost-to-follow-up rate of 15%, 306 patients (153 patients in each group) have to be enrolled. Initial estimated enrollment time was 2\u00c2\u00a0years but had to be extended due to the COVID-19 pandemic.", "id": 22, "split": "train"} +{"trial_id": "NCT02541968", "pmid": "30185575", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Internet-based vs Face-to-face Cognitive Behavioural Therapy for Obsessive-compulsive Disorder - a Randomized Controlled Non-inferiority Trial\n\nIncluded conditions:\n- Obsessive-compulsive Disorder\n\nStudy Armgroups:\n- {'label': 'Face-to-face CBT', 'type': 'ACTIVE_COMPARATOR', 'description': '16 sessions of individual CBT delivered in 14 weeks.', 'interventionNames': ['Behavioral: Cognitive-behavioral therapy (face-to-face)']}\n- {'label': 'Internet-based CBT', 'type': 'EXPERIMENTAL', 'description': 'Internet-based CBT (ICBT) with therapist support (14 weeks).', 'interventionNames': ['Behavioral: Internet-based Cognitive-behavioral therapy']}\n- {'label': 'ICBT without therapist support', 'type': 'EXPERIMENTAL', 'description': 'Internet-based CBT without therapist support (14 weeks).', 'interventionNames': ['Behavioral: Internet-based Cognitive-behavioral therapy without therapist support']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive-behavioral therapy (face-to-face)', 'armGroupLabels': ['Face-to-face CBT'], 'otherNames': ['CBT']}\n- {'type': 'BEHAVIORAL', 'name': 'Internet-based Cognitive-behavioral therapy', 'description': 'With therapist support', 'armGroupLabels': ['Internet-based CBT'], 'otherNames': ['ICBT']}\n- {'type': 'BEHAVIORAL', 'name': 'Internet-based Cognitive-behavioral therapy without therapist support', 'armGroupLabels': ['ICBT without therapist support']}\n\nPrimary Outcomes:\n- {'measure': 'Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)', 'timeFrame': 'Change from baseline to treatmentweek 2, 4, 6, 8, 10 , 12, 15 and 3- and 12-month follow-up.'}\n\nPlease estimate the sample size based on the assumption: \nVariance of the random intercept: 10.5, variance for the random slope: 0.04, within-individual residual variance: 20.4, significance level not specified, power: over 90%, interim power analysis with 80 individuals.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In order to provide accurate estimates for the power calculation in the current trial, we\u00c2\u00a0used individual-level data from a previous study of therapist-guided ICBT with identical Y-BOCS assessments by blinded raters and six repeated observations.14 To calculate the required sample size, we used a bootstrap simulation with 1000 samples using the following assumptions, based on data from the previous trial: a variance of the random intercept of 10.5, a variance for the random slope of 0.04 and a within-individual residual variance of 20.4. With three treatment groups and eight observations (Y-BOCS) per patient, we estimated that a total of 120 participants would be needed to detect a slope difference between two groups (ie, group 1 vs group 2 and group 1 vs group 3) of 3 points at 3-month follow-up with over 90% power. We will request an interim power analysis by the KTA to test these assumptions, using data from 80 individuals, and adjust sample size if power is lower than anticipated (see online\u00c2\u00a0supplementary file 1 for a detailed description).\n \n 10.1136/bmjopen-2018-022254.supp1\n Supplementary file 1", "id": 23, "split": "train"} +{"trial_id": "NCT02556294", "pmid": "30021566", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Fostering Resilience to Psychosocial and HIV Risk in Indian MSM\n\nIncluded conditions:\n- HIV Infection\n- Sexual Behavior\n- Health Behavior\n\nStudy Armgroups:\n- {'label': 'Self-acceptance behavioral intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention will consist of individual and 4 group counseling sessions and 6 individual counseling sessions. The individual sessions are focused on specific individualized risk reduction plans, whereas the group sessions are focused on increasing self-acceptance and reducing HIV risk. Additionally, participants in this arm will receive HIV and STI counseling and testing.', 'interventionNames': ['Behavioral: Self-acceptance based intervention', 'Behavioral: HIV/STI counseling and testing']}\n- {'label': 'Comparison/Control', 'type': 'OTHER', 'description': 'The comparison group will receive HIV and STI counseling and testing.', 'interventionNames': ['Behavioral: HIV/STI counseling and testing']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Self-acceptance based intervention', 'description': 'The intervention will consist of HIV/STI counseling and testing as well as individual counseling sessions and group sessions. The primary focus of the group sessions are to help foster self-acceptance by the support from the group, as well as learn skills to reduce distress and HIV risk. The primary purpose of the individual sessions is to help develop and implement an individualized plan for HIV risk reduction, and, as needed and available, linkage to other services.', 'armGroupLabels': ['Self-acceptance behavioral intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'HIV/STI counseling and testing', 'description': 'The counseling component is standard of care in India and will focus on HIV/STI risk and how to minimize risk. This is followed by biological testing for HIV and STIs.', 'armGroupLabels': ['Comparison/Control', 'Self-acceptance behavioral intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in frequency of condomless sex', 'description': 'Self-reported insertive or receptive anal sex without the use of a condom.', 'timeFrame': '4 month visit, 8 month visit, 12, month visit'}\n- {'measure': 'Number of incident STIs from Baseline', 'description': 'Chlamydia, gonorrhea, syphilis, and HIV', 'timeFrame': '12 month visit'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level of 0.05, power of 90%, and an attrition rate of 20% between baseline assessment and 12-month follow-up.", "answer": 608, "answer_type": "ACTUAL", "explanation": "Power considerations and sample size calculations\n The power analysis for the primary aim is based on detecting a 30% (or greater) difference in 12-month STI incidence and sexual risk (number of unprotected anal sex acts in the past 4\u00c2\u00a0months, baseline to 12-month follow-up) between the intervention and control. Based on this data, with an alpha level of 0.05 and a power of 90%, 480 study completers are needed. Assuming an attrition rate of 20% between the baseline assessment and 12-month follow-up, we need 600 study completers. However, in an attempt to have approximately 8 participants in each batch, our goal is to randomize 608 participants.", "id": 24, "split": "train"} +{"trial_id": "NCT02608554", "pmid": "30236149", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Taichi for Treating Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)\n\nIncluded conditions:\n- Polycystic Ovary Syndrome\n\nStudy Armgroups:\n- {'label': 'Taichi', 'type': 'EXPERIMENTAL', 'description': 'The 24 forms of simplified TCC recommended as the popular health sport by the General Administration of Sport of China were applied.', 'interventionNames': ['Behavioral: Taichi']}\n- {'label': 'Self-monitored exercise', 'type': 'ACTIVE_COMPARATOR', 'description': 'Exercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise.', 'interventionNames': ['Behavioral: Self-monitored exercise']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Taichi', 'description': 'The program of Taichi training consisted of 60 minutes exercise sessions, 3 days per week for 12 weeks, based on their original level of physical activity. Each session comprised 40 minutes of Taichi training plus a 10-minute warm-up and cool-down. The Taichi training was instructed by the same experienced Taichi instructors who were qualified in the teaching of Taichi. The 24 forms of simplified Taichi recommended as the popular health sport by the General Administration of Sport of China were applied.', 'armGroupLabels': ['Taichi']}\n- {'type': 'BEHAVIORAL', 'name': 'Self-monitored exercise', 'description': 'Exercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise for 60 mins. 3 days per week for 12 weeks.', 'armGroupLabels': ['Self-monitored exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Body mass index (BMI)', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-sided 5% significance level, allocation ratio of 3:2.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n This study is an exploratory study of the evaluation of the effectiveness of Tai Chi for PCOS subjects and the feasibility of a large clinical trial; therefore, the minimum sample size necessary to evaluate the effectiveness was used [22].\n For such a trial designed with 90% power and two-sided 5% significance,\n the sample size was set to 50 patients with an allocation ratio of 3:2.", "id": 25, "split": "train"} +{"trial_id": "NCT02611232", "pmid": "35797241", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Incretin-based Therapy in Preclinical Type 1 Diabetes in Adults\n\nIncluded conditions:\n- Type 1 Diabetes\n\nStudy Armgroups:\n- {'label': 'Victoza\u00ae', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects with preclinical type 1 diabetes aged 18-30 years are treated with Victoza\u00ae (liraglutide)', 'interventionNames': ['Drug: Victoza\u00ae']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Subjects with preclinical type 1 diabetes aged 18-30 years are treated with placebo', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Victoza\u00ae', 'description': 'Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.', 'armGroupLabels': ['Victoza\u00ae']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'FPIR (first phase insulin response)', 'description': 'First phase insulin response during 10-min IVGTT (intravenous glucose tolerance test )', 'timeFrame': 'From baseline to 26 and 104 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) of 0.05, power of 80%, and a dropout rate of 10% initially, later adjusted to a 20% dropout rate.", "answer": 42, "answer_type": "ESTIMATED", "explanation": "2.10\n Sample size\n Based on reference values reported earlier, we expected that in stage 1 and stage 2 trials, 6\u00c2\u00a0months after randomisation, FPIR mean would be 46 (SD 15) and 40 (SD 15) mU/L in placebo groups, respectively.\n24\n For stage 3 trial, C\u00e2\u0080\u0090peptide AUC in 2\u00e2\u0080\u0090h MMTT was assumed to be 1.0\u00c2\u00a0nmol/L/120\u00e2\u0080\u0089min (SD 0.3) after 6\u00c2\u00a0months from early diagnosis of type 1 diabetes in the placebo group. This was based on C\u00e2\u0080\u0090peptide AUC data in 2\u00e2\u0080\u0090h OGTT at diagnosis in the DPT\u00e2\u0080\u00901 study.\n26\n Thus, sample sizes of 42, 54 and 14 participants in stage 1, 2 and 3 trials, respectively, would give an 80% probability to observe a 30% higher FPIR in 10\u00e2\u0080\u0090min IVGTT and 50% higher C\u00e2\u0080\u0090peptide AUC in 2\u00e2\u0080\u0090h MMTT in the liraglutide groups as compared with the placebo groups when using two\u00e2\u0080\u0090sided t\u00e2\u0080\u0090tests given alpha 0.05 and 10% dropout. However, our early observations from still blinded stage 1 and 2 trials indicated that some participants had marked increases of 100% to 360% in FPIR whereas others had stable or declining FPIR. Therefore, we supposed that the remarkable increase in FPIR had occurred in the participants receiving active investigational product and recalculated the sample size under the assumption of 100% increase after liraglutide treatment, and sample sizes of 10 participants to be randomised in stage 1 and 2 trials were found to be sufficient to detect a clinically significant difference even when assuming a dropout rate of 20%. The participants who withdraw from the study before visit 4 will be replaced and randomised as a new participant. However, data from all randomised participants will be included in the intention to treat analyses.", "id": 26, "split": "train"} +{"trial_id": "NCT02618902", "pmid": "31501122", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A \"negative\"dendritic Cell-based Vaccine for the Treatment of Multiple Sclerosis: a First-in-human Clinical Trial\n\nIncluded conditions:\n- Multiple Sclerosis\n\nStudy Armgroups:\n- {'label': 'tolerogenic dendritic cells (tolDC)', 'type': 'EXPERIMENTAL', 'description': 'Each vaccine (5x106, 10x106 , or 15x106cells in 500 \u00b5L NaCl 0.9% solution supplemented with 5% human albumin) will be administered through intradermal injection at 5 sites (100 \u00b5L/site) in the subclavicular region (5-10 cm from the cervical lymph nodes). Injection sites will alternate between left and right sides.', 'interventionNames': ['Biological: tolerogenic dendritic cells (tolDC)']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'tolerogenic dendritic cells (tolDC)', 'description': 'dose-escalation', 'armGroupLabels': ['tolerogenic dendritic cells (tolDC)']}\n\nPrimary Outcomes:\n- {'measure': 'Safety (Occurrence and severity of adverse events will be recorded)', 'description': 'Occurrence and severity of adverse events will be recorded', 'timeFrame': '6 months'}\n- {'measure': 'Feasibility (Generation of GMP-grade cell product released according to QC)', 'description': 'Generation of GMP-grade cell product released according to QC', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nDose escalation decisions are made after 3 months of follow-up for all subjects in the cohort, with safety and tolerability analyses reviewed by investigators and the independent Data Safety Monitoring Board (DSMB). The trial terminates if three or more DLT are observed.", "answer": 9, "answer_type": "ACTUAL", "explanation": "Determination of sample size and dose-escalation procedure\n The studies will be conducted according to a \u00e2\u0080\u0098best of five\u00e2\u0080\u0099 design,41 an alternative of the traditional 3+3 design in that one additional patient is added when one or even two dose-limiting toxicities (DLT) are observed among the first three patients. Another patient is added when two DLT are observed among four treated patients. Dose escalation is allowed if DLT are observed among none of three, one of four or two of five patients, but the trial will terminate if three or more DLT are observed. A DLT is defined as a serious adverse event (SAE) that is attributable to the study cells administered, or of which the severity prevents further escalation. Dose escalation decisions will be made after all subjects in the cohort have completed at least 3 months of follow-up and when the results of the safety and tolerability analyses of the preceding dose regimen are satisfactory in the judgement of the investigators and the independent Data Safety Monitoring Board (DSMB).\n An overview of the dose escalation is provided in table 3. Altogether, each phase I study is intended to accrue a total number of 9\u00e2\u0080\u009315 evaluable patients.\n \n Table 3\n \n Outline of the cell doses and patient numbers, per phase I clinical trial, in the dose escalation cohorts for intradermal and intranodal administration of tolDC\n \n \n \n \n Cohort\n Treatment regimen\n Patient numbers\n \n \n \n \n 1\n 6 i.d./i.n. injections of 5\u00c3\u0097106 tolDC\n N=3 (+1+1)\n \n \n 2\n 6 i.d./i.n. injections of 10\u00c3\u0097106 tolDC\n N=3 (+1+1)\n \n \n 3\n 6 i.d./i.n. injections of 15\u00c3\u0097106 tolDC\n N=3 (+1+1)\n \n \n \n \n \n N, number; i.d., intradermal; i.n., intranodal; tolDC, tolerogenic dendritic cells.", "id": 27, "split": "train"} +{"trial_id": "NCT02621749", "pmid": "29562937", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cerebral Microembolism in the Critically Ill With Acute Kidney Injury: A Prospective Multi-Center Randomized Controlled Trial Comparing Continuous With Intermittent Renal Replacement Therapy.\n\nIncluded conditions:\n- Cerebral Embolism\n\nStudy Armgroups:\n- {'label': 'CRRT group', 'type': 'ACTIVE_COMPARATOR', 'description': 'the CRRT group receives continuous renal replacement therapy for acute kidney injury', 'interventionNames': ['Device: Renal replacement therapy']}\n- {'label': 'IRRT group', 'type': 'ACTIVE_COMPARATOR', 'description': 'the IRRT group receives intermittent renal replacement therapy after termination of CRRT.', 'interventionNames': ['Device: Renal replacement therapy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Renal replacement therapy', 'description': 'Patients receive renal replacement therapy according to institutional standards', 'armGroupLabels': ['CRRT group', 'IRRT group'], 'otherNames': ['Hemodialysis']}\n\nPrimary Outcomes:\n- {'measure': 'Cerebral Microembolic Load detected by Transcranial Doppler Ultrasound', 'timeFrame': 'During hemodialysis therapy'}\n\nPlease estimate the sample size based on the assumption: \nDesired power of 0.8, significance level (alpha) of 0.05, and a dropout rate of 15%.", "answer": 66, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Based on our preliminary study, [19] we expect a true difference in the mean high-intensity transient signals (HITS) value of 700 and a standard deviation of 950 HITS between the two groups of interest. With a desired power of 0.8 and an alpha of 0.05, the number of required patients is 58 (29/group). Taking into consideration a dropout rate of 15%, we plan to include a total number of patients of 66.", "id": 28, "split": "train"} +{"trial_id": "NCT02630485", "pmid": "30445999", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Graceful Lifestyle Changes Intervention Study for Women With PCOS and Infertility\n\nIncluded conditions:\n- Polycystic Ovary Syndrome\n- Infertility\n\nStudy Armgroups:\n- {'label': 'Graceful Lifestyle Changes & MYO', 'type': 'EXPERIMENTAL', 'description': 'The 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness.\\n\\nIn addition, this group will take myo-inositol (6 grams in juice or water every morning).', 'interventionNames': ['Behavioral: Graceful Lifestyle Changes', 'Dietary Supplement: Myo-inositol']}\n- {'label': 'Graceful Lifestyle Changes', 'type': 'EXPERIMENTAL', 'description': 'The 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness.\\n\\nIn addition, this group will take a white powder placebo (6 grams in juice or water every morning).', 'interventionNames': ['Behavioral: Graceful Lifestyle Changes']}\n- {'label': 'Letrozole & MYO', 'type': 'PLACEBO_COMPARATOR', 'description': 'The women assigned to the fertility medication group will be prescribed letrozole. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.\\n\\nIn addition, this group will take myo-inositol (6 grams in juice or water every morning).', 'interventionNames': ['Dietary Supplement: Myo-inositol', 'Drug: Letrozole']}\n- {'label': 'Letrozole', 'type': 'PLACEBO_COMPARATOR', 'description': 'The women assigned to the fertility medication group will be prescribed letrozole. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.\\n\\nIn addition, this group will take a white powder placebo (6 grams in juice or water every morning).', 'interventionNames': ['Drug: Letrozole']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Graceful Lifestyle Changes', 'description': 'Participants will be educated in small groups of 8-10. A wellness booklet designed by physicians and researchers at Grace Fertility Centre will be provided.The target diet for our study is 45% carbohydrates and 55 grams of glycemic load. Participants will keep a 3-day food diary at baseline, 4, 8 and 12 weeks. Secondly, participants will be provided a pedometer and a goal to reach 10,000 steps a day. The third aspect of the program will be to decrease overall stress through mindfulness. Educational sessions will be held to teach the relaxation response and meditation techniques such as breathing and grounding exercises. Participants will be required to meditate for at least 20 minutes each day and record this.', 'armGroupLabels': ['Graceful Lifestyle Changes', 'Graceful Lifestyle Changes & MYO'], 'otherNames': ['GLC']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Myo-inositol', 'description': 'Myo-inositol will be consumed in juice or water every morning (6 grams) for 12 weeks.', 'armGroupLabels': ['Graceful Lifestyle Changes & MYO', 'Letrozole & MYO'], 'otherNames': ['Inositol', 'MYO']}\n- {'type': 'DRUG', 'name': 'Letrozole', 'description': 'Letrozole will be administered to patients. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.', 'armGroupLabels': ['Letrozole', 'Letrozole & MYO']}\n\nPrimary Outcomes:\n- {'measure': 'Ovulation Occurence', 'description': 'Ovulation is the primary outcome and expressed as any ovulation (categorical \"yes\" or \"no\") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.', 'timeFrame': '12 weeks'}\n- {'measure': 'Ovulation Frequency', 'description': 'Ovulation is the primary outcome can be expressed in according to frequency (nominal \"0\", \"1\", \"2, or \"3\") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe power calculation uses a 5% significance level and 80% power for comparing two proportions. A drop-out rate of 32% is also considered.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculations\n Assuming no interactions between the two main effects as discussed earlier, the target sample size will be 240 participants (120 participants in the GLC group and 120 participants on oral medication). This is based on: a power calculation using a 5% significance level, 80% power comparing two proportions, and current knowledge of the average ovulation rates of lifestyle interventions and letrozole, our primary comparison. We explored a number of combinations of the ovulation rates from letrozole and lifestyle interventions and chose the most conservative estimate to ensure that our sample size was adequate, i.e., 91 in each group. By enrolling 120 participants in each group, we have allowed for a drop-out rate of 32%. Table\u00c2\u00a01 describes the lowest and highest reported ovulation rates for letrozole and lifestyle interventions, the sample size required in each scenario comparing the two proportions, and the three highest sample sizes required from our calculations, accounting for the length of lifestyle intervention and the start dose of letrozole.Table 1Sample size calculation based on previous literatureRange of reportedovulation ratesLetrozole ovulation rateLifestyle ovulation rateTotal sample size neededLowest62%a38%b130Highest86%c67%d150Median70%50%182aLegro et al. [29]bPalomba et al. [36]cZeinalzadeh et al. [37]dKarimzadeh and Javedani [38]\n When calculating the sample size necessary to assess the effect of myo-inositol on ovulation rates, we reviewed the few published studies available acknowledging that these studies all had small sample size. One randomized controlled trial reported an ovulation rate of 70% when myo-inositol was given to women with PCOS versus a 21% ovulation rate in controls [24]. Similarly, another randomized controlled trial reported an ovulation rate of 65% using myo-inositol in PCOS [32]. Using these rates in a comparison of two proportions, a total sample size of 26 is needed, and easily covered by our original calculation above.", "id": 29, "split": "train"} +{"trial_id": "NCT02630589", "pmid": "31201186", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus\n\nIncluded conditions:\n- Tinnitus\n\nStudy Armgroups:\n- {'label': 'ABI implantation', 'type': 'EXPERIMENTAL', 'description': 'All 10 patients included in the study will be neurosurgically implanted with the ABI. This is open label, not blinded. The implant is permanent, but can be switched off.', 'interventionNames': ['Device: Auditory brainstem implant']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Auditory brainstem implant', 'description': 'The ABI will be implanted by the neurosurgeon. The implant is fixed in a bed drilled in the parietal-temporal cortex, and the ABI electrode array is inserted into the lateral recess of the fourth ventricle and placed on the cochlear nucleus. Access to the cochlear nucleus will be made via retrosigmoid transcranial approach.', 'armGroupLabels': ['ABI implantation'], 'otherNames': ['ABI']}\n\nPrimary Outcomes:\n- {'measure': 'Tinnitus Functioning Index (TFI)', 'description': 'Unit of measure: Items on a scale.\\n\\nThe TFI (tinnitus functioning index) is a questionnaire validated to detect changes in tinnitus outcome after an intervention', 'timeFrame': 'pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative'}\n\nPlease estimate the sample size based on the assumption: \nNo power analysis was performed.", "answer": 10, "answer_type": "ESTIMATED", "explanation": "Sample size\n This is a pilot study. Due to the experimental nature of the study, no power analysis was performed. It was empirically decided to select a cohort of 10 patients for this study.", "id": 30, "split": "train"} +{"trial_id": "NCT02633423", "pmid": "30477541", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Expiratory Flow Limitation and Mechanical Ventilation During Cardiopulmonary Bypass in Cardiac Surgery\n\nIncluded conditions:\n- Mitral Regurgitation\n- Aortic Regurgitation\n\nStudy Armgroups:\n- {'label': 'PEEP and CPAP', 'type': 'EXPERIMENTAL', 'description': 'Patients will be ventilated with positive end-expiratory pressure(PEEP) before and after cardiopulmonary bypass(CPB); during CPB continous positive airway pressure(CPAP) will be adopted.', 'interventionNames': ['Procedure: Use of PEEP before and after CPB', 'Procedure: Ventilation with CPAP during CPB']}\n- {'label': 'ZEEP and CPAP', 'type': 'EXPERIMENTAL', 'description': 'Patients will be ventilated without PEEP(ZEEP) before and after cardiopulmonary bypass(CPB); during CPB continous positive airway pressure(CPAP) will be adopted.', 'interventionNames': ['Procedure: No use of PEEP before and after CPB(ZEEP)', 'Procedure: Ventilation with CPAP during CPB']}\n- {'label': 'PEEP and NO VM', 'type': 'EXPERIMENTAL', 'description': 'Patients will be ventilated with positive end-expiratory pressure(PEEP) before and after cardiopulmonary bypass(CPB); during CPB no mechanical ventilation will be adopted(no VM)', 'interventionNames': ['Procedure: Use of PEEP before and after CPB', 'Procedure: No ventilation during CPB']}\n- {'label': 'ZEEP and NO VM', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients will be ventilated without PEEP(ZEEP) before and after cardiopulmonary bypass(CPB); during CPB no mechanical ventilation will be adopted(no VM)', 'interventionNames': ['Procedure: No use of PEEP before and after CPB(ZEEP)', 'Procedure: No ventilation during CPB']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Use of PEEP before and after CPB', 'description': 'PEEP will be set in order to reach an airway pressure of 5 cmH2O', 'armGroupLabels': ['PEEP and CPAP', 'PEEP and NO VM']}\n- {'type': 'PROCEDURE', 'name': 'No use of PEEP before and after CPB(ZEEP)', 'description': 'No PEEP will be used', 'armGroupLabels': ['ZEEP and CPAP', 'ZEEP and NO VM']}\n- {'type': 'PROCEDURE', 'name': 'Ventilation with CPAP during CPB', 'description': 'A continuous Positive Airway Pressure (CPAP) will be applied during CPB', 'armGroupLabels': ['PEEP and CPAP', 'ZEEP and CPAP']}\n- {'type': 'PROCEDURE', 'name': 'No ventilation during CPB', 'description': 'No ventilation will be provided during CPB. Patients will be deconnected from ventilator. Lungs will completely collapse.', 'armGroupLabels': ['PEEP and NO VM', 'ZEEP and NO VM']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of expiratory flow limitation in cardiac surgery', 'timeFrame': 'Immediately after weaning from cardiopulmonary bypass'}\n- {'measure': 'Incidence of Postoperative pulmonary complications in cardiac surgery', 'timeFrame': 'From immediately after cardiac surgery until discharge from the hospital'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided \u03b1 error of 0.05, 80% power (\u03b2), and a drop-out rate of 10%.", "answer": 204, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculation was based on a two-sided \u00ce\u00b1 error of 0.05 and a 80% power (\u00ce\u00b2). On the basis of our experience, we anticipate that the 50% of patients with ventilation cessation during CPB and no PEEP before and after CPB will reach the composite endpoint of EFL after CPB and respiratory complications at 5\u00e2\u0080\u0089days, while only the 30% of the patients treated with an optimal ventilatory strategy will develop this composite endpoint. Including a drop-out fraction of 10%, we will enroll 51 patients per group, 204 in total.", "id": 31, "split": "train"} +{"trial_id": "NCT02651454", "pmid": "32000419", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Pilot Study Exploring the Efficacy and Safety of Herbal Medicine on Korean Obese Women With Metabolic Syndrome Risk Factors - Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial -\n\nIncluded conditions:\n- Metabolic Syndrome\n- Obesity\n\nStudy Armgroups:\n- {'label': 'Daesiho-tang', 'type': 'EXPERIMENTAL', 'description': 'Dose: 6g, three times a day, each taken before or between meals for 12 weeks', 'interventionNames': ['Drug: Daesiho-tang']}\n- {'label': 'Jowiseungcheung-tang', 'type': 'EXPERIMENTAL', 'description': 'Dose: 6g, three times a day, each taken before or between meals for 12 weeks', 'interventionNames': ['Drug: Chowiseungcheng-tang']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Dose: 6g, three times a day, each taken before or between meals for 12 weeks', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Daesiho-tang', 'description': 'Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \\\\& FOODS Co. Ltd.', 'armGroupLabels': ['Daesiho-tang'], 'otherNames': ['DSHT', 'Elsion Granule']}\n- {'type': 'DRUG', 'name': 'Chowiseungcheng-tang', 'description': 'Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.', 'armGroupLabels': ['Jowiseungcheung-tang'], 'otherNames': ['CST']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM \\\\& FOODS Co. Ltd.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Changes from baseline in body weight', 'timeFrame': 'baseline, 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size was determined based on the frequency of clinic visits, availability of study staff, funding availability, and dropout rates.", "answer": 120, "answer_type": "ACTUAL", "explanation": "3.5\n Sample size\n This trial is a pilot study to examine the feasibility of a full randomized controlled trial for evaluating the efficacy and safety of DSHT and CST in obesity and to determine the effect size for further large-scale studies. A sample cohort comprising of 120 patients have been considered after assessing their frequency of clinic visits, availability of study staff, funding availability, and dropout rates at each participating site.", "id": 32, "split": "train"} +{"trial_id": "NCT02653768", "pmid": "31138256", "question": "Here is the design of a clinical trial:\n\nOfficial Title: STepped Exercise Program for Knee Osteoarthritis (STEP-KOA)\n\nIncluded conditions:\n- Osteoarthritis, Knee\n\nStudy Armgroups:\n- {'label': 'STEP-KOA', 'type': 'EXPERIMENTAL', 'description': 'This is a stepped exercise program. It begins with an internet-based exercise training program (STEP 1). After three months, participants are assessed to see if they have achieved clinically meaningful improvement in key osteoarthritis outcomes. If so, they remain at STEP 1. If not, they move on to STEP 2, which adds telephone-based coaching. Participants are assessed again three months later. Those that still have not achieved clinically relevant improvement move on to STEP 3, which adds a series of in-person physical therapy visits.', 'interventionNames': ['Behavioral: Stepped Exercise Program']}\n- {'label': 'Arthritis Education (AE)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the AE control group will receive low literacy educational materials via mail every two weeks. Because STEP-KOA is a multi-component intervention, with participants receiving different numbers of Steps, it is not possible to implement a control condition that will mirror the exact intervention \"dose\" received by all participants in the STEP-KOA group. However, AE will achieve the goal of providing an active, OA-related control condition.', 'interventionNames': ['Behavioral: Arthritis Education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Stepped Exercise Program', 'description': 'STEP 1: Participants have access to an internet-based exercise program for knee OA.\\n\\nSTEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.\\n\\nSTEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit', 'armGroupLabels': ['STEP-KOA'], 'otherNames': ['STEP-KOA']}\n- {'type': 'BEHAVIORAL', 'name': 'Arthritis Education', 'description': 'The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to OA and its management, based on established treatment guidelines.', 'armGroupLabels': ['Arthritis Education (AE)'], 'otherNames': ['AE']}\n\nPrimary Outcomes:\n- {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'description': 'This is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total scale range is 0-96, and higher scores mean a worse outcome.', 'timeFrame': 'Change from baseline to 3-month, 6-month, 9-month follow-ups. For STEP-KOA only, change from 9-month to 15-month follow-up.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha = 0.05, standard deviation = 17.5, correlation (rho) = 0.4, and approximately 20% attrition rate by 9 months.", "answer": 345, "answer_type": "ACTUAL", "explanation": "Sample Size\n The sample size estimate of n\u00c2\u00a0=\u00e2\u0080\u0089345 patients was based on a 2:1 randomization and the comparison of the primary outcome between the STEP-KOA and AE control arms at 9\u00e2\u0080\u0089months. Since AIM 3 is to describe the responder patterns for the Step progression in STEP-KOA we used a 2:1 randomization to facilitate our ability to evaluate these patterns [55]. For sample size calculations we used methods appropriate for Analysis of Covariance type analyses [56], which are equivalent in terms of efficiency to our linear model in randomized trials [49]. This method is based on performing a two-sample t-test sample size calculation for the between group difference and adjusting based on an assumed correlation between baseline and follow-up time point outcome measures. Based on our previous data, we assumed a correlation of 0.4 between baseline and follow-up WOMAC scores, a standard deviation of 17.5 and an attrition rate of 20% at 9-months [17, 57, 58]. With 80% power, alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, standard deviation\u00e2\u0080\u0089=\u00e2\u0080\u008917.5, rho\u00e2\u0080\u0089=\u00e2\u0080\u0089.4, and approximately 20% attrition rate by 9-months, 230 and 115 participants are needed in the STEP-KOA and AE groups, respectively, for an effect size of 0.33. This corresponds to a 5.8 point difference in mean total WOMAC scores at 9-months between STEP-KOA and AE, which is a clinically relevant improvement [59]. We are also powered to detect medium effect size differences in secondary study outcomes.\n \n Economic Evaluation\n The overall goal of Specific Aim #4 is to provide the VA with information about the value of the STEP-KOA program, from a cost effectiveness perspective. In addition to informing the VA regarding the overall average cost of STEP-KOA per patient, this evaluation will provide information on how much improvement in outcomes can be achieved for that cost. The analysis will begin with descriptive statistics of the cost and effectiveness (utility) data. We will examine each measure of effectiveness, WOMAC and mean QALY (and the pain/discomfort sub-core of the EQ-5D-5\u00e2\u0080\u0089L), using the general analytic procedures described above for primary and secondary outcomes. We will calculate the incremental cost effectiveness ratio (ICER) of STEP-KOA compared to the AE control group, separately for WOMAC and QALYs. The ICER will be calculated as the difference in the average total cost per participant STEP-KOA and AE, divided by the difference in the average effectiveness per participant between STEP-KOA and AE. Bootstrapping of estimates, multiple imputation for missing EuroQoL values, and sensitivity analyses will all be conducted to ensure robustness of our results.", "id": 33, "split": "train"} +{"trial_id": "NCT02660073", "pmid": "31443727", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits After Spinal Cord Injury\n\nIncluded conditions:\n- Spinal Cord Injuries\n\nStudy Armgroups:\n- {'label': 'NMES+FES group', 'type': 'EXPERIMENTAL', 'description': 'NMES+FES group (n=24; 2 days/week for 24 weeks); this group will undergo twice weekly of 12 weeks of surface NMES and ankle weights followed by 12 additional weeks of twice weekly of progressive FES-LEC using the RT300 bike. The total participation duration is 24 weeks +3 weeks for measurements.', 'interventionNames': ['Device: NMES+FES']}\n- {'label': 'Control+FES group', 'type': 'EXPERIMENTAL', 'description': 'Control+FES group (n=24; 2 days/week for 24 weeks); this group will undergo twice weekly of 12 weeks of passive leg extension/flexion with no ankle weights followed by 12 additional weeks of twice weekly of progressive FES-LEC using the RT300 bike. The total participation duration is 24 weeks+3 weeks for measurements.', 'interventionNames': ['Device: Control+FES']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'NMES+FES', 'description': '12 weeks of electrically evoked resistance training followed by 12 weeks of functional electrical stimulation cycling.', 'armGroupLabels': ['NMES+FES group'], 'otherNames': ['(NMES; Theratouch)+(FES; RTI300 Bike)']}\n- {'type': 'DEVICE', 'name': 'Control+FES', 'description': '12 weeks of passive movement followed by 12 weeks of functional electrical stimulation cycling.', 'armGroupLabels': ['Control+FES group'], 'otherNames': ['Control+(FES; RTI300 Bike)']}\n\nPrimary Outcomes:\n- {'measure': 'Glucose uptake', 'description': 'by measuring glucose effectiveness', 'timeFrame': '24 weeks'}\n- {'measure': 'Insulin Sensitivity', 'description': 'By performing frequent blood drawing of 32 samples over 3 hour period while the patient is fasting.', 'timeFrame': '24 weeks'}\n- {'measure': 'Oxygen Uptake', 'timeFrame': '24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe correlation between pre- and post-treatment measurements is assumed to be 0.3735 for glucose effectiveness and 0.4 for insulin sensitivity and VO2. The study aims for 90% power with a Type-1 error rate of 0.05. A 20% dropout rate is considered.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size\n We have acquired pilot data for all outcomes of this project. Glucose effectiveness possesses the smallest effect size from baseline to follow-up with NMES-RT showing a mean baseline effectiveness of 0.01716 and post-treatment mean of 0.02258. Cohen\u00e2\u0080\u0099s f was found to be 0.271 using a sample variance of 0.0001 [25]. Assuming the correlation between the pre- and post-treatment measurements is 0.3735 and three total measurements are acquired, 38 individuals will need to complete the study at 90% power using a Type-1 error rate of 0.05. At least 48 participants will need to be recruited, adjusting for a 20% dropout rate. All sample sizes were calculated using the software G*Power (V3.1.9.2). A sample size of 24 was calculated using insulin sensitivity data without regard to dropout rate.\n Other factors, such as insulin sensitivity and VO2, are considered; each representing larger effect sizes than glucose effectiveness (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.313 and f\u00e2\u0080\u0089=\u00e2\u0080\u00890.432, respectively). Our study would result in a power of 97.51% and 99.82% for observing the baseline to follow-up difference between the NMES + FES and Control + FES groups, provided the correlation between baseline and follow-up measurements are 0.4 for the outcomes.", "id": 34, "split": "train"} +{"trial_id": "NCT02662426", "pmid": "30944133", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Double-Blinded, Oseltamivir-and-Placebo-Controlled Clinical Study About Lingdancao Granules in the Treatment of Seasonal Influenza\n\nIncluded conditions:\n- Influenza\n\nStudy Armgroups:\n- {'label': 'Drugs for experimental group', 'type': 'EXPERIMENTAL', 'description': 'Lingdancao granules, 4 packs per time (3g/pack), three times per day; analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day.Drugs must be used on the day of fever and last for five days continuously.', 'interventionNames': ['Drug: Lingdancao granules', 'Drug: analogous oseltamivir phosphate capsule']}\n- {'label': 'Drugs for positive control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oseltamivir phosphate capsule (tamiflu), 1 capsule per time (75mg), twice per day; analogous Lingdancao granules, 4 packs per time, three times per day.Drugs must be used on the day of fever and last for five days continuously.', 'interventionNames': ['Drug: Oseltamivir phosphate capsule', 'Drug: analogous Lingdancao granules']}\n- {'label': 'Drugs for placebo control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Analogous Lingdancao granules, 4 packs per time, three times per day, analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day.Drugs must be used on the day of fever and last for five days continuously.', 'interventionNames': ['Drug: analogous oseltamivir phosphate capsule', 'Drug: analogous Lingdancao granules']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lingdancao granules', 'description': '4 packs per time (3g/pack), three times per day', 'armGroupLabels': ['Drugs for experimental group'], 'otherNames': ['Lingdancao granules,z53021634']}\n- {'type': 'DRUG', 'name': 'analogous oseltamivir phosphate capsule', 'description': '1 capsule per time, twice per day', 'armGroupLabels': ['Drugs for experimental group', 'Drugs for placebo control group'], 'otherNames': ['analogous oseltamivir phosphate capsule,0221503013']}\n- {'type': 'DRUG', 'name': 'Oseltamivir phosphate capsule', 'description': '1 capsule per time (75mg), twice per day', 'armGroupLabels': ['Drugs for positive control group'], 'otherNames': ['tamiflu,0221503013']}\n- {'type': 'DRUG', 'name': 'analogous Lingdancao granules', 'description': '4 packs per time, three times per day', 'armGroupLabels': ['Drugs for placebo control group', 'Drugs for positive control group'], 'otherNames': ['analogous Lingdancao granules,z53021634']}\n\nPrimary Outcomes:\n- {'measure': 'The time needed for alleviation of all influenza symptoms', 'description': 'fever,nasal obstruction, running nose, sore throat, cough, myalgia, fatigue, headache, aversion to cold and sweating', 'timeFrame': 'Up to 30 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) is 0.05, power is 0.80, and an expansion rate of 20% to account for dropouts.", "answer": 318, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Eligible subjects, aged 14\u00e2\u0080\u009365 years will be accepted. Recommendations from WHO for influenza-like illnesses (ILIs) were used as the basis for influenza surveillance. If a patient presents with an acute cough and fever, clinicians must be highly vigilant to test for infections caused by the influenza virus. In general, the rate of ILI cases that lead to a clinical diagnosis of influenza infection is approximately 18%\u00e2\u0080\u009380%, which is higher than other clinical diagnoses, for example, acute infections of the upper respiratory tract.27 33 We selected adult patients with ILI for inclusion into the study.\n Furthermore, this trial is a confirmatory study on the treatment of influenza by CLD granules. The patients will be randomly assigned in three groups: positive group, test group and placebo group. In this trial, the number of sample cases was estimated based on the test hypothesis that the test group was superior to the placebo group and the test group was not inferior to the positive control group.\n The main index of treatment effectiveness is the period of time until subsidence of symptoms (hours). It has been reported that the average period of time for remission of these symptoms in the placebo group was about 5 days (120\u00e2\u0080\u0089hours).32 This trial requires that the average time for symptomatic remission of the test group should be at least 12\u00e2\u0080\u0089hours shorter than the placebo group, it means the permissible error (\u00ce\u00b4) of the superiority trial is 12\u00e2\u0080\u0089hours. In order to be considered clinically significant, the mean time for symptomatic remission in the positive group must <12\u00e2\u0080\u0089hours compared with the placebo group, which means \u00ce\u00b4 of the superiority trial is within 12\u00e2\u0080\u0089hours (table 6).\n \n Table 6\n \n The average time for symptom relief\n \n \n \n \n Group\n Average time for symptom relief (hours)\n SD\n \n \n \n \n Positive\n 96\n 50\n \n \n Test\n 108\n 50\n \n \n Placebo\n 120\n 50\n \n \n \n \n Based on the above data, the SAS Software was used to estimate the sample size required for \u00e2\u0080\u0098one-way analysis of variance\u00e2\u0080\u0099. The calculation result is designed for three parallel groups (table 7).\n \n Table 7\n \n The calculation of sample size\n \n \n \n \n Power\n Alpha\n Cases/group\n Expand 20%\n Total cases\n \n \n \n \n 0.80\n 0.05\n 85\n 106\n 318\n \n \n \n \n For achieving adequate participant enrolment, patients are recruited for clinical trials mainly through local advertising. And each participant will receive financial compensation after they finish the entire treatment. For patients who drop out, payments will be prorated for the length of time they stayed in the study, but payment will not be made until the study would have been completed.", "id": 35, "split": "train"} +{"trial_id": "NCT02665169", "pmid": "31230026", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Fall Prevention Trial For Aging Females by Providing Supervised Exercises and Free Use of Municipal Recreation Facilities.\n\nIncluded conditions:\n- Accidental Falls\n- Health Behavior\n- Aging\n\nStudy Armgroups:\n- {'label': 'Exercise intervention group', 'type': 'EXPERIMENTAL', 'description': 'Supervised exercise intervention of 12 months. One Taiji and one gym training per week for first six months followed by 6 months free independent use of municipal facilities, including gym, swimming hall and weight room. Written and oral health counselling provided.', 'interventionNames': ['Behavioral: Supervised physical exercise', 'Other: Health counselling']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Control group, without any induced exercise intervention. Written and oral health counselling provided.', 'interventionNames': ['Other: Health counselling']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Supervised physical exercise', 'description': 'Supervised physical exercises in Taiji and weight training. Free use and access into municipal recreation and training facilities for one year.', 'armGroupLabels': ['Exercise intervention group']}\n- {'type': 'OTHER', 'name': 'Health counselling', 'description': 'Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.', 'armGroupLabels': ['Control group', 'Exercise intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Risk of falls', 'description': 'Method of assessment; Personal fall diary. In case of fall, subject records the event into logbook. Outcome: Number of Falls during follow up.', 'timeFrame': 'Two years'}\n- {'measure': 'Risk of fall', 'description': 'Biweekly text message (SMS) question concerning recent falls during last 2 weeks (Reply:Yes/No). In a case of a positive reply, following phone call to the subject to validate the event. Outcome: Number of Falls during follow up.', 'timeFrame': 'Two years'}\n\nPlease estimate the sample size based on the assumption: \n5% error margin, 80% power, 3% annual mortality, 20% drop-out rate for intervention group, 16% drop-out rate for control group, 80% compliance", "answer": 914, "answer_type": "ACTUAL", "explanation": "Study power and sample size\n \n Fall rate and OSTPRE study data\n A primary outcome is falling. The entire OSTPRE-study cohort has been questioned for fall history in the preceding 12 months at 5-year intervals, most recently in 2014. At the 20-year questionnaire (in 2009), 35.0% of the OSTPRE women reported a fall during the last 12 months. Of these, 54.2% had fallen at least twice or more. Recent meta-analysis has reported very heterogeneous drop-out rates depending on factors such as geographic location, demography, duration and intensity of the protocol.14 Original estimation of the drop-outs, based on this meta-analysis, was set to 20% for the intervention group and 16% for the control group.\n \n \n Death rates\n Annual mortality in Finland from 2011 to 2012 was 2.5% for women aged 75\u00e2\u0080\u009379 years.4 Respondents of the OSTPRE cohort have had lower mortality than the national average. Therefore, the cumulative mortality was estimated to have been 10% for the last 5 years (n=2502\u00e2\u0080\u00932250).\n \n \n Summary of group sizes and study power\n The estimation was, with a 5% error margin, that 341 women in both groups would be required to give 80% power for detecting 31% fall reduction within a 30% general fall incidence during the 12-month follow-up. With a 3% annual mortality and 20% to 16% drop-out percentages for intervention and control samples, respectively, the estimated group sizes would be (341/0.77)+(341/0.81)=442+420. Adjusted for 80% compliance with mixed effects, the total group size was estimated to be 1078. However, the total final study population of 914 women (457 for each study group) presents an adequate sample size due to the significantly lower than estimated drop-out rate and a higher number of falls.", "id": 36, "split": "train"} +{"trial_id": "NCT02672345", "pmid": "33407763", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB\n\nIncluded conditions:\n- Inflammatory Response\n\nStudy Armgroups:\n- {'label': 'Sevoflurane Group', 'description': 'Group of patients receiving sevorane during extracorporeal circulation period.', 'interventionNames': ['Drug: Sevoflurane']}\n- {'label': 'Not Sevoflurane Group', 'description': 'Group of patients who did not receive the sevorane during extracorporeal circulation period.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sevoflurane', 'description': 'The Sevoflurane Group will receive between 0.7 and 1.5% of sevoflurane CAM only during CPB period. While Not Sevoflurane Group will receive only intravenous anesthetic agents.', 'armGroupLabels': ['Sevoflurane Group']}\n\nPrimary Outcomes:\n- {'measure': 'Reduction of systemic inflammatory response', 'description': 'Cytokines are assayed in both groups at 4 different times in order to check the impact of sevoflurane on the inflammatory response. The first one is the baseline of measurement with which the others are compared and all will be compared within and between groups.', 'timeFrame': 'Through study completion, an average of 1 year'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5%, power of 80%, and no inclusion of loss of follow-up due to intraoperative death.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size is based on the calculations performed from the data provided by the authors of an experimental article [2] whose difference in nanograms per milliliter is greater than 50% between the means of the groups that used or not the volatile anesthetic sevoflurane during the longest CPB applied by those authors (90\u00e2\u0080\u0089min) with a standard deviation (SD) of 30.71, a significance level of 5%, and a power of the sample of 80% generated from 100 patients causing a significant reduction in plasma PMN-elastase levels in the group that included sevoflurane in the gas circuit. Selected patients who die during the entire follow-up will be cited at the end of the trial and will remain in the study for a final analysis of the results. Therefore, the sample size calculation was consistent with the proposal to assess the inflammatory response by measuring PMN-elastase 90\u00e2\u0080\u0089min after the onset of CPB. We use the SPSS V.19.0 software.\n The analysis of subgroups of this study will be based on the cause and effect relationship between producing a reduction in the inflammatory response after 90\u00e2\u0080\u0089min of exposure to sevoflurane anesthetic during CPB and the intubation times, length of stay in the ICU, and length of hospital stay.\n Finally, loss of follow-up due to intraoperative death was not included, as the death rate in this period is very low for this type of procedure at the Dante Pazzanese Institute of Cardiology.", "id": 37, "split": "train"} +{"trial_id": "NCT02673931", "pmid": "34740932", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of a Glucagon-like-peptide-1 Agonist and Restrictive vs. Liberal Oxygen Supply in Patients Undergoing Coronary Artery Bypass Grafting or Aortic Valve Replacement - a 2-by-2 Factorial Designed, Randomized Clinical Study\n\nIncluded conditions:\n- Coronary Disease\n- Shock, Cardiogenic\n- Renal Failure\n- Stroke\n- Brain Injury\n- Aortic Valve Disease\n\nStudy Armgroups:\n- {'label': 'GLP-1', 'type': 'EXPERIMENTAL', 'description': '700 patients will be randomized to GLP-1, that will be administered as follows:\\n\\n248.5 mL of isotonic sodium chloride added 1.5 mL of 20% human albumin added 25 microg Byetta (Lilly, Exenatide).\\n\\nThe study drug infusion is initiated immediately before open heart surgery and ended after 6 hours and 15 minutes. A set dose of 17.4 microg will be given.', 'interventionNames': ['Drug: Byetta (Lilly, Exenatide)']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '20% Human Albumin is given as placebo. 700 patients will be randomized to placebo, that will be administered as follows:\\n\\n248.5 mL of isotonic sodium chloride added 1.5 mL of 20% human albumin.\\n\\nThe placebo infusion is initiated immediately before open heart surgery and ended after 6 hours and 15 minutes at the same rate as the study drug.', 'interventionNames': ['Drug: 20% Human Albumin']}\n- {'label': 'Restrictive Oxygenation', 'type': 'EXPERIMENTAL', 'description': \"The intervention is FiO2 of 50%, given as 'Conoxia (AGA, oxygen)'. 700 patients will be randomized to a FiO2 of 50% as long as the arterial O2 saturation (Sa02) remains above 91% during cardiopulmonary bypass, when weaning from and the following hour after weaning from cardiopulmonary bypass. The oxygenation strategy is discontinued and the patient is treated at the discretion of the attending physician after\\n\\n1. a maximum of 1 hours of intervention or\\n2. the patient is slid from the operating table to a hospital bed for transfer to the intensive care unit, whichever comes first.\", 'interventionNames': ['Drug: Conoxia (AGA, oxygen)']}\n- {'label': 'Liberal Oxygenation', 'type': 'ACTIVE_COMPARATOR', 'description': \"The intervention is a FiO2 of 100%, given as 'Conoxia (AGA, oxygen)'. 700 patients will be randomized to a FiO2 of 100% during cardiopulmonary bypass, when weaning from and the following hour after weaning from cardiopulmonary bypass. The oxygenation strategy is discontinued and the patient is treated at the discretion of the attending physician after\\n\\n1. a maximum of 1 hours of intervention or\\n2. the patient is slid from the operating table to a hospital bed for transfer to the intensive care unit, whichever comes first.\", 'interventionNames': ['Drug: Conoxia (AGA, oxygen)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Byetta (Lilly, Exenatide)', 'description': 'See description of arms', 'armGroupLabels': ['GLP-1'], 'otherNames': ['GLP-1 agonist']}\n- {'type': 'DRUG', 'name': 'Conoxia (AGA, oxygen)', 'description': 'See description arms', 'armGroupLabels': ['Liberal Oxygenation', 'Restrictive Oxygenation'], 'otherNames': ['Oxygen']}\n- {'type': 'DRUG', 'name': '20% Human Albumin', 'armGroupLabels': ['Placebo'], 'otherNames': ['Albumin']}\n\nPrimary Outcomes:\n- {'measure': 'Time in days to the first occurring of the following co-primary end-points throughout the follow-up period', 'description': '1. Death from any cause or\\n2. Any of the following adverse events\\n\\n 1. Renal failure requiring any type of renal replacement therapy\\n 2. Stroke, defined as persisting (\\\\>24 hours) of any neurological sign or symptom of neurological dysfunction as determined by the treating physician based on available clinical information or CT-scan\\n 3. New onset/worsening heart failure defined as need for mechanical circulatory support at the ICU, inability to close the sternotomy due to post-surgical hemodynamic instability and/or persistent (\\\\> 48 hours from initiation of first surgical procedure after randomization) need for inotropic hemodynamic support. In addition admission for heart failure during follow-up following discharge from the index admission.', 'timeFrame': 'Minimum 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 80% with a significance level (\u00ce\u00b1) of 0.05 (two-sided).", "answer": 1400, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n This parallel group trial investigates two interventions, and we plan to analyse these two interventions as two separate studies. The effect of the two interventions are not expected to interact, therefore, the design and sample size estimation did not account for such interaction. The study involving restrictive versus liberal oxygenation is subordinate to the study involving the GLP-1 analogue, and the potential interactions of the two interventions will be analysed in the GLP-1 analogue trial. Thus, the power calculations are based on the GLP-1 analogue intervention.\n The trial is event driven, aiming at 323 primary endpoints to be able to show a 25% reduction in the primary endpoint with a power of 80% at an \u00ce\u00b1-level of 0.05 (two sided). Based on cumulative event rates from the surgical register at Rigshospitalet (unpublished), a total of 1400 patients are needed to reach a total of 323 events during follow-up. We will include 1400 patients in the trial. We will follow all patients until 323 events have been reached and the last patient has been followed for a minimum of 12 months. Accordingly, the follow-up period will vary from approximately 6 years from the earliest included patients to 12 months for the last included patient.", "id": 38, "split": "train"} +{"trial_id": "NCT02683902", "pmid": "30012180", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Hypocaloric Diet Associated With tDCS on Weight Loss and Metabolic Profile: a Pilot, Double Blind, Randomized, Placebo-controlled Study\n\nIncluded conditions:\n- Prediabetes\n- Obesity\n- Weight Loss\n- Diabetes\n- Overweight\n\nStudy Armgroups:\n- {'label': 'Active tDCS + Diet', 'type': 'ACTIVE_COMPARATOR', 'description': 'The participants will receive active tDCS treatment every day for 5 days per week, a total of 20 sessions. They will also be prescribed a hypocaloric dietary during these 4-week treatment.', 'interventionNames': ['Device: Active tDCS', 'Behavioral: Hypocaloric diet']}\n- {'label': 'Sham tDCS + Diet', 'type': 'SHAM_COMPARATOR', 'description': 'The participants will receive sham tDCS treatment every day for 5 days per week, a total of 20 sessions. They will also be prescribed a hypocaloric dietary during these 4-week treatment.', 'interventionNames': ['Behavioral: Hypocaloric diet', 'Device: Sham tDCS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Active tDCS', 'description': 'The anode electrode will be placed over F4 position and the cathode electrode over F3, right and left respectively (using EEG 10/20 system). The electric current will be ramped up until it reaches 2 milliampere (mA), and subjects will be stimulated for 20 min.', 'armGroupLabels': ['Active tDCS + Diet'], 'otherNames': ['Active']}\n- {'type': 'BEHAVIORAL', 'name': 'Hypocaloric diet', 'description': 'A hypocaloric dietary prescription and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment.', 'armGroupLabels': ['Active tDCS + Diet', 'Sham tDCS + Diet'], 'otherNames': ['Diet']}\n- {'type': 'DEVICE', 'name': 'Sham tDCS', 'description': 'The electrodes will be placed at the same positions as in active stimulation; however, the device will be turned off after 30 s of stimulation.', 'armGroupLabels': ['Sham tDCS + Diet'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Weight loss', 'description': '3% weight loss', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level (\u03b1) of 0.05, and an additional 40% of participants to account for possible dropouts.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated on the basis of a significant reduction in the amount of calories ingested after a single 20-minute session of active tDCS (F1,8\u00c2\u00a0=\u00e2\u0080\u00898.4, p\u00c2\u00a0=\u00e2\u0080\u00890.02, \u00ce\u00b7p2\u00c2\u00a0=\u00e2\u0080\u00890.5) [12]. Three types of analysis were performed using G*Power 3.1.9.2\u00c2\u00ae software, considering a power of 80% and an \u00ce\u00b1 of 0.05, as follows: effect size (f)\u00e2\u0080\u0089=\u00e2\u0080\u00891.0, 10 subjects; effect size (f)\u00e2\u0080\u0089=\u00e2\u0080\u00890.8, 12 subjects; and effect size (f)\u00e2\u0080\u0089=\u00e2\u0080\u00890.6, 20 subjects. In another study, a 14.2% reduction in the amount of calories ingested was observed after 8 consecutive days of active tDCS sessions. The authors considered a medium effect size (d)\u00e2\u0080\u0089>\u00e2\u0080\u00891.09 as sufficient for their findings [13]. Following these assumptions, a total of at least ten subjects would be required in each group to detect a medium-sized effect. Because of possible dropouts, we will include an additional 40% of participants in this study.", "id": 39, "split": "train"} +{"trial_id": "NCT02687555", "pmid": "29961004", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Role of Computerized Training in Post-Traumatic Stress Disorder\n\nIncluded conditions:\n- Post-Traumatic Stress Disorder\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Computerized Cognitive Bias Modification of Appraisals (CBM-App), developed from that used by Woud et al. (2012,2013). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.', 'interventionNames': ['Behavioral: Cognitive Bias Modification of Appraisals (CBM-App)']}\n- {'label': 'Control', 'type': 'SHAM_COMPARATOR', 'description': 'Computerized Peripheral Vision Task (PVT), developed from that used by Calkins et al. (2015). The intervention comprises 8 sessions completed over a period of 2 weeks. The training takes place while participants are also receiving specialized inpatient treatment for PTSD at the Clinic for Psychosomatic Medicine and Psychotherapy, LWL University Clinic of Ruhr University of Bochum.', 'interventionNames': ['Behavioral: Peripheral Vision Task (control condition)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive Bias Modification of Appraisals (CBM-App)', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Peripheral Vision Task (control condition)', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Dysfunctional trauma-related appraisals as measured using an open-ended ambiguous scenarios task', 'timeFrame': 'Post-intervention (~ 2 weeks post-baseline)'}\n\nPlease estimate the sample size based on the assumption: \nThe power calculation was based on 80% power at a significance level of p=0.05, with an allowance for up to 15% attrition.", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size\n Sample size was informed by a power calculation to find a between-group effect of d=0.70, with 80% power at p=0.05. A meta-analysis by Hallion and Ruscio54 found an effect size of g=0.81 for the effect of CBM on interpretation bias. We took a more conservative estimate of d=0.70, requiring 35 participants per group. To allow for up to 15% attrition, we planned to recruit 80 participants.", "id": 40, "split": "train"} +{"trial_id": "NCT02701608", "pmid": "32665381", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus (Relais Oral Dans le Traitement Des Endocardites \u00e0 Staphylocoques Multi-sensibles)\n\nIncluded conditions:\n- Infective Endocarditis\n\nStudy Armgroups:\n- {'label': 'Oral switch treatment', 'type': 'EXPERIMENTAL', 'description': 'Oral switch to the combination of levofloxacin and rifampicin', 'interventionNames': ['Drug: Levofloxacin', 'Drug: Rifampicin']}\n- {'label': 'Conventional IV treatment according to european guidelines', 'type': 'ACTIVE_COMPARATOR', 'description': 'Conventional IV treatment of staphylococci IE (European guidelines 2015)', 'interventionNames': ['Procedure: Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Levofloxacin', 'description': 'levofloxacin 500 mg x1/day (for patients \u226470kg) or levofloxacin 750 mg x1/day (for patients \\\\>70kg)', 'armGroupLabels': ['Oral switch treatment'], 'otherNames': ['Fluoroquinolones']}\n- {'type': 'DRUG', 'name': 'Rifampicin', 'description': 'rifampicin 600mg x1/day (for patients \u226470kg) or rifampicin 900mg x1/day (for patients \\\\>70kg)', 'armGroupLabels': ['Oral switch treatment']}\n- {'type': 'PROCEDURE', 'name': 'Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine', 'description': 'Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine', 'armGroupLabels': ['Conventional IV treatment according to european guidelines']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment failure', 'description': 'Failure is a composite outcome defined by death from all causes and/or symptomatic embolic events and/or unplanned valvular surgery and/or a microbiological relapse (with the primary pathogen).', 'timeFrame': 'up to 3 months after the end of antibiotic treatment'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided type I error of 2.5%, a power of 80%, and an expected dropout rate of 10%.", "answer": 324, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculations are based on a null hypothesis of H0: \u00cf\u00802\u00e2\u0080\u0093\u00cf\u00801\u00e2\u0089\u00a5delta (ie, inferior); where \u00cf\u00801 is the proportion of patients expected to experience failure in the intravenous group, \u00cf\u00802 is the proportion in the oral switch group, and the non-inferiority margin delta is 10%. The alternative hypothesis is \u00cf\u00802\u00e2\u0080\u0093\u00cf\u0080180% power, and a two-sided significance level of \u03b1 = 0.05, using the continuity-corrected chi-squared test for proportions.", "answer": 300, "answer_type": "ACTUAL", "explanation": "Power and sample size estimate\n The primary efficacy endpoint of this study is the proportion of patients who achieve any reduction in ICS or OCS dose from baseline to week 48. It is estimated that up to 10% of the patients in the symptom-based algorithm (control) group will achieve a reduction in ICS or OCS. Operating characteristics for achieving additional reductions in the biomarker-based algorithm (active intervention) group are provided in Table\u00c2\u00a06, with 200, 300, and 400 subjects with each scenario assuming a patient drop-out rate of 20% by week 48 with\u00e2\u0080\u0089>\u00e2\u0080\u008980% power at the two-sided \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 significance level with use of the continuity-corrected chi-squared test for proportions.Table 6Operating characteristics for detecting differences in the primary endpointTotal N(intervention\u00e2\u0080\u0089+\u00e2\u0080\u0089control)RatioType 1 errorProportion of patients achieving a reduction in ICS or OCSPowerControlInterventionDifference400 (320\u00e2\u0080\u0089+\u00e2\u0080\u008980)4:10.0510%26%16%83%300 (240\u00e2\u0080\u0089+\u00e2\u0080\u008960)4:10.0510%29%19%83%200 (160\u00e2\u0080\u0089+\u00e2\u0080\u008940)4:10.0510%34%24%83%Assumes a 20% drop out rateICS inhaled corticosteroid, OCS oral corticosteroid\n Efficacy analyses will be conducted on an intent-to-treat (ITT) population consisting of all randomised participants who completed at least one post-baseline efficacy assessment, with patients allocated to the group to which they were randomised. The number and proportion of patients who enrol, discontinue, and complete the study will be tabulated by the Trial Management Group. Reasons for early termination from the study will be listed and summarised by Trial Management Group. Any eligibility criteria exceptions and other major protocol deviations will also be summarized by the Trial Management Group. A full CONSORT diagram (Fig.\u00c2\u00a01) will be produced for the study including patients screened and reason for screen failure. Demographic and baseline characteristics (e.g. age, sex, ethnicity, weight, FEV1) will be summarized for all randomised patients by the Trial Management Group using descriptive statistics.Fig. 1CONSORT diagram displaying flow of patients through the RASP-UK biomarker study", "id": 42, "split": "train"} +{"trial_id": "NCT02721420", "pmid": "30029620", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-Piperaquine for the Post-discharge Management of Severe Anaemia in Children Less Than 5 Years in Malawi\n\nIncluded conditions:\n- Malaria\n- Severe Anemia\n\nStudy Armgroups:\n- {'label': 'Drug + short message(SMS) reminder', 'type': 'OTHER', 'description': 'dihydroartemesinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with SMS reminders prior to each treatment course', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine', 'Other: short message(SMS) reminder']}\n- {'label': 'Drug + no short message(SMS) reminder', 'type': 'OTHER', 'description': 'dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) without SMS reminders prior to each treatment course.', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine']}\n- {'label': 'Drug+ Health worker reminder', 'type': 'OTHER', 'description': 'dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with Health surveillance assistants reminders prior to each treatment course.', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine', 'Other: Health worker reminder']}\n- {'label': 'Drug at hospital + SMS reminder', 'type': 'OTHER', 'description': 'dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department without an SMS reminders prior to each treatment course.', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine']}\n- {'label': 'Drug at Hospital+no SMS reminder', 'type': 'OTHER', 'description': 'dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department with a short message reminder prior to each treatment course', 'interventionNames': ['Drug: dihydroartemisinin-piperaquine', 'Other: message(SMS) reminder']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'dihydroartemisinin-piperaquine', 'armGroupLabels': ['Drug + no short message(SMS) reminder', 'Drug + short message(SMS) reminder', 'Drug at Hospital+no SMS reminder', 'Drug at hospital + SMS reminder', 'Drug+ Health worker reminder']}\n- {'type': 'OTHER', 'name': 'message(SMS) reminder', 'armGroupLabels': ['Drug at Hospital+no SMS reminder']}\n- {'type': 'OTHER', 'name': 'Health worker reminder', 'description': 'Health surveillance assistants reminders prior to each treatment course', 'armGroupLabels': ['Drug+ Health worker reminder']}\n- {'type': 'OTHER', 'name': 'short message(SMS) reminder', 'armGroupLabels': ['Drug + short message(SMS) reminder']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of those with 100 % uptake of PMC drugs during the 15 weeks of the study period.', 'description': '100 % uptake is defined as administration of all study drugs and compliance to study visits during the course of 15 weeks.', 'timeFrame': '15 weeks'}\n\nPlease estimate the sample size based on the assumption: \nICC of 0.1, 10% loss-to-follow-up, 80% power, significance level (\u03b1) of 0.05", "answer": 375, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation has been adjusted for the design effect using the coefficient of variation method in order to account for the Intra-cluster Correlations (ICC) [15, 16]. We assumed that the cluster sizes would be uniformly distributed between 2 and 4 children [2, 4]. This gives a mean cluster size of 3 children per village per year and a standard deviation of cluster sizes of 0.58. Hence the coefficient of variation of cluster sizes (CV) is 0.58/3\u00e2\u0080\u0089=\u00e2\u0080\u00890.19 and CV2\u00c2\u00a0=\u00e2\u0080\u00890.036. Assuming an intra-cluster correlation coefficient (ICC) of 0.1 and allowing for 10% loss-to-follow-up, a sample size of 25 clusters (villages) of an average of 3 children per village (75 children per arm, N\u00e2\u0080\u0089=\u00e2\u0080\u0089375 overall (for 125 clusters for the 5 arms)) has 80% power to detect a 25% absolute increase in uptake from an estimated 50% in the OPD and delivery at home groups to 75% in the arms supported by SMS reminders (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05). The ICC of 0.1 is slightly more conservative than the ICC in a previous trial of delivery approaches for IPTc in the Gambia.", "id": 43, "split": "train"} +{"trial_id": "NCT02726087", "pmid": "29454380", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Health-related Quality of Life, Satisfaction and Outcomes After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement. A Randomized Controlled Trial (QUALITY-AVR TRIAL)\n\nIncluded conditions:\n- Aortic Valve Stenosis\n- Heart Valve Diseases\n- Aortic Valve Disease\n\nStudy Armgroups:\n- {'label': 'ministernotomy', 'type': 'EXPERIMENTAL', 'description': 'Minimally invasive aortic valve replacement with Partial \"J\" upper hemisternotomy through right 4th intercostal space, performed according to current standard of care practice.', 'interventionNames': ['Procedure: ministernotomy']}\n- {'label': 'full sternotomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Full sternotomy AVR through a standard median sternotomy, performed according to current standard of care practice.', 'interventionNames': ['Procedure: Full sternotomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'ministernotomy', 'description': 'Partial upper \"J\" hemisternotomy trough 4th right intercostal space)', 'armGroupLabels': ['ministernotomy']}\n- {'type': 'PROCEDURE', 'name': 'Full sternotomy', 'description': 'Conventional full median sternotomy', 'armGroupLabels': ['full sternotomy']}\n\nPrimary Outcomes:\n- {'measure': 'Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L\u00ae Index at 1, 6 or 12 months', 'description': 'Questionnaire EQ-5D-5L\u00ae for quality of life', 'timeFrame': 'baseline-1-6-12 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha error of 0.05, beta error of 0.1, power of 90%, and a standard deviation of 0.15 for the EQ-5D-5L index were used for the calculations.", "answer": 96, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n A review of previous work [28, 29] shows that the standard deviations of the EQ-5D-5\u00c2\u00a0L\u00c2\u00ae index in cardiovascular disease varies between 0.10 and 0.22, while VAS score varies between 8 and 21 depending on the severity. Likewise, in the only (multicentre) study [17] that determines quality of life in aortic stenosis, the standard deviation for high-risk patients scheduled for AVR was 0.17 in patients randomised to FS versus TAVI. For these reasons, on summary of all previous work, we used a standard deviation of 0.15 for the EQ-5D-5\u00c2\u00a0L\u00c2\u00ae index to calculate the sample size.\n In QOL studies, it is not only important to ascertain whether there are significant differences, but also to know if these differences are clinically relevant. This is why the concept of the minimal important difference (MID) was created, which in previous research among patients with cancer was 0.08 points on the EQ-5D index and 7\u00e2\u0080\u009311 points on the VAS [29], and in patients with stroke it was 0.10 points on the EQ-index (95% CI 0.08\u00e2\u0080\u00930.12) [28]. This difference was also 0.06 points (95% CI 0.02\u00e2\u0080\u00930.10) on the EQ index during the first month in the PARTNER 1 study (transfemoral TAVI versus FS) [17], and 0.12 (95% CI 0.08\u00e2\u0080\u00930.16) in the CoreValve PIVOTAL trial study [18]. As there was no existing specific calculation of MID for cardiology patients with severe aortic stenosis, we arbitrarily established the interval of 0.10 points on the EQ-5D index (the mean value from previous studies) as the clinically relevant difference to detect. Thus, to detect an MID of at least 0.10 points in the QOL scale EQ-5D-5\u00c2\u00a0L\u00c2\u00ae index, with alpha error of 0.05, beta error of 0.1 and power of 90% for two-tailed contrast of two independent means (SD 0.15), two groups of 48 patients are necessary to provide a minimum of 96 patients. In view of possible losses to follow up, 100 patients will be randomised. If patients drop out or are excluded during the study, additional patients will be recruited until a minimum of 96 patients is achieved, and inclusion of an additional patient will be considered again for each patient not completing the 1-year follow-up assessment.", "id": 44, "split": "train"} +{"trial_id": "NCT02729779", "pmid": "31122227", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of the Pilates Method Versus Aerobic Exercises in the Treatment of Chronic Non-specific Low Back Pain in the Elderly: Randomized Controlled Trial\n\nIncluded conditions:\n- Low Back Pain\n\nStudy Armgroups:\n- {'label': 'Pilates Group', 'type': 'EXPERIMENTAL', 'description': 'Elderly will be submitted to a specific exercise program of modified Pilates method performed in the mat and apparatus. In the first session, participants will receive basic guidance on the Pilates training and activation of the power house. The session will be divided in: global warming and stretching (5 minutes), Pilates exercises for upper and lower limbs, abdomen and spine (45 minutes), global stretching (5 minutes) and local relaxing massage (5 minutes).The session will consist of a minimum of 5 exercises and a maximum of 15 Pilates exercises. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.', 'interventionNames': ['Other: Pilates Group']}\n- {'label': 'Aerobic Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The Aerobic Group will be submitted to an exercise program with global stretching (for lower and upper limbs and column with two repetitions and 30 seconds of maintenance in each segment) for 10 minutes, walking on a treadmill for 20 to 40 minutes and relaxing massage for 5 minutes. The intensity of the effort during walking on a treadmill will be based on a combination of heart rate (based on the percentage of maximum heart rate: 208 - (0.7 x age)) and rate of perceived effort assessed by the Borg scale. Exercise will be performed respecting the fraction of 50-75% of maximum heart rate and levels between 12 to 13 (moderate intensity) of the Borg scale. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.', 'interventionNames': ['Other: Aerobic Group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Pilates Group', 'description': 'Elderly will be submitted to a specific exercise program of modified Pilates method performed in the mat and apparatus. In the first session, participants will receive basic guidance on the Pilates training and activation of the power house. The session will be divided in: global warming and stretching (5 minutes), Pilates exercises for upper and lower limbs, abdomen and spine (45 minutes), global stretching (5 minutes) and local relaxing massage (5 minutes).The session will consist of a minimum of 5 exercises and a maximum of 15 Pilates exercises. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.', 'armGroupLabels': ['Pilates Group']}\n- {'type': 'OTHER', 'name': 'Aerobic Group', 'description': 'Elderly will be submitted to an exercise program with global stretching (for lower and upper limbs and column with two repetitions and 30 seconds of maintenance in each segment) for 10 minutes, walking on a treadmill for 20 to 40 minutes, and relaxing massage for 5 minutes. The intensity of the effort during walking on a treadmill will be based on a combination of heart rate (based on the percentage of maximum heart rate: 208 - (0.7 x age)) and rate of perceived effort assessed by the Borg scale. Exercise will be performed respecting the fraction of 50-75% of maximum heart rate and levels between 12 to 13 (moderate intensity) of the Borg scale. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.', 'armGroupLabels': ['Aerobic Group']}\n\nPrimary Outcomes:\n- {'measure': 'Pain intensity', 'description': 'Pain intensity will be measured by an 11-point Pain Numerical Rating Scale', 'timeFrame': 'Eight weeks after randomization'}\n- {'measure': 'Disabitity', 'description': 'Disability associated with low back pain will be measured using the 24-item Roland Morris Disability Questionnaire', 'timeFrame': 'Eight weeks after randomization'}\n\nPlease estimate the sample size based on the assumption: \ntwo-tailed t-test, \u03b1=0.05, power=80%, 15% loss to follow-up", "answer": 74, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study was designed to detect a clinically significant 2-point difference in pain intensity assessed by the Pain Numerical Rating Scale (estimate for standard deviation\u00e2\u0080\u0089=\u00e2\u0080\u00892.5) and a 5-point difference in disability assessed by the Roland Morris Disability Questionnaire (estimate for standard deviation\u00e2\u0080\u0089=\u00e2\u0080\u00896.5) [49, 50] eight weeks after randomization, using a two-tailed t-test of difference between means and assuming \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, statistical power of 80% [51], and loss to follow-up of 15%. Estimations indicated that 34 patients per group will be required using pain intensity to calculate sample size, and 37 patients per group using disability. Therefore, the biggest number resulting from sample size calculation will be considered, which corresponds to 74 patients. To reach this number, the study will be promoted in community newspapers and on the internet.", "id": 45, "split": "train"} +{"trial_id": "NCT02734420", "pmid": "30985667", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial\n\nIncluded conditions:\n- Dental Caries\n\nStudy Armgroups:\n- {'label': 'PapacarieMBlue and PDT', 'type': 'EXPERIMENTAL', 'description': 'Initial periapical and interproximal radiographs; Microbiological sample with otoscope curette to standardize volume of carious tissue; Application on PapacarieMBlue (addition of toluidine blue) for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with non-cutting curette; No removal of carious tissue on pulp floor; Irradiation of dental tissue for one minute on a single point; Second microbiological sample of remaining dentin with curette; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); Follow up: Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.', 'interventionNames': ['Drug: PapacarieMBlue and PDT', 'Device: Laser']}\n- {'label': 'Toluidine Blue O and PDT', 'type': 'EXPERIMENTAL', 'description': 'Initial periapical and interproximal radiographs;Microbiological sample with otoscope curette to standardize volume of carious tissue;Application of Toluidine Blue O for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with sharp curette; No removal of carious tissue on pulp floor;non-cutting curette; Irradiation of dental tissue for one minute on a single point;Second microbiological sample of remaining dentin with curette; Follow up; Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.', 'interventionNames': ['Drug: Toluidine Blue O and PDT', 'Device: Laser']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'PapacarieMBlue and PDT', 'description': 'Initial periapical and interproximal radiographs Microbiological sample with otoscope curette to standardize volume of carious tissue; Application on PapacarieMBlue (addition of toluidine blue) for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with non-cutting curette; No removal of carious tissue on pulp floor; Irradiation of dental tissue for one minute on a single point; Second microbiological sample of remaining dentin with curette; Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.', 'armGroupLabels': ['PapacarieMBlue and PDT'], 'otherNames': ['Photodynamic therapy and lower level laser therapy']}\n- {'type': 'DRUG', 'name': 'Toluidine Blue O and PDT', 'description': 'Initial periapical and interproximal radiographs;Microbiological sample with otoscope curette to standardize volume of carious tissue;Application of Toluidine Blue O for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with sharp curette; No removal of carious tissue on pulp floor;non-cutting curette; Irradiation of dental tissue for one minute on a single point;Second microbiological sample of remaining dentin with curette;Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE);Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.', 'armGroupLabels': ['Toluidine Blue O and PDT'], 'otherNames': ['Photodynamic therapy and lower level laser therapy']}\n- {'type': 'DEVICE', 'name': 'Laser', 'armGroupLabels': ['PapacarieMBlue and PDT', 'Toluidine Blue O and PDT']}\n\nPrimary Outcomes:\n- {'measure': 'Microbiological analysis - collection of dentinal tissue and restoration with glass ionomer cement', 'description': 'Based on a study by Guglielmi et al. (2011)(30) teeth with be selected (n = 48) and divided into three groups, as delineated in Chart 4. Fragments of dentinal tissue will be collected from all teeth before and after treatment for microbiological analysis. The teeth will be restored with glass ionomer cement in all cases.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nPaired samples, significance level (\u03b1) = 1.96 (5%), power (\u03b2) = 0.84 (20%), and 80% test power.", "answer": 3, "answer_type": "ESTIMATED", "explanation": "3.1.8\n Sample size\n The sample size will be calculated based on a previous study in the literature[30] (Fig. 1), considering the expected difference and standard deviation and weighting colony forming units (CFU) of bacteria. For the statistical calculation, paired samples were considered, with \u00ce\u00b1\u00e2\u0080\u008a=\u00e2\u0080\u008a1.96 (5%); \u00ce\u00b2\u00e2\u0080\u008a=\u00e2\u0080\u008a0.84 (20%), and an 80% test power. The minimum number in this clinical trial was determined to be 16 teeth per group (Fig. 2).\n \n Figure 1\n \n Sample size calculation used for this clinical research.\n \n \n \n \n Figure 2\n \n Determination of the sample size for this clinical research.", "id": 46, "split": "train"} +{"trial_id": "NCT02736526", "pmid": "36855155", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia\n\nIncluded conditions:\n- Moderate Intermittent Exotropia\n\nStudy Armgroups:\n- {'label': 'Surgical treatment', 'type': 'EXPERIMENTAL', 'description': 'The recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial.', 'interventionNames': ['Procedure: recession or resection of the horizontal extraocular muscles']}\n- {'label': 'Observation only', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'recession or resection of the horizontal extraocular muscles', 'armGroupLabels': ['Surgical treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Ocular alignment (Prism alternative cover test)', 'timeFrame': '5 years'}\n- {'measure': 'Binocular stereopsis at distance and near (Random dot stereopsis test)', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \n5% type I error, 80% power, 30% dropout rate.", "answer": 280, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size for this study was calculated based on a standard two-sided trial with a continuous outcome, and the calculations assume 5% type I error with 80% power. According to an average 30% dropout rate in long-term follow-up period, we anticipate that we will require 280 total participants.", "id": 47, "split": "train"} +{"trial_id": "NCT02747251", "pmid": "29499710", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Additional Home-based Strengthening Exercises in Shoulder Impingement Rehabilitation (The SEXSI-Trial): A Pragmatic Randomized Controlled Trial.\n\nIncluded conditions:\n- Subacromial Impingement Syndrome\n\nStudy Armgroups:\n- {'label': 'Strengthen your Shoulder & Usual Care', 'type': 'EXPERIMENTAL', 'description': 'Instructions in a home-based intervention consisting of progressive high volume resistance training with an elastic band. Instructions provided 0, 2, 5, and 10 weeks after baseline. Usual care includes all treatment received by a patient during the time between baseline and follow-up, except that included in \"Strengthen your Shoulder\".', 'interventionNames': ['Other: Strengthen your Shoulder', 'Other: Usual Care']}\n- {'label': 'Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Includes all treatment received by a patient during the time between baseline and follow-up, except that included in \"Strengthen your Shoulder\".', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Strengthen your Shoulder', 'description': 'A simple home-based elastic band strengthening exercise intervention. This program consists of progressive high volume resistance training exercises with an elastic band.', 'armGroupLabels': ['Strengthen your Shoulder & Usual Care']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Usual care, consisting of a referral to general rehabilitation in the municipal under the Danish Health Act \u00a7 140, most often with the alternative option to choose a private physiotherapeutic clinic, partly at their own expense. Also includes any additional treatment the patient receives between baseline and follow-up, except that included in \"Strengthen your Shoulder\".', 'armGroupLabels': ['Strengthen your Shoulder & Usual Care', 'Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'SPADI', 'description': 'Shoulder Pain And Disability Index score (continuous)\\n\\nFor all continuous outcomes with Time Frame 16 weeks, a constrained Linear Mixed Model (cLMM) is applied to compare the change from baseline to 16 weeks in the intervention group (IG) to that in the control group (CG), with the outcome at 16 weeks as dependent variable, treatment group (IG or CG) as main effect and both baseline score and any additional follow up measurements as repeated measurements. The covariance structures will be selected based on the MAICE procedure. These analyses will be conducted as intention to treat (ITT) analyses, including all randomized participants, regardless of protocol adherence. Participants will be analysed as randomized.', 'timeFrame': '16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 5% and a power of 95% are assumed. The impact of dropouts is considered, with a power of 89.7% for a 20% dropout rate and 85.4% for a 40% dropout rate.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size estimation is based on the primary outcome SPADI. Studies on patients with SIS have shown standard deviations (SD) for SPADI change score after 11\u00e2\u0080\u009312 weeks of between 17 [12] and 18.5 [56], while longer durations seem to entail larger SDs, with a SD of 22 reported for SPADI change from 0 to 22 weeks [12]. The latter is similar to our own unpublished data from SIS patients, showing a SD of 22.5 for SPADI change from 0 to 6 months. Based on this previous data, we expect a common SD of 19.5 for SPADI change values from week 0 to 16, the primary outcome. For the purpose of this study, the MCID for SPADI will be considered to be 10 points, based on previous studies [45, 48]. The negative effect that any dropouts will have on the statistical power will, to some degree, be reduced by the use of multiple imputation. However, the imputation of data will not fully redeem this, as multiple imputation can cause an underestimation of the effect and a larger variation in outcomes. Therefore, we aim at having a high power of 95% to verify an effect equal to or higher than the MCID of 10 points on SPADI, at a 5% significance level. To obtain this, a total of 200 patients will be required (100 in each group). This corresponds to a power of 89.7% in case of a 20% dropout and a power of 85.4% in case of a 40% dropout.", "id": 48, "split": "train"} +{"trial_id": "NCT02755623", "pmid": "31014369", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Structural and Functional Correlates of Clinical Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Schizophrenia Patients With Resistant Auditory Hallucinations\n\nIncluded conditions:\n- Schizophrenia\n\nStudy Armgroups:\n- {'label': 'Active Repetitive Transcranial Magnetic Stimulation (rTMS)', 'type': 'ACTIVE_COMPARATOR', 'description': 'low-frequency (1 Hertz) rTMS', 'interventionNames': ['Device: Repetitive Transcranial Magnetic Stimulation (rTMS)']}\n- {'label': 'Sham Repetitive Transcranial Magnetic Stimulation (rTMS)', 'type': 'SHAM_COMPARATOR', 'description': 'sham TMS', 'interventionNames': ['Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Repetitive Transcranial Magnetic Stimulation (rTMS)', 'description': 'Participants are sequentially randomly assigned to either 20 active rTMS sessions or 20 sham rTMS sessions that were applied over the left temporoparietal junction. Treatments are administered daily, over a period of two weeks.', 'armGroupLabels': ['Active Repetitive Transcranial Magnetic Stimulation (rTMS)']}\n- {'type': 'DEVICE', 'name': 'Sham Repetitive Transcranial Magnetic Stimulation (rTMS)', 'armGroupLabels': ['Sham Repetitive Transcranial Magnetic Stimulation (rTMS)']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in the integrity of white matter tracts between responder and non-responder patients', 'timeFrame': 'Baseline'}\n- {'measure': 'Changes in the variations of the blood-oxygen-dependent level (BOLD) signal between responder and non-responder patients', 'timeFrame': 'Baseline'}\n\nPlease estimate the sample size based on the assumption: \nAn \u03b1 risk of 0.05, a 1-\u03b2 power of 0.80, and an estimated 10% dropout rate were assumed.", "answer": 45, "answer_type": "ESTIMATED", "explanation": "Sample size\n The aim of this trial is to investigate the difference in brain functional and structural connectivity in schizophrenia patients receiving an active rTMS treatment and clinically responding to it or not as assessed by an amelioration of their AVH symptoms. Therefore, the sample size was calculated to determine the number of patients to be included in the active rTMS group on the basis of the primary outcome, namely the difference in FA values at baseline between \u00e2\u0080\u0098responders\u00e2\u0080\u0099 and \u00e2\u0080\u0098non-responders\u00e2\u0080\u0099. Unfortunately, no study provides a significant difference of rs-fMRI measures or FA values for a given tract (such as the left arcuate fasciculus) before and following a clinically effective versus a non-clinically effective rTMS treatment in schizophrenia patients, which would allow us to accurately estimate the adequate sample size for our trial. Nonetheless, FA values are highly reproducible and have a reliable estimation of variance. Therefore, we focused on FA values to determine sample size. Therefore, on the basis of a significant difference in the FA values between schizophrenia patients and healthy subjects for the left arcuate fasciculus [51] and assuming an \u00ce\u00b1 risk of 0.05 and a 1-\u00ce\u00b2 power of 0.80, we estimated the need to include 32 patients for the active rTMS group. To overcome an estimated 10% drop-out, we increased our recruitment needs for active rTMS group to 35 patients. Given a proportion of \u00e2\u0080\u0098responders\u00e2\u0080\u0099 and \u00e2\u0080\u0098non-responders\u00e2\u0080\u0099 to rTMS treatment as the one we propose for AVH in schizophrenia estimated at 40% and 60%, respectively [52], we will divide our cohort into 14 \u00e2\u0080\u0098responders\u00e2\u0080\u0099 and 21 \u00e2\u0080\u0098non-responder\u00e2\u0080\u0099 patients. According to a prior study [22], a minimum of 14 participants per group (\u00e2\u0080\u0098responders\u00e2\u0080\u0099 or \u00e2\u0080\u0098non-responders\u00e2\u0080\u0099) has been deemed sufficient to conduct statistical analysis in neuroimaging and detect a significant effect of rTMS on brain structural connectivity. Moreover, a sham rTMS group of 10 patients will be followed in parallel to control for the placebo rTMS effect on AVH. As a result, the total number of participants required for the study is of 45 patients.", "id": 49, "split": "train"} +{"trial_id": "NCT02757794", "pmid": "34517869", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial\n\nIncluded conditions:\n- Children Born Extremely Premature\n- Disturbance of Visuo-spatial Working Memory\n\nStudy Armgroups:\n- {'label': 'Cognitive remediation parents', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: computerized cognitive remediation program']}\n- {'label': 'Remediation standard', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Other: standard remediation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'computerized cognitive remediation program', 'description': 'a computer program online re-educating the working memory is completed by the parents and the child. The child made a series of interactive exercises accompanied by parents or a practitioner. The exercises are adapted automatically and individually to the performance at each session.', 'armGroupLabels': ['Cognitive remediation parents']}\n- {'type': 'OTHER', 'name': 'standard remediation', 'description': 'A speech therapy and / or academic support is realized.', 'armGroupLabels': ['Remediation standard']}\n\nPrimary Outcomes:\n- {'measure': 'Increase of the measuring index visuospatial', 'description': 'This index consists of two subtests : block design and object assembly. The average score is 100 with a standard deviation of 15.', 'timeFrame': '18 months (more or less 2 months) post inclusion'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an 80% power, a significance level of 0.05, and a 15% dropout rate.", "answer": 166, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was calculated to obtain an 80% power to detect a difference of 7.5 points on the VSI index (estimated standard deviation: 15) at 18\u00e2\u0080\u0089months (+/\u00e2\u0088\u0092\u00e2\u0080\u00892\u00e2\u0080\u0089months) between the two groups. This has been considered to be clinically significant considering other similar studies [5]. With the threshold for statistical significance set at a p-value of 0.05, assuming that a potential 15% of patients will be lost to follow-up between baseline and last assessments, these calculations showed that 166 patients are needed (83 per group [Power Analysis and Sample Size Software Version 2008, Utah, USA]). Assuming that 30\u00e2\u0080\u009340% of the EPIPAGE 2 children will present with a WM abnormality, 1600 children will be required for screening.", "id": 50, "split": "train"} +{"trial_id": "NCT02758418", "pmid": "29855281", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of an Internet-based CBT Program for Adjustment Disorders: A Randomized Controlled Trial\n\nIncluded conditions:\n- Online Computerized Program Group\n- Waiting List Control Group\n\nStudy Armgroups:\n- {'label': 'Online Computerized Program group.', 'type': 'EXPERIMENTAL', 'description': 'Intervention group that uses \"TAO\" program.', 'interventionNames': ['Other: TAO']}\n- {'label': 'Waiting list control group.', 'type': 'NO_INTERVENTION', 'description': 'Participants of this group are able to access the treatment program after 7 weeks of waiting period. After this waiting period of 7 weeks, those participants still interested in receiving assistance are randomly assigned to one of two intervention conditions (Online Computerized Program group or Bibliotherapy group).'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'TAO', 'description': '\"TAO\" is a self-applied online treatment program and consists on the computerized version of the traditional CBT protocol for Adjustment Disorders.\\n\\nThe treatment protocol comprises different therapeutic components (see section Intervention) which are presented to the patients through 7 modules (one of them introductory). The Internet platform allows audiovisual resources (videos, illustrations, music and exercises that provide quick feedback) to be included, that makes the program more interactive.', 'armGroupLabels': ['Online Computerized Program group.'], 'otherNames': ['TAO: Adjustment Disorders Online', 'Online Computerized CBT for Adjustment Disorders', 'Internet-based CBT for Adjustment Disorders']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Beck Depression Inventory - Second Edition (BDI-II) (Beck, Steer, & Brown, 1996; validated in Spanish population by Sanz, Navarro, & V\u00e1zquez, 2003) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups.', 'description': \"BDI-II is a self-report inventory that measures characteristic attitudes and symptoms of depression. The total score is obtained adding the 21 items which constitute the instrument and can be a maximum of 63 points. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and a test-retest reliability of around 0.8.\", 'timeFrame': 'Up to 12 months'}\n- {'measure': 'Change in Beck Anxiety Inventory (BAI) (Beck & Steer, 1990; validated in Spanish population by Mag\u00e1n, Sanz, & Garc\u00eda-Vera, 2008) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups.', 'description': \"BAI measures the severity of both physiological and cognitive symptoms of anxiety. The 21 items are rated on a 4-point Likert-type scale (from 0 to 3) and the total score, which oscillates between 0 and 63, is obtained after directly adding the score of each item. Psychometric analysis carried out so far show excellent internal consistency (Cronbach's alpha \u2265 0.85).\", 'timeFrame': 'Up to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 5%, a power of 80%, and a dropout rate of around 30% were considered.", "answer": 68, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size for the trial was calculated following the method described by Campbell, Julious, and Altman [37], and Freiman, Chalmers, Smith, and Kuebler [38]. G*Power 3 software [39] was used to facilitate power analysis.\n Because there is no published research on the effectiveness of ICBT for the treatment of AjD, the sample size was calculated taking into account outcomes found in trials that used the BAI and BDI-II as measures of clinical change after an ICBT intervention in patients with clinical depression or anxiety disorder [40\u00e2\u0080\u009342]. After reviewing the literature and adopting a more conservative approach, an effect size of .70 was assumed in the present study. Considering a significance level of 5% and a power of 80%, 26 participants in each group would be enough to detect the assumed difference. However, because the literature reveals dropout rates from ICBTs of around 30% [43], a sample of 68 participants will be recruited (34 per group).", "id": 51, "split": "train"} +{"trial_id": "NCT02763878", "pmid": "31300019", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy\n\nIncluded conditions:\n- Nutrition Disorders\n- Postoperative Complications\n\nStudy Armgroups:\n- {'label': 'uncut Roux-en-Y anastomosis', 'type': 'EXPERIMENTAL', 'description': 'After distal gastrectomy, duodenal stump closure, side to side anastomosis was underwent on the remnant stomach and jejunum,which was 25cm from Treitz ligament. Then underwent side to side anastomosis between jejunum about 35cm distance from gastrojejunostomy and jejunum about 5cm from Triez ligament . close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis by using uncut Closure devices', 'interventionNames': ['Procedure: Uncut Roux-en-Y anastomosis']}\n- {'label': 'Billroth II anastomosis', 'type': 'SHAM_COMPARATOR', 'description': 'After distal gastrectomy, duodenal stump closure, the investigators first underwent remnant stomach and upper jejunum side anastomosis. Then choose the jejunum about 25cm from Treitz ligament, premenstrual colon using a disposable cutting closure (or tubular stapling) in the rear wall of the stomach and jejunum anastomosis, common opening was closed with the (barbed wire) hand-stitched. After that, steps were same with the group A.', 'interventionNames': ['Procedure: Billroth II anastomosis']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Uncut Roux-en-Y anastomosis', 'description': 'Uncut Closure devices would be used to close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis.', 'armGroupLabels': ['uncut Roux-en-Y anastomosis']}\n- {'type': 'PROCEDURE', 'name': 'Billroth II anastomosis', 'description': 'Typical Billroth II anastomosis would be made after the Distal gastrectomy.', 'armGroupLabels': ['Billroth II anastomosis']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis', 'timeFrame': '0-5 years'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size estimation used a difference test with 80% power, a 5% significance level, and accounted for a 15% drop-out rate. The allocation ratio is 1:1.", "answer": 832, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our study is designed as a superiority trial whose primary outcome is postoperative reflux gastritis or not. Current experience suggests the predicted rate of postoperative reflux gastritis will be 8% for the uncut Roux-en-Y anastomosis group and 12% for the control group of Billroth II anastomosis. The difference test was used to estimate the sample size with 80% test power and a 5% significance level. Accounting for a 15% drop-out rate and the 1:1 allocation ratio, the total number of patients required per group is 416 (832 in total), which was calculated using the software PASS version 11.0. Considering a completion rate of 75% for each coordinating center, 1040 envelopes were designed for random allocation. The number of cases will be increased if necessary according to the results of the interim analysis.", "id": 52, "split": "train"} +{"trial_id": "NCT02763956", "pmid": "35354635", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy Study of the Gelstix\u2122 Device to Treat Chronic Discogenic Low Back Pain\n\nIncluded conditions:\n- Degeneration of Lumbar Intervertebral Disc\n\nStudy Armgroups:\n- {'label': 'Gelstix', 'type': 'EXPERIMENTAL', 'description': 'The intradiscal insertion of the GelStix\u2122 Nucleus Augmentation Device.', 'interventionNames': ['Device: GelStix\u2122 Nucleus Augmentation Device']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Intradiscal saline solution (1 mL NaCl 0.9%) injection.', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'GelStix\u2122 Nucleus Augmentation Device', 'description': 'Intradiscal Gelstix insertion', 'armGroupLabels': ['Gelstix'], 'otherNames': ['Hydrogel']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Intradiscal saline injection', 'armGroupLabels': ['Placebo'], 'otherNames': ['Saline, NaCl 0,9%']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Lumbar Pain intensity measured on Numeric Rating Scale', 'description': \"Pain intensity will be assessed employing an 11-point (i.e. 0-10) NRS with 0 meaning 'no pain' and '10' meaning 'worst possible pain'. Three times daily pain scores will be assessed for five consecutive days around the intended measurement time.\", 'timeFrame': 'The mean NRS scores on the pain diary will be measured at baseline, and at one week, and one, three, six (primary outcome) and twelve months.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha of 5% (two-tailed), 20% expected drop-out rate", "answer": 72, "answer_type": "ESTIMATED", "explanation": "Sample size\n Twenty-eight patients per group will be required to have 80% power to detect a minimally clinically relevant difference of 1.5 points on the NRS between groups, with an estimated SD of 2, based on the pooled SD of NRS scores of similar patients in the RCT of Kallewaard et al,29 and testing with an alpha of 5% (two tailed). With an expected drop-out rate of about 20%, a total of 72 patients will be randomised.", "id": 53, "split": "train"} +{"trial_id": "NCT02772289", "pmid": "29499740", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars\n\nIncluded conditions:\n- Cicatrix\n\nStudy Armgroups:\n- {'label': 'Mesenchymal Stem Cells low-dose group', 'type': 'EXPERIMENTAL', 'description': 'Target dose of 3 million Mesenchymal Stem Cells', 'interventionNames': ['Biological: Mesenchyme Stem Cells low-dose group']}\n- {'label': 'Mesenchymal Stem Cells high-dose group', 'type': 'EXPERIMENTAL', 'description': 'Target dose of 6 million Mesenchymal Stem Cells', 'interventionNames': ['Biological: Mesenchyme Stem Cells high-dose group']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo without Mesenchyme Stem Cells', 'interventionNames': ['Biological: Placebo']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Mesenchyme Stem Cells low-dose group', 'description': 'Participants will receive transdermal one dose of 1\\\\*10\\\\^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous three days and then receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous next three days.', 'armGroupLabels': ['Mesenchymal Stem Cells low-dose group']}\n- {'type': 'BIOLOGICAL', 'name': 'Mesenchyme Stem Cells high-dose group', 'description': 'Participants will receive transdermal one dose of 1\\\\*10\\\\^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.', 'armGroupLabels': ['Mesenchymal Stem Cells high-dose group']}\n- {'type': 'BIOLOGICAL', 'name': 'Placebo', 'description': 'Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change of Vancouver Scar Scale (VSS)', 'description': 'The investigators measured quartile grading scale at 1st, 3rd and 6th months of study and evaluated the change of the scale', 'timeFrame': '1st, 3rd, 6th month post treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is 0.05, the power (\u03b2) is 0.1, and the ratio of MSC to control group sample size is 2:1.", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size\n Our sample size calculation is based on previous results from Professor Yu-Chen Huang\u00e2\u0080\u0099s preliminary trial in Taipei Medical University WanFang Hospital [42]. These results found that the mean VSS was 4.50\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.68 in healthy pregnant women. The ratio of the MSC and control group sample size sets was 2:1. We will use the conventional values \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.1 for two-sided tests of probability. Meanwhile, we hypothesize that the difference in mean VSS at 6 months after treatment between the MSCs and placebo group will be \u00ce\u00b4\u00e2\u0080\u0089=\u00e2\u0080\u00891.5. The total sample size is estimated to be 74. Considering a dropout and other potential influencing factors, the final participant is estimated to be about 90 (n\u00e2\u0080\u0089=\u00e2\u0080\u008930 in each group).", "id": 54, "split": "train"} +{"trial_id": "NCT02773966", "pmid": "31072314", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intraoperative Radiotherapy During Kyphoplasty/Vertebroplasty (Kypho-IORT) Versus EBRT in the Treatment of Painful Vertebral Metastases - a Randomized Prospective Phase III Study -\n\nIncluded conditions:\n- Metastasis\n\nStudy Armgroups:\n- {'label': 'Arm A: Kypho-IORT', 'type': 'EXPERIMENTAL', 'description': 'balloon kyphoplasty/vertebroplasty + intraoperative radiotherapy', 'interventionNames': ['Radiation: Kypho-IORT']}\n- {'label': 'Arm B: EBRT', 'type': 'ACTIVE_COMPARATOR', 'description': 'external beam radiotherapy with 30 Gy during 10 days (3 Gy/day)', 'interventionNames': ['Radiation: EBRT']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Kypho-IORT', 'description': 'During kyphoplasty/vertebroplasty a intraoperative radiotherapy of the affected vertebrae is done with a miniature X-ray generator (INTRABEAM\u00ae, Carl Zeiss, Surgical, Oberkochen, Germany). The prescription dose will be 8 Gy in a distance of 13 mm from the isocenter of the radiation source. IORT will take about five minutes. After radiation the applicator will be removed and the operation will be finished as usual.', 'armGroupLabels': ['Arm A: Kypho-IORT']}\n- {'type': 'RADIATION', 'name': 'EBRT', 'description': 'The external beam radiotherapy will be usually carried out as an outpatient procedure. All patients will receive a planning CT before the first irradiation. EBRT will be performed with 30 Gy, added in 3 Gy per fraction or 8 Gy single dose (only for international study centers, not permitted in Germany) on a conventional linear accelerator (LINAC).', 'armGroupLabels': ['Arm B: EBRT']}\n\nPrimary Outcomes:\n- {'measure': 'pain evaluation', 'description': 'Evaluation of the percentage of patients with a pain reduction of VAS-3 points after Kypho-IORT vs. EBRT at day 1 (one day after Kypho-IORT; one day after the first EBRT)', 'timeFrame': 'day 1'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha of 0.05, power of 0.817, and a dropout rate of 20%.", "answer": 6, "answer_type": "ACTUAL", "explanation": "Trial sample size\n This study is designed to test if the analgesic efficiency of Kypho-IORT is superior to standard-of-care EBRT in patients with painful vertebral metastases by comparing percentages of patients with a pain reduction of at least 3 points on VAS at defined points in time (day 1, week 2 and 6 after start of treatment).\n Assuming a pain reduction of VAS-3 points at day one (first day after Kypho-IORT, one day after the first EBRT) for 40% of the patients after Kypho-IORT vs 5% of the patients after EBRT under standard pain medication (no change of the pretherapeutic pain medication 12\u00e2\u0080\u0089h after Kypho-IORT or 24\u00e2\u0080\u0089h after the first EBRT), the study will require 22 patients in each arm in order to have a two-sided alpha of 0.05 and a power of 0.817. Including a dropout rate of 20% at least 54 patients have to be recruited. The effect size was estimated on the basis of the results of the preceded phase I/II trial [11] and the results of RTOG 9714 [3].", "id": 55, "split": "train"} +{"trial_id": "NCT02783534", "pmid": "32993752", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Manual Acupuncture vs Sham Acupuncture and Usual Care for the Prevention of Primary Dysmenorrhea: A Multicenter, Randomized, Controlled, Clinical Trial\n\nIncluded conditions:\n- Primary Dysmenorrhea\n\nStudy Armgroups:\n- {'label': 'Verum acupuncture', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive verum acupuncture plus usual care. Participants will receive acupuncture treatment start from the 5th or 7th day before the estimated first day of menstrual cycle, and for each cycle, participants will receive one session of treatment each day for 5 consecutive days, totally be treated with 15 sessions.Verum needles will be inserted into the skin and manipulated manually until deqi occurs. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and manipulates the needles to maintain the intensity of deqi. Participants will receive the same usual care as those in the usual care group.', 'interventionNames': ['Device: Verum acupuncture', 'Behavioral: Usual care']}\n- {'label': 'Sham acupuncture', 'type': 'SHAM_COMPARATOR', 'description': 'Participants will receive sham acupuncture plus usual care. The Streitberger placebo needle will be placed at non-acupuncture points which are distant from the meridian parts and not located on the same neuromuscular segments as the prescribed points used in the VA group, so as to minimize any therapeutic and segmental effects. The same acupuncture schedule as that in the verum acupuncture group will be applied. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and pretends to manipulate the needles but deqi is not sought.Participants will receive the same usual care as those in the usual care group.', 'interventionNames': ['Device: Sham acupuncture', 'Behavioral: Usual care']}\n- {'label': 'Usual care', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will not receive acupuncture treatment besides health education as a control group.', 'interventionNames': ['Behavioral: Usual care']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Verum acupuncture', 'description': 'Participants allocated to VA group will receive traditional acupuncture treatment on the \"Guanyuan\"(RN 4), bilateral \"Sanyinjiao\"(SP 6), bilateral \"Zigong\"(EX-CA1), bilateral \"Xuehai\"(SP 10). Additional points will be chosen according to TCM syndrome differentiation constitution of patients. If patients with deficient syndrome, bilateral \"Zusanli\" (ST 36) will be included. If patients with sufficiency syndrome, bilateral \"Diji\" (SP 8) will be included. The NO.16 special type of acupuncture needle (0.30 x 30 mm) produced by German asia-med company will be applied.The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.', 'armGroupLabels': ['Verum acupuncture']}\n- {'type': 'DEVICE', 'name': 'Sham acupuncture', 'description': 'We use a non-insertive sham control produced by Asia-med Company in Germany-the streitberger placebo-needle. Sham points are described as follows: 1) 5 inch lateral to the seventh thoracic spine; 2) 5 inch lateral to the eighth thoracic spine; 3) 5 inch lateral to the ninth thoracic spine; and 4) 5 inch lateral to the tenth thoracic spine.', 'armGroupLabels': ['Sham acupuncture']}\n- {'type': 'BEHAVIORAL', 'name': 'Usual care', 'description': 'Patients in usual care group will not receive acupuncture treatment but enhance usual care by providing them with detailed information via propaganda booklets or the internet in the form of health education.', 'armGroupLabels': ['Sham acupuncture', 'Usual care', 'Verum acupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'Change of Cox Menstrual Symptom Scale (CMSS) in a menstrual cycle compared to baseline.', 'timeFrame': 'At baseline (one menstrual cycle/one month before randomization), the first\uff0csecond, third, fourth, fifth, and sixth month after randomization.'}\n\nPlease estimate the sample size based on the assumption: \nSuperiority design with a power level of 80% and a significance level set at 5%. For the verum vs. sham acupuncture comparison, a 1:1 ratio is used. For the verum acupuncture vs. usual care comparison, a 2:1 ratio is used. An attrition rate of 20% is considered.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was estimated using the Statistical Analysis System software program (version 9.3; SAS Institute Inc., Cary, NC, USA). According to our pilot trial, we anticipate a greater CMSS score decline of 0.2\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.55 in the verum acupuncture group compared with the sham acupuncture group. This sample size calculation is based on a superiority design with a power level of 80% and a significance level set at 5%, with a 1:1 ratio. Based on these assumptions, 170 patients will be needed, with 85 patients in each group. Moreover, we anticipate a greater CMSS score decline of 0.5\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.15 in the verum acupuncture group compared with the usual care group. This sample size calculation is based on a superiority design with a power level of 80% and a significance level set at 5%, with a 2:1 ratio. Based on these assumptions, 150 patients will be required, including 100 patients in the verum acupuncture group and 50 patients in the usual care group. This sample size will be inflated to 300 to account for an attrition rate of 20%. Thus, we plan to enroll 300 patients, including 120 patients in the VA and SA groups and 60 patients in the usual care group.", "id": 56, "split": "train"} +{"trial_id": "NCT02789371", "pmid": "29343303", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparing of Modified Wet Suction Technique and Dry Suction Technique for Endoscopic Ultrasound -Guided Fine Needle Aspiration (EUS-FNA) of Solid Occupying Lesions: a Prospective Multi-center,Randomized,and Controlled Trial\n\nIncluded conditions:\n- Pancreas Neoplasms\n- Lymphatic Metastasis\n- Neoplasm Metastases\n- Unknown Primary Neoplasm Metastasis\n- Infection\n- Inflammation\n- Sarcoid\n- Lymphadenopathy\n\nStudy Armgroups:\n- {'label': 'Arm A', 'type': 'OTHER', 'description': 'the first pass is made with 5ml suction technique', 'interventionNames': ['Procedure: the first pass is made with 5ml suction technique']}\n- {'label': 'Arm B', 'type': 'OTHER', 'description': 'the first pass is made with modified wet suction technique', 'interventionNames': ['Procedure: the first pass is made with modified wet suction technique']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'the first pass is made with 5ml suction technique', 'description': 'the first pass is made with 5ml suction technique, then modified wet suction technique / 5ml suction technique/ modified wet suction technique is operated successively.', 'armGroupLabels': ['Arm A']}\n- {'type': 'PROCEDURE', 'name': 'the first pass is made with modified wet suction technique', 'description': 'the first pass is made with modified wet suction technique, then 5ml suction technique/ modified wet suction technique/ 5ml suction technique is operated successively.', 'armGroupLabels': ['Arm B']}\n\nPrimary Outcomes:\n- {'measure': 'the overall diagnostic accuracy of modified wet suction technique and 5ml dry suction technique to the solid occupying lesions', 'description': \"The investigators' primary outcome measure is to compare the overall diagnostic accuracy of modified wet suction technique and dry suction technique to the solid occupying lesions.\", 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-sided significance level of 5%, 20% dropout or withdrawal rate, statistically significant for P < 0.05, using a two-tailed distribution.", "answer": 296, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n Based on a literature review of suction techniques for heterogeneous indications [12, 14], we expected a difference between DRST and wet suction technique on diagnostic yields of 75% vs. 85% after four needle passes. The calculation yielded target sample sizes of 248 for 5 ml DRST and 248 for MWST, with a power of 80% and a two-sided significance level of 5%. Each group should have 124 patients following the 2\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00892 cross-over design. Assuming a 20% dropout or withdrawal rate, we calculated a final sample size of 296 patients (148 per group).\n The safety set comprises all the randomized subjects who will receive at least one trial treatment. The full analysis set should be as close as possible to the intention-to-treat set. The standards and population of the per-protocol set will be finalized after data blinding verification. The direct deletion method will be used to treat missing data.\n A two-tailed distribution will be used and statistically significance will be considered for P\u00e2\u0080\u0089<\u00e2\u0080\u00890.05. All category variables will be described in terms of the count and percentage using the \u00cf\u00872 test, whereas continuous variables will be described as mean\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u0089standard deviation using t tests or Wilcoxon rank-sum tests. Sensitivity, specificity, positive predictive value, negative predictive value, receiver operating characteristic curve, and diagnostic accuracy will be computed using a 2\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00892 table and \u00cf\u00872 test for DRST and MWST. The blood contamination and cellularity in specimens will be divided into three levels (Grade A, Grade B, and Grade C), and McNemar\u00e2\u0080\u0099s test for correlated proportions will be used. All analyses will be performed using SAS version 9.2.", "id": 57, "split": "train"} +{"trial_id": "NCT02797067", "pmid": "29096689", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)\n\nIncluded conditions:\n- Pancreatitis\n\nStudy Armgroups:\n- {'label': 'Indomethacin', 'type': 'EXPERIMENTAL', 'description': 'Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.', 'interventionNames': ['Drug: indomethacin suppository']}\n- {'label': 'Glycerin', 'type': 'PLACEBO_COMPARATOR', 'description': 'Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.', 'interventionNames': ['Drug: Glycerin Suppository']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'indomethacin suppository', 'description': '100mg rectal indomethacin 30min before ESWL', 'armGroupLabels': ['Indomethacin']}\n- {'type': 'DRUG', 'name': 'Glycerin Suppository', 'description': '30min before ESWL', 'armGroupLabels': ['Glycerin']}\n\nPrimary Outcomes:\n- {'measure': 'the Incidence of Post-ESWL Pancreatitis', 'description': 'Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\\\\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.', 'timeFrame': 'up to 1 months'}\n\nPlease estimate the sample size based on the assumption: \nThe trial assumes a one-sided alpha of 0.025, a power of 80%, and a possible withdrawal rate of 5%.", "answer": 1370, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size calculation is based on our previous research on the incidence rate of post-ESWL pancreatitis. Post-ESWL pancreatitis occurs in 6.8% of the patients for the first P-ESWL sessions and accounting for 69.4% of complications [9]. The RIPEP trial is a superiority trial in which the sample size is based on the assumption that rectally administered indomethacin reduces the incidence of the primary endpoint by a relative reduction of 50%. This amounts to an expected incidence of post-ESWL in the rectally administered indomethacin group of 3.4%. Assuming a one-sided alpha of 0.025 and a power of 80%, 1370 patients (685 per arms) would be necessary to detect a 6.8 to 3.4% reduction of post-ESWL pancreatitis, including a possible withdrawal rate of 5%.", "id": 58, "split": "train"} +{"trial_id": "NCT02797249", "pmid": "30400937", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.\n\nIncluded conditions:\n- Preeclampsia\n\nStudy Armgroups:\n- {'label': 'aspirin', 'type': 'EXPERIMENTAL', 'description': 'Low dose aspirin (100 mg) starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy, taking at night.', 'interventionNames': ['Drug: Aspirin']}\n- {'label': 'blank', 'type': 'OTHER', 'description': 'Routine examination during pregnancy.', 'interventionNames': ['Other: Blank']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Aspirin', 'description': 'Low dose aspirin\uff08100mg\uff09per day starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy,taking at night.', 'armGroupLabels': ['aspirin'], 'otherNames': ['ASA', 'acetyl salicylic acid']}\n- {'type': 'OTHER', 'name': 'Blank', 'description': 'Routine examination during pregnancy.', 'armGroupLabels': ['blank']}\n\nPrimary Outcomes:\n- {'measure': 'Prevention of preeclampsia', 'description': 'The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 80% and the significance level at 0.05. A 10% withdrawal/loss to follow-up rate is also considered.", "answer": 1000, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n For the primary outcome indicator, \u00e2\u0080\u009cpre-eclampsia,\u00e2\u0080\u009d we assume that the estimated detection rate for PE is 20% in the control group, according to previous studies [25\u00e2\u0080\u009327]. The occurrence of PE in the intervention group is supposed to be 16%, and thus the estimate of risk reduction with the intervention is 20%. For 80% power and a level of significance set at 0.05, 446 participants are required in each group. Thus, the total number of women required in the study is 892. Accounting for 10% withdrawal/loss to follow-up, 981 women will need to be recruited. Finally, we set the number of women to be recruited into the study at 1000 (500 per group). The power calculation was performed using PASS 2011 software (NCSS, Kaysville, UT, USA).", "id": 59, "split": "train"} +{"trial_id": "NCT02804074", "pmid": "30573476", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MASked-unconTrolled hypERtension Management Based on Office BP or on Out-of-office (Ambulatory) BP Measurement (MASTER Study)\n\nIncluded conditions:\n- Masked Hypertension\n\nStudy Armgroups:\n- {'label': 'Group 1', 'type': 'ACTIVE_COMPARATOR', 'description': 'Management strategy of blood pressure based on office BP as a guide to treatment', 'interventionNames': ['Other: Optimization of antihypertensive treatment based on office BP']}\n- {'label': 'Group 2', 'type': 'EXPERIMENTAL', 'description': 'Management strategy of blood pressure based on 24-hour ABPM as a guide to treatment', 'interventionNames': ['Other: Optimization of antihypertensive treatment based on 24-hour ABPM']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Optimization of antihypertensive treatment based on office BP', 'description': 'Optimization of antihypertensive treatment based on office BP', 'armGroupLabels': ['Group 1']}\n- {'type': 'OTHER', 'name': 'Optimization of antihypertensive treatment based on 24-hour ABPM', 'description': 'Optimization of antihypertensive treatment based on 24-hour ABPM', 'armGroupLabels': ['Group 2']}\n\nPrimary Outcomes:\n- {'measure': 'changes in LVMI (co-primary endpoint)', 'timeFrame': '12 months'}\n- {'measure': 'UAE (albumin/creatinine ratio, co-primary end-point)', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha of 0.025 (one-sided t-test), a power of 90%, and a dropout rate of 15%. The SD of LVMI is assumed to be \u00b125 g/m2.", "answer": 1240, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size calculation was based on the primary study endpoint of changes in left ventricular mass index (LVMI) at 12th month. We do not know what proportion of the enrolled patients will have a diagnosis of LVH; therefore, the primary endpoint has not been based on categorical changes in LVH but rather on changes in LVM as a continuous variable. As the enrolled individuals\u00c2\u00a0are hypertensive patients with BP incompletely controlled by treatment, we expect LVM to be often higher than in subjects with sustained BP control (normal OPB\u00c2\u00a0and ABP levels). To calculate the sample size, we have assumed a difference of 5\u00e2\u0080\u0089g/m2 in the change of LVMI with the ABP-guided (group 2) compared with the OBP-guided (group 1) management strategy. This has been based on the consideration that SBP will be reduced by about 8\u00e2\u0080\u0089mm\u00c2\u00a0Hg more in the ABP-guided group, as well as on the echocardiographic data of studies such as REGAAL and CATCH in which differences in echo LVMI changes between treatments producing similar BP reductions were lower than 3\u00e2\u0080\u0089g/m2.20 21 The SD of\u00c2\u00a0\u00c2\u00b125\u00e2\u0080\u0089g/m2 was also derived from data of REGAAL and CATCH as well as from previous assessment of within operator reproducibility.21 22 Considering a LVMI difference between groups of 5.0\u00e2\u0080\u0089g/m2 and a SD of 25\u00e2\u0080\u0089g/m2, an alpha of 0.025 (one-sided t-test) and a power (1-beta) of 90%, with a dropout rate of 15% during the study period, a minimum of 620 subjects per study group was deemed necessary, for a total number of 1240 subjects to be randomised. However, given the uncertainty about the true LVMI difference we might observe and/or the related SD, performance of an interim analysis has been decided aimed at a possible re-estimation of the sample size. This analysis will be carried out at 18th month when about 30% of randomised patients will achieve 1\u00e2\u0080\u0089year of follow-up. A re-estimation of the sample size will be calculated using the method of conditional power.23", "id": 60, "split": "train"} +{"trial_id": "NCT02810678", "pmid": "30898826", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Enhancing the Public Health Impact of Latent Tuberculosis (TB) Infection Diagnosis and Treatment: A Pragmatic Cluster Randomized Trial\n\nIncluded conditions:\n- Latent Tuberculosis Infection\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'No Intervention: Program runs as per usual. Minimal interference and visits from study staff. Main study outcomes evaluated in first and last 6 months of trial. Minimal visits to collect information on costing at control sites.'}\n- {'label': 'Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Latent Tuberculosis Infection program evaluation \\\\& diagnosis: In intervention health facilities the current Latent Tuberculosis Infection program will be evaluated and gaps in the Latent Tuberculosis Infection cascade of care will be identified. Gaps in the current cascade will be quantified and solution proposed that are unique to the problems identified in each site. In phase 2 of the study low cost solutions will be implemented and the Latent Tuberculosis Infection program scaled up and improved. Study outcomes are evaluated in the first and last 6 months of trial. Costing evaluations are done throughout the trial.', 'interventionNames': ['Other: Latent Tuberculosis Infection program evaluation & diagnosis']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Latent Tuberculosis Infection program evaluation & diagnosis', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'The primary outcome will be the change in the number of household contacts (HHC) initiating treatment per newly diagnosed TB index patient within 3- 4 months from index patient diagnosis, between Phase 1 and Phase 2', 'description': 'A new TB index patient will be microbiologically confirmed using AFB smear, culture, and/or molecular tests such as Xpert\u00aeMTB/RIF, depending on local protocols. A HHC will be defined as someone who slept in the same house at least one night per week, or spent more than one hour in the house at least five days per week, on average, over the preceding 3 months. The house will be defined as the dwelling, or buildings, which the family unit occupies and uses regularly. In each of the 6 month periods, the total number of index patients, the number of their contacts who were recorded in clinic documents, and the number of these HHC who initiate LTBI therapy will be collected in both the control and intervention arms. For TB index patients diagnosed towards the end of each 6-month period in most sites we will allow up to 3 or 4 additional months for the HHC to be started on LTBI treatment.', 'timeFrame': 'The primary outcome will be recorded at all health facilities for the full duration of phase 1 (6 months) and for the last 6 months of phase 2.'}\n\nPlease estimate the sample size based on the assumption: \nThe variance of the random effect was set at 0.7, 1.4, and 2.8, resulting in ICCs of 0.16\u20130.40. Power was estimated using 500 datasets for each combination of parameters, with a significance level (alpha) of 0.05. The power to detect a significant effect was 73%-75% for an increase of 10 contacts, and over 96% for an increase of 15 contacts.", "answer": 24, "answer_type": "ACTUAL", "explanation": "Sample size\n Twenty-four randomisation units (single health facilities or groups of health facilities) were identified, such that each unit anticipated seeing 20 index TB patients and 80 HHCs over a 6\u00e2\u0080\u0089month period. The anticipated number of TB patients and HHCs in each country is shown in table 1. The annual number of TB patients was obtained from pre-existing registries at each of the sites.\n \n Table 1\n \n Anticipated number of index tuberculosis patients and their household contacts at participating sites\n \n \n \n \n Country\n Number of index TB patients in 6\u00e2\u0080\u0089months*\n Household contacts\n Randomisation units (cluster/health facilities)\n \n \n Identified\u00e2\u0080\u00a0\n With LTBI\u00e2\u0080\u00a1 (TST pos.)\n \n \n \n \n Canada\n 125\n 525\n 150\n 4\n \n \n Benin\n 250\n 1050\n 540\n 2\n \n \n Ghana\n 150\n 630\n 325\n 2\n \n \n Indonesia\n 150\n 630\n 325\n 8\n \n \n Vietnam\n 150\n 630\n 325\n 8\n \n \n Total\n 825\n 3465\n 1665\n 24\n \n \n \n \n \n *Approximate number based on retrospective information provided from TB registries at sites.\n \n \n \u00e2\u0080\u00a0Estimated based on 4.2 contacts identified per active TB case - from systematic review.33\n\n \n \n \u00e2\u0080\u00a1Estimated based on prevalence of LTBI among contacts screened: of 51.5% in low-income and middle-income countries (LMIC)28 33 and 28.1% in Canada.28\n\n \n \n LTBI, latent tuberculosis infection; TB, tuberculosis.\n \n \n \n For each randomisation unit, the number of HHCs expected to initiate treatment per index TB patient was generated in a simulation exercise, using a Poisson distribution with a rate that depended on the effect of the intervention, the effect of time and a normally distributed random effect for each randomisation unit. We varied the potential effect of the intervention from 5, 10, 15, 30 contacts initiating treatment per 100 index TB patients. The variance of the random effect was set at 0.7, 1.4 and 2.8. These variances resulted in approximate ICCs (intraclass correlation coefficients) of 0.16\u00e2\u0080\u00930.40. We generated 500 datasets for each distinct combination of data generation parameters (12 scenarios).\n Using this approach we estimated power as the number of generated datasets that resulted in a statistically significant value. As shown in table 2, we will have 73%\u00e2\u0080\u009375%\u00e2\u0080\u0089power to detect a statistically significant (alpha=0.05) effect of the intervention if the increase in the number of HHCs initiating LTBI treatment (between phases 1 and 2), is at least 10 per 100 index TB patients. However, we will have more than 96% power to detect a significant effect of the intervention, if it results in at least 15 more HHCs initiating treatment per 100 index TB patient.\n \n Table 2\n \n Power with 24 randomisation units for various Intra-class correlations coefficient in all countries, with alpha=0.05\n \n \n \n \n Variance of the random effect\n Approximate intraclass correlation coefficients\n Difference in the change from phase 1 to phase 2 in the number of household contact starting latent tuberculosis infection treatment per index tuberculosis patient between the intervention and control arms\n Power (%)\n \n \n \n \n 0.7\n 0.21\n 5\n 28\n \n \n 1.4\n 0.30\n 5\n 32\n \n \n 2.8\n 0.40\n 5\n 26\n \n \n 0.7\n 0.18\n 10\n 74\n \n \n 1.4\n 0.28\n 10\n 76\n \n \n 2.8\n 0.38\n 10\n 73\n \n \n 0.7\n 0.18\n 15\n 96\n \n \n 1.4\n 0.26\n 15\n 97\n \n \n 2.8\n 0.36\n 15\n 97\n \n \n 0.7\n 0.16\n 30\n 100\n \n \n 1.4\n 0.22\n 30\n 100\n \n \n 2.8\n 0.31\n 30\n 100", "id": 61, "split": "train"} +{"trial_id": "NCT02811276", "pmid": "31881910", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Controlled, Cross-over Trial Investigating the Impact of a High Protein Diet on Substrate Oxidation and Energy Metabolism in Healthy Women\n\nIncluded conditions:\n- Dietary Modification\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': \"Those assigned to the Control Group will receive a eucaloric diet (a diet designed to meet the person's energy needs and maintain body weight) composed of 55% of carbohydrate, 15% of protein, and 30% of lipid.\"}\n- {'label': 'High-Protein Diet Group', 'type': 'EXPERIMENTAL', 'description': 'Those assigned to the High-Protein Diet Group will receive a eucaloric diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased\u00ae).', 'interventionNames': ['Other: Diet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Diet', 'description': 'The High-Protein Diet Group will receive a eucaloric diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased\u00ae) for one and a half day. Participants will consume 1 gram \u00b1 0.1 of Almased\u00ae per kg of body weight mixed with linseed oil and skim milk in their breakfast, lunch and dinner. Two snacks (afternoon and evening) composed of 1 gram \u00b1 0.1 of Almased\u00ae per kg of body weight mixed with vegetable juice and linseed oil will also be provided.', 'armGroupLabels': ['High-Protein Diet Group']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in fat balance assessed by indirect calorimetry during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.', 'description': 'To measure the differences in fat balance during 32 hours of a high-protein (HP) total diet replacement compared to 32hours of a control (CON) diet.', 'timeFrame': 'During a 32-hour period while receiving a HP total diet replacement or a CON diet.'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided t-test with 88% power, significance level of 0.05, and a 20% attrition rate. An alternative calculation used a two-sided Mann-Whitney test with 90% power, significance level of 0.05, and a 20% attrition rate.", "answer": 20, "answer_type": "ACTUAL", "explanation": "Sample size estimate\n The sample size estimation was conducted separately for each sex. A total of 12 participants will enable detection of an effect size of 1.41, which was calculated based on differences in RQ between dependent groups receiving a HP-TDR (0.85\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.03) or maintaining usual dietary intake (0.90\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.04) from a previously published study [20]. A two-sided t-test achieves 88% power to infer that the mean difference is not 0.05 when the total sample size of a 2\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00892 crossover design is 12, the actual mean difference is 0.06, the standard deviation of the paired difference is 0.01, and the significance level is 0.05. Accounting for a 20% attrition rate, a total sample size of 14 participants of each sex would be needed to complete the study. An alternative sample size calculation was conducted based on differences in fat balance between dependent groups receiving a HP-TDR (5.55 \u00c2\u00b1 4.20 g/day) or maintaining usual dietary intake (10.25 \u00c2\u00b1 4.19 g/day) using unpublished data from Koohkan et al. (2012) [20]. Group sample sizes of 19 in each arm achieves 90% power to detect a difference of -4.7 g/day with a significance level of 0.05 using a two-sided Mann-Whitney test. Assuming a 20% attrition rate, a total 23 participants would be needed in each group. The sample size calculation was done using PASS Power Analysis and Sample Size software version 19.0.1 (NCSS Statistical Software, Kaysville, Utah, USA).", "id": 62, "split": "train"} +{"trial_id": "NCT02813824", "pmid": "32887653", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessment of the Effect of a Daily Chemoprevention by Low-dose Aspirin of New or Recurrent Colorectal Adenomas in Patients With Lynch Syndrome\n\nIncluded conditions:\n- Lynch Syndrome\n\nStudy Armgroups:\n- {'label': 'Aspirin300', 'type': 'ACTIVE_COMPARATOR', 'description': 'Acetylsalicylic acid 300 mg tablet by mouth, daily dose during 4 years', 'interventionNames': ['Drug: Acetylsalicylic acid lysinate 300 mg']}\n- {'label': 'Placebo300', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo (like Acetylsalicylic acid 300 mg) tablet by mouth, daily dose during 4 years', 'interventionNames': ['Drug: Placebo (for Aspirin 300)']}\n- {'label': 'Aspirin100', 'type': 'ACTIVE_COMPARATOR', 'description': 'Acetylsalicylic acid 100 mg tablet by mouth, daily dose during 4 years', 'interventionNames': ['Drug: Acetylsalicylic acid lysinate 100 mg']}\n- {'label': 'Placebo100', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo (like Acetylsalicylic acid 100 mg) tablet by mouth, daily dose during 4 years', 'interventionNames': ['Drug: Placebo 100 (for Aspirin 100)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Acetylsalicylic acid lysinate 300 mg', 'description': 'Daily dose during 4 years', 'armGroupLabels': ['Aspirin300'], 'otherNames': ['Aspirin300']}\n- {'type': 'DRUG', 'name': 'Placebo (for Aspirin 300)', 'description': 'Daily dose during 4 years', 'armGroupLabels': ['Placebo300'], 'otherNames': ['Placebo300']}\n- {'type': 'DRUG', 'name': 'Acetylsalicylic acid lysinate 100 mg', 'description': 'Daily dose during 4 years', 'armGroupLabels': ['Aspirin100'], 'otherNames': ['Aspirin100']}\n- {'type': 'DRUG', 'name': 'Placebo 100 (for Aspirin 100)', 'description': 'Daily dose during 4 years', 'armGroupLabels': ['Placebo100'], 'otherNames': ['Placebo100']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients with at least one adenoma seen on chromo-endoscopy 48 months after complete withdrawal of polyps and initiation of treatment (aspirin or placebo)', 'description': 'To look for a preventive effect of low-dose aspirin (100 or 300 mg/d) compared with placebo on new or recurrent colorectal adenomas in patients with Lynch syndrome', 'timeFrame': '4 years'}\n\nPlease estimate the sample size based on the assumption: \n5% alpha risk, 80% power.", "answer": 852, "answer_type": "ESTIMATED", "explanation": "Sample size\n The main objective of this trial is to show that adenoma prevalence is less important in the aspirin group (regardless of the dose) than in the placebo group. The initial hypothesis was constructed with a 30% adenoma prevalence in the placebo group and a reduction of 28% expected in the aspirin group, based on our previous RCT on patients without Lynch syndrome but with a history of colorectal adenomas [8]. For a 5% alpha risk and 80% power, according to this hypothesis, 426 patients will be needed in the aspirin group (213 patients for aspirin 100\u00e2\u0080\u0089mg arm and 213 patients for aspirin 300\u00e2\u0080\u0089mg arm) and 426 patients in the placebo group (213 patients for placebo aspirin 100\u00e2\u0080\u0089mg arm and 213 patients for placebo aspirin arm 300\u00e2\u0080\u0089mg). A total of 852 patients will be included.", "id": 63, "split": "train"} +{"trial_id": "NCT02819141", "pmid": "35578315", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients\n\nIncluded conditions:\n- Critical Illness\n- Anxiety\n- Respiratory Failure\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'These patient will get usual care - sedation administered by ICU Nurses as deemed necessary by primary care team'}\n- {'label': 'Dexmedetomidine', 'type': 'EXPERIMENTAL', 'description': 'These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.', 'interventionNames': ['Drug: Dexmedetomidine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.', 'armGroupLabels': ['Dexmedetomidine'], 'otherNames': ['Precedex']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in anxiety using the 100mm vertical visual analog scale', 'description': 'Vertical visual analog scale will be used to measure level of state anxiety', 'timeFrame': '7 days'}\n- {'measure': 'Changes in duration of days receiving mechanical ventilation after study enrollment', 'description': \"Patients' self-management of sedative therapy (SMST) using dexmedetomidine compared to usual sedation practices in mechanically ventilated subjects.\", 'timeFrame': 'up to 6 months'}\n- {'measure': 'Changes in delirium using the CAM-ICU tool', 'description': 'Confusion Assessment Method-ICU (CAM-ICU) will be used as a pre-enrollment delirium screening tool and to measure level of alertness and presence of delirium', 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (alpha) is set at 0.05, and the power is greater than 80%. The study design includes a minimum of 7 data collection points per patient, resulting in approximately 1050 observations.", "answer": 190, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Our primary outcomes are anxiety, duration of mechanical ventilation, and presence of delirium. Each primary outcome is analysed separately. In our preliminary study [18], anxiety decreased over time for the experimental self-management of sedative therapy group by 5 points from 58.1 to 53.1 (0\u00e2\u0080\u0093100 mm visual analogue scale), whereas it increased by 15.5 points from 43.7 to 53.9 for the control group. The calculated delta change for anxiety = .45 for an effect size = .11 with a sample size of 95 per group (190 total). We base our target sample size on these anxiety data for this efficacy RCT. During the pilot RCT, no patients randomized to the experimental group became delirious, while four patients randomized to the control group developed delirium (p = .058). A sample of 35 subjects per group would be required (70 total). The power calculation for the duration of mechanical ventilatory support after study enrolment (Mann-Whitney U) with an effect size of .41 would = 43 per group (86 total). We estimated the power for multilevel models approximating our study design. A sample size of 95 patients per arm, 190 total (at a minimum of 7 data collection points for each, resulting in ~ 1050 observations) will have greater than 80% power to detect small to moderate effects (i.e. 0.11 or greater) in between-group differences in anxiety, delirium, and duration of mechanical ventilation at alpha = .05 for all proposed models.", "id": 64, "split": "train"} +{"trial_id": "NCT02841293", "pmid": "33795299", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cost-utility Evaluation of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma: Perineal Filling With Biological Meshes vs. Primary Perineal Wound Closure\n\nIncluded conditions:\n- Abdominoperineal Resection\n\nStudy Armgroups:\n- {'label': 'Arm with biological mesh', 'type': 'EXPERIMENTAL', 'description': 'The intervention consists of perinal reconstruction using biological mesh (Cellis prosthesis from Meccellis Biotech, reference C1015E size 10x15cm)', 'interventionNames': ['Procedure: Biological mesh']}\n- {'label': 'Arm with primary perineal wound closure', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention consists of perinal reconstruction by primary perineal wound closure', 'interventionNames': ['Procedure: Primary perineal wound closure']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Biological mesh', 'description': 'The intervention consists of suturing a biological mesh in the pelvic floor defect. The mesh will be sutured at each side of the coccyx or distal sacrum and directly to the residual pelvic floor muscle and fascia by using interrupted or continuous hand-sewn sutures with an appropriate amount of tension. The mesh that will be used is the Cellis prosthesis from Meccellis Biotech, reference C1015E which size is 10x15cm.', 'armGroupLabels': ['Arm with biological mesh']}\n- {'type': 'PROCEDURE', 'name': 'Primary perineal wound closure', 'description': 'The intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure', 'armGroupLabels': ['Arm with primary perineal wound closure']}\n\nPrimary Outcomes:\n- {'measure': 'Incremental Cost-Utility Ratio (ICUR)', 'description': 'The primary endpoint in this study is based on the assessment of the incremental cost-utility ratio at 1 year, from the collective perspective between biological mesh perineal reconstructions versus. primary perineal closure in patients operated for anorectal carcinoma with proven rectal adenocarcinoma or anal canal epidermoid carcinoma.', 'timeFrame': 'At 12 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided t-test with a 5% significance level, 80% power for EQ-5D-5L and complication rate, 90% power for ICUR, and a 10% drop-out rate.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary objective of this protocol is to assess the ICUR at 12 months of two surgical procedures of pelvic reconstruction. A difference of 0.5 SD for EQ-5D-5L between arm A and arm B will be considered clinically meaningful.15 This effect size will be detected with at least 80% power, using a two-sided t-test with a 5% two-sided significance level and a drop-out rate of 10%.\n Furthermore, based on the literature which indicates that the rate of early complications following conventional primary perineal wound closure may range between 35% and 65% (Foster colorectal disease 2012), a sample size of 140 patients will also provide at least 80% power assuming an absolute difference in complication rate of 25% (with the conventional arm response at 45%). The other parameters used in the calculation are a two-sided \u00ce\u00a72 test with a two-sided significance level of 0.05, a drop-out rate of 10%.\n Additionally, the sample size was calculated according to the ICUR using the Glick formula. ICUR will result in cost per quality-adjsted life-year (QALY).16 According to a study conducted in 2012, the cost difference will be \u00e2\u0088\u0092\u00e2\u0082\u00ac5704 (SD \u00e2\u0082\u00ac8000) in favour of biological meshes.5 According to a study assessing the significant minimum difference in terms of QALY, we estimate a difference of 0.06 (SD 0.20) in favour of biological meshes.17 The correlation coefficient was estimated at \u00e2\u0080\u00930.6 using an analysis of variance. The willingness-to-pay threshold has been set at \u00e2\u0082\u00ac50 000. This effect size will be detected with at least 90% power, using a two-sided t-test with a 5% two-sided significance level. The drop-out rate has been set at 10%. The total sample size was evaluated at 132, in other words 66 patients to be recruited per arm.\n The calculation of the number of subjects to be included in the study, using the Glick formula, was carried out based on conservative assumptions in terms of cost of care and utility. In fact, the cost difference was calculated using inflated costs (\u00e2\u0082\u00ac2020) and all the complications avoided, thanks to biological meshes, those were not included in the cost calculation. Furthermore, concerning the significant minimum difference of QALY, the article by Walters et al proposes a mean of 0.074 and an SD of 0.10. We have chosen to include in our calculation an average difference of 0.06 and an SD of 0.2.", "id": 65, "split": "train"} +{"trial_id": "NCT02843191", "pmid": "29739356", "question": "Here is the design of a clinical trial:\n\nOfficial Title: KCSP Trial of CONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After NeoadjUvant Concurrent ChemoraDiothErapy: a Multicenter, Randomized Controlled Trial (KONCLUDE)\n\nIncluded conditions:\n- Rectal Cancer\n\nStudy Armgroups:\n- {'label': 'Adjuvant chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.', 'interventionNames': ['Drug: Chemotherapy']}\n- {'label': 'Consolidation chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.', 'interventionNames': ['Drug: Chemotherapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Chemotherapy', 'description': '5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)', 'armGroupLabels': ['Adjuvant chemotherapy', 'Consolidation chemotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Pathologic complete response', 'description': 'Pathologic complete response is defined as no residual tumor on the surgical specimen after chemoradiotherapy. (i.e. Mandard grade 1 or Dworak grade 4)', 'timeFrame': '2 years'}\n- {'measure': 'Disease-free survival', 'description': 'The rates of patients who survive without recurrence', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a one-sided proportion test and log-rank test with an \u03b1-error of 0.025 and a power of 90% for both primary endpoints: pCR and 3-year DFS. The accrual period is 2 years and the follow-up period is 3 years. A drop-out rate of 10% is considered.", "answer": 358, "answer_type": "ACTUAL", "explanation": "Sample size calculation and randomization\n Based on literatures, pCR rates and 3-year DFS after CRT for rectal cancer were known to be 10 to 28% and 50-65%, respectively [2, 6, 8\u00e2\u0080\u009313]. Thus we hypothesize that the experimental arm would show a 15% improvement in pCR and in 3-year DFS, compared with the control arm (15 to 30% and 65 to 80%, respectively). The accrual period is 2\u00c2\u00a0years and the follow-up period is 3\u00c2\u00a0years. Based on the superiority design, one-sided proportion test and log-rank test with \u00ce\u00b1-error of 0.025 and a power of 90% was conducted for both primary endpoints: pCR and 3-year DFS. The pCR of each group was considered to be 15 and 30%, and the 3-year DFS of each group was considered to be 65 and 80% assuming that accrual time was 2\u00c2\u00a0years and follow up time was 3\u00c2\u00a0years. Allowing neoadjuvant CRT for a drop-out rate of 10%, 358 patients (179 per arm) for pCR and 316 patients (158 per arm) for 3-year DFS will need to be recruited. Therefore a total of 358 participants (among 358 and 316) are needed. This study of 358 participants had at least 81% power (90% each\u00e2\u0080\u0089=\u00e2\u0080\u00890.9, so 0.9\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00890.9\u00e2\u0080\u0089=\u00e2\u0080\u00890.81) to simultaneously detect a difference of pCR and 3-year DFS of two groups. Randomization will be performed in a 1:1 ratio by computer-generated random numbers, with the use of stratified permuted 4 blocks. It will stratified according to age (<\u00e2\u0080\u008970 vs. \u00e2\u0089\u00a570), clinical T stage (T1/2 or T3), and clinical N stage (N0 or N1/2). Among 8 strata, 2 strata will not be used because clinical T1/2\u00c2\u00a0N0 (age\u00e2\u0080\u0089<\u00e2\u0080\u008970 and\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008970) are not indicated for neoadjuvant CRT.", "id": 66, "split": "train"} +{"trial_id": "NCT02858856", "pmid": "29982213", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy\n\nIncluded conditions:\n- Breast Carcinoma\n\nStudy Armgroups:\n- {'label': 'A group', 'type': 'EXPERIMENTAL', 'description': 'Take Sipjeondaebo-tang on 0\\\\~2 week, 3\\\\~5 week of clinical trial period, total of 4 weeks', 'interventionNames': ['Drug: Sipjeondaebo-tang']}\n- {'label': 'B group', 'type': 'EXPERIMENTAL', 'description': 'Take Sipjeondaebo-tang on 6\\\\~8 week, 9\\\\~11 week of clinical trial period, total of 4 weeks', 'interventionNames': ['Drug: Sipjeondaebo-tang']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sipjeondaebo-tang', 'description': 'Herbal medicine which is a compound of 10 herbs.', 'armGroupLabels': ['A group', 'B group'], 'otherNames': ['Deciten granule']}\n\nPrimary Outcomes:\n- {'measure': 'Brief Fatigue Inventory change', 'timeFrame': '0-5 week'}\n- {'measure': 'Brief Fatigue Inventory change', 'timeFrame': '6-11 week'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the paragraph.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size\n This is a pilot study that examines the feasibility of conducting a large-scaled randomised clinical trial of SJDBT for treating cancer-related fatigue in patients with breast cancer. Considering that a sample size between 24 and 50 has been recommended for a pilot study,17 18 and the sample size of other similar pilot studies, a total of 48 participants will be recruited for the present study.19 20 Thus, 24 participants will be allocated to group A and another 24 to group B.", "id": 67, "split": "train"} +{"trial_id": "NCT02862249", "pmid": "30772848", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective, Randomised Placebo Controlled Feasibility Trial of Faecal Microbiota Transplantation in Cirrhosis\n\nIncluded conditions:\n- Cirrhosis of the Liver\n\nStudy Armgroups:\n- {'label': 'Faecal microbiota transplantation', 'type': 'EXPERIMENTAL', 'description': 'Faecal microbiota transplantation.', 'interventionNames': ['Biological: Faecal microbiota transplantation']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo solution.', 'interventionNames': ['Biological: Placebo']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Faecal microbiota transplantation', 'description': \"The FMT (200mls) will be administered following preparation of the bowel with MoviPrep\u00ae, into the duodenum via a gastroscope derived from 50g of fresh donated stool from a healthy donor. The gastroscopy will be performed as per the King's College Hospital Gastroenterology Protocol.\", 'armGroupLabels': ['Faecal microbiota transplantation']}\n- {'type': 'BIOLOGICAL', 'name': 'Placebo', 'description': 'An identical appearing placebo solution (200mls 0.9% normal saline and 12.5% glycerol) will be administered into the duodenum via a gastroscope in a single blinded fashion following preparation of the bowel with MoviPrep\u00ae.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Assessment of the feasibility of FMT', 'description': 'Assess recruitment rates and tolerability of FMT (e.g reflux rates):\\n\\n* \\\\>50% fulfil inclusion/exclusion criteria (of all screened- about 160)\\n* \\\\>25% consent rate (of all those fulfilling inclusion/exclusion criteria about 80 patients)\\n* \\\\>80% randomised patients treated successfully and completing study up to D90 (out of those randomised approx 22 patients)\\n* Availability of obtaining sufficient donor samples for the study\\n* Reflux rates of transplanted material \\\\<20% e.g. foul taste, foul smell, nausea, vomiting, indigestion.\\n* Intolerable (resulting in withdrawal from the study GI side effects including diarrhoea, constipation, abdominal pain, flatulence and bloating) of \\\\<20%', 'timeFrame': '18 months'}\n- {'measure': 'Assessment of the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'description': '1. Incidence of any transmissible bacterial or viral infection that is deemed to have been acquired from the donor including Clostridium Difficile infection\\n2. The development of any SAE/SAR or USAR that is not pre-specified or is a known consequence of disease progression or complication of cirrhosis as outlined in section 7.2.5.1 that: results in death/is life threatening/requires hospitalisation or prolongation of existing hospitalisation/results in persistent or significant disability or incapacity.', 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a 95% CI for feasibility parameters, aims for at least 80% power, and considers a 25% consent rate, 50% eligibility rate, and 80% completion rate. The significance level is not explicitly mentioned, but the precision of estimates is discussed.", "answer": 32, "answer_type": "ACTUAL", "explanation": "Sample size\n This feasibility study will evaluate feasibility parameters using 95% CIs. The sample size has been proposed mainly to enable the trial to be conducted within the allocated budget and with acceptable precision for continuous outcomes. According to the simulation work by Teare et al,18 even with the relatively small pilot sample size of 20, the planned studies would have at least 80% power to detect the target effect size (for continuous outcomes) more than 75% of the time. Teare et al recommend that 60\u00e2\u0080\u0093100 subjects are sufficient to estimate an event rate (such as recruitment rates) with acceptable precision in a feasibility study, while sample sizes between 24 and 50 have been recommended for the accurate estimation of SDs. Therefore, we have chosen a sample size of 32 patients in this trial to have reliable data on all critical parameters (including event rates) which can also be used\u00c2\u00a0when planning a larger intervention trial. For event rates (eg, recruitment rates) and particularly in the extreme case with lower rates, for\u00c2\u00a0example, 10%, we estimate a drop of precision by only 5% using our updated sample size and the minimum recommended by Teare et al (0.16 for 60 patients vs 0.21 for 32 patients). Figure 2 illustrates the reduction in precision of different rates when the sample size increases for binary outcomes. This sample size will also be feasible within the budget and will provide acceptable information for planning a future large clinical trial.\n \n Figure 2\n \n CI width around one proportion (P) by sample size (N) from PASS software\u00c2\u00a0V.15.\n \n \n \n The sample size of 32 patients will undergo randomisation in a 3:1 ratio. This will allow the study to demonstrate the\u00c2\u00a0feasibility of randomising, yet providing robust evidence with respect to the feasibility of the treatment and preliminary evidence of efficacy parameters.\n The following feasibility criteria have been established:Twenty-five per cent of screened patients will consent: 256 patients will allow the estimate of the two-sided 95% CI of the proportion of consented patients, where the distance from the observed proportion to the limit is 0.058 units.Fifty per cent of patients screened will fulfil inclusion/exclusion criteria for the trial: screening 64 patients will allow the estimate of the two-sided 95% CI of the proportion of patients eligible, where the distance from the observed proportion to the limit is 0.128 units.Eighty per cent of randomised patients will complete treatment and follow-up: 26 of 32 patients completing will allow the estimate of the two-sided 95% CI for a single proportion, where the distance from the observed proportion to the limit is 0.177 units.\n\n Differences between the placebo and treatment group in efficacy binary outcomes will be estimated along with the two-sided 95%\u00e2\u0080\u0089CI\u00c2\u00a0(table 1). Assuming the proportion with the outcome in the control group is 0.5, our sample size will allow estimation of the half-width of the CIs for different size of differences as indicated below. Differences of 0.4 or higher will be distinguishable from 0.\n \n Table 1\n \n Half-width of CIs for differences in proportions between two groups with given sample size, placebo group, p=0.5 (created with PASS software REF\u00e2\u0080\u0094PASS V.15)\n \n \n \n \n Difference\n 0.1\n 0.2\n 0.3\n 0.4\n 0.5\n \n \n Width\n 0.398\n 0.392\n 0.382\n 0.337\n 0.347\n \n \n \n \n \n The half-width of the 95%\u00e2\u0080\u0089CI of the difference in means for continuous outcome will be 0.889 SD.", "id": 68, "split": "train"} +{"trial_id": "NCT02862665", "pmid": "29973224", "question": "Here is the design of a clinical trial:\n\nOfficial Title: N/A\n\nIncluded conditions:\n- Complex Valvular Heart Surgery\n\nStudy Armgroups:\n- {'label': 'IV iron', 'type': 'EXPERIMENTAL', 'description': 'The patients will receive iron isomaltoside 1000 (Monofer\u00ae) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery. They will receive iron isomaltoside 1000 (Monofer\u00ae) 1000 mg over 15 min.', 'interventionNames': ['Drug: iron isomaltoside 1000 (Monofer\u00ae)']}\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'The patients will receive normal saline 100 ml as an i.v. infusion twice; 3 days before surgery and 3 days after surgery. They will receive normal saline 100 ml over 15 min.', 'interventionNames': ['Drug: normal saline 100 ml']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'iron isomaltoside 1000 (Monofer\u00ae)', 'description': 'The patients will receive iron isomaltoside 1000 (Monofer\u00ae) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery. They will receive iron isomaltoside 1000 (Monofer\u00ae) 1000 mg over 15 min.', 'armGroupLabels': ['IV iron']}\n- {'type': 'DRUG', 'name': 'normal saline 100 ml', 'description': 'The patients will receive normal saline 100 ml as an i.v. infusion twice; 3 days before surgery and 3 days after surgery. They will receive normal saline 100 ml over 15 min.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'the proportion of patients who need blood transfusion', 'description': 'Investigator will assess the number of patients in each group who will need blood transfusion during hospital stays, and evaluate the effect of iron isomaltoside 1000 (Monofer\u00ae) on perioperative blood transfusion.', 'timeFrame': 'patients will be followed for the duration of hospital stay, an expected average of 10 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level at 0.05, power at 80%, effect size of 0.5, two-sided test, 10% dropout rate", "answer": 214, "answer_type": "ACTUAL", "explanation": "Sample size\n Sample size estimation is based on the null and alternative hypotheses. In our study, the null hypothesis is that \u00e2\u0080\u009cIVFe has no significantly different effect on Hb level and transfusion need after complex cardiac surgery\u00e2\u0080\u009d and we want to prove that the null hypothesis is wrong for replacing the alternative hypothesis by the two-sided test method. Previous reports [15, 16] suggested a 35% reduction in transfusion rate using IVFe but we set a higher transfusion rate (40%) considering the complexity and severity of cardiac surgery. The sample size calculation was based on superiority analysis under the hypothesis that all data was normally distributed data. We set the significance level at 0.05, the power at 80%, and the effect size was 0.5. A two-sided test was used and consequentially 97 patients were need for each group; however, we set each group as 107 considering a 10% dropout rate (total 214).", "id": 69, "split": "train"} +{"trial_id": "NCT02885948", "pmid": "29284510", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The NAPRESSIM Trial. The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.\n\nIncluded conditions:\n- Respiratory Depression\n\nStudy Armgroups:\n- {'label': 'Naloxone', 'type': 'EXPERIMENTAL', 'description': 'The naloxone arm of the study will receive naloxone at a rate of 5mcg/kg/hr which equates to 0.25ml/kg/hr. Each 1 ml ampoule of solution contains 400 micrograms (0.4mg) naloxone hydrochloride present as naloxone hydrochloride dihydrate.\\n\\nExcipients: each 1ml contains 3.55mg sodium. This will be diluted to a concentration of 20mcg/ml with 0.9% NaCl. Presented as solution for injection or infusion. Clear colourless sterile solution.', 'interventionNames': ['Drug: Naloxone']}\n- {'label': 'Saline', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo arm of the study will receive an infusion of normal saline at a rate of 0.25ml/kg/hr.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Naloxone', 'description': 'used to block the effects of opioids, especially in overdose', 'armGroupLabels': ['Naloxone']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo, ineffective control arm', 'armGroupLabels': ['Saline'], 'otherNames': ['Placebo Saline']}\n\nPrimary Outcomes:\n- {'measure': 'Respiratory depression', 'timeFrame': 'within 16 - 24 hours of participation'}\n\nPlease estimate the sample size based on the assumption: \nTo achieve a power of 80% at a 5% significance level, a one-tailed, two-proportion Z test with continuity correction was used. The initial sample size was 86, which was later inflated to account for a 10% dropout rate.", "answer": 96, "answer_type": "ACTUAL", "explanation": "Sample size and power\n Sample size was estimated to determine the superiority of the prophylactic naloxone infusion compared to placebo in reducing the rate of respiratory depression. Based on an audit of 29 patient charts in our unit containing information on respiratory depression, the percentage of the target patient population who develop respiratory depression without treatment is estimated to be 31% (95% confidence interval (CI) 14.2\u00e2\u0080\u009347.9%). This is based on the definition of respiratory depression in the ASA guidelines for prevention of respiratory depression with ITM [40].\n A clinically significant difference was defined as a 75% reduction in the percentage of respiratory depression among those on treatment, compared to those on placebo. Given the estimate of 31% for the placebo group, this is equivalent to a clinically significant relative risk of 4 (a four-times greater risk of respiratory depression for patients on placebo, than for those on treatment).\n Sample size calculations are based on a superiority hypothesis test of the risk of respiratory depression, formulated with the objective of testing whether the risk of respiratory depression is less for those on treatment than for those on placebo. To achieve a power of 80% for this test at a 5% significance level, a sample size of 43 per group is required or a total sample size of 86. This sample size calculation was calculated based on a one-tailed, two-proportion Z test with continuity correction.\n After commencement of the study the sample size was inflated to compensate for an un-anticipated dropout rate of up to 10%. The final sample size is 96 (48 per treatment group).", "id": 70, "split": "train"} +{"trial_id": "NCT02896400", "pmid": "29287665", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimizing Tobacco Dependence Treatment in the Emergency Department\n\nIncluded conditions:\n- Tobacco Use Disorder\n\nStudy Armgroups:\n- {'label': 'BNI+NRT+QL+Text', 'type': 'EXPERIMENTAL', 'description': 'Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)', 'interventionNames': ['Behavioral: Brief Negotiated Interview (BNI)', 'Drug: Nicotine replacement therapy (NRT)', 'Other: CT Smokers Quitline (QL)', 'Other: SmokefreeText (Text)']}\n- {'label': 'BNI+NRT+QL', 'type': 'EXPERIMENTAL', 'description': 'Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)', 'interventionNames': ['Behavioral: Brief Negotiated Interview (BNI)', 'Drug: Nicotine replacement therapy (NRT)', 'Other: CT Smokers Quitline (QL)']}\n- {'label': 'BNI+NRT+Text', 'type': 'EXPERIMENTAL', 'description': 'Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)', 'interventionNames': ['Behavioral: Brief Negotiated Interview (BNI)', 'Drug: Nicotine replacement therapy (NRT)', 'Other: SmokefreeText (Text)']}\n- {'label': 'BNI+NRT', 'type': 'EXPERIMENTAL', 'description': 'Brief Negotiated Interview (BNI) Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply', 'interventionNames': ['Behavioral: Brief Negotiated Interview (BNI)', 'Drug: Nicotine replacement therapy (NRT)']}\n- {'label': 'BNI+QL+Text', 'type': 'EXPERIMENTAL', 'description': 'Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)', 'interventionNames': ['Behavioral: Brief Negotiated Interview (BNI)', 'Other: CT Smokers Quitline (QL)', 'Other: SmokefreeText (Text)']}\n- {'label': 'BNI+QL', 'type': 'EXPERIMENTAL', 'description': 'Brief Negotiated Interview (BNI) Referral to CT Smokers Quitline (QL)', 'interventionNames': ['Behavioral: Brief Negotiated Interview (BNI)', 'Other: CT Smokers Quitline (QL)']}\n- {'label': 'BNI+Text', 'type': 'EXPERIMENTAL', 'description': 'Brief Negotiated Interview (BNI) Registration in SmokefreeText (Text)', 'interventionNames': ['Behavioral: Brief Negotiated Interview (BNI)', 'Other: SmokefreeText (Text)']}\n- {'label': 'BNI only', 'type': 'EXPERIMENTAL', 'description': 'Brief Negotiated Interview (BNI)', 'interventionNames': ['Behavioral: Brief Negotiated Interview (BNI)']}\n- {'label': 'NRT+QL+Text', 'type': 'EXPERIMENTAL', 'description': 'Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)', 'interventionNames': ['Drug: Nicotine replacement therapy (NRT)', 'Other: CT Smokers Quitline (QL)', 'Other: SmokefreeText (Text)']}\n- {'label': 'NRT+QL', 'type': 'EXPERIMENTAL', 'description': 'Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Referral to CT Smokers Quitline (QL)', 'interventionNames': ['Drug: Nicotine replacement therapy (NRT)', 'Other: CT Smokers Quitline (QL)']}\n- {'label': 'NRT+Text', 'type': 'EXPERIMENTAL', 'description': 'Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply Registration in SmokefreeText (Text)', 'interventionNames': ['Drug: Nicotine replacement therapy (NRT)', 'Other: SmokefreeText (Text)']}\n- {'label': 'NRT only', 'type': 'EXPERIMENTAL', 'description': 'Nicotine replacement therapy (NRT) patches and gum, 6 weeks supply', 'interventionNames': ['Drug: Nicotine replacement therapy (NRT)']}\n- {'label': 'QL+Text', 'type': 'EXPERIMENTAL', 'description': 'Referral to CT Smokers Quitline (QL) Registration in SmokefreeText (Text)', 'interventionNames': ['Other: CT Smokers Quitline (QL)', 'Other: SmokefreeText (Text)']}\n- {'label': 'QL only', 'type': 'EXPERIMENTAL', 'description': 'Referral to CT Smokers Quitline (QL)', 'interventionNames': ['Other: CT Smokers Quitline (QL)']}\n- {'label': 'Text only', 'type': 'EXPERIMENTAL', 'description': 'Registration in SmokefreeText (Text)', 'interventionNames': ['Other: SmokefreeText (Text)']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Control arm, no intervention'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Brief Negotiated Interview (BNI)', 'description': 'Brief motivational interview on smoking behavior', 'armGroupLabels': ['BNI only', 'BNI+NRT', 'BNI+NRT+QL', 'BNI+NRT+QL+Text', 'BNI+NRT+Text', 'BNI+QL', 'BNI+QL+Text', 'BNI+Text']}\n- {'type': 'DRUG', 'name': 'Nicotine replacement therapy (NRT)', 'description': '6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.', 'armGroupLabels': ['BNI+NRT', 'BNI+NRT+QL', 'BNI+NRT+QL+Text', 'BNI+NRT+Text', 'NRT only', 'NRT+QL', 'NRT+QL+Text', 'NRT+Text']}\n- {'type': 'OTHER', 'name': 'CT Smokers Quitline (QL)', 'description': 'Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.', 'armGroupLabels': ['BNI+NRT+QL', 'BNI+NRT+QL+Text', 'BNI+QL', 'BNI+QL+Text', 'NRT+QL', 'NRT+QL+Text', 'QL only', 'QL+Text']}\n- {'type': 'OTHER', 'name': 'SmokefreeText (Text)', 'description': \"Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.\", 'armGroupLabels': ['BNI+NRT+QL+Text', 'BNI+NRT+Text', 'BNI+QL+Text', 'BNI+Text', 'NRT+QL+Text', 'NRT+Text', 'QL+Text', 'Text only']}\n\nPrimary Outcomes:\n- {'measure': 'Tobacco Abstinence', 'description': 'Abstinence self reported and verified by exhaled carbon monoxide', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided 0.05 significance level, 80% power, and a 15% dropout rate by 3 months.", "answer": 1056, "answer_type": "ACTUAL", "explanation": "2.11. Justification of sample size\n The goal of this proposal is to identify individual tobacco dependence treatment intervention components which show clinical efficacy, subject to constraints of cost effectiveness and acceptability. As each component is allocated to half the participants, the sample size to detect main effects in a full factorial MOST design depends not on the number of components evaluated, but rather the smallest clinically important difference between the presence and absence of a component. In our previous trial, we found a difference of 7.3% in biochemically confirmed abstinence between the control and intervention arms at 3 months. It is reasonable to expect that, in this factorial trial, the effect of individual components will be less than that seen in the multi-component trial [17,44]. Therefore, we have chosen an absolute difference of 5% for the main effects of each component. (We considered a narrower difference of 4%, but the sample size and resources needed become unfeasible.) With a two-sided 0.05 significance level, and an average abstinence proportion of 4.9% in the absence of a component, a total sample size of 860 participants will provide 80% power to detect a 5% increase in the abstinence rate. We will enroll 1056 participants to account for a 15% dropout rate by 3 months. We will investigate whether the effect of a component is dependent on the levels of other components (i.e. interactions), but our trial is not powered with the intent to detect these interactions.", "id": 71, "split": "train"} +{"trial_id": "NCT02902653", "pmid": "30621614", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction: Randomized Clinical Trial\n\nIncluded conditions:\n- Labor, Induced\n\nStudy Armgroups:\n- {'label': 'Oral misoprostol', 'type': 'EXPERIMENTAL', 'description': 'Administration of oral misoprostol according to a \"3x1\" diagram, that is,3 oral doses (1 per hour) and then 1 hour without treatment', 'interventionNames': ['Drug: Oral misoprostol']}\n- {'label': 'Vaginal misoprostol', 'type': 'ACTIVE_COMPARATOR', 'description': 'vaginal misoprostol, 25 microgs every 4 hours', 'interventionNames': ['Drug: Vaginal misoprostol']}\n- {'label': 'Vaginal dinoprostone', 'type': 'ACTIVE_COMPARATOR', 'description': 'vaginal dinoprostone, 10 mg during 24 hours (maximum)', 'interventionNames': ['Drug: Vaginal dinoprostone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oral misoprostol', 'description': 'hourly titrated misoprostol', 'armGroupLabels': ['Oral misoprostol']}\n- {'type': 'DRUG', 'name': 'Vaginal misoprostol', 'description': 'Administration of 25 microgs every 6 hours, maximum 150 microgr', 'armGroupLabels': ['Vaginal misoprostol']}\n- {'type': 'DRUG', 'name': 'Vaginal dinoprostone', 'description': 'Vaginal delivery system of 10mg of dinoprostone', 'armGroupLabels': ['Vaginal dinoprostone']}\n\nPrimary Outcomes:\n- {'measure': 'Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)', 'timeFrame': '24 hours'}\n\nPlease estimate the sample size based on the assumption: \npower of 90%, confidence level of 95%, 10% rate of losses during follow-up", "answer": 372, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Taking data in the scientific literature on the rate of vaginal delivery within 24\u00e2\u0080\u0089h after the administration of the study drugs (70% for oral misoprostol [12], 55% for dinoprostone [12] and 54% of vaginal misoprostol [24]) as a reference, we will need to analyse 333 women (111 per arm) to detect significant differences between the groups with a power of 90% and a confidence level of 95%. Assuming a 10% rate of losses during the follow-up period, we will therefore need to recruit a total of 372 women (124 per arm).", "id": 72, "split": "train"} +{"trial_id": "NCT02907229", "pmid": "31072845", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms: a Multicenter, Uncontrolled, Exploratory Trial\n\nIncluded conditions:\n- Intracranial Aneurysm\n\nStudy Armgroups:\n- {'label': 'Treatment group', 'type': 'EXPERIMENTAL', 'description': 'neuroendovascular therapy(NCVC-CS1)', 'interventionNames': ['Device: NCVC-CS1']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'NCVC-CS1', 'description': 'Intervention Description', 'armGroupLabels': ['Treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'Safety evaluation: Any stroke or death related to the procedure within 180 days', 'timeFrame': '180 days after the procedure'}\n- {'measure': 'Efficacy evaluation: Complete obliteration of target aneurysm and patency of target vessel (less than 50% stenosis) confirmed by angiography at 180 days after the procedure', 'timeFrame': '180 days after the procedure'}\n\nPlease estimate the sample size based on the assumption: \ntwo-sided 95% exact (Clopper-Pearson type) CI with a width equal to 44.2%", "answer": 10, "answer_type": "ACTUAL", "explanation": "Sample size\n The planned subject number in this study is 12. The sample size was calculated based on the primary efficacy endpoint. A sample size of 10 would provide a two-sided 95% exact (Clopper-Pearson type) CI with a width equal to 44.2% (55.5% to 99.7%), assuming 90% complete obliteration of the target aneurysm and patency of the target vessel (PASS V.11; NCSS, Kaysville, UT, USA). A total of 12 patients will be recruited into the study, accounting for withdrawals from the study.", "id": 73, "split": "train"} +{"trial_id": "NCT02907502", "pmid": "34876419", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial\n\nIncluded conditions:\n- Healthy\n\nStudy Armgroups:\n- {'label': 'Experimental formula', 'type': 'EXPERIMENTAL', 'description': 'Young-child formula with low protein content', 'interventionNames': ['Dietary Supplement: Young-child formula with low protein content']}\n- {'label': 'Control formula', 'type': 'ACTIVE_COMPARATOR', 'description': \"Young-child formula with protein content similar to that of cow's milk\", 'interventionNames': [\"Dietary Supplement: Young-child formula with protein content similar to that of cow's milk\"]}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Young-child formula with low protein content', 'description': 'Young-child formula with low protein content', 'armGroupLabels': ['Experimental formula']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': \"Young-child formula with protein content similar to that of cow's milk\", 'description': \"Young-child formula with protein content similar to that of cow's milk\", 'armGroupLabels': ['Control formula']}\n\nPrimary Outcomes:\n- {'measure': 'BMI-for-age z-score', 'description': 'WHO-growth standard', 'timeFrame': 'Age 24 months'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a significance level of 5% (two-sided alpha of 0.05), and an assumed loss to follow-up of 30%.", "answer": 1618, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size calculation is based on the observations from the CHOP-study.1 This trial examined the difference in BMI-for-age z-scores between two groups of children fed a higher or lower protein content formula during the first year of life. At 24 months of age the BMI for age z-score difference between both formula groups was 0.2 SD. The absolute difference in protein content between intervention and control group in the CHOP-trial was lower (Infant formula: 0.8\u00e2\u0080\u0089g/100\u00e2\u0080\u0089mL; Follow-on formula: 1.6\u00e2\u0080\u0089g/100\u00e2\u0080\u0089mL) compared with the ToMI-trial (2.2\u00e2\u0080\u0089g/100\u00e2\u0080\u0089mL). Despite a higher protein difference, we expect a lower effect of the intervention due to the lower contribution of milk to the total protein intake in the second year of life. Thus, we assume a slightly lower mean difference in BMI for age z-score of 0.15 SD at 24 months of life.\n The sample size was calculated with an anticipated effect size on BMI for age z-score of 0.15 SD and a SD of 0.9. Assuming a power of 80% and a significance level of 5% (two-sided alpha of 0.05), a sample size of 566 subjects per intervention arm is calculated. Therefore, 1132 subjects in total are needed. To have enough power to detect also a difference of the same magnitude at 72 months (6 years) of age, at an assumed loss to follow-up of 30%, a final sample size of 1618 subjects was estimated.", "id": 74, "split": "train"} +{"trial_id": "NCT02907554", "pmid": "29665840", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Cyclosporine a Pretreatment of Deceased Donor on Kidney Graft Function: a Randomized Controlled Trial\n\nIncluded conditions:\n- Brain Death\n- Kidney Transplantation\n\nStudy Armgroups:\n- {'label': 'control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'control group receives a placebo', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'intervention group', 'type': 'EXPERIMENTAL', 'description': 'the intervention group receives 2.5 mg/kg of cyclosporine', 'interventionNames': ['Drug: cyclosporine A']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'cyclosporine A', 'description': 'the intervention group receives 2.5 mg/kg of cyclosporine', 'armGroupLabels': ['intervention group']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'control group receives a placebo', 'armGroupLabels': ['control group']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of delayed graft function defined by a need of at least one hemodialysis session', 'timeFrame': 'within the 7 days following renal transplantation.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level of 0.05 (two-sided alpha), and a 10% dropout rate.", "answer": 648, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was determined to obtain 80% power to detect a 10% difference for rate of DGF (as defined in the primary endpoint section) at day 7 between the two groups, as this difference is considered to be clinically significant. In accordance with previous studies [7, 8], we hypothesized that 30% of the patients in the placebo group and 20% of the patients in the intervention group will develop DGF. With the threshold for statistical significance set at a p value of 0.05 (two-sided alpha), these calculations showed that 588 participants (recipients) are needed (294 per group). Assuming that a potential 10% of participants will be lost to follow-up (for the primary or the secondary endpoints), a total of 648 recipients needs to be included. Secondary outcomes will be compared between the two groups: using the chi2 test or Fisher\u00e2\u0080\u0099s exact test for categorical variables and Student\u00e2\u0080\u0099s t test for continuous variables.", "id": 75, "split": "train"} +{"trial_id": "NCT02912949", "pmid": "38348690", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)\n\nIncluded conditions:\n- Solid Tumours Harboring NRG1 Fusion\n- NSCLC Harboring NRG1 Fusion\n- Pancreatic Cancer Harboring NRG1 Fusion\n- NRG1 Fusion\n\nStudy Armgroups:\n- {'label': 'Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.', 'interventionNames': ['Drug: zenocutuzumab (MCLA-128)']}\n- {'label': 'Part 2 NSCLC cancer harboring NRG1 fusion', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.', 'interventionNames': ['Drug: zenocutuzumab (MCLA-128)']}\n- {'label': 'Part 2 Solid tumour (basket) harboring NRG1 fusion', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.', 'interventionNames': ['Drug: zenocutuzumab (MCLA-128)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'zenocutuzumab (MCLA-128)', 'description': 'full length IgG1 bispecific antibody targeting HER2 and HER3', 'armGroupLabels': ['Part 2 NSCLC cancer harboring NRG1 fusion', 'Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion', 'Part 2 Solid tumour (basket) harboring NRG1 fusion'], 'otherNames': ['bispecific', 'MCLA-128']}\n\nPrimary Outcomes:\n- {'measure': \"Objective overall response rate (ORR) as per local investigator's assessment\", 'description': 'Evaluation of clinical benefit assessed by RECIST v1.1 determining objective overall response rate (ORR)', 'timeFrame': '36 months'}\n- {'measure': \"Duration of response per RECIST v1.1 as per local Investigator's assessment.\", 'description': 'To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed locally', 'timeFrame': '36 Months'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed to provide substantial evidence of effectiveness in a setting where a randomized trial will not be feasible, supporting a regulatory submission.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size\n Among patients with NRG1+ NSCLC, enrollment is planned to be limited to 100 patients. Enrollment of patients with NRG1+ PDAC is planned to be limited to 50 patients, and enrollment of patients with NRG1+ in other solid tumors into a\u00c2\u00a0basket cohort is planned to be limited to 100 patients across the various tumor types.\n The eNRGy study in patients with NRG1 fusions was designed to initially assess the\u00c2\u00a0presence of antitumor activity in patients with NSCLC, PDAC, or other tumor types, such as breast cancer and cholangiocarcinoma. The overall sample size was increased to a maximum of 250 patients to ensure a sufficient sample size to support a regulatory submission in NSCLC (to ensure at least 100 NSCLC patients previously treated with platinum-based combination), PDAC, and/or tumor agnostic setting, where a sufficient number of patients across multiple tumor types is expected to be treated to provide substantial evidence of effectiveness in a setting where a randomized trial will not be feasible.", "id": 76, "split": "train"} +{"trial_id": "NCT02920086", "pmid": "29301555", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improving Partnerships With Family Members of ICU Patients: The IMPACT Trial\n\nIncluded conditions:\n- Critical Illness\n\nStudy Armgroups:\n- {'label': 'Nutrition Education Program', 'type': 'EXPERIMENTAL', 'description': 'Nutrition education for family members of an elderly critically ill patient', 'interventionNames': ['Behavioral: Nutrition Education Program']}\n- {'label': 'Decision Support Program', 'type': 'EXPERIMENTAL', 'description': 'Decision support education for family members of an elderly critically ill patient', 'interventionNames': ['Other: Decision Support Program']}\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'No intervention'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Nutrition Education Program', 'description': \"* The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICS) intervention\\n* Nutritional education will be provided to ICU patents' families by a dietitian\\n* Tracking of nutritional information by family\\n* Encouragement for families to advocate for two or more Oral Nutritional Supplements per day for the patients (approximately 400 kcal/day)\", 'armGroupLabels': ['Nutrition Education Program'], 'otherNames': ['OPTICS']}\n- {'type': 'OTHER', 'name': 'Decision Support Program', 'description': '* Families will be provided with a web-based decision support tool (My ICU Guide)\\n* Families will meet with the ICU medical team early in ICU stay to review goals of care', 'armGroupLabels': ['Decision Support Program'], 'otherNames': ['The REALISTIC-80 Decision Support Intervention', 'My ICU Guide']}\n\nPrimary Outcomes:\n- {'measure': 'Nutritional adequacy during the ICU stay', 'timeFrame': 'Up to 30 days in ICU'}\n- {'measure': 'Consumption of Oral Nutritional Supplements', 'timeFrame': 'First four weeks once on ward'}\n- {'measure': 'Intake on hospital wards (3 day calorie count)', 'timeFrame': 'First four weeks once on ward'}\n- {'measure': 'Hand grip strength', 'description': 'Hydraulic hand dynamometer', 'timeFrame': 'At or before hospital discharge or up to 90 days'}\n- {'measure': 'Use of shared-decision making (OPTION tool)', 'timeFrame': 'Within first week in ICU'}\n- {'measure': 'Change in decisional conflict', 'description': '10-item Decisional Conflict Scale', 'timeFrame': '1 week'}\n- {'measure': 'Family satisfaction with decision-making', 'timeFrame': '1 week'}\n- {'measure': 'Overall family satisfaction with ICU', 'timeFrame': 'At ICU discharge, an average of 12 days'}\n\nPlease estimate the sample size based on the assumption: \n50 patients per group will achieve 92% power at a two-sided alpha = 0.05 for nutritional adequacy. For the decision-support intervention, 50 evaluable subjects per group will achieve 71% power at a two-sided alpha = 0.05 to detect a 5.5-point difference. A sample size of 50 per group allows for reasonable precision in assessing feasibility, compliance, and contamination endpoints.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n The total sample size for this phase II trial is 150 patients (50 per group). We expect the subsequent phase III trial will require 20\u00e2\u0080\u009330 sites with up to 1000 patients in total. As one of the primary goals of this phase II trial is to assess the feasibility of implementing the study interventions, we plan to assess feasibility at multiple sites. With approximately 10\u00e2\u0080\u009320 patients per site, we expect to gain enough experience to assess the feasibility of the study protocol per site.\n For each intervention, we have performed a sample size calculation for one of the key short-term outcomes of each intervention. From our prior work, we know that the average nutritional adequacy of these patients during their ICU stay will be 40\u00e2\u0080\u009350% with a standard deviation of 30% [36]. We aim to detect a small but clinically meaningful increase in nutritional adequacy of approximately 20%. Under these assumptions 50 patients per group will achieve 92% power at a two-sided alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05. For the decision-support intervention, we will power the trial to evaluate family satisfaction with decision-making. In our prior REALISTIC-80 study, the standard deviation of the FS-ICU24 \u00e2\u0080\u009cDecision-making\u00e2\u0080\u009d domain was 11; we consider an increase of 5.5 points (a medium effect size) to be plausible and clinically important. With 50 evaluable subjects per group, we would achieve 71% power at a two-sided alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 to detect a 5.5-point difference between groups.\n Given the other objectives of the study related to feasibility, compliance, and contamination, a sample size of 50 per group will allow us to assess these endpoints with reasonable precision, consistent with the sample size of other phase II studies. For example, with 50 patients per group there is a 95% chance of estimating a binary variable (such as loss to follow-up, contamination, compliance, etc.) to within\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008914% and any variable with a rate\u00e2\u0080\u0089<\u00e2\u0080\u008915% or\u00e2\u0080\u0089>\u00e2\u0080\u008985% (as would be expected for loss to follow-up, contamination, or compliance) could be estimated to within\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008910% or 19 times out of 20.", "id": 77, "split": "train"} +{"trial_id": "NCT02923843", "pmid": "30309994", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Are Care Given by a Geriatric Hospital-Based Out Patient-Care Team Better Than Usual Care? - a Randomised Controlled Trial (The GerOP-Ca-trial)\n\nIncluded conditions:\n- Elderly\n- Frail\n\nStudy Armgroups:\n- {'label': 'intervention', 'type': 'EXPERIMENTAL', 'description': 'Comprehensive Geriatric Assessment', 'interventionNames': ['Other: Comprehensive Geriatric Assessment']}\n- {'label': 'control', 'type': 'NO_INTERVENTION', 'description': 'Standard care'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Comprehensive Geriatric Assessment', 'description': 'The CGA is person-centered and unique for each patient, but is based on the core elements such as socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, providing a comprehensive assessment tailored for each person.', 'armGroupLabels': ['intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Days in hospital', 'description': 'Register data', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided test, significance level of \u03b1=0.05, 80% power, almost no loss to follow-up.", "answer": 450, "answer_type": "ACTUAL", "explanation": "Sample size\n A power calculation was made based on the primary outcome variable, that is, mean number of days in hospital. Based on a former similar study, there will be an assumed difference between the IG\u00c2\u00a0and the CG\u00c2\u00a0of 4.1 days in hospital during the 24-month study period (11.1 days in the IG and 15.2 in the CG) with an SD of 15 days in both groups. To be able to detect a difference between the IG and the CG with a two-sided test and with a significance level of \u00ce\u00b1=0.05% and 80% power, at least 211 participants in each group will be needed. There will be almost no loss to follow-up of the primary outcome based on previous research of this patient\u00c2\u00a0group and intervention.10 Thus, a total of 450 persons will be included.", "id": 78, "split": "train"} +{"trial_id": "NCT02931058", "pmid": "29347947", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Pre-operative Quadriceps Strength Training on Knee-extension Strength Before and Shortly Following Total Knee Arthroplasty: A Randomized Dose-response Trial (The QUADX-1 Trial)\n\nIncluded conditions:\n- Osteoarthritis, Knee\n\nStudy Armgroups:\n- {'label': 'Group 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'Two knee-extension exercise sessions per week. Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set.\\n\\nThe knee-extension resistance training exercise is performed with an elastic exercise band.', 'interventionNames': ['Other: Two knee-extension exercise sessions per week.']}\n- {'label': 'Group 4', 'type': 'ACTIVE_COMPARATOR', 'description': 'Four knee-extension exercise sessions per week. Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set.\\n\\nThe knee-extension resistance training exercise is performed with an elastic exercise band.', 'interventionNames': ['Other: Four knee-extension exercise sessions per week.']}\n- {'label': 'Group 6', 'type': 'ACTIVE_COMPARATOR', 'description': 'Six knee-extension exercise sessions per week. Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set.\\n\\nThe knee-extension resistance training exercise is performed with an elastic exercise band.', 'interventionNames': ['Other: Six knee-extension exercise sessions per week.']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Two knee-extension exercise sessions per week.', 'description': 'Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set.\\n\\nThe knee-extension resistance training exercise is performed with an elastic exercise band.', 'armGroupLabels': ['Group 2']}\n- {'type': 'OTHER', 'name': 'Four knee-extension exercise sessions per week.', 'description': 'Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set.\\n\\nThe knee-extension resistance training exercise is performed with an elastic exercise band.', 'armGroupLabels': ['Group 4']}\n- {'type': 'OTHER', 'name': 'Six knee-extension exercise sessions per week.', 'description': 'Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set.\\n\\nThe knee-extension resistance training exercise is performed with an elastic exercise band.', 'armGroupLabels': ['Group 6']}\n\nPrimary Outcomes:\n- {'measure': 'Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass', 'description': 'The measurement will be assessed using a computerized strength chair (Good Strength Chair, Metitur Oy, Jyvaskyla, Finland).', 'timeFrame': 'Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided significance level of 0.05, power of 80%, and a dropout rate of 10%.", "answer": 140, "answer_type": "ACTUAL", "explanation": "Sample size\n For a three-group-level One-way ANOVA of a normal mean difference with a two-sided significance level of 0.05, a common standard deviation of 0.22\u00c2\u00a0Nm/kg (isometric knee-extensor strength measurement) [51], and a minimal clinically important difference of 0.15\u00c2\u00a0Nm/kg (15%), a sample size of 126 (42 per group) patients is required to obtain a power of 80%. To allow for a dropout rate of 10%, we will include 140 patients in total for the intention-to-treat (ITT) analysis (3\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u008942\u00e2\u0080\u0089+\u00e2\u0080\u008914\u00e2\u0080\u0089=\u00e2\u0080\u0089140).", "id": 79, "split": "train"} +{"trial_id": "NCT02932358", "pmid": "29654049", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial\n\nIncluded conditions:\n- Delirium\n\nStudy Armgroups:\n- {'label': 'Flexible Family Visitation Model (FFVM)', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the FFVM, two or fewer family members will be allowed to visit the patient for up to 12 consecutive hours each day. In addition to family visitation, patients will be allowed to receive social visits in specific time intervals (according local ICU regulation). To have access to the FFVM, family members of ICU patients will have to attend a structured meeting at ICU in which they will receive orientations about the ICU environment, common ICU treatments, rehabilitation and basic infection control practices, multidisciplinary work at ICU and palliative treatment. Social visitors will not be required to attend the structured meeting.', 'interventionNames': ['Other: Flexible Family Visitation Model (FFVM)']}\n- {'label': 'Restrictive Family Visitation Model (RFVM)', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the RFVM, patients will be allowed to receive restricted visits according routine ICU practices, but respecting the maximum limit of 4.5 hours of visitation per day. Visitors will not be required to attend the structured meeting. The length of ICU visits will be similar to those of social visits in the FFVM.', 'interventionNames': ['Other: Restrictive Family Visitation Model (RFVM)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Flexible Family Visitation Model (FFVM)', 'description': 'Visitation to ICU patients allowed during the period of 12 consecutive hours per day.', 'armGroupLabels': ['Flexible Family Visitation Model (FFVM)']}\n- {'type': 'OTHER', 'name': 'Restrictive Family Visitation Model (RFVM)', 'description': 'Visitation to ICU patients allowed during intermittent periods according local ICU regulation.', 'armGroupLabels': ['Restrictive Family Visitation Model (RFVM)']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of Delirium among ICU patients', 'description': 'Incidence of delirium will be verified by trained intensive care professionals with the confusion assessment method for the ICU 2 times per day.', 'timeFrame': 'During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-tailed 0.05 alpha, intraclass correlation coefficient (ICC) of 0.05 for subjects in the same cluster/time period and 0.01 for subjects in the same cluster/different time periods.", "answer": 1650, "answer_type": "ACTUAL", "explanation": "Sample size and sampling\n A minimum of 33 ICUs with recruitment rate of 50 patients per ICU (25 patients per study phase) will be needed (total of 1650 patients) to detect an absolute difference\u00c2\u00a0>6.0%\u00e2\u0080\u0089in the cumulative incidence of delirium between the two study arms (considering an outcome incidence rate of 20.5% in the RFVM), with 80% power, and two-tailed 0.05 alfa. Two levels of intraclass correlation coefficient (ICC) were considered to calculate the sample size: 0.05 for subjects in the same cluster/time period and 0.01 for subjects in the same cluster/different time periods. Estimates of sample size for the primary outcome were made on the basis of the cumulative incidence of delirium found in a single centre before-and-after study that evaluated the effect of different policies of family visitation on the incidence of delirium.12 In order to compensate for potential ICU and patient losses, the present study plans to recruit 40 ICUs.", "id": 80, "split": "train"} +{"trial_id": "NCT02936973", "pmid": "33235115", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Effect of Catgut Implantation at Acupoints for the Treatment of Simple Obesity: a Multicentre Randomized Controlled Trial\n\nIncluded conditions:\n- Obesity\n\nStudy Armgroups:\n- {'label': 'Real catgut implantation', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive real catgut implantation at acupoints plus lifestyle modification. Participants will receive catgut implantation treatment every two weeks to fulfill a 8-session treatment course.When the acupoints and surrounding skin are disinfected, an absorbable surgical suture of an appropriate length will be embedded into the muscular layer or subcutaneous tissue of the acupoints by the specified disposable embedding needles. The absorbable surgical suture then stimulated those points over a long period.', 'interventionNames': ['Device: Real catgut implantation at acupoints']}\n- {'label': 'sham catgut implantation', 'type': 'SHAM_COMPARATOR', 'description': 'Participants will receive sham catgut implantation at acupoints and lifestyle modification every two weeks to fulfill a 8-session treatment course.The operation process will be similar to that applied in the real catgut implantation group. Empty needles without catgut will be pushed into the chosen position, to a depth equivalent to that used for catgut implantation at acupoints. The frequency and duration were the the same as the catgut embedding group.', 'interventionNames': ['Device: sham catgut implantation at acupoints']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Real catgut implantation at acupoints', 'description': \"1. Absorbable surgical suture will be embedded in acupoints as below. Group A \uff1aZhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B \uff1aQuchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40). Each group will be used alternatively and treated once every 2 weeks.\\n2. lifestyle intervention :Experienced nutritionists calculated every participant's basal metabolic rate,then designed a proper diet and exercise treatment for them. During the treatment, a diet and exercise diary will be distributed to the patients, and detailed guidance concerning their diet and exercise will be provided according to the diary. The patients should be encouraged to maintain the diet and exercise diary for at least 4 days per week .\", 'armGroupLabels': ['Real catgut implantation']}\n- {'type': 'DEVICE', 'name': 'sham catgut implantation at acupoints', 'description': 'Empty needles without catgut will be pushed into the chosen position as below :Group A \uff1a1 cun lateral from the Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B \uff1a1 cun lateral from the Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40).Those two groups of acupoints will ultimately be selected for alternative treatment. Each group will be used alternatively and treated once every 2 weeks.\\n\\nlifestyle intervention :It will be performed as the same as the real catgut implantation at acupoints group.', 'armGroupLabels': ['sham catgut implantation']}\n\nPrimary Outcomes:\n- {'measure': 'the rate of waistline reduction compared with baseline', 'timeFrame': 'week4 ,week8,week12,week16,week28,week40.'}\n\nPlease estimate the sample size based on the assumption: \n2-sided significance level at 5%, power at 80%, and a 20% attrition rate", "answer": 216, "answer_type": "ACTUAL", "explanation": "2.6\n Sample size estimation\n Based on a review of the literature, clinical experience and discussion among clinical experts, we anticipated 7% waistline reduction at 16 weeks in the CIA group and 2% reduction in the sham CIA group. Eighty six participants per group was required based on:\n \n \n 1.\n a mean clinically relevant difference of 5% (2% reduction in the sham CIA group), with a pooled standard deviation (SD) of 8.1%;\n \n \n 2.\n 2-sided at 5% and 1- at 80%.\n \n \n Assuming 20% attrition rate, we plan to enrol a total of 216 participants (108 per group).", "id": 81, "split": "train"} +{"trial_id": "NCT02937051", "pmid": "30309993", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults\n\nIncluded conditions:\n- Tobacco Products\n\nStudy Armgroups:\n- {'label': 'Own Brand Cigarette Condition', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Tobacco product administration and assessment']}\n- {'label': 'Original-flavor Black&Mild cigar', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Tobacco product administration and assessment']}\n- {'label': 'Apple-flavor Black&Mild cigar', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Tobacco product administration and assessment']}\n- {'label': 'Cream-flavor Black&Mild cigar', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Tobacco product administration and assessment']}\n- {'label': 'Wine-flavor Black&Mild cigar', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Tobacco product administration and assessment']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Tobacco product administration and assessment', 'description': 'two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment', 'armGroupLabels': ['Apple-flavor Black&Mild cigar', 'Cream-flavor Black&Mild cigar', 'Original-flavor Black&Mild cigar', 'Own Brand Cigarette Condition', 'Wine-flavor Black&Mild cigar']}\n\nPrimary Outcomes:\n- {'measure': 'Change in saliva nicotine concentration', 'description': 'Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).', 'timeFrame': 'Saliva will be collected at baseline before the first product administration, at 10 min following each product administration, and 55 min following the first product administration (baseline for the second product administration).'}\n- {'measure': 'Change in breakpoint from two behavioral choice tasks (Cigarette Purchase Task, Multiple Choice Procedure)', 'description': 'Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).', 'timeFrame': 'A behavioral choice task (cigarette purchase cask) will be completed at baseline before the first product administration, 5, 15, 30, and 45 min following each bout. 45 min after the second bout, the multiple choice procedure will be administered.'}\n- {'measure': 'Change in Addiction Research Center Inventory subjective abuse liability', 'description': 'Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).', 'timeFrame': 'Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.'}\n- {'measure': 'Change in Direct Effects of Nicotine and Tobacco Scale subjective abuse liability', 'description': 'Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).', 'timeFrame': 'Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.'}\n- {'measure': 'Change in Tobacco Abstinence Symptoms and Drug Effects subjective abuse liability', 'description': 'Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).', 'timeFrame': 'Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.'}\n\nPlease estimate the sample size based on the assumption: \npower > 0.80, moderate correlation between measures (r > 0.50)", "answer": 25, "answer_type": "ACTUAL", "explanation": "Sample size\n This study will recruit 25 young adults 18\u00e2\u0080\u009325 years of age. This number was necessary to detect moderate within-subjects effects (ie, f=0.35) with power\u00c2\u00a0>0.80 between conditions for the primary outcome measures, assuming a moderate correlation between measures (r>0.50).", "id": 82, "split": "train"} +{"trial_id": "NCT02938975", "pmid": "34802455", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents To Reduce Malaria Incidence In Military Personnel On Active Duty In Regions Of Hyperendemicity\n\nIncluded conditions:\n- Malaria\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'placebo group receiving untreated army combat uniform and placebo lotion. Assigned interventions: Placebo lotion - a liposome lotion with no DEET Army combat uniform - army combat uniform with no permethrin', 'interventionNames': ['Other: Placebo lotion', 'Other: Army combat uniform']}\n- {'label': 'Combo', 'type': 'ACTIVE_COMPARATOR', 'description': 'Combined intervention group of receiving Permethrin treated uniform 0.52% w/w and 30% DEET liposome formula.\\n\\nUltra 30 Insect Repellent Lotion (30% Lipo DEET) One application of Lipo DEET protects for up to 12 hours. DEET is a broad spectrum insect repellent that has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors.\\n\\nPermethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft Permethrin is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings.', 'interventionNames': ['Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET)', 'Other: Permethrin Factory-Treated Army Combat Uniforms']}\n- {'label': 'Permethrin', 'type': 'ACTIVE_COMPARATOR', 'description': 'permethrin intervention group receiving Permethrin treated uniform 0.52% w/w and placebo lotion.\\n\\nPermethrin Factory-Treated Army Combat Uniforms treated by the military apparel contractor Warmkraft\\n\\nPlacebo lotion: liposome lotion with no DEET', 'interventionNames': ['Other: Permethrin Factory-Treated Army Combat Uniforms', 'Other: Placebo lotion']}\n- {'label': 'DEET', 'type': 'ACTIVE_COMPARATOR', 'description': 'DEET intervention group receiving untreated army combat uniform and 30% DEET liposome formula.\\n\\nUltra 30 Insect Repellent Lotion (30% Lipo DEET) Army combat uniform with no permethrin', 'interventionNames': ['Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET)', 'Other: Army combat uniform']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Ultra 30 Insect Repellent Lotion (30% Lipo DEET)', 'description': 'One application of Lipo DEET protects for up to 12 hours and has a pleasant odour and non-greasy \"feel\" on the skin. DEET is a broad spectrum insect repellent and was selected this study because it has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors. DEET was first registered in 1957 and has been conclusively proven to be safe for use on adults, children, pregnant and lactating mothers.\\n\\nThis Liposome-based repellent is the newest advancement in insect repellent technology. The Liposome envelops the active ingredient, DEET, and slowly time-releases it as needed, thereby extending the effectiveness of the repellent and reducing dermal absorption.', 'armGroupLabels': ['Combo', 'DEET']}\n- {'type': 'OTHER', 'name': 'Permethrin Factory-Treated Army Combat Uniforms', 'description': \"Permethrin is the U.S., Australian and United Kingdom (UK) military's standard repellent for application to fabric and is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings; an objective easily met through factory treatment of uniforms, which demonstrates 99-100% bite protection up to 50 launderings (the expected lifetime of the uniform).\", 'armGroupLabels': ['Combo', 'Permethrin']}\n- {'type': 'OTHER', 'name': 'Placebo lotion', 'description': 'A liposome lotion with no DEET', 'armGroupLabels': ['Permethrin', 'Placebo']}\n- {'type': 'OTHER', 'name': 'Army combat uniform', 'description': 'Army combat uniform with no permethrin', 'armGroupLabels': ['DEET', 'Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of Plasmodium falciparum malaria through monthly measurement of malaria positivity by direct polymerase chain reaction (PCR) to detect parasite DNA', 'description': 'Blood spots will be collected on Whatman 3 filter paper and processed for PCR detection of parasites', 'timeFrame': 'Monthly active case detection for 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size was estimated using a simulation of 1000 trials with generalized linear mixed effects models. We assumed a Poisson distribution for the incidence of malaria infections and a lognormal distribution of the combania cluster effects. With 12 clusters each of 40 recruits and 12 months of follow-up, we would have 89% power to detect this difference as significant and estimate the IRR with a confidence interval of 0.49 to 0.88.", "answer": 1500, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size calculations are based on the comparison of the incidence of malaria infection between the trial arms. The primary comparison is between ETU + DEET and PTU + DEET. An expected total of 1500 recruits per year form combania with a mean of 40 recruits each. We expect roughly 37 combania available for randomisation. A combania is a military subsection of recruits who carry out all activities together and sleep in the same dormitory. The dormitories can accommodate 30 to 50 recruits. The trial is randomised by combania because of the risk of contamination between recruits in the same company if the trial were individually randomised and because it is expected that a whole company will use the same interventions in practice in a \u00e2\u0080\u009creal world\u00e2\u0080\u009d use scenario.\n The outcome is the incidence of malaria infection determined by PCR every 2\u00e2\u0080\u0089weeks. As a baseline estimate (with neither treated uniform nor repellent), the most recent available incidence of malaria infection in Mgambo camp among recruits is 0.68 per person per year in 2015 [40].\n The sample size was estimated using a simulation of 1000 trials using generalized linear mixed effects models written in R statistical software version to estimate the power and the precision of the estimated incidence rate ratio (IRR) (the precision is measured here by the expected width of the confidence interval). We assumed a Poisson distribution for the incidence of malaria infections among recruits and a lognormal distribution of the combania cluster effects.\n An assumed efficacy of 50% for PTU + DEET with a compliance of 80% would lead to an incidence rate of 0.41 infections per person per year. An assumed efficacy of 70% for ETU + DEET and compliance of 80% would lead to an incidence rate of 0.27 and an IRR of 0.66. With 12 clusters each of 40 recruits and 12\u00e2\u0080\u0089months of follow-up, we would have 89% power to detect this difference as significant and be able to estimate the IRR with a confidence interval of 0.49 to 0.88. After exploring different scenarios for unequal cluster randomisation to maximise power, we will randomise 12 combania (about 480 participants) for each arm of the primary comparison (PTU + DEET vs. ETU + DEET) and 6 combania (about 240 participants) to each of PTU + placebo lotion and untreated uniform + placebo lotion.", "id": 83, "split": "train"} +{"trial_id": "NCT02941107", "pmid": "31727664", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The ORVAC Trial: A Phase IV, Double-blind, Randomised, Placebo-controlled Clinical Trial of a Third Scheduled Dose of RV1 Rotavirus Vaccine in Australian Indigenous Infants to Improve Protection Against Gastroenteritis\n\nIncluded conditions:\n- Viral Gastroenteritis Due to Rotavirus\n\nStudy Armgroups:\n- {'label': 'Rotarix', 'type': 'EXPERIMENTAL', 'description': 'Rotarix (RV1) vaccine, 1mL liquid suspension administered orally.', 'interventionNames': ['Drug: Rotarix (RV1)']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo liquid suspension manufactured to mimic Rotarix (RV1) vaccine, 1ml administered orally', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rotarix (RV1)', 'description': 'ROTARIX\u2122 (RV1) is a live-attenuated human monovalent oral vaccine containing attenuated G1P\\\\[8\\\\] human rotavirus strain sponsored and distributed in Australia by GlaxoSmithKline Biologicals where it is licensed for the prevention of rotavirus gastroenteritis.', 'armGroupLabels': ['Rotarix'], 'otherNames': ['ROTARIX\u2122']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'The placebo for this trial will be Viscosweet, a clear and flavoured solution used as a pharmaceutical excipient repackaged into a labelled syringe identical to the active and firmly sealed with an end cap.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Viscosweet']}\n\nPrimary Outcomes:\n- {'measure': 'Time from randomisation to medical attendance for acute gastroenteritis or acute diarrhoea illness', 'description': 'Time from randomisation to medical attendance (hospitalisation, emergency department presentation, medical clinic presentation) for which the primary reason for presentation is presumed or confirmed acute gastroenteritis or acute diarrhoea illness between randomisation and age 36 months.', 'timeFrame': 'Randomisation to 36 months'}\n- {'measure': 'Occurrence of anti-rotavirus IgA seroconversion', 'description': 'Anti-rotavirus IgA seroconversion, defined as serum anti-rotavirus IgA \\\\> 20U/ ml 28 to 55 days post RV1/placebo among infants with anti-rotavirus serum IgA \\\\< 20U/ ml before RV1/placebo, to be summarised as the proportion of all children per group.', 'timeFrame': '28-55 Days post RV1/placebo administration'}\n\nPlease estimate the sample size based on the assumption: \nThe analyses will be conducted within a Bayesian framework. Interim analyses will occur after every 50th child enrolled or every 3 months, with the first interim analysis at 70 participants. The clinical endpoint analysis will start at 200 participants. The trial will stop for futility if there is a very low chance of observing a greater proportion of seroconversion or median time to medical attendance in the treatment arm. The trial will stop for expected success if the probability of higher seroconversion or median time to event in the treatment arm exceeds a threshold controlling type I error.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Data analyses and sample size\n Participant demographics and baseline characteristics will be summarised and tabulated by treatment group and location of residence. For the immunological endpoint, multivariate logistic regression will be used to compute the logs odds of the treatment effect. For the clinical endpoint, a Weibull parametric survival model will be used to compute the treatment effect, obtaining an absolute measure of median time to medical attendance in each arm. All analyses will occur within a Bayesian framework.\n In addition to modelling the treatment effects, we will include parameters to account for locality of residence, breastfeeding status in the 7 days prior to randomisation and, where applicable, indicator variables for gastroenteritis outbreaks.\n Secondary endpoints will be analysed using the same methods. Hypotheses, methods, prior distribution specification and probability thresholds that are alluded to here but omitted for brevity and accessibility will be detailed in a separately published statistical analysis plan.\n The first interim analysis will occur when 70 participants have immunogenicity results available. Further interim analyses will occur after every subsequent 50th child is enrolled or after every 3 months, whichever occurs sooner. If fewer than 25 children are enrolled in the 3-month interval, then the analyses will be deferred until the next scheduled interim. Analysis of the clinical endpoint will start when 200 children are enrolled in order that there are enough events to meaningfully undertake a time to event analysis. At each interim analysis, we will independently estimate:\n \n \n The posterior probability that the proportion of children achieving an IgA seroconversion in one arm is greater than in the other arm.\n \n \n The posterior probability that the median time to first medical attendance is greater in one arm than in the other arm.\n \n \n To assess futility, we will compute the predicted probability of trial success in both endpoints as if all resources were fully expended. If there is a very low chance of observing a greater proportion of seroconversion in the treatment arm OR there is very low chance of observing a greater median time to medical attendance in the treatment arm, then the trial will be stopped. Futility can be determined based on the results from either the immunological or the clinical endpoint. If futility is not concluded, we will then evaluate (1) whether the treatment arm has a higher rate of seroconversion compared with the placebo arm, and (2) whether a treatment effect is apparent in the clinical endpoint.\n If the probability that the rate of seroconversion in the Rotarix group is higher than in the placebo group, above a threshold level chosen to control the type I error, then we will cease collecting blood samples. Enrolment into the trial will continue, as will interim analyses, in order to assess the clinical endpoint until a decision rule is triggered for expected success or futility, or until we reach the maximum sample size of 1000 participants. If 250 infants with immunogenicity results have been enrolled without the above stopping rules having been met, no further venous blood samples will be collected.\n If the probability that the median time to event in the Rotarix group is greater than in the placebo group, above a threshold level chosen to control the type I error, then we will cease enrolment into the trial for expected success. We will continue to process any outstanding immunological results and follow patients up to 36 months old at which point we will undertake the final analysis and publish our findings. We note that expected success can only be determined based on the clinical endpoint.\n After 1000 infants have been enrolled without meeting a trial stopping rule, no further participants will be enrolled. Regardless of whether the trial is ceased for superiority or futility or continues to the maximum sample size, we will complete a final analysis once all follow-up data have been received.\n With the necessary governance and ethics approvals, access will be granted to the full protocol, Statistical Analysis Plan (SAP), analysis code and final dataset to allow for independent validation of the analysis.", "id": 84, "split": "train"} +{"trial_id": "NCT02941965", "pmid": "35831058", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preimplantation Genetic Screening in Patients With Male Factor Infertility\n\nIncluded conditions:\n- Infertility, Male\n- Diagnosis, Preimplantation\n\nStudy Armgroups:\n- {'label': 'ICSI without PGS', 'type': 'EXPERIMENTAL', 'description': 'Selection of embryos are based on blastocyst morphology criteria on day 5. A maximum of 2 embryos will be transferred for each treatment cycle.', 'interventionNames': ['Procedure: ICSI without PGS']}\n- {'label': 'ICSI with PGS', 'type': 'EXPERIMENTAL', 'description': 'PGS will be applied to select embryos on day 5, only euploid embryos will be transferred.\\n\\nA maximum of 2 embryos will be transferred for each treatment cycle.', 'interventionNames': ['Procedure: ICSI with PGS']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'ICSI without PGS', 'description': 'Selection of embryos are based on morphology criteria on the 5th day of ICSI.', 'armGroupLabels': ['ICSI without PGS']}\n- {'type': 'PROCEDURE', 'name': 'ICSI with PGS', 'description': 'PGS will be applied to selected embryos on the 5th day of ICSI.', 'armGroupLabels': ['ICSI with PGS']}\n\nPrimary Outcomes:\n- {'measure': 'live birth rate', 'description': 'This will be based on the outcome of either the PGS+ICSI or the outcome of the ICSI after first embryo transfer cycle.', 'timeFrame': '42 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) is set at 0.05, power (\u03b2) is set at 0.20, and a dropout rate of 20% is considered. The significance level for interim analysis is 0.001 and 0.05 for the final analysis.", "answer": 450, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to our previous research and the average live birth rate calculated over all study sites, the live birth rate of conventional IVF with non-male factor infertility is about 35% per cycle. And the live birth rate of ICSI with male factor infertility is about 25% per cycle. If we estimated the live birth rate of our control group (conventional ICSI group) is 25%, and ICSI+PGT-A can improve the live birth rate of severe male factor infertility to about 35%. Set \u00ce\u00b1=0.05 and \u00ce\u00b2=0.20, according to the sample size calculation formula, we need 188 participants in each group. Plus taking consideration a dropout of 20%, the total participant recruitment number is 450 (the ratio between groups will be 1:1). For the interim analysis, we will use the Haybittle-Peto boundary. The significance level for the interim analysis will be 0.001 and 0.05 for the final analysis.16", "id": 85, "split": "train"} +{"trial_id": "NCT02942927", "pmid": "34702336", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Team Approach to Polypharmacy Evaluation and Reduction Randomized Controlled Trial\n\nIncluded conditions:\n- Multi-morbidity\n- Medication Therapy Management\n- Polypharmacy\n\nStudy Armgroups:\n- {'label': 'TAPER', 'type': 'EXPERIMENTAL', 'description': 'The intervention is medication reduction. This arm is comprised of:\\n\\n1. Medication reconciliation\\n2. Identification of patient priorities for care\\n3. Identification of medications that are potentially appropriate for discontinuation/dose reduction\\n4. Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce\\n5. Identification of medications for trial of discontinuation/dose reduction (shared decision making)\\n6. Pause of medication and clinical monitoring', 'interventionNames': ['Other: Medication reduction']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Standard of Care as wait list control. Control group will be offered intervention as part of usual clinical care at 6 months.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Medication reduction', 'description': 'Systematic approach to reduction in polypharmacy.', 'armGroupLabels': ['TAPER'], 'otherNames': ['Medication discontinuation/dose reduction']}\n\nPrimary Outcomes:\n- {'measure': 'Successful discontinuation (mean difference in number of medications)', 'description': 'Difference in mean number of medications', 'timeFrame': 'Baseline, 6 months'}\n\nPlease estimate the sample size based on the assumption: \nPower set at 80%, significance level 5%, 10% attrition rate.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculations for the RCT were performed by the team biostatistician (LT). We used data from our feasibility study to estimate sample size: mean number of medications of 7.7, a post-intervention reduction in mean (standard deviation) of 4.2 (\u00c2\u00b1 2.5). There was consensus from the expert international polypharmacy advisory group that a mean reduction of 2 medications is clinically important [42].\n A sample size of at least 160 per group is sufficient to detect a difference in mean number of medications of 2, assuming a starting mean of 7 and a static control group (power set at 80%, significance level 5%). It will also allow detection of an absolute difference in the proportion of patients with drug-related side effects of 15% (10% versus 25%) and provides adequate power for subgroup analysis for the primary outcome if proportions are 40% or more. Allowance has been made for 10% attrition; therefore, the final minimum recruitment target is 180 per group (total N = 360).", "id": 86, "split": "train"} +{"trial_id": "NCT02946632", "pmid": "30249630", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Tolerability of Novel, Initial Triple Combination Therapy With Xigduo (Dapagliflozin Plus Metformin) and Saxagliptin vs. Conventional Stepwise add-on Therapy in Drug-na\u00efve Patients With Type 2 Diabetes\n\nIncluded conditions:\n- Diabetes Mellitus, Type II\n\nStudy Armgroups:\n- {'label': 'Triple combination therapy group', 'type': 'EXPERIMENTAL', 'description': 'Xigduo (metformin 1000mg + dapagliflozin 10mg), saxagliptin 5mg once daily for 104 weeks', 'interventionNames': ['Drug: triple combination therapy']}\n- {'label': 'Stepwise add-on therapy group', 'type': 'ACTIVE_COMPARATOR', 'description': '* Participants were started on metformin 1000mg once daily after screening \\\\& assignment\\n* At each visits, FPG and HbA1c are measured. Sequential add-on therapy regimen is described', 'interventionNames': ['Drug: Stepwise add-on therapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'triple combination therapy', 'description': 'Xigduo (metformin 1000mg + dapagliflozin 10mg) saxagliptin 5mg', 'armGroupLabels': ['Triple combination therapy group'], 'otherNames': ['metformin 1000mg', 'dapagliflozin 10mg', 'saxagliptin 5mg']}\n- {'type': 'DRUG', 'name': 'Stepwise add-on therapy', 'description': 'metformin -\\\\> glimepirde -\\\\> sitagliptin', 'armGroupLabels': ['Stepwise add-on therapy group'], 'otherNames': ['Metformin', 'Glimepiride', 'Sitagliptin']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patients who met HbA1c < 6.5% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 104 weeks', 'timeFrame': '104 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 90% power to detect a 60% difference in tolerability and a 30% increase in HbA1c target goal achievement rate, with a two-sided 5% level of significance. Additionally, a 10% dropout rate is assumed.", "answer": 104, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The tolerability will be measured using a composite endpoint with no hypoglycaemia, no weight gain or discontinuation due to a safety concern. It is assumed that the initial triple combination therapy will show a total of at most 10% intolerability (5% for hypoglycaemia, 0% for weight gaining or 5% for discontinuation due to AEs), while the stepwise add-on therapy will show a total of at most 70% intolerability (20% for hypoglycaemia, 30% for weight gaining or 20% for discontinuation due to AEs). A total of 10 subjects per group provided 90% power to detect a difference of 60% tolerability decrease (90% vs 30%) for the initial triple combination therapy compared with the stepwise add-on therapy with a two-sided 5% level of significance.\n To compare the efficacy of therapies, we assume that half of the subjects who are tolerable to the therapies will reach the target HbA1c level. A total of 46 subjects per group, then, are needed to provide 90% power in order to detect a 30% (45% vs 15%) increase in HbA1c target goal achievement rate of the initial triple combination therapy compared with the stepwise add-on therapy with a two-sided 5% level of significance based on normal approximation with unpooled variance.\n Assuming that about 10% of subjects would be lost to follow-up during study periods, we aim to recruit 52 subjects per group (104 subjects in total) for this study.", "id": 87, "split": "train"} +{"trial_id": "NCT02947503", "pmid": "35354633", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pregnancy Outcomes: Effects of Metformin Study (POEM Study), a Long Term Randomized Controlled Study in Gestational Diabetes\n\nIncluded conditions:\n- Gestational Diabetes\n- Insulin Resistance\n\nStudy Armgroups:\n- {'label': 'Metformin on top of usual care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Metformin TEVA 850 mg (1-3 times daily) added to usual care from start of the diagnosis GDM.\\n\\nUsual care has been defined as intensive counselling for diet and lifestyle plus insulin therapy if needed.\\n\\nIntervention: metformin TEVA 850 mg (1-3 times daily) on top of usual care.', 'interventionNames': ['Drug: Metformin TEVA 850 mg']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Usual care from start of the diagnosis GDM. Control group without metformin. Usual care has been defined as intensive counselling for diet and lifestyle plus insulin therapy if needed.\\n\\nIntervention: usual care.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Metformin TEVA 850 mg', 'description': 'At inclusion, patients (N=500) will be randomized 1:1 to metformin vs usual care (850 mg tablets, 3 times daily or, if tolerance is suboptimal, a lower maximally tolerated dose, 1-2 times daily), on top of diet and lifestyle, with an insulin rescue in both arms if needed.', 'armGroupLabels': ['Metformin on top of usual care'], 'otherNames': ['Metformin']}\n\nPrimary Outcomes:\n- {'measure': 'GDM Outcome Score (GOS) in Phase A', 'description': 'An aggregate score of eight clinically relevant endpoints, as previously defined:\\n\\n1. pregnancy related hypertension, including (pre-) eclampsia, according validated guidelines,\\n2. large for gestational age baby (LGA) at delivery according validated guidelines,\\n3. premature delivery with a gestational age \\\\< 37 weeks,\\n4. instrumental delivery,\\n5. caesarean delivery,\\n6. birth trauma, like fractures of clavicle and humerus, subdural / intracerebral haemorrhage,\\n7. neonatal hypoglycaemia, defined as blood glucose \\\\< 2.6 mmol/l,\\n8. admission for neonatal intensive care.', 'timeFrame': '30 months'}\n- {'measure': 'T2D and obesity at the end of Phase B', 'description': 'Incidence of maternal T2DM Weight (kg) and BMI (category) development mother Weight (kg) and BMI (percentile) development child', 'timeFrame': '42 months'}\n- {'measure': 'Development of T2D and obesity during Phase C', 'description': 'Incidence of maternal T2DM Weight (kg) and BMI (category) development mother Weight (kg) and BMI (percentile) development child', 'timeFrame': '282 months'}\n\nPlease estimate the sample size based on the assumption: \nThe distribution of GOS follows a Poisson distribution with a mean \u03bb close to 1. A ratio rate of 0.7 and a baseline final correlation in the range 0\\updelta $$\\end{document}HA:PT-PS>\u00ce\u00b4\n PT: CAL-free rate in test group =0.846.\n PS: CAL-free rate in standard group =0.83.\n \u00ce\u00b4 = \u00e2\u0088\u00920.1.\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ n=\\frac{{\\left({Z}_{\\alpha }+{Z}_{\\beta}\\right)}^2}{{\\left(\\varepsilon -\\delta \\right)}^2}\\left[{P}_T\\left(1-{P}_T\\right)+{P}_S\\left(1-{P}_S\\right)\\right] $$\\end{document}n=Z\u00ce\u00b1+Z\u00ce\u00b22\u00ce\u00b5\u00e2\u0088\u0092\u00ce\u00b42PT1\u00e2\u0088\u0092PT+PS1\u00e2\u0088\u0092PS\n Assuming that the type I and type II error rates are \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.2, respectively, the clinically meaningful difference \u00ce\u00b4 is \u00e2\u0088\u0092\u00e2\u0080\u00890.1. The CAL-free rate of the test group (IVIG alone) PT is 0.846 while that of the standard group (IVIG + high dose aspirin) PS is 0.83. Define\u00c2\u00a0\u00ce\u00b5\u00e2\u0080\u0089=\u00e2\u0080\u0089PT\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089PS. Assuming the sample sizes of the two groups are equal, each group for the non-inferiority trial must have 125 patients. In order to offset a maximum dropout of 10%, 139 patients are needed for each group. Therefore, a total sample size of 278 patients is required for this trial.", "id": 90, "split": "train"} +{"trial_id": "NCT02965313", "pmid": "39446736", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vaginal Surgery for the Pelvic Floor: A Randomized Trial of Synthetic Mesh Versus Synthetic Sutures\n\nIncluded conditions:\n- Pelvic Organ Prolapse\n\nStudy Armgroups:\n- {'label': 'SSLS Procedure', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: BSSVF-M Procedure']}\n- {'label': 'BSSVF-M Procedure', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: SSLS Procedure']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'SSLS Procedure', 'description': 'Synthetic suture repair', 'armGroupLabels': ['BSSVF-M Procedure']}\n- {'type': 'PROCEDURE', 'name': 'BSSVF-M Procedure', 'description': 'Bilateral sacrospinous vaginal vault fixation with synthetic mesh arms', 'armGroupLabels': ['SSLS Procedure']}\n\nPrimary Outcomes:\n- {'measure': 'Composite outcome of 3 objective signs and 1 subjective symptom of POP (yes/no answers). The definition of surgical success, used in the OPTIMAL trial as described in the description below.', 'description': 'The Optimal Trial Outcome is the absence of all the following: (1) objectively recorded, via POP quantification (POP-Q)15, recurrent POP of the top of the vagina beyond the upper third of the vaginal canal; (2) objectively recorded, via POPQ, recurrent POP of the anterior or posterior vaginal walls beyond the hymenal ring (vaginal entrance); (3) vaginal bulge symptoms reported by the patient, as indicated by an affirmative response to either: \"Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?\" and any response other than \"not at all\" to the question \"How much does that bother you?\" (4) re-treatment for prolapse by either surgery or pessary (conservative treatment with insertion of a silicone ring in the vagina for support). The POPQ is a validated quantification system with adequate interrater reliability which measures, in centimeters, the extent of vaginal wall descent with respect to a reference point at the hymenal ring.', 'timeFrame': '2 years postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a two-sample test of independent proportions (Chi-square test) with a two-sided significance level (\u03b1) of 0.05, a power of 80%, and an estimated 15% loss to follow-up.", "answer": 358, "answer_type": "ESTIMATED", "explanation": "Sample size\n We conducted a survey of 50 surgeons in Western Canada who indicated the smallest clinically relevant difference to change surgical practice would be an absolute change of 14%. The proportion of success in the control SSLS group was 60.5% in the OPTIMAL trial [11] and the success rate with BSSVF-M was 77% in our one-year pilot study [6]. Our pilot study was small and designed to inform a power calculation for an RCT; it did not study long-term results or cost effectiveness. Studies of mesh vs sutures in surgery for urinary incontinence indicate that mesh is more successful, durable and cost-effective than sutures, [22\u00e2\u0080\u009325] therefore we expect similar results for POP, with sustained durability of mesh over time. Sample size was determined based on a two-sample test of independent proportions (ie., Chi-square test), using two-sided \u00e2\u0088\u009e = 0.05, anticipated successful outcome rates 60 and 75%, power = 80% and yielded 152 patients/group. To account for an estimated 15% loss to follow-up (patients who never had a follow-up visit or who were deemed successful on their last follow-up), similar to the OPTIMAL trial [26], our sample size was increased to 179 per group for a total of 358 participants.", "id": 91, "split": "train"} +{"trial_id": "NCT02970864", "pmid": "32685131", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury\n\nIncluded conditions:\n- Injury of Nerves at Wrist and Hand Level\n\nStudy Armgroups:\n- {'label': 'Polynerve', 'type': 'EXPERIMENTAL', 'description': 'Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve.', 'interventionNames': ['Device: Polynerve']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Polynerve', 'description': 'Polymer biomaterial nerve conduit', 'armGroupLabels': ['Polynerve']}\n\nPrimary Outcomes:\n- {'measure': 'Assessment of safety and tolerability: number of patients with treatment-related adverse events as assessed by the Clavien-Dindo classification of surgical complications', 'description': 'To assess the safety and tolerability of use of the polymer biomaterial nerve conduit to repair a sensory nerve transection of the hand', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nNo specific assumptions on significance level, power, or missing/dropout rate were made.", "answer": 17, "answer_type": "ACTUAL", "explanation": "Sample size\n As this was a phase I study, primarily assessing safety of the device, a pragmatic decision on achievable recruitment numbers at a single centre who would be able to complete 12-months follow-up was made, and no formal power calculations were performed. The trial will recruit 17 participants over 12 months at an intended rate of approximately 1 to 2 participants per month. All participants fitting the eligibility criteria will be recruited.", "id": 92, "split": "train"} +{"trial_id": "NCT02975310", "pmid": "33268434", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial\n\nIncluded conditions:\n- Sinusitis\n- Nasal Polyps\n\nStudy Armgroups:\n- {'label': 'Endoscopic polypectomy in clinic (EPIC)', 'type': 'EXPERIMENTAL', 'description': 'Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic', 'interventionNames': ['Procedure: Endoscopic polypectomy in clinic (EPIC)', 'Other: Local and topical anesthesia']}\n- {'label': 'Endoscopic Sinus Surgery (ESS)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients assigned to this arm will undergo endoscopic sinus surgery (ESS),', 'interventionNames': ['Procedure: Endoscopic Sinus Surgery (ESS)', 'Other: General Anesthesia']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Endoscopic polypectomy in clinic (EPIC)', 'description': 'The experimental intervention is endoscopic polypectomy performed in clinic (EPIC) where nasal polyps are removed using a microdebrider under local and topical anesthesia in the outpatient clinic.', 'armGroupLabels': ['Endoscopic polypectomy in clinic (EPIC)']}\n- {'type': 'PROCEDURE', 'name': 'Endoscopic Sinus Surgery (ESS)', 'description': 'The control intervention is endoscopic sinus surgery (ESS), a minimally invasive procedure that is the current standard that involves polypectomy with a microdebrider as well as sinus ostia enlargement of the affected sinuses performed in the operating room under general anesthesia.', 'armGroupLabels': ['Endoscopic Sinus Surgery (ESS)']}\n- {'type': 'OTHER', 'name': 'General Anesthesia', 'description': 'ESS will be performed under general anesthesia in the operating room', 'armGroupLabels': ['Endoscopic Sinus Surgery (ESS)']}\n- {'type': 'OTHER', 'name': 'Local and topical anesthesia', 'description': 'EPIC will be performed under topical and local anesthesia in a clinic setting', 'armGroupLabels': ['Endoscopic polypectomy in clinic (EPIC)']}\n\nPrimary Outcomes:\n- {'measure': 'Sinonasal Outcome Test-22 (SNOT-22)', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n95% one-sided confidence limit on the difference in scores; 80% power; 10% dropouts and cross-overs.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our primary outcome, the SNOT-22 score, is a validated and reliable tool for assessing symptoms of CRS with polyps.29 Considering the primary outcome of SNOT-22 score, and based on an analysis of covariance (ANCOVA) test of the group differences in SNOT-22 scores, we calculated the minimum necessary sample size with the following assumptions: equal effects of EPIC and ESS; a margin of non-inferiority of 8.9 points, which is equal to the minimally clinically important difference of the SNOT-22 score; an SD of 20 points on SNOT-22 score; a 95% one-sided confidence limit on the difference in scores; and 80% power. Using a non-inferiority test of the null hypothesis that EPIC is superior to ESS by more than the margin of non-inferiority (8.9 points on the SNOT-22 score), a total of about 63 people would be required for enrolment in each arm of the study. Accounting for 10% dropouts and cross-overs from each arm of the trial, using the method of Lachin,30 an adjusted study size of 140 patients will be required. We selected a non-inferiority margin of 8.9 as it has been demonstrated to be the minimally important difference for the SNOT-22, that is, a change of less than 8.9 points cannot be perceived by a patient to be a clinically important improvement.", "id": 93, "split": "train"} +{"trial_id": "NCT02976961", "pmid": "29969990", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and CaRE of Patients with an Implantable Cardioverter Defibrillator\n\nIncluded conditions:\n- Implantable Defibrillator User\n- Distress\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Implantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge', 'interventionNames': ['Other: Supportive care']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Implantable cardioverter defibrillator implant + usual care'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Supportive care', 'description': 'Information, guidance, supportive care, and psychological intervention', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Device acceptance', 'description': 'Measured with the Florida Patient Acceptance Survey (FPAS)', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 0.05 (two-sided), power of 90%, and an estimated loss to follow-up rate of 20%.", "answer": 478, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Based on historical data from the Web-based Distress Management Program for Implantable Cardioverter Defibrillator (WEBCARE) patients that evaluated the effectiveness of an online behavioural treatment based on problem-solving principles of cognitive behavioural therapy [47, 48], we assume that a difference in device acceptance, as measured by the Florida Patient Acceptance Survey, of 3 points at 12\u00c2\u00a0months is the minimal clinically relevant difference between treatment groups. We further assume a standard deviation (SD) of 9 points. Targeting the power analysis to these assumptions, with a type I error of 0.05 (two-sided) and a power of 90%, 382 patients need to be evaluable for the primary endpoint. To compensate for loss to follow-up (estimated at 20%), we will aim to randomise a total of 478 patients (239 in each arm).", "id": 94, "split": "train"} +{"trial_id": "NCT02980367", "pmid": "32410697", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of the Clinical and Cost Effectiveness of Two Management Strategies for Non-acute Anterior Cruciate Ligament (ACL) Injury: Rehabilitation Versus Surgical Reconstruction.\n\nIncluded conditions:\n- Anterior Cruciate Ligament Injury\n\nStudy Armgroups:\n- {'label': 'ACL Rehabilitation Group', 'type': 'EXPERIMENTAL', 'description': 'Non-surgical management \\\\[Rehabilitation\\\\] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required.', 'interventionNames': ['Other: Non-Surgical Management (Rehabilitation)']}\n- {'label': 'ACL Reconstruction Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery', 'interventionNames': ['Procedure: Surgical Management (Reconstruction)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Non-Surgical Management (Rehabilitation)', 'description': 'Routine ACL rehabilitation protocols used at the participating site will be followed. As part of the site selection process, documentary evidence of the use of or willingness to adopt a rehabilitation protocol that reflects the guidelines of the mandatory aims/goals set for the study rehabilitation intervention will be required.', 'armGroupLabels': ['ACL Rehabilitation Group'], 'otherNames': ['Physical Therapy', 'Physiotherapy', 'Conservative Rehabilitation', 'Conservative Management']}\n- {'type': 'PROCEDURE', 'name': 'Surgical Management (Reconstruction)', 'description': \"All surgical reconstructions will be patella tendon or hamstrings tendon depending on the surgeon's preference. All other care will be routine, including immediate post-operative care.\", 'armGroupLabels': ['ACL Reconstruction Group'], 'otherNames': ['ACL Reconstruction', 'ACLR', 'ACL surgery', 'Anterior Cruciate Ligament Surgery', 'Surgical Management']}\n\nPrimary Outcomes:\n- {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS4)', 'description': 'The score is derived from 4 of 5 subscales; pain, symptoms, difficulty in sports and recreational activities, knee related quality of life.', 'timeFrame': '18 months post randomisation'}\n\nPlease estimate the sample size based on the assumption: \n90% power at a two-sided 5% significance level, intra-cluster correlation (ICC) of 0.06, cluster size mean (SD) of 26, 5 (12) for ACL reconstruction and 43, 3 (5) for rehabilitation groups, and just over 15% missing data.", "answer": 320, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n The number of participants\n In total, 320 participants will be recruited to the study. The minimal clinically important change (MIC) for the KOOS score is 8\u00e2\u0080\u009310 points [36]. Estimates of the minimal detectable change (MDC) for the two KOOS subscales most relevant for ACLD vary between five and 12 points (Symptoms 5\u00e2\u0080\u00939, and Sport/Rec 6\u00e2\u0080\u009312) [36]. A mean target difference of eight points in the primary outcome, KOOS4, along with a standard deviation of 19 (the highest value observed in a trial of acute patients at baseline amongst the KOOS subscales) were assumed [37, 38]. Given these assumptions, 120 participants per group are required (1:1 allocation, 240 in total) to achieve 90% power at two-sided 5% significance level in the absence of any clustering of outcome. However, to ensure sufficient power, clustering (clsampsi Stata command [39]) has been allowed for by conservatively assuming an intra-cluster correlation (ICC) of 0.06 [40] and cluster size n, mean (SD) of 26, 5 (12) and 43, 3 (5) for the ACL reconstruction and rehabilitation groups, respectively. This leads to the larger number of 130 participants per group (260), which has just over 80% power. Given the conservative nature of the assumed values and the anticipated gain in precision from adjusting for the baseline scores and other randomisation factors, actual power is likely to be higher even in the presence of clustering. To allow for just over 15% missing data (response in a similar trial [26]), 320 participants will be needed.\n An interim analysis will be carried out to estimate the magnitude of clustering for the 6\u00e2\u0080\u0089months KOOS4 outcome once data is available for 100 participants. Based upon this, a decision as to whether the sample size should be increased to allow for a greater level of clustering than anticipated will be made.", "id": 95, "split": "train"} +{"trial_id": "NCT02982122", "pmid": "31542757", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Clinical Trial Assessing the Effect of \"Optimal\" Cerebral Perfusion Pressure Monitoring in the Management of Severe Traumatic Brain Injury\n\nIncluded conditions:\n- Brain Injuries, Traumatic\n- Cerebrovascular Circulation\n- Homeostasis\n\nStudy Armgroups:\n- {'label': 'CPPopt intervention group', 'type': 'EXPERIMENTAL', 'description': 'Patients are managed according to Brain Trauma Foundation guidelines, except for CPP where the CPPopt is targeted.', 'interventionNames': ['Other: For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.']}\n- {'label': 'CPP control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients are managed according to Brain Trauma Foundation guidelines with CPP between 60 and 70 mmHg.\\n\\nCPPopt information is recorded but hidden for the treating clinicians.', 'interventionNames': ['Other: For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.', 'description': 'For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.', 'armGroupLabels': ['CPP control group', 'CPPopt intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of monitoring time with measured CPP within 5 mmHg of calculated CPPopt', 'description': 'Main feasible endpoint: In pilot studies, we showed that, on average, patients spent a mean (+SD) of 30% ( 8%) of their monitored time with measured CPP within 5 mmHg of CPPopt. The study will be powered to target an increase in this metric to 50% of monitored time.', 'timeFrame': 'First 5 days during intensive care unit admission'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 5% and power of 80% were assumed. The analyses will be conducted according to the intention-to-treat principle. The sample size was increased to account for dropout, technical problems, or the need for non-parametric analysis.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size justification is based on the primary endpoint for the feasibility objective. The analyses will be conducted according to the intention-to-treat principle, therefore all the enrolled and randomised patients will be included in the analysis, regardless of their compliance with the protocol. Sample sizes were determined using the R statistical language19 and the PWR package.20 A significance of 5% and power of 80% were assumed.\n As described in the outcome measures paragraph, the primary endpoint for the main objective, feasibility, is the percentage of monitored time with measured CPP within a range of 5\u00e2\u0080\u0089mm Hg above or below CPPopt. Retrospective analysis in unpublished data showed that on average patients spent a mean (+SD) of 30% (+8%) of their monitored time with measured CPP within 5\u00e2\u0080\u0089mm Hg of CPPopt. In the absence of prospective data, we powered COGiTATE study to target a relative increase in CPPopt target adherence by 20% (a pragmatic choice but justifiable on typical differences seen between good/poor outcome in the retrospective data), that is, from 30% to 36% of monitored time within the CPPopt target margin, while keeping the SD at 8%. This produced a desired sample size of 56, which was increased to 60 patients, to allow for dropout, technical problems or need for a non-parametric analysis.\n The primary endpoint for the safety secondary objective is to assess whether there is an increase of the daily TIL score of >3 in the CPPopt treatment arm. We regard an increase of daily TIL of 3 as a significant effect as it represents a difference comparable to one treatment tier and in comparison with typical TIL variability from pilot data. Conversely, a TIL score increase of 2 can be expected in the intervention group because two points are counted for CPP-related therapy (vasopressor therapy/fluids), so this could be not interpreted as a significant worsening of TBI therapy. We estimate, for 80% power and 5% significance an averaged change in daily TIL score of 3 would require an n=25 in each arm (although this is a secondary endpoint and this estimation does not correct for multiple comparisons).", "id": 96, "split": "train"} +{"trial_id": "NCT02999022", "pmid": "31915160", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial\n\nIncluded conditions:\n- Fractures\n\nStudy Armgroups:\n- {'label': 'Lithium carbonate', 'type': 'EXPERIMENTAL', 'description': 'Lithium carbonate 300mg capsule; once per day for 2 weeks.', 'interventionNames': ['Drug: Lithium Carbonate']}\n- {'label': 'Lactose placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Lactose placebo capsule; once per day for 2 weeks.', 'interventionNames': ['Drug: Lactose Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lithium Carbonate', 'description': 'Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.', 'armGroupLabels': ['Lithium carbonate'], 'otherNames': ['Lithium']}\n- {'type': 'DRUG', 'name': 'Lactose Placebo', 'description': 'Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.', 'armGroupLabels': ['Lactose placebo'], 'otherNames': ['placebo']}\n\nPrimary Outcomes:\n- {'measure': 'radiographic healing of fracture', 'description': 'radiographic healing using the RUST score at 8 weeks', 'timeFrame': '8 weeks after injury (non-surgical participants) or 8 weeks after surgery (surgical participants)'}\n\nPlease estimate the sample size based on the assumption: \nA two-sample two-sided t-test with 80% power at an alpha of 0.05, assuming a drop-out rate of 10%-15%. The O'Brien-Fleming function partitions the alpha for interim and final analysis to approximately 0.003 and 0.047, respectively.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n The sample size calculation was based on pilot data analysis previously completed comparing mean Radiographic Union Scores (RUSTs) between treatment and placebo at 24 weeks in the pilot study. With the mean RUST of the placebo taken to be 8.25 and an SD of 2.6 based on our pilot data, a two-sample two-sided t-test with 70 per group has 80% power at alpha of 0.05 to test a difference in means of 1.24 or greater. Assuming a drop-out rate of 10%\u00e2\u0080\u009315%,\u00e2\u0080\u0089this sample size will be inflated to 80 per group, or 160 participants in total. The participants will be randomised 1:1 into the two groups and stratified according to long bone and smoking. The sample size calculation was run using PASS V.12 (Hintze, J. (2014), NCSS; Kaysville, Utah, USA). A single interim analysis will be carried out at 50% recruitment. The O\u00e2\u0080\u0099Brien-Fleming function was used with the sample size estimates to partition the alpha for the interim and final analysis to approximately 0.003 and 0.047, respectively.", "id": 97, "split": "train"} +{"trial_id": "NCT03004729", "pmid": "29773698", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Symptoms Based Awareness Confirmation Study - CoMiSS Validation\n\nIncluded conditions:\n- Cow Milk Allergy\n\nStudy Armgroups:\n- {'label': 'CoMiSS', 'type': 'OTHER', 'description': \"Measure of CoMiSS followed by two weeks eviction Cow's milk protein diet and second CoMiSS measurement.\", 'interventionNames': ['Other: CoMiSS questionnaire']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'CoMiSS questionnaire', 'armGroupLabels': ['CoMiSS']}\n\nPrimary Outcomes:\n- {'measure': 'The accuracy in terms of the Area Under Curve (AUC) of the Receiver Operating Characteristic (ROC) curve of the change in CoMiSS.', 'timeFrame': 'baseline, Week 2'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 90% power and a 5% significance level (2.5% for one-sided testing). The dropout rate is assumed to be 15-20%.", "answer": 300, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The hypothesis of interest is that the AUC > A0 (=0.75) and is tested using the test-statistic\n \nZ=A^\u00e2\u0088\u0092A0Var\u00c2\u00a00(AUC)\n\n where A^\u00c2\u00a0is the estimated AUC on the holdout set, A0=0.75\u00c2\u00a0is the benchmark or minimum clinically relevant AUC of the ROC curve and Var0(A) is the variance of the AUC under the null hypothesis H0. The variance of the AUC at a given value A\u00c2\u00a0is given by Hajian-Tilaki9\n\n \nVarA(AUC)=0.0099\u00c2\u00a0e\u00e2\u0088\u0092a22(5a2+8nd+a2+8nh),\n\n where a=(2)\u00ce\u00a6\u00e2\u0088\u00921(A)\u00c2\u00a0\u00ce\u00a6\u00c2\u00a0is the cumulative distribution function of the standard normal distribution n\u00e2\u0088\u0092 and n+\u00c2\u00a0and are the number of subjects in the holdout set who test negative and positive in the OFC, respectively.\n The corresponding sample size for the required number of subjects who would test positive on the OFC test when the assumed AUC is A is given by:\n \nn+=[z\u00ce\u00b1/2V0(AUC)+z\u00ce\u00b2VA(AUC)]2(A\u00e2\u0088\u0092A0)2\n\n where\u00c2\u00a0VA(AUC)=n+VarA(AUC).\n The pooled prevalence from three recent CoMiSS trials of children with a positive OFC, that is, confirmed CMPA was 83%.10 Entry criterion for these studies was a CoMiSS \u00e2\u0089\u00a512. For the present study, patients will be recruited based on symptoms and the estimated prevalence of CMPA in the study population will therefore lower (estimated prevalence of challenge-proven CMPA 70%). Based on the above asymptotic sample size formula and prevalence estimate for CMPA, around 80 subjects with a positive OFC and 35 subjects with a negative OFC will be required in the holdout set to test the above hypothesis regarding the AUC with 90% power and at 5% level of significance and 2.5% for one-sided testing. Thus, the overall sample size accommodating the training and holdout set splits is\u00c2\u00a0N=2\u00c3\u0097115=230. Assuming a 15\u00e2\u0080\u009320% dropout rate, 300 subjects will need to be enrolled.", "id": 98, "split": "train"} +{"trial_id": "NCT03008083", "pmid": "31852711", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Multi-center Open-label Controlled Trial of Comparison 3 vs 12 Months of Dual Anti-Platelet Therapy After Implantation of Firehawk Sirolimus Target- Eluting Stent in Patients With Stable Coronary Artery Disease\n\nIncluded conditions:\n- Drug-Eluting Stents\n- Percutaneous Coronary Intervention\n\nStudy Armgroups:\n- {'label': '3 months DAPT Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'After implantation of Firehawk coronary stents, all subjects in intervention group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor)for 3 months.', 'interventionNames': ['Drug: 3 months DAPT']}\n- {'label': '12 months DAPT Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'After implantation of Firehawk coronary stents, all subjects in control group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor)for 12 months.', 'interventionNames': ['Drug: 12 months DAPT']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '3 months DAPT', 'description': 'Subjects will continue DAPT with P2Y12 inhibitors and Aspirin (ASA) up to 90 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.', 'armGroupLabels': ['3 months DAPT Intervention'], 'otherNames': ['Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)']}\n- {'type': 'DRUG', 'name': '12 months DAPT', 'description': 'Subjects will continue DAPT with P2Y12 inhibitors and Aspirin (ASA) up to 360 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.', 'armGroupLabels': ['12 months DAPT Intervention'], 'otherNames': ['Ticagrelor (180 mg/day) or Clopidogrel (75 mg/day)']}\n\nPrimary Outcomes:\n- {'measure': 'Net Adverse Clinical and Cerebral Events (NACCE)', 'description': 'A composite of all-cause death, MI, cerebral vascular accident (CVA) and major bleeding at 18 months', 'timeFrame': 'At 18 months after index procedure'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80.2%, 1-sided type I error rate of 0.025, and 5% loss to follow-up.", "answer": 2446, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Based on the event rates and previous data involving a real-world patient population treated with DES,8 18 24\u00e2\u0080\u009327 we predicted the NACCE rates of the 3-month DAPT group and the 12-month DAPT group to be at least 10.0% at 18 months after the index PCI. The non-inferiority margin is of 3.5%. We estimated that with a total of 2446 patients (1223 per group), the power of the study would be at 80.2% to detect non-inferiority with a 1-sided type I error rate of 0.025, assuming that 5% of patients would be lost to follow-up.", "id": 99, "split": "train"} +{"trial_id": "NCT03009435", "pmid": "29444695", "question": "Here is the design of a clinical trial:\n\nOfficial Title: RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate\n\nIncluded conditions:\n- Fetal Manual Rotation\n\nStudy Armgroups:\n- {'label': 'prophylactic manual rotation', 'type': 'EXPERIMENTAL', 'description': 'Only obstetricians will participate in the study. Manual rotation is performed at full dilatation.The technique employed will be at the discretion of the operator performing the procedure :\\n\\n* Tarnier and Chantreuil technique\\n* or SOGC technique', 'interventionNames': ['Other: prophylactic manual rotation']}\n- {'label': 'expectative management', 'type': 'NO_INTERVENTION', 'description': 'Expectative management . No manual rotation'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'prophylactic manual rotation', 'armGroupLabels': ['prophylactic manual rotation']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of spontaneous vaginal delivery', 'timeFrame': 'At the time of delivery'}\n\nPlease estimate the sample size based on the assumption: \npower of 90%, alpha risk of 5%, 10% of patients lost to follow-up", "answer": 238, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to the hypothesis of Le Ray et al.\u00e2\u0080\u0099s study in 2013, 214 patients are required to show a 20% increase in the percentage of spontaneous vaginal delivery (60% without manual rotation vs 80% with manual rotation) with a power of 90% and an alpha risk of 5% (107 per group). We plan to include 238 patients in total to take into account the 10% of patients lost to follow-up.", "id": 100, "split": "train"} +{"trial_id": "NCT03013595", "pmid": "32299401", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness of Managed Transition in Improving the Health and Social Outcomes for Young People Transitioning From Child to Adult Mental Health Care: the MILESTONE Study\n\nIncluded conditions:\n- Mental Health Impairment\n- Mental Health Disorder\n\nStudy Armgroups:\n- {'label': 'TRAM feedback', 'type': 'EXPERIMENTAL', 'description': '1. The completion of the \"Transition Readiness and Appropriateness Measure\" (TRAM, a standardized structured assessment ) prior to the transition boundary by the child and adolescent mental health service (CAMHS) clinician, young person and parent/carer.\\n2. Feedback of TRAM findings to the CAMHS clinician to support decisions made regarding transition, communication with stakeholders and the transition process. Clinicians will be expected to communicate the findings to the young person and parent/carer, and, if a referral is made, to send the TRAM feedback to the adult clinician along with the referral letter.\\n3. The clinicians will also receive information prior to recruitment begin on the use of TRAM and the way in which it fits in with optimal transition.', 'interventionNames': ['Behavioral: TRAM feedback']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': \"Patients, parent/carers and clinicians in the control arm will complete the TRAM prior to the transition boundary, but the clinicians won't receive any feedback from it nor any information on the benefits of using the decision support tool.\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'TRAM feedback', 'armGroupLabels': ['TRAM feedback'], 'otherNames': ['Managed transition']}\n\nPrimary Outcomes:\n- {'measure': 'Mental health status (need for care) as measured by Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA - clinician version) at 15 months', 'description': 'The measure will be completed by a trained MILESTONE research assistant taking into account all available sources of information (including the young person, parent/carer, relevant clinician and the medical records) to ensure accuracy of data.', 'timeFrame': '15 months'}\n\nPlease estimate the sample size based on the assumption: \nPower calculations and significance levels are described in the protocol paper for the MILESTONE study.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Sample size\n For the preliminary validation of the scales, the total sample size across the eight countries was calculated to be approximately 100 participants in each group (i.e., 100 young people, 100 parents/carers/spouses, and 100 mental health professionals), which was based on sample size calculations.\n The power calculations linked with the external validation have been described in the protocol paper for the MILESTONE study [39]. For the analysis of external validity, all participants in the MILESTONE study (the cohort and control arms) participated, resulting in a group of approximately 3000 participants (1000 YP, 1000 PC and 1000 CL).", "id": 101, "split": "train"} +{"trial_id": "NCT03024827", "pmid": "29981580", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cannabidiol in Children With Refractory Epileptic Encephalopathy: A Phase 1 Open Label Dose Escalation Study (CARE-E)\n\nIncluded conditions:\n- Epileptic Encephalopathy\n\nStudy Armgroups:\n- {'label': 'Medical Cannabis Oil', 'type': 'EXPERIMENTAL', 'description': 'CanniMed\u00ae 1:20', 'interventionNames': ['Drug: CanniMed\u00ae 1:20']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'CanniMed\u00ae 1:20', 'description': 'A cannabidiol (CBD): tetrahydrocannabinol (\u03949 THC) 20:1 ratio product will be provided as an oil-based suspension.', 'armGroupLabels': ['Medical Cannabis Oil'], 'otherNames': ['Medical Cannabis Oil']}\n\nPrimary Outcomes:\n- {'measure': 'Heart Rate', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Blood Pressure', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Weight', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Complete Blood Count (CBC) and Differential', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Sodium, potassium, chloride, calcium, magnesium, phosphate and carbon dioxide (mmol/L)', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Blood Urea Nitrogen (mmol/L)', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Creatinine (umol/L)', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-glutamyl transferase (GGT) and Lipase (U/L)', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Total and Direct Bilirubin (umol/L)', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Albumin (g/L)', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Total Cholesterol and Triglyceride (mmol/L)', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Clobazam and Norclobazam Levels (umol/L)', 'description': 'For participants taking clobazam who become excessively sedated', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Clonazepam Level (umol/L)', 'description': 'For participants taking clonazepam who become excessively sedated', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Urine Ketones', 'description': 'For participants on the ketogenic diet', 'timeFrame': 'Up to 6 months'}\n- {'measure': 'Trough Level of Concomitant Anti-Convulsants', 'description': 'Measure interactions with any anti-convulsants participants may be already on', 'timeFrame': 'Up to 7 months'}\n- {'measure': 'Adverse Events', 'description': 'Side effect rating scale, includes items related to sleepiness/lethargy, irritability, nausea/vomiting and diarrhea', 'timeFrame': 'Through study completion, up to 7 months'}\n- {'measure': '2-hour Electroencephalogram (EEG) Recording', 'timeFrame': 'Up to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated; phase I study focused on safety and tolerability.", "answer": 20, "answer_type": "ACTUAL", "explanation": "Sample size determination\n As CARE-E is a phase I dose escalation safety and tolerability study designed to find the most appropriate dose of CBD in a pediatric population it was felt that power analysis was not required to calculate sample size. The sample size of 28 participants each receiving 4 separate dosage escalations is within usual guidelines for standard phase I clinical trial designs. In this multi-site dose escalation study, we chose to escalate within the same participant with 7 participants at each site because the low pediatric population incidence of epileptic encephalopathy (the inclusion criterion), precluded ability to escalate in cohorts of 6, where a new cohort of six would be administered the next dosing level [20, 21]. Any patient exhibiting a dose limiting toxicity will not receive the next dose escalation.", "id": 102, "split": "train"} +{"trial_id": "NCT03033719", "pmid": "31801485", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years\n\nIncluded conditions:\n- Colonic Cancer\n\nStudy Armgroups:\n- {'label': 'Laparotomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Open surgery', 'interventionNames': ['Procedure: Laparotomy']}\n- {'label': 'Laparoscopy', 'type': 'EXPERIMENTAL', 'description': 'Minimally invasive surgery', 'interventionNames': ['Procedure: Laparoscopy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Laparotomy', 'description': 'Open surgery', 'armGroupLabels': ['Laparotomy'], 'otherNames': ['Open surgery']}\n- {'type': 'PROCEDURE', 'name': 'Laparoscopy', 'description': 'Minimally invasive surgery', 'armGroupLabels': ['Laparoscopy'], 'otherNames': ['Minimally invasive surgery']}\n\nPrimary Outcomes:\n- {'measure': 'Global postoperative morbidity in both arms', 'description': 'Postoperative morbidity is defined as any surgical or medical complications occurring up to 30 days after surgery. It will be collected using a standardized collection form during hospitalization and eventual subsequent consultations in case of patient discharge before then', 'timeFrame': 'At 30 days after the surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a two-sided alpha risk of 5% and a power of 80% (beta = 0.20). No interim analysis will be performed. Statistical significance is considered for two-tailed P-values <0.05.", "answer": 276, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size\n This study is multicenter, open-label randomized, 2-arm phase III superiority trial, comparing arm A (colectomy by laparoscopy) versus arm B (colectomy by laparotomy) for patients aged 75\u00e2\u0080\u0089years old or more with uncomplicated colon cancer. The hypotheses for sample size calculation are: (i) H0: there is no difference in overall postoperative morbidity between the two arms; (ii) H1: there is a significant difference, with estimated global morbidities in the laparoscopy and laparotomy groups of 20 and 35%, respectively. With a two-sided \u00ce\u00b1 risk of 5% and a power of 80% (\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.20) as alternative hypothesis H1, 276 patients will be included in total (138 patients in each arm). No interim analysis will be performed. The endpoints will be analyzed according to the intention-to-treat principle, in such a way that patients who did not receive their allocated surgical procedure were analyzed in the treatment group to which they had been randomized. An additional as-treated analysis will also be done, taking into account intraoperative conversions to the open-surgery group.\n Continuous variables will be described via the mean, standard deviation, median, minimum and maximum. Categorical variables will be described using frequencies and percentages. The percentages will be calculated with the missing data item. 95% confidence intervals (95% CI) will be calculated when necessary.\n Percentage differences between groups will be compared with the Pearson\u00e2\u0080\u0099s \u00cf\u00872 test or Fisher\u00e2\u0080\u0099s exact test, as appropriate. Comparison of continuous data will be done by use of the Student\u00e2\u0080\u0099s t test or the nonparametric Mann-Whitney U test, depending on their distribution. Two-tailed P-values <0.05 will be considered statistically significant.\n Quality of life will be described preoperatively and 3\u00e2\u0080\u0089months postoperatively in both treatment arms. Rate of patients having a QLQ-C30 or QLQ-CR29 score improved, deteriorated or stabilized at the second quality of life assessment will be reported in each arm with frequency and percent. The weighted means at baseline (preoperative score) and at 3\u00e2\u0080\u0089months will be compared in each arm using the Wilcoxon\u00e2\u0080\u0099s signed-rank test. Based on the study by Osoba and colleagues [32], this analysis will be limited to domains showing a difference of at least 10 points between the two assessments, which can be interpreted as a clinically important change. Mean quality of life changes from baseline will be computed in each arm with 95% CI. The weighted mean differences between both arms will be compared using the nonparametric Mann-Whitney U test.", "id": 103, "split": "train"} +{"trial_id": "NCT03034343", "pmid": "31619196", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Brief Psychological Mindfulness Based Intervention for the Treatment of Depression in Primary Care: Face-to-face Application, Treatment as Usual and Application Through ICTs\n\nIncluded conditions:\n- Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'TAU+mindfulness applied face to face', 'type': 'EXPERIMENTAL', 'description': '4 sessions of 90 minutes/session Mindfulness based intervention applied in groups of 10-12 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is one month.', 'interventionNames': ['Behavioral: Mindfulness']}\n- {'label': 'TAU + Mindfulness ICTs intervention', 'type': 'EXPERIMENTAL', 'description': '4 sessions of 60 minutes/session Mindfulness based intervention applied by ICTs (Internet-based program). The online intervention will be individual and interactive, which will be supported by multimedia material (videos, sound recordings, etc.) and will have internet support. The estimated duration of the online program is two months.', 'interventionNames': ['Behavioral: Mindfulness']}\n- {'label': 'Usual medical treatment (TAU)', 'type': 'NO_INTERVENTION', 'description': 'In this group the general practitioner will apply the usual treatment (medication) but there will be no psychological treatment.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness', 'armGroupLabels': ['TAU + Mindfulness ICTs intervention', 'TAU+mindfulness applied face to face']}\n\nPrimary Outcomes:\n- {'measure': 'Beck Depression Inventory-II', 'timeFrame': 'Baseline'}\n- {'measure': 'Beck Depression Inventory-II', 'description': 'In the mindfulness-based intervention applied by ICTs', 'timeFrame': 'Post-treatment 8 weeks from baseline in 8 weeks intervention group'}\n- {'measure': 'Beck Depression Inventory-II', 'description': 'In the mindfulness-based intervention applied face-to-face and TAU group', 'timeFrame': 'post-treatment 4 weeks from baseline in 4 weeks intervention group'}\n- {'measure': 'Beck Depression Inventory-II', 'timeFrame': 'Six-months follow-up'}\n- {'measure': 'Beck Depression Inventory-II', 'timeFrame': 'Twelve-months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nWe assumed a 5% significance level, 80% statistical power, a 1:1:1 ratio, a baseline correlation of 0.6, a decay rate of 0.35, a common SD of 5, and a dropout rate of approximately 20%.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size estimation was based on testing whether the trend in the change is different between the intervention groups throughout the 4 time points. Firstly, we assumed that MBI groups would be able to present moderately high effects, compared to \u00e2\u0080\u009cTAU alone\u00e2\u0080\u009d, on the BDI-II at post-treatment. To operationalize this, we considered a standardized difference between arms on the main outcome of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.7, which corresponds to the average effect observed in ten studies comparing MBIs with different wait-list conditions [36] and surpasses the 0.5 standard deviation criterion considered clinically relevant in previous studies [37, 38]. A preceding study by our research group with mild or moderate depressed patients in a similar Spanish PC setting found BDI-II means and standard deviations (SDs) of 22 and 5, respectively [20]. The inclusion criteria used in this study restricted the entry of mild or moderate depressed patients, thus reducing the SD compared to the general population and presenting a less skewed distribution of the data, as we predict will occur in the present study. The effect size referred to above corresponds to a difference of 3.5 points, which implies a reduction of slightly more than 15% in the BDI-II scale used. According to the GLIMMPSE v2.0.0 \u00e2\u0080\u0093 time x group interaction in a general linear repeated measures (RM) design \u00e2\u0080\u0093 and GPower v3.1.9.4 \u00e2\u0080\u0093 ANOVA test for RM within-between interaction \u00e2\u0080\u0093 statistical tools, considering the referred difference between the \u00e2\u0080\u009cface-to-face MBI + TAU\u00e2\u0080\u009d vs. \u00e2\u0080\u009cTAU alone\u00e2\u0080\u009d groups of depressed patients, which corresponds to a partial eta square value of roughly 0.09 and an effect size f of 0.31, with a common mean at baseline of 22, a mean at post-test of 16 and 19.5 respectively, and a mean at post-test of 17 for the \u00e2\u0080\u009cInternet delivered MBI + TAU\u00e2\u0080\u009d condition, and assuming a one point reduction in each group at each following time point, a baseline correlation of 0.6 and a decay rate of 0.35, assuming a common SD of 5, a 5% significance level, a statistical power of 80% using a 1:1:1 ratio, and an univariate approach to RM with Greenhouse-Geisser correction [39], we needed 33 subjects in each group. Because we expected a dropout rate of approximately 20% [40], we inflated the numbers to reach a total sample size of 120 patients, 40 per arm [41].", "id": 104, "split": "train"} +{"trial_id": "NCT03036436", "pmid": "30852540", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Investigating the Feasibility and Acceptability of a Technology Delivered Physical Activity (PA) Intervention in Cancer: The IMPETUS Cancer Trial. (IMproving Physical Activity and Exercise With Technology Use in Cancer Survivors)\n\nIncluded conditions:\n- Cancer, Breast\n- Cancer, Colorectal\n- Malignancy\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive the intervention. They will receive a Fitbit activity tracker, and will also receive support and goal setting with a view to improving their daily physical activity.', 'interventionNames': ['Behavioral: Intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Intervention', 'description': 'A physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Physical Activity (Objective)', 'description': 'Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.', 'timeFrame': 'Baseline, 12 weeks, 24 weeks'}\n- {'measure': 'Evaluation of recruitment capability and resulting sample characteristics', 'description': 'The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.', 'timeFrame': '12 weeks'}\n- {'measure': 'Data collection procedures and outcome measures', 'description': 'Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes', 'timeFrame': '12 weeks'}\n- {'measure': 'Acceptability and suitability of the intervention and study procedures', 'description': 'Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed', 'timeFrame': '12 weeks'}\n- {'measure': 'Use of resources and ability to manage and implement the study and intervention', 'description': 'The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention', 'timeFrame': '12 weeks'}\n- {'measure': 'Preliminary evaluation of participant responses to intervention', 'description': \"The qualitative outcome in this feasibility study will invite participants' to provide feedback on the intervention's likelihood of being successful. Satisfaction with the technological intervention will be measured using a questionnaire given to participants at study end (12 weeks).\", 'timeFrame': '12 weeks'}\n- {'measure': 'Change in body composition', 'description': 'This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in percentage body fat.', 'timeFrame': 'Baseline, 12 weeks and 24 weeks'}\n- {'measure': 'Change in self-report PA', 'description': 'A modified version of the Godin Leisure Time Exercise Questionnaire will be used.', 'timeFrame': 'Baseline, 12 weeks and 24 weeks'}\n- {'measure': 'Change in quality of life', 'description': 'The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.', 'timeFrame': 'Baseline, 12 weeks and 24 weeks'}\n- {'measure': 'Change in aerobic capacity/endurance', 'description': 'This will be measured using the 6MWT (Six minute walk test).', 'timeFrame': 'Baseline,12 weeks and 24 weeks'}\n- {'measure': 'Change in BMI', 'description': 'This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg/m\\\\^2.', 'timeFrame': 'Baseline, 12 weeks and 24 weeks'}\n- {'measure': 'Change in Body Weight (kg)', 'description': 'This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.', 'timeFrame': 'Baseline,12 weeks and 24 weeks'}\n- {'measure': 'Change in waist circumference', 'description': 'This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.', 'timeFrame': 'Baseline,12 weeks and 24 weeks'}\n- {'measure': 'Change in quality of life', 'description': 'The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.', 'timeFrame': 'Baseline,12 weeks and 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \n20% dropout rate is assumed.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n The difficulties of generating accurate sample size calculation for feasibility studies are well known. For feasibility studies, sample sizes between 24 and 50 have been recommended.40 Based on this, we propose to recruit a sample size of 60 which allows for a\u00c2\u00a020% dropout.", "id": 105, "split": "train"} +{"trial_id": "NCT03053791", "pmid": "34593490", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase I/II Open-label Multicenter Trial to Evaluate Safety and Preliminary Efficacy of Unilateral Deep Brain Stimulation of the Mesencephalic Locomotor Region in Patients With Incomplete Spinal Cord Injury\n\nIncluded conditions:\n- Spinal Cord Injury\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Single-armed study. All patients will receive treatment.', 'interventionNames': ['Procedure: Deep brain stimulation in mesencephalic locomotor region', 'Device: Implantation of a Deep brain stimulation system']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Deep brain stimulation in mesencephalic locomotor region', 'description': 'Implantation of Electrodes in the Mesencephalic Locomotor Region for improvement of Locomotion and Gait', 'armGroupLabels': ['Intervention group']}\n- {'type': 'DEVICE', 'name': 'Implantation of a Deep brain stimulation system', 'description': 'Implantation of a Medtronic Percept PC Impulse Generator for chronic Stimulation of the selected target.', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in 6 Minute Walk Test at baseline and 6 months post intervention', 'description': 'Standardized test. Patient is asked to walk for 6 minutes. Result is the distance covered', 'timeFrame': 'preoperative, 6 months post intervention'}\n\nPlease estimate the sample size based on the assumption: \npower (1-\u03b2) of 80%, \u03b1=0.05", "answer": 5, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on data on the 6MWT48 82 83 published in the literature and our clinical experience we estimate a relative effect size of 30% improvement in the 6MWT 6 months after treatment start compared with performance at baseline to be clinically relevant. A sample size of five patients provides us with a power (1\u00e2\u0088\u0092\u00ce\u00b2) of 80% (\u00ce\u00b1=0.05). Founded on previous experience in DBS of the MLR,84 85 we judge that the selected sample size will provide acceptable clinical validity for the study objectives.", "id": 106, "split": "train"} +{"trial_id": "NCT03055871", "pmid": "32957959", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Parents and Children Active Together: Examining Motivational, Regulatory, and Habitual Intervention Approaches\n\nIncluded conditions:\n- Physical Activity\n\nStudy Armgroups:\n- {'label': 'Standard education control group', 'type': 'NO_INTERVENTION', 'description': \"The control group package will consist of Canada's PA guidelines recommending 180 min per week for young children, transitioning to 60 minutes of activity a day for children at five and a breakdown of ways for the parent to help their child achieve this PA (unstructured, endurance, strength, activities) commensurate with this guide. The guide also contains arguments and information about the benefits of PA.\"}\n- {'label': 'Physical activity planning intervention', 'type': 'OTHER', 'description': 'The physical activity planning intervention condition will receive the same guidelines as the standard education control group but will also be provided with family physical activity planning material. This material will include workbook on how to plan for family physical activity; brainstorming exercise for children where they list physical activities that they have found fun in the past, as well as activities that they would find enjoyable to do as a family.', 'interventionNames': ['Behavioral: Physical activity planning intervention']}\n- {'label': 'Habit formation intervention', 'type': 'OTHER', 'description': 'The habit formation intervention condition will receive the same content as the education control condition and the physical activity planning condition but with additional material on creating physical activity support habits. The material includes a brief discussion of what habits are with some very straightforward examples such as preparing for sleep routines, or initiating to drive a car to work. A key component of the habit section will be based on planning for context-dependent repetition, with pointers on how to maintain repetition as habit forms.', 'interventionNames': ['Behavioral: Habit formation intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Habit formation intervention', 'description': 'In addition to the control content and the planning content, this intervention will include material provided to the family that assists with creating physical activity support habits. The material contains a discussion of what habits are, straightforward examples, planning and pointers for forming habits. A key component of the habit intervention will be planning for context-dependent repetition.', 'armGroupLabels': ['Habit formation intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Physical activity planning intervention', 'description': 'This arm will receive the control education content, but will also be provided with family PA planning material. This material will include skill training content (workbook on how to plan for family PA). The material includes a brainstorming exercise for parents where they list physical activities they think their children have found fun in the past, as well as activities that they would find enjoyable to do as a family. We also have Canadian parental survey data on the most preferred co-physical activities for children 3-6. We will provide this material as prompts/suggestions. This list helps create the template for PA planning by contextualizing what the parents would like to do with their kids.', 'armGroupLabels': ['Physical activity planning intervention']}\n\nPrimary Outcomes:\n- {'measure': \"Change from baseline in children's physical activity to 6 months\", 'description': \"Children's physical activity will be quantified by accelerometry. Children will wear an accelerometer for a minimum of 6 hours per day for 7 days at baseline and 6 months. Additionally this measure will assess intermediate outcomes at 6 weeks and 3 months.\", 'timeFrame': 'Baseline and 6 months'}\n\nPlease estimate the sample size based on the assumption: \n4 repeated assessments, 3 groups, a power of .90, an alpha of .05, and an anticipated attrition rate of 15%.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Justification of sample size\n G-Power (Version 3.1.9.2) was used to calculate sample size. With 4 repeated assessments, 3 groups, a power of .90, an alpha of .05, effect sizes ranging from .25 to .30, and an anticipated attrition rate of 15% [34], a minimum of 165 families with a goal of 240 families (i.e., 55\u00e2\u0080\u009380 families per condition) are needed to show a significant difference in physical activity accelerometry (minutes of MVPA primary outcome) by condition over time. The effect sizes represent the findings from our prior intervention research comparing planning to education with this demographic [34] and considering our pilot study on habit formation [42], yet it is clearly in the clinically meaningful range for the detection of differences between the planning and habit formation conditions [107, 108]. However, detection is dependent on the performance of the habit versus planning conditions which is largely unknown.", "id": 107, "split": "train"} +{"trial_id": "NCT03056391", "pmid": "29690924", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Paracetamol on Renal Function in Plasmodium Knowlesi Malaria: A Randomised Controlled Clinical Trial\n\nIncluded conditions:\n- Malaria\n\nStudy Armgroups:\n- {'label': 'Paracetamol', 'type': 'EXPERIMENTAL', 'description': '\\\\>50kg: Paracetamol 1gm PO/NG 6 hourly for 72 hours (maximum dose 4g/24h) plus IV artesunate or oral artemether/lumefantrine.\\n\\n\\\\<50kg: Paracetamol 12.5-15mg/kg/dose 6 hourly for 72 hours (maximum total dose 5doses/24hours;75mg/kg) plus IV artesunate or oral artemether/lumefantrine.', 'interventionNames': ['Drug: Paracetamol']}\n- {'label': 'No Paracetamol', 'type': 'NO_INTERVENTION', 'description': 'No Paracetamol plus IV artesunate or oral artemether/lumefantrine.\\n\\nIf temperature \\\\>39.5\u00b0C, tepid sponging and mechanical antipyresis will be performed by research staff and/or relatives.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Paracetamol', 'description': '\\\\>50kg: Paracetamol 1gm PO/NG 6 hourly for 72 hours (maximum dose 4g/24h) plus IV artesunate or oral artemether/lumefantrine.\\n\\n\\\\<50kg: Paracetamol 12.5-15mg/kg/dose 6 hourly for 72 hours (maximum total dose 5doses/24hours;75mg/kg) plus IV artesunate or oral artemether/lumefantrine.', 'armGroupLabels': ['Paracetamol'], 'otherNames': ['acetaminophen']}\n\nPrimary Outcomes:\n- {'measure': 'Effect of Paracetamol on kidney function', 'description': 'Change in creatinine concentration (umol/L) at 72 hours from enrolment in patients receiving regularly-dosed paracetamol compared to those not receiving regular paracetamol, stratified by the level of intravascular haemolysis (cell-free haemoglobin).', 'timeFrame': '72 hours'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05; Power (1-\u03b2) = 0.9; Log-transformed estimated mean 72 h creatinine in control group = 4.38 \u03bcmol/L (SD 0.36); Log-transformed estimated mean 72 h creatinine in treatment group = 4.275 \u03bcmol/L (SD 0.36); Correlation between baseline and 72 h creatinine = 0.59; Loss to follow-up rate = 10%.", "answer": 360, "answer_type": "ACTUAL", "explanation": "Sample size\n Our sample size for ANCOVA was calculated using the Stata command sampsi, with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05; 1\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089\u00ce\u00b2 (power)\u00e2\u0080\u0089=\u00e2\u0080\u00890.9; log-transformed estimated mean 72 h creatinine in control group\u00e2\u0080\u0089=\u00e2\u0080\u00894.38 \u00ce\u00bcmol/L (estimated SD 0.36); log-transformed estimated mean 72 h creatinine in treatment group\u00e2\u0080\u0089=\u00e2\u0080\u00894.275\u00c2\u00a0\u00ce\u00bcmol/L (estimated SD 0.36); correlation between baseline and 72 h creatinine (data log-transformed)\u00e2\u0080\u0089=\u00e2\u0080\u00890.59. The mean 72 h creatinine in the control group, the correlation between baseline and 72 h creatinine, and the standard deviation of the creatinine was estimated using existing data from prospectively enrolled patients with non-severe knowlesi malaria at a tertiary hospital in Sabah [9], with non-severe malaria patients used to more accurately reflect the patients at the district hospital sites. The mean 72 h creatinine in the treatment group was estimated using an estimated effect size of 10%, consistent with data from a pilot randomised trial of regularly dosed paracetamol, versus no paracetamol, in patients with severe and moderately severe falciparum malaria in Bangladeshi adults [29]. We estimated that this effect size would be similar in patients with knowlesi malaria of any severity, given the greater haemolysis that occurs in severe knowlesi malaria compared to severe falciparum malaria, and in non-severe knowlesi malaria compared to non-severe falciparum malaria [32].\n Using the above calculation, a minimum sample size of 324 will be required. Allowing for a loss to follow-up of 10% (primarily due to patients discharged from hospital <\u00e2\u0080\u008972\u00c2\u00a0h), we will require a minimum of 360 patients enrolled in the study, 180 in each arm.", "id": 108, "split": "train"} +{"trial_id": "NCT03057691", "pmid": "31492778", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Impact of Depression and/or Anxiety on Patients With Acute Coronary Syndrome After Percutaneous Coronary Interventions\n\nIncluded conditions:\n- Acute Coronary Syndrome\n- Depression\n- Anxiety\n\nStudy Armgroups:\n- {'label': 'No depression/anxiety', 'description': 'patients suffered from ACS who have undergone PCI without depression or anxiety'}\n- {'label': 'Depression', 'description': 'patients suffered from post-ACS depression who have undergone PCI', 'interventionNames': ['Other: antidepressive and anti-anxiety therapy']}\n- {'label': 'Anxiety', 'description': 'patients suffered from post-ACS anxiety who have undergone PCI', 'interventionNames': ['Other: antidepressive and anti-anxiety therapy']}\n- {'label': 'Depression with anxiety', 'description': 'patients suffered from post-ACS depression with anxiety who have undergone PCI', 'interventionNames': ['Other: antidepressive and anti-anxiety therapy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'antidepressive and anti-anxiety therapy', 'description': 'These therapies include antidepressants, antianxiety drugs and psychotherapy. Subjects choose the therapy follow their own will. All of the above-mentioned therapies are identified by experienced psychiatrists in the same center. The treatment information will be recorded in each visit. The study is considered non-interventional, and no antidepressive or anti-anxiety therapies are mandated.', 'armGroupLabels': ['Anxiety', 'Depression', 'Depression with anxiety']}\n\nPrimary Outcomes:\n- {'measure': 'Major Adverse Cardiovascular Events', 'description': 'death, myocardial infarction, stroke, angina pectoris, revascularization.', 'timeFrame': 'From date of first visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, power larger than 85%, follow-up loss rate of 20%", "answer": 5000, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to our preliminary research, about 20% patients with ACS post-PCI developed depression and/or anxiety [Pr(x=1)], the incidence of MACE in ACS patients without emotional disorders post-PCI was about 15% [Pr(y=1|x=0)]. We presumed conservatively that the HR of MACE in 2 years for patients with depression and/or anxiety was 1.3, and the rate of follow-up loss was approximately 20%, a total of 5000 patients would yield power larger than 85% in a two-sided test at \u00ce\u00b1 of 0.05.", "id": 109, "split": "train"} +{"trial_id": "NCT03058900", "pmid": "29703851", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Peripheral Psoriatic Arthritis: a 6-month, Double-Blind, Randomized, Placebo-Controlled Trial\n\nIncluded conditions:\n- Psoriatic Arthritis\n\nStudy Armgroups:\n- {'label': 'Fecal microbiota transplantation (FMT)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Fecal microbiota transplantation (FMT)', 'Drug: Methotrexate (MTX)']}\n- {'label': 'Placebo (saline)', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Other: Drug: Placebo (saline)', 'Drug: Methotrexate (MTX)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Fecal microbiota transplantation (FMT)', 'description': 'One fecal microbiota transplantation is performed at baseline using gastroscopic guidance. The transplant consists of 50 g feces obtained from a healthy non-related donor. The donor feces is suspended into NaCl (0.9%) and glycerol (10%), and will be stored at minus 80 degrees celsius until use. The total volume of the suspension is 250 mL and its temperature will be 37 degrees celsius when infused into the small intestine of the recipient.', 'armGroupLabels': ['Fecal microbiota transplantation (FMT)']}\n- {'type': 'OTHER', 'name': 'Drug: Placebo (saline)', 'description': 'One identical appearing sham procedure is performed at baseline using gastroscopic guidance. 250 mL saline (NaCl 0.9%) is infused into the small intestine of the recipient.', 'armGroupLabels': ['Placebo (saline)']}\n- {'type': 'DRUG', 'name': 'Methotrexate (MTX)', 'description': 'Weekly methotrexate in maximum tolerable dosis', 'armGroupLabels': ['Fecal microbiota transplantation (FMT)', 'Placebo (saline)']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment failure', 'description': 'Proportion of patients in each group who experience treatment failure according to shared decision making between patient and rheumatologist defined as at least one of the following:\\n\\n* Need for more than 1 intra-articular glucocorticoid injection due to disease activity.\\n* Need for change to other conventional DMARDs (at the moment oral leflunomide, sulfasalazin or ciclosporin) according to the updated Danish guideline treatment due to disease activity.\\n* Need for biologic treatment according to the updated Danish guideline treatment due to severe disease activity.', 'timeFrame': '6 months (+/- 14 days)'}\n\nPlease estimate the sample size based on the assumption: \nThe trial uses a two-sided significance level of 0.05 and aims for a power of 90% (0.895) for the primary comparison. It also considers a power of 80% (0.8) to account for a potential dropout rate of 20%. For secondary outcomes, a power of 82% is assumed.", "answer": 31, "answer_type": "ACTUAL", "explanation": "Sample size and power considerations\n When designing this trial, no prior data for FMT efficacy in patients with rheumatic disease were available. However, we found it reasonable to assume that if patients with\u00c2\u00a0rheumatic disease should be willing to receive FMT as a future standardised treatment, the procedure should at least provide an effect size well beyond a moderate effect size. Consequently, we decided that at least twice as many patients with PsA in the sham group should be treatment failures compared with the FMT group if the procedure should be considered clinically relevant. For a comparison of two independent binomial proportions using the Pearson\u00e2\u0080\u0099s \u00ce\u00a72 statistic with a \u00ce\u00a72 approximation (a two-sided significance level of 0.05), a sample size of 40 patients with PsA per group has a power of 90% (0.895), if we assume that the proportions of treatment failures are 35% (FMT-active group) and 70% (FMT-sham group), respectively. Consequently, the inclusion of 80 patients with PsA allocated (1:1) to two treatment arms is believed to be sufficient to reveal any difference of clinical importance between treatment groups (ie, an Number needed to treat (NNT) <3 patients).\n Assuming that there will be some attrition during the 6-month trial period, we also estimated how much dropout would be possible while still having a reasonable statistical power (80%): a total sample size of 62 patients with PsA assuming a comparable level of withdrawals (31 patients completing in each group) achieves a power of at least 0.8 with the proportion of treatment failures indicated above, that\u00c2\u00a0is, even if we experience a dropout rate of 20%, our trial will have 80% chance of detecting the intentional difference between groups.\n Beyond the primary end\u00c2\u00a0point, a total sample size of 80 (with a balanced design) corresponds to a sufficient statistical power (82%) to detect a standardised mean difference of 0.65 SD units (ie, Cohen\u00e2\u0080\u0099s effect size) in any of the patient-reported outcome measures.", "id": 110, "split": "train"} +{"trial_id": "NCT03062410", "pmid": "30717745", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Heath Related Quality of Life Assessment for Patients With Advanced or Metastatic Renal Cell Carcinoma Treated With Tyrosine Kinase Inhibitor Using Electronic Patient Reported Outcome in Daily Clinical Practice.\n\nIncluded conditions:\n- Renal Carcinoma Metastatic\n- Kidney Neoplasms\n- Renal Cancer\n\nStudy Armgroups:\n- {'label': 'Electronic PRO', 'type': 'OTHER', 'description': 'All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.', 'interventionNames': ['Other: Electronic PRO in daily clinical practice']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Electronic PRO in daily clinical practice', 'description': 'All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.', 'armGroupLabels': ['Electronic PRO']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of filled questionnaires at 12-months', 'description': 'Number of completed questionnaires compared to the number of consultations carried out during the first 12 months of follow-up.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided \u03b1 type I error rate of 0.05, statistical power of 0.90, 20% drop-out rate", "answer": 56, "answer_type": "ESTIMATED", "explanation": "Sample size\n The following hypotheses will be tested:\n H0 (null hypothesis for inefficiency): 60% or fewer patients having good compliance with REMOQOL during the first 12\u00e2\u0080\u0089months following the initiation of treatment will be considered as irrelevant;\n H1 (alternative efficiency hypothesis): 80% of patients having good compliance with REMOQOL during the first 12\u00e2\u0080\u0089months following the initiation of treatment is expected.\n Considering Fleming\u00e2\u0080\u0099s One-Stage design [32, 33] with a one-sided \u00ce\u00b1 type I error rate of 0.05 and a statistical power of 0.90, it will be necessary to include 45 evaluable patients. Due to an estimated 20% drop-out rate and non-evaluable patients, the overall number of patients included will be 56 (28 per treatment group).", "id": 111, "split": "train"} +{"trial_id": "NCT03062514", "pmid": "30642370", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)\n\nIncluded conditions:\n- Refractory Epilepsy\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': \"Subjects'Vagus Nerve stimulator is on always\", 'interventionNames': ['Device: PINS Vagus Nerve Stimualtor']}\n- {'label': 'Control', 'type': 'SHAM_COMPARATOR', 'description': \"Subjects'Vagus Nerve stimulator is off from enrollment to 3 month\", 'interventionNames': ['Device: PINS Vagus Nerve Stimualtor']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'PINS Vagus Nerve Stimualtor', 'description': 'PINS Vagus Nerve Stimualtor', 'armGroupLabels': ['Control', 'Experimental']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in seizure frequency', 'timeFrame': '12 weeks of stimulation'}\n\nPlease estimate the sample size based on the assumption: \nThe standard deviation of the two groups is set at 35%. The significance level (\u03b1) is 0.025 for a unilateral test (0.05 for a bilateral test if needed), and the power (1-\u03b2) is 0.8, with a second-class error level (\u03b2) of 0.2. The maximum possible loss rate is 10%.", "answer": 84, "answer_type": "ESTIMATED", "explanation": "Sample size\n We adopted a pilot study design to evaluate efficacy and to primarily quantify the frequency of seizure reduction between the EG and the CG at 12\u00e2\u0080\u0089weeks\u00e2\u0080\u0099 follow-up after VNS treatment. It has been estimated that the variation of seizure frequency in the EG (VNS\u00e2\u0080\u0089+\u00e2\u0080\u0089AEDs) will be conservatively higher (25%) than the CG (AEDs only). The standard deviation of the two groups is set at 35%. Therefore, the sample size calculation formula is:1\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ n=\\frac{2{\\left({\\mu}_{\\alpha /2}+{\\mu}_{1-\\beta}\\right)}^2{\\sigma}^2}{{\\left({x}_T-{x}_C\\right)}^2}, $$\\end{document}n=2\u00ce\u00bc\u00ce\u00b1/2+\u00ce\u00bc1\u00e2\u0088\u0092\u00ce\u00b22\u00cf\u00832xT\u00e2\u0088\u0092xC2,where xT is the expected curative effect of the EG, xC is the expected curative effect of the CG, \u00cf\u0083 is the standard deviation of the two groups (35%), \u00ce\u00bc is the quantile of the standard normal distribution, \u00ce\u00b1 is the first-class error level for statistical test (0.025, here for unilateral test; 0.05 for bilateral test if need), and \u00ce\u00b2 is the second-class error level for statistical test (0.2, here). The calculated sample size per group through this calculation is 38. Considering that the maximum possible loss rate is 10%, the final sample size is 42 pairs (N\u00e2\u0080\u0089=\u00e2\u0080\u008984) [43\u00e2\u0080\u009345] .", "id": 112, "split": "train"} +{"trial_id": "NCT03063931", "pmid": "30287600", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain\n\nIncluded conditions:\n- Neuropathic Pain Induced by Mastectomy\n\nStudy Armgroups:\n- {'label': 'magnesium', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Magnesium: Magn\u00e9sium UPSA Action Continue\u00ae']}\n- {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo: Lactose']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Magnesium: Magn\u00e9sium UPSA Action Continue\u00ae', 'description': 'This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale', 'armGroupLabels': ['magnesium']}\n- {'type': 'DRUG', 'name': 'Placebo: Lactose', 'description': 'This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale', 'armGroupLabels': ['placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Measure of average pain intensity by a numerical rating scale', 'description': 'Measure of average pain intensity by a numerical rating scale assessed 5 days before the visit at 1 month post-mastectomy in magnesium and placebo groups.', 'timeFrame': '5 days before the visit at 1 month post-mastectomy'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) is 0.05 (two-sided type I error) and power (\u03b2) is 0.10.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size estimation has been performed using Stata software V.13 (StataCorp) with command sampsi based on usual sample size estimation.49 Considering the literature, the prevalence of postmastectomy pain is 20%.50 51 However, these data may vary depending on demographic, psychological and medical/surgical factors52 and will be taken into consideration in this study. The number of subjects required is 100 patients with breast cancer undergoing total mastectomy (50 in each group). The minimum \u00ce\u00b4 difference in numerical pain scale between magnesium and placebo groups at M1 is estimated at 1.0 and \u00cf\u0083 standard deviation at 1.5 with \u00ce\u00b1=0.05\u00e2\u0080\u0089two-sided type I error and \u00ce\u00b2=0.10.", "id": 113, "split": "train"} +{"trial_id": "NCT03065088", "pmid": "30898801", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The PreventIT Feasibility Randomised Controlled Trial in Young Older Adults, Comparing Two Lifestyle-integrated Exercise Interventions Delivered by Use of ICT or an Instructor, With a Control Group\n\nIncluded conditions:\n- Young Older Adults\n\nStudy Armgroups:\n- {'label': 'aLiFE', 'type': 'EXPERIMENTAL', 'description': 'The aLiFE programme is developed for young older adults, where balance activities, strengthening activities, and specific recommendations for increasing physical activity, are embedded within everyday activities, so that the activities can be performed multiple times throughout the day. The programme is presented by an instructor by use of a paper based manual during a 6 month intervention period in participants homes.', 'interventionNames': ['Behavioral: aLIFE']}\n- {'label': 'eLiFE', 'type': 'EXPERIMENTAL', 'description': 'The aLiFE programme is transferred to a mobile health system, called the eLiFE. The intervention is delivered on smartphones and smartwatches including inertial sensors well suited to monitor physical activity and movement quality in daily life. An instructor teaches the participants how to use the mobile health system during home visits and phone calls during the 6 month intervention period. A virtual instructor teaches the participants the eLiFE programme. Pictures and videos of the aLiFE activities are delivered by use of the system. Behavioural change strategies are also included in the system.', 'interventionNames': ['Behavioral: eLIFE']}\n- {'label': 'control', 'type': 'ACTIVE_COMPARATOR', 'description': \"The control group follows the World Health Organization's recommendations of physical activity.\", 'interventionNames': ['Behavioral: control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'aLIFE', 'description': 'The aLiFE programme is taught by an instructor during six home visits and 3 phone calls during the 6-month intervention period. The programme will be personalised by use of an initial balance and strength assessment (aLiFE assessment tool). The participants assigns activities to his or her daily activities, and during subsequent home visits, the number of activities and task demands are upgraded. Participants will be taught how to select opportunities themselves to embed activities into their individual daily routine, and how to progress over time.', 'armGroupLabels': ['aLiFE']}\n- {'type': 'BEHAVIORAL', 'name': 'eLIFE', 'description': 'The eLIFE includes a personalised ICT-administered training schedule using the activities developed in aLiFE, delivered in the form of video clips, pictures and text/verbal instructions on a smartphone and smartwatch application. Personalisation of activity content will be decided based on a phenotype tool and initial difficulty level is decided through the aLiFE assessment tool. In addition, a virtual instructor teaches the participants how to carry out the eLiFE programme. The user receives motivational messages and feedback, and there will be a possibility for social interaction between the participants. The instructors teach the eLiFE participants the programme during 4 home visits and 3 phone calls during the 6 month intervention period.', 'armGroupLabels': ['eLiFE']}\n- {'type': 'BEHAVIORAL', 'name': 'control', 'description': \"The control group follows the World Health Organization's recommendations of physical activity. The control participants will receive one home visit and be given a written letter with the activity recommendations.\", 'armGroupLabels': ['control']}\n\nPrimary Outcomes:\n- {'measure': 'Self-reported function and disability', 'description': 'Measured using the Late-Life Function and Disability Instrument (LLFDI)', 'timeFrame': 'Change; baseline, 6 months and 12 months'}\n- {'measure': 'Behavioural complexity metric', 'description': 'A composite measure of physical activity, sleep, and social participation, measured by a unitless scale. Physical activity and sleep is objectively measured by activity monitors worn at the lower back and the wrist, while social interaction is assessed as phone calls.', 'timeFrame': 'Change; baseline, 6 months and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to estimate critical parameters based on a Norwegian population-based study. The sample size of 180 participants is considered sufficient, which is twice the minimum required number of participants (2\u00d7 n=90) as a general rule to estimate a parameter.", "answer": 180, "answer_type": "ACTUAL", "explanation": "Sample size and recruitment\n No sample size calculation was performed for this study as it is a feasibility study not designed to conclude on effectiveness. However, based on a Norwegian population-based study,25 the sample size (n=180) is estimated to be large enough to estimate critical parameters,26 which equals twice the minimum required number of participants suggested (2\u00c3\u0097 n=90) as a general rule to estimate a parameter.27 28\n Participants are drawn from the general population with the purpose of identifying those estimated to be at risk of accelerated functional decline. The number required to invite in order to reach 180 participants is not predefined, due to insufficient knowledge about ability/function in this age group and because the risk screening tools (see below) are newly developed.16 A contact list was provided for home-dwelling individuals between 61 and 70 years of age living in Trondheim, Amsterdam and Stuttgart, stratified by age and with even distribution of men and women in each age stratum. The initial draw from each local registry was set at 2000 persons, with the intention of performing a second draw if necessary.", "id": 114, "split": "train"} +{"trial_id": "NCT03080844", "pmid": "30419931", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Smoking Cessation and Brain Activation: How Practice Changes the Brain\n\nIncluded conditions:\n- Smoking Cessation\n\nStudy Armgroups:\n- {'label': 'Practice', 'type': 'EXPERIMENTAL', 'description': 'Participants will be asked to delay time to smoking first cigarette of the day for up to two weeks.', 'interventionNames': ['Behavioral: Delay time to first cigarette', 'Behavioral: Therapy']}\n- {'label': 'No Practice', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will continue with their normal smoking behavior.', 'interventionNames': ['Behavioral: Therapy']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Delay time to first cigarette', 'description': 'Participants asked to delay time until they smoke first cigarette of the day.', 'armGroupLabels': ['Practice']}\n- {'type': 'BEHAVIORAL', 'name': 'Therapy', 'description': 'Participants receive tips on how to resist the urge to smoke and control cravings to smoke.', 'armGroupLabels': ['No Practice', 'Practice']}\n\nPrimary Outcomes:\n- {'measure': 'Increase in percent blood oxygenation level dependent (BOLD) signal change in cognitive control network in response to smoking versus nonsmoking cues', 'description': 'Change measured via functional magnetic resonance imaging (fMRI)', 'timeFrame': 'Baseline (Day 7) to End of Study (Day 22)'}\n\nPlease estimate the sample size based on the assumption: \n80% power at 0.025 significance level (Bonferroni correction for two brain regions) in a two-sided two-sample t-test. Using a sample size of n=40 per group provides 79% and >99% power for dlPFC and vmPFC, respectively.", "answer": 79, "answer_type": "ACTUAL", "explanation": "Power and sample size\n The sample size was based on aim 1 and calculated based on changes in brain activation observed in pilot data following 1\u00c2\u00a0week of practicing CBT skills and 2\u00c2\u00a0weeks of CBT sessions. Assuming the no practice group will have a mean of 0 change in brain activation between day 7 and day 21, and equal variance in the two groups, our preliminary data suggest Cohen\u00e2\u0080\u0099s d effect sizes of 2.77 and 3.70 for dlPFC and vmPFC, respectively. These effect sizes suggest n\u00e2\u0080\u0089=\u00e2\u0080\u00895 and 4 subjects per group are required to achieve 80% power at 0.05/2\u00e2\u0080\u0089=\u00e2\u0080\u00890.025 significance level (Bonferroni correction needed to compensate for tests involving each of two brain regions) in a two-sided two-sample t-test. However, the small sample in our pilot data (N\u00e2\u0080\u0089=\u00e2\u0080\u00896) also indicates wide 95% confidence intervals. Using the conservative estimates of the lower bound of the mean and upper bound of the standard deviation, the effect sizes are (0.0991/0.1415)\u00e2\u0080\u0089=\u00e2\u0080\u00890.70 and (0.2037/0.1889)\u00e2\u0080\u0089=\u00e2\u0080\u00891.08. Using a sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008940 per group provides 79% and\u00e2\u0080\u0089>\u00e2\u0080\u008999% power for dlPFC and vmPFC, respectively; the power will be greater if the actual effect sizes are larger than the conservative estimates.", "id": 115, "split": "train"} +{"trial_id": "NCT03083184", "pmid": "31039759", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Efficacy of an inTerdialytic \"Ethanol 40% v/v - enoxapaRin 1000 U/mL\" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients: a mulTi-centre, Randomized, Single Blind, Parallel Group studY (ETERNITY)\n\nIncluded conditions:\n- Tunnelled Hemodialysis Catheter Infection\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Enrolled patients will be randomly assigned in a 1:1 ratio either to the intervention group (Ethenox) or to the control group (reference solution: UFH 5000 U/mL or citrate 4% w/v depending on which solution is generally used).', 'interventionNames': ['Drug: Ethanol']}\n- {'label': 'control group', 'type': 'OTHER', 'description': 'Enrolled patients will be randomly assigned in a 1:1 ratio either to the intervention group (Ethenox) or to the control group (reference solution: UFH 5000 U/mL or citrate 4% w/v depending on which solution is generally used).', 'interventionNames': ['Drug: enoxaparin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ethanol', 'description': 'An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution', 'armGroupLabels': ['Intervention group']}\n- {'type': 'DRUG', 'name': 'enoxaparin', 'description': 'An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution', 'armGroupLabels': ['control group']}\n\nPrimary Outcomes:\n- {'measure': 'Time to first TC infection (TCI)', 'description': 'TCI is a composite endpoint defined by the occurrence of at least one of the three following events:\\n\\nDefinitive TC-related bloodstream infection (definitive TCBSI) or Probable TC-related bloodstream infection (probable TCBSI) or TC exit-site infection (ESI). TCI diagnosis and its type (definitive or probable TCBSI or ESI) will be assessed by an endpoint adjudication committee (EAC) according to predefined criteria', 'timeFrame': 'at 1 year'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 90%, type I error risk of 5%, enrollment period of 24 months.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The working hypothesis of this randomized controlled trial is that Ethenox will double the median time to TCI. On the basis of the data collected in DIALIN, median TC duration use is 6\u00e2\u0080\u0089months [29]. The median survival time without TCI reported in recent clinical trials ranges between 690 and 1150\u00e2\u0080\u0089days. However, to achieve a statistical power of 90% with a risk of type I error of 5%, a total of 400 patients need to be enrolled over a period of 24\u00e2\u0080\u0089months.", "id": 116, "split": "train"} +{"trial_id": "NCT03083431", "pmid": "29982217", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity\n\nIncluded conditions:\n- Retinopathy of Prematurity\n\nStudy Armgroups:\n- {'label': 'Propranolol', 'type': 'EXPERIMENTAL', 'description': 'Oral propranolol (1.6 mg propranolol-HCl/kg/d in 3-4 divided dosages) given for a maximum of 10 weeks (depending on postmenstrual gestational age at birth)', 'interventionNames': ['Drug: Propranolol']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo (same duration as oral propranolol solution)', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Propranolol', 'description': 'Oral propranolol (1.6 mg propranolol-hydrochloride/kg/d in 4 divided dosages)', 'armGroupLabels': ['Propranolol']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Oral solution containing the same excipients as propranolol solution', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Survival without adverse ophthalmological outcome (stage \u2265 3, AP-ROP, or any ROP treatment)', 'description': 'The primary endpoint for efficacy is survival until 48 weeks postmenstrual age without adverse ophthalmological outcome (stage \u2265 3, AP-ROP, or any ROP treatment) diagnosed according to the International Committee for the Classification of Retinopathy of Prematurity Revisited.', 'timeFrame': '48 weeks postmenstrual age'}\n\nPlease estimate the sample size based on the assumption: \n80% power at a two-sided alpha level of 5%, with an anticipated loss to follow-up of 5%, 10% of eligible patients not recruited due to lack of parental consent, and 3% excluded for medical or organisational reasons.", "answer": 276, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The ROPROP study is designed to demonstrate the superiority of oral propranolol in comparison with placebo in increasing the rate of infants surviving to 48 weeks postmenstrual age without threshold ROP (primary endpoint). Assuming a rate of 30% of infants who will progress to threshold ROP or die,21 262 infants (131 in each group) will have to be analysed to have 80% power (at a two-sided alpha level of 5%) to detect a 50% lower risk in the treatment group (two-sided Fisher\u00e2\u0080\u0099s exact test-based calculations, G*power 3.1.9.2, 2014).22 With an anticipated loss to follow-up of 5% (withdrawal or other reasons), the total number of infants allocated to treatment will be 276. Assuming that 10% of eligible patients will not be recruited for lack of parental consent and 3% for medical or organisational exclusion criteria, a total of 312 patients will be assessed for eligibility. This translates to 624 patients screened by funduscopy, assuming a rate of incipient ROP of 50%, and 718 infants below 28 weeks\u00e2\u0080\u0099 gestational age admitted to neonatal care, assuming an early mortality rate of 15%.", "id": 117, "split": "train"} +{"trial_id": "NCT03086889", "pmid": "30728055", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Immersive Virtual Reality Based Training for Motor Function Rehabilitation of Upper Limbs After Subacute Stroke\uff1aStudy Protocol of a Randomized Clinical Trial\n\nIncluded conditions:\n- Immersion Virtual Reality Training ,Stroke, Upper Extremity, Randomized Controlled Trial\n\nStudy Armgroups:\n- {'label': 'The intervention group', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will participate in immersion virtual reality based rehabilitation training for 3 weeks.', 'interventionNames': ['Other: immersion virtual reality (VR)-based rehabilitation']}\n- {'label': 'The control group', 'type': 'OTHER', 'description': 'The control group will receive for traditional rehabilitation training for 3 weeks.', 'interventionNames': ['Other: traditional rehabilitation training']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'immersion virtual reality (VR)-based rehabilitation', 'description': 'Intervention group received VR-based rehabilitation,including Virtual kitchen and so on.The patients took part in the exercise program for 30 minutes each day, five times per week, for 3 weeks. All subjects received physiotherapy, which accounts for an average of 30 minutes of physiotherapy per day on tolerance.', 'armGroupLabels': ['The intervention group']}\n- {'type': 'OTHER', 'name': 'traditional rehabilitation training', 'description': 'The traditional rehabilitation training included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 60 minutes each day, five times per week, for 3 weeks.', 'armGroupLabels': ['The control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Arm Movement Ability at 3 months', 'description': 'The Fugl-Meyer Assessment', 'timeFrame': 'Baseline and at 3 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-tailed comparison with a type I error rate of 0.05 and 80% power. A conservative dropout rate of 25% is assumed.", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size considerations\n This randomized controlled trial is a two-group independent design examining the effects of immersive VR on rehabilitation of subjects with subacute stroke. We assumed a two-tailed comparison and set the type I error rate at 0.05 with 80% power. We plan to screen approximately 100 individuals with subacute stroke. After screening, 80 subjects will be recruited and randomized to the experimental group or the control group. As a conservative estimate (dropout rate\u00e2\u0080\u0089=\u00e2\u0080\u008925%), we presume that 60 subjects will complete the study. To reduce the dropout rate, we will employ two strategies to keep participants engaged: regular communication via phone or social media and clinician visits. After conducting a power analysis based on the aforementioned statistical parameters using the software GPower3.1.9.2 [39], the effect size is calculated as 0.74, which is between a medium (0.5) and large (0.8) effect size [40]. Moreover, there is evidence from a small sample (8 subjects) that VR-enhanced treadmill training for 5 sessions per week over 3\u00e2\u0080\u0089weeks induces significant cerebral reorganization [41]. Thus, 30 subjects for one group is sufficient to assess the effectiveness of immersive VR training in post-stroke rehabilitation in eliciting upper-limb motor recovery post-stroke compared to traditional rehabilitation training, and to investigate the underlying brain mechanisms of immersive VR-based rehabilitation using three MRI modalities.", "id": 118, "split": "train"} +{"trial_id": "NCT03090113", "pmid": "32994371", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Random, Double-blind, Parallel, Placebo-controlled, Multi-center Study of Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism\n\nIncluded conditions:\n- Embolic Stroke\n\nStudy Armgroups:\n- {'label': 'Shuxuetong Injection', 'type': 'EXPERIMENTAL', 'description': 'Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;', 'interventionNames': ['Drug: Shuxuetong Injection']}\n- {'label': 'Placebo Injection', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;', 'interventionNames': ['Drug: Placebo Injection']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Shuxuetong Injection', 'description': 'intravenous drip', 'armGroupLabels': ['Shuxuetong Injection'], 'otherNames': ['Shuxuetong']}\n- {'type': 'DRUG', 'name': 'Placebo Injection', 'description': 'intravenous drip', 'armGroupLabels': ['Placebo Injection'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Symptomatic or Asymptomatic New Cerebral Infarction', 'description': 'Those patients who are still alive at 10 days after randomization will be contacted to set up a follow-up clinical visit. Information of recurrent symptomatic cerebral infarction will be collected and MRI examination will be performed to detect asymptomatic new cerebral infarction.', 'timeFrame': '10 days'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-sided \u03b1 of 0.05, 5% loss to follow-up", "answer": 2416, "answer_type": "ACTUAL", "explanation": "Sample size\n The estimated sample size for the study is 2416 subjects. With a sample size of 2416 patients, the study has 90% power to detect a relative risk reduction of 20% with an assumed 30% event rate of primary outcome in the control group at two-sided \u00ce\u00b1 of 0\u00c2\u00b705 with the t-test for two independent proportions. Sample size calculation is based on the primary outcome with inflation to account for 5% loss to follow-up.", "id": 119, "split": "train"} +{"trial_id": "NCT03090646", "pmid": "33167882", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Use of Financial Incentives to Increase Live Kidney Donor Follow-up Compliance\n\nIncluded conditions:\n- Living Donors\n- Nephrectomy\n- Kidney\n\nStudy Armgroups:\n- {'label': 'Standard of Care', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control arm will be instructed to attend required follow-up as is standard of care, but will not receive a financial incentive.'}\n- {'label': 'Financial Incentive', 'type': 'EXPERIMENTAL', 'description': 'Up to three gift cards to a major online retailer will be mailed to participants assigned to the intervention arm after complete (i.e. all components addressed) and timely (i.e. within the policy-defined follow-up period) submission of follow-up data at each 6-month, 1-year, and 2-year follow-up visit.', 'interventionNames': ['Other: Financial Incentive']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Financial Incentive', 'description': 'Up to three gift cards to a major online retailer.', 'armGroupLabels': ['Financial Incentive'], 'otherNames': ['Behavioral']}\n\nPrimary Outcomes:\n- {'measure': 'Patient Compliance with Follow-Up', 'description': 'Rate of policy-defined complete (all components addressed) and timely (within 60 days before or after the 6-month, 1-year, or 2-year post donation date; i.e. 120-day period) submission of data at 6-month, 1-year, and 2-year follow-up visits (assessed separately for each follow-up time point and as a composite outcome over the study period).', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed to have 80% power to detect a difference if the follow-up rate in the intervention group is 83%, and 90% power if the follow-up rate is 85%.", "answer": 320, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The total sample size for this study (including participants at both MDJH and MDUM) is N\u00e2\u0080\u0089=\u00e2\u0080\u0089320. With 160 participants in each arm given the hypothesized follow-up in control group of 70%, we will have 80% power to detect a difference between the study arms if the follow-up rate is 83% in the intervention group, and 90% power to detect a difference between study arms if follow-up in intervention group is 85% (Fig.\u00c2\u00a02). The hypothesized follow-up in the control group is derived from historical follow-up percentages at MDJH and MDUM.\nFig. 2Power calculation of evaluating the effectiveness of the financial incentive intervention with 320 donors enrolled at MDJH and MDUM over 4\u00e2\u0080\u0089years", "id": 120, "split": "train"} +{"trial_id": "NCT03098173", "pmid": "29615078", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-center, Randomized Controlled Trial Comparing Early Versus Elective Colonoscopy in Outpatients With Acute Lower Gastrointestinal Bleeding\n\nIncluded conditions:\n- Acute Lower Gastrointestinal Bleeding\n\nStudy Armgroups:\n- {'label': 'Early colonoscopy', 'type': 'EXPERIMENTAL', 'description': 'Performance of prepared colonoscopy within 24 h of arrival', 'interventionNames': ['Procedure: Early colonoscopy']}\n- {'label': 'Elective colonoscopy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Performance of prepared colonoscopy between 24 and 96 h after arrival', 'interventionNames': ['Procedure: Elective colonoscopy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Early colonoscopy', 'description': 'Performance of prepared colonoscopy within 24 h of arrival', 'armGroupLabels': ['Early colonoscopy']}\n- {'type': 'PROCEDURE', 'name': 'Elective colonoscopy', 'description': 'Performance of prepared colonoscopy between 24 and 96 h after arrival', 'armGroupLabels': ['Elective colonoscopy']}\n\nPrimary Outcomes:\n- {'measure': 'Stigmata of Recent Hemorrhage (SRH) Identification Rate', 'description': 'Stigmata of Recent Hemorrhage (SRH) based on colonoscopic visualization of lesions, such as diverticulosis, tumor, ulcer, hemorrhoid, angioectasia, and polyps exhibiting active bleeding, a visible vessel, or an adherent clot.', 'timeFrame': '0-4 day'}\n\nPlease estimate the sample size based on the assumption: \nalpha level of 5% (two-sided), 80% statistical power, and correction for patient noncompliance/dropout", "answer": 162, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n Assuming that the SRH rate in the elective-colonoscopy patients is 9% and the SRH rate in the early-colonoscopy patients is 26% (or higher) [14], with an alpha level of 5% (two-sided), a sample size of 142 (2\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u008971) patients will be required to ensure an 80% probability of obtaining a statistically-significant \u00cf\u00872 test result (i.e., an 80% statistical power). Because the observed difference might be diminished by patient noncompliance and/or dropout, we will recruit 20 additional patients to correct for these effects, and thus will recruit a total of 162 patients for this trial.", "id": 121, "split": "train"} +{"trial_id": "NCT03102788", "pmid": "33593307", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Task Shifting in the Care for Patients With Hand Osteoarthritis: May the First Consultation in Specialist Health Care be Performed by an Occupational Therapy Specialist?\n\nIncluded conditions:\n- Osteoarthritis Both Hands\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in the control group will receive their first consultation in specialist health care by a rheumatologist. Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid. The rheumatologist may also refer participants to occupational therapy if needed.', 'interventionNames': ['Behavioral: Rheumatologist-led care.']}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Patients in the intervention group will receive their first consultation in specialist health care by an occupational therapy specialist. Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.', 'interventionNames': ['Behavioral: Occupational therapist-led care.']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Rheumatologist-led care.', 'description': 'Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid.\\n\\nThe rheumatologist may also refer participants to occupational therapy if needed.', 'armGroupLabels': ['Control']}\n- {'type': 'BEHAVIORAL', 'name': 'Occupational therapist-led care.', 'description': 'Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Number of treatment responders', 'description': \"Number of treatment responders will be calculated as number of OMERACT/OARSI-responders. This is a composite index that presents the results of changes after treatment in the three domains of pain, function and patient's global assessment as a single variable (responder yes/no).\", 'timeFrame': 'One year'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power, a two-sided 95% confidence interval, and an estimated drop-out rate of 20%.", "answer": 400, "answer_type": "ACTUAL", "explanation": "Sample size calculations\n The primary outcome will be number of patients classified as OMERACT/OARSI-responders after six months [38]. We have not been able to identify any study examining the effect of rheumatologist-led care for hand OA, but in a double-blind, randomized, placebo-controlled study with 70 participants, the effect of low-dose oral prednisolone in hand OA was assessed using the responder criteria [44]. A total of 20 participants (57%) in each group met the responder criteria after four weeks. However, it is likely that the percentage of responders declines over time. Based on discussions in the project group, we have conservatively estimated that the percentage of responders after six months in rheumatologist-led care will be 35%. With a non-inferiority margin set to 15%, 80% statistical power, a two-sided 95% confidence interval, and an estimated drop-out rate of 20%, we estimate that 400 patients (200 in each arm) will provide sufficient power to exclude that OT-led care is inferior to rheumatologist led care, assuming a response probability of 35% in each group.", "id": 122, "split": "train"} +{"trial_id": "NCT03108157", "pmid": "32473654", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF\n\nIncluded conditions:\n- EMBRYO IMPLANTATION\n\nStudy Armgroups:\n- {'label': 'GROUP A: intervention group', 'type': 'EXPERIMENTAL', 'description': 'Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.', 'interventionNames': ['Procedure: Endometrial scratch']}\n- {'label': 'GROUP B: no intervention group', 'type': 'NO_INTERVENTION', 'description': 'Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Endometrial scratch', 'description': 'Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.', 'armGroupLabels': ['GROUP A: intervention group'], 'otherNames': ['Scratching']}\n\nPrimary Outcomes:\n- {'measure': 'Positive Pregnancy Test', 'description': 'Positive test (hcG\\\\>10 UI/ml)', 'timeFrame': '12 to 14 days after embryo transfer'}\n- {'measure': 'Clinical Pregnancy', 'description': 'Ultrasound confirmation of intrauterine pregnancy', 'timeFrame': '5 weeks of pregnancy'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power, two-sided alpha of 0.05, and a 5% dropout rate.", "answer": 352, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The average CPR after embryo transfer in egg donor IVF cycles is 60% at our centre. Based on previous studies, where the difference in CPR for IVF cycles varied between 10 to 30% [9, 11, 12, 19, 20, 23\u00e2\u0080\u009325], we estimated that a 15% difference in CPR would be clinically relevant. According to that percentage, a total of 332 patients will be needed to detect a 15% difference between the two groups, with 80% statistical power and two-sided alpha of 0,05. Considering a 5% dropout rate, we will include 176 patients per study arm, 352 patients in total.", "id": 123, "split": "train"} +{"trial_id": "NCT03114878", "pmid": "30626414", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Value of Eye Movement Desensitization Reprocessing in the Treatment of Tinnitus\n\nIncluded conditions:\n- Tinnitus\n\nStudy Armgroups:\n- {'label': 'TRT / EMDR', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tinnitus Retraining Therapy / Eye Movement Desensitization Reprocessing', 'interventionNames': ['Behavioral: TRT / CBT']}\n- {'label': 'TRT / CBT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tinnitus Retraining Therapy / Cognitive Behavioral Therapy', 'interventionNames': ['Other: TRT / EMDR']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'TRT / EMDR', 'description': \"Tinnitus Retraining Therapy:\\n\\nTRT is a therapy developed by Prof. Pawel Jastrebroff and Dr. Jonathan Hazell. During the counseling, the patient is educated about the work mechanism of tinnitus and how to deal with the emotional and physical responses. The main goal is to habituate to the sound of the ringing in the ears.\\n\\nEye Movement Desensitization and Reprocessing:\\n\\nThis is a scientifically, psychotherapeutic approach, developed in 1987 by Francine Shapiro. EMDR represents a specific method within a wider theoretical model called 'Adaptive Information Processing (AIP)'. Within the treatment bilateral stimulation is used i.e. visual, auditory and tactile stimuli can be used to stimulate both the left - and the right hemisphere.\", 'armGroupLabels': ['TRT / CBT'], 'otherNames': ['TRT / Eye Movement Desensitization Reprocessing']}\n- {'type': 'BEHAVIORAL', 'name': 'TRT / CBT', 'description': 'Tinnitus Retraining Therapy:\\n\\nTRT is a therapy developed by Prof. Pawel Jastrebroff and Dr. Jonathan Hazell. During the counseling, the patient is educated about the work mechanism of tinnitus and how to deal with the emotional and physical responses. The main goal is to habituate to the sound of the ringing in the ears.\\n\\nCognitive Behavioral Therapy:\\n\\nCBT is the combination of behavioral therapy with interventions that have been developed from cognitive psychology. The founders of CBT are Aaron Beck and Albert Ellis. The core idea is the assumption that so-called negative cognitions are responsible for dysfunctional behavior. The techniques used in the cognitive behavioral therapy focus on changing the content of these irrational cognitions.', 'armGroupLabels': ['TRT / EMDR'], 'otherNames': ['TRT / Cognitive Behavioral Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Tinnitus Functional Index (TFI)', 'description': \"The TFI is a self-reported questionnaire, consisting of 25 questions, which assesses the impact of tinnitus on patients' daily lives. The patient answers each question on a Likert scale ranging from 0 to 10. Questions 1 and 3 are expressed in percentages, and the Likert scale ranges from 0 % to 100 %. The total score is calculated with the mean of all questions. The answers are converted and the total score is expressed as a number between 0 and 100. In addition to the total score, the score of eight subscales can be determined. The subscales are the following: intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties attributed to tinnitus, interference with relaxation, reduced quality of life and emotional distress.\\n\\nA decrease in the score on the TFI in the TRT-CBT-treatment group versus a decrease in the TFI-score in the TRT- EMDR-treatment group is the primary focus of attention in this study.\", 'timeFrame': 'Change will be assessed at 3 test moments during the trial: before the start of therapy (T0), after 3 months (10 treatment sessions) (T1) and 3 months after the last therapy session (T2). The change will be assessed at every test moment.'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level (\u00ce\u00b1) of 0.05, and consideration of possible dropout.", "answer": 166, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n A sample size calculation was carried out to determine the sample size required to obtain a power of 80% with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 in a two-sided, two-sample t test. Assuming an average difference of 0.7 SD between both treatment groups \u00e2\u0080\u0093 simplifying the calculation by considering the change in outcome between the first and the last point \u00e2\u0080\u0093 a power of 80% is reached with minimal sample size of 65 patients per treatment group. To cover possible drop out, 166 patients will be randomized between therapy group TRT\u00e2\u0080\u0089+\u00e2\u0080\u0089CBT and therapy group TRT\u00e2\u0080\u0089+\u00e2\u0080\u0089EMDR. The CONSORT guidelines will be followed and the enrollment data will be transferred into the flow diagram.", "id": 124, "split": "train"} +{"trial_id": "NCT03116542", "pmid": "33157979", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Study of 18F-FLT Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Cases of Prefibrotic/Early Primary Myelofibrosis (PMF) and Essential Thrombocythemia (ET)\n\nIncluded conditions:\n- Essential Thrombocythemia\n- Primary Myelofibrosis, Fibrotic Stage\n- Primary Myelofibrosis, Prefibrotic Stage\n\nStudy Armgroups:\n- {'label': 'Diagnostic (18F-FLT PET/CT)', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo 18F-FLT (3\\'-18Fluoro-3\\'-deoxy-L-thymidine) PET/CT (Positron Emission Tomography/Computed Tomography) at baseline. No specific dietary restrictions or hydration are required for FLT-PET scans, however, patients will be urged to drink plenty of water before and after the PET studies. \\\\[18F\\\\] FLT will be prepared by the cyclotron core facility and assessed for quality control following \"good manufacturing practice\" criteria. The radiopharmaceutical will immediately be brought to the Molecular Imaging and Therapy Service Radiopharmacy for dispensation in the PET suite. For each scan, patients will receive approximately up to 370 MBq (target of 10 mCi) \\\\[18F\\\\] FLT by intravenous infusion.', 'interventionNames': ['Device: Diagnostic (18F-FLT PET/CT)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Diagnostic (18F-FLT PET/CT)', 'description': \"The tracer compound \\\\[F-18\\\\] FLT will be injected into the patient's veins in a small volume of normal saline solution. The PET scan data collection is started immediately and is continued for 2 hours.\", 'armGroupLabels': ['Diagnostic (18F-FLT PET/CT)'], 'otherNames': ['18F-FLT PET/CT', \"3'-Deoxy-3'-(18F) Fluorothymidine\", \"3'-deoxy-3'-[18F]fluorothymidine\", 'Fluorothymidine F 18']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients with 50% or more uptake of FLT-PET in patients with Prefibrotic/Early Primary Myelofibrosis (PMF) and Essential Thrombocythemia (ET) 12 months from the baseline', 'description': \"Evaluate the uptake of 3'-deoxy-3'-\\\\[18F\\\\] fluorothymidine (FLT) positron emission tomography/computed tomography (PET) imaging and it is value in assessing the malignant hematopoiesis in patients with Prefibrotic/Early Primary Myelofibrosis (PMF) and Essential Thrombocythemia (ET).\", 'timeFrame': '12 Months'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 21, "answer_type": "ESTIMATED", "explanation": "5.3\n Sample size and recruitment\n All patients will undergo static whole-body FLT PET/CT imaging at baseline in a cohort of 21 patients.", "id": 125, "split": "train"} +{"trial_id": "NCT03122080", "pmid": "31005904", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Electroacupuncture on Treating Depression Related Insomnia: Study Protocol for a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Insomnia Due to Mental Disorder\n\nStudy Armgroups:\n- {'label': 'Electroacupuncture group', 'type': 'ACTIVE_COMPARATOR', 'description': 'electroacupuncture+standard care', 'interventionNames': ['Device: Electroacupuncture(EA)']}\n- {'label': 'Control A group', 'type': 'PLACEBO_COMPARATOR', 'description': 'placebo acupuncture+standard care', 'interventionNames': ['Device: Placebo acupuncture']}\n- {'label': 'Control B group', 'type': 'OTHER', 'description': 'standard care', 'interventionNames': ['Other: Standard care']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Electroacupuncture(EA)', 'description': 'Participants in EA group will receive electroacupuncture treatment. Acupuncture will be applied at Baihui (GV20), Shenting (GV24), Yintang (GV29), bilateral Anmian (EX-HN22), Shenmen (HT7), SanYinjiao (SP6) and Neiguan (PC6). After needle insertion, rotating or lifting-thrusting manipulation will be applied for \"Deqi\" sensation. The EA apparatus (CMNS6-1, Jianjian Medical Device CO., LTD, China) will be connected to the needles at GV20 and GV29 for 30 minutes and deliver a continuous wave. The frequency will be set at about 30 Hz and the amplitude will be less than 20V. Participants can regularly take the antidepressants or sedative-hypnotics as before during the intervention. Besides, the investigators will strengthen health education about insomnia and depression for the patients.', 'armGroupLabels': ['Electroacupuncture group']}\n- {'type': 'DEVICE', 'name': 'Placebo acupuncture', 'description': \"Participants in the control A group will receive placebo acupuncture treatment with streitberger needles at the same acupoints as the electroacupuncture group. When the tip of the blunt needles touches to the skin, the patient will get a pricking sensation but there is no real needle inserted into the skin. The electroacupuncture apparatus will be set beside the patients, with no connection to the needles. Inform the patients when removing the needles after 30 minutes. Use the dry cotton ball to press the acupoints so that patients can feel the withdrawal of the 'needles'. Same health education and regular administration of antidepressants or sedative-hypnotics will be given to the participants during the intervention.\", 'armGroupLabels': ['Control A group']}\n- {'type': 'OTHER', 'name': 'Standard care', 'description': 'Participants in the control B group will keep their standard medical care for the first 8 weeks. Participants will take their regular antidepressants and the sedative-hypnotics during the whole intervention period. Same health education will be conducted as well for the participants. And after waiting for two months, these patients will be treated with the same electroacupuncture treatment as the EA group.', 'armGroupLabels': ['Control B group']}\n\nPrimary Outcomes:\n- {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'description': \"The Pittsburgh Sleep Quality Index (PSQI) is a widely-used questionnaire to assess one's sleep disorders over one month. It is comprised of 19 self-rated items and 5 other-rated items. The scores include the following indicators: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of medication, and daytime dysfunction. Each indicator is rated from 0 to 3. The accumulated scores of the seven indicators constitute the total score of PSQI (0-21). The higher score indicates the worse sleep quality and severer sleep disorders. The investigators set the PSQI score at 8th week post-treatment as the primary outcome, compared with PSQI scores at other time points, to evaluate the effectiveness of acupuncture for depression related insomnia.\", 'timeFrame': '8 week post-treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for a power of 90% to detect a superior effect of 1.5 of PSQI at a significance level (\u03b1) of 0.025 and a \u03b2-value of 0.1. A 10% dropout rate is also assumed.", "answer": 270, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample calculation is based on changes in the primary outcome of this trial, the PSQI score. In our previous trial, we also used PSQI score as the primary outcome to evaluate and compare the effects between acupuncture, superficial acupuncture at sham points and sham acupuncture on treating depression related insomnia.18 According to the preliminary results, the PSQI score of the acupuncture group at the end of the 8 weeks\u00e2\u0080\u0099 intervention was 9.83\u00c2\u00b13.11 and that of the sham acupuncture group was 13.93\u00c2\u00b13.22. We assumed 0.2 of the PSQI difference is the superior effect.\n H0: A-B<= but H1: A-B>\n We used the following formula to calculate the sample size in this trial:\n N=[(Z\u00ce\u00b1+Z\u00ce\u00b2\u00cf\u0083)\u00ce\u00b4\u00e2\u0088\u0092\u00ce\u0094]2\u00c3\u00972,\n where \u00ce\u00b4\u00c2\u00a0is the difference between group,\u00c2\u00a0\u00ce\u0094 is the assumed superior effect threshold and N is the estimated sample size of each group. \u00cf\u0083\u00c2\u00a0is the [(S12+S22)/2]0.5.\n According to the previous study,25 the minimal clinically important differenceof PSQI is about 1.14\u00e2\u0080\u00931.75. Since there will be a comparison between the treatment group and the control A group as well as a comparison between the treatment group and the control B group, a sample size of 27 in each group will have a power of 90% to detect the superior effect of 1.5 of PSQI at an \u00ce\u00b1-value of 0.025 and a \u00ce\u00b2-value of 0.1. Assuming a 10% dropout rate, a sample size of 30 for each group is needed. For a better power and quality control among centres, we decided the recruiting sample size to 30 for each group in each healthcare centre. As a result, the total number of participants needed to be randomised is 270.", "id": 126, "split": "train"} +{"trial_id": "NCT03126942", "pmid": "29685161", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Single-implant Overdentures Retained by the Novaloc Attachment System: Study Protocol for a Mixed Methods Randomized Cross-over Trial\n\nIncluded conditions:\n- Edentulous Mouth\n- Edentulous Jaw\n\nStudy Armgroups:\n- {'label': 'Novaloc, then Locator', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive the Novaloc attachment on a single implant inserted in the mandibular midline. This attachment will be used for 3 months and then changed by the Locator attachment. The second attachment will be used for another 3-month period. Participants will keep preferred attachment for further 12 months', 'interventionNames': ['Device: Novaloc', 'Device: Locator']}\n- {'label': 'Locator, then Novaloc', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive the Locator attachment on a single implant inserted in the mandibular midline. This attachment will be used for 3 months and then changed by the Novaloc attachment. The second attachment will be used for another 3-month period. Participants will keep preferred attachment for further 12 months', 'interventionNames': ['Device: Novaloc', 'Device: Locator']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Novaloc', 'description': 'Attachment composed by a polyetheretherketone (PEEK) capsule and carbon-coated abutment. The yellow (medium) retentive component will be used', 'armGroupLabels': ['Locator, then Novaloc', 'Novaloc, then Locator']}\n- {'type': 'DEVICE', 'name': 'Locator', 'description': 'Traditional cylindrical attachment (Locator system) with pink (medium) retentive components', 'armGroupLabels': ['Locator, then Novaloc', 'Novaloc, then Locator']}\n\nPrimary Outcomes:\n- {'measure': 'Denture satisfaction', 'description': 'To be assessed by specific questionnaires', 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided alpha of 0.01, a power of 90%, and a 20% dropout rate.", "answer": 10, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n Sample size for the quantitative phase was determined based on the primary outcome of this study (patient satisfaction). According to previous trials, a minimally important difference of 10\u00c2\u00a0mm was considered for the estimation [40], as well as a standard deviation of the difference in satisfaction of 7.5\u00c2\u00a0mm [41]. A two-sided alpha of 0.01 will be also considered to compensate for the number of secondary outcomes. Based on a power of 90%, this trial requires at least 21 participants [42]. An additional 20% will be added to the planned sample to compensate for possible dropouts, thus resulting in a total of 26 participants.", "id": 127, "split": "train"} +{"trial_id": "NCT03127059", "pmid": "31892661", "question": "Here is the design of a clinical trial:\n\nOfficial Title: BEAT DB-study; Breathing Exercises in Asthma Targeting Dysfunctional Breathing-a Randomised Controlled Trial\n\nIncluded conditions:\n- Dysfunctional Breathing in Asthma\n\nStudy Armgroups:\n- {'label': 'Breathing Exercises', 'type': 'EXPERIMENTAL', 'description': 'Individual instruction from a nurse at baseline aimed at knowledge on pharmacological treatment and optimized inhalation techniques. The participants will be encouraged to use online video instruction.\\n\\nThree physiotherapist-sessions of Breathing Exercises (BrEX) with duration of 60 minutes (the initial) and 30 minutes (other sessions) at week 1, 4, and 9. The participant is expected to do 10 minutes of home exercise twice daily. The entire intervention combines elements of the Papworth method, and the Buteyko technique.', 'interventionNames': ['Other: Breathing Exercises']}\n- {'label': 'Usual care', 'type': 'OTHER', 'description': 'Individual instruction from a nurse at baseline aimed at knowledge on pharmacological treatment and optimized inhalation techniques. The participants will be encouraged to use online video instruction.\\n\\nBesides the individual instruction described above, patients will receive only short information given initially at recruitment. They are allowed to receive instruction in positive expiratory pressure-treatment and physiotherapy targeting other problems than dysfunctional breathing (DB).', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Breathing Exercises', 'description': 'Key points in the intervention are\\n\\n* Reduction (or normalising) of the respiration rate; use of rhythmic, nasal inspiration, diaphragmatic breathing; reduction of depth of breath, longer expiration; breath-holding at functional residual capacity.\\n* Relaxation, especially the neck, jaw, tongue, and shoulders. Emphasizing the impact of gravity to the body.\\n* Inclusion of the breathing modification into walking and other physical activities.\\n* Daily home exercise of BrEX.', 'armGroupLabels': ['Breathing Exercises'], 'otherNames': ['BrEX']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.', 'armGroupLabels': ['Usual care'], 'otherNames': ['UC']}\n\nPrimary Outcomes:\n- {'measure': 'Mini Asthma Quality of Life Questionnaire (MiniAQLQ)', 'description': 'MiniAQLQ is a disease-specific patient-reported outcome on experiences during the previous two weeks. The original version of AQLQ (32 items) is recommended for clinical use, whereas this shortened version is suggested for research. In moderate to severe asthma cohorts, MiniAQLQ has good reliability (ICC 0.83-0.86) and strong validity (criteria validity to AQLQ, r\u22650.80; construct validity against ACQ, r=0.69). MiniAQLQ has 15 items in four domains (symptoms, activity limitation, emotions, environment), which are answered using a 7-point Likert scale (1=maximum impairment; 7=no impairment).', 'timeFrame': 'Primary endpoint: Change from baseline to 6 months follow up. Secondary endpoints will be 3 and 12 months follow up.'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a power of 90%, a significance level (p value) of 0.05 (two-sided), and accounts for potential drop-outs.", "answer": 190, "answer_type": "ESTIMATED", "explanation": "Sample size\n As argued by Norman et al,73 no universal minimal important difference (MID) exists, as MID depends on the clinical setting, population and the intervention. However, it can often be estimated as half a standard deviation (SD).73 Thomas et al. (breathing exercises vs education by a nurse in mild to moderate asthma) found a 0.38 change in MiniAQLQ score.27\n\n We will use the effect size found in Thomas et al27 as MID in our sample calculation (with a calculated SD of 0.76) and expect to find a similar or higher effect size, as (a) BrEX will be an add-on intervention to standard specialist care instead of a head-to-head comparison as in Thomas et al, and (b) as this secondary care asthma population is expected to have a higher disease burden due to asthma, that is, greater room for improvement.\n There is an inherent risk of the trial being underpowered because the SD of MiniAQLQ after BrEX in secondary care is unknown. However, based on previous studies,27 28 we expect that our SD will be sufficient to reflect the population.\n For the present trial, the sample size needed is 172 to detect a 0.38 unit difference between groups in MiniAQLQ score (SD of 0.76, power of 90%, and p value of 0.05 (two-sided)). To allow for drop-outs, we will aim to randomise 190 participants.", "id": 128, "split": "train"} +{"trial_id": "NCT03132974", "pmid": "32791704", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of Efficacy and Safety of Single and Multiple Therapy of Herbal Medicine/Chuna Therapy on Non-specific Chronic Low Back Pain: A Study Protocol for Multicenter, 3-arm, Randomized, Single Blinded, Parallel Group, Incomplete Factorial Design, Pilot Study -\n\nIncluded conditions:\n- Chronic Low Back Pain\n\nStudy Armgroups:\n- {'label': 'SGHH', 'type': 'EXPERIMENTAL', 'description': 'Admission to Sogyeonghwalhyeol-tang granule', 'interventionNames': ['Drug: Sogyeonghwalhyeol-tang granule']}\n- {'label': 'SGHH with manipulation therapy', 'type': 'EXPERIMENTAL', 'description': 'Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy', 'interventionNames': ['Other: Sogyeonghwalhyeol-tang granule with manipulation procedure']}\n- {'label': 'Placebo with manipulation therapy', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Other: Placebo with manipulation procedure']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sogyeonghwalhyeol-tang granule', 'description': 'Sogyeonghwalhyeol-tang herbal extract granule', 'armGroupLabels': ['SGHH']}\n- {'type': 'OTHER', 'name': 'Sogyeonghwalhyeol-tang granule with manipulation procedure', 'description': 'Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure', 'armGroupLabels': ['SGHH with manipulation therapy']}\n- {'type': 'OTHER', 'name': 'Placebo with manipulation procedure', 'description': 'Placebo granule with manipulation procedure', 'armGroupLabels': ['Placebo with manipulation therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline in Numeric Rating Scale of Pain', 'description': \"A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.\", 'timeFrame': 'Screening Visit, At baseline, week 2, 4, 6, 8'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size was considered based on LBP clinic visit rates, skilled labor availability, budget, and expected attrition at each site. It was not estimated based on previous studies.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "2.5.4\n Sample size\n This is a pilot study to explore the efficacy of single or multiple therapies using SGHH and Chuna, feasibility of the study design and effect size for further large-scale studies. A sample size of 150 patients, which is not estimated based on previous studies, was considered after assessing their LBP clinic visit rates, skilled labor availability, budget, and expected attrition at each site.", "id": 129, "split": "train"} +{"trial_id": "NCT03133273", "pmid": "34419125", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study of the Therapeutic Response and Survival of Patients with Metastatic Colorectal Cancer (stage IV) and Treated According to the Guidelines of a Chemosensitivity Test, Oncogramme\u00ae\n\nIncluded conditions:\n- Colorectal Cancer Metastatic\n- Chemotherapy\n\nStudy Armgroups:\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Patient is followed within the usual care for stage 4 colorectal cancer'}\n- {'label': 'Oncogramme\u00ae', 'type': 'EXPERIMENTAL', 'description': 'For patients in the Oncogramme\u00ae group, chemotherapy will be adapted to Oncogramme\u00ae results.', 'interventionNames': ['Other: Oncogramme\u00ae']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Oncogramme\u00ae', 'description': 'Patient is followed within the usual care for stage 4 colorectal cancer, but an Oncogramme test will be made and chemotherapy will be adapted to the results.', 'armGroupLabels': ['Oncogramme\u00ae']}\n\nPrimary Outcomes:\n- {'measure': 'Occurrence of the progression or death of the patient.', 'description': 'The event studied is the occurrence of the progression or death of the patient during the year following the inclusion in the study. The progression of the patient is determined by the RECIST (Response Evaluation Criteria in Solid Tumors).', 'timeFrame': 'Year 1'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level of 0.05, power of 80%, and a 20% addition for non-assessable patients", "answer": 256, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Based on a 1-year PFS of 15% in the control arm, and 30% in the Oncogramme\u00c2\u00ae-assisted arm, a log-rank test evaluated the total number of patients to include at 204 (with a significance level of 0.05 and a power of 80%). Sample size ratio is 1:1, meaning that each arm should include 102 patients. Taking into consideration the eventuality of non-assessable patients, 20% has been added to the initial sample size, which eventually reached 256. Based on clinical data observed at Limoges hospital, it has been estimated that the study should include 5 patients per month, allowing to reach the target population of 256 patients in a 48-month timeframe.", "id": 130, "split": "train"} +{"trial_id": "NCT03133845", "pmid": "31656179", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Shaping Anesthetic Techniques to Reduce Post-Operative Delirium\n\nIncluded conditions:\n- Delirium\n- Lumbar Radiculopathy\n- Lumbar Osteoarthritis\n- Lumbar Spine Disc Degeneration\n\nStudy Armgroups:\n- {'label': 'General anesthesia', 'type': 'ACTIVE_COMPARATOR', 'description': 'In this group patients will receive general anesthesia. Anesthetic induction will occur with propofol (generally 1-2 mg/kg), maintenance with a volatile anesthetic, muscle paralysis with a muscle relaxant, and pain control with fentanyl (generally 2-5 mcg/kg titrated). Patients on baseline opioids may receive additional opioids (such as dilaudid) based on clinical criteria. The anesthetic provider will be blinded to BIS values. Discretionary use of intrathecal morphine may be used.', 'interventionNames': ['Procedure: Induction with propofol', 'Procedure: Maintenance anesthetic using a volatile anesthetic', 'Procedure: Muscle relaxant during maintenance anesthesia', 'Procedure: Pain control with fentanyl', 'Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia', 'Procedure: Cerebrospinal fluid collection', 'Procedure: Administration of intrathecal morphine']}\n- {'label': 'Spinal anesthesia with light sedation', 'type': 'EXPERIMENTAL', 'description': 'In this group patients will receive light sedation with propofol and a spinal anesthetic. Spinal anesthesia will be obtained by injecting approximately 10-15 mg of bupivacaine into the subarachnoid space. Up to 2 mg of midazolam may be given during spinal needle insertion. Although spinal anesthesia is sufficient for surgery, sedation is routinely administered using a propofol infusion, titrated to a BIS\\\\>60-70. Discretionary use of intrathecal morphine may be used.', 'interventionNames': ['Procedure: Light sedation with propofol', 'Procedure: Bispectral Index (BIS) monitoring for depth of anesthesia', 'Procedure: Spinal Anesthesia', 'Procedure: Midazolam administered during spinal anesthesia', 'Procedure: Cerebrospinal fluid collection', 'Procedure: Administration of intrathecal morphine']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Light sedation with propofol', 'description': 'Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.', 'armGroupLabels': ['Spinal anesthesia with light sedation']}\n- {'type': 'PROCEDURE', 'name': 'Induction with propofol', 'description': 'Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.', 'armGroupLabels': ['General anesthesia']}\n- {'type': 'PROCEDURE', 'name': 'Maintenance anesthetic using a volatile anesthetic', 'description': 'Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.', 'armGroupLabels': ['General anesthesia']}\n- {'type': 'PROCEDURE', 'name': 'Muscle relaxant during maintenance anesthesia', 'description': 'Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.', 'armGroupLabels': ['General anesthesia']}\n- {'type': 'PROCEDURE', 'name': 'Pain control with fentanyl', 'description': 'Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.', 'armGroupLabels': ['General anesthesia']}\n- {'type': 'PROCEDURE', 'name': 'Bispectral Index (BIS) monitoring for depth of anesthesia', 'description': \"All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.\", 'armGroupLabels': ['General anesthesia', 'Spinal anesthesia with light sedation']}\n- {'type': 'PROCEDURE', 'name': 'Spinal Anesthesia', 'description': 'Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.', 'armGroupLabels': ['Spinal anesthesia with light sedation']}\n- {'type': 'PROCEDURE', 'name': 'Midazolam administered during spinal anesthesia', 'description': 'Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.', 'armGroupLabels': ['Spinal anesthesia with light sedation']}\n- {'type': 'PROCEDURE', 'name': 'Cerebrospinal fluid collection', 'description': '8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.', 'armGroupLabels': ['General anesthesia', 'Spinal anesthesia with light sedation']}\n- {'type': 'PROCEDURE', 'name': 'Administration of intrathecal morphine', 'description': 'Patient may receive intrathecal morphine for post-operative pain control.', 'armGroupLabels': ['General anesthesia', 'Spinal anesthesia with light sedation']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of delirium', 'description': 'The patient will be assessed for delirium using the Confusion Assessment Method on each of the first 3 post-operative days.', 'timeFrame': 'First 3 postoperative days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05, power of 0.8, and an estimated 6% withdrawal rate.", "answer": 218, "answer_type": "ESTIMATED", "explanation": "Sample size\n Assuming a delirium incidence of 35% in the control and a 50% reduction in the intervention group [2, 20], 206 patients would be needed to show a difference in incidence of delirium at a 0.05 significance level with a power of 0.8. With an estimated 6% withdrawal, the target enrollment is 218 patients. The expected sample size of 206 patients will also be sufficient for the secondary outcome of MMSE change at 3-months after surgery: the minimum detectable change in MMSE with 206 patients is \u00c2\u00b10.235 at a 0.05 significance level with a power of 0.8.", "id": 131, "split": "train"} +{"trial_id": "NCT03135886", "pmid": "37749635", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs\n\nIncluded conditions:\n- HIV/AIDS\n- Hepatitis C\n- Substance Use Disorders\n- Opioid-use Disorder\n\nStudy Armgroups:\n- {'label': 'HIV Testing Practice Coaching Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'The HIV Testing Practice Coaching (PC) Intervention is designed to improve the provision and sustained implementation of on-site HIV testing and linkage to care among OTP patients.', 'interventionNames': ['Other: HIV Testing Practice Coaching Intervention']}\n- {'label': 'HIV and HCV Testing Practice Coaching Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'The HIV and HCV Testing Practice Coaching (PC) Intervention will leverage the HIV PC intervention and follow the same interventional steps described above, and, in addition, provide information and training to support joint HIV/HCV testing and linkage to care among OTP patients.', 'interventionNames': ['Other: HIV and HCV Testing Practice Coaching Intervention']}\n- {'label': 'Information Control Group', 'type': 'OTHER', 'description': 'The administrators of OTPs assigned to the control condition will receive a website link to and hard copy of the NIDA/SAMHSA Blending Initiative product for HIV rapid testing.', 'interventionNames': ['Other: Information Control']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Information Control', 'description': 'The OTPs assigned to this group will be provided access to the NIDA/SAMHSA Blending Initiative product for HIV rapid testing. Resources generated from the HIV rapid testing Blending Initiative product include a fact sheet, resource guide, marketing materials, and an Excel-based budgeting tool. In addition to the HIV-specific materials, the website provides opportunities for training, self-study progress, workshop, and distance learning. OTPs also will receive a link to the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention training website which provides information and training courses. Sites also will receive a hard (or electronic) copy of the ARTAS implementation manual and information about the provision of HIV testing, linkage to care and PrEP.', 'armGroupLabels': ['Information Control Group']}\n- {'type': 'OTHER', 'name': 'HIV and HCV Testing Practice Coaching Intervention', 'description': 'The practice coaches (PCs) will work with the program team a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV and HCV testing and evidence--based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV and HCV testing. Also, due to the expense of HCV treatment, and potentially more complicated mechanisms for linking HCV-positive patients to further evaluation and care which may take more time than anticipated, PCs will provide OTPs with basic education and motivation about the importance of HCV testing for reasons other than immediate curative treatment. Information on PrEP also will be provided. The intervention will occur over approximately 29 weeks (or 6 months).', 'armGroupLabels': ['HIV and HCV Testing Practice Coaching Intervention Group']}\n- {'type': 'OTHER', 'name': 'HIV Testing Practice Coaching Intervention', 'description': 'The practice coaches (PCs) will work with the programs a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV testing and evidence-based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV testing. Information on Pre-Exposure Prophylaxis (PrEP) also will be provided. The intervention will occur over approximately 29 weeks (or 6 months) consisting of four distinct evidence-based phases designed to establish competency in the implementation of organizational change towards establishing HIV testing outcomes among OTP clientele.', 'armGroupLabels': ['HIV Testing Practice Coaching Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of OTP patients HIV tested at 6 months post intervention or control, while controlling for HIV testing during the baseline period (T1)', 'description': 'The primary outcome measure will be a contrast of the proportion of OTP patients HIV tested during T3, controlling for HIV testing at baseline (T1). The primary test will be whether the proportion of patients tested across the two PC interventions--HIV Testing PC Intervention Group and HIV/HCV Testing PC Intervention Group--differs from the proportion of patients tested in the Information Control Group.', 'timeFrame': 'The period 7-12 months post site-randomization (T3).'}\n\nPlease estimate the sample size based on the assumption: \nIntra-class correlations (ICC) range from 0.04 to 0.08. Over 95% power for the primary outcome and 85% power for the secondary outcome. If some sites drop out, over 95% power for the primary and 83% power for the secondary with 45 sites remaining. Over 80% power for the quasi-experimental evaluation and analysis of change in proportion of facilitators/barriers.", "answer": 51, "answer_type": "ESTIMATED", "explanation": "Power and sample size\n Statistical power and sample size were determined using a simulation programmed in SAS 9.3. The simulation generated data with a range of intra-class correlations (ICC) from 0.04 to 0.08, and an information control condition with a proportion of clients\u00e2\u0080\u0099 HIV testing of 20% as found in the control condition in CTN0032, a study assessing the relative effectiveness of three HIV testing strategies on increasing receipt of test results and reducing HIV risk behaviors among patients seen at drug use treatment centers [13]. A sample size of 51 OTPs and an average of about 100 clients per site per 6-month period provides over 95% power for the primary outcome and 85% power for the secondary outcome if the proportion of clients\u00e2\u0080\u0099 HIV testing in the HIV PC condition is 30% (absolute difference of 10% from control condition) and the proportion of clients\u00e2\u0080\u0099 HIV testing in the HIV/HCV PC condition is 41% (absolute difference of 11% from the HIV PC condition) for all expected levels of ICC (0.04 to 0.08). Should some sites drop out, there is still over 95% power for the primary and 83% power for the secondary, as long as 45 sites remain in the study. For the quasi-experimental evaluation of the blending product, the study will have over 80% power to uncover an absolute change in proportion testing for HIV of 6 to 7%. For analysis of change in proportion of facilitators/barriers, the study will have over 80% power to uncover a significant difference in change if the difference in change is 0.5 to 0.65 of a standard deviation, a medium effect size.", "id": 132, "split": "train"} +{"trial_id": "NCT03136445", "pmid": "31615553", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Double-blind, Randomised Controlled Trial Evaluating the Safety and Efficacy of Antifibrinolytics (Tranexamic Acid) in Patients With Haematological Malignancies With Severe Thrombocytopenia\n\nIncluded conditions:\n- Hematologic Neoplasms\n- Hemorrhage\n- Hematopoietic Stem Cell Transplantation\n\nStudy Armgroups:\n- {'label': 'Intervention Arm', 'type': 'EXPERIMENTAL', 'description': 'Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.', 'interventionNames': ['Drug: Tranexamic acid (TXA).']}\n- {'label': 'Control Arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tranexamic acid (TXA).', 'description': 'IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.', 'armGroupLabels': ['Intervention Arm'], 'otherNames': ['Cyklokapron\u00ae', 'trans-4-(aminomethyl)cyclohexanecarboxylic acid', 'Lysteda']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'IV (saline) or oral placebo tablets', 'armGroupLabels': ['Control Arm'], 'otherNames': ['Placebo for tranexamic acid']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of patients who die or have bleeding of WHO grade 2 or above by WHO criteria during the first 30 days from the first dose of trial treatment, or planned first dose for those participants who do not receive treatment.', 'description': 'The proportion of patients who die or have bleeding of WHO grade 2 or above by WHO criteria during the first 30 days from the first dose of trial treatment, or planned first dose for those participants who do not receive treatment.\\n\\nA time-to-event analysis will be used to determine this proportion to ensure that all patients are included in the primary outcome analysis, not just those who are followed up for the full 30 days. Any patients lost to follow-up will be included in the analysis and censored at the time that they were lost.', 'timeFrame': 'The first 30 days from first dose of trial treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe trial is designed with 80% power to detect an 11% absolute decrease in bleeding rates, with a significance level of 0.05. An additional 5% of patients are included to account for those who may not receive the trial treatment. The trial is not powered to definitively establish the safety of the treatment regarding VTE frequency.", "answer": 616, "answer_type": "ACTUAL", "explanation": "Sample size\n Based on the experience of similar patients in the TOPPS trial [9], in the absence of anti-fibrinolytic therapy, it is anticipated that 43% of eligible patients will experience death or WHO grade 2 bleeding or higher within the first 30\u00e2\u0080\u0089days of the TREATT trial. We judged that a 26% relative reduction in bleeding rates would be sufficient to change clinical practice because it would be necessary to treat only 8.9 patients to have an impact on 1 patient provided that no new safety issues related to anti-fibrinolysis in the thrombocytopenic population are uncovered. We thus evaluated the planned sample size of the trial relative to this hypothesised effect. We plan to recruit 616 participants to the TREATT trial. The primary endpoint will be analysed by using the Kaplan\u00e2\u0080\u0093Meier (KM) method to estimate the probability of bleeding or death within 30\u00e2\u0080\u0089days in the analysis populations. Power and sample size calculations are based on a log-rank test for comparing two survival curves, as described in Collett [28]. Under the assumption that anti-fibrinolysis results in a decrease of death or WHO grade 2 bleeding from 43% to 32%, the 616 patients planned to be recruited will provide 80% power to detect an observed absolute decrease in bleeding rates of 11% (a relative reduction of 26% with a number needed to treat (NNT) of 8.9) and will be judged statistically significant at the two-sided 0.05 level. The planned trial size of 616 subjects includes an additional 5% of patients above the required sample size of 586. This 5% figure is more than the proportion of patients within TOPPS (4%) who dropped their platelet count below 50\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089109/L but did not drop their platelet below 30\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089109/L. This therefore accounts for the number of patients within the trial who are randomly assigned but never receive the trial treatment.\n We do not expect there to be a problem with the assessment of the primary outcome since, in the recent TOPPS trial conducted by our group and using the same bleeding assessment tool, completeness of bleeding outcome documentation was excellent. A bleeding assessment was completed on 95% (17,138/18,000) of study days. The majority of patients had bleeding information completed on each trial day (median of 30\u00e2\u0080\u0089days). There were also only 6 deaths (1% of patients) while on the trial.\n This trial is not powered to definitively establish the safety of the treatment with respect to the frequency of venous thromboembolism (VTE). However, with the planned enrolment of 616 patients, observed differences in frequency of VTE of 3.6% in the placebo arm and 5% or less in the TXA arm would result in a 95% confidence interval that excluded a relative risk of 3.5.", "id": 133, "split": "train"} +{"trial_id": "NCT03138018", "pmid": "31594904", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Potential Impact of Aging Stereotypes in the Assessment of Memory Deficits and Screening for Prodromal State of Alzheimer's Disease\n\nIncluded conditions:\n- Mild Cognitive Impairment (MCI)\n\nStudy Armgroups:\n- {'label': 'Standard instruction', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient)']}\n- {'label': 'Reduced threat instruction', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: Diagnosis of MCI versus No MCI (SCI or healthy patient)']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Diagnosis of MCI versus No MCI (SCI or healthy patient)', 'description': 'Neuropsychological tests', 'armGroupLabels': ['Reduced threat instruction', 'Standard instruction']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Diagnosis of MCI versus No MCI (SCI or healthy patient)', 'description': 'Neuroimaging biomarkers of neurodegeneration', 'armGroupLabels': ['Reduced threat instruction', 'Standard instruction']}\n\nPrimary Outcomes:\n- {'measure': 'Neuropsychological tests', 'description': 'Neuropsychological battery used for the diagnosis of Mild Cognitive Impairment (MCI, amnestic single or multiple domain)', 'timeFrame': '48 months'}\n\nPlease estimate the sample size based on the assumption: \nThe error rate was set at 0.05, and the power was set at 0.80. A power analysis indicated that a sample of 250 participants would be sufficient. An additional 10 participants were added as a safety margin, making the total 260 participants.", "answer": 260, "answer_type": "ESTIMATED", "explanation": "Sample size\n The number of participants needed in the study was determined45 on the basis of the anticipated effect size of the ST. Lamont et al\n21 conducted a meta-analysis of age-based ST and found an effect size of d=0.52 (95% CI .248 to .717, corresponding to f\n2=0.15), when they manipulated ST as we do here. However, as ours is the first study of age-based ST in a clinical setting, we decided to use a lower effect size (f2=0.07) to determine our target sample size, in order to have sufficient power to accurately detect a probably smaller effect in an ecologically valid field experiment. Using this smaller effect size, with the error rate set at 0.05, and power set at 0.80, a power analysis46 indicated that a sample of 250 participants would be sufficient to detect the critical effects of the conditions and their potential interactions with several moderators in a multiple regression analysis (11 predictors: condition, age, physiological stress, 4 vulnerability factors and the interaction terms between condition and these vulnerability factors). We added 10 participants as a safety margin (n=260), in order to ensure that at least 30 participants in each arm meet aMCI criteria for visit 3. Patients will be continuously recruited until the desired sample size is achieved, but not beyond December 2020, to allow sufficient time for the 9-month follow-up before September 2021. Since February 2019, strategies have been implemented to increase recruitment: communication on the AGING protocol has been improved (eg, poster displays in hospitals and general practices, call for participation in AGING on hospital websites) and appointment scheduling and reminders via post, email and/or telephone are being used to retain patients already enrolled in the trial.", "id": 134, "split": "train"} +{"trial_id": "NCT03138733", "pmid": "31918579", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Double-blind, Multi-center Study to Establish the Efficacy and Safety of Ceftobiprole Medocaril Compared to Daptomycin in the Treatment of Staphylococcus Aureus Bacteremia, Including Infective Endocarditis\n\nIncluded conditions:\n- Staphylococcus Aureus Bacteremia\n\nStudy Armgroups:\n- {'label': 'Ceftobiprole medocaril', 'type': 'EXPERIMENTAL', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)', 'interventionNames': ['Drug: Ceftobiprole medocaril']}\n- {'label': 'Daptomycin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards), with or without aztreonam', 'interventionNames': ['Drug: Daptomycin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ceftobiprole medocaril', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) as a 2 h infusion', 'armGroupLabels': ['Ceftobiprole medocaril']}\n- {'type': 'DRUG', 'name': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam', 'armGroupLabels': ['Daptomycin']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit', 'description': 'Comparison of overall success rates in the mITT population\\n\\nOverall success at PTE for the mITT population was defined as all of the following criteria being met (Responder):\\n\\n1. Patient alive at Day 70 (\u00b1 5 days) post-randomization.\\n2. No new metastatic foci or complications of the SAB infection.\\n3. Resolution or improvement of SAB-related clinical signs and symptoms.\\n4. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)', 'timeFrame': 'PTE visit on Day 70 (\u00b1 5 days) post-randomization'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided alpha level of 0.025; power of >80%; approximately 90% of patients in the ITT population will have confirmed SAB and will be included in the mITT population.", "answer": 390, "answer_type": "ACTUAL", "explanation": "Planned sample size\n The sample size has been estimated based on: a point estimate for overall success of 40% in each treatment group in the mITT population; a one-sided alpha level of 0.025; power of >80%; and a noninferiority margin of 15% for the between-group difference in the primary end point. The assumption of an overall success rate of 40% in each treatment group is based on the success rates in the Phase III study of daptomycin compared with standard-of-care treatment in patients with SAB including IE [8]. With these assumptions, enrollment of 350\u00c2\u00a0patients (175 per group) is required for the mITT population. Based on the previously mentioned daptomycin Phase III study [8], it is assumed that approximately 90% of patients in the ITT population will have confirmed SAB and will be included in the mITT population, and therefore a total of 390\u00c2\u00a0patients (195 per group) will need to be randomized and receive treatment. This sample size will provide \u00e2\u0089\u00a580% power to reject the null hypothesis (H0) against the alternative hypothesis (HA) at the one-sided alpha level of 0.025 as follows, using a two-group large-sample normal approximation test of proportions:H0:Pdaptomycin-Pceftobiprole\u00c2\u00a0\u00e2\u0089\u00a50.15\u00c2\u00a0versus\u00c2\u00a0HA:Pdaptomycin-Pceftobiprole<0.15", "id": 135, "split": "train"} +{"trial_id": "NCT03139006", "pmid": "30826767", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Diagnostic Accuracy of Spectral Computed Tomography for Detection of Flow Limiting Coronary Stenosis Using Fractional Flow Reserve as the Standard of Reference\n\nIncluded conditions:\n- Coronary Stenosis\n- Myocardial Ischemia\n- Cardiovascular Diseases\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Dual-layer spectral detector CT', 'description': 'A dual energy CT approach', 'otherNames': ['SDCT']}\n\nPrimary Outcomes:\n- {'measure': 'Flow limiting stenosis in the coronary arteries defined by invasive fractional flow reserve (FFR)', 'description': 'An invasive FFR \\\\<0.8 indicates a flow limiting stenosis', 'timeFrame': 'within 30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is not explicitly stated, but the confidence intervals (CIs) are mentioned: the lower limit of the 95% CI for specificity should increase from 35% to 60%, and the lower limit of the 95% CI for sensitivity should be around 65%. An attrition rate is considered, leading to an increase in the sample size.", "answer": 75, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n To allow for evaluation of sensitivity and specificity within our study population, the proportions of cases (FFR\u00c2\u00a0\u00e2\u0089\u00a40.80) and controls (FFR\u00c2\u00a0>0.8) in our sample should take the prevalence of disease into account. Internal research of patient records of the past 3 years showed that 50% of the patients who underwent invasive FFR had at least one positive FFR measurement (FFR\u00c2\u00a0\u00e2\u0089\u00a40.80). With a prevalence of 0.5, the proportion of cases to controls is 1, indicating that the same amount of cases and controls is required. The main goal of the CLARITY study is to increase the specificity of SDCT (including CTP) for the identification of functionally significant coronary artery stenosis. In the targeted population, the sensitivity and specificity of CCTA are currently around 95% and 50%, respectively.1\u00e2\u0080\u00933 Using SDCT (including CTP), we aim to increase the specificity from 50% to 85%.22\u00e2\u0080\u009324 Raising the lower limit of the 95% CI for specificity from a typical value of 35% to 60%, necessitates inclusion of at least 66 patients (33 cases and 33 controls).25 However, this should not come at a too high cost in sensitivity. Using SDCT (including CTP), we expect a sensitivity around 90% with a lower limit of the 95% CI of 65%,22\u00e2\u0080\u009324 which necessitates inclusion of at least 62 patients (31 cases and 31 controls).25 Because we are interested in both the sensitivity and specificity, we take the largest number of patients of the two calculated sample sizes (n=66). To account for attrition, 75 patients will be included. Our internal research also showed that in most cases FFR is measured in more than one vessel, with an average of 1.6 vessels per patient. Thus, for evaluation on a vessel basis, the amount of measurements is expected to be around 120 individual measurements.", "id": 136, "split": "train"} +{"trial_id": "NCT03141619", "pmid": "31243036", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2\n\nIncluded conditions:\n- Critical Illness\n- Respiratory Failure\n- Shock\n- Delirium\n\nStudy Armgroups:\n- {'label': 'Respiratory failure and/or shock', 'description': 'All enrolled patients will undergo 72 hours of monitoring of cerebral oxygenation with near-infrared spectroscopy.'}\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Regional cerebral oxygenation (rSO2) and delirium', 'description': 'Multivariate linear regression will be used to characterize the association between poor cerebral perfusion (as measured using duration of time (minutes) outside of MAPOPT, mean rSO2, and duration of disturbed cerebral autoregulation) and delirium severity to determine if poor cerebral perfusion is an independent predictor of delirium severity. We will estimate the unadjusted effect of each individual predictor on delirium severity (i.e., cumulative CAM-7 scores per patient). The simultaneous multivariate regression model will adjust for the following covariates (sex, a history of hypertension, a history of alcohol abuse, total sedative dose (in midazolam equivalents), total narcotic dose (fentanyl equivalents), severity of illness (APACHE II scores), pre-existing cognitive impairment (CDR score), length of ICU stay, and blood urea nitrogen. The multivariable model will provide the adjusted regression coefficients after controlling for all predictors included in the model.', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level (alpha) of 0.050, 90% power, and accounts for a 20% dropout rate for the primary outcome and a 30% mortality rate for secondary outcomes. A Bonferroni correction (0.0056) is used for multiple testing in secondary outcomes.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Primary outcome: Our overall hypothesis is that poor cerebral perfusion contributes to delirium and long-term cognitive impairment. For study purposes, we define poor cerebral perfusion as the composite of (1) low mean rSO2, (2) duration of impaired cerebral autoregulation and (3) time outside individualised optimal MAP MAPOPT, which will be discussed in more detail in the statistical plan section. We acknowledge that this is an imperfect measure of cerebral perfusion. However, this is a comprehensive, continuous and non-invasive assessment of cerebral perfusion. For our primary outcome (CAM-7 delirium severity score), we will enrol a total of 500 patients, as our prior work has demonstrated that ~20% of patients remain comatose (RASS=\u00e2\u0088\u00924 or \u00e2\u0088\u00925) during their entire ICU stay,16 and cannot be assessed for delirium. Therefore, using our pilot data, we estimate that ~100 patients will be remain comatose resulting in approximately 400 patients to assess our primary outcome, which will allow for 10 df for our 3 measures of perfusion (ie, mean rSO2, duration of disturbed cerebral autoregulation, duration outside MAPOPT) and controlling for the nine covariates (see below). The 10 df will allow us to model non-linear relationships between the 3 measures of cerebral perfusion and delirium severity. This sample size achieves 90% power to detect an R2 of 0.050 collectively among these measures of cerebral perfusion and using an F-test with a significance level (alpha) of 0.050 (see figure 5).\n \n Figure 5\n \n A power curve indicating the study sample size, and the respective statistical power, to asses the primary study outcome. Red dots represent the sample size needed for a given statistical power. The primary sample size was calculated using the following multivariate regression model parameters: 10 independent variables tested, controlling for 9 additional covariates, power=0.90, R2=0.050, \u00ce\u00b1=0.05, which would require a sample size of 400.\n \n \n \n \n Secondary outcomes: physiological determinants of rSO2 and neurological outcomes\n For evaluating the determinants of the rSO2 signal during critical illness, we will assess the association between each of the nine prespecified candidate predictors of rSO2 after controlling for the four covariates (see below for covariates). We will use a Bonferroni correction (0.05/9=0.0056) to control for multiple testing. With the total 500 patients recruited, and a multivariate regression model that includes 13 independent variables, this testing strategy will provide 90% power to identify any predictor that explains an additional 3.2% of the variance of rSO2 after controlling for the other variables in the model. This sample size is sufficient to identify independent significant predictors that account for a small-moderate degree of variance in the overall rSO2 signal. However, our pilot data indicated a 30% mortality rate. Given our overall sample size of 500 patients recruited, we are anticipating ~350\u00e2\u0080\u0089ICU survivors (ie, 500\u00e2\u0080\u0093150) to return for follow-up assessment. This cohort will provide sufficient power to detect important predictors of long-term neurological outcomes. However, these predictors have been intentionally not specified a priori, as this analysis will be dependent on our findings related to cerebral perfusion and delirium.\n All sample size calculations were conducted using Power Analysis and Sample Size Software (V.15).37\n\n The actual start date at KHSC began on 26 January 2018 and our estimated primary completion data is June 2022. Due to our 12-month follow-up, we expect the study to be completed June 2023.", "id": 137, "split": "train"} +{"trial_id": "NCT03141866", "pmid": "31753876", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"Determining the Feasibility of Chair-based Physical Activity Interventions, Aimed at Improving Various Aspects of Health and Wellbeing in Geriatric Populations With Pre-existing Frailty, Within a Hospital Ward Setting\"\n\nIncluded conditions:\n- Frail Elderly Syndrome\n- Frailty\n- Physical Activity\n\nStudy Armgroups:\n- {'label': 'Exercise Intervention 1: Move It Or Lose It (MIOLI)', 'type': 'EXPERIMENTAL', 'description': 'An established chair-based physical activity programme for older adults.', 'interventionNames': ['Other: Exercise Intervention 1: Move It Or Lose It (MIOLI)']}\n- {'label': 'Exercise Intervention 2: Machine-based resistance training', 'type': 'EXPERIMENTAL', 'description': 'Specialised, chair-based resistance training equipment for older adults.', 'interventionNames': ['Other: Exercise Intervention 2: Machine-based resistance training intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Exercise Intervention 1: Move It Or Lose It (MIOLI)', 'description': 'An established chair-based physical activity programme for older adults.', 'armGroupLabels': ['Exercise Intervention 1: Move It Or Lose It (MIOLI)']}\n- {'type': 'OTHER', 'name': 'Exercise Intervention 2: Machine-based resistance training intervention', 'description': 'Specialised, chair-based, pneumatic resistance training equipment for older adults.', 'armGroupLabels': ['Exercise Intervention 2: Machine-based resistance training']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility', 'description': 'The primary dependent variable of this feasibility study will relate to the eight primary areas of focus of feasibility studies (Bowen et al. 2009), relating to:\\n\\n* Acceptability\\n* Demand\\n* Implementation\\n* Practicality\\n* Adaptation\\n* Integration\\n* Expansion and\\n* Limited-efficacy testing\\n\\nThese eight aforementioned areas (constituting the one variable of feasibility) will serve as the primary dependent variable for this study, in order to establish the feasibility of a proposed future clinical trial within this setting. The dependent variable of feasibility will be assessed through semi-structured interviews with participants post intervention, while focus groups will be utilised with both the intervention implementers and study support staff in order to assess the primary dependent variable of the study. Participant uptake and adherence records will also be employed throughout.', 'timeFrame': 'Post-Intervention (2 weeks)'}\n\nPlease estimate the sample size based on the assumption: \nThis sample size was based on initial expectations related to the obtainment of data saturation in the qualitative component of the study given its phenomenological approach.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n This study aims to recruit a convenience sample of n =~30 participants: 15 in each intervention. No formal power calculations were conducted due to the feasibility nature of this study. This sample size was based on initial expectations related to the obtainment of data saturation in the qualitative component of the study given its phenomenological approach.50 51", "id": 138, "split": "train"} +{"trial_id": "NCT03143335", "pmid": "32041661", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Direct to Implant Extracellular Matrix Hammock Based pre-or Retropectoral Breast Reconstruction\n\nIncluded conditions:\n- Breast Reconstruction\n\nStudy Armgroups:\n- {'label': 'Retropectoral immediate breast reconstruction', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants are randomized to immediate breast reconstruction with the implant placed retropectoral.', 'interventionNames': ['Procedure: Retropectoral immediate breast reconstruction']}\n- {'label': 'Prepectoral immediate breast reconstruction', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants are randomized to direct to immediate breast reconstruction with the implant placed prepectoral using acellular dermal matrix for support.', 'interventionNames': ['Procedure: Prepectoral immediate breast reconstruction']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Retropectoral immediate breast reconstruction', 'description': 'Immediate reconstruction with the implant placed in a standard fashion, i.e. retropectoral in combination with an acellular dermal matrix.', 'armGroupLabels': ['Retropectoral immediate breast reconstruction']}\n- {'type': 'PROCEDURE', 'name': 'Prepectoral immediate breast reconstruction', 'description': 'Immediate breast reconstruction with the implant placed prepectoral supported by acellular dermal matrix alone.', 'armGroupLabels': ['Prepectoral immediate breast reconstruction']}\n\nPrimary Outcomes:\n- {'measure': 'Breast animation deformity', 'description': 'Breast animation deformity (BAD) is one of the more unpleasant cosmetic results that can be seen after breast reconstruction with a retropectoral placed implant. The degree of breast distortion will be evaluated by two experienced plastic surgeons and classified according to the published classification by Spear S. Because the degree of breast distortion will be the primary outcome measure of this randomised trial, the sample size will be based on assumptions regarding the grade of distortion between groups. For this purpose, the distortion will be divided into two groups: 1) Severe distortion containing degree 3 and 4 and 2) Moderate distortion containing degree 1 and 2. In bilateral cases the most severe side will be the one used for comparison', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05 (one-sided), power of 0.95, and an interim analysis with 60% of the patients included using an O'Brien-Fleming type \u03b1-spending function with a significance level of 0.0114 at interim.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size\n A non-parametric calculation of the sample size was made based on our assumptions and experience regarding the degree of BAD in the two groups. We used Fisher\u00e2\u0080\u0099s exact test for small sample sizes. Based on our experience we expected that approximately 60% of the patients who are reconstructed using subpectoral implant placement would suffer from BAD as opposed to 20% of the women who are reconstructed using prepectoral implant placement. By using these assumptions in combination with a significance level of 0.05 (one-sided) and a power of 0.95, the total sample size was calculated to 70 patients, 35 women in each group.\n However, a retrospective cohort study in women over 18\u00e2\u0080\u0089years of age who had a unilateral or bilateral direct-to-implant breast reconstruction between November 2011 and December 2017 suggested the above sample size assumptions to be too conservative [15]. Therefore, we will conduct an interim analysis with 60% of the patients included (i.e. 0.6\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u008970\u00e2\u0080\u0089=\u00e2\u0080\u008942). The primary hypothesis will be tested conservatively with n\u00e2\u0080\u0089=\u00e2\u0080\u008942 patients applying an O\u00e2\u0080\u0099Brien-Fleming type \u00ce\u00b1-spending function (i.e. \u00ce\u00b11* in [18]), resulting in a significance level of 0.0114 at interim and securing an experiment-wise type 1 error of maximal 0.05.\n The sample size is calculated using STATA, version 14.0 (StataCorp, College Station, TX, USA) using a two-sample proportion test.", "id": 139, "split": "train"} +{"trial_id": "NCT03145688", "pmid": "32295773", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Promoting Habit Formation in Family Physical Activity\n\nIncluded conditions:\n- Physical Activity\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control group package will consist of the Canadian 24 Hour Movement Guidelines recommending 60 minutes of moderate to vigorous physical activity per day for children. The guide also contains arguments \\\\& information about the benefits of physical activity.'}\n- {'label': 'Family physical activity Planning', 'type': 'EXPERIMENTAL', 'description': 'Behavoural: Family Physical Activity Planning. The physical activity planning intervention condition will receive the same guidelines as the standard education control group but will also be provided with family physical activity planning material. This material will include workbook on how to plan for family physical activity; brainstorming exercises for parents \\\\& children where they list physical activities that they have found fun in the past, as well as some new activities they would like to try \\\\& skill training content to help with goal setting \\\\& tracking of physical activity.', 'interventionNames': ['Behavioral: Family Physical Activity Planning']}\n- {'label': 'Family Physical Activity Habit Formation', 'type': 'EXPERIMENTAL', 'description': 'Behavioural: Family Physical Activity Habit formation. The Habit formation intervention condition will receive the same content as the education control condition and the physical activity planning condition but with additional material on creating physical activity support habits. The material includes a brief discussion of what habits are with some very straightforward examples such as preparing for sleep routines or initiating to drive a car to work. A key component of the habit section will be based on planning for context-dependent repetition, with pointers on how to maintain repetition as habit forms.', 'interventionNames': ['Behavioral: Family Physical Activity Habit Formation']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Family Physical Activity Planning', 'description': 'Families will receive the same guidelines as the standard education control group but will also be provided with family physical activity planning material. This material will include a skill training content workbook on how to plan for family physical activity. The material includes a brainstorming exercise for parents where they list physical activities they think their children have found fun in the past, as well as activities that they would find enjoyable to do as a family. We will provide this material as prompts/suggestions. Families will be instructed to plan for \"when,\" \"where,\" \"how,\" and \"what\" physical activity will be performed \\\\& then track their physical activity. These aspects will be re-introduced and discussed at week 6 and week 12 in booster sessions', 'armGroupLabels': ['Family physical activity Planning']}\n- {'type': 'BEHAVIORAL', 'name': 'Family Physical Activity Habit Formation', 'description': 'Families will receive the same content as the education control condition and the physical activity planning condition but with additional material on creating physical activity support habits. A key component of the habit section will be based on planning for context-dependent repetition, with pointers on how to maintain repetition as habit forms. The importance of creating cues for parental support of child physical activity is then outlined. Cues will also be considered factors that a) can precede the support activity but b) not be present very often when the activity is not to be performed. We will suggest that cues that have repeated exposure during times when family physical activity is not present Parents will then be asked to brainstorm and create a plan of consistency and cues with the workbooks provided. These aspects will be re-introduced and discussed at week 6 and week 12 in booster sessions.', 'armGroupLabels': ['Family Physical Activity Habit Formation']}\n\nPrimary Outcomes:\n- {'measure': \"Change from baseline in children's physical activity to 6 months\", 'description': \"Children's physical activity will be quantified by accelerometry. Children will wear an accelerometer for a minimum of 10 hours per day for 7 days at baseline and 6 months. Additionally this measure will assess intermediate outcomes at 6 weeks and 3 months.\", 'timeFrame': 'Baseline & 6 months'}\n\nPlease estimate the sample size based on the assumption: \nfour measurement occasions, three conditions, duration of 6 months, within-person variance of 1.0", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Statistical power and sample size\n Given the hierarchical nature of the data (ie, the four measurement occasions at level-1 were considered to be nested within the participant at level-2), the OpDes Program for power estimation of hierarchical linear models90 was used. With a frequency of four measurement occasions, three conditions, a duration of 6 months as the primary end-point, within-person variance of 1.0, a growth rate of 1.0 and a small effect size (d=0.30\u00e2\u0080\u00930.40), a minimum of 150 families with a goal of 240 families (ie, 50\u00e2\u0080\u009380 children per condition) are needed to show significant difference in PA accelerometry (minutes of MVPA primary outcome) by condition over time. The effect size represents the findings from our prior intervention research with this demographic18 22 and considering our pilot study on habit formation,36 yet it is clearly in the range for the detection of differences between the PLANNING and HABIT conditions.91 92", "id": 140, "split": "train"} +{"trial_id": "NCT03147859", "pmid": "33033101", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection\n\nIncluded conditions:\n- HIV-infection/AIDS\n\nStudy Armgroups:\n- {'label': 'Group A-150mg dose of vedolizumab per infusion followed by ATI - Low Dose', 'type': 'EXPERIMENTAL', 'description': '\\\\* Please note that the previous low dose arm was 75mg of vedolizumab per infusion, but no participant was ever given this dose. The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 150 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 doses as tolerated. ATI will begin between weeks 6 and 7, and infusions continued at weeks 8, 12, 16 and 20.', 'interventionNames': ['Biological: Vedolizumab (brand name Entyvio)']}\n- {'label': 'Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid Dose', 'type': 'EXPERIMENTAL', 'description': 'The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 300 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 (and up to 12) doses as tolerated. ATI will begin between week 10, and infusions continued at weeks 12, 16 and 20. Infusions may also be given at weeks 24, 28, 32, 36 and 40 depending on tolerance and pVL response.', 'interventionNames': ['Biological: Vedolizumab (brand name Entyvio)']}\n- {'label': 'Group C-600mg dose of vedolizumab per infusion followed by ATI - High Dose', 'type': 'EXPERIMENTAL', 'description': 'The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 600 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 (and up to 12) doses as tolerated. ATI will begin between week 10, and infusions continued at weeks 12, 16 and 20. Infusions may also be given at weeks 24, 28, 32, 36 and 40 depending on tolerance and pVL response.', 'interventionNames': ['Biological: Vedolizumab (brand name Entyvio)']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Vedolizumab (brand name Entyvio)', 'description': 'IV infusion', 'armGroupLabels': ['Group A-150mg dose of vedolizumab per infusion followed by ATI - Low Dose', 'Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid Dose', 'Group C-600mg dose of vedolizumab per infusion followed by ATI - High Dose']}\n\nPrimary Outcomes:\n- {'measure': 'Vedolizumab safety and tolerance', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, with their timing of onset and resolution.', 'timeFrame': '6 months vedolizumab treatments, serial assessments over 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe trial does not explicitly state assumptions on significance level, power, or missing/dropout rate.", "answer": 10, "answer_type": "ESTIMATED", "explanation": "Study design, settings, sample size and recruitment strategy\n HAVARTI is a single-arm, dose-ranging pilot trial of serial vedolizumab infusions for the induction of HIV SVR in adults with chronic HIV infection on ART. Twelve consenting volunteers respecting all inclusion and exclusion criteria will be enrolled sequentially in groups of four to receive vedolizumab by infusion in 2-week to 4-week intervals for a total of seven doses. After three doses of vedolizumab, the participants will initiate the ATI portion of the study. During the ATI, participants will discontinue ART but continue with the four remaining scheduled vedolizumab treatments and monitoring of pVL and immunological markers. They will also have regular clinical assessment at each infusion visit. Participants will restart ART according to CD4 T-cell count and pVL threshold levels and trajectory, personal choice, or consensus judgement of the volunteer patient, treating physician and/or study investigators. Decisions to continue ATI or restart ART in the presence of CD4, pVL and clinical indicators will be reviewed by an independent expert medical monitor and reported to the Data Safety Monitoring Board (DSMB) in a timely manner.\n Study participants will be recruited from The Ottawa Hospital (TOH) HIV clinic and referring primary care facilities. Informed consent will be obtained from those patients who are documented to be eligible for the trial after pre-screening. Table 1 shows the safety laboratory tests and concomitant medication surveys to be done during screening. Individuals who wish to discuss enrolment in the trial with family, partner, friends or their treating physician may take the time and choose to enrol at a subsequent clinic visit. Once enrolled, the participant will be followed concomitantly by the principal investigator and study staff at TOH for the duration of the trial.\n \n Table 1\n \n Study visit schedule\n \n \n \n \n Study activity/visit*\n Screening\n Baseline\n Week 0\n Week 2\n Week 5\n Weeks 6 to 7\u00e2\u0080\u00a0\n Week 8\n Week 12\n Week 16\n Week 20\n Week 24\n Weeks 28, 32, 36, 40, 44, 48\n Week 52\n \n \n \n \n Informed consent\n X\n X\n X\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \n \n Eligibility confirmation\n X\n X\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \n \n Concomitant medicines\n X\n X\n X\n X\n X\n \n X\n X\n X\n X\n X\n X\n \n \n \n Pregnancy test if applicable\u00e2\u0080\u00a1\n X\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \n \n Safety laboratories (CBC, WBC, serum chemistry\u00c2\u00a7, ESR)\n X\u00c2\u00b6\n X\n X\n X\n \n \u00e2\u0080\u0083\n X\n X\n X\n X\n X\n X\n X\n \n \n Serum (10\u00e2\u0080\u0089mL)\n \n X\n X\n X\n X\n \n X\n X\n X\n X\n X\n X\n \n \n \n Plasma (10\u00e2\u0080\u0089mL)\n \n X\n X\n X\n X\n X\n X\n X\n X\n X\n X\n X\n \n \n \n PBMCs from whole blood**\n \n X\n \n \u00e2\u0080\u0083\n X\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n X\n \n \u00e2\u0080\u0083\n \n \n Plasma viral load\n X\n X\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n X\n X\n X\n X\n X\n X\n X\n \n \n CD4\n X\n X\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n X\n X\n X\n X\n X\n X\n X\n \n \n Vedolizumab intravenous infusion\n \n \u00e2\u0080\u0083\n X\n X\n X\n \n X\n X\n X\n X\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \n \n History and physical\n X\u00e2\u0080\u00a0\u00e2\u0080\u00a0\n X\n X\n X\n X\n \n X\n X\n X\n X\n X\n X\n X\n \n \n Optional CSF specimen\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n X\n \n \u00e2\u0080\u0083\n \n \n Optional rectal mucosal biopsy\n \n X\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n X\n \n X\n \n \n Optional stool sample\n \n X\n \n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n \u00e2\u0080\u0083\n X\n \n X\n \n \n AE assessment\n \n X\n X\n X\n X\n X\n X\n X\n X\n X\n X\n X\n X\n \n \n \n \n \n *Study visits may occur \u00c2\u00b11\u00e2\u0080\u0089week from the time points outlined in the table.\n \n \n \u00e2\u0080\u00a0ATI (analytical treatment interruption) will occur at weeks 6\u00e2\u0080\u00937.\n \n \n \u00e2\u0080\u00a1Pregnancy testing with urine dip for \u00ce\u00b2-human chorionic gonadotropin may be repeated at any study visit where it is felt to be indicated by the patient or the study investigator.\n \n \n \u00c2\u00a7Serum chemistry includes albumin (total), alanine transaminase, alkaline phosphatase, amylase, aspartate transaminase, bilirubin (total), blood glucose (random), blood urea nitrogen, calcium, chloride, C reactive protein, creatinine, gamma-glutamyl transferase, potassium, protein (total) and sodium.\n \n \n \u00c2\u00b6Safety laboratory items have been measured within 1\u00e2\u0080\u0089year of the screening visit; these results may be used for screening purposes.\n \n \n **50\u00e2\u0080\u0093100\u00e2\u0080\u0089mL whole blood for separation and cryopreservation of PBMCs.\n \n \n \u00e2\u0080\u00a0\u00e2\u0080\u00a0The history taken at screening will be more thorough than subsequent visits (ie, height only taken once). Confirmation of HIV+ by western blot or other standard test required only at screening visit.\n \n \n AE, adverse event; CBC, complete blood cell count; CSF, cerebrospinal fluid; ESR, erythrocyte sedimentation rate; PBMC, peripheral blood mononuclear cell; WBC, white blood cell count.", "id": 141, "split": "train"} +{"trial_id": "NCT03149640", "pmid": "34521664", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia\n\nIncluded conditions:\n- Pneumonia, Ventilator-Associated\n\nStudy Armgroups:\n- {'label': 'Inhaled amikacin', 'type': 'EXPERIMENTAL', 'description': 'Inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.', 'interventionNames': ['Drug: Inhaled amikacin']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.', 'interventionNames': ['Drug: Inhaled placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Inhaled amikacin', 'description': 'Once a day, inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.', 'armGroupLabels': ['Inhaled amikacin']}\n- {'type': 'DRUG', 'name': 'Inhaled placebo', 'description': 'Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of a first VAP episode from randomization to day 28', 'timeFrame': 'Patients will be followed from randomization to day 28'}\n\nPlease estimate the sample size based on the assumption: \nPower set at 80%, two-tailed type I error at 5%, and consideration of the competing risk of death before extubation or VAP occurrence.", "answer": 850, "answer_type": "ACTUAL", "explanation": "Sample size\n The following hypothesis is based on data of a previous trial of the CRICS-TriggerSEP research network and epidemiological surveillance data39 40:\n \n \n Incidence of first VAP episode of 12% in the control group.\n \n \n Incidence of first VAP episode of 6% in the experimental group.\n \n \n Those hypotheses are conservative in terms of baseline VAP incidence and plan an important relative risk reduction which is deemed necessary to drive clinical practice change towards pre-emptive antibiotic inhalation in case of a positive trial. Indeed, a smaller risk reduction may be considered insufficient by the clinical community to implement large scale pre-emptive antibiotic therapy.\n Sample size calculation took into consideration the competing risk of death occurring before extubation or VAP occurrence.41 Power was set at 80% and two-tailed type I error at a 5%. A total number of 850 patients (425 in each arm) will be included in the trial.", "id": 142, "split": "train"} +{"trial_id": "NCT03151343", "pmid": "31780586", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of SGLT-2 Inhibitor on Myocardial Perfusion, Function and Metabolism in Type 2 DM Patients at High Cardiovascular Risk: The SIMPle Randomized Clinical Trial\n\nIncluded conditions:\n- Type2 Diabetes Mellitus\n\nStudy Armgroups:\n- {'label': 'Empagliflozin', 'type': 'EXPERIMENTAL', 'description': 'Empagliflozin, coated tablets, 25mg, once daily, for 13 weeks', 'interventionNames': ['Drug: Empagliflozin']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo, coated tablets, once daily, for 13 weeks', 'interventionNames': ['Drug: Placebo Oral Tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Empagliflozin', 'description': 'Empagliflozin tablet', 'armGroupLabels': ['Empagliflozin'], 'otherNames': ['Jardiance']}\n- {'type': 'DRUG', 'name': 'Placebo Oral Tablet', 'description': 'Sugar pill, visually identical to active comparator', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Rb-82 PET', 'description': 'Between group difference in the change in myocardial flow reserve (MFR) by Rb-82 PET. Measured as change in global perfusion from rest to adenosine-induced stress.', 'timeFrame': '13 weeks'}\n- {'measure': 'Invasive hemodynamics', 'description': 'Substudy, performed on 38 participants from the main group. Using right heart catheterisation to measure between group difference in the change in pulmonary capillary weight pressure (PCWP) at 25 watts (supine bicycle ergometer)', 'timeFrame': '13 weeks'}\n\nPlease estimate the sample size based on the assumption: \nFor both endpoints, a power of 80% and a two-sided significance level of 5% are assumed. A 10% drop-out rate is assumed for the primary endpoint, and a 15% drop-out rate is assumed for the substudy key endpoint.", "answer": 92, "answer_type": "ACTUAL", "explanation": "Sample size\n \n Primary endpoint\n The primary endpoint is change in MFR. In a previous study on a comparable population, the SD of measurements of MFR by 82Rb-PET was 0.8. Assuming a clinically relevant difference between the treatment and placebo groups after 6 months of 0.5 in MFR,27 a sample size of 41:41 (empagliflozin: placebo) can be detected with 80% power and a two-sided significance level of 5%. In all, 92 patients will be randomised to allow for a 10% drop-out rate from the ITT population.\n \n \n Substudy key endpoint\n Based on recent experiments in a comparable study population,28 a difference of 5\u00e2\u0080\u0089mm Hg in PCWP during exercise was considered clinically significant. The SD of measurements of PCWP was 5\u00e2\u0080\u0089mm Hg; thus, a sample size of 16:16 is required with a power of 80% and a two-sided significance level of 5% to detect a difference of 5\u00e2\u0080\u0089mm Hg between groups. In total 38 patients will be included in the substudy to allow for a 15% drop-out rate.\n In the ITT population, none of the randomised participants will be excluded, and the patients will be analysed according to the randomisation group. The per-protocol population will consist of all the patients who completed the study with a documented valid baseline and a final-week assessment of the primary objective without any major protocol violations. Analysis of the primary outcome parameter will focus on a change in global MBF from the baseline to week 13 between the treatment and control groups. The primary analysis will be based on the ITT population. The primary outcome measure will be analysed using Analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. The model will include the prespecified covariates age and gender. Missing data will be estimated using the maximum likelihood method. Normally distributed variables will be presented as mean\u00c2\u00b1SD, and non-parametric statistics or appropriate log transformation will be performed if an assumption of normality is not met. After log transformation, the variable will be further tested for normality distribution as indicated. A two-tailed p value of less than 0.05 will be considered statistically significant.\n Comparisons between the treatment groups will be performed by an unpaired two sample t-test, Mann-Whitney test or \u00cf\u00872 test as appropriate.", "id": 143, "split": "train"} +{"trial_id": "NCT03153527", "pmid": "37018188", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial\n\nIncluded conditions:\n- Inflammatory Disorder\n- Autoimmune\n\nStudy Armgroups:\n- {'label': 'Placebo arm (intervention arm)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Stop glucocorticoid treatment; administer placebo matching the verum preparation in weekly intervals.', 'interventionNames': ['Other: Placebo Arm']}\n- {'label': 'Verum group (control/standard arm)', 'type': 'ACTIVE_COMPARATOR', 'description': 'If patient is on \\\\> 7.5 mg prednisone-equivalent daily: administer 7.5 mg q.d. for 7 days, then 5 mg q.d. for 7 days, then 2.5 mg q.d. for 7 days, then 2.5 mg q.d. every second day, then stop. If patient on 7.5 mg q.d.: maintain for 7 days, then taper as above.', 'interventionNames': ['Drug: Prednisone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Prednisone', 'description': 'The control intervention (standard treatment) consists of prednisone treatment in decreasing doses, starting with 7.5 mg q.d. and reducing the dose every 7 days, such that prednisone treatment is stopped after a total of 4 weeks.', 'armGroupLabels': ['Verum group (control/standard arm)']}\n- {'type': 'OTHER', 'name': 'Placebo Arm', 'description': 'The experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.', 'armGroupLabels': ['Placebo arm (intervention arm)']}\n\nPrimary Outcomes:\n- {'measure': 'Time to any incidence', 'description': 'Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia \\\\[serum sodium \\\\< 135 millimole (mM)\\\\], hyperkalemia \\\\[serum potassium \\\\> 5 mM\\\\], hypoglycemia \\\\[plasma glucose \\\\< 3.5 mM\\\\]); whichever occurs first.', 'timeFrame': 'up to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nPatients are randomized in a 1:1 ratio. All patients are followed for 6 months, with a 10% dropout rate. The significance level is 5%. The power is estimated to be 80%.", "answer": 573, "answer_type": "ESTIMATED", "explanation": "Sample size\n To assess the primary outcome measure, a Cox proportional hazards regression model will be fitted to the data. Noninferiority will be concluded if the two-sided 95% confidence interval of the hazard ratio between the experimental and the control arm lies entirely below the critical hazard ratio defined as\n\nHR=\u00ce\u00bbe\u00ce\u00bbe=\u00e2\u0088\u0092log(\u00cf\u0080et)t\u00e2\u0088\u0092log(\u00cf\u0080ct)t=\u00e2\u0088\u0092log(\u00cf\u0080et)\u00e2\u0088\u0092log(\u00cf\u0080ct)=\u00e2\u0088\u0092log(\u00cf\u0080ct\u00e2\u0088\u0092m)\u00e2\u0088\u0092log(\u00cf\u0080ct)\n\nwhere \u00ce\u00bbe and \u00ce\u00bbc are the hazard rates in the experimental and control arms, t is a fixed point of time, \u00cf\u0080et and \u00cf\u0080ct are the proportions of event-free patients at time t, and m is the noninferiority margin expressed as the additional proportion of patients having had an event in the experimental arm, assuming that the occurrence of events follows an exponential distribution. Noninferiority will be concluded if the upper limit of the two-sided 95% confidence interval of the hazard ratio lies below the critical hazard ratio.\n For the sample size estimation, the following assumptions were made:\n \n \n Patients are randomized to the control and experimental arms in a 1:1 ratio.\n \n \n After inclusion, all patients are followed for 6 months. Patients without an event within 6 months are considered right-censored and are not followed any further even though the trial might be ongoing.\n \n \n 10% of patients will drop out within the 6 months follow-up period. The drop-out events are distributed uniformly over this period.\n \n \n The event rate within the 6 months follow-up period, i.e., the proportion of patients with an event, is 40%, both for the control and the experimental arms. We estimated this overall figure based on expected relapse rates for the various eligible diseases, as indicated by clinical experts and published data, e.g. in COPD or inflammatory bowel disease. Our estimation is conservative since the other components of the combined primary outcome will contribute to the event rate.\n \n \n The survival curves in the control and experimental arms follow the same exponential distribution. The rate parameter of the exponential distribution is chosen so that the corresponding cumulative distribution function value at 6 months equals the assumed event rate.\n \n \n The noninferiority margin is defined as an absolute increase of the event rate by 13% over 6 months. We used a modified Delphi approach to determine this margin. 10 experienced clinicians board-certified in internal medicine and/or rheumatology, gastroenterology, and endocrinology were individually asked to define the maximum increase in outcome events they would accept for the benefit of rapid glucocorticoid stop and gain of high-quality scientific data in the area of steroid withdrawal. Assuming an event rate of 40% in the standard treatment arm, the mean tolerable increase under experimental treatment was 13.6% (range, 5 to 20%; median, 13%).\n \n \n The significance level is 5%.\n \n \n For each combination of the noninferiority margins 7.5%, 7.6%, \u00e2\u0080\u00a6, 17.5%, and the sample sizes n = 200, 210, \u00e2\u0080\u00a6, 1200, 999 individual data sets were simulated based on the above assumptions. A Cox proportional hazards regression model was fitted to each data set, and the hazard ratios for the experimental vs. the control arm with the associated 95% confidence interval were estimated. Noninferiority was concluded if the upper limit of the two-sided 95% confidence interval of the hazard ratio was below the critical hazard ratio (see above equation). The power was estimated as the proportion of positive conclusions divided by the total number of the 999 iterations per parameter combination. To achieve a power of 80%, 573 patients (95% CI, 565 to 580) need to be included, assuming an event rate of 40% over the 6 months follow-up period and setting the noninferiority margin to 13%. The critical hazard ratio for this noninferiority scenario is 1.478.\n The sample size of n = 573 is a conservative estimation, since the assumed drop-out rate of 10% is relatively high.", "id": 144, "split": "train"} +{"trial_id": "NCT03154138", "pmid": "34819284", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessment of the Rehabilitation of Postural Imbalance After Chronic Right Supratensorial Stroke by Prismatic Adaptation: Multicentric Randomised Sham-controlled Trial\n\nIncluded conditions:\n- Chronic Right Supratensorial Stroke Patients\n\nStudy Armgroups:\n- {'label': 'Prismatic adaptation (PA) group', 'type': 'EXPERIMENTAL', 'description': 'Patients in the experimental group will benefit from 10 sessions of adaptation prismatic (PA) by means of one daily session of 20 minutes (5 times by week; 2 weeks), performed by an experienced physical therapist or occupational therapist. All patients will also benefit from conventional rehabilitation (Standard physical therapy, standard occupational therapy, standard speech therapy ...) according to the needs of the patients.', 'interventionNames': ['Device: The prismatic adaptation (PA)']}\n- {'label': 'Sham group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients in the sham group will benefit from 10 sessions of sham adaptation prismatic (S-PA) by means of one daily session of 20 minutes (5 times by week; 2 weeks), performed by an experienced physical therapist or occupational therapist. All patients will also benefit from conventional rehabilitation (Standard physical therapy, standard occupational therapy, standard speech therapy ...) according to the needs of the patients.', 'interventionNames': ['Device: The sham prismatic adaptation (S-PA)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'The prismatic adaptation (PA)', 'description': 'Prismatic adaptation (PA) is based on the wearing of a pair of glasses producing a visual field deviation of 10\u00b0 to rightward. While wearing theses glasses, the patient is asked to perform fast pointing movements towards targets by the right hand. Targets are symmetrical located at 10\u00b0 in the right and left side in front of the patient. The order of pointing between these two targets is pseudo-randomly by the therapist. At the beginning of the exposure, the patient performs pointing movements with a shift toward the right side (initial errors consecutive to the prism deviation). Taking into account theses errors, the patient then compensates the optical deviation. After removing the prismatic glasses, the asked pointing movement to the targets is once again shifted but to the left side this time (after-effects attesting the prismatic adaptation)', 'armGroupLabels': ['Prismatic adaptation (PA) group']}\n- {'type': 'DEVICE', 'name': 'The sham prismatic adaptation (S-PA)', 'description': 'The sham prismatic adaptation (S-PA) is based on the wearing of a pair of glasses producing no visual field deviation. Theses sham glasses is identical with theses used in PA group without the optical deviation. The conditions are similar with theses in the PA group.\\n\\nThe procedure with the sham glasses are similar with these one used in the PA group: While wearing the sham glasses, the patient is asked to perform fast pointing movements towards targets by the right hand. Targets are symmetrical located at 10\u00b0 in the right and left side in front of the patient. The support with targets are the same as these one used in the PA group. The order of pointing between these two targets is pseudo-randomly by the therapist. At the beginning of the exposure, the patient performs pointing movements without shift. No compensation of movement is observed. After removing the prismatic glasses, the asked pointing movement to the targets is not shifted (No after-effects observed)', 'armGroupLabels': ['Sham group']}\n\nPrimary Outcomes:\n- {'measure': 'Balance: The inter-group difference of within-group changes for the Berg Balance Scale (BBS)', 'description': 'Balance : The inter-group difference of within-group changes for the Berg Balance Scale (BBS) Score between 0 and 56 points', 'timeFrame': 'Change from baseline (mean of the 2 pre-tests) at 7 days after the end of treatment (3 weeks about after the baseline)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, statistical power of 95%, bilateral test, and consideration of potential lost to follow-up or dropping out.", "answer": 28, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to the pilot study,62 we could postulate a within-group difference at D+7 of 4.83 points on BBS for the experimental group and of 2 points for the control group, with a pooled SD of change of 2. To our best knowledge, in patients after stroke at chronic stage, the minimal clinically important difference for BBS was never assessed while the minimal detectable change was estimated between 2.5 and 4.7 points.83\u00e2\u0080\u009386 On the basis of these hypotheses, considering alpha risk of 0.05, a statistical power of 95%, and a bilateral test, we have to include 13 participants per group. To take into account potential lost to follow-up or dropping out before the primary outcome, one additional participant by group could be included. We could therefore include 28 participants.", "id": 145, "split": "train"} +{"trial_id": "NCT03158610", "pmid": "32143730", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Biological-guided Metronomic Chemotherapy as Maintenance Strategy in Responders After Induction Therapy in Metastatic Colorectal Cancer\n\nIncluded conditions:\n- Colorectal Cancer\n\nStudy Armgroups:\n- {'label': 'Capecitabine metronomic chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'Capecitabine 500mg/m2 bid po qd', 'interventionNames': ['Drug: Capecitabine']}\n- {'label': 'Capecitabine standard dosage chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Capecitabine 1000mg/m2 bid po d1-d14,q3w', 'interventionNames': ['Drug: Capecitabine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Capecitabine', 'description': 'Oral fluorouracil', 'armGroupLabels': ['Capecitabine metronomic chemotherapy', 'Capecitabine standard dosage chemotherapy'], 'otherNames': ['Xeloda']}\n\nPrimary Outcomes:\n- {'measure': 'Progression Free Survival 1 (PFS1)', 'description': 'from enrollment to progression', 'timeFrame': '10 months'}\n- {'measure': 'Progression Free Survival 2 (PFS2)', 'description': 'from randomization to progression', 'timeFrame': '4 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a dropout rate of 20%, 80% power, and a one-sided significance level (\u00ce\u00b1) of 0.025.", "answer": 20, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n This project is a non-inferiority study. The patients are allocated to the capecitabine metronomic chemotherapy group (experimental group) and the capecitabine conventional chemotherapy group (control group) in a ratio of 1:1. The non-inferiority boundary in PFS was defined at 1.40 in reference to the results of the trial reported by Luo et al. [19]. The HR for the capecitabine maintenance group versus the observation group in the trial was 0.54 and the reciprocal was 1.85, which leads to 1.43 as 50% survival benefit. So, the boundary of 1.4 was used in this study. Considering a dropout rate of 20%, we estimated that 386 patients (193 in each group) would be needed to achieve 80% power at a one-sided value of \u00ce\u00b1 = 0.025 (significance level).", "id": 146, "split": "train"} +{"trial_id": "NCT03160378", "pmid": "34715906", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Organizational Skills Training for Children With ADHD\n\nIncluded conditions:\n- ADHD\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The participants in the intervention group will receive treatment as usual + 10 sessions of organizational skills training', 'interventionNames': ['Behavioral: Organizational skills training', 'Other: Treatment as usual']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'Control participants will receive treatment as usual.', 'interventionNames': ['Other: Treatment as usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Organizational skills training', 'description': '10 sessions of parent and child training in a group format.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Treatment as usual', 'description': 'Treatment as usual in the outpatient clinic', 'armGroupLabels': ['Control', 'Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Children Organizational Skills Scale (COSS)-parent', 'description': 'organizational skills questionnaire', 'timeFrame': 'after 10 weeks of intervention'}\n\nPlease estimate the sample size based on the assumption: \n90% power and 5% significance level for primary outcome; 80% power and 5% significance level for secondary outcomes; 10% expected dropout rate.", "answer": 142, "answer_type": "ESTIMATED", "explanation": "Sample size\n We are conducting a randomized controlled trial using the continuous response variable COSS-total parent rating from independent control and experimental participants allocated at a 1:1 ratio. The primary outcome measure COSS has been tested in previous trials [30, 31].\n Using data from Pfiffner and colleagues [31], we conducted a sample size calculation based on the COSS total score by parent rating as primary outcome. Based on a minimal relevant difference of 0.30 and a standard deviation of 0.36, it requires 32 participants in each group to reach 90% power with 5% significance level. Furthermore, to have sufficient power to analyze secondary outcomes with standardized effect size 0.5 SD, the required sample size was doubled to n = 64 in each group, resulting in 80% power for the secondary outcomes using 5% significance level. Finally, to account for an expected dropout of 10% during the study period, the required sample size was increased to 71 in each group (total sample size n = 142).", "id": 147, "split": "train"} +{"trial_id": "NCT03162289", "pmid": "33059765", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers - a Randomized, Controlled, Two-armed Intervention Study\n\nIncluded conditions:\n- Breast Cancer\n- Ovarian Cancer\n\nStudy Armgroups:\n- {'label': 'Fasting', 'type': 'ACTIVE_COMPARATOR', 'description': '60-72 h-modified fasting (36-48 h before and 24 h after chemotherapy)', 'interventionNames': ['Other: Fasting']}\n- {'label': 'Vegan', 'type': 'ACTIVE_COMPARATOR', 'description': '60-72 h-vegan diet (36-48 h before and 24 h after chemotherapy)', 'interventionNames': ['Other: Vegan']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Fasting', 'description': 'Patients follow a modified fasting regime of 60-72 h (36-48 h before and 24 h after CT) with a dietary energy supply of 350-400kcal per day with vegetable juices during the first four cycles of CT. During the rest of the CT cycles they will observe two days of caloric restriction (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed and the patients are encouraged to follow a pattern of time restricted feeding with 14 h fasting over night at least for six days a week. The patients will receive an individual nutrition training by trained nutritionists.', 'armGroupLabels': ['Fasting']}\n- {'type': 'OTHER', 'name': 'Vegan', 'description': 'Patients follow a 60-72 h vegan diet with sugar restriction (36-48 h before and 24 h after CT) during the first four cycles of CT. During the rest of the CT cycles they will observe two days of vegan and sugar-restricted diet (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed. The patients will receive an individual nutrition training by trained nutritionists.', 'armGroupLabels': ['Vegan']}\n\nPrimary Outcomes:\n- {'measure': 'FACT-G', 'description': 'Summarized change of FACT-G score', 'timeFrame': 'Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 0.05, the power is 80%, and a 10% dropout rate is assumed. The minimal important differences (MIDs) are over 3-7 (mean 5) for FACT-G\u00a9, over 3-4 for the fatigue subscale, and 6 for total FACT-F. Normality will be tested with the Shapiro-Wilks test. Various statistical adjustments will be applied, including change score analysis, analysis of covariance, logistic regression, and Mantel-Haenszel test. Statistical analysis will be performed using R version 3.5.1 and IBM SPSS Statistics version 26.0.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Data analysis (sample size and statistical analysis)\n The sample size was calculated using a 2-sided Wilcoxon-Mann-Whitney test. The sample size with a fasting group of 67 patients and a plant-based group of 67 patients reaches a power of 80% at a significance level of p\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 to detect an effect size of 0.5 for FACT-G\u00c2\u00a9 between these two groups. If an additional 10% dropout rate is assumed, we need a minimum of 148 patients. With a ratio of 4:1 between breast cancer and ovarian cancer patients, we need a total of 150 patients (120 breast cancer and 30 ovarian cancer patients), divided into 75 patients each (60 breast cancer and 15 ovarian cancer patients) for the STF group and the plant-based group. All FACIT\u00c2\u00a9 scales are designed with a higher score indicating better well-being. Accordingly, we reversed response scores on negatively phrased questions. The scores will be obtained in accordance with the formula that was previously established by the FACIT\u00c2\u00a9 system. In cases where individual questions are skipped, scores will be prorated using the average of the other answers in the subscale (prorated subscale score\u00e2\u0080\u0089=\u00e2\u0080\u0089[sum of the item scores]\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089[N of items in subscale]/[N of items answered]) as long as more than 50% of the items are answered (minimum of 4 items for the subscales). The FACT-G score is considered appropriate as long as at least 22 of 27 FACT-G items are completed (\u00e2\u0089\u00a5\u00e2\u0080\u008980%). Inter-subscale correlations will be computed using Pearson correlation, and the reliability of the internal consistency for all scales will be assessed by computing Cronbach\u00e2\u0080\u0099s alpha. When Cronbach\u00e2\u0080\u0099s alpha exceeded 0.90, the scale is considered to have sufficient precision for individual classification or diagnosis. The minimal important differences (MIDs) of STF and plant-based groups, i.e., the \u00e2\u0080\u009csmallest change in the score that patients perceive as important, either beneficial or harmful, and that would lead the clinician to consider a change in the patient\u00e2\u0080\u0099s management\u00e2\u0080\u009d will be used to find clinically meaningful improvements [54]. MID values over 3\u00e2\u0080\u00937 (mean 5) for FACT-G\u00c2\u00a9 and over 3\u00e2\u0080\u00934 for the fatigue subscale and 6 for total FACT-F will be considered significant. Normality will be tested with the Shapiro-Wilks test. Furthermore, various methods for adjustment at the statistical analysis stage will be applied. We will use \u00e2\u0080\u009cchange score analysis\u00e2\u0080\u009d that determines group effect, based on the difference between the baseline and the post-treatment score (basic adjustment) and analysis of covariance. This is a model-based adjustment that includes the baseline of the outcome variable in the model. Statistical adjustment can also be performed by the use of logistic regression or by pooling the stratified analyses, using, for example, a Mantel-Haenszel test. We will simultaneously use these various design methods that reduce covariate imbalance and statistical adjustment during analysis. Statistical analysis will be performed using R version 3.5.1 (R Foundation) and IBM SPSS Statistics, version 26.0 (IBM Corp., Armonk, NY, USA).", "id": 148, "split": "train"} +{"trial_id": "NCT03162653", "pmid": "31248390", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of ALlopurinol in Addition to Hypothermia for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome - a Blinded Randomized Placebo-controlled Parallel Group Multicenter Trial for Superiority (Phase III)\n\nIncluded conditions:\n- Encephalopathy, Hypoxic-Ischemic\n- Infant, Newborn, Diseases\n\nStudy Armgroups:\n- {'label': 'Allopurinol', 'type': 'ACTIVE_COMPARATOR', 'description': 'Allopurinol, powder for injection (PFI), administered in two doses. First dose (20 mg/kg in 2ml/kg sterile water for injection) given as soon as intravenous access is established and no later than 30min postnatally and second dose (10mg/kg in 1ml/kg sterile water for injection) 12 hours thereafter. The second dose will only be administered to in infants on therapeutic hypothermia. Infants who recover quickly and do not qualify for and hence do not undergo hypothermia will not receive a second dose. Administration will be by continuous infusion using a syringe pump over 10min through secure venous access.', 'interventionNames': ['Drug: Allopurinol']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'mannitol, powder for injection (PFI), administered in two doses. First dose (20 mg/kg in 2ml/kg sterile water for injection) given as soon as intravenous access is established and no later than 30min postnatally and second dose (10mg/kg in 1ml/kg sterile water for injection) 12 hours thereafter. The second dose will only be administered to in infants on therapeutic hypothermia. Infants who recover quickly and do not qualify for and hence do not undergo hypothermia will not receive a second dose. Administration will be by continuous infusion using a syringe pump over 10min through secure venous access.', 'interventionNames': ['Drug: Mannitol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Allopurinol', 'description': 'Allopurinol, powder for injection (PFI), administered in two doses. First dose (20 mg/kg in 2ml/kg sterile water for injection) given as soon as intravenous access is established and no later than 30min postnatally and second dose (10mg/kg in 1ml/kg sterile water for injection) 12 hours thereafter. The second dose will only be administered to in infants on therapeutic hypothermia. Infants who recover quickly and do not qualify for and hence do not undergo hypothermia will not receive a second dose. Administration will be by continuous infusion using a syringe pump over 10min through secure venous access.', 'armGroupLabels': ['Allopurinol']}\n- {'type': 'DRUG', 'name': 'Mannitol', 'description': 'Placebo (Mannitol, PFI, 20mg/kg in the same volume and at the same time intervals as the intervention group - (2nd dose 10mg/kg only if infant undergoes therapeutic hypothermia)).', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'death versus severe neurodevelopmental impairment versus survival without severe neurodevelopmental impairment', 'description': 'Where severe neurodevelopmental impairment is defined as any of the following: cognitive or language delay defined as a cognitive-composite-score or a language-composite-score on the Bayley Scales of Infant and Toddler Development (3rd edition) \\\\< 85 and/or cerebral palsy (CP) according to SCPE criteria \\\\[SCPE Dev Med Child Neurol 2000\\\\]. In case of missing Bayley III test results, Bayley II or other developmental test results or PARCA-R parent questionnaire results may substitute for the Bayley III test result in a predefined hierarchical order.\\n\\nPrimary endpoint with three mutually exclusive responses (healthy, death, composite outcome for impairment) will be analyzed in the two treatment groups by a generalized logits model according to Bishop, Fienberg, Holland 1975 with SAS 9.4 procedure proc catmod.', 'timeFrame': 'at the age of 24 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided X2-test with alpha = 0.05 and power of 80% was used. A drop-out rate of 10% for loss to follow-up and an additional 10% refusal rate after the initial dose were assumed.", "answer": 760, "answer_type": "ESTIMATED", "explanation": "Sample size, power and study duration\n The primary assessment for efficacy will compare the proportions of infants surviving without severe NDI versus those of infants who died or survived with severe NDI at the age of two years.\n Based on the above referenced (preliminary) clinical studies from the pre-therapeutic hypothermia era and clinical studies on hypothermic treatment, it is estimated that the combined incidence of death and severe NDI in the control group will be 37 and 27% in the allopurinol group. Therefore, we calculated with a two-sided X2-test (alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, power 80%) a sample size of 682 infants (341 per treatment group) in which the primary outcome should be ascertained. Assuming a drop-out rate of 10% for loss to follow-up, a total of 760 infants need to be enrolled. And assuming that 10% of the parents will refuse participation after the initial dose of the study drug, 846 infants have to be randomized (see Fig. 2).Fig. 2Anticipated Trial Flow\n We estimate a recruitment of about 35 patients per month in approximately 70 study centers (the recruitment of additional study sites is ongoing) and therefore recruitment will last 24\u00e2\u0080\u0089months.", "id": 149, "split": "train"} +{"trial_id": "NCT03163979", "pmid": "30075736", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Individualized Precise Radiotherapy With the Guidance of Radiosensitivity: A Study on the Clinical Management Model of Locally Advanced Cervical Cancer\n\nIncluded conditions:\n- Cervical Cancer\n\nStudy Armgroups:\n- {'label': 'PET/CT and Comet assay guided IMRT', 'type': 'ACTIVE_COMPARATOR', 'description': '18F-FDG PET/CT and Comet assay guide IMRT Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.', 'interventionNames': ['Biological: 18F-FDG PET/CT and Comet assay guide IMRT']}\n- {'label': 'PET/CT and Comet assay guided RapidArc', 'type': 'ACTIVE_COMPARATOR', 'description': '18F-FDG PET/CT and Comet assay guide RapidArc:\\n\\n1.A Rapid-Arc plan for cancer of the cervix uteri improved the sparing of organs at risk (OARs) with uncompromised target coverage. 2.Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.', 'interventionNames': ['Biological: 18F-FDG PET/CT and Comet assay guide RapidArc']}\n- {'label': 'RapidArc', 'type': 'ACTIVE_COMPARATOR', 'description': 'RapidArc:\\n\\nA maximum DR of 600 MU/min was set for comparing the 7f-IMRT treatment time. Two 360\u00b0 coplanar arcs (one clockwise arc rotated from 181\u00b0 to 179\u00b0 and the other counter-clockwise arc rotated from 179\u00b0 to 181\u00b0) sharing the same isocentre were used.', 'interventionNames': ['Biological: RapidArc']}\n- {'label': '7f-IMRT', 'type': 'SHAM_COMPARATOR', 'description': 'seventy-five patients received IMRT. The 7f-IMRT gantry angles were 0\u00b0, 51\u00b0, 102\u00b0, 153\u00b0, 204\u00b0, 255\u00b0 and 306\u00b0, with 20 intensity levels and a dose rate of 400 monitor units (MU)/min. Doses were delivered using the step-and-shoot method.Conventional fractionation was used in all patients for a total dose 45-50.4 Gy with 6 MV high-energy photons.', 'interventionNames': ['Biological: 7f-IMRT']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': '18F-FDG PET/CT and Comet assay guide RapidArc', 'description': '1.A Rapid-Arc plan for cancer of the cervix uteri improved the sparing of organs at risk (OARs) with uncompromised target coverage. 2.Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.', 'armGroupLabels': ['PET/CT and Comet assay guided RapidArc']}\n- {'type': 'BIOLOGICAL', 'name': '18F-FDG PET/CT and Comet assay guide IMRT', 'description': 'Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.', 'armGroupLabels': ['PET/CT and Comet assay guided IMRT']}\n- {'type': 'BIOLOGICAL', 'name': 'RapidArc', 'description': 'RapidArc:\\n\\nA maximum DR of 600 MU/min was set for comparing the 7f-IMRT treatment time. Two 360\u00b0 coplanar arcs (one clockwise arc rotated from 181\u00b0 to 179\u00b0 and the other counter-clockwise arc rotated from 179\u00b0 to 181\u00b0) sharing the same isocentre were used.', 'armGroupLabels': ['RapidArc']}\n- {'type': 'BIOLOGICAL', 'name': '7f-IMRT', 'description': 'seventy-five patients received IMRT. The 7f-IMRT gantry angles were 0\u00b0, 51\u00b0, 102\u00b0, 153\u00b0, 204\u00b0, 255\u00b0 and 306\u00b0, with 20 intensity levels and a dose rate of 400 monitor units (MU)/min. Doses were delivered using the step-and-shoot method.Conventional fractionation was used in all patients for a total dose 45-50.4 Gy with 6 MV high-energy photons.', 'armGroupLabels': ['7f-IMRT']}\n\nPrimary Outcomes:\n- {'measure': 'PFS', 'description': 'Progression-Free-Survival', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Study sample size and grouping method\n A total of 300 patients will be enrolled in the study. Due to the sample size, a block randomization procedure with randomly chosen block sizes is being used to assign participants to each group (1:1 ratio), resulting in one intervention and one control group. This method helps to maintain the balance of treatment assignment while reducing the potential for selection bias. Randomization is performed with random number generator of SPSS 20.0 software.", "id": 150, "split": "train"} +{"trial_id": "NCT03164317", "pmid": "30086778", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Cluster Randomised Controlled Trial of M-health Enabled, Nurse Care Coordinator Led Intervention to Improve Management of Hypertension in India: m-Power Heart Project\n\nIncluded conditions:\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Trained NCC together with electronic decision support system', 'interventionNames': ['Other: Intervention']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'No trained NCC and electronic decision support system', 'interventionNames': ['Other: Control']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Intervention', 'description': 'A trained nurse care coordinator enabled with a electronic decision support system placed at the CHCs to share the task of management of hypertension.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Control', 'description': 'No NCC or EDSS will be placed in the CHCs. Doctors working in the CHCs will be given training (one day) on evidence based management of hypertension', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in the mean systolic blood pressure', 'description': 'Difference in the mean systolic blood pressure between the intervention and control arm at the end of the intervention', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nsignificance at 5%, power of 80%, attrition rate of 20%", "answer": 1872, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size has been calculated based on the following \u00e2\u0080\u0093 significance at 5%, power of 80%, mean difference in SBP of 6.5\u00c2\u00a0mmHg between the intervention and standard treatment arms, standard deviation (SD) of SBP of 17, intracluster coefficient of 0.03 (estimated from the baseline study of a comprehensive diabetes and hypertension prevention and management program entitled UDAY in Visakhapatnam) and attrition rate of 20%. The sample size will be 936 participants from six CHCs in each arm, which totals to 1872 from 12 CHCs.", "id": 151, "split": "train"} +{"trial_id": "NCT03172377", "pmid": "32461297", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients\n\nIncluded conditions:\n- Crohn Disease in Remission\n- Crohn Disease\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Lengthening adalimumab dosing interval: The adalimumab injection interval during maintenance therapy (40 mg sc / 2 weeks) will be extended through a stepwise disease activity guided manner to 3 weeks and subsequently - after 24 weeks - to 4 weeks. If a step-down leads to recurrence of disease activity patients will return to the preceding effective dosing interval.', 'interventionNames': ['Other: Lengthening adalimumab dosing interval']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Standard care: patients will continue adalimumab maintenance treatment of 40mg per 2 weeks. Treatment decisions are made at the discretion of the treating physician.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Lengthening adalimumab dosing interval', 'description': 'Lengthening adalimumab dosing interval from 2 weeks to 3 weeks and -later- to 4 weeks.', 'armGroupLabels': ['Intervention group'], 'otherNames': ['Lengthening Humira dosing interval', 'Longer adalimumab interval', 'Longer Humira interval', 'Adalimumab dose reduction', 'Humira dose reduction']}\n\nPrimary Outcomes:\n- {'measure': 'Cumulative incidence of persistent disease flares.', 'description': 'A persistent flare is defined as two of three of the following criteria persisting for \\\\> 8 weeks, despite dose escalation of adalimumab; FC \\\\>250 \u00b5g/g, CRP\u226510 mg/L, HBI \u22655. Non-inferiority is reached if the difference in cumulative incidence of persistent flares not exceeds the non-inferiority margin of 15%.', 'timeFrame': 'From the date of randomization up to week 48.'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided testing is used with an alpha of 0.05 (Z\u03b1=1.64), power 1-beta 0.8 (Z\u03b2=0.84), and a randomisation ratio of 2:1 intervention versus control. A 10% drop-out rate is also accounted for.", "answer": 174, "answer_type": "ESTIMATED", "explanation": "Sample size\n The null hypothesis in non-inferiority studies is that the intervention is inferior compared with the control arm by more than the non-inferiority margin. The alternative hypothesis is that the intervention is not worse than the control by more than the non-inferiority margin. Therefore, if the null hypothesis is rejected, the alternative hypothesis that the intervention is non-inferior is accepted.34 Based on an extrapolation of data from the DRESS study and results from a real-life CD cohort in Leuven, an estimated 15% of patients will experience the primary outcome (persistent flare) in the control arm. In the Leuven cohort, 41/156 (26%) patients discontinued adalimumab due to loss of response, despite adalimumab dose escalation.21 35 The latter 26% was adjusted to an expected 15% for our cohort because the follow-up time in our cohort concerns 12 rather than 20 months, and our cohort is a preselected cohort of patients in long and stable remission rather than a cross-sectional cohort. In non-inferiority analyses, one-sided testing is used. Applying one sided testing, an alpha of 0.05 (Z\u00ce\u00b1=1.64), power 1-beta 0.8 (Z\u00ce\u00b2=0.84), a non-inferiority margin of 15% and randomisation ratio of 2:1 intervention versus control resulted in n=105\u00e2\u0080\u0089and n=53 for intervention and control arm, respectively. Accounting for a 10% drop-out, 174 patients have to be included in total.\n A non-inferiority margin of 15% means a maximum difference in persistent flare of 15% between the usual care and intervention group. We believe this strikes an acceptable balance between the potential harms of flare, and the benefits of dose reduction (fewer injections, potential for reduced risk of side effects and cost-savings). The large Nor-Switch trial also used a non-inferiority margin of 15% for disease worsening during follow-up.36 Based on this example, discussions in our study-group and approval of the protocol by the Dutch Organisation for Health Research and Development, we believe this margin is appropriate. The DRESS study used a non-inferiority margin of 20%. Although side effects/SAEs of adalimumab seem comparable in RA versus IBD, rheumatologists probably accept a higher proportion of flares because there are more alternative biological therapies available, thus a loss of effect of one biological therapy might be given less weight in RA.6", "id": 152, "split": "train"} +{"trial_id": "NCT03175328", "pmid": "33608398", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Timing of Continuous Renal Replacement Therapy Initiation in Sepsis-associated Acute Kidney Injury in the Intensive Care Unit\n\nIncluded conditions:\n- Sepsis-Associated Organ Dysfunction\n- RTT\n\nStudy Armgroups:\n- {'label': 'early group', 'type': 'EXPERIMENTAL', 'description': 'In the early group, continuous renal replacement therapies was started within 8 hours after randomization.', 'interventionNames': ['Procedure: continuous renal replacement therapies']}\n- {'label': 'delayed group', 'type': 'EXPERIMENTAL', 'description': 'In the delayed group, continuous renal replacement therapies was initiated if at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter after randomization.', 'interventionNames': ['Procedure: continuous renal replacement therapies']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'continuous renal replacement therapies', 'description': 'The choice of the method of continuous renal replacement therapy (device setting and anticoagulation method) is left to the discretion of each study site and was prescribed and monitored according to national guidelines.', 'armGroupLabels': ['delayed group', 'early group']}\n\nPrimary Outcomes:\n- {'measure': 'overall mortality', 'description': 'overall survival measured from randomization to death or day 90', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nDifferences between the two groups will be detected with a power of 85% at a bilateral \u03b1 risk of 0.05. The rate of non-evaluable cases is expected to be 15%.", "answer": 460, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary end point in this study is to compare the effect of early and delayed CRRT strategy on overall survival at day 90 in patients with SAKI. Our primary hypothesis is that the early CRRT strategy might beneficial to patients with SAKI. According to the IDEAL-ICU Study, the expected mortality of patients with SAKI in the delayed group may be estimated around 55%. Considering that the timing setting of CRRT in this study is similar to the ELAIN Study, a reduction in mortality of 15% in the early group (55% mortality in the delayed CRRT group vs 40% in the early CRRT group) can be expected. Differences between two groups will be detected with a power of 85% at a bilateral \u00ce\u00b1 risk of 0.05. Considering that in China, some patients will give up treatment and request discharge from hospital due to economic reasons or customs, the rate of non-evaluable cases is expected to be 15% for the worst. Hence, a total of 460 patients (230 per group) is required. Power calculations were performed using the Power Analysis & Sample Size (PASS) V.14.0 software.", "id": 153, "split": "train"} +{"trial_id": "NCT03181360", "pmid": "33446083", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST). A Randomised-controlled Trial of Thrombolytic Treatment With Tenecteplase for Acute Ischaemic Stroke Upon Awakening\n\nIncluded conditions:\n- Ischemic Stroke\n- Stroke, Acute\n\nStudy Armgroups:\n- {'label': 'Tenecteplase', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tenecteplase + Best standard treatment', 'interventionNames': ['Drug: Tenecteplase']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'No tenecteplase + Best standard treatment', 'interventionNames': ['Other: Control']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tenecteplase', 'description': 'Single dose intravenous injection of recombinant fibrin-specific tissue plasminogen activator (tenecteplase) 0.25 mg (200 IU) per kg body weight up to a maximum of 25 mg (5000 IU), given as a bolus over approx. 10 seconds.', 'armGroupLabels': ['Tenecteplase'], 'otherNames': ['Metalyse']}\n- {'type': 'OTHER', 'name': 'Control', 'description': 'Best standard treatment', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Functional outcome at 3 months.', 'description': 'Functional outcome will be assessed by the modified Rankin Scale (mRS), values 0-6', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-sided significance level of 5%", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n We assume a treatment effect of 10% absolute difference in a binary endpoint setting (mRS 0\u00e2\u0080\u00931 vs. mRS 2\u00e2\u0080\u00936) and a distribution between modified Rankin Scale categories similar to that of the WAKE-UP trial\n3\n with 42% with favourable outcome in the non-thrombolysed group versus 52% in the thrombolysed group, corresponding to an odds ratio of 1.50. Assuming an effect size specified as an odds ratio of 1.5 from an ordinal logistic regression model and similar distribution of mRS scores in the control group in six levels as in the WAKE-UP trial (categories 5 and 6 merged) of 15%, 27%, 23%, 17%, 13%, and 5%\n3\n, the estimated sample size of 600 patients yields a power of 80%, with a two-sided significance level of 5%.", "id": 154, "split": "train"} +{"trial_id": "NCT03183440", "pmid": "31005913", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter Clinical Trial To Assess The Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children.\n\nIncluded conditions:\n- Dermatitis, Atopic\n\nStudy Armgroups:\n- {'label': 'PREBIOTICS', 'type': 'EXPERIMENTAL', 'description': '188 pregnant women', 'interventionNames': ['Dietary Supplement: PREBIOTICS']}\n- {'label': 'PLACEBO', 'type': 'PLACEBO_COMPARATOR', 'description': '188 pregnant women', 'interventionNames': ['Other: PLACEBO']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'PREBIOTICS', 'description': 'women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery', 'armGroupLabels': ['PREBIOTICS']}\n- {'type': 'OTHER', 'name': 'PLACEBO', 'description': 'women will daily take placebo (maltodextrin) from inclusion to delivery', 'armGroupLabels': ['PLACEBO']}\n\nPrimary Outcomes:\n- {'measure': 'atopic dermatitis prevalence at M12', 'description': 'prevalence will be evaluated according to UK party working group criteria', 'timeFrame': 'at 12 months of age'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% alpha risk", "answer": 376, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to the literature, the risk of AD at 1\u00e2\u0080\u0089year in children at risk is estimated at 45%.24 We assume a 33% risk reduction for children whose mothers have been exposed to prebiotics, or a 30% risk of AD. With 80% power and 5% alpha risk, 326 participants are needed. To ensure statistical power, 376 participants (188 per group) will be randomised.", "id": 155, "split": "train"} +{"trial_id": "NCT03185000", "pmid": "39855667", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A First in Human Feasibility Study of T Regulatory Cells (TR004) for Inflammatory Bowel Disease Using (ex Vivo) Treg Expansion\n\nIncluded conditions:\n- Crohn Disease\n\nStudy Armgroups:\n- {'label': 'Immediate ATIMP (AP)', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive Treg immunotherapy (TR004) infusion at Week 0.', 'interventionNames': ['Drug: TR004 (Treg immunotherapy)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'TR004 (Treg immunotherapy)', 'description': 'Administered Intravenously (IV)', 'armGroupLabels': ['Immediate ATIMP (AP)'], 'otherNames': ['Autologous regulatory T cells (Tregs) expanded in vitro']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of dose-limiting toxicities (DLTs)', 'description': 'Pre-defined safety events occurring within 5 weeks post-infusion', 'timeFrame': 'One period will be assessed, from Week 0 to Week 5'}\n\nPlease estimate the sample size based on the assumption: \nThe study was initially planned for 24 subjects but was reduced to 4 due to funding changes. Additional patients will be recruited if withdrawals occur before or during the 5-week active period without experiencing a DLT.", "answer": 4, "answer_type": "ESTIMATED", "explanation": "Sample size\n A sample size of four participants will be recruited to assess the safety and tolerability of TR004 for further investigation in a larger clinical trial. The initial plan was to recruit 24 subjects but a change in funding because of the COVID-19 pandemic required a reduction in sample size and a change to a feasibility study. The sample size was a balance between the available funding and an ability to show feasibility of recruitment and the manufacturing process.\n In situations where a patient has to be withdrawn or decides to withdraw from the study, an additional patient will be recruited and dosed if:\n \n \n They withdraw prior to the start of their 5-week active period.\n \n \n They withdraw during their 5-week active period, and have not yet experienced a DLT.", "id": 156, "split": "train"} +{"trial_id": "NCT03186924", "pmid": "32051025", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Reducing Sedentary Time in Rheumatoid Arthritis: The Take a STAND for Health Study\n\nIncluded conditions:\n- Rheumatoid Arthritis\n\nStudy Armgroups:\n- {'label': 'Take a STAND for health', 'type': 'EXPERIMENTAL', 'description': 'A newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity', 'interventionNames': ['Behavioral: Take a STAND for health']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive all regular medical care and advice on healthy lifestyle, including the promotion of recommended physical activity levels and health nutrition.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Take a STAND for health', 'description': 'The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior', 'armGroupLabels': ['Take a STAND for health']}\n\nPrimary Outcomes:\n- {'measure': 'Sedentary behaviour as assessed by ActivPAL\u2122', 'timeFrame': '4 months'}\n\nPlease estimate the sample size based on the assumption: \n95% power, 5% significance level, and an estimated dropout rate of approximately 25%.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculations were performed using G-Power\u00c2\u00ae software, v. 3.1 (Universit\u00c3\u00a4t D\u00c3\u00bcsseldorf, D\u00c3\u00bcsseldorf, Germany), based on the study by Lewis et al. that reported the effects of reducing sedentary behavior in an elderly population (i.e., a reduction of 52\u00e2\u0080\u0089min in total sitting time) [33]. According to the estimation, 24 patients (12 per arm) are required to achieve 95% power (\u00ce\u00b1), with a significance level of 5% (\u00ce\u00b2), and assuming an effect size of 0.58 for the primary outcome (i.e., sedentary time). Estimating a dropout rate of ~\u00e2\u0080\u008925%, at least 30 patients will be recruited. Considering that this sample size could be underpowered for some secondary outcomes, we will try to increase this estimated sample based on the feasibilities of our laboratory (including funding, capacity of research staff and facilities, and available patients), in line with contemporary recommendations [34, 35].", "id": 157, "split": "train"} +{"trial_id": "NCT03188796", "pmid": "31722941", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients With Severe Vitamin D Deficiency: a Multicenter, Placebo-controlled Double-blind Phase III Randomized Controlled Trial (RCT)\n\nIncluded conditions:\n- Critical Illness\n- Vitamin D Deficiency\n- Covid19\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'oral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'High Dose Vitamin D3', 'type': 'EXPERIMENTAL', 'description': 'oral/enteral pharmacological dose of cholecalciferol (vitamin D3) - total dose 900,000\\n\\n* loading dose of 540,0000 (dissolved in 37.5 ml of medium chain triglycerides - MCT)\\n* followed by 4000 IU daily (10 drops) for the entire active study period (90 days)', 'interventionNames': ['Drug: Cholecalciferol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Cholecalciferol', 'description': 'oral/enteral loading dose of 37.5 ml MCT including 540,000 IU vitamin D3 followed by 10 drops daily (4000 IU) for 90 days', 'armGroupLabels': ['High Dose Vitamin D3'], 'otherNames': ['Vitamin D3']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'oral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': '28-day mortality', 'description': 'all-cause mortality', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a two-sided log-rank test with a significance level of 5% and a power of 80%. It also accounts for a 10% dropout rate and includes one interim analysis using an O'Brien-Fleming spending function.", "answer": 2400, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n The sample size for this multinational study is based on the primary endpoint 28-day mortality. In the VITdAL-ICU study, 28-day mortality rates of 36% (37/102) in the placebo group and 20% (20/98) in the vitamin D Group were observed.6 The VITDALIZE study has been designed to be sufficiently powered to detect a smaller, but clinically relevant absolute mortality difference of 5% with a power of 80% with an assumed baseline mortality rate of 25%. This corresponds to a clinically highly relevant relative risk reduction of 20%.\n Multicentre trials generally have a smaller treatment effect than monocentre studies.9 We assume that this will also be the case for the VITDALIZE study. Furthermore, our assumed 5% absolute mortality difference is in line with a recent survey among clinical intensivists that the largest median treatment effect considered plausible by intensivists for current ongoing ICU multicentre trials is 3%\u00e2\u0080\u00935%.10\n\n Using a fixed sample size design and a two-sided log-rank test for equality of survival curves with a two-sided alpha level of 5%, a sample size of n=1093 per group will be needed to achieve a power of 80% (total sample size of 2186).\n Incorporating one interim analysis after inclusion of 50% of the patients a total sample size of at least n=2194 (494 events) is required to achieve 80% power using an O\u00e2\u0080\u0099Brien-Fleming spending function.11 Accounting for a drop-out rate of approximately 10% yields a total sample size of n=2400 patients. For sample size calculation the software package nQuery 7.0+nTerim 2.0 was used.", "id": 158, "split": "train"} +{"trial_id": "NCT03190863", "pmid": "39433413", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Investigating the Effect of Motor Imagery With or With no Visual Neurofeedback on Grasping Capabilities After C6-C7 Tetraplegia: a Multicentric Randomized Controlled Trial.\n\nIncluded conditions:\n- Individuals With C6-C7 Tetraplegia (AIS A or B)\n\nStudy Armgroups:\n- {'label': 'Motor imagery combined with neurofeedback (MINF)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Motor imagery combined with neurofeedback (MINF)']}\n- {'label': 'Motor imagery (MI)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Behavioral: Motor imagery (MI)']}\n- {'label': 'Control (C)', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Behavioral: Control (C)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Motor imagery combined with neurofeedback (MINF)', 'description': '7 individuals with C6-C7 tetraplegia randomize in the experimental group consisting in motor imagery practice combined with visual neurofeedback (NF - i.e. performance of the imagined movement).\\n\\nIntervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions. After each imagined movement, the NF based on brain activity measured by electroencephalography is display on a screen.', 'armGroupLabels': ['Motor imagery combined with neurofeedback (MINF)']}\n- {'type': 'BEHAVIORAL', 'name': 'Motor imagery (MI)', 'description': '7 individuals with C6-C7 tetraplegia randomized in the active comparator group consisting in motor imagery practice alone without visual NF. This means that the performance of the imagined movement is not displayed to the participants.\\n\\nIntervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions.', 'armGroupLabels': ['Motor imagery (MI)']}\n- {'type': 'BEHAVIORAL', 'name': 'Control (C)', 'description': '7 individuals with C6-C7 tetraplegia randomized in the sham comparator group consisting in imagining geometric shapes by visualization. Shapes are successively displayed on a screen.\\n\\nIntervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions.', 'armGroupLabels': ['Control (C)']}\n\nPrimary Outcomes:\n- {'measure': 'Wrist extension angle in degree during grasping with 3D motion analysis system', 'description': 'Individuals with C6-C7 tetraplegia extend their wrist to grasp using tenodesis. Specifically, the wrist extension shortens the tendons of fingers and thumbs flexors that elicit either a palmar or a lateral grip. A complete reach-to-grasp movement will be recorded using a 3D motion analysis system (Vicon Motion Systems Ltd. UK). Wrist extension angle in degree will be measure during grasping when the object is grasped.', 'timeFrame': 'Up to 19 weeks'}\n\nPlease estimate the sample size based on the assumption: \nAlpha is set to 5% (0.05), the effect size is medium (f2=0.35), and the calculated power is 85%. No participants are expected to withdraw from the study.", "answer": 21, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Our sample size calculation is based on data from healthy participants collected during a similar MI intervention. Mateo et al13 reported that wrist extension angle in people with SCI was an average of 17.8\u00c2\u00b0 before MI tenodesis grasp training and increased up to an average of 26.9\u00c2\u00b0 after, thus representing a medium effect size.13 We expect this MI-related gain to increase by a further 10\u00c2\u00b0 in participants who receive MI training with neurofeedback. Based on these assumptions, we used the R software package \u00e2\u0080\u0098pwr\u00e2\u0080\u0099 and the associated function to compute the power for a general linear model \u00e2\u0080\u0098pwr.f2.test\u00e2\u0080\u0099.57 We considered an interaction between GROUP (three levels, ie, MI with neurofeedback, MI and control) and VISIT (three levels: baseline grouping visits 1, 2 and 3, visit 4 and visit 5), that is 3\u00c3\u00973 factorial design. We then computed the degrees of freedom (df) for the numerator (u = (3 \u00e2\u0080\u0093 1)*(3 \u00e2\u0080\u0093 1) = 4); considering n=7 participants in each of the 9 cells (GROUP * VISIT) of the design, a total N of 63, the denominator df was v=63\u00e2\u0080\u00939=54; with alpha set to 5% (a=0.05) and a medium effect size as previously reported13 (f2=0.35), the calculated power is 85%.57 This indicated that seven participants should be included in each group, thus requiring a total of 21 participants.58 Based on our experience of patient motivation to improve hand-arm function we do not expect any participants to withdraw from the study after giving their consent to participate.", "id": 159, "split": "train"} +{"trial_id": "NCT03192852", "pmid": "30181185", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of Bleaching In-office With Violet LEd Light (405 nm): Randomized, Controlled Double Blind and Clinical Trial\n\nIncluded conditions:\n- Esthetics, Dental\n\nStudy Armgroups:\n- {'label': 'Violet LED (405 nm)+ gel placebo', 'type': 'EXPERIMENTAL', 'description': '20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with Violet LED 405 nm (Bright Max Whitening, MMO, S\u00e3o Carlos, SP, Brazil) with gingival barrier + gel placebo', 'interventionNames': ['Other: dental bleaching']}\n- {'label': 'Violet LED + CP 35%', 'type': 'ACTIVE_COMPARATOR', 'description': '20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with carbamide peroxide 35% ( Whiteform - F\u00f3rmula \\\\& A\u00e7\u00e3o, S\u00e3o Paulo, Brazil) actived with Violet LED 405 nm (Bright Max Whitening, MMO, S\u00e3o Carlos, SP, Brazil) with gingival barrier', 'interventionNames': ['Other: dental bleaching']}\n- {'label': 'HP 35%', 'type': 'ACTIVE_COMPARATOR', 'description': '20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with hydrogen peroxide 35% (Whiteness HP, FGM, Joinvile, SC, Brasil) and gingival barrier', 'interventionNames': ['Other: dental bleaching']}\n- {'label': 'HP 35% + Violet LED + Gingivoplasty', 'type': 'EXPERIMENTAL', 'description': '20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with Violet LED 405 nm (Bright Max Whitening, MMO, S\u00e3o Carlos, SP, Brazil) with gingival barrier split-mouth at first session. After 48 hours will be do Gingivoplasty.', 'interventionNames': ['Other: dental bleaching', 'Procedure: Gingivoplasty']}\n- {'label': 'CP 35%', 'type': 'ACTIVE_COMPARATOR', 'description': '20 patients will be submitted to dental bleaching involving the teeth 15-25 and 45 - 35 with carbamide peroxide 35% ( Whiteform - F\u00f3rmula \\\\& A\u00e7\u00e3o, S\u00e3o Paulo, Brazil)', 'interventionNames': ['Other: dental bleaching']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'dental bleaching', 'description': 'dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel', 'armGroupLabels': ['CP 35%', 'HP 35%', 'HP 35% + Violet LED + Gingivoplasty', 'Violet LED (405 nm)+ gel placebo', 'Violet LED + CP 35%']}\n- {'type': 'PROCEDURE', 'name': 'Gingivoplasty', 'description': 'gengivoplasty will be realized to in illuminated tissue an no illuminated tissue to morphometrically evaluate the tissue', 'armGroupLabels': ['HP 35% + Violet LED + Gingivoplasty']}\n\nPrimary Outcomes:\n- {'measure': 'Color Evaluation', 'description': 'Color evaluation will be done before and after each bleaching session through the Vita Classical scale (VITA Zanhnfabrik, BadS\u04d3ckingrn, Germany) and SpectroShade \u2122 Micro MHT Optic Research by a previously trained and blind evaluator in the 4 groups', 'timeFrame': 'baseline'}\n- {'measure': 'Color Evaluation', 'description': 'Color evaluation will be done 3 months after bleaching through the Vita Classical scale (VITA Zanhnfabrik, BadS\u04d3ckingrn, Germany) and SpectroShade \u2122 Micro MHT Optic Research by a previously trained and blind evaluator in the 4 groups', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nConsidering a 5% acceptable rate of error and 95% test power. The protocol has repeated sessions (four sessions), and there is an expected dropout rate due to patients losing interest after achieving a pleasing tooth color.", "answer": 80, "answer_type": "ACTUAL", "explanation": "Calculation of sample size\n Using the G* Power software V.3.1.9.2, the sample size was calculated using analysis of covariance (ANCOVA) F tests with fixed effects, main effects and interactions, since the groups will begin the study with different colour tones, which will influence the final response of each patient.\u00c2\u00a0We based our sample size calculation on Bernardon et al study, which compares the mean\u00c2\u00b1SD of \u00ce\u0094E differences of four distinct groups.\n The effect size was determined using the following formula:\n \n \n \n \n \n d\n =\n \n \n l\n a\n r\n g\n e\n s\n t\n \u00e2\u0088\u0092\n s\n m\n a\n l\n l\n e\n s\n t\n \n \n \n (\n \n \u00cf\u0083\n \n n\n \n \n )\n \n \n 2\n \n \n \n =\n \n \n 10.82\n \u00e2\u0088\u0092\n 8.41\n \n \n \n (\n \n 3.62\n \n 4\n \n \n )\n \n \n 2\n \n \n \n =\n 0.74\n \n \n \n \n \n The effect size is as a standardised index that is independent of sample size and quantifies the magnitude of the difference between populations or the relationship between explanatory and response variables. The largest and smallest mean values as well as the SD (\u00cf\u0083) were based on the literature.5 Considering a 5% acceptable rate of error and 95% test power, 11 patients per group will be necessary to detect differences in tooth whitening (\u00ce\u0094E).\n We believe it will be difficult to maintain adherence of patients in this study. The protocol has repeated sessions (four sessions). As seen in previous studies,39 once teeth have reached a pleasing colour, some patients are not interested in continuing during the follow-up period, just to verify colour stability after bleaching. Therefore, we believe it will be necessary to include more patients in this study. According to our original sample size calculation, only 11 patients were necessary for our study. However, we have included nine more patients in each group to compensate for this drop-out factor.\n Thus, the decision was made to increase the sample to 20 patients per group (total: 80 participants) to compensate for possible drop-outs during the course of the study.\n Once we have reached n=10 patients per group in our study, we will recalculate the sample size based on our own results. We expect there will be a need to increase sample size to find a difference between the groups as there are no controlled clinical studies on this subject (violet LED).", "id": 160, "split": "train"} +{"trial_id": "NCT03198702", "pmid": "31575585", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy\n\nIncluded conditions:\n- Obstetrical Brachial Plexus Palsy\n\nStudy Armgroups:\n- {'label': 'Toxin group', 'type': 'EXPERIMENTAL', 'description': 'The babies receive a botulinum toxin type A injection at the age of 12 months', 'interventionNames': ['Drug: Botulinum toxin type A injection']}\n- {'label': 'Sham group', 'type': 'SHAM_COMPARATOR', 'description': 'The babies receive a simulated injection procedure at the age of 12 months', 'interventionNames': ['Other: Sham']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Botulinum toxin type A injection', 'description': 'A total of 8UI/kg will be injected in the internal shoulder rotator muscles: 2UI/kg in the sub scapular muscle, 3UI/kg in the pectoralis major muscle and 3UI/kg in the teres major/latissimus dorsi muscle.', 'armGroupLabels': ['Toxin group']}\n- {'type': 'OTHER', 'name': 'Sham', 'description': 'The injection is mimed, the procedure is the same as the botulinum toxin injection.', 'armGroupLabels': ['Sham group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the percentage posterior migration of the humeral head measured on axial MRI slices between 11 (before the BTI carried out at 12 months) and 18 months of age (6 months post BTI).', 'timeFrame': 'At 18 month age'}\n\nPlease estimate the sample size based on the assumption: \nIn order to guarantee a power of 90%, a sample of 22 babies per group is required. To account for babies lost to follow-up (10%) and babies who will not be treated because of a lack of true subluxation on MRI, 62 babies will be recruited. P<0.05 will be considered as statistically significant.", "answer": 62, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n No longitudinal data regarding the progression of bony deformities in children with BPBI are available in the literature. Only transversal studies have been carried out, indicating that posterior subluxation is significantly greater on the affected side compared with the healthy side at the age of 4.8 months (affected side 32.1%\u00e2\u0080\u0094: SD=19.7%\u00e2\u0080\u0089vs healthy side 49.8%: SD=7.3%).6 The calculation of the number of subjects necessary for this study was based on a difference of the standard deviation at 12 months, for a SD of 5%.\n In order to guarantee a power of 90%, a sample of 22 babies per group is required, thus a total of 44. In order to account for babies lost to follow-up (10%) and babies who will not be treated because of a lack of true subluxation on MRI, 62 babies will be recruited.\n The characteristics of the babies in both groups will be described using means, SD, medians, quartiles or frequencies. Mean changes in 2D percentage humeral subluxation, 3D humeral subluxation, 2D and 3D glenoid version, the AMS score and passive shoulder ROM will be compared using analysis of covariance (ANCOVA) adjusted on the initial values. If the hypotheses underlying the ANCOVA model are not respected, a non-parametric Wilcoxon test will be used. Shoulder muscle volumes and the mini-AHA scores will be compared between the groups using a Student\u00e2\u0080\u0099s t-test or a non-parametric Mann-Whitney test, depending on the distribution of the variable of interest. Lastly, the number of serious and non-serious adverse events, and the degree of fibrosis and fatty infiltration will be compared between the two groups using a \u00cf\u00872 test or Fisher\u00e2\u0080\u0099s exact test, so as the number of secondary surgeries. P<0.05\u00e2\u0080\u0089will be considered as statistically significant.\n Data analysis will be carried out on an intention to treat basis by a biostatistician after blind review and database freezing at the end of the study. No intermediate analysis is planned during this trial.", "id": 161, "split": "train"} +{"trial_id": "NCT03200834", "pmid": "38956698", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of D2 vs D3 Lymph Node Dissection for Right Colon Cancer (RICON)\n\nIncluded conditions:\n- Colon Cancer\n\nStudy Armgroups:\n- {'label': 'D2 lymph node dissection for right colon cancer', 'type': 'ACTIVE_COMPARATOR', 'description': 'Hemicolectomy for right colon cancer with D2 lymph node dissection', 'interventionNames': ['Procedure: Right Hemicolectomy with D2 lymph node dissection']}\n- {'label': 'D3 lymph node dissection for right colon cancer', 'type': 'EXPERIMENTAL', 'description': 'Hemicolectomy for right colon cancer with D3 lymph node dissection', 'interventionNames': ['Procedure: Right Hemicolectomy with D3 lymph node dissection']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Right Hemicolectomy with D2 lymph node dissection', 'description': 'Remove right part of colon with lymph node dissection \u2116201, \u2116202, \u2116211, \u2116212 (if present), \u2116221,\u2116222 (Japanese classification).', 'armGroupLabels': ['D2 lymph node dissection for right colon cancer']}\n- {'type': 'PROCEDURE', 'name': 'Right Hemicolectomy with D3 lymph node dissection', 'description': 'Remove right part of colon with lymph node dissection \u2116201, \u2116202, \u2116 203, \u2116211, \u2116212 (if present), \u2116213 (if present) \u2116221,\u2116222, \u2116223 (for hepatic flexure and proximal part of transverse colon cancer)(Japanese classification).', 'armGroupLabels': ['D3 lymph node dissection for right colon cancer']}\n\nPrimary Outcomes:\n- {'measure': '5-year survival', 'description': 'death from any cause', 'timeFrame': 'Up to 5 years post-operative'}\n\nPlease estimate the sample size based on the assumption: \nThe power of the study is set at 80%, with a type I error of 5%. An expected loss of follow-up is estimated at 15% for patients in each group. The enrollment period for patients is 3 years, and the total duration of the study will be 8 years.", "answer": 239, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n According to the SEER database (2004\u00e2\u0080\u00932012) and AJCC 5th, 6th, and 7th editions, the 5-year overall survival for stage II right colon cancer was 68\u00e2\u0080\u009384%, and for stage III, it was approximately 57 to 60% [21\u00e2\u0080\u009323]. In the JCOG0404 trial, the 5-year overall survival for stage II-III was 91% [24]. Literature data suggests that the baseline survival for D2 lymph node dissection group is estimated to be 75% for stage II-III of the disease, and for D3 group, it is 90%, respectively. An anticipated difference of 15% in 5-year overall survival between D2 and D3 LND groups is expected. The log-rank test (Lacatos, proportion of surviving) was utilized in the PASS 11 program for sample size calculation. The power of the study is set at 80%, with a type I error 5%. An expected loss of follow-up is estimated at 15% for patients in each group. The enrollment period for patients is 3\u00c2\u00a0years, and the total duration of the study will be 8\u00c2\u00a0years. Based on aforementioned conditions, 239 patients should be included in the study (Table 1). Ultimately, 120 patients will be included in D3 group, and 119 patients in D2 group. The anticipated number of deaths in the D2 group is 24, and in the D3 group, it is 10.\n \nTable 1Sample size calculation", "id": 162, "split": "train"} +{"trial_id": "NCT03201263", "pmid": "30157955", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PRessure suppOrT vEntilation + Sigh in aCuTe hypoxemIc respiratOry Failure patieNts (PROTECTION): a Pilot Randomized Controlled Trial\n\nIncluded conditions:\n- Respiratory Failure\n- Acute Respiratory Distress Syndrome\n- Ventilator Lung\n\nStudy Armgroups:\n- {'label': 'PSV group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Will be treated by standard of care for patients undergoing assisted mechanical ventilation (e.g., protective PSV settings, protocolized weaning, etc.).', 'interventionNames': ['Procedure: Standard of care']}\n- {'label': 'PSV+Sigh group', 'type': 'EXPERIMENTAL', 'description': 'Will be treated by standard of care for patients undergoing assisted mechanical ventilation (e.g., protective PSV settings, protocolized weaning, etc.) + Sigh (short cyclic recruitment breath once every minute) until death or spontaneous breathing trial and extubation.', 'interventionNames': ['Procedure: Sigh']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Sigh', 'description': 'Application of cyclic pressure control breath delivered at 30 cmH2O for 3 seconds once per minute in patients undergoing pressure support ventilation', 'armGroupLabels': ['PSV+Sigh group'], 'otherNames': ['Short cyclic recruitment breath']}\n- {'type': 'PROCEDURE', 'name': 'Standard of care', 'description': 'Standard of care', 'armGroupLabels': ['PSV group']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical feasibility of PSV+Sigh vs. standard of carde (PSV)', 'description': 'Feasibility will be assessed by measuring the number of patients in each group experiencing at least one of the following failure criteria:\\n\\n* switch to controlled ventilation following presence of predefined criteria;\\n* use of PEEP \u226515 cmH2O, prone positioning, inhaled nitric oxide, extracorporeal membrane oxygenation;\\n* re-intubation within 48 hours from extubation following predefined criteria.\\n\\nBased on previous data, the expected rate of failure in patients undergoing PSV will be 22% and we hypothesize a rate of 15% for patients in the PSV+Sigh group. Furthermore, we assume a non-inferiority of the treatment with PSV+Sigh, with a tolerance of 5%. Thus, a sample size of 258 patients (with 129 patients per study arm) will be sufficient to assess feasibility of the PSV+Sigh strategy in this pilot phase with power of 0.8 and alpha 0.05.', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nNon-inferiority tolerance of 5%, power of 0.8, and alpha of 0.05.", "answer": 258, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was computed based on the hypothesis that PSV\u00e2\u0080\u0089+\u00e2\u0080\u0089sigh might decrease the rate of failure of assisted ventilation compared to standard PSV. Based on previous data [21], the expected proportion of failure in patients undergoing PSV will be 22% and we hypothesized a proportion of 15% for patients in the PSV\u00e2\u0080\u0089+\u00e2\u0080\u0089sigh group. Assuming non-inferiority of PSV\u00e2\u0080\u0089+\u00e2\u0080\u0089sigh treatment, with a tolerance of 5% we estimated that a sample size of 258 patients (with 129 patients per study arm) will be sufficient to assess feasibility of the PSV\u00e2\u0080\u0089+\u00e2\u0080\u0089sigh strategy in this pilot phase with power of 0.8 and alpha 0.05.", "id": 163, "split": "train"} +{"trial_id": "NCT03201575", "pmid": "31118101", "question": "Here is the design of a clinical trial:\n\nOfficial Title: REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study\n\nIncluded conditions:\n- Septic Shock\n\nStudy Armgroups:\n- {'label': 'Remote ischemic conditioning', 'type': 'EXPERIMENTAL', 'description': 'A brachial cuff is positioned around the arm of the patient. The remote ischemic conditioning consists in alternative inflations and deflations of the brachial cuff.', 'interventionNames': ['Device: Remote Ischemic conditioning']}\n- {'label': 'Control group', 'type': 'OTHER', 'description': 'A brachial cuff is positioned around the arm of the patient. No inflation or deflation is made.', 'interventionNames': ['Device: Patients with no remote ischemic conditioning']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Remote Ischemic conditioning', 'description': 'A brachial cuff is positioned around the arm of the patient. Four cycles of \\\\[5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation\\\\] started as soon as possible after randomization. The intervention is repeated at 12 and 24 hours after inclusion.', 'armGroupLabels': ['Remote ischemic conditioning']}\n- {'type': 'DEVICE', 'name': 'Patients with no remote ischemic conditioning', 'description': 'A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Average SOFA score (Sequential Organ Failure Assessment)', 'description': 'The SOFA score ranges from 0 to 24 (higher scores indicate more severe organ failure), with 0 to 4 points assigned for each of 6 organ dysfunctions (ie, central nervous system, cardiovascular, respiratory, renal, coagulation, and liver).', 'timeFrame': '96 hours.'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90% (\u03b2 = 10%) and type 1 error at \u03b1 = 5% (two-tailed). Assumed mean daily SOFA score ranging from 8 to 12 with a standard deviation ranging from 4 to 6. Additional 7% patients to account for potential loss to follow-up and withdrawal of consent.", "answer": 180, "answer_type": "ACTUAL", "explanation": "Sample size\n No a priori evidence suggests the magnitude of the effect of RECO on the severity of MOF in septic shock patients. Under the alternative hypothesis of an expected difference of half the standard deviation (effect size: 0.5) of the mean daily SOFA score of the first 4\u00e2\u0080\u0089days after inclusion, at least 168 patients have to be enrolled to reject the null hypothesis of a similar mean SOFA score in both arms with a power of 90% (\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u008910%) and type 1 error at \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00895% (two-tailed). Even though there is no published data regarding the mean daily SOFA score in patients meeting our eligibility criteria, one can assume a mean value ranging from 8 to 12 with a standard deviation ranging from 4 to 6. Thus, for example, if the standard deviation is found to be 4, then a decrease of 2 or more in the mean daily SOFA score will be needed to reach significance. We planned to recruit an additional 7% patients (n\u00e2\u0080\u0089=\u00e2\u0080\u008912) to account for potential loss to follow-up and withdrawal of consent. Thus, the planned sample size is 180 patients (90 patients in each arm). Based on the enrollment capacity of the participating centers, the recruitment is expected to be completed within 18\u00e2\u0080\u0089months. The sample size was calculated with the use of nQuery Advisor, version 5.0 (Statistical solution, Cork, Ireland).", "id": 164, "split": "train"} +{"trial_id": "NCT03201783", "pmid": "29773699", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Trial Comparing the Effect of Immediate Versus Delayed Frozen-thawed Embryo Transfer Following a Stimulated IVF Cycle\n\nIncluded conditions:\n- Fertilization in Vitro\n- Embryo Transfer\n\nStudy Armgroups:\n- {'label': 'immediate group', 'type': 'OTHER', 'description': 'the intervention: immediate frozen-thawed embryo transfer (FET) which means FET will be performed in the first cycle following the stimulated IVF cycle', 'interventionNames': ['Other: immediate frozen-thawed embryo transfer']}\n- {'label': 'delayed group', 'type': 'OTHER', 'description': 'the intervention: delayed frozen-thawed embryo transfer (FET) which means FET will be performed at least in the second cycle following the stimulated IVF cycle', 'interventionNames': ['Other: delayed frozen-thawed embryo transfer']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'immediate frozen-thawed embryo transfer', 'description': 'Frozen-thawed embryo transfer will be performed in the first cycle following the stimulated IVF cycle', 'armGroupLabels': ['immediate group']}\n- {'type': 'OTHER', 'name': 'delayed frozen-thawed embryo transfer', 'description': 'Frozen-thawed embryo transfer will be performed at least in the second cycle following the stimulated IVF cycle', 'armGroupLabels': ['delayed group']}\n\nPrimary Outcomes:\n- {'measure': 'ongoing pregnancy', 'description': 'viable pregnancy beyond gestation 12 weeks', 'timeFrame': 'viable pregnancy beyond gestation 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, type I error of 0.05, and a 10% drop-out rate.", "answer": 724, "answer_type": "ACTUAL", "explanation": "Sample size calculations and statistical analysis\n \n Sample size estimation\n According to our data of the centre, the ongoing pregnancy rate per FET was about 30%. We hypothesise that a difference in the ongoing pregnancy rate of 10% between the immediate versus delayed groups as equivalence, the sample size required for a test of equivalence would be 329 in each arm to give a power of 0.8 and type I error of 0.05. Allowing 10% drop-out, 724 subjects or 362 in each arm will be needed.\n \n \n Data analysis\n Data will be analysed with an intention to treat and per protocol. Demographic features of the two groups will be compared. Comparison of quantitative variables will be performed using Student\u00e2\u0080\u0099s t-test, while categorical variables will be compared using a \u00cf\u00872 analysis. If randomisation fails to achieve two balanced groups, we will use the multivariable logistic regression to adjust for potentially confounding factors and results, namely female age (as a continuous variable), failed fresh ET or freeze-all, retrieved oocytes, COH protocol, ovulation trigger, number of good-quality embryos produced (as a continuous variable) and number of embryos transferred (one vs two), developmental stage (cleavage vs blastocyst stage) and quality of the embryos transferred (quality of the embryo transferred). If the primary unadjusted analysis and secondary adjusted analysis are discordant, we will give greater weighting to the primary analysis in the interpretation of trial findings.\n All statistical analyses of the data will be performed using the SPSS program V.21.0 (SPSS), and a p value <0.05\u00e2\u0080\u0089will be considered statistically significant.", "id": 165, "split": "train"} +{"trial_id": "NCT03201783", "pmid": "29773699", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Trial Comparing the Effect of Immediate Versus Delayed Frozen-thawed Embryo Transfer Following a Stimulated IVF Cycle\n\nIncluded conditions:\n- Fertilization in Vitro\n- Embryo Transfer\n\nStudy Armgroups:\n- {'label': 'immediate group', 'type': 'OTHER', 'description': 'the intervention: immediate frozen-thawed embryo transfer (FET) which means FET will be performed in the first cycle following the stimulated IVF cycle', 'interventionNames': ['Other: immediate frozen-thawed embryo transfer']}\n- {'label': 'delayed group', 'type': 'OTHER', 'description': 'the intervention: delayed frozen-thawed embryo transfer (FET) which means FET will be performed at least in the second cycle following the stimulated IVF cycle', 'interventionNames': ['Other: delayed frozen-thawed embryo transfer']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'immediate frozen-thawed embryo transfer', 'description': 'Frozen-thawed embryo transfer will be performed in the first cycle following the stimulated IVF cycle', 'armGroupLabels': ['immediate group']}\n- {'type': 'OTHER', 'name': 'delayed frozen-thawed embryo transfer', 'description': 'Frozen-thawed embryo transfer will be performed at least in the second cycle following the stimulated IVF cycle', 'armGroupLabels': ['delayed group']}\n\nPrimary Outcomes:\n- {'measure': 'ongoing pregnancy', 'description': 'viable pregnancy beyond gestation 12 weeks', 'timeFrame': 'viable pregnancy beyond gestation 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, type I error of 0.05, and a 10% drop-out rate.", "answer": 724, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n According to our data of the centre, the ongoing pregnancy rate per FET was about 30%. We hypothesise that a difference in the ongoing pregnancy rate of 10% between the immediate versus delayed groups as equivalence, the sample size required for a test of equivalence would be 329 in each arm to give a power of 0.8 and type I error of 0.05. Allowing 10% drop-out, 724 subjects or 362 in each arm will be needed.", "id": 166, "split": "train"} +{"trial_id": "NCT03203460", "pmid": "31278095", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Exercise Group', 'type': 'EXPERIMENTAL', 'description': 'Supervised high-intensity aerobic interval training (HIIT) during active surveillance', 'interventionNames': ['Behavioral: High-intensity aerobic interval training (HIIT)']}\n- {'label': 'Usual Care Group', 'type': 'NO_INTERVENTION', 'description': 'The usual care group will be provided with standard active surveillance medical care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'High-intensity aerobic interval training (HIIT)', 'description': 'A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals', 'armGroupLabels': ['Exercise Group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes of Peak Oxygen Consumption (VO2peak)', 'description': 'VO2peak is a measure of cardiopulmonary fitness and a powerful surrogate outcome for cancer-specific and overall survival. VO2peak will be defined as the highest oxygen-uptake value recorded during the test and quantified where participants reach a plateau in oxygen consumption, which will be expressed as relative to body mass (i.e., ml O2\u00b7kg-1\u00b7min-1).', 'timeFrame': 'At baseline and 12-week (postintervention)'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed alpha <0.05, 80% power, <10% dropout rate.", "answer": 52, "answer_type": "ACTUAL", "explanation": "Sample size\n A sample size of 60 participants (30 per group) provides 80% power using a two-tailed alpha\u00c2\u00a0<0.05\u00e2\u0080\u0089to detect a clinically meaningful between-group difference of 1-metabolic equivalent task (1-MET; 3.5\u00e2\u0080\u0089mL/kg/min) on our primary outcome of VO2peak, assuming a SD of 5.6\u00e2\u0080\u0089mL/kg/min and adjustment for baseline value and other prognostic covariates. It will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes.51 Considering a potential dropout rate of\u00c2\u00a0<10% based on our previous exercise oncology trials,52\u00e2\u0080\u009355 a total of 66 participants (33 per group) will be randomised. This power will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes if the effects are moderate (ie, a standardised effect size of d\u00e2\u0089\u00a50.6\u00e2\u0080\u0089approximately). This power is not sufficient for detecting potentially meaningful differences in any of the exploratory clinical outcomes. Given that the purpose of this phase II trial is to inform larger phase II and III trials, the patient-reported and clinical outcomes will also be interpreted for potential clinical significance based on the direction and magnitude of numerical differences.", "id": 167, "split": "train"} +{"trial_id": "NCT03206801", "pmid": "30975673", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial of Urine CXCL10 Chemokine Monitoring Post-renal Transplant\n\nIncluded conditions:\n- Kidney Transplant; Complications\n- Rejection of Renal Transplant\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants with high urine CXCL10 randomized to the Intervention Arm will undergo a kidney transplant biopsy to check for rejection. Biopsy-proven subclinical rejection will be treated per study protocol.', 'interventionNames': ['Procedure: Kidney transplant biopsy']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants with high urine CXCL10 randomized to the Control Arm will continue routine post-transplant surveillance with serum creatinine and proteinuria; serial urine samples will continue to be collected and analyzed (blinded), but not used to direct care.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Kidney transplant biopsy', 'description': 'Elevated urine CXCL10 will trigger a study biopsy in patients randomized to the intervention arm. Subclinical rejection will be treated per protocol.', 'armGroupLabels': ['Intervention'], 'otherNames': ['Protocol biopsy']}\n\nPrimary Outcomes:\n- {'measure': 'Death-censored graft loss', 'description': 'Return to dialysis or re-transplant', 'timeFrame': '2 weeks-12 months post-transplant'}\n- {'measure': 'Clinical indication biopsy-proven acute rejection', 'description': 'Clinical rejection, Banff criteria', 'timeFrame': '2 weeks-12 months post-transplant'}\n- {'measure': 'De novo donor specific antibody development', 'description': 'De novo human leukocyte antibody (HLA) antibodies, donor specific', 'timeFrame': '2 weeks-12 months post-transplant'}\n- {'measure': 'Subclinical tubulitis', 'description': 'Subclinical rejection, Banff criteria', 'timeFrame': '12-month study exit biopsy'}\n- {'measure': 'Interstitial fibrosis and inflammation (IFTA + i)', 'description': 'IFTA + i, defined by Mayo criteria', 'timeFrame': '12-month study exit biopsy'}\n\nPlease estimate the sample size based on the assumption: \nAlpha error 0.05, power 0.80, and 20% drop-out rate.", "answer": 420, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n Sample size calculation: randomisation phase\n The TMAKP has a 2% cumulative incidence of death-censored graft loss and 13.6% clinical biopsy-proven acute rejection within the first-year post-transplant (censored for primary non-function and HLA 0\u00e2\u0080\u0089MM, 1999\u00e2\u0080\u00932014), in a population that is not enriched for subclinical rejection by urine CXCL10. A conservative estimate of 13.6% clinical biopsy-proven acute rejection was used. The prevalence of dnDSA development varies in the literature, due to confounding by the inadequate exclusion of pretransplant DSA. In studies that exclude pretransplant DSA with a flow cross-match or solid phase assays, the prevalence of dnDSA ranges from 2.0% to 27% at 12\u00e2\u0080\u0089months after transplant,17 43 52\u00e2\u0080\u009355 therefore, we assumed a conservative estimate of 2%.\n The literature demonstrates a range of IFTA\u00c2\u00a0+\u00c2\u00a0inflammation from 9.5% to 26%, depending on the patient population, time post-transplant and biopsy indication.10 11 41\u00e2\u0080\u009343 56 As 12-month surveillance biopsies showed a 20.2% prevalence of unfavourable prognostic features, including IFTA\u00c2\u00a0+\u00c2\u00a0inflammation, in patients on modern immunosuppression, this was the estimate we used11 (table 1). In unselected populations, the prevalence of subclinical tubulitis at 12\u00e2\u0080\u0089months is 3.4%.11 However, patients with elevated urine CXCL10 have a 63% prevalence of subclinical tubulitis.28 Therefore, a conservative estimate of 17.4% subclinical tubulitis was used, as the study design enriches for patients at high risk of rejection through elevated urine CXCL10. Therefore, a conservative estimate of the overall prevalence of the primary outcome in the control arm is 55%, allowing for some overlap in endpoints.\n \n Table 1\n \n IFTA\u00c2\u00a0+ inflammation prevalence estimates\n \n \n \n \n Study\n Population\n Biopsy\n Time post-Transplant\n Prevalence\n Definition\n Ref\n \n \n \n \n Park et al\n\n LD recipients 2000\u00e2\u0080\u00932007\n Protocol\n 1\u00e2\u0080\u0089year\n 20/151 13%\n Mayo\n \n41\n\n \n \n Cosio et al\n\n LD\u00c2\u00a0and DD recipients 1998\u00e2\u0080\u00932001\n Protocol\n 1\u00e2\u0080\u0089year\n 53/292 18%\n Mayo\n \n10\n\n \n \n Gago et al\n\n LD\u00c2\u00a0and DD recipients 2000\u00e2\u0080\u00932006\n Protocol: 151/207,\u00c2\u00a073% Indication: 56/207, 27.1%\n 16.9\u00c2\u00b115.5\u00c2\u00a0mos (1, 3, 5\u00e2\u0080\u0089years)\n 207/795 26%\n Mayo\n \n42\n\n \n \n Gago et al\n\n LD\u00c2\u00a0and DD recipients 2000\u00e2\u0080\u00932006\n Protocol*\n 1\u00e2\u0080\u0089year\n 14.4%\n Mayo\n \n42\n\n \n \n Cosio et al\n\n LD\u00c2\u00a0and DD recipients 1999\u00e2\u0080\u00932010 LD=78%\n Protocol\n 1\u00e2\u0080\u0089year\n 86/935 9.5%\u00e2\u0080\u00a0\n Mayo\n \n11\n\n \n \n Ho et al\n\n LD\u00c2\u00a0and DD recipients\n Protocol\n 2\u00e2\u0080\u0089years\n 28/111 25%\u00e2\u0080\u00a1\n Mayo\n \n56\n\n \n \n Ho et al\n\n LD\u00c2\u00a0and DD recipients\n Protocol\n 6\u00c2\u00a0mos\n 22/94 23.4%\n Mayo\n \n56\n\n \n \n TMAKP\n LD\u00c2\u00a0and DD recipients\n Protocol\n 6\u00c2\u00a0mos\n 48/222 21.6%\n Mayo\n \n \n \n TMAKP\n LD\u00c2\u00a0and DD recipients\n Protocol\n 6\u00c2\u00a0mo\n Pure IFTA alone (ci+ct\u00c2\u00a0\u00e2\u0089\u00a52)\u00c2\u00a7 93/222 41.9%\n \n \n \n \n Garc\u00c3\u00ada-Carro\u00c2\u00a0et\u00c2\u00a0al\n\n LD\u00c2\u00a0and DD recipients\n Protocol\n 6\u00c2\u00a0wks\n 108/598 18.1%\n Oslo\n \n43\n\n \n \n Garc\u00c3\u00ada-Carro\u00c2\u00a0et\u00c2\u00a0al\n\n LD\u00c2\u00a0and DD recipients\n Protocol\n 1\u00e2\u0080\u0089year\n 125/588\u00c2\u00b6 21.25%\n Oslo\n \n43\n\n \n \n \n \n \n The most recent Banff classification has been revised to include i-IFTA\u00c2\u00a0as part of chronic active TCMR. Prevalence estimates for IFTA\u00c2\u00a0+\u00c2\u00a0inflammation were used, as prior to February 2018, there was no internationally accepted definition for IFTA\u00c2\u00a0+\u00c2\u00a0inflammation. The primary composite outcome for i-IFTA will be measured using the new Banff schema.37\n \n \n *They did not explicitly state that the 1\u00e2\u0080\u0089year 14.4% reported IFTA\u00c2\u00a0+\u00c2\u00a0inflammation was from protocol biopsies, but based on their treatment protocols, it is assumed to be largely protocol biopsies.\n \n \n \u00e2\u0080\u00a0Reported as 9.5%, but calculated as 9.2%.\n \n \n \u00e2\u0080\u00a1It is anticipated that later protocol biopsies would have higher rates of IFTA\u00c2\u00a0+\u00c2\u00a0inflammation, based on 1, 3, 5-year biopsy data from Gago et al.42\n \n \n \u00c2\u00a7Only 16 cases met the \u00e2\u0080\u0098conservative criteria for IFTA\u00c2\u00a0+\u00c2\u00a0inflammation\u00e2\u0080\u0099: ci\u00c2\u00a0+ct\u00c2\u00a0\u00e2\u0089\u00a52, i>0 (16/222, 7.2%). The whole table is otherwise scored with the Mayo clinic criteria for IFTA\u00c2\u00a0+\u00c2\u00a0inflammation.\n \n \n \u00c2\u00b6Personal communication: Daniel Ser\u00c3\u00b3n, Clara Garc\u00c3\u00ada-Carro and Anna Reisaeter.\n \n \n DD, deceased donor; LD, living donor; mo, month; TCMR, T-cell mediated rejection; TMAKP, Transplant Manitoba Adult Kidney Program; wks, weeks.\n \n \n \n A 35.6% reduction in the primary composite outcome was considered clinically significant. The multicentre, interventional clinical transplant trials FKC008 and FKC014 had 82% and 78% of patients complete the study protocol, including 24-month protocol biopsies (Rush, personal communication). These were pharmacological interventional studies with serial surveillance biopsies and more intensive study protocols. This study protocol is much less intensive and a conservative 20% drop-out was assumed. Therefore, with an alpha error 0.05, power 0.80 and 20% drop-out rate, we will randomise 250 incident adult renal transplant patients. Sample size estimates were based on two-sample test of proportions using the power.prop.test function in R.57 There will be no interim analyses.\n \n \n Patient enrolment:\u00c2\u00a0screening phase, urine CXCL10\n We anticipate approximately 420 patients will need to be enrolled for urine CXCL10 screening to obtain 250 patients at high risk of rejection for randomisation. TMAKP had 87% patients meet the eligibility criteria of adult incident kidney transplant patients on tacrolimus and mycophenolate mofetil with HLA\u00c2\u00a0\u00e2\u0089\u00a51\u00e2\u0080\u0089DR/DQ MM. We anticipate that approximately 40% patients will be persistently CXCL10 negative (low risk of rejection) on screening and will remain off-study, and 60% patients will have a confirmed elevated urine CXCL10 and undergo randomisation, based on observational studies.28", "id": 168, "split": "train"} +{"trial_id": "NCT03207828", "pmid": "30486843", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"Eficacia de la Terapia de activaci\u00f3n Conductual Para Pacientes Con Dolor cr\u00f3nico: Ensayo cl\u00ednico Randomizado\"\n\nIncluded conditions:\n- Fibromyalgia\n- Depression\n\nStudy Armgroups:\n- {'label': 'Behavioral activation group', 'type': 'EXPERIMENTAL', 'description': 'This group will receive usual care for fibromyalgia with comorbid major depression plus in-group behavioral activation.', 'interventionNames': ['Behavioral: Behavioral activation', 'Other: Usual care']}\n- {'label': 'Usual care', 'type': 'OTHER', 'description': 'This group of participants will only receive usual care for fibromyalgia with comorbid depression.\\n\\nParticipants will be attended by a Medical Doctor that has a high level of expertise in fibromyalgia (rheumatologist or chronic pain specialist) of the Red Salud Christus, the most important private medical care network in Chile. In this clinic treatment of fibromyalgia includes administering pregabalin and pain killers (avoiding opioids). I addition, muscle relaxant such as cyclobenzaprine can be also administered. In a high proportion of cases (around 42%), antidepressant with analgesic properties, namely duloxetine, is prescribed. In addition, usual care includes derivation to psychiatrist if needed.', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Behavioral activation', 'description': 'The Brief Behavioral Activation Treatment for Depression (Lejuez, Hopko, Acierno, Daughters, \\\\& Pagoto, 2011; Lejuez, Hopko, LePage, Hopko, and McNeil; 2001) will be used. It aims are (1) to increase engagement with activities associated with pleasure or mastery experiences; (2) decrease engagement with activities that maintain or increase the risk of depression; (3) and remove the barriers that limit the access to gratification. The sessions of therapy are well structured and described in its manual. The protocol was originally designed to be applied individually. However, for the present research, it will be adjusted to be applied in group sessions (5-8 participants). Materials will be also adjusted to be use with Chilean population. Treatment core aspects will not be altered. The treatment will last 10 sessions over two months. Two psychologist trained in behavioral activation will lead the sessions.', 'armGroupLabels': ['Behavioral activation group'], 'otherNames': ['Brief behavioral activation for depression']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Participants will be attended by a Medical Doctor that has a high level of expertise in fibromyalgia (rheumatologist or chronic pain specialist) at the Red Salud Christus, the most important private medical care network in Chile. In this clinic the protocol for the treatment of fibromyalgia includes administering pregabalin or gabapentin and pain killer (avoiding opioids). I addition, muscle relaxant such as cyclobenzaprine can be also administered to improve sleep quality. In a high proportion of cases (around 42%), antidepressant with analgesic properties, namely duloxetine, is prescribed. In addition, usual care includes derivation to psychiatrist if needed.', 'armGroupLabels': ['Behavioral activation group', 'Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in depressive symptoms severity', 'description': 'Patients Health Questionnaire-9 (PHQ-9; Baader et al., 2008). It consists of 9 items evaluating the presence of depressive symptoms in the last two weeks. Its psychometric properties have been examined in Chilean population. It shows a sensitivity of 92% and specificity of 89%. Item response options are: 0 = never, 1 = some days, 2 = more than half the days and 3 = almost every day. Patients can be classified in:\\n\\nMajor depressive syndrome: presence of 5 or more of the 9 depressive symptoms with an index of severity of more than half of the days, and one of the symptoms is mood depressive or anhedonia.\\n\\nOther depressive syndrome: presence of 2, 3 or 4 depressive symptoms for more of half the days and one of the symptoms is depressive mood or anhedonia.\\n\\nPositive depressive symptoms: presence of at least one or two of the symptoms depressive, but fails to complete the above criteria.\\n\\nNegative depressive symptoms: does not present any diagnostic criteria more than half of the days.', 'timeFrame': 'Depressive symptoms will be assessed four times: at baseline, during treatment (one month after the start of the treatment), immediately after the treatment, and at three month follow up. As such the participant will be assessed during five months.'}\n\nPlease estimate the sample size based on the assumption: \nThe study aimed for a power of 0.80. The correlation between the intercept and the slope was specified to be -0.4. The variances of the intercept, slope, and scores of all variables were specified as 1. The correlation between treatment and each covariate was specified as 0.1, and the correlation between covariates was specified as 0.3.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The study sample size was calculated for a Hierarchical Linear Model (HLM) in which the primary outcome (depressive symptom severity) was the dependent variable. Using Mplus [20], we determined that a sample of 90 participants will be needed to reach a power of .80. In this power analysis, the correlation between the intercept and the slope was specified to be \u00e2\u0088\u0092\u00e2\u0080\u00890.4. The average slope was assumed to be negative, as depression scores are expected to drop, and was specified as \u00e2\u0088\u0092\u00e2\u0080\u00890.5. To simplify the model, the variances of the intercept, slope, and scores of all the variables in the model (depressive symptom severity, and covariates) were specified as 1, so as to have the standardized model solution. The treatment effect on the slope (standardized Beta) was specified as 0.45. This corresponds to a medium-to-large effect size [21, 22]. In addition, the effect of two covariates was included. The effect of each of the covariates on the slope was specified as 0.1. The correlation between treatment and each covariate was specified as 0.1, and the correlation between covariates was specified as 0.3.", "id": 169, "split": "train"} +{"trial_id": "NCT03213938", "pmid": "29273095", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Chronic Prostatitis With Chronic Pelvic Pain Syndrome\n\nStudy Armgroups:\n- {'label': 'Acupuncture', 'type': 'EXPERIMENTAL', 'description': 'The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 \u00d7 75mm; size 0.30 \u00d7 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.', 'interventionNames': ['Device: Acupuncture']}\n- {'label': 'Sham acupuncture', 'type': 'SHAM_COMPARATOR', 'description': 'The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 \u00d7 25mm) will be inserted with a depth of 2-3 mm without any manipulation.', 'interventionNames': ['Device: Sham acupuncture']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Acupuncture', 'description': 'For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 \u00d7 75mm; size 0.30 \u00d7 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.\\n\\nAcupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).', 'armGroupLabels': ['Acupuncture']}\n- {'type': 'DEVICE', 'name': 'Sham acupuncture', 'description': 'For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 \u00d7 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.\\n\\nSham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).', 'armGroupLabels': ['Sham acupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of Responders at the End of 8-week', 'description': 'The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).', 'timeFrame': 'week 8'}\n- {'measure': 'Proportion of Responders at the End of 32-week', 'description': 'The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.', 'timeFrame': 'week 32'}\n\nPlease estimate the sample size based on the assumption: \nThe calculations are based on 90% power, a two-sided alpha level of 0.05, and a 15% increase to account for dropouts. All hypothesis testing will be carried out at the 5% (two-sided) significance level.", "answer": 440, "answer_type": "ACTUAL", "explanation": "Calculation of sample size and statistical analyses\n The primary study hypothesis is that acupuncture is more effective than sham acupuncture in relieving symptoms of CP/CPPS. Sample-size calculations were based on 90% power to detect a difference of 17% between response rates in the two groups (63.7% in the acupuncture group compared with 46.7% in the control group) for the primary outcome, defined as a decline of 6 or more points in the NIH-CPSI total score [21]. These values are equivalent to an odds ratio of 2.0. On the basis of a two-sided alpha level of 0.05, we calculated that a sample of 440 participants will be required (220 in each group). This proposed sample size includes a 15% increase to account for dropouts. To control for type I error, the two time points will have to be positive in order for the trial to prove the efficacy of acupuncture.\n Summary tables (descriptive statistics and/or frequency tables) will be provided for all variables as appropriate. Means and standard deviations will be presented for continuous variables, unless the variable has a skewed distribution, in which case medians, and 25th and 75th percentiles will be presented. The number and percentage of participants in each category will be presented for categorical variables. Missing values will be reported for each variable (continuous or categorical). All randomized participants will be included in the analyses. All analyses will be based on the intention-to-treat principle.\n Primary outcome analysis will be conducted with a logistic generalized linear mixed model (GLMM) for repeated measures. Response or non-response at each scheduled post-baseline visit (end of treatment, and 20 and 24\u00c2\u00a0weeks after treatment) is the dependent variable. Subjects who discontinue without providing a post-baseline NIH-CPSI score will be considered non-responders at visit 1 (week 1). The logistic GLMM is fit using the logit link and the binomial distribution. The model will include the baseline NIH-CPSI total score as a fixed-effect covariate, with fixed-effect categorical factors for a treatment group (acupuncture and sham acupuncture), visit and treatment\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089visit interaction. The interaction will remain in the model regardless of significance. Treatment group comparisons at each visit will be estimated by differences between least squares means from the treatment\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089visit interaction, and will be presented as odds ratios with accompanying p values and 95% CIs. The predicted probability of response at each visit will also be presented. Such models provide fairly robust results for treatment comparisons when longitudinal binary responses are missing, with an assumption that data are missing at random, according to reported values [45]. Sensitivity analysis will be performed if necessary, with a control-based pattern imputation model under the assumption of missing not at random.\n Changes from baseline in the NIH-CPSI total score will be analyzed using linear mixed-effects models. The observed change from baseline score at each assessment point will be considered as the dependent variable. The model will include the baseline value, treatment group (acupuncture and sham acupuncture), visit and treatment\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089visit interaction. Treatment group comparisons at each visit will be estimated by differences between least squares means from the treatment\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089visit interaction, with accompanying p values and 95% CIs. Log-transformation may be applied in the case of serious violations of the model assumptions (normality and constant variance of the residuals). If not appropriate, the Wilcoxon rank-sum test will be used. The effect of the treatment will be estimated by the difference (or ratio, in the case of log-transformation) between treatments and will be presented along with its associated 95% CI. The same approach as for the NIH-CPSI total score will be used in other longitudinal continuous outcomes such as NIH-CPSI subscales (pain, urinary symptoms, and QoL).\n Other categorical data or ordinal data will be compared between groups using the Wilcoxon rank-sum test, chi-square test or Fisher\u00e2\u0080\u0099s exact test, as appropriate. The James and Bang blinding indices will be used to assess the success of blinding. The James blinding index is a variation on the statistic in which 1 represents perfect blinding. The Bang blinding index for each group represents the proportion of participants making a correct treatment guess beyond chance; 0 represents perfect blinding, a positive index indicates a correct guess, and a negative index indicates a guess in the opposite direction [46]. For all statistical analyses, SAS 9.4 software will be used. All hypothesis testing will be carried out at the 5% (two-sided) significance level.", "id": 170, "split": "train"} +{"trial_id": "NCT03216564", "pmid": "29665833", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes (IDEAL-2)\n\nIncluded conditions:\n- Diabetic Nephropathies\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Participants are treated with angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB) AND active vitamin D (Calcitriol) 0.25 micrograms orally per day for 26 weeks.', 'interventionNames': ['Drug: Calcitriol']}\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Participants are treated with ACEI/ARB alone for 26 weeks.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Calcitriol', 'description': 'Active vitamin D (Calcitriol) 0.25 micrograms', 'armGroupLabels': ['Intervention Group'], 'otherNames': ['Active Vitamin D']}\n\nPrimary Outcomes:\n- {'measure': 'Urinary albumin creatinine ratio (ACR) measured biochemically', 'description': 'Urine albumin and creatinine will be measured biochemically and their ratio calculated', 'timeFrame': '26 weeks'}\n\nPlease estimate the sample size based on the assumption: \npower of 80%, significance level (\u03b1) of 0.05, and a potential dropout rate of 20%", "answer": 320, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n A sample size of 320 individuals will be enrolled in the study. Based on the VITAL study, we estimate a treatment effect for albuminuria of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.25 sd and an intraclass correlation coefficient of 75% for our current study. To achieve a power of 80% to detect a statistically significant treatment effect for a two-tailed test with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, we calculate a minimum of 256 participants. To cater for a potential dropout of 20%, we will enrol a total of 320 individuals.", "id": 171, "split": "train"} +{"trial_id": "NCT03222024", "pmid": "30373783", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Features, Management and Outcomes of Severe Ischaemic Stroke in Tertiary Hospitals in China: a Multi-centre Prospective Observational Study\n\nIncluded conditions:\n- Severe Ischaemic Stroke\n- Malignant Ischaemic Stroke\n\nStudy Armgroups:\n- {'label': 'Severe ischaemic stroke', 'description': 'patients with severe stroke on admission', 'interventionNames': ['Other: routine medical care']}\n- {'label': 'Malignant ischaemic stroke', 'description': 'patients without severe stroke on admission but developing it in hospital', 'interventionNames': ['Other: routine medical care']}\n- {'label': 'Mild to moderate ischaemic stroke', 'description': 'patients without severe stroke from onset to discharge', 'interventionNames': ['Other: routine medical care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'routine medical care', 'description': \"This is an observational study for clinical course and outcomes of severe ischaemic stroke; therefore, interventions are prescribed by responsible doctors based on patients' clinical conditions, which is not interfered by current study\", 'armGroupLabels': ['Malignant ischaemic stroke', 'Mild to moderate ischaemic stroke', 'Severe ischaemic stroke']}\n\nPrimary Outcomes:\n- {'measure': 'Functional outcome at 3 months after stroke onset', 'description': 'Modified Rankin scale score of patients at 3 months after the onset of ischaemic stroke.', 'timeFrame': '3 months after stroke onset'}\n\nPlease estimate the sample size based on the assumption: \nAt least 10 events per variable, testing 5-10 variables, and a withdrawal rate of 10%", "answer": 2500, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n This is an observational study with a primary aim to describe the clinical features and outcomes of patients with severe ischaemic stroke, which would often not require sample size estimation. Therefore, we calculate the sample size for the logistic analysis for predicting malignant brain oedema, for which we anticipate to test 5\u00e2\u0080\u009310 variables as potential predictors. Based on the criteria of at least 10 events per variable,21 22 we will need 50\u00e2\u0080\u0093100 patients with malignant brain oedema. Assuming a proportion of 4% of general patients with ischaemic stroke would develop malignant brain oedema,1 a sample of 1250\u00e2\u0080\u00932500 patients is required. In this observational study, we aim to recruit 2500 patients in order to allow a possible withdrawal rate of 10% and provide sufficient information on different subgroups of patients for further analyses.", "id": 172, "split": "train"} +{"trial_id": "NCT03224858", "pmid": "30547847", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Does a Clinic Based Complex Care Coordination Intervention Improve Patient Quality Outcomes in an Underserved Clinic Population? the Streamlined, Unified, Meaningfully Managed Interdisciplinary Team (SUMMIT) Ambulatory ICU Study\n\nIncluded conditions:\n- Health Services\n- Comorbidity\n- Primary Health Care\n\nStudy Armgroups:\n- {'label': 'SUMMIT intervention group', 'type': 'EXPERIMENTAL', 'description': 'This group will transfer primary care to the SUMMIT team, which consists of: 1 primary care provider, 1 clinical nurse, 1 team manager, 2 care-coordinators, 2 behavioralists, 1 clinical pharmacist. This interdisciplinary team will have reduced patient panel load and increased flexibility in time and scheduling in order to foster trust and continuity with the patient with a goal of decreasing treatment burden and increasing patient capacity. Specific activities that participants will receive include: 1) comprehensive initial intake and care plan development that incorporates patient goal setting; 2) flexible scheduling of appointments with outreach; 3) transitional care coordination; 4) built-in behavioural counselling and case management; 5) regular review of care plan by team members.', 'interventionNames': ['Other: SUMMIT intervention']}\n- {'label': 'enhanced usual care group', 'type': 'ACTIVE_COMPARATOR', 'description': \"This group will continue to receive primary care as usual for 6 months. This includes care provided by the patient's existing primary care provider, access to a clinic's Health Resilience outreach worker, mental health consultation, and other services provided by usual care. After 6 months, the baseline survey is administered and the participant will transfer care to the intervention as described above in the SUMMIT intervention group.\", 'interventionNames': ['Other: Enhanced usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'SUMMIT intervention', 'description': 'See description in experimental arm.', 'armGroupLabels': ['SUMMIT intervention group'], 'otherNames': ['intensive primary care team, complex care team']}\n- {'type': 'OTHER', 'name': 'Enhanced usual care', 'description': 'See description in active comparator arm.', 'armGroupLabels': ['enhanced usual care group'], 'otherNames': ['usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Medical Hospitalizations', 'description': 'Administrative data will be used to determine hospital admissions', 'timeFrame': '6 months'}\n- {'measure': 'Emergency Care visits', 'description': 'Administrative data will be used to determine Emergency Department (ED) visits over study period', 'timeFrame': '6 months'}\n- {'measure': 'Primary care utilization', 'description': 'Clinic administrative data will be used to determine primary care visits over study period', 'timeFrame': '6 months'}\n- {'measure': 'Patient Activation Measure (PAM)', 'description': 'Study survey of the PAM measure is a validated instrument to assess patient self-efficacy', 'timeFrame': '6 months'}\n- {'measure': 'Patient Experience (ambulatory CAHPS)', 'description': 'Study survey of patient reported assessment of patient experience', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 2-tailed alpha, standard deviation of 1.9 for hospitalizations and 10 for PAM score", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n We conducted several sample size calculations to estimate the study size population.\n We examined the sample size necessary to demonstrate a 40% reduction in our primary outcomes of hospital utilization over 6\u00c2\u00a0months. We determined average number of hospitalizations over the prior 6\u00c2\u00a0months for a pilot sample of SUMMIT patients (2.3 hospitalizations/person over 6\u00c2\u00a0months, SD\u00e2\u0080\u0089=\u00e2\u0080\u00891.9). Assuming 80% power and 2-tailed alpha, the sample size estimated was 140 participants. Based on preliminary data, we believed 400 existing patients met SUMMIT eligibility for utilization, but targeted an enrollment of 200 based on potential difficulties with recruitment and retention. We used prior literature to determine an effect size of a four-point increase on the secondary outcome of PAM score, with standard deviation of 10; therefore, at 80% power and 2 tailed alpha, the sample size estimated was 196 [41].", "id": 173, "split": "train"} +{"trial_id": "NCT03229330", "pmid": "30001202", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Low-level Light Therapy on Treatment of Venous Ulcers Assessed by Nursing Outcomes Classification (NOC): Randomized Clinical Trial\n\nIncluded conditions:\n- Venous Ulcer\n- Low-Level Light Therapy\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Low-level Light Therapy: Wavelength of 660 nm (red laser) and Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.', 'interventionNames': ['Procedure: Low-level Light Therapy', 'Combination Product: Conventional treatment']}\n- {'label': 'Controls', 'type': 'ACTIVE_COMPARATOR', 'description': 'Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks.', 'interventionNames': ['Combination Product: Conventional treatment']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Low-level Light Therapy', 'description': 'Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.', 'armGroupLabels': ['Intervention'], 'otherNames': ['Wavelength of 660 nm', 'red laser']}\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Conventional treatment', 'description': 'Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress', 'armGroupLabels': ['Controls', 'Intervention'], 'otherNames': ['Topical and compressive treatments']}\n\nPrimary Outcomes:\n- {'measure': 'Decreased Wound Size and Scar formation', 'description': 'NOC Wound Healing: Second Intention - Greater length (in the cephalopheudial direction) versus greater width, in cm2 evaluated by the Likert scale, being 1 the worst score and 5 best score.\\n\\nNOC Wound Healing: Second Intention - Wound covered with epithelial tissue (new pink or bright tissue that develops from the edges or as \"islands\" on the surface of the lesion) evaluated by the Likert scale, being 1 the worst score and 5 best score.', 'timeFrame': '16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a statistical power of 80%, a significance level of 5%, and accounts for a 20% dropout rate.", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size\n The WINPEPI program, version 11.43, was used to calculate the sample size. A sample of 34 subjects (n\u00e2\u0080\u0089=\u00e2\u0080\u008917 per group) would be able to detect a 1-point difference on a NOC indicator score between group means (laser intervention versus conventional control) as significant. The indicators are scored on 5-point Likert scales (range 1 to 5), in which the lowest score represents the worst possible state and the highest score represents the most desirable state after implementation of interventions. A change in one level, i.e., one point on the Likert scale, characterizes a positive effect of the intervention implemented throughout the treatment study, according to mixed linear models and generalized estimating equations. The standard deviation common to the groups [18], with a statistical power of 80% and significance level of 5% were defined for the study. To account for possible refusals and losses to follow-up, the sample was oversized by 20%. Thus, 40 subjects (n\u00e2\u0080\u0089=\u00e2\u0080\u008920 per group) will be recruited.", "id": 174, "split": "train"} +{"trial_id": "NCT03229681", "pmid": "30012193", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial\n\nIncluded conditions:\n- Rehabilitation With CHF; NYHA Class I or II\n\nStudy Armgroups:\n- {'label': 'Baduanjin exercise group', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group received routine rehabilitation training and Baduanjin exercise', 'interventionNames': ['Behavioral: Baduanjin exercise']}\n- {'label': 'Routine rehabilitation group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this group only received routine rehabilitation training', 'interventionNames': ['Behavioral: Routine rehabilitation group']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Baduanjin exercise', 'description': 'Participants in this groups received routine rehabilitation training and Baduanjin exercise. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. Baduanjin exercise protocol according to the \"Health Qigong Baduanjin Standard\" enacted by the General Administration of Sports in 2003. Due to the low-activity tolerance of CHF patients, we performed with a refined version of Baduanjin. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks.', 'armGroupLabels': ['Baduanjin exercise group'], 'otherNames': ['Routine rehabilitation']}\n- {'type': 'BEHAVIORAL', 'name': 'Routine rehabilitation group', 'description': 'Participants in this qroup only received the routine rehabilitation training. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. They should also come to rehabilitation center for physical exercise,45 minutes per day\uff0ctwice per week, lasts 12 weeks.', 'armGroupLabels': ['Routine rehabilitation group']}\n\nPrimary Outcomes:\n- {'measure': 'Six-minute walk test\uff086MWT\uff09', 'description': 'Testing patients changes on walking distance and accompanies symptoms in 6 minutes', 'timeFrame': 'Baseline, 3 months'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate (alpha) = 0.05, \u03bc1-\u03b1 = 1.64, Type II error rate (beta) = 0.1 (power = 90%), \u03bc1-\u03b2 = 1.282, 20% loss to follow-up within 6 months.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size is calculated, based on the 6MWT, according to the following superiority test formula:\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ {n}_c=\\frac{\\left(1+\\frac{1}{k}\\right){\\left({\\mu}_{1-\\alpha }+{\\mu}_{1-\\beta}\\right)}^2{\\sigma}^2}{{\\left[\\left({x}_t-{x}_c\\right)-\\varDelta \\right]}^2}, $$\\end{document}nc=1+1k\u00ce\u00bc1\u00e2\u0088\u0092\u00ce\u00b1+\u00ce\u00bc1\u00e2\u0088\u0092\u00ce\u00b22\u00cf\u00832xt\u00e2\u0088\u0092xc\u00e2\u0088\u0092\u00ce\u00942,\n nt\u00e2\u0080\u0089=\u00e2\u0080\u0089knc, The patients\u00e2\u0080\u0099 numbers were arranged in equal proportion (k\u00e2\u0080\u0089=\u00e2\u0080\u00891), a superiority one-sided test was employed. According to result of a previous study [32], xt\u00e2\u0080\u0089=\u00e2\u0080\u0089512.5, xc\u00e2\u0080\u0089=\u00e2\u0080\u0089436.2, \u00ce\u00b4t\u00e2\u0080\u0089=\u00e2\u0080\u008950.2, \u00ce\u00b4c\u00e2\u0080\u0089=\u00e2\u0080\u008949.8, \u00ce\u00b4 is the estimated standard difference calculated as 50.0, and \u00ce\u0094\u00e2\u0080\u0089=\u00e2\u0080\u00890.9, \u00ce\u00b4\u00e2\u0080\u0089=\u00e2\u0080\u008945.0. Setting a type I error rate of alpha at 0.05, \u00ce\u00bc1-a=\u00e2\u0080\u00891.64, and setting a type II error rate of beta at 0.1 (a power of 90%), \u00ce\u00bc1-\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00891.282, the calculated sample size of each group is around 49. Assuming conservatively that 20% may be lost to follow-up within 6\u00c2\u00a0months, the total sample size needed to detect this difference at a 5% level of significance with a power of 90% is 118 patients. For our study, we decided to recruit 120 patients for the convenience of randomization.", "id": 175, "split": "train"} +{"trial_id": "NCT03229811", "pmid": "33619188", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Integrating Conservative Kidney Management Options and Advance Care Planning Into a Pre-Dialysis Educational Program\n\nIncluded conditions:\n- Advance Care Planning\n- Chronic Kidney Diseases\n- Conservative Kidney Management\n\nStudy Armgroups:\n- {'label': 'Standard pre-dialysis education', 'type': 'NO_INTERVENTION', 'description': 'Standard pre-dialysis options education including hemodialysis, peritoneal dialysis, and kidney transplantation'}\n- {'label': 'ESRD education + ACP', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard ESRD education + conservative kidney management and advance care planning education', 'interventionNames': ['Other: ESRD education + conservative kidney management and ACP education']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ESRD education + conservative kidney management and ACP education', 'description': 'Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers', 'armGroupLabels': ['ESRD education + ACP']}\n\nPrimary Outcomes:\n- {'measure': 'Knowledge of Conservative Kidney Management and Advance Care Planning (Pre-intervention)', 'description': 'Knowledge of conservative kidney management and advance care planning pre-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning', 'timeFrame': 'Pre-intervention and Day 1 post-intervention'}\n- {'measure': 'Knowledge of Conservative Kidney Management and Advance Care Planning (Post-intervention)', 'description': 'Knowledge of conservative kidney management and advance care planning post-intervention (mean score) Total score ranges from 0 to 9, where 9 represents having the most knowledge about conservative kidney management and advance care planning', 'timeFrame': 'Immediate post-intervention'}\n\nPlease estimate the sample size based on the assumption: \n85% power", "answer": 4, "answer_type": "ACTUAL", "explanation": "Power and sample size\n Based on the published data demonstrating poor knowledge of conservative kidney management among patients with advanced kidney disease,48 we anticipate that recruitment of 50 patients to each arm will provide 85% power to detect an effect size of 0.5 SD when comparing the change in knowledge of conservative kidney management and ACP between the two groups.49 50", "id": 176, "split": "train"} +{"trial_id": "NCT03230071", "pmid": "30572524", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Twice Daily TMBCZG in Mild to Moderate Vascular Dementia: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Trial\n\nIncluded conditions:\n- Vascular Dementia\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'placebo identified to TMBCZG,0.1g per pill which contains 0mg TMBCZG\uff0c3 pills per time, 2 times per day for 24 weeks.', 'interventionNames': ['Other: placebo']}\n- {'label': 'TMBCZG-high dose', 'type': 'EXPERIMENTAL', 'description': 'TMBCZG, 0.1g per pill which contains 14mg TMBCZG, 3 pills per time, 2 times per day for 24 weeks.', 'interventionNames': ['Drug: TMBCZG']}\n- {'label': 'TMBCZG-medium dose', 'type': 'EXPERIMENTAL', 'description': 'TMBCZG( 0.1g per pill which contains 14mg TMBCZG) and placebo identified to TMBCZG(0.1g per pill which contains 0mg TMBCZG), 2 TMBCZG pills and 1 placebo pill per time, 2 times per day for 24 weeks.', 'interventionNames': ['Drug: TMBCZG', 'Other: placebo']}\n- {'label': 'TMBCZG-low dose', 'type': 'EXPERIMENTAL', 'description': 'TMBCZG( 0.1g per pill which contains 14mg TMBCZG) and placebo identified to TMBCZG(0.1g per pill which contains 0mg TMBCZG), 1 TMBCZG pills and 2 placebo pill per time, 2 times per day for 24 weeks.', 'interventionNames': ['Drug: TMBCZG', 'Other: placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'TMBCZG', 'description': '0.1g per pill which contains 14mg TMBCZG', 'armGroupLabels': ['TMBCZG-high dose', 'TMBCZG-low dose', 'TMBCZG-medium dose'], 'otherNames': ['TianMaBianChunZhiGanPian', 'TianMaYouJiDuoSuanBianZhiGanPian(TMYJDSBZG)']}\n- {'type': 'OTHER', 'name': 'placebo', 'description': '0.1g per pill which contains 0mg TMBCZG', 'armGroupLabels': ['Placebo', 'TMBCZG-low dose', 'TMBCZG-medium dose']}\n\nPrimary Outcomes:\n- {'measure': 'Vascular Dementia Assessment Scale-cognitive subscale(VADAS-Cog)', 'description': 'Change from baseline to end of double-blind treatment of VADAS-Cog.', 'timeFrame': 'baseline, 4-week, 12-week, 24-week and 28-week.'}\n- {'measure': 'Clinical Dementia Rating-Sum of Boxes (CDR-SB)', 'description': 'Change from baseline to end of double-blind treatment of CDR-SB.', 'timeFrame': 'baseline, 4-week, 12-week, 24-week and 28-week.'}\n\nPlease estimate the sample size based on the assumption: \nThe variance of the 4 groups of VADAS-cog means is 1.14, and the standard deviation within is 7.44 points. The 2-sided test level \u03b1 = 0.20 and the power 1-\u03b2 = 0.50. A greater rate of discontinuation of 20% is considered.", "answer": 160, "answer_type": "ACTUAL", "explanation": "2.7\n Sample size\n There are no similar studies using TMBCZG tablets to treatment patients with VaD for the proposed study duration (24 weeks). The sample size was calculated based on the primary endpoints, VADAS-cog. It is hypothesized that the efficacy of TMBCZG in the treatment of mild to moderate VaD is similar to that of donepezil. Previous studies reported that the mean changes of ADAS-cog scores after 5 and 10\u00e2\u0080\u008amg donepezil treatment were (5.75\u00e2\u0080\u008a\u00c2\u00b1\u00e2\u0080\u008a7.44) points and (2.25\u00e2\u0080\u008a\u00c2\u00b1\u00e2\u0080\u008a7.44) points, respectively. We assume that the placebo control group has a certain progression after 24 weeks\u00e2\u0080\u0099 treatment (\u00e2\u0096\u00b3\u00e2\u0080\u008a=\u00e2\u0080\u008a\u00e2\u0088\u00920.25). The mean scores of the 3 groups of VADAS-cog scale improvement were set at equal intervals, that is, the changes before and after the scores of each group were \u00e2\u0088\u00920.25, 0.75, 1.50, 2.25, and the variance of the 4 groups of VADAS-cog means 1.14. The standard deviation within is 7.44 points. For this phase IIa study, the 2-sided test level \u00ce\u00b1 = 0.20 and the power 1-\u00ce\u00b2 = 0.50. This clinical trial adopts a balanced design and uses nQuery Advisor 7.0 to calculate, 32 cases are needed for each group. Considering a greater rate of discontinuation of 20%, the sample size was increased to 39 per group to ensure adequate patients to complete the study. The total number of cases was 160 cases, that is, 40 cases in the placebo control group and 40 cases in the 3 dose groups of the TMBCZG tablets. Note also that because this study is a pilot efficacy study (phase IIa), a larger sample size to reach a higher degree of statistical power is not required.", "id": 177, "split": "train"} +{"trial_id": "NCT03235804", "pmid": "37709337", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota: a 12-week Study in Individuals With Excessive Body Weight\n\nIncluded conditions:\n- Dietary Modification\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': \"Those assigned to the Control group will be asked to maintain their usual dietary intake over 12 weeks. Participants' usual dietary intake is expected to reflect the North American dietary pattern (i.e. \\\\~15% of total energy intake coming from protein, \\\\~50% from carbohydrate and \\\\~35% from fat).\"}\n- {'label': 'Powdered Meal Replacement Group', 'type': 'EXPERIMENTAL', 'description': 'Those assigned to the Powdered Meal Replacement group will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).', 'interventionNames': ['Dietary Supplement: Soy protein, honey and yogurt.']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Soy protein, honey and yogurt.', 'description': 'Participants will be asked to maintain their usual dietary intake and consume a powdered meal replacement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).', 'armGroupLabels': ['Powdered Meal Replacement Group']}\n\nPrimary Outcomes:\n- {'measure': 'Interleukin-6.', 'description': 'Changes in blood interleukin-6 will be assessed at baseline, middle and end of the 12-week dietary intervention period.', 'timeFrame': 'At baseline (week 1), middle (week 6) and end (week 12) of the intervention period (12 weeks).'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5%, power of 80%, and a 20% attrition rate.", "answer": 88, "answer_type": "ACTUAL", "explanation": "Sample size estimate\n A total of 74 participants (37 in each group) will be needed to detect a medium effect size (ES) of 0.669. The ES was calculated based on a previously published study,30 in which the mean per cent change in IL-6 from baseline to 12\u00e2\u0080\u0089months was \u00e2\u0088\u00926.76\u00c2\u00b136.95\u00e2\u0080\u0089pg/mL in a group receiving soy protein versus 17.62\u00c2\u00b135.92\u00e2\u0080\u0089pg/mL in the CON. Accounting for a 20% attrition rate, the total sample size of 88 participants (44 in each group) will have a power of 80% with a significance level of 5%. The sample size calculation was done using G*Power V.3.1.9.2.", "id": 178, "split": "train"} +{"trial_id": "NCT03236961", "pmid": "30558607", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis: a Prospective Randomised Multicenter Study (The APPAC II Study)\n\nIncluded conditions:\n- Acute Appendicitis\n\nStudy Armgroups:\n- {'label': 'Intravenous & per oral antibiotics', 'type': 'ACTIVE_COMPARATOR', 'description': 'Ertapenem 1 g x 1 for two days i.v. followed by p.o. levofloxacin 500 mg x 1 and metronidazole 500 mg x 3 for 5 days, duration of treatment one week.', 'interventionNames': ['Drug: Ertapenem']}\n- {'label': 'Per oral antibiotics', 'type': 'ACTIVE_COMPARATOR', 'description': 'Moxifloxacin 400 mg x 1 foe seven days, duration of treatment one week.', 'interventionNames': ['Drug: Moxifloxacin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ertapenem', 'description': 'I.v. ertapenem 1 g for 2 days followed by p.o. levofloxacin 500 mg x1 and metronidazole 500 mg x 3 for 5 days', 'armGroupLabels': ['Intravenous & per oral antibiotics'], 'otherNames': ['Levofloxacin', 'Metronidazole']}\n- {'type': 'DRUG', 'name': 'Moxifloxacin', 'description': 'P.o. moxifloxacin 400 mg x1 for 7 days', 'armGroupLabels': ['Per oral antibiotics']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment success', 'description': 'The resolution of acute uncomplicated appendicitis with allocated antibiotic treatment. Treatment success is defined as discharge from the hospital without the need for surgical intervention after the primary hospitalisation and no recurrent appendicitis during one-year follow-up.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 0.9 (1-\u03b2) with a one-sided significance level (\u03b1) of 0.05 and an estimated dropout rate of 15%.", "answer": 552, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n As the primary objective of the study is to demonstrate that p.o. antibiotics are non-inferior compared to a combination of i.v. and p.o. antibiotic therapy, a non-inferiority design is used and sample size calculations were based on non-inferiority test for binomial proportion. Sample size was calculated from an estimated success rate of 73% for i.v. + p.o. antibiotic group during the one year follow-up based on the results of our previous APPAC trial [10]. The hypothetical difference between the two groups ((i.v. + p.o.) \u00e2\u0080\u0093 (p.o.)) was set to zero and non-inferiority margin was set to 6 percentage points. We estimated that a total of 469 patients would yield a power of 0.9 (1-\u00ce\u00b2) to establish whether p.o. antibiotic therapy was non-inferior to i.v. + p.o. using a one-sided significance level (\u00ce\u00b1) of 0.05. With an estimated dropout rate of 15% total of 552 patients, 276 patients per group will be enrolled in the study. Targeted minimum sample size per study hospital will be 20 patients.", "id": 179, "split": "train"} +{"trial_id": "NCT03240783", "pmid": "29980542", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain: Evaluate Route Versus Pharmacology of Intervention, and Feasibility in Public Hospital and Community Practice Settings.\n\nIncluded conditions:\n- Acute Sciatica\n\nStudy Armgroups:\n- {'label': 'Arm 1', 'type': 'EXPERIMENTAL', 'description': 'Betamethasone OR Dexamethasone Injectable CT - fluoroscopic guided transforaminal lumbar epidural steroid', 'interventionNames': ['Drug: Betamethasone OR Dexamethasone Injectable', 'Other: Sham Injection and/or oral placebo']}\n- {'label': 'Arm 2', 'type': 'EXPERIMENTAL', 'description': 'Normal Saline Flush, 0.9% Injectable Solution CT - fluoroscopic guided transforaminal lumbar epidural normal saline', 'interventionNames': ['Drug: Normal Saline Flush, 0.9% Injectable Solution', 'Other: Sham Injection and/or oral placebo']}\n- {'label': 'Arm 3', 'type': 'EXPERIMENTAL', 'description': 'Dexamethasone Oral Tablet:\\n\\nOral dexamethasone 15 day tapered dosing is as follows: (i) days 1-5, 4 mg morning and evening, (ii) days 6-10, 2 mg morning and evening, and (iii) days 11-15, 1mg morning and evening.', 'interventionNames': ['Drug: Dexamethasone Oral Tablet', 'Other: Sham Injection and/or oral placebo']}\n- {'label': 'Arm 4', 'type': 'OTHER', 'description': 'Sham Injection and/or oral placebo: CT/fluoroscopic guided (parameters set to zero) transforaminal lumbar sham (needle placement down to muscle and no injection of any fluid) AND placebo oral tablets taper.', 'interventionNames': ['Other: Sham Injection and/or oral placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Betamethasone OR Dexamethasone Injectable', 'description': 'Procedural agents. The steroid and local anaesthetic preparation will be standardized to replicate current radiology interventional practices that use either particulate or non-particulate steroids. Betamethasone Sodium Phosphate/Acetate 5.7 mg/ml Injectable is a particulate corticosteroid and is used with the local anaesthetic bupivacaine 0.5% (1ml). Dexamethasone 4mg (1ml) is a non-particulate corticosteroid and is used with the local anaesthetic lignocaine 1% (1ml).', 'armGroupLabels': ['Arm 1'], 'otherNames': ['celestone chondrase 5.7 mg/ml injectable suspension']}\n- {'type': 'DRUG', 'name': 'Normal Saline Flush, 0.9% Injectable Solution', 'description': 'Procedural agents. The local anaesthetic preparation used with the Normal Saline Flush, 0.9% Injectable Solution, will be standardized to replicate current radiology interventional practices: either local anaesthetic bupivacaine 0.5% (1ml) or local anaesthetic lignocaine 1% (1ml).', 'armGroupLabels': ['Arm 2'], 'otherNames': ['There is no other name.']}\n- {'type': 'DRUG', 'name': 'Dexamethasone Oral Tablet', 'description': 'Dexamethasone Oral Tablet: 15 day taper dosing is: days 1-5 8mg (4mg bd) , days 6-10 4 mg (2mg bd), and days 11-15 2 mg (1mg bd). The dexamethasone is over-encapsulated in a gelatine capsule that is identical to the placebo capsule in appearance.', 'armGroupLabels': ['Arm 3'], 'otherNames': ['Dexmethsone']}\n- {'type': 'OTHER', 'name': 'Sham Injection and/or oral placebo', 'description': 'The sham Injection procedure is needle placement down to muscle at the designated spinal level and no injection of any fluid. The oral placebo is a gelatine capsule packed with filler.', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4'], 'otherNames': ['There is no other name']}\n\nPrimary Outcomes:\n- {'measure': 'Oswestry Disability Index (ODI) version 2.0', 'description': 'ODI is a functional status measure specifically developed for disorders of the spine', 'timeFrame': '3 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical test used is the independent two-sample t-test with a two-tailed alpha of 0.05. The pilot study has 85% power, while the full-scale study aims for 90% power. A 20% dropout rate is considered for the full-scale study.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n Most trials of subacute and chronic sciatica of a selective CT fluoroscopy TESI have a sample size of 30 participants per arm. The primary outcome in this pilot/feasibility study is the ODI at 3 weeks comparing epidural steroid and sham injection (arm 1\u00c2\u00a0vs\u00c2\u00a0arm 4). With 15 participants per arm, there is 85% power to detect a difference of 17 ODI points between these two arms, given a SD of change of ODI of 15.1 points.31 Statistical test on which calculation is based is the independent two-sample t-test with a two-tailed alpha of 0.05 (Stata V.14). This is a total of 60 participants in this pilot/feasibility study. This is sufficient to evaluate feasibility of the study design, study conduct and determine sample size for a full-scale multicentre study. However, this ODI difference is a large unrealistic effect. The minimum clinically important difference in ODI scores in one study was 7.0 points,47 and an international consensus group found empirical evidence of 4 to 15 ODI points48 and recommended a cut-off value of 10 ODI points. In a full-scale study recruiting participants with acute sciatica of less than 4 weeks\u00e2\u0080\u0099 duration, an ODI difference of at least 10 ODI points is very reasonable. A sample size of 49 participants per arm would\u00c2\u00a0provide 90% power to detect a minimum clinically important difference of 10 ODI points assuming a SD of 15.1 with a two-tailed alpha of 0.05 (Stata V.14). Allowing for 20% dropout (which at 3 weeks is unlikely but at 48 weeks is more likely), 236 participants would\u00c2\u00a0be recruited, 59 to each arm. Although there are six possible comparisons in a four-arm trial, controlling for type\u00c2\u00a01 error rate is not needed when several different experimental arms are compared with the control.49 50 Therefore, no multiplicity adjustment is needed for (1) comparison I\u00e2\u0080\u0094arm 1 versus\u00c2\u00a0arm 4 (epidural steroid is superior to control), (2) comparison II\u00e2\u0080\u0094arm 2 versus\u00c2\u00a0arm 4 (epidural saline is superior to control) and (3) comparison III\u00e2\u0080\u0094arm 3 versus\u00c2\u00a0arm 4 (oral steroid is superior to control). However, in order to proceed to comparison IV, arm 1 versus\u00c2\u00a0arm 3 (epidural steroid is superior to oral steroids), we must first demonstrate that comparisons I and III were statistically significant, and there must be a type\u00c2\u00a01 error consideration.51 Furthermore, if the hypothesis is that oral steroid is non-inferior to epidural steroids, then the ignorable difference must also be prespecified. The pilot/feasibility study will provide data that will be helpful in determining these sample size calculations. The feasibility study will be informative regarding the estimated mean difference in this population, its SD and pattern of missing data at each of the study visits.", "id": 180, "split": "train"} +{"trial_id": "NCT03244514", "pmid": "32265240", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Biomarker-guided Implementation of the Cardiovascular (CV) Surgery AKI Bundle to Reduce the Occurrence of AKI After Cardiac Surgery- Prevention of AKI\n\nIncluded conditions:\n- Acute Kidney Injury (Nontraumatic)\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Implementation of the cardiovascular surgery AKI bundle\\n\\n1. discontinuation of all nephrotoxic agents when possible\\n2. optimization of volume status and hemodynamic parameters\\n3. close monitoring of serum creatinine, fluid balance and urinary output\\n4. avoidance of hyperglycemia\\n5. considerations of alternatives to radiocontrast agents\\n6. discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period\\n7. avoidance of HES, gelatin, and chlorid-rich solutions', 'interventionNames': ['Other: Intervention']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'The patients will receive standard of care (according to each center)'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Intervention', 'description': 'Implementation of the cardiovascular AKI bundle (see arm description)', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Compliance rate', 'description': 'proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time', 'timeFrame': '48 hours after start of intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe primary analysis will estimate the compliance rate with a two-sided 95% CI. The CI is calculated using the Clopper-Pearson method, and the precision of the compliance rate estimation is \u00b16%.", "answer": 280, "answer_type": "ACTUAL", "explanation": "Sample size\n For the survey, no power analysis is required. The number of patients is based on surgical volumes in the two consecutive days prior to the interventional trial and is expected to be about n=100.\n In the interventional trial, 1000 patients will be assessed for eligibility, and 280 patients will be enrolled into the trial and randomised (based on our previous findings). This sample size is determined as follows:\n Patients will be randomised in a 1:1 ratio to one of the two treatment arms (intervention vs control). Randomisation serves to estimate the incidence of AKI as a secondary outcome to generate preinformation in preparation for an upcoming confirmatory trial.\n The primary endpoint of the interventional trial is the compliance rate, that is, the proportion of patients treated according to the trial protocol (intervention group: CV surgery AKI bundle fulfilled at all time; control group: documented standard of care according to current clinical practice). In order to estimate the compliance rate, the two treatment groups will be pooled together. In the primary analysis, the compliance rate across all study patients will be estimated along with a two-sided 95% CI.\n As the compliance rate cannot be quantified in advance, we pursue a worst-case approach and assume a compliance rate of 50%. In this case, the CI has maximal width. Based on this assumption, with a sample size of n=280 patients, the calculated 95% CI according to Clopper-Pearson (Fleiss 2003) ranges from 44% to 56%. Therefore, in case of any observed compliance rate apart from the worst-case scenario, the 95% CI is never wider than 56%\u00e2\u0088\u009244%=12%. This corresponds to an estimation of the compliance rate with a precision of \u00c2\u00b16%.", "id": 181, "split": "train"} +{"trial_id": "NCT03245593", "pmid": "29653535", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Shared Medical Decision Making in the Prophylactic Treatment of Bipolar Disorder\n\nIncluded conditions:\n- Bipolar Disorder\n\nStudy Armgroups:\n- {'label': 'Shared Decision making for care', 'interventionNames': ['Other: Shared-decision making process']}\n- {'label': 'Standard decision making for care', 'interventionNames': ['Other: standard care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Shared-decision making process', 'description': 'Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available', 'armGroupLabels': ['Shared Decision making for care']}\n- {'type': 'OTHER', 'name': 'standard care', 'description': 'Care of patients according to standard practice of managing patients with bipolar disorder', 'armGroupLabels': ['Standard decision making for care']}\n\nPrimary Outcomes:\n- {'measure': 'Measure the difference of prophylactic treatment compliance between bipolar patients receiving treatment according to standard care versus a shared decision making care plan following a mood episode.', 'description': 'Clinician Rating Scale (1-7)', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, standard deviation of 1.4, intra-cluster coefficient of 0.05, two-sided T-test with a significance level of 0.05, 20% dropout rate at 12 months.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated using PASS Power Analysis and Sample Size Software 15.\n The number of subjects required was determined from the assumptions based on the primary outcome, the adherence score measured from the CRS (score rated between 1 and 7).\n A minimum difference of 1 point between the two groups is considered as clinically relevant (minimal clinically observable change) [21, 22]. A sample size of 5 clusters per group with 23 individuals per cluster achieves 90% power to detect a difference of 1 between the two group means when the standard deviation is 1.4 and the intra-cluster coefficient is 0.05 using a two-sided T-test with a significance level of 0.05 [45, 46]. To prevent 20% of dropout at 12\u00c2\u00a0months, 30 individuals per cluster is necessary and a total of 300 patients should be included.", "id": 182, "split": "train"} +{"trial_id": "NCT03246321", "pmid": "31352425", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Repetitive Electrostatic Pressurised Intraperitoneal Aerosol Chemotherapy With Oxaliplatin (ePIPAC-OX) as a Palliative Monotherapy for Isolated Unresectable Colorectal Peritoneal Metastases: Protocol of a Multicentre, Open-label, Single-arm, Phase II Study (CRC-PIPAC)\n\nIncluded conditions:\n- Colorectal Neoplasms\n- Peritoneal Neoplasms\n- Appendiceal Neoplasms\n- Peritoneal Carcinomatosis\n\nStudy Armgroups:\n- {'label': 'repetitive ePIPAC-OX', 'type': 'EXPERIMENTAL', 'interventionNames': ['Combination Product: repetitive ePIPAC-OX']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'repetitive ePIPAC-OX', 'description': 'Instead of standard palliative treatment, enrolled patients receive laparoscopy-controlled electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) (92 mg/m2 body-surface area \\\\[BSA\\\\]) with intravenous leucovorin (20 mg/m2 BSA) and bolus 5-fluorouracil (400 mg/m2 BSA) every six weeks. Four weeks after each procedure, patients undergo clinical, radiological, and biochemical evaluation. ePIPAC-OX is repeated until clinical, radiological, or macroscopic disease progression, after which standard palliative treatment is (re)considered.', 'armGroupLabels': ['repetitive ePIPAC-OX']}\n\nPrimary Outcomes:\n- {'measure': 'Major toxicity', 'description': 'Number of patients with Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade III-V, up to 4 weeks after the last ePIPAC-OX', 'timeFrame': 'Expected (in case of three ePIPAC-OX): 16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe expected mean number of procedures is three per patient. Enrolled patients who do not undergo a first ePIPAC-OX are replaced to ensure 20 patients receive at least one procedure.", "answer": 20, "answer_type": "ACTUAL", "explanation": "Sample size\n Given the absence of evident clinical endpoints in this patient category, the investigators pragmatically determined the sample size of this exploratory study. The investigators agreed that 60 procedures are required to explore the feasibility, safety, tolerability and preliminary efficacy of repetitive ePIPAC-OX in this setting. Since the expected mean number of procedures is three per patient,36 the initial sample size is determined at 20 patients. This pragmatically determined sample size is approved by the central ethics committee. Enrolled patients who do not undergo a first ePIPAC-OX (eg, systemic metastases on baseline radiology, non-access, resectable disease) are replaced to enrol 20 patients who receive at least one ePIPAC-OX.", "id": 183, "split": "train"} +{"trial_id": "NCT03247491", "pmid": "31779683", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Mindfulness and Compassion Group Intervention Applied to Pregnant Women and Their Partners to Decrease Stress, Negative Affect and Depression During Pregnancy and Breastfeeding. Controlled and Randomized Study\n\nIncluded conditions:\n- Pregnancy, Childbirth and Postpartum\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': 'TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.', 'interventionNames': ['Behavioral: Mindfulness']}\n- {'label': 'No intervention', 'type': 'NO_INTERVENTION', 'description': 'Usual medical treatment (TAU) In this group the midwife will apply the usual treatment (childbirth education class in the third trimester of pregnancy).'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness', 'description': 'TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.', 'armGroupLabels': ['Experimental']}\n\nPrimary Outcomes:\n- {'measure': 'Edinburgh postnatal depression scale (EPDS)', 'description': 'In the mindfulness and compassion based intervention group', 'timeFrame': 'Baseline'}\n- {'measure': 'Edinburgh postnatal depression scale (EPDS)', 'description': 'In the TAU control group', 'timeFrame': 'Baseline'}\n- {'measure': 'Edinburgh postnatal depression scale (EPDS)', 'timeFrame': 'Post-treatment 8 weeks from baseline in intervention group'}\n- {'measure': 'Edinburgh postnatal depression scale (EPDS)', 'timeFrame': 'Post-treatment 8 weeks from baseline in TAU control group'}\n- {'measure': 'Edinburgh postnatal depression scale (EPDS)', 'timeFrame': 'Post-partum 3 months follow up in 8 weeks intervention group'}\n- {'measure': 'Edinburgh postnatal depression scale (EPDS)', 'timeFrame': 'Post-partum 3 months follow up in TAU control group'}\n- {'measure': 'Edinburgh postnatal depression scale (EPDS)', 'timeFrame': 'Post-partum 6 months follow up in 8 weeks intervention group'}\n- {'measure': 'Edinburgh postnatal depression scale (EPDS)', 'timeFrame': 'Post-partum 6 months follow up in TAU control group'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, a 5% significance level, a local alpha of 0.017 in the first test using Benjamini-Hochberg's procedure, and a dropout rate in the range of 15%-20%.", "answer": 122, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size estimation was based on the expectation of a moderate standardized mean difference between groups on depressive symptoms at post-birth of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.59. Like the protocol that will be used in the present study, this effect size was found in a recent RCT that used a modified MBCP program [24] compared to a TAU active standard childbirth preparation course with no mind\u00e2\u0080\u0093body components. This effect size is also similar to that obtained in other studies using other programs [44], a pilot study evaluating the effectiveness of MBCE [33], a cohort study assessing the MindBabyBody program [34], and a brief pilot adaptation based upon the MBCP program [9]. Considering a statistical power of 80%, a 5% significance level in a between-group interaction with a local alpha of 0.017 in the first test\u00e2\u0080\u0094using Benjamini\u00e2\u0080\u0093Hochberg\u00e2\u0080\u0099s procedure\u00e2\u0080\u0094and a dropout rate in the range of 15%\u00e2\u0080\u009320%, as has been observed in these types of studies [45], 61 participants are needed in each group, for a total sample size of 122 women.", "id": 184, "split": "train"} +{"trial_id": "NCT03249532", "pmid": "33858390", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of High-volume Online hemodiafiLtration on Intra-diaLytic hemodynAmic (iN)sTability and Cardiac Function in Chronic Hemodialysis Patients (the HOLLANT Study)\n\nIncluded conditions:\n- End Stage Renal Disease (ESRD)\n- Hemodialysis\n- Hemodiafiltration\n- Intradialytic Hypotension\n- Diastolic Dysfunction\n\nStudy Armgroups:\n- {'label': 'standard hemodialysis', 'type': 'ACTIVE_COMPARATOR', 'description': 'prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 0 Liters (L)', 'interventionNames': ['Device: cool hemodialysis', 'Device: low volume hemodiafiltration', 'Device: high volume hemodiafiltration']}\n- {'label': 'cool hemodialysis', 'type': 'ACTIVE_COMPARATOR', 'description': 'prescription of dialysate temperature: 35.5 degrees celsius prescription of convection volume: 0 L', 'interventionNames': ['Device: standard hemodialysis', 'Device: low volume hemodiafiltration', 'Device: high volume hemodiafiltration']}\n- {'label': 'low volume hemodiafiltration', 'type': 'ACTIVE_COMPARATOR', 'description': 'prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L', 'interventionNames': ['Device: standard hemodialysis', 'Device: cool hemodialysis', 'Device: high volume hemodiafiltration']}\n- {'label': 'high volume hemodiafiltration', 'type': 'ACTIVE_COMPARATOR', 'description': 'prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L', 'interventionNames': ['Device: standard hemodialysis', 'Device: cool hemodialysis', 'Device: low volume hemodiafiltration']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'standard hemodialysis', 'description': 'hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 36.5 degrees Celsius; convection volume: not applicable', 'armGroupLabels': ['cool hemodialysis', 'high volume hemodiafiltration', 'low volume hemodiafiltration']}\n- {'type': 'DEVICE', 'name': 'cool hemodialysis', 'description': 'hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 35.5 degrees Celsius; convection volume: not applicable', 'armGroupLabels': ['high volume hemodiafiltration', 'low volume hemodiafiltration', 'standard hemodialysis']}\n- {'type': 'DEVICE', 'name': 'low volume hemodiafiltration', 'description': 'hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L', 'armGroupLabels': ['cool hemodialysis', 'high volume hemodiafiltration', 'standard hemodialysis']}\n- {'type': 'DEVICE', 'name': 'high volume hemodiafiltration', 'description': 'hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L', 'armGroupLabels': ['cool hemodialysis', 'low volume hemodiafiltration', 'standard hemodialysis']}\n\nPrimary Outcomes:\n- {'measure': 'intradialytic hypotension', 'description': 'nadir in systolic blood pressure (SBP) of 90 mmHg for patient with predialysis SBP \\\\<160mmHg and a nadir of 100 mmHg for patients with predialysis SBP \u2265160 mmHg during treatment (blood pressure will be measured before and every 15 minutes after the start of dialysis during the treatment)', 'timeFrame': 'up to 4 hours (= one dialysis treatment); assessed during 3 treatments on each modality'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level (\u03b1) = 0.05, power (\u03b2) = 0.80, loss to follow-up = 20%", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size considerations\n We plan to include 40 patients. Loss to follow-up (due to an event) is expected to be about 20%. The number of patients with complete follow-up will be sufficient to detect a 40% lower risk (relative risk of 0.60, \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.80) in the occurrence of the primary endpoint. The power calculation applied was designed for cross-over studies [60].", "id": 185, "split": "train"} +{"trial_id": "NCT03250975", "pmid": "31352415", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Incidence of Acute Laryngeal Injury Following Endotracheal Intubation\n\nIncluded conditions:\n- Intubation Complication\n\nStudy Armgroups:\n- {'label': 'Medical Therapy', 'type': 'EXPERIMENTAL', 'description': 'medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days', 'interventionNames': ['Drug: Budesonide and Azithromycin']}\n- {'label': 'Placebo Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo control medication for 14 days', 'interventionNames': ['Other: Placebo control of budesonide and azithromycin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Budesonide and Azithromycin', 'description': 'Participant with acute laryngeal injury will be randomized at discharge to either a non-drug placebo control group or a medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days.', 'armGroupLabels': ['Medical Therapy']}\n- {'type': 'OTHER', 'name': 'Placebo control of budesonide and azithromycin', 'description': 'placebos of the medications will be given for 14 days in patients randomized to the control group', 'armGroupLabels': ['Placebo Control']}\n\nPrimary Outcomes:\n- {'measure': 'Acute Laryngeal Injury', 'description': 'Endoscopic examination with evidence of laryngeal injury', 'timeFrame': 'Within 72 hours of extubation'}\n- {'measure': 'Chronic Obstructive Pulmonary Disease Dyspnea Questionnaire (CCQ)', 'description': '12 week patient-reported dyspnea via CCQ. Total score is recorded, with a range of 0-60 with higher values representing worse outcomes.', 'timeFrame': '12 week follow up'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is 0.05, the power is 0.8, and the anticipated dropout rate is 25%.", "answer": 64, "answer_type": "ESTIMATED", "explanation": "Sample size\n We are planning a study of a continuous response variable from independent control and experimental subjects. To calculate sample size, we have used CCQ data in a previous study, in which the response within each subject group was normally distributed with SD of\u00c2\u00a011.25. If the true difference in the experimental and control means is 9.15, we will need to study 24 experimental subjects and 24 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8 (total n=48). The type I error probability associated with this test of this null hypothesis is 0.05. Anticipating 25% dropout rate, we will recruit 64 participants.", "id": 186, "split": "train"} +{"trial_id": "NCT03256916", "pmid": "35387819", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase III Randomized Clinical Trial to Study the Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Uterine Cervix.\n\nIncluded conditions:\n- Carcinoma Cervix,Stage III\n\nStudy Armgroups:\n- {'label': 'Nelfinavir Arm', 'type': 'EXPERIMENTAL', 'description': 'If patient is randomized to nelfinavir arm then nelfinavir will be given orally with food at the dose of 1250 mg bid 5-7 days prior to start of chemoradiation.\\n\\nThen Pelvic EBRT (45-50 Gy/23-25 #/5weeks) + Weekly cisplatin 40mg/m2 \\\\& ICRT 7Gy X4 # will be given.', 'interventionNames': ['Drug: Nelfinavir', 'Drug: Cisplatin', 'Radiation: Pelvic EBRT and Brachytherapy']}\n- {'label': 'Standard Arm', 'type': 'OTHER', 'description': 'If patient is randomized to standard arm (Cisplatin +Pelvic EBRT and Brachytherapy).\\n\\nIn this patient will receive Pelvic EBRT (45-50 Gy/23-25 #/5weeks) + Weekly cisplatin 40mg/m2 \\\\& ICRT 7Gy X4 #', 'interventionNames': ['Drug: Cisplatin', 'Radiation: Pelvic EBRT and Brachytherapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Nelfinavir', 'description': 'Nelfinavir (HIV protease inhibitor) targets proteasome and inhibits AKT phosphorylation and plays an important role in radiosensitization of tumour cells.Nelfinavir will be given to the patient orally with food, because the bioavailability increases under the influence of food.', 'armGroupLabels': ['Nelfinavir Arm']}\n- {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Cisplatin will be administered on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT. Patient will be premedicated with I.V Ondansetron to prevent emesis. Pre chemotherapy and post chemotherapy, patient will be administered IV fluids for effective renal clearance of cisplatin.', 'armGroupLabels': ['Nelfinavir Arm', 'Standard Arm']}\n- {'type': 'RADIATION', 'name': 'Pelvic EBRT and Brachytherapy', 'description': 'Pelvic EBRT will delivered by standard 4 field technique using 6MV/15 MV photon beams. Prior to delivery of radiation, patients will be simulated by CT simulator for planning the beam arrangements. Total dose of pelvic EBRT will be 45- 50Gy/23-25 #/5 weeks. The prescribed dose will be specified according to ICRU 50 guidelines. All patients will be treated with 3D conformal external radiation with target delineation and multileaf collimator leaf shaping.', 'armGroupLabels': ['Nelfinavir Arm', 'Standard Arm'], 'otherNames': ['Radiation Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Improvement in 3 year disease free survival', 'description': 'Improvement in 3 year disease free survival by the addition of Nelfinavir to patients with advanced carcinoma of cervix and receiving standard chemoradiation (Cisplatin and Radiotherapy).', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nThe trial uses a group sequential design with 1:1 randomization. Safety analysis is scheduled at 50% recruitment, with safety assessed based on specific toxicity criteria. The significance level for toxicity is set at p < 0.01. An interim analysis for futility is planned at 32 events (or 190 patients), and the final analysis at 192 events. The study assumes a two-sided type I error of 0.05 and a type II error of 0.20.", "answer": 348, "answer_type": "ESTIMATED", "explanation": "Statistical considerations and sample size calculation\n The study\u00e2\u0080\u0099s primary endpoint is 3-year DFS which will be defined as time in months from date of randomization to date of any recurrence/relapse/death due to any cause. This is a superiority trial design that intends to demonstrate a 3-year improvement in DFS from 65%6 9 39 to 75%. Using a group sequential design, considering a HR of 0.66, 1:1 randomisation is planned. A safety analysis report is scheduled at 50% recruitment. Safety will be assessed in terms of the following: diarrhoea>grade 3, which does not settle with optimal use of antidiarrheal medication for more than 3\u00e2\u0080\u0089days or any>grade 4 haematological toxicity. The test regimen will be deemed to be associated with higher toxicity if the incidence of the above toxicities is different with a p value of <0.01. An interim analysis is planned for futility at 32 events (or 190) patients, and the final analysis is planned at 192 events. With two-sided type, I error of 0.05 and type II error of 0.20, a total sample size of 348 patients is planned. The details of statistical assumption are provided in online supplemental appendix A.\n \n 10.1136/bmjopen-2021-055765.supp1\n Supplementary data", "id": 187, "split": "train"} +{"trial_id": "NCT03259204", "pmid": "34016662", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prevention of Thromboembolism and Failed Healing During Lower Limb Immobilization - Multicenter Study With Adjuvant Intermittent Pneumatic Compression Therapy\n\nIncluded conditions:\n- Achilles Tendon Rupture\n- Ankle Fractures\n- Venous Thromboembolism\n\nStudy Armgroups:\n- {'label': 'Leg Immobilization', 'type': 'NO_INTERVENTION', 'description': 'Routine care include that the lower limb will be immobilized in an orthosis or a below-knee plaster cast according to local routines.'}\n- {'label': 'Adjuvant IPC', 'type': 'EXPERIMENTAL', 'description': 'Leg Immobilization with the addition of IPC. Patients will during lower limb immobilization receive bilateral calf IPC.', 'interventionNames': ['Device: Adjuvant IPC']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Adjuvant IPC', 'description': 'This IPC-system delivers sequential circumferential compression. The IPC device is mobile and should therefore not restrict patient mobilization, but can be taken off if the patient wants to mobilize independently.', 'armGroupLabels': ['Adjuvant IPC']}\n\nPrimary Outcomes:\n- {'measure': 'Venous Thromboembolic Events (VTE)', 'description': 'The primary outcome is VTE defined as symptomatic Deep venous Thrombosis (DVT) or asymptomatic DVTs,or symptomatic pulmonary embolism', 'timeFrame': 'Up til the time of removal of leg immobilization, approx. 6-8 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses an alpha of 0.05, a power (1-beta) of 90%, and accounts for a drop-out rate of 5%-10%.", "answer": 1400, "answer_type": "ESTIMATED", "explanation": "Sample size\n The STOP leg clots is designed on a hypothesis of superiority of adjuvant IPC therapy compared with standard treatment during lower leg immobilisation in prevention of VTE. Based on the existing literature, the expected occurrence of DVT in the control group as detected by screening ultrasound is up to 25% for AF and 50% in ATR.9 10 The estimates are dependent on the case-mix ratio as the incidence of DVT is higher in ATR than in AF. We expect the case-mix to be 30% ATR and 70% AF, resulting in an expected DVT rate of 33%. As extra precautions, we reduced the expected total DVT rate from 33% to 28%. The expected relative risk reduction of DVT is 40% based on earlier studies,32 and we chose to calculate with a lower risk reduction value of 29%. This leads to an absolute risk reduction of DVT of 8%, which is higher than the suggested minimum clinically relevant absolute risk reduction of 4%.9 32 The sample size calculations for the study are based on the following estimates and parameters: alpha=0.05, 1-beta=90%, estimated incidence of DVT=28%, the smallest relative risk reduction to detect=29%. The sample size needed using these study parameters is 597 in each group. Expecting a drop-out rate of 5%\u00e2\u0080\u009310%\u00e2\u0080\u0089and to compensate for the uncertainty of the final case-mix distribution, we aim to include 1400 patients in our study, around 1000 AF patients and 400 ATR patients.", "id": 188, "split": "train"} +{"trial_id": "NCT03259815", "pmid": "32037592", "question": "Here is the design of a clinical trial:\n\nOfficial Title: How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? - a Randomised Controlled Trial of FFR Targeted PCI (the Target FFR Study)\n\nIncluded conditions:\n- Coronary Artery Disease\n- Coronary Stenosis\n\nStudy Armgroups:\n- {'label': 'PIOS Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Operator-blinded pre and post-PCI coronary physiology measurements will be recorded. If FFR is \\\\<0.90, the result will be disclosed to the operator and a hyperaemic pressure wire pullback will be performed during a standard peripheral intravenous adenosine infusion (140mcg/kg/min).\\n\\nThe operator will then follow the PIOS protocol to attempt to obtain the target optimal post-PCI FFR result.', 'interventionNames': ['Procedure: P.I.O.S.', 'Diagnostic Test: Pre and post-PCI coronary physiology measurements']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Operator-blinded pre and post-PCI coronary physiology measurements will be recorded and the angiographically defined result will be accepted.', 'interventionNames': ['Diagnostic Test: Pre and post-PCI coronary physiology measurements']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'P.I.O.S.', 'description': 'Physiologically-Guided Incremental Optimisation Strategy', 'armGroupLabels': ['PIOS Intervention Group']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Pre and post-PCI coronary physiology measurements', 'description': 'Pre and post-PCI coronary physiology measurements will be performed but not disclosed to the operator', 'armGroupLabels': ['Control Group', 'PIOS Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of patients with a final post-PCI FFR result \u22650.90', 'description': 'The proportion of patients with a final post-PCI FFR result \u22650.90 will be compared between the randomised groups', 'timeFrame': '1 day'}\n\nPlease estimate the sample size based on the assumption: \nA sample size of 130 patients per group would be required to have 90% power to detect a 20% difference between groups at the 5% significance level.", "answer": 260, "answer_type": "ACTUAL", "explanation": "2.6\n Pilot data, power, and sample size calculation\n Pilot data from 50 patients who underwent post\u00e2\u0080\u0090PCI FFR assessment at our institution revealed that an initial post\u00e2\u0080\u0090PCI FFR result \u00e2\u0089\u00a50.90 was achieved in only 16/50 (32%). Additional optimization measures (further postdilation, stenting or both) were attempted in just nine patients (18%). Initial post\u00e2\u0080\u0090PCI FFR increased from a median of 0.83 (0.80\u00e2\u0080\u00900.86) to a final FFR of 0.88 (0.86\u00e2\u0080\u00900.89) in these patients. The results of pullback measurements performed in all 50 vessels, however, revealed at least one target for additional optimization measures was present in up to 40% of patients (HTG \u00e2\u0089\u00a50.05 in 19/50 (38%); focal step\u00e2\u0080\u0090up \u00e2\u0089\u00a50.05 either proximal or distal to the stented segment in 21/50 (42%). It is hypothesized that systematically applying the PIOS intervention will result in a 20% absolute increase in the proportion of patients with a final post\u00e2\u0080\u0090PCI FFR \u00e2\u0089\u00a50.90 compared to the control group. A sample size of 130 patients per group would be required to have 90% power to detect a 20% difference between groups at the 5% significance level; therefore, 260 patients will be randomized. Patients presenting with stable angina or NSTEMI who attend our institution for diagnostic coronary angiography proceed to PCI during the same procedure in approximately 40% of cases. It is therefore estimated that approximately 650 patients will be enrolled in the study in order to randomize 260 patients following their standard\u00e2\u0080\u0090of\u00e2\u0080\u0090care PCI.", "id": 189, "split": "train"} +{"trial_id": "NCT03260478", "pmid": "36216432", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatioN: The HEMOTION Trial\n\nIncluded conditions:\n- Traumatic Brain Injury\n- Transfusion\n\nStudy Armgroups:\n- {'label': 'Liberal Transfusion Strategy', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive red blood cells transfusion if Hb \u2264 100 g/L.', 'interventionNames': ['Procedure: Red Blood Cells Transfusion']}\n- {'label': 'Restrictive Transfusion Strategy', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive red blood cells transfusion if Hb \u2264 70 g/L.', 'interventionNames': ['Procedure: Red Blood Cells Transfusion']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Red Blood Cells Transfusion', 'description': 'Transfusion of packed red blood cells unit(s).', 'armGroupLabels': ['Liberal Transfusion Strategy', 'Restrictive Transfusion Strategy']}\n\nPrimary Outcomes:\n- {'measure': 'extended Glasgow Outcome Scale (GOSe)', 'description': 'Assessment of neurological outcome by the extended Glasgow Outcome Scale (GOSe)', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed with a power of 80% and a type 1 error of 5%. A 2% dropout rate is also considered.", "answer": 742, "answer_type": "ACTUAL", "explanation": "Sample size\n Our sample size was calculated based on the proportion of patients who will experience an unfavourable outcome (GOSe \u00e2\u0089\u00a44).24 27 28 Assuming a 40% risk of unfavourable outcome in the control group,27 28 a sample size of 712\u00e2\u0080\u0089patients will allow us to detect an absolute risk reduction of 10% with a power of 80% and a type 1 error of 5%. Our sample size is conservative as it was based on the simple dichotomous cut-off and most used definition of an unfavourable outcome in TBI using the GOSe. Based on simulated data, a sliding dichotomy approach will increase our ability to observe the planned effect size with 95% power. To account for an estimated 2% dropout rate (consent withdrawals and losses to follow-up) based on observed aggregate rates at the interim analysis, the final sample size was increased to 742.40", "id": 190, "split": "train"} +{"trial_id": "NCT03260582", "pmid": "30678709", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementation and Assessment of a Life-style Focused Patient Support Application (App) and Activity Trackers for Improving Risk Factor Management, Physical Activity, Quality of Life and Prognosis in Post-myocardial Infarction Patients\n\nIncluded conditions:\n- Myocardial Infarction\n\nStudy Armgroups:\n- {'label': 'Control arm (n=50)', 'type': 'NO_INTERVENTION', 'description': 'Patients randomized to the control arm will receive usual cardiac rehabilitation care post-myocardial infarction.'}\n- {'label': 'Intervention arm: LifePod arm (n=100)', 'type': 'EXPERIMENTAL', 'description': 'In addition to usual cardiac rehabilitation care, patients randomized to the LifePod arm will receive access to the LifePod\u00ae support software for six months.', 'interventionNames': ['Other: LifePod\u00ae']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'LifePod\u00ae', 'description': 'The software is a web-based application designed to support persons adhering to lifestyle advice and medication. The patient can log information about lifestyle (i.e. diet, exercise, and smoking), measurements (i.e. weight, pulse and blood pressure), symptoms and medication and can review data in graphs displaying registered values in relation to recommended targets. The software provides positive feedback on healthy choices and gives general recommendations on exercise training, physical activity and healthy diet. Reminders are generated in the case of decreasing registrations. Finally, short text messages (SMS) will be sent out 2-3 times a week with tips on healthy lifestyle.', 'armGroupLabels': ['Intervention arm: LifePod arm (n=100)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in submaximal exercise capacity in watts (W)', 'description': \"Submaximal exercise capacity reflects the patients\u00b4 level of physical fitness.The submaximal exercise test is performed on a bicycle ergometer according to the World Health Organisation (WHO) protocol, with an increased workload of 25W every 4.5 minutes The initial starting load, 25W or 50W, is decided, based on the patient's exertion history. After two and four minutes of each workload; heart rate, rate of perceived exertion according to Borg's rating of perceived exertion scale (RPE) and subjective symptoms, including chest pain and dyspnea according to Borg's Category Ratio Scale, CR-10, scale are rated. After three minutes, the systolic blood pressure is registered. The exercise test is discontinued at Borg RPE 17 and/or dyspnea 7 on Borg's CR-10 scale.\", 'timeFrame': 'Change between first (2-4 weeks post-MI) and second (4-6 months post-MI) submaximal exercise test conducted at physiotherapist visits'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, two-sided significance level of 0.05, and a 40% loss of adherence in the intervention arm.", "answer": 150, "answer_type": "ACTUAL", "explanation": "Statistical analysis, power, and sample size\n Sample size calculations were based on results from a local registry (SEPHIA) data analysis including 40 post-MI patients attending CR at one of the study centers (Sk\u00c3\u00a5ne University Hospital in Malm\u00c3\u00b6). Out of the 40 patients included in the analysis, 73% participated in a hospital-based exercise program, on average 7 times (range 2\u00e2\u0080\u009312) during an 8-week exercise period. The difference (\u00ce\u0094) in cardiac exercise capacity (W), measured using a symptom-limited bicycle ergometer test at 2\u00e2\u0080\u00934\u00e2\u0080\u0089weeks post-discharge and after completing a hospital-based exercise program (around 3\u00e2\u0080\u00936\u00e2\u0080\u0089months post-discharge), was calculated. The average difference was +\u00e2\u0080\u008914.6 (\u00c2\u00b1\u00e2\u0080\u008915.6) W. With a power of 90%, a two-sided significance level of 0.05, and a least mean difference at 10 W (standard deviation (SD) \u00c2\u00b1\u00e2\u0080\u008920 W) between groups, the estimated sample size was 150 patients: 50 patients in the usual care arm and 100 patients in the intervention arm. This included an intention-to-treat dilution effect based on a 40% loss of adherence in the intervention arm, an estimation based on our own feasibility study as well as other studies reporting adherence to eHealth interventions in CR [11, 13\u00e2\u0080\u009315, 17]. The study is not powered to detect effects on major adverse cardiac events. As such, these analyses will only be exploratory.\n Differences in outcomes between the control arm and intervention arm will be performed using an independent samples t test (continuous variables) and a chi-square test (categorical variables). If differences in baseline characteristics, number of follow-up visits, or telephone contacts are observed, linear and logistic regression analysis will be applied, adjusting for the observed differences between the two study arms.\n A full study protocol and a\u00c2\u00a0Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist\u00c2\u00a0(recommended items to address in a clinical trial protocol and related documents)\u00c2\u00a0are provided as additional files (Additional files\u00c2\u00a01 and 2).", "id": 191, "split": "train"} +{"trial_id": "NCT03268304", "pmid": "30012780", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility of Two Novel Interactive Software Modules for the Rehabilitation of Patients With Neuromuscular Upper Limb Impairments Using the YouGrabber Training System - the KAYO Study Protocol\n\nIncluded conditions:\n- Stroke\n- Parkinson Disease\n- Traumatic Brain Injury\n- Guillain-Barre Syndrome\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': 'VR-based training including AO and MI', 'description': 'Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber\u00ae training device'}\n\nPrimary Outcomes:\n- {'measure': 'cARAT', 'description': 'Score on the conventional Action Research Arm Test', 'timeFrame': '17 weeks'}\n- {'measure': 'dARAT', 'description': 'score on the digital ARAT', 'timeFrame': '17 weeks'}\n- {'measure': 'SUS', 'description': 'System Usability Scale questionnaire', 'timeFrame': '15 weeks'}\n\nPlease estimate the sample size based on the assumption: \nProject 1 assumes a sample size of 75 patients to check for validity and other objectives. Project 2 does not apply confirmatory statistics and does not conduct a power analysis.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Determination of sample size\n \n Project 1\n In order to determine an adequate sample size for testing the psychometrics, we assessed the available literature on the ARAT. It has been reported to be valid,13 32 56\u00e2\u0080\u009358 reliable13 31 32 57 and sensitive to change.59\u00e2\u0080\u009361 The number of included patients for the estimation of the validity coefficients varies between the cited publications from 12 to 59. However, Hobart et al found that validity estimates would generally be stable in samples n\u00e2\u0089\u00a580, for 75% of scales in samples of 40 subjects and for 50% of scales in samples of 20.62 They also stated that sample sizes of a minimum of 20 for reliability provided highly representative estimates.62 Thus, after consideration of the available literature and project constraints, we decided to include 75 patients in order to check for the validity of the d-ARAT module and the other objectives of project 1 (table 1). Of\u00c2\u00a0these 75 patients,\u00c2\u00a030 are planned to additionally practise on the AO-MI module in project 2.\n \n \n Project 2\n Further, as it is not intended in the course of this study to apply confirmatory statistics for the evaluation of the AO-MI module a sample size calculation by conducting a power analysis is also not envisaged for project 2. Substantial and reliable data on the effect of BMT practice in adults have not yet been published. Therefore, the sample size determination for project 2 had to rely on according available literature on pilot and feasibility study methodology.63\u00e2\u0080\u009370 We decided on that basis to include 30 patients into project 2 which aims to evaluate the practice on the AO-MI module.", "id": 192, "split": "train"} +{"trial_id": "NCT03270566", "pmid": "31434765", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Outcome Assessor-blinded Pilot Randomised Controlled Trial of an Ion-exchange Water Softener for the Prevention of Atopic Eczema in Neonates, With an Embedded Mechanistic Study\n\nIncluded conditions:\n- Atopic Eczema\n\nStudy Armgroups:\n- {'label': 'Domestic ion-exchange water softener', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will have a domestic ion-exchange water softener installed prior to birth.', 'interventionNames': ['Device: Domestic ion-exchange water softener']}\n- {'label': 'Usual hard water supply', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive their usual domestic water supply.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Domestic ion-exchange water softener', 'description': 'Ion-exchange water softeners exchange calcium and magnesium, amongst other divalent cations, for monovalent sodium cations using a polystyrene resin. The sodium ions come from sodium chloride (common salt). The salt needs to be topped up every 3-4 weeks and sufficient quantities of block salt will be supplied to participants. The water softener used in this study does not require electricity and has two cylinders of resin which are used alternately. A control valve alternates the flow between the two cylinders and ensures a constant supply of regenerated resin. Ion-exchange water softeners typically reduce downstream water hardness to close to zero.', 'armGroupLabels': ['Domestic ion-exchange water softener']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of eligible families screened who are willing and able to be randomised.', 'description': 'This is key to the determination of the likely success of a future, large-scale definitive randomised controlled trial (RCT).', 'timeFrame': 'Before birth'}\n\nPlease estimate the sample size based on the assumption: \nThe study is a pilot and not powered to establish efficacy. It aims for a 95% confidence interval within 10 percentage points. Additionally, 27% of eligible families may not participate due to unsuitable home conditions.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n This is a pilot study and therefore not powered to establish the efficacy of the intervention. A total of 80 families (40 per group) is judged to provide a sufficiently precise (within 10 percentage points for a 95% CI) estimate of the proportion of families who are willing to be randomised and who will go on to complete the trial.\n Findings from the Enquiring About Tolerance (EAT) study8 and the BEEP feasibility study24 allowed us to make a conservative estimate that approximately 70% of families screened will have a history of atopy that predisposes to a high risk of eczema in their offspring. Of these, 40%\u00e2\u0080\u009360%\u00e2\u0080\u0089would be expected to be willing and able to participate. Home factors also need to be considered: in SWET, 27% of eligible families could not participate because their home was not suitable for installation.16", "id": 193, "split": "train"} +{"trial_id": "NCT03271190", "pmid": "31118095", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of a Cognitive Intervention Enriched With Leisure Activities on Cognition, Daily Life Functioning and Brain Structure and Function in Persons With Subjective Cognitive Decline: The ENGAGE Program\n\nIncluded conditions:\n- Subjective Cognitive Decline\n\nStudy Armgroups:\n- {'label': 'ENGAGE SPANISH/MUSIC', 'type': 'EXPERIMENTAL', 'description': 'Cognitive strategies to improve attention and memory skills and application in selected leisure activities (music or Spanish lessons, and videogames) over 4 months.', 'interventionNames': ['Behavioral: ENGAGE SPANISH/MUSIC']}\n- {'label': 'ENGAGE DISCOVERY', 'type': 'ACTIVE_COMPARATOR', 'description': 'Educational program about brain and healthy aging complemented by learning of new information with videogames, documentaries and group discussions over 4 months.', 'interventionNames': ['Behavioral: ENGAGE DISCOVERY']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ENGAGE SPANISH/MUSIC', 'description': 'Cognitive strategies to improve attention and memory skills (21 hours), leisure activities (music lessons or Spanish lessons) (27 hours), selected videogames to practice variable attention strategies (4 hours in class + about 10 hours at home). Total of 24 2-hour in class sessions over 4 months. The training will be delivered to small groups of 5 to 8 participants by a trained therapist for formal sessions and a professional music or Spanish teacher for leisure sessions.', 'armGroupLabels': ['ENGAGE SPANISH/MUSIC']}\n- {'type': 'BEHAVIORAL', 'name': 'ENGAGE DISCOVERY', 'description': 'Educational content about brain and healthy aging (21 hours), leisure activities (watching documentaries followed by group discussion and debate) (27 hours), selected non-stimulating videogames (4 hours in class + about 10 hours at home). Total of 24 2-hour in class sessions over 4 months. The training will be delivered to small groups of 5 to 8 participants by the same trained therapist as in the ENGAGE arm.', 'armGroupLabels': ['ENGAGE DISCOVERY']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in episodic memory (composite score)', 'description': \"A composite score will be computed by averaging z-scores from the delayed recall of the Rey Auditory Verbal Learning Test (RAVLT) and the delayed recall of the face-name association task (an associative memory test adapted from Simona Brambati's task for the Consortium pour l'Identification precoce de la Maladie d'Alzheimer (CIMA-Q) study currently running in Quebec).\", 'timeFrame': 'PRE (within 12 weeks before intervention starts) + POST-1 (within 8 weeks after the end of intervention) + POST-2 (2 years from PRE, +/- 3 months)'}\n\nPlease estimate the sample size based on the assumption: \nThe power analysis was conducted using G*power, considering an 18% attrition rate, and based on the pilot findings with the MEMO program.", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size\n The trial will recruit 144 participants. The sample size was estimated from a power analysis with G*power based on pilot findings collected with the MEMO program [10, 12], using word recall and face-name associations tasks. The MEMO program is included as part of the formal training in this intervention in addition to stimulating leisure activities and attentional training. Therefore, it is reasonable to expect that the effect should be at least as large as the one observed when using MEMO alone. The pilot data indicated a medium effect size for the group-by-time interaction when examining face-name association and a large effect size when examining word recall (see Additional\u00c2\u00a0file\u00c2\u00a02: Appendix 2). It shows that the sample size would be sufficient to detect an interaction given a similar effect size considering the same attrition rate that we obtained in this prior study (18%). Half of the sample will be recruited in Montreal and the other half will be recruited in Toronto.", "id": 194, "split": "train"} +{"trial_id": "NCT03273855", "pmid": "38151280", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity\n\nIncluded conditions:\n- Obesity, Morbid\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'Active Comparator. Transplant from Donor A or Donor B, or Donor C or Donore D, one transplant consist of 50-80g of feacal matter.', 'interventionNames': ['Other: Fecal microbiota transplantation']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo. Patient will recieve an autologous fecal microbiota transplantation.', 'interventionNames': ['Other: Placebo: fecal microbiota transplantation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Fecal microbiota transplantation', 'description': 'The intervention treatment is fecal microbiota transplantation made of frozen donor feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Placebo: fecal microbiota transplantation', 'description': 'The placebo group get fecal microbiota transplantation made of their own feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change in individual weight loss (kg).', 'description': 'Partisipants will be measured at the outpatient clinic, medical department UNN Harstad, and weight in kilograms (kg) will be recorded. The data will be represented both as average weight change and as bar charts with \\\\>10%, with comparison between the intervention and control group.\\n\\nChi Square or Fischer exact test will be used to present responders and non-responders in the active and controll group. We will use odds ratio to present responders in the active group.', 'timeFrame': 'Change from baseline body weight at 12 months post FMT'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a power of 0.90, a significance level of 0.05, and a high dropout rate of approximately one third. Extreme values more than 3 SD from the average will be eliminated.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Determination of sample size\n To determine the sample size, we looked at data from our outpatient clinic and found that patients have an average weight loss of 2.5% with our conservative treatment, SD near 7. This will therefore be the expected result in the control group (receiving placebo). A weight reduction of \u00e2\u0089\u00a510% leads to significant improvement in health and quality of life,14 and a weight change of this magnitude is therefore considered clinically relevant. The difference between the two groups is estimated to be 7.5%, and with these historical results, the sample size is estimated to be 19 participants in each group with a power of 0.90 and significance level of 0.05. We will eliminate extreme values, more than 3 SD out of the average in the group. We must be prepared for a high drgree of loss to follow-up (near one third), as this is the experience from the outpatient clinic for severe obesity.15 Therefore, we will include 60 participants, 30 in each group.", "id": 195, "split": "train"} +{"trial_id": "NCT03275012", "pmid": "30646965", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Double-blind, Placebo Controlled, Superiority Phase II Study to Evaluate the Safety, Pharmacokinetic, Efficacy of Gabapentin as add-on to Morphine in Children From 3 Months to Less Than 18 Years\n\nIncluded conditions:\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'Group 1', 'type': 'EXPERIMENTAL', 'description': 'Gabapentin + Morphine', 'interventionNames': ['Drug: Gabapentin + Morphine']}\n- {'label': 'Group 2', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo + Morphine', 'interventionNames': ['Drug: Placebo + Morphine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Gabapentin + Morphine', 'description': 'Gabapentin: liquid oral formulation (syrup) - 75 mg/ml-three times daily. The starting dose during the optimization period will be defined according to 2 weight groups (5-15kg and \\\\>15kg). Dose will be scaled at Day 1,3,5,14,and 21 according to a specific schedule. Maintenance dosing will be scheduled in accordance to the body weight.\\n\\nMorphine: background therapy as oral, liquid and solid formulations. Patients with BW\u226430kg :liquid oral formulation four times daily throughout the whole treatment period. Patients with BM\\\\>30kg : immediate release solid and/or liquid oral formulation four times daily during titration phase and an extended release solid oral formulation twice daily during the maintenance period.', 'armGroupLabels': ['Group 1']}\n- {'type': 'DRUG', 'name': 'Placebo + Morphine', 'description': 'Placebo liquid oral formulation. Morphine: background therapy as oral, liquid and solid formulations. Patients with BW\u226430kg :liquid oral formulation four times daily throughout the whole treatment period. Patients with BM\\\\>30kg : immediate release solid and/or liquid oral formulation four times daily during titration phase and an extended release solid oral formulation twice daily during the maintenance period.', 'armGroupLabels': ['Group 2']}\n\nPrimary Outcomes:\n- {'measure': 'Pain scores', 'description': 'Pain scores in the two treatment groups assessed at baseline and at the end of the treatment by age-appropriate pain scales. FLACC (the Faces, Legs, Arms, Cry and Consolability - pts aged 3-24 months) scale composed by 5 categories. Each category is scored on the 0-2 scale, which results in a total score of 0-10, where 0=Relaxed and comfortable, 4-6=Moderate pain, 1-3=Mild discomfort, 7-10=Severe discomfort or pain or both.\\n\\nFPS-R scale (Faces Pain Scale - Revised - pts aged 3-7 years): score is associated with face 0, 2, 4, 6, 8, or 10, where 0 = no pain and 10=very much pain.\\n\\nNRS-11(Numerical Rating Scale - pts aged 8-17 years): numerical rating scale where 0=no pain and 10=worst possible pain', 'timeFrame': 'on average of 16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA two-tailed test with a significance level of 0.5, a power of 80%, and 10% dropout rate.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n A total sample size of 66 is needed. It will allow detection of a significant difference between morphine plus placebo and morphine plus gabapentin groups in mean pain scores at EOS. Mean baseline pain scores of 8.5 are assumed for both groups, with estimated EOS pain scores of 5.4 for morphine alone versus 4.5 for morphine plus gabapentin based on percentage change in pain scores in a previous trial in adults [31].\n A minimum number of patients is defined per age group: (1) at least 5 patients aged 3\u00e2\u0080\u0089months to less than 3\u00e2\u0080\u0089years, (2) at least 15 patients aged 3\u00e2\u0080\u0089years to less than 7\u00e2\u0080\u0089years, and (3) at least 20 patients aged 7\u00e2\u0080\u0089years to less than 18\u00e2\u0080\u0089years. No maximum number of patients per age group is specified. A two-tailed test will be applied with a significance level of 0.5 and a power of 80%, and 10% dropout is anticipated.", "id": 196, "split": "train"} +{"trial_id": "NCT03277898", "pmid": "32736542", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Aerobic Exercise and Cognitive Functioning in Women With Breast Cancer: the ACTIVATE Trial\n\nIncluded conditions:\n- Breast Neoplasms\n\nStudy Armgroups:\n- {'label': 'Aerobic Exercise', 'type': 'EXPERIMENTAL', 'description': 'Participants will complete three supervised aerobic exercise sessions each week using the treadmill, stationary bicycle or elliptical training for the duration of their chemotherapy (12-18 weeks). Aerobic exercise will be performed for 20-40 minutes at 50-75% of heart rate reserve. Participants will wear heart rate monitors during all supervised sessions (Polar Electro Inc., Lake Success, NY) and will be provided with target heart rates that will be individualized using their baseline (i.e., week 0) assessment data. Home-based exercise will be introduced in week 3. For the home-based sessions, participants will be asked to complete at least 1 session per week of 30 minutes of aerobic exercise (an activity of their choosing; e.g., walking).', 'interventionNames': ['Behavioral: Aerobic Exercise']}\n- {'label': 'Usual Care (Wait-list Control)', 'type': 'OTHER', 'description': 'Participants randomly assigned to UC group will be advised to continue with their regular activities of daily living. Following their chemotherapy, the UC group will receive the exercise intervention (lasting 12 weeks).', 'interventionNames': ['Behavioral: Usual Care (Wait-list Control)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Aerobic Exercise', 'description': 'Three weekly moderate-vigorous intensity supervised aerobic exercise training for the duration of adjuvant chemotherapy. Home-based exercise will also be introduced in week 3 of the intervention.', 'armGroupLabels': ['Aerobic Exercise']}\n- {'type': 'BEHAVIORAL', 'name': 'Usual Care (Wait-list Control)', 'description': 'Three weekly moderate-vigorous intensity supervised aerobic exercise training starting upon adjuvant chemotherapy completion. Home-based exercise will also be introduced in week 3 of the intervention.', 'armGroupLabels': ['Usual Care (Wait-list Control)']}\n\nPrimary Outcomes:\n- {'measure': 'Change with treatment and maintenance post-treatment in objective neuropsychology test battery composite score', 'description': 'A neuropsychological test battery. The tests are as follows: WAIS-IV (Digit-Symbol Coding, Letter-Number-Sequencing), Auditory Consonant Trigrams Test, Brief Visuospatial Memory Test Revised, Controlled Oral Word Association Test, Hopkins Verbal Learning Test-Revised, and Trail Making Test A\\\\&B. Alternate forms will be used, with the exception of the WAIS-IV tests, the Controlled Oral Word Association Test, and Trail Making A\\\\&B. These tests are combined to form a composite score called the COGSUM.', 'timeFrame': 'Pre-chemotherapy (baseline, week 0), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline), 1-year follow-up (52 weeks post-baseline)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided 5% level of significance, correlation with baseline measure of 0.8, and a potential dropout rate of 10%.", "answer": 84, "answer_type": "ESTIMATED", "explanation": "Sample size\n A power calculation was performed to detect changes in cognitive functioning (as measured by a composite cognitive summary score (COGSUM; developed by Collins et al. [52\u00e2\u0080\u009355]). Using a minimum clinically important difference of 0.4 standard deviation units between EX versus UC at post-chemotherapy (i.e., post-intervention/post-wait period; primary endpoint), a total sample size of 74 women is needed to achieve 80% power using an analysis of covariance (ANCOVA) at a two-sided 5% level of significance. The correlation with the baseline measure was assumed to be 0.8. To account for a potential dropout rate of 10%, a sample of 84 participants (42 per condition) will be recruited.", "id": 197, "split": "train"} +{"trial_id": "NCT03282292", "pmid": "29941012", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery\n\nIncluded conditions:\n- Central Line-associated Bloodstream Infection (CLABSI)\n- Central Venous Catheter Associated Bloodstream Infection\n- Heart; Surgery, Heart, Functional Disturbance as Result\n- Congenital Heart Disease\n- Newborn; Infection\n\nStudy Armgroups:\n- {'label': 'Jugular', 'type': 'EXPERIMENTAL', 'description': 'CVC insertion in the left or right internal jugular vein', 'interventionNames': ['Procedure: Internal jugular vein CVC insertion']}\n- {'label': 'Femoral', 'type': 'ACTIVE_COMPARATOR', 'description': 'CVC insertion in the right or left femoral vein', 'interventionNames': ['Procedure: Internal jugular vein CVC insertion']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Internal jugular vein CVC insertion', 'description': 'Double lumen CVC insertion in the internal jugular vein', 'armGroupLabels': ['Femoral', 'Jugular']}\n\nPrimary Outcomes:\n- {'measure': 'CVC colonization', 'description': 'CVC positive culture after removal', 'timeFrame': '14 days'}\n- {'measure': 'CRBSI', 'description': 'Positive CVC culture and blood stream infection for the same organism', 'timeFrame': '14 days'}\n- {'measure': 'CLABSI', 'description': 'A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.', 'timeFrame': 'More than 48 hours'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumed an alpha error value of 5%, a power of 80%, and a dropout rate of 4%.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size\n The power analysis was conducted on the basis of the endpoint of catheter colonization. Previous observational data on catheter line\u00e2\u0080\u0093associated bloodstream infections (CLABSIs) in a non-surgical neonatal intensive care showed that the femoral line was associated with a CLABSI rate of 10.2% but that the jugular site had a CLABSI rate of 2.7% [11]. We assumed a 2:1 ratio between catheter colonization rate and CLABSI rate and therefore hypothesized colonization rates of 20.4% for the femoral line and 5.4% for the jugular line. With an alpha error value of 5% and a power of 80%, 77 patients are required for each group. Considering a dropout rate of 4%, we increased this number to 80 subjects for each group.", "id": 198, "split": "train"} +{"trial_id": "NCT03282682", "pmid": "31492775", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male (ADAM)\n\nIncluded conditions:\n- Hypogonadism, Male\n- Physical Activity\n- Testosterone Deficiency\n\nStudy Armgroups:\n- {'label': 'hypogonadal males without TRT', 'type': 'EXPERIMENTAL', 'description': 'Strength training', 'interventionNames': ['Procedure: Strength training']}\n- {'label': 'hypogonadal males with TRT', 'type': 'EXPERIMENTAL', 'description': 'Strength training and regular prescribed testosterone therapy given by participant urologist.', 'interventionNames': ['Procedure: Strength training']}\n- {'label': 'healthy eugonadal males', 'type': 'ACTIVE_COMPARATOR', 'description': 'Strength training', 'interventionNames': ['Procedure: Strength training']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Strength training', 'description': 'The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.', 'armGroupLabels': ['healthy eugonadal males', 'hypogonadal males with TRT', 'hypogonadal males without TRT']}\n\nPrimary Outcomes:\n- {'measure': 'Change From Baseline in Lean Mass', 'description': 'Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.', 'timeFrame': '7 days before intervention, 7 days after intervention'}\n\nPlease estimate the sample size based on the assumption: \nType I error probability of 0.05, power of 0.90 and 0.95, 10% dropout rate", "answer": 22, "answer_type": "ACTUAL", "explanation": "Sample size\n The pre-existing data from our previous 12 week exercise intervention study related to fat (5.6% decrease p=0.002) & lean body mass (1.8% increase, p=0.047, dual-energy X-ray absorptiometry) and that of maximal voluntary contraction force measured on linear leg-press (31% increase, p<0.0001, 1RM). Lean body mass was used to determine sample size for the population of the designed intervention study. The Type I error probability was set at 0.05 and the power to 0.90 and 0.95. Results indicate that 22 patients per group will be sufficient to detect exercise intervention related change of 1,06\u00c2\u00b11,56 kg (average \u00c2\u00b1SD) of lean body mass at the power of 0.90, accounting for the 10% patients drop-out.", "id": 199, "split": "train"} +{"trial_id": "NCT03283735", "pmid": "30018092", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Deprescribing: a Portrait and Out-comes of the Reduction of Polypharmacy in Portugal\n\nIncluded conditions:\n- Polypharmacy\n- Deprescriptions\n\nStudy Armgroups:\n- {'label': 'Elderly Enablement', 'type': 'EXPERIMENTAL', 'description': 'The investigators will give enablement tools and talks with their GPs about how to issue the problem of polypharmacy.', 'interventionNames': ['Behavioral: Elderly Enablement']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'This will be the control group.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Elderly Enablement', 'description': 'The information given in this group will result from the knowledge obtained in previous phase of the study in the shape of small leaflets and other information materials to be made according to the best practice, to be given and remembered at scheduled times to the intervention group', 'armGroupLabels': ['Elderly Enablement']}\n\nPrimary Outcomes:\n- {'measure': 'Willingness to be deprescribed after the intervention with open-questions', 'description': 'Assess the enablement of older adults while being Deprescribed in the rise of Willingness to be Deprescribed with two open-questions (one to assess the facilitators and the other to assess the barriers) together with their perception of medication (Beliefs about Medicines Questionnaire).', 'timeFrame': 'six months'}\n\nPlease estimate the sample size based on the assumption: \nA 95% confidence interval (CI) and a maximum precision error of 5% are considered. A dropout rate of around 25% is assumed.", "answer": 380, "answer_type": "ESTIMATED", "explanation": "Sample size\n Since the prevalence of polypharmacy in older adults in Centre of Portugal is unknown, we will consider that it is around 60% of the older adults\u00e2\u0080\u0099 population in this region (around 520 000). So we need at least 380 patients with polypharmacy, to obtain a sample with a 95%\u00e2\u0080\u0089CI and a maximum precision error of 5%. However, assuming a dropout rate of around 25%, we will increase the required\u00c2\u00a0sample by 25% in order to compensate for dropouts, so we will need at least 474 patients with polypharmacy. Then we will create two groups with a minimum of 237 patients each (one will be the intervention group and the other the control).", "id": 200, "split": "train"} +{"trial_id": "NCT03284463", "pmid": "32527232", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Efficacy of Glibenclamide Combined With Rt-PA in Treating Acute Ischemic Stroke: a Prospective, Randomized, Double-blind, Placebo-control, Multi-center Study\n\nIncluded conditions:\n- Acute Stroke\n\nStudy Armgroups:\n- {'label': 'Glibenclamide', 'type': 'ACTIVE_COMPARATOR', 'description': 'Glibenclamide Tablets', 'interventionNames': ['Drug: Glibenclamide']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo for Glibenclamide', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Glibenclamide', 'description': 'Glibenclamide is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.', 'armGroupLabels': ['Glibenclamide']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points', 'description': 'The proportion of mordified Rankin Scale of 0 to 2 points at 90 days', 'timeFrame': '90 days after the stroke onset'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided significance level of 0.05, a power of 80%, the O'Brien-Fleming alpha spending function, and a dropout rate of less than 10% are assumed.", "answer": 306, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n The sample size calculation was based on previous findings, and the proportion of patient with a mRS of 0\u00e2\u0080\u00932 at 90\u00e2\u0080\u0089days of 41% was estimated for the placebo group, and of 58% was assumed for the glibenclamide-treated group [11]. When half of the planned subjects finish their 90-day follow up an interim analysis will be conducted and the O\u00e2\u0080\u0099Brien - Fleming method will be used to control the type I error. Using nQuery + nTerim 4.0 (Statistical Solutions Ltd., Farmer\u00e2\u0080\u0099s Cross, Cork, Ireland) with a 2-sided \u00cf\u00872 test, a two-sided significance level of 0.05, a power of 80%, the O\u00e2\u0080\u0099Brien - Fleming alpha spending function and a dropout rate\u00e2\u0080\u0089<\u00e2\u0080\u008910%, 153 patients are required in each group, for a total sample size of 306.", "id": 201, "split": "train"} +{"trial_id": "NCT03288246", "pmid": "32868354", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti\n\nIncluded conditions:\n- HIV\n\nStudy Armgroups:\n- {'label': 'Standard-of-care', 'type': 'NO_INTERVENTION', 'description': 'Participants in the standard-of-care arm will receive a standard laboratory-based viral load test at baseline, 3, and 6 months.'}\n- {'label': 'Point-of-care', 'type': 'EXPERIMENTAL', 'description': 'Participants in the point-of-care arm will receive a point-of-care viral load test at baseline, 3, and 6 months.', 'interventionNames': ['Diagnostic Test: point-of-care viral load test']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'point-of-care viral load test', 'description': 'A point-of-care viral load test returns viral load test results within 90 minutes.', 'armGroupLabels': ['Point-of-care']}\n\nPrimary Outcomes:\n- {'measure': 'The number of steps in the HIV care cascade involved with viral load testing.', 'description': 'The number of steps within the HIV care cascade involved with viral load testing will be measured comparing standard laboratory-based testing to POC testing.', 'timeFrame': '1 day of clinic visit'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed tests, significance level at 5%, power of 80%, and 85% follow-up rate.", "answer": 150, "answer_type": "ACTUAL", "explanation": "Sample size and power calculations\n We calculated the required sample size to address the primary outcome of the study: the proportion of adolescents who receive a VL result within 6 weeks of the month 1 VL test. We calculated the sample size based on a retrospective review of VL results available in the EMR and interviews with providers at GHESKIO and hypothesise the primary outcome will be common. Between July 2016 and December 2016, we observed that 50% of participants\u00e2\u0080\u0099 VL results were entered into the EMR within 6 weeks of sample collection and confirmed this with providers in the clinic. The method we have chosen for calculation of the sample size is a simple comparison of proportions. We assume two-tailed tests, set a significance level at 5% and power of 80%. For the primary outcome, with a sample size of 124 (62 per arm) we will have 80% power to detect a 20% increase (on the additive scale) in the proportion of patients who receive their VL result within 6 weeks of the month 1 VL test (ie, 70% in the SOC arm vs 90% in the POC arm).\n We also calculated the required sample size to address a secondary outcome of the study: the proportion of adolescents who achieve a VL <1000 copies/\u00c2\u00b5L at 6 months. We anticipate that the secondary outcome will be slightly less common. A cross-sectional retrospective analysis of VL results among adolescents aged 10\u00e2\u0080\u009324 who had been on ART \u00e2\u0089\u00a56 months at the GHESKIO adolescent HIV clinic in 2016 showed 40% were virally suppressed. For the secondary outcome, with the same sample size of 124 (62 per arm), we will have 80% power to detect a 25% increase in the proportion of participants who are virally suppressed at 6 months from the index VL test (ie, 40% in the SOC arm vs 65% in the POC arm). Assuming we will achieve 85% follow-up in both arms, we are enroling a total sample size of 150 (75 per arm).", "id": 202, "split": "train"} +{"trial_id": "NCT03292237", "pmid": "35260448", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial\n\nIncluded conditions:\n- Critical Illness\n- Critically Ill\n\nStudy Armgroups:\n- {'label': 'Standard Nutrition Arm', 'type': 'NO_INTERVENTION', 'description': 'In ICU:\\n\\n1. After enrolment, patients allocated to the standard nutrition therapy (control) group will commence or continue nutrition via an enteral tube to a target rate according to unit protocol including the use of promotility agents and the placement of nasojejunal feeding tubes if required.\\n2. PN will only be used if the above methods have been attempted, or an absolute contraindication to EN develops.\\n3. Unless there is specific indication for a compounded PN solution, the PN used in the standard care group will be the same as used in the intervention arm.\\n\\nAfter ICU:\\n\\n1. Nutrition management will be as per usual site management at that hospital.\\n2. Nutrition intake amounts will be recorded 3 times per week using provided study documents and assessment tools.'}\n- {'label': 'Intensive Arm', 'type': 'EXPERIMENTAL', 'description': 'Intervention\\n\\nIn ICU:\\n\\n1. Supplemental PN will be commenced within 2 hours of randomisation. The starting dose of PN will be determined by the amount of energy received in the 24 hours prior to randomisation\\n2. The need for the intervention will be based on the adequacy of nutrition provision from both PN and EN and assessed daily until ICU discharge\\n3. If there is an actual or anticipated interruption of EN for greater than 2 hours the PN must be run at 20 kcal/kg calculated body weight until EN is recommenced. After the interruption, EN should be recommenced as per local protocol.\\n\\nAfter ICU:\\n\\nAn intensive nutrition intervention will be provided on the ward in the intervention group. This will include daily review from dedicated study dietitians and a clearly protocolized hierarchical management plan which reflects best practice clinical management.', 'interventionNames': ['Dietary Supplement: Supplemental parenteral nutrition']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Supplemental parenteral nutrition', 'description': 'Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)', 'armGroupLabels': ['Intensive Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Daily energy delivered from nutrition therapy', 'description': 'Daily energy delivered from nutrition therapy', 'timeFrame': 'Day 28'}\n\nPlease estimate the sample size based on the assumption: \n95% power with a two-sided p value of 0.05, and a potential loss to follow-up of 20%.", "answer": 240, "answer_type": "ACTUAL", "explanation": "Sample size and power\n A recent study conducted in six ICUs in Australia and New Zealand enrolling 100 patients using a similar inclusion and exclusion criteria and coordinated by the Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) found that the mean (SD) energy delivered to the standard nutrition arm throughout their hospital stay (median 22 days) was 1540 (410) kcal/day.17 Based on a minimum acceptable clinical difference of 15% (215 kcal/day), with 190 subjects, this study will have a 95% power (two-sided p value of 0.05). To account for a potential loss to follow-up of 20% due to the longitudinal nature of the study intervention, the sample size has been inflated to recruit a total of 240 participants (120 in each group). This loss to follow-up rate is based on previous work conducted by the investigators and has been observed in other studies with longitudinal follow-up.14 17 19", "id": 203, "split": "train"} +{"trial_id": "NCT03294668", "pmid": "31815642", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Developing and Evaluating a Social Skills Group Training for Adolescents on the Autism Spectrum\n\nIncluded conditions:\n- Autism Spectrum Disorder\n\nStudy Armgroups:\n- {'label': 'KONTAKT Australia', 'type': 'EXPERIMENTAL', 'description': 'A social skills group training', 'interventionNames': ['Behavioral: KONTAKT Australia']}\n- {'label': 'Super Chef', 'type': 'ACTIVE_COMPARATOR', 'description': 'A social cooking group', 'interventionNames': ['Other: Super Chef']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'KONTAKT Australia', 'description': 'KONTAKT is a manualized Social skills group training program designed for children and adolescents on the Autism Spectrum aimed at improving communication, social interaction skills, the severity of ASD symptoms, and the ability to empathise and adapt in a group setting. The KONTAKT participants (4-8 participants) meet face to face weekly for 16 weeks for an hour and a half in a group facilitated by two trainers.', 'armGroupLabels': ['KONTAKT Australia'], 'otherNames': ['KONTAKT']}\n- {'type': 'OTHER', 'name': 'Super Chef', 'description': 'The Super Chef is a cooking group designed for this study for adolescents on the Autism Spectrum, aimed at teaching basic cooking skills in a social environment. The Super Chef participants (4-8 participants) meet face to face weekly for 16 weeks for an hour and a half in a group facilitated by two trainers.', 'armGroupLabels': ['Super Chef'], 'otherNames': ['Social cooking group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the Goal Attainment Scale (GAS)', 'description': \"The GOAL Attainment Scale will be used as the adolescents' primary outcome. Using the scale the participants personally meaningful social goals will be specified, and a behavioural expectation that ranges from the worst to the best possible outcome will be listed for each goal. This allows qualitative data to be quantified in relation to the success of the participant in achieving expectations of change.\", 'timeFrame': 'Baseline (week 0), Post-test (week 20), follow up (week 36), and long follow up (week 74)'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.95, significance level (\u03b1) of 5%, and an attrition rate of 37%.", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size calculations\n The KONTAKT\u00c2\u00a9 study in Sweden (both 12-week and 24-week versions) employed the Social Responsive Scale - second edition (SRS-2) as the primary outcome measure. Based on an effect size of 0.54, derived from roughly averaging the effect size (ES) as measured by the SRS-2 from trials examining the efficacy of the long 24-session (ES = 0.76) and the short 12-session (ES = 0.32) versions of KONTAKT\u00c2\u00a9 at post-test, and applying multivariate analysis of variance (MANOVA) for repeated measures (within-between interactions) at the three time points (using the intent-to-treat approach), a minimum of 57 participants are required (as calculated by G*Power [53] with power of 0.95 at a conventional error probability (\u00ce\u00b1 = 5%)). However, unlike the Swedish study, the present study will employ the Goal Attainment Scaling (GAS) as the primary outcome. It has been argued that GAS has good reliability when used as an outcome measure with interventions for adolescents with ASD [54\u00e2\u0080\u009356]. Further, unlike previous investigation of KONTAKT\u00c2\u00a9 [17, 32], the current study will compare this SSGT efficacy against an active control group, to control for exposure to a social context with peers with ASD. It is likely that both these factors will have a limiting impact on the power of the study, and as such we will aim to recruit a sample of at least 90 participants into this study, increasing the likelihood of detecting possible effects [19]. This sample size will also account for an attrition rate of 37%, which is larger than what is expected based on the previous KONTAKT\u00c2\u00a9 studies.", "id": 204, "split": "train"} +{"trial_id": "NCT03294785", "pmid": "30497483", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain: A Multi-center Randomized Controlled Trial\n\nIncluded conditions:\n- Chronic Neck Pain\n\nStudy Armgroups:\n- {'label': 'Chuna manual therapy', 'type': 'EXPERIMENTAL', 'description': 'The Chuna manual therapy group will receive Chuna manual therapy alone. Chuna manual therapy will employ a semi-standardized treatment plan of Chuna manual therapy through Chuna technique selection based on physician judgement of techniques from Chuna Medicine (Korean Society of Chuna Manual Medicine for Spine \\\\& Nerves: Chuna Medicine: Seoul: Korean Society of Chuna Manual Medicine for Spine \\\\& Nerves; 2017) and osteopathic manipulative medicine. The Chuna techniques employed in this study are divided into cervical, thoracic and rib cage, lumbar, pelvic, sacral, pubic, and hip joint area techniques. Chuna manual therapy sessions will be administered 2 sessions/week over a period of 5 weeks (total 10 sessions). The time duration of 1 Chuna manual therapy session will consist of approximately 10-20 minutes of diagnosis and approximately 10 minutes of treatment.', 'interventionNames': ['Procedure: Chuna manual therapy']}\n- {'label': 'Usual care', 'type': 'ACTIVE_COMPARATOR', 'description': 'The usual care group will receive usual care alone. Usual care will be limited to physical therapy and conventional medication in this study. Usual care will be provided with reference to a list of most frequently used treatments in neck pain-related patients from Korean Health Insurance Review and Assessment (HIRA) 2014 statistics. Frequency and types of physical therapy used will be recorded in a separate electronic case report form for outcome assessor blinding purposes.', 'interventionNames': ['Drug: Conventional medication', 'Procedure: Physical therapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Chuna manual therapy', 'description': 'Chuna is a Korean manual therapy that has absorbed and incorporated aspects of osteopathic manipulative medicine. Chuna manual therapy utilizes spinal manipulation techniques for joint mobilization including high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement, muscle energy, and fascial techniques.', 'armGroupLabels': ['Chuna manual therapy'], 'otherNames': ['Chuna manipulation']}\n- {'type': 'DRUG', 'name': 'Conventional medication', 'description': 'Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.', 'armGroupLabels': ['Usual care'], 'otherNames': ['Conventional medicine', 'Conventional drugs']}\n- {'type': 'PROCEDURE', 'name': 'Physical therapy', 'description': 'Physical therapy will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.', 'armGroupLabels': ['Usual care'], 'otherNames': ['Physiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline', 'description': \"VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.\", 'timeFrame': 'Week 5 post-baseline (screening)'}\n\nPlease estimate the sample size based on the assumption: \nLevel of significance (\u03b1) is 0.05; Type II error (\u03b2) is 0.2 with a power of 80%; Compliance rate is set at 85%; 15% dropout rate is considered.", "answer": 108, "answer_type": "ACTUAL", "explanation": "Sample size\n \nCalculation of number of participants required\u00c2\u00a0for the clinical trial: for calculation of significant number of participants, the following is hypothesized based on the\u00c2\u00a0previous literature:Level of significance, \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05;Type II error (\u00ce\u00b2) is set at 0.2 with power of the test set at 80%;According to a previous clinical study using VAS as the main assessment tool for Chuna manual therapy in neck pain patients, the effect size of Chuna manual therapy in comparison to the control can be considered to be 1.03 [30], and\u00c2\u00a01.49 [31], respectively;Compliance rate will be set at 85% (the\u00c2\u00a0predicted rate of receiving \u00e2\u0089\u00a5\u00c2\u00a06 sessions of treatment during the five-week treatment period);For calculation of sample size, G*Power 3.1.7 was used. With evidence from item (3), application of mean\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u0089SD resulted in conservatively hypothesizing the\u00c2\u00a0effect size of this clinical trial as 0.6 because of the high clinical heterogeneity of manual therapies such as Chuna. Application of items (1) and (2) and the effect size resulted in the calculation of a sample size of 90 participants (45 in each group).The mean comparison of pain requires a total of 90 participants (45 in each group), which is the minimum number of participants needed for testing the abovementioned hypothesis. Considering that 15% of participants received <\u00e2\u0080\u00896 sessions of treatment within the five-week treatment period, a total of 108 participants, 54 in each group, will be extracted for the study.", "id": 205, "split": "train"} +{"trial_id": "NCT03296709", "pmid": "31445509", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preformed Pediatric Crown Zirconia Versus Preformed Pediatric Metal Crown PPC Z-M\n\nIncluded conditions:\n- Tooth Decay\n\nStudy Armgroups:\n- {'label': 'PPC m', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: PPC m']}\n- {'label': 'PPC z', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: PPC z']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'PPC z', 'description': 'Installation of a preformed pediatric zircona crown', 'armGroupLabels': ['PPC z']}\n- {'type': 'DEVICE', 'name': 'PPC m', 'description': 'Installation of a preformed pediatric metal crown', 'armGroupLabels': ['PPC m']}\n\nPrimary Outcomes:\n- {'measure': 'clinical and radiographique observations', 'description': 'Success of the treatment defined by the absence of major failure. A composite measure of signs and symptoms leading to diagnosis of irreversible pulpitis or periradicular periodontitis will be used to define major failure (pain, pulp infection, dental abscess, periradicular pathology visible on radiograph', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nAlpha equal to 5%, 90% power, two one-sided test (TOST) Z\u03b1 = 1.64, 80% power for equivalence test, dropout rate around 20%.", "answer": 101, "answer_type": "ACTUAL", "explanation": "Sample size\n Table\u00c2\u00a02 shows the sample size calculation for success rates ranging from 95% to 97%, alpha equal to 5%, with 90% power and an equivalence margin between the study groups of 10%. This table illustrates that the effective sample size of 81 teeth per treatment group will provide a power of 90% to assess effectiveness equivalence between the treatment groups. These rates were based on the systematic review of Innes et al. [3]. This calculation was based on the formula (Z 0.95\u00e2\u0080\u0089+\u00e2\u0080\u0089Z 0.90)2 [Ps (1 \u00e2\u0080\u0093 Ps)\u00e2\u0080\u0089+\u00e2\u0080\u0089Pn (1 \u00e2\u0080\u0093 Pn)] / (Ps \u00e2\u0080\u0093 Pn \u00e2\u0080\u0093 D)2 (see http://people.ucalgary.ca/~patten/blackwelder.html) [14].\nTable 2Sample size calculationRateTeethTotal required8027454885218438901543089581162974998Note: Rate of the outcome for the study groups, power\u00e2\u0080\u0089=\u00e2\u0080\u008990%, alpha\u00e2\u0080\u0089=\u00e2\u0080\u00895%, equivalence margin\u00e2\u0080\u0089=\u00e2\u0080\u008910%\n Additionally, when we consider a hazard ratio (HR)\u00e2\u0080\u0089=\u00e2\u0080\u00891, moderate intraclass correlation (ICC) = 0.05, the percentage of teeth in each study group of 50%, the probability of observing an event of 90%, and two one-sided test (TOST) Z\u00ce\u00b1 = 1.64, this sample size of 81 teeth provides 80% power to test the equivalence between the study groups for margins ranging from 0.7 to 0.9. This sample size was calculated as described in [15].\n Furthermore, assuming a dropout around 20%, the total sample size necessary will be 101 children. This dropout value was based on the experience of the research team from previous RCTs conducted in France [16]. This sample size is higher than those of past RCTs assessing the effectiveness of esthetic PPCs, which included 11 to 60 teeth per treatment group [6, 7].", "id": 206, "split": "train"} +{"trial_id": "NCT03296735", "pmid": "29793550", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Difference in the Cross-section Area of Subclavian Vein Between Supine and Lateral Tilt Position: Its Clinical Impact on Subclavian Venous Catheterization - Stage II\n\nIncluded conditions:\n- Catheterization\n- Posture\n\nStudy Armgroups:\n- {'label': 'Ipsilateral tilt', 'type': 'EXPERIMENTAL', 'description': 'Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.', 'interventionNames': ['Procedure: Ipsilateral tilt']}\n- {'label': 'Supine', 'type': 'NO_INTERVENTION', 'description': 'Measuring the cross-sectional area of right subclavian vein in supine position.'}\n- {'label': 'Contralateral tilt', 'type': 'ACTIVE_COMPARATOR', 'description': 'Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.', 'interventionNames': ['Procedure: Contralateral tilt']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Ipsilateral tilt', 'description': 'The operation table will be tilted 20 degrees right laterally.', 'armGroupLabels': ['Ipsilateral tilt']}\n- {'type': 'PROCEDURE', 'name': 'Contralateral tilt', 'description': 'The operation table will be tilted 20 degrees left laterally.', 'armGroupLabels': ['Contralateral tilt']}\n\nPrimary Outcomes:\n- {'measure': 'The cross-sectional area of right subclavian vein', 'description': 'The cross-sectional area of right subclavian vein', 'timeFrame': '1 minutes after position change'}\n\nPlease estimate the sample size based on the assumption: \nStage I: alpha level of 0.017, beta level of 0.2, 10% dropout rate; Stage II: alpha level of 0.05, beta level of 0.2, 10% dropout rate", "answer": 17, "answer_type": "ESTIMATED", "explanation": "Sample size\n The right csSCV in the supine position for stage I was reported to be 0.93\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.17\u00c2\u00a0cm2 in a previous study [10]. At an alpha level of 0.017 and a beta level of 0.2, a minimum of 15 patients are required to confirm a 15% increase in the csSCV in the ipsilateral tilt position compared to the supine position in the same patient. Considering a 10% dropout rate, 17 patients are needed for stage I.\n In stage II, the primary venipuncture success rate has been reported to be 74.5% in the supine position during right SCV catheterization [11]. At the alpha level of 0.05 and a beta level of 0.2, at least 100 patients per group are needed to determine a 15% increase in primary venipuncture success rate in the ipsilateral tilt position. Assuming a 10% dropout rate, 110 patients are needed in each group.", "id": 207, "split": "train"} +{"trial_id": "NCT03298087", "pmid": "30935383", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer\n\nIncluded conditions:\n- Newly Diagnosed Oligometastatic Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Experimental Arm', 'type': 'EXPERIMENTAL', 'description': 'Radical prostatectomy (and post-operative fractionated radiotherapy for pT=3a, pN1, or positive margins), metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy.', 'interventionNames': ['Procedure: radical prostatectomy', 'Radiation: stereotactic body radiotherapy', 'Drug: Leuprolide', 'Drug: apalutamide', 'Drug: abiraterone']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'radical prostatectomy', 'description': 'surgical removal of the prostate', 'armGroupLabels': ['Experimental Arm']}\n- {'type': 'RADIATION', 'name': 'stereotactic body radiotherapy', 'description': 'Highly targeted radiation', 'armGroupLabels': ['Experimental Arm'], 'otherNames': ['SBRT']}\n- {'type': 'DRUG', 'name': 'Leuprolide', 'description': 'Lowers serum testosterone', 'armGroupLabels': ['Experimental Arm'], 'otherNames': ['ADT']}\n- {'type': 'DRUG', 'name': 'apalutamide', 'description': 'antiandrogen', 'armGroupLabels': ['Experimental Arm'], 'otherNames': ['ARN-509']}\n- {'type': 'DRUG', 'name': 'abiraterone', 'description': 'Inhibits androgen synthesis', 'armGroupLabels': ['Experimental Arm'], 'otherNames': ['zytiga']}\n\nPrimary Outcomes:\n- {'measure': 'PSA<0.05ng/mL (radical prostatectomy) or PSA \u00e2\u0080\u0089150\u00e2\u0080\u0089ng/dL. A sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u008925 evaluable patients has an 80% power to test the null hypothesis response rate of 5.5% against a two sided alternative response rate of 20% at a significance level (alpha) of 0.1. Assuming 10% of patients may not recover testosterone to \u00e2\u0089\u00a5150\u00e2\u0080\u0089ng/dL, total study N\u00e2\u0080\u0089=\u00e2\u0080\u008928.", "id": 208, "split": "train"} +{"trial_id": "NCT03298659", "pmid": "33452200", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Instantaneous Wave-free Ratio Guided Multi-vessel revascularizatiOn During Percutaneous Coronary intervEntion for Acute myocaRdial iNfarction (iMODERN)\n\nIncluded conditions:\n- Acute Myocardial Infarction\n- Multi Vessel Coronary Artery Disease\n\nStudy Armgroups:\n- {'label': 'Active iFR-guided revascularization', 'type': 'EXPERIMENTAL', 'description': 'Decision to treat the nonculprit coronary stenosis if there is a significant pressure drop over the stenosis, as measured by intracoronary iFR assessment', 'interventionNames': ['Diagnostic Test: iFR']}\n- {'label': 'Deferred CMR-guided revascularization', 'type': 'ACTIVE_COMPARATOR', 'description': 'Decision to treat the nonculprit coronary stenosis if perfusion defect visible in corresponding coronary territory as visualized on stress perfusion CMR imaging', 'interventionNames': ['Diagnostic Test: CMR']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'iFR', 'description': 'Treatment guided by instantaneous wave-free ratio', 'armGroupLabels': ['Active iFR-guided revascularization']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'CMR', 'description': 'Treatment guided by stress perfusion CMR', 'armGroupLabels': ['Deferred CMR-guided revascularization']}\n\nPrimary Outcomes:\n- {'measure': 'Composite end point of Major Adverse Cardiac Events', 'description': 'All-cause death, recurrent myocardial infarction and hospitalization for heart failure', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided alpha level of 5%", "answer": 1146, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The study is powered to assess and compare the difference in the primary end point between the iFR-guided revascularisation during index procedure group vs the CMR-guided approach after 12\u00e2\u0080\u0089months. Assuming a 16% incidence of the primary end point in the CMR-guided group based on previous literature,6 153 primary endpoint events are needed and should be provided by 1146 patients in order to provide the study with 80% power to detect a relative risk reduction of 35%, implying an HR of 0.63, at a two-sided alpha level of 5%.", "id": 209, "split": "train"} +{"trial_id": "NCT03299322", "pmid": "29973284", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Assessment of Jia Wei Yang He Formula as a Plus Therapy in the Treatment of Persistent Asthma and Airway Microbiome Exploration Research\n\nIncluded conditions:\n- Bronchial Asthma\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'PLACEBO_COMPARATOR', 'description': '80 participants will take oral therapy of 9.25 g Jia Wei Yang He granule Placebo twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.', 'interventionNames': ['Drug: Jia Wei Yang He granule Placebo']}\n- {'label': 'High dose Treatment Group', 'type': 'EXPERIMENTAL', 'description': 'Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 18.5g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.', 'interventionNames': ['Drug: Jia Wei Yang He granule']}\n- {'label': 'Low dose Treatment Group', 'type': 'EXPERIMENTAL', 'description': 'Participants in high Jia Wei Yang He formula group will receive Jia Wei Yang He granule 9.25g twice a day for 28 consecutive days and also standard therapy of inhaled corticosteroid or beta2-agonist.', 'interventionNames': ['Drug: Jia Wei Yang He granule']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Jia Wei Yang He granule', 'description': 'This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time', 'armGroupLabels': ['High dose Treatment Group', 'Low dose Treatment Group'], 'otherNames': ['Jia Wei Yang He Formula']}\n- {'type': 'DRUG', 'name': 'Jia Wei Yang He granule Placebo', 'description': 'Made from 1/20 doses which has certain taste, but no therapeutic effect', 'armGroupLabels': ['Control Group'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Asthma Control Test Score variation', 'description': 'Measured the change from Baseline to the end of treatment', 'timeFrame': 'Baseline and 4 weeks'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level, 80% power, and an estimated dropout rate of 20%.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculations are based on the primary endpoint (ACT score at 4\u00c2\u00a0weeks). At the 5% significance level, a total of 64 patients per group is required to achieve 80% power and to determine an increase of 2 points in the ACT score between the high-dose TCM plus usual care group and the placebo plus usual care group, assuming that the standard deviation of the groups is equal to 4 [30]. If the previous hypothesis is rejected, then the difference of 1.5 points in ACT score between the low-dose TCM plus usual care group and the placebo plus usual care group at the 5% significance level is tested. With an estimated dropout rate of 20%, a total of 240 patients is enrolled. If the initial hypothesis is not rejected, subsequent comparison is considered exploratory, and no conclusion is made [31, 32].", "id": 210, "split": "train"} +{"trial_id": "NCT03299439", "pmid": "30282686", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points\n\nIncluded conditions:\n- Acupuncture\n- Knee Osteoarthritis\n- Sensitive Acupoints\n- Tender Points\n\nStudy Armgroups:\n- {'label': 'acupuncture at highly sensitive points', 'type': 'EXPERIMENTAL', 'description': 'Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five highly sensitive points.', 'interventionNames': ['Other: acupuncture']}\n- {'label': 'acupuncture at lowly/non-sensitive points', 'type': 'ACTIVE_COMPARATOR', 'description': 'Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five low/non-sensitive points.', 'interventionNames': ['Other: acupuncture']}\n- {'label': 'no acupuncture (waiting-list)', 'type': 'NO_INTERVENTION', 'description': 'Patients in the waiting-list group will not receive any acupuncture intervention during the study.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'acupuncture', 'description': 'a stimulation of the body or auricular points', 'armGroupLabels': ['acupuncture at highly sensitive points', 'acupuncture at lowly/non-sensitive points']}\n\nPrimary Outcomes:\n- {'measure': 'The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks', 'description': 'It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function.', 'timeFrame': 'Assessments will be conducted at baseline and 16 weeks after randomization'}\n\nPlease estimate the sample size based on the assumption: \nSD of total score of 33, a two-sided significance level of 0.025, a power of 0.9, and a loss to follow-up rate of 10%.", "answer": 666, "answer_type": "ACTUAL", "explanation": "Sample size\n Our primary study hypothesis is that acupuncture on high-sensitive points (ie, experimental group) would achieve more reduction in the total WOMAC score than acupuncture on low/non-sensitive points (ie, active control group) or waiting-list group (ie, no treatment group).\n The sample size estimation was based on the mean difference in the change of total WOMAC score from baseline given the estimates obtained from our pilot trial. The following assumptions were made to calculate the sample size: a mean difference of 12 between the high and low/non-sensitisation groups, SD of total score of 33, a two-sided significance level of 0.025 (adjusted for multiple testing) and a power of 0.9. With these assumptions, a sample size 189 patients per arm is required to provide a power of 90% at the alpha level of 0.025 to detect a difference of 12 points between the high and low/non-sensitisation groups. This sample size would provide adequate power to detect the difference between high-sensitisation group versus waiting-list group, on the ground that the treatment effect between high-sensitisation group and low/non-sensitisation group would be smaller than that between high-sensitisation group and waiting-list group.\n To allow for a loss to follow-up of 10%, a minimum sample size of 666 patients (222 patients per arm) at baseline was required.", "id": 211, "split": "train"} +{"trial_id": "NCT03304158", "pmid": "30348188", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Community Based Intervention for Management of Diabetes in Nepal (COBIN-D): A Cluster Randomised Controlled Trial\n\nIncluded conditions:\n- Type 2 Diabetes Mellitus\n\nStudy Armgroups:\n- {'label': 'FCHV visit-diabetes', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: FCHV visit']}\n- {'label': 'FCHV no visit-diabetes', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'FCHV visit', 'description': 'FCHVs will visit selected households 3 times a year for providing health promotion messages and measure the blood glucose', 'armGroupLabels': ['FCHV visit-diabetes']}\n\nPrimary Outcomes:\n- {'measure': 'Mean fasting blood glucose level', 'description': 'Change in mean fasting blood glucose level in diabetes populations', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence interval, significance level of 0.05, standard deviation of 2.1, intracluster correlation of 0.01, design effect of 1.1, 80% power, and up to 20% loss to follow-up.", "answer": 224, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size for the baseline survey will be calculated with 95% confidence interval (z\u00e2\u0080\u0089=\u00e2\u0080\u00891.96), based on the following assumptions: margin of error (alpha),\u00c2\u00a05%; estimated prevalence of diabetes,\u00c2\u00a09.5% [31]; design effect,\u00c2\u00a02; and anticipated response rate,\u00c2\u00a080%. We will only include the \u00e2\u0089\u00a5\u00e2\u0080\u008925\u00c2\u00a0years age group, so we will have four age groups for each sex (total strata\u00e2\u0080\u0089=\u00e2\u0080\u00898); this will result in a sample size\u00c2\u00a0of\u00c2\u00a02643. The sample size was calculated based on the method suggested by the WHO STEPWISE Approach [32]. According to the STEPS sample size calculator, a margin of error of 0.05 is suggested in a prevalence survey for an expected prevalence of 10% or greater. In addition, a smaller margin of error of 0.02 or 0.01 is considered appropriate when the expected prevalence is lower than 10%. The anticipated prevalence of type 2 diabetes was 9.5% in the earlier study [31], which is very close to 10%; this being an assumption, a margin of error of 0.05 was included. For the intervention study, we took a reference of a lifestyle intervention study for diabetes management conducted in a rural community-based setting, which showed a mean reduction in fasting blood glucose by 1.0\u00c2\u00a0mmol/L after intervention in the diabetic population [33]. Using the two-sided t test with a significance level of 0.05 and assuming a standard deviation of 2.1, considering an intracluster correlation of 0.01, and the design effect of 1.1 and 80% power, we will need seven clusters with 13 individuals per intervention arm. Allowing for up to 20% loss to follow-up, the sample size was adjusted to 16 in each cluster, i.e., 112 individuals per arm or a total of 224 diabetes patients.", "id": 212, "split": "train"} +{"trial_id": "NCT03309501", "pmid": "31234919", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study on Efficacy, Safety and Economy of Tong-Luo-Qu-Tong Plaster Treatment for Knee Osteoarthritis: Study Protocol for a Randomised, Double-blind, Parallel Positive Control, Multi-center Clinical Trial\n\nIncluded conditions:\n- Knee Osteoarthritis\n- Chronic Musculoskeletal Disease\n\nStudy Armgroups:\n- {'label': 'Tong-Luo-Qu-Tong Plaster group', 'type': 'EXPERIMENTAL', 'description': 'Intervention: Tong-Luo-Qu-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses', 'interventionNames': ['Drug: Tong-Luo-Qu-Tong Plaster']}\n- {'label': 'Qi-Zheng-Xiao-Tong Plaster group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention: Qi-Zheng-Xiao-Tong Plaster, daily 1 time, conventional treatment lasted for 14 days as two courses', 'interventionNames': ['Drug: Qi-Zheng-Xiao-Tong Plaster']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tong-Luo-Qu-Tong Plaster', 'description': 'for 14 days as two period of treatment, daily 1 time.', 'armGroupLabels': ['Tong-Luo-Qu-Tong Plaster group']}\n- {'type': 'DRUG', 'name': 'Qi-Zheng-Xiao-Tong Plaster', 'description': 'for 14 days as two period of treatment, daily 1 time', 'armGroupLabels': ['Qi-Zheng-Xiao-Tong Plaster group']}\n\nPrimary Outcomes:\n- {'measure': 'WOMAC scores', 'description': 'Western Ontario and McMaster universities osteoarthritis index, ranges 0-96. Higher values represent a worse outcome.', 'timeFrame': 'from baseline to 2 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 80% and the alpha value is 2.5% (two-tailed). A conservative 20% dropout rate is also assumed.", "answer": 2000, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Our study was designed as a non-inferiority trial and sample size calculations are based on the primary outcome measurement. First, the minimal clinically important difference in WOMAC scales in KOA is estimated from previous studies [28] as 15.50 points. Second, we assume that based on previous literature [29], the square deviation of the WOMAC score is 318.88. For power of 80% and an alpha value of 2.5% (two-tailed), the sample size is calculated using the following formula:\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ n=\\frac{\\frac{4}{3}{\\left({u}_{\\upalpha}+{u}_{\\beta}\\right)}^2{\\upsigma}^2}{{\\left(\\varDelta -\\updelta \\right)}^2}\\ \\left({u}_{\\upalpha}=1.6449,\\kern0.5em {u}_{\\beta }=1.2816\\right) $$\\end{document}n=43u\u00ce\u00b1+u\u00ce\u00b22\u00cf\u00832\u00ce\u0094\u00e2\u0088\u0092\u00ce\u00b42u\u00ce\u00b1=1.6449u\u00ce\u00b2=1.2816\n Thus, we obtained the sample size of 1600 patients for this trial; allowing for a conservative 20% dropout rate, the total sample size was set at 2000 patients (1500 in the Tong-luo Qu-tong plaster group).", "id": 213, "split": "train"} +{"trial_id": "NCT03310385", "pmid": "29764875", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis: a Phase 2, Double-blind, Randomized Placebo-controlled Trial\n\nIncluded conditions:\n- Acute Bronchitis\n\nStudy Armgroups:\n- {'label': 'High-dose GHX02 group(1,920mg/day)', 'type': 'EXPERIMENTAL', 'description': '4 tablets of the GHX02, three times daily for 7 days', 'interventionNames': ['Drug: GHX02']}\n- {'label': 'Standard-dose GHX02 group(960mg/day)', 'type': 'EXPERIMENTAL', 'description': '2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days', 'interventionNames': ['Drug: GHX02', 'Drug: Placebo']}\n- {'label': 'Placebo control', 'type': 'PLACEBO_COMPARATOR', 'description': '4 tablets of the placebo, three times daily for 7 days', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'GHX02', 'description': 'Herbal medicine originating from gualouhengryunhwan', 'armGroupLabels': ['High-dose GHX02 group(1,920mg/day)', 'Standard-dose GHX02 group(960mg/day)']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo tablets', 'armGroupLabels': ['Placebo control', 'Standard-dose GHX02 group(960mg/day)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in BSS(Bronchitis Severity Score)', 'description': \"BSS comprises the sum of five major symptom scores for acute bronchitis: cough, sputum, dyspnea, chest pain during coughing, and rales on auscultation. Each symptom is scored on a 4-point-scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe), with a maximum total score of 20 points. The investigator assesses symptom scores on the basis of the patient's subjective symptoms.\", 'timeFrame': 'Day0, Day7'}\n\nPlease estimate the sample size based on the assumption: \nThe power to detect the difference is 0.8, the two-sided significance level is 0.05, the ratio of allocation of subjects between the groups is 1:1:1, and the dropout rate is 0.2.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n The estimated sample size required for this study is 150 patients (50 patients per group).19 The estimation of the number of subjects is based on whether there is a difference in the change from baseline (day 0) to postdose (day 7) Bronchitis Severity Score (BSS), between the control and standard-dose GHX02 group. In an earlier comparable clinical study, the difference was reported to be 2.3, and the SD of the changes in BSS, was estimated to be 3.2.20 The power to detect the difference was assumed to be 0.8, and the two-sided significance level was 0.05. The ratio of allocation of subjects between the groups was 1:1:1, and drop-out rate was presumed to be 0.2.", "id": 214, "split": "train"} +{"trial_id": "NCT03317990", "pmid": "35869497", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Single Blinded, IDEAL Stage 3, Multi-centre, Randomised Controlled Trial to Assess NeuroSAFE Robotic Assisted Radical Prostatectomy (RARP) Vs Standard Robotic Assisted Radical Prostatectomy (RARP) in Men with Prostate Cancer\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'NeuroSAFE procedure', 'type': 'EXPERIMENTAL', 'description': 'These patients will undergo robotic radical prostatectomy with bilateral nerve spare.The pathologist will remove the pre-painted surface of the gland (which had been in contact with the neurovascular bundles) using a sharp blade.The tissue sample will be snap frozen and embedded in OCT.Using a cryostat, 10 micron thick slices will be placed on slides.The entire length of the area of interest will be sampled in this way generating \u224810 frozen sections per side.The slides will be stained with H\\\\&E and will be examined by a consultant pathologist.As soon as examination is complete the pathologist will telephone the operating surgeon to give the result.Presence of cancer cells at the margin of resection constitutes a positive margin and the neurovascular bundle on that side will be resected if the PSM is present in more than one slice on the same side or for a distance of 3 or more mm.', 'interventionNames': ['Procedure: NeuroSAFE procedure']}\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'These patients will undergo robotic radical prostatectomy with a nerve sparing procedure based on surgical planning performed by a consultant radiologist. The mp-MRI will be reviewed by a consultant radiologist along with the details of the prostate biopsy and DRE a decision to perform unilateral, bilateral or non-nerve sparing will be established and recorded in the clinical record form (CRF) for each patient.', 'interventionNames': ['Procedure: Standard RARP']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'NeuroSAFE procedure', 'description': 'When the prostate is removed from within the patient as it is disconnected from its attachments. The specimen will then be painted (right=blue, left =black) by the operating surgeon and delivered expediently to the pathologist who will perform frozen section analysis of the painted areas. The pathologist will remove the pre-painted surface of the gland (which had been in contact with the neurovascular bundles) using a sharp blade. The tissue sample will be snap frozen and embedded in OCT. If a significant positive margin (on more than one section from one side or in a single section but greater than or equal to 3mm) is reported by the pathologist, the entire neurovascular bundle on the affected side will be removed and sent for formal pathological examination.', 'armGroupLabels': ['NeuroSAFE procedure'], 'otherNames': ['NeuroSAFE RARP']}\n- {'type': 'PROCEDURE', 'name': 'Standard RARP', 'description': 'Patients will undergo the standard intervention - RARP without NeuroSAFE Frozen section analysis', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Erectile Function', 'description': 'Comparison of the erectile function at 12-months according to allocated treatment arm (i.e. NeuroSAFE RARP \\\\[intervention\\\\] vs. standard RARP \\\\[control\\\\]). Erectile function is measured using the IIEF-5 questionnaire\\n\\no Pre-defined sub-group analysis: comparison of the erectile function at 12-months according to treatment arm, restricted to men who did not receive a pre-operative radiologist recommendation for bilateral nerve sparing', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \n90% power, alpha of 0.05, loss to follow-up rate of 10%", "answer": 404, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size calculation was based on the results of the NeuroSAFE PROOF feasibility study data. Patients from the feasibility study will not be included in the main trial analysis. A sample of 416 patients (374 evaluable) is needed to detect a 14% or higher difference between groups with 90% power, alpha of 0.05, and a loss to follow-up rate of 10%. EF preservation rates from the feasibility study have not been presented here to protect equipoise and because the feasibility study was not powered to detect treatment effect estimates. The Independent Data Monitoring Committee (IDMC) reviewed the sample size assumptions on 16 February 2021, unblinded to results from the first 150 men recruited to the main trial and advised the study to continue recruitment to the original number of 404 men (364 evaluable men). The IDMC has continued reviewing the recruitment target during the trial.", "id": 215, "split": "train"} +{"trial_id": "NCT03318133", "pmid": "30928924", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Combined Lumbar and Sacral Plexus Block With Sedation Versus General Endotracheal Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Hip Fracture Surgery(CLSB-HIPELD): Rationale and Design of a Prospective, Multicenter, Randomized Controlled Trial\n\nIncluded conditions:\n- Anesthesia Morbidity\n- Anesthesia; Adverse Effect\n\nStudy Armgroups:\n- {'label': 'GA group', 'type': 'EXPERIMENTAL', 'description': 'general anesthesia(GA) group:\\n\\n1. Open peripheral vein fluid infusion, radial arterial cannulation under local lidocaine anesthesia and arterial blood pressure monitoring\\n2. Propofol (1.5-3mg/kg), cis-atracurium(0.1-0.15mg/kg) and sulfentanyl(0.2-0.6\u03bcg/kg) anesthesia-induced intubation, mechanical ventilation to maintain normal PETCO2\\n3. Use sevoflurane, propofol and sulfentanyl to maintain anesthesia, and add cis-atracurium as needed\\n4. Transfer to ICU after surgery', 'interventionNames': ['Procedure: anesthesia']}\n- {'label': 'CLSB group', 'type': 'EXPERIMENTAL', 'description': 'combined lumbar plexus and sacral plexus block(CLSB) group:\\n\\n1. Open peripheral vein fluid infusion\\n2. In lateral position (affected side upward), ultrasound-guided lumbar plexus block (0.375% ropivacaine, Lumbar 2-3 or/and 3-4vertebral space level, 25ml), then sacral plexus block (0.375% ropivacaine, 20ml)\\n3. Radial arterial cannulation under local lidocaine anesthesia and arterial blood pressure monitoring, and blockade effectiveness was evaluated 30min after nerve block\\n4. After reaching satisfactory blockade, target-controlled infusion of propofol was used to maintain Ramsay sedation score between 5-6 points, monitoring PETCO2 through nasopharyngeal airway, maintain autonomous respiration, and add small-dose fentanyl (10-20\u03bcg/time) as needed\\n5. Transfer to ICU after surgery', 'interventionNames': ['Procedure: anesthesia']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'anesthesia', 'description': 'in this study, we plan to make a prospective, multicenter, randomized controlled clinical trial to compare the effects of general anesthesia with endotracheal intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly patients with hip fracture.', 'armGroupLabels': ['CLSB group', 'GA group']}\n\nPrimary Outcomes:\n- {'measure': 'mortality', 'description': 'Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.', 'timeFrame': 'month 1'}\n- {'measure': 'mortality', 'description': 'Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.', 'timeFrame': 'months 3'}\n- {'measure': 'mortality', 'description': 'Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.', 'timeFrame': 'month 6'}\n- {'measure': 'mortality', 'description': 'Telephone follow-up will be performed to confirm whether the patient survival or not after surgery.', 'timeFrame': 'month 12'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level is 0.05 (one-sided), power is 0.80, and an additional 20% is added to account for possible loss to follow-up.", "answer": 1086, "answer_type": "ESTIMATED", "explanation": "Power and sample size calculation\n We estimate the sample size using the formula by Schoenfeld under the assumption of the validity of the proportional-hazards regression model.23 24 We take significance level 0.05 (one-sided) and power 0.80. Patients will be randomly assigned to one of the two anaesthesia groups in five different clinical centres. A retrospective study included patients over 65 years old showed that the 1-year mortality was 41.7% for GA group and 28.3% for combined peripheral nerve block group.14 In this study, only patients with age 75 years or older will be included, so we expect the actual mortality of the GA group will be higher than that in the previous study. Therefore, we assume the mortality to be 55% for GA group and 46.75% for CLSB group (15% relative reduction compared with GA group). Then the sample size needed for this study is 868 (with 434 in each of the two groups). When the mortality of the GA group is only 45%, the above calculated sample size can still detect a 20% improvement in the CLSB group with the power of at least 0.80. In consideration of the possible lost to follow-up, we add an additional 20% to the above calculated sample size. So, the total number of patients needed for this study is 1086.", "id": 216, "split": "train"} +{"trial_id": "NCT03320200", "pmid": "31409380", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial\n\nIncluded conditions:\n- Adhesive Capsulitis of Shoulder\n- Frozen Shoulder\n\nStudy Armgroups:\n- {'label': 'CNS-focused treatment', 'type': 'EXPERIMENTAL', 'description': 'Group of subjects receiving a 10 week CNS (Central Nervous System) -focused treatment program for frozen shoulder in addition to 5 days per week home treatment program', 'interventionNames': ['Other: CNS-focused treatment']}\n- {'label': 'Standard Care Treatment', 'type': 'EXPERIMENTAL', 'description': 'Group of subjects receiving a 10 week standard care treatment program for frozen shoulder in addition to 5 days per week home treatment program based on conventional physiotherapy', 'interventionNames': ['Other: Standard Care Treatment']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'CNS-focused treatment', 'description': 'The CNS-focused treatment will last for 10 weeks, conducted in 60-minute sessions on a weekly basis. In addition, participants in this group will complete a home treatment program for 30 minutes, five times a week.', 'armGroupLabels': ['CNS-focused treatment'], 'otherNames': ['graded motor and sensory imagery traininng']}\n- {'type': 'OTHER', 'name': 'Standard Care Treatment', 'description': 'The standard physiotherapy group will receive a 10-session treatment program that will include one corticosteroid infiltration provided in the early acute stage followed by a multimodal physiotherapy program including analgesic modalities (e.g. TENS, cryotherapy) and exercise and manual therapy techniques addressing the specific mobility deficits of each patient. This program also include a home treatment based on conventional physiotherapy that involves a training load comparable to that in the CNS-focused group.', 'armGroupLabels': ['Standard Care Treatment'], 'otherNames': ['Conventional physiotherapy treatment']}\n\nPrimary Outcomes:\n- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Baseline'}\n- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Change from baseline SPADI at 10 weeks'}\n- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Change from baseline SPADI at 3 months'}\n- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Change from baseline SPADI at 6 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha level of 0.05, 15% dropout rate.", "answer": 34, "answer_type": "ACTUAL", "explanation": "Statistical analysis including sample size calculation\n \n Sample size calculations\n The sample size will be calculated using G*Power 3.0.18 Software based on the SPADI as the primary outcome measure. To our knowledge, there are no studies investigating the effects of GMI or graded sensory discrimination training on FS. Based on similar studies applying physiotherapy on FS (SPADI mean of 66 points; standard deviation (SD) = 16) [8], and the minimal detectable change attained in the study by Tveita et al. (17 points) [41], to detect a 17-point (SD\u00e2\u0080\u0089=\u00e2\u0080\u008916) between-group difference, with 80% power and an alpha level of 0.05, a total sample size of 30 patients is estimated (15 per group). An allowance will be made for a 15% dropout rate, increasing the sample size to 34 patients (17 per group). However, since this calculation is not based in the use of GMI, to assure an adequate sample size, we will carry out a pilot study with 20 participants (10 per group) to test these assumptions. Mean differences and standard deviations from the inter-group comparison on the primary outcome (SPADI) will then be used to recalculate the sample size, if necessary.\n \n \n Statistical analysis\n Data will be analyzed using the statistical package SPSS 21.00 for Windows. Statistical significance will be set at p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05. Prior to statistical comparisons, all data will be tested for normal distribution. Then, a descriptive analysis of the data will be obtained for the dependent variables in the different assessment times. Subsequently, homogeneity of the two intervention groups will be studied. To confirm if there are differences in each group (intra-group comparisons), considering each group in isolation, between the four assessments in each of the variables (baseline, post treatment, 3-month follow-up, 6-month follow-up), repeated measures analysis of variance ANOVA will be used. To calculate inter-group differences between baseline and follow-ups, a four-way repeated-measures ANOVA will be conducted, with the scores of every primary and secondary outcome as dependent factors, with four levels corresponding to every time of assessment (t1, t2, t3 and t4), and the two intervention groups (CNS-focused treatment vs standard care treatment) as independent factors. Between- and within-group effect sizes for all quantitative variables will be measured with the Cohen d coefficient. An effect size greater than 0.8 will be considered large, around 0.5 moderate, and less than 0.2 small [42]. In cases of missing data, an intention-to-treat analysis will be performed. Double data entry will be carried out in order to promote data quality.", "id": 217, "split": "train"} +{"trial_id": "NCT03320200", "pmid": "31409380", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Central Nervous System Focused Treatment Approach for People With Frozen Shoulder: Protocol for a Randomised Clinical Trial\n\nIncluded conditions:\n- Adhesive Capsulitis of Shoulder\n- Frozen Shoulder\n\nStudy Armgroups:\n- {'label': 'CNS-focused treatment', 'type': 'EXPERIMENTAL', 'description': 'Group of subjects receiving a 10 week CNS (Central Nervous System) -focused treatment program for frozen shoulder in addition to 5 days per week home treatment program', 'interventionNames': ['Other: CNS-focused treatment']}\n- {'label': 'Standard Care Treatment', 'type': 'EXPERIMENTAL', 'description': 'Group of subjects receiving a 10 week standard care treatment program for frozen shoulder in addition to 5 days per week home treatment program based on conventional physiotherapy', 'interventionNames': ['Other: Standard Care Treatment']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'CNS-focused treatment', 'description': 'The CNS-focused treatment will last for 10 weeks, conducted in 60-minute sessions on a weekly basis. In addition, participants in this group will complete a home treatment program for 30 minutes, five times a week.', 'armGroupLabels': ['CNS-focused treatment'], 'otherNames': ['graded motor and sensory imagery traininng']}\n- {'type': 'OTHER', 'name': 'Standard Care Treatment', 'description': 'The standard physiotherapy group will receive a 10-session treatment program that will include one corticosteroid infiltration provided in the early acute stage followed by a multimodal physiotherapy program including analgesic modalities (e.g. TENS, cryotherapy) and exercise and manual therapy techniques addressing the specific mobility deficits of each patient. This program also include a home treatment based on conventional physiotherapy that involves a training load comparable to that in the CNS-focused group.', 'armGroupLabels': ['Standard Care Treatment'], 'otherNames': ['Conventional physiotherapy treatment']}\n\nPrimary Outcomes:\n- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Baseline'}\n- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Change from baseline SPADI at 10 weeks'}\n- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Change from baseline SPADI at 3 months'}\n- {'measure': 'shoulder pain-related disability questionnaire (SPADI)', 'description': 'The SPADI is a 13-items shoulder function index assessing pain and disability related to shoulder dysfunction. Each item is scored by a numeric rate scale ranging from 0 (no pain/no difficulty) to 10 (worst pain imaginable/so difficult it required help). The total score ranges from 0 to 100 points where a higher score indicates greater disability.', 'timeFrame': 'Change from baseline SPADI at 6 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha level of 0.05, 15% dropout rate.", "answer": 34, "answer_type": "ACTUAL", "explanation": "Sample size calculations\n The sample size will be calculated using G*Power 3.0.18 Software based on the SPADI as the primary outcome measure. To our knowledge, there are no studies investigating the effects of GMI or graded sensory discrimination training on FS. Based on similar studies applying physiotherapy on FS (SPADI mean of 66 points; standard deviation (SD) = 16) [8], and the minimal detectable change attained in the study by Tveita et al. (17 points) [41], to detect a 17-point (SD\u00e2\u0080\u0089=\u00e2\u0080\u008916) between-group difference, with 80% power and an alpha level of 0.05, a total sample size of 30 patients is estimated (15 per group). An allowance will be made for a 15% dropout rate, increasing the sample size to 34 patients (17 per group). However, since this calculation is not based in the use of GMI, to assure an adequate sample size, we will carry out a pilot study with 20 participants (10 per group) to test these assumptions. Mean differences and standard deviations from the inter-group comparison on the primary outcome (SPADI) will then be used to recalculate the sample size, if necessary.", "id": 218, "split": "train"} +{"trial_id": "NCT03320538", "pmid": "31335741", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases: A Multicenter, Randomized, Double-blinded, Controlled Trial\n\nIncluded conditions:\n- Peptic Ulcer Disease\n\nStudy Armgroups:\n- {'label': 'Hou Gu Mi Xi', 'type': 'EXPERIMENTAL', 'description': 'Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).\\n\\nMaintain treatment period (3rd to 6th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\\n\\nRecuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\\n\\nExtensional observational period (53 to 104 weeks): no intervention.', 'interventionNames': ['Other: Hou Gu Mi Xi']}\n- {'label': 'Hou Gu Mi Xi + rabeprazole', 'type': 'EXPERIMENTAL', 'description': 'Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).\\n\\nMaintain treatment period (3rd to 6th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day) plus rabeprazole (once 10 mg, once a day).\\n\\nRecuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\\n\\nExtensional observational period (53 to 104 weeks): no intervention.', 'interventionNames': ['Other: Hou Gu Mi Xi', 'Drug: Rabeprazole']}\n- {'label': 'Placebo + rabeprazole', 'type': 'PLACEBO_COMPARATOR', 'description': 'Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).\\n\\nMaintain treatment period (3rd to 6th week): Patients in this arm receive Placebo of Hou Gu Mi Xi (once 10 g, twice a day) plus rabeprazole (10 mg/d, qd).\\n\\nRecuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\\n\\nExtensional observational period (53 to 104 weeks): no intervention.', 'interventionNames': ['Other: Placebo', 'Drug: Rabeprazole']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day).\\n\\nMaintain treatment period (3rd to 6th week): Patients in this arm receive placebo of Hou Gu Mi Xi (once 10 g, twice a day).\\n\\nRecuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day).\\n\\nExtensional observational period (53 to 104 weeks): no intervention.', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Hou Gu Mi Xi', 'description': 'Hou Gu Mi Xi is an oatmeal-liked, solid food (dry or dissolved eating).', 'armGroupLabels': ['Hou Gu Mi Xi', 'Hou Gu Mi Xi + rabeprazole']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'The placebo is as same as Hou Gu Mi Xi in respect of color, taste, and smell.', 'armGroupLabels': ['Placebo', 'Placebo + rabeprazole']}\n- {'type': 'DRUG', 'name': 'Rabeprazole', 'description': 'Rabeprazole is produced by Shanghai Xinyi Pharmaceutical Corp. Ltd.', 'armGroupLabels': ['Hou Gu Mi Xi + rabeprazole', 'Placebo + rabeprazole'], 'otherNames': ['Trade name: Xin Wei An']}\n\nPrimary Outcomes:\n- {'measure': 'Total effective rate', 'description': 'The ulcer was classified for 6 grades:\\n\\nA1: The ulcer is round or elliptical with the center covers thick and white fur; it can be accompanied by errhysis or blood clot, and was surrounded by the obvious flush, hyperemia and edema.\\n\\nA2: The ulcer is covered by yellow or white fur, no bleeding, alleviated congestion and edema H1: The ulcer is healing, no hyperemia and edema disappear around the ulcer; the ulcer moss becomes thin, subside, accompanied by the new capillaries.\\n\\nH2: The ulcer continuously changes to shallow and small. The surrounding mucosa plica centralized to the ulcer.\\n\\nS1: The white fur of ulcer disappears and the new ulcer mucosa presents red. S2: The new ulcer mucosa goes from red to white.\\n\\nClinical cure: The ulcer heals with or without scar Markedly effective: The healing of ulcer reaches grade H2, or improves 2 grades Effective: The healing of ulcer reaches grade H1, or improves 1 grades Non-effective: No efficacy by the endoscopic observation', 'timeFrame': 'At baseline, and 12, 26, 52, and 104 weeks'}\n- {'measure': 'Quality of ulcer healing', 'description': \"According to Pan et al's method, we will classify the quality of ulcer healing as three ranks by histological assessment: 1) good: integral villus and epithelium, many glands, good morphology, many blood capillary, and few inflammatory cells infiltration. 2) fair: short villus, incomplete or rough epithelium, less glands, structural distortion, few blood capillary, and moderate inflammatory cells infiltration; 3) poor: a little new epithelial cell, poor integrity of epithelium, poor morphology of villus and glands, very few blood capillary, and large amount of inflame cells.\", 'timeFrame': 'At baseline and 12 and 26 weeks'}\n- {'measure': 'Changes in Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (unit: score on a scale)', 'description': 'This outcome will be assessed based on the Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (SQD scale) score. Construct of SQD scale: A total of 15 items, of which 7 items assess main symptoms, including stomach pain, stomach distension, acid reflux, abdominal distension, powerless defecation, fatigue and weak, and inappetence; 8 items assess secondary symptoms, including stomach tightness, stomach burn, belching, nausea and vomiting, abnormal stool, tired mind and taciturnity, sallow complexion, and tastelessness and hypodipsia.\\n\\nScale ranges and explanations: Assessment of each item includes three aspects: degree, frequency in one day, and episodes within one week. The total score of each item is the sum of points of the three aspects. The higher score indicate the worse symptom. The items for assessing main symptoms are double weighted. The score range is 0 to 283 point.', 'timeFrame': 'At basline and 6, 12, 26, 52 and 104 weeks'}\n\nPlease estimate the sample size based on the assumption: \ntype I error (\u00ce\u00b1) of 0.05, type II error (\u00ce\u00b2) of 0.2, and a maximum drop-out rate of 15%", "answer": 360, "answer_type": "ACTUAL", "explanation": "2.9\n Sample size estimation\n The main objective of this trial is to assess the effects of HGMX compared with placebo on the total effective rate. Therefore, the sample size estimation is based on the formula for a superiority design.[24] Because there are no previous studies available for reference, we estimated a P of .85 (total effective rate in the two groups receiving HGMX) and a P0 of .65 (total effective rate in the 2 groups receiving placebo) according to the results of our pilot survey and expert opinions. In addition, we adopted a type I error (\u00ce\u00b1) of 0.05, a type II error (\u00ce\u00b2) of 0.2, and a maximum drop-out rate of 15%. Based on these assumptions and our funding constraints, we computed a sample size of 360, with 90 in each group.", "id": 219, "split": "train"} +{"trial_id": "NCT03321682", "pmid": "32334527", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cardiopulmonary Capacity and Quality of Life in Patients With Chronic Heart Failure Submitted to Functional Training - a Randomized Clinical Trial\n\nIncluded conditions:\n- Heart Failure\n\nStudy Armgroups:\n- {'label': 'Functional Training', 'type': 'EXPERIMENTAL', 'description': 'Patients in the functional training group, in addition to maintaining their usual care, will perform functional training including exercises for core strength, power training, knee dominance, hip dominance, horizontal pressure, vertical pressure, horizontal pull and vertical pull, using unstable surfaces.', 'interventionNames': ['Other: Functional Training']}\n- {'label': 'Strength Training', 'type': 'ACTIVE_COMPARATOR', 'description': 'These group, in addition to maintaining their usual care, will perform the exercise protocol as recommended by the American Heart Association.', 'interventionNames': ['Other: Strength Training']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Functional Training', 'description': 'Exercises performed in circuit, using weights, elastic bands, suspension tapes, cones and on unstable surfaces.', 'armGroupLabels': ['Functional Training']}\n- {'type': 'OTHER', 'name': 'Strength Training', 'description': 'Exercises carried out using weights and involving the main muscle groups.', 'armGroupLabels': ['Strength Training']}\n\nPrimary Outcomes:\n- {'measure': 'Cardiopulmonary Capacity', 'description': 'Cardiopulmonary capacity assessed by peak oxygen consumption in treadmill cardiopulmonary exercise test.', 'timeFrame': 'After 12 weeks of training.'}\n- {'measure': 'Quality of life', 'description': \"Quality of life assessed by the Minnesota Living With Heart Failure Questionnaire. It is composed of 21 questions about limitations that are often associated with how heart failure interferes with patients' quality of life. The patient should consider the last month to answer the questions. The scale of responses for each question varies from 0 (zero) to 5, where 0 represents without limitations and 5, maximum limitation. These questions involve a physical dimension (from 1 to 7, 12 and 13 questions) that are highly interrelated with dyspnea and fatigue, an emotional dimension (17 to 21 questions) and other issues (8, 9, 10, 11, 14, 15 and 16 questions) which, added to the previous dimensions, form the total score. The scale totals 105 points. Higher values indicate maximum limitation and poorer quality of life.\", 'timeFrame': 'After 12 weeks of training.'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a significance level of 5%, and a 20% estimated participant loss or refusal rate.", "answer": 38, "answer_type": "ACTUAL", "explanation": "Sample size\n Our sample size calculation was based on Feiereisen et al., who enrolled subjects with HF with reduced ejection fraction to assess the effect of strength in comparison with aerobic and combined aerobic-strength training on their peak VO2 [31]. Considering a power of 80%, a significance level of 5% and an effect size of 0.2 for the peak VO2, a total sample size of 32 subjects was estimated, including 16 in each study group. To account for a 20% estimated participant loss or refusal rate, we defined that 19 patients should be enrolled in each group, totalizing 38 subjects.", "id": 220, "split": "train"} +{"trial_id": "NCT03323580", "pmid": "36401274", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Intraoperative Goal-directed Fluid Therapy (GDFT) on the Postoperative Brain Edema in Neurosurgical Patients With Malignant Supratentorial Gliomas\n\nIncluded conditions:\n- Fluid Therapy\n- Brain Edema\n- Brain Tumor\n\nStudy Armgroups:\n- {'label': 'GDFT group', 'type': 'EXPERIMENTAL', 'description': 'The patients will receive fluid therapy under goal directed.', 'interventionNames': ['Other: GDFT']}\n- {'label': 'Routine group', 'type': 'SHAM_COMPARATOR', 'description': 'The patients will receive routine fluid therapy.', 'interventionNames': ['Other: traditional fluid therapy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'GDFT', 'description': 'Target parameter will be titrated with fluid bolus, and thus individual amount varied depending on the parameter value at that time. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.', 'armGroupLabels': ['GDFT group']}\n- {'type': 'OTHER', 'name': 'traditional fluid therapy', 'description': 'Fluid therapy will be done without goal directed. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as mean arterial pressure and heart rate, will be applied according to the same standard for each patient.', 'armGroupLabels': ['Routine group']}\n\nPrimary Outcomes:\n- {'measure': 'Quantitative analysis of brain edema', 'description': 'Postoperative brain edema is defined as edema surrounding the surgical resection cavity, which will be evaluated through CT images.Image evaluators will manually delineate region of interest (ROI) and operative cavity on each slice. The area will be calculated automatically by PACS system. The total volume will be acquired by multiplying area and slice thickness. The volume of edema will be calculated by the totoal volume of edema plus cavity minus the volume of cavity.', 'timeFrame': 'Within 24 hours postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nA two-tailed significance level of 0.05 and a power of 80% were used. A drop-out rate of 5% was considered. Descriptive statistics will be reported as means with standard deviation and medians with inter-quartile range (IQR) for normally distributed and skewed continuous data, respectively. Statistical tests include Student's t-test, Mann-Whitney U test, X2 analysis, Fisher's exact test, and repeated measurements of variance analysis with Bonferroni correction. Missing data will be imputed using inverse probability weighting and worst-case imputation scenarios. Statistical significance will be declared at a type I error of 0.05.", "answer": 480, "answer_type": "ACTUAL", "explanation": "Sample size calculation and statistical plan\n We used the PASS 2011 software (NCSS LLC, USA) for Windows to calculate the sample size. According to the pilot study we conducted, the sample size of 450 will find the difference in postoperative brain edema volume of 4 cm3 with a standard deviation of 18 and 16 in the two groups. Considering the drop-out rate of 5%, we calculated the sample size of 480. In addition, we also estimated the sample size based on previous studies reporting the incidence of brain edema varying from 6.8 to 50% after malignant brain tumor resection. The sample size of 480 patients (240 for each group) will be sufficient to detect the difference of 13% at a two-tailed significant level of 0.05 and a power of 80% using the Student\u00e2\u0080\u0099s t-test, with a drop-out rate of 5%. Our medical center completed about 800 high-grade glioma resection surgeries each year, which could ensure enough participants.\n Descriptive statistics will be reported as means with standard deviation and medians with inter-quartile range (IQR) for normally distributed data and skewed continuous data, respectively, and counts (percentage) for categorical data. Normally distributed continuous variables will be compared with Student\u00e2\u0080\u0099s t-test, while skewed variables will be compared using the Mann-Whitney U test. The categorical variables will be compared with X2 analysis or Fisher\u00e2\u0080\u0099s exact test. The repeated measurement data will be analyzed by repeated measurements of variance analysis with Bonferroni correction. The primary outcome, brain edema volume, will be compared between groups using the Student\u00e2\u0080\u0099s t-test on intention to treat and per protocol, and the conclusion will be drawn according to the intention-to-treat analysis.\n The intention-to-treat analysis will depend on the allocated population while the per-protocol analysis will depend on the actual fluid therapy the population receives. Furthermore, subgroup analysis is required in this study, and patients will be analyzed according to preoperative ASA physical status, KPS score, and WHO classification given by postoperative pathology. In addition, missing data will be imputed using inverse probability weighting and the worst-case imputation scenarios for sensitivity analysis will be performed for missing values of primary outcomes. SPSS 16.0 for windows will be used for all statistical analyses. The statistical significance will be declared at a type I error of 0.05.", "id": 221, "split": "train"} +{"trial_id": "NCT03330756", "pmid": "36273149", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of the Laparoscopic Roux-en-Y Gastric Bypass and the Laparoscopic Mini Gastric Bypass on the Remission of Type II Diabetes Mellitus and the Pathophysiological Mechanisms That Drive the Conversion of Malign to Benign Obesity\n\nIncluded conditions:\n- Obesity, Morbid\n- Type 2 Diabetes Mellitus\n\nStudy Armgroups:\n- {'label': 'Laparoscopic Roux-en-Y gastric bypass', 'type': 'ACTIVE_COMPARATOR', 'description': 'Laparoscopic Roux-en-Y gastric bypass', 'interventionNames': ['Procedure: laparoscopic Roux-en-Y gastric bypass']}\n- {'label': 'Laparoscopic Mini Gastric Bypass', 'type': 'EXPERIMENTAL', 'description': 'laparoscopic Mini gastric bypass', 'interventionNames': ['Procedure: laparoscopic Mini gastric bypass']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'laparoscopic Roux-en-Y gastric bypass', 'description': 'laparoscopic Roux-en-Y gastric bypass with a 50 cm biliary limb and a 150 cm alimentary limb', 'armGroupLabels': ['Laparoscopic Roux-en-Y gastric bypass'], 'otherNames': ['gastric bypass']}\n- {'type': 'PROCEDURE', 'name': 'laparoscopic Mini gastric bypass', 'description': 'laparoscopic Mini gastric bypass with a gastrojejunostomy at 200 centimeters measured from the ligament of Treitz', 'armGroupLabels': ['Laparoscopic Mini Gastric Bypass'], 'otherNames': ['One anastomosis gastric bypass, omega loop gastric bypass']}\n\nPrimary Outcomes:\n- {'measure': 'glycaemic control', 'description': 'as measured by the difference in HBa1C', 'timeFrame': '12 months FU'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided significance level of P < 0.05, power of 80%, and a 10% dropout rate.", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Power calculation and sample size\n Sample size calculation was performed based on a retrospective analysis of patients after RYGB (n\u00e2\u0080\u0089=\u00e2\u0080\u008990) and OAGB (n\u00e2\u0080\u0089=\u00e2\u0080\u008937). Patients were matched in a 3:1 ratio on baseline age, BMI, and gender. The mean pre-operative Hba1c in the RYGB group was 7.5\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.4% and 7.5\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.5% in the OAGB group (p\u00e2\u0080\u0089=\u00e2\u0080\u00890.97). Null hypothesis is as follows: there is no difference in decrease of Hba1c at 12 months after RYGB or OAGB in patients with T2DM. Alternative hypothesis: the decrease in Hba1c after OAGB is higher than after RYGB in patients with T2DM at 12 months after surgery. For sample size calculation, the mean Hba1c of both groups was compared with a two-sided significance level of P < 0.05 and a power of 80%. Based on the retrospective results, 100 subjects per group will be required. Considering a 10% dropout rate, 220 patients are needed.", "id": 222, "split": "train"} +{"trial_id": "NCT03330769", "pmid": "29991631", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ultrasound in PSoriatic Arthritis TREAtMent - UPSTREAM\n\nIncluded conditions:\n- Arthritis, Psoriatic\n- Ultrasonography\n- Minimal Disease, Residual\n\nStudy Armgroups:\n- {'label': 'Patients with active Psoriatic Arthritis', 'description': 'Patients with clinically diagnosed PsA with clinically active joint disease starting a new course of treatment.', 'interventionNames': ['Drug: New course of treatment']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'New course of treatment', 'description': 'Prescription of new course of NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional DMARDs, biologic DMARDs, including switches or dose augmentations, indicated by the treating rheumatologist according to usual clinical practice.', 'armGroupLabels': ['Patients with active Psoriatic Arthritis'], 'otherNames': ['NSAIDs', 'steroid intra-articular injections', 'Conventional DMARDs', 'biologic DMARDs']}\n\nPrimary Outcomes:\n- {'measure': 'Minimal disease activity', 'description': 'The Minimal disease activity (MDA) calculation will be based on the evaluation of 7 variables:\\n\\n1. 68 tender joints count (\u22641)\\n2. 66 swollen joint count (\u22641)\\n3. Body Surface Area (BSA) \u22643\\n4. Patient pain VAS (\u226415 mm);\\n5. Patient global disease activity VAS (\u226420 mm);\\n6. HAQ (\u22640.5);\\n7. Leeds Enthesitis Index (LEI) tender entheseal points (\u22641) Patients will be classified as having MDA if they meet 5 out of these 7 criteria (value in brackets).', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe simulations used the Stata procedure rocsize, aiming for over 90% power with a 5% significance level. The percentage of diseased subjects was assumed to be 60%. A maximum attrition rate of 20% was considered.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation was done minimising the number of false positives (ie, the number of false non-responsive to treatment) in order to minimise the risk of overtreating patients who actually have a good response to therapy. Therefore, sample size was calculated to minimise this risk by 40% (null hypothesis H0) to 20% (alternative hypothesis H1), maintaining stable at 70% (both for the H0 for both the H1), the percentage of true positives (true unresponsive to therapy).\n The simulations were carried out using the Stata procedure rocsize (by M. Pepe), which allows to determine the power to detect an improvement in the\u00c2\u00a0receiver operating characteristic (ROC) curve. The procedure requires that the percentage of false and true positives are specified for both the null and the alternative hypothesis and also the percentage of diseased.\n Using the command rocsize 0.7 0.2, na (150) ndb (100) tpnull (0.7) fpnull (0.4) of Stata, it results that 250 patients are sufficient to evaluate the performance of a model (and its ROC curve) with over 90% of power (setting a 5% alpha). Specifically, we have assumed a 70% and a 20% of subjects true positives and false positives, respectively, according to the alternative hypothesis, a 70% and a 40% of subjects true positives and false positives, respectively, according to the null hypothesis, and a percentage of diseased of 60% (150 of 250 subjects).\n Under the assumption of maximum attrition of 20%, the sample size will be increased to 300 patients. The same sample size is sufficient to precisely estimate a logistic model of achievement of an MDA (probability of 0.4 at 6 months) with 10 predictors (rule of thumbs).\n Based on the prestudy activities, 40 investigators will be involved, 15 from tertiary and 20\u00e2\u0080\u009325 from secondary rheumatology centres. Enrolment will last 12 months at each participating centre; assuming four eligible patients per month for tertiary and one per month in secondary centres and a 40% enrolment rate, about 30 patients per month are expected.", "id": 223, "split": "train"} +{"trial_id": "NCT03331718", "pmid": "31399139", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PoLyglycolic Acid Felt reiNforcEmenT of the PancreaticoJejunostomy; Multicenter Prospective Randomized Phase III Trial in Japan and Korea (PLANET-PJ Trial)\n\nIncluded conditions:\n- Disease of Pancreatic or Periampullary Lesions\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Pancreaticojejunostomy with duct-to-mucosa anastomosis is performed as usual.'}\n- {'label': 'PGA felt reinforcement', 'type': 'ACTIVE_COMPARATOR', 'description': 'In addition to usual pancreaticojejunostomy, PGA felt is used in duplicate.', 'interventionNames': ['Drug: PGA felt reinforcement']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'PGA felt reinforcement', 'description': 'During pancreaticojejunostomy, 1) a 0.3 mm thick PGA felt (Neoveil\u00ae, Gunze, Japan) is pasted on the ventral side and the dorsal side of pancreatic parenchyma, through which suture between pancreatic parenchyma and jejunum is performed. 2) Before abdominal closure (after completion of all reconstruction, after washing in the abdominal cavity), a 0.15 mm thick PGA felt is further covered around the anastomotic site and fibrin glue is sprayed.', 'armGroupLabels': ['PGA felt reinforcement']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of a clinically relevant POPF (ISGPS grade B/C)', 'description': 'Incidence of a clinically relevant POPF (grade B/C), according to the ISGPS criteria which is the evaluation criteria for POPF', 'timeFrame': 'within 3 months after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at \u03b1 = 0.05 (two-sided) with a power of more than 80%. Approximately 10% of patients are expected to be ineligible for surgery.", "answer": 514, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n This trial was designed to evaluate the efficacy of group A compared with group B in terms of the incidence of POPF. In cases using PGA felt at the pancreaticojejunostomy in partial pancreatoduodenectomy with an MPD diameter of 3\u00e2\u0080\u0089mm or less, the incidence of POPF was 15.5% [18, 19]. The incidence of POPF was 26% in a previous report without PGA felt at the pancreaticojejunostomy in partial pancreatoduodenectomy with an MPD diameter of 3\u00e2\u0080\u0089mm or less [29]. When statistical analysis is performed for a significance level of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (two-sided) in a superiority design, 231 patients are calculated to be required per arm, with a power 100(1\u00c2\u00a0\u00e2\u0080\u0093\u00c2\u00a0\u00ce\u00b2) of more than 80%, under the assumption that a small number of patients may be deemed ineligible and may thus be excluded from the analysis. Furthermore, as approximately 10% of the patients are expected to be ineligible for surgery, the sample size was eventually increased to 514 patients (257 patients per arm). This sample size was calculated using software PASS 15.0.6.\n In the evaluation of the secondary endpoints, a hypothesis test will be used for comparison between both groups, although formal power calculations for these analyses have not been performed.", "id": 224, "split": "train"} +{"trial_id": "NCT03332888", "pmid": "30918029", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Phase II Clinical Trial Testing the Safety of a Humanized Monoclonal Antibody Anti-CD20 in Patients With Heart Failure With Reduced Ejection Fraction\n\nIncluded conditions:\n- Heart Failure With Reduced Ejection Fraction\n\nStudy Armgroups:\n- {'label': 'Interventional Group', 'type': 'EXPERIMENTAL', 'description': \"For this trial, HMA-CD20 will be given as an intravenous infusion of 1000 mg I.V twice in a month separating them by fourteen days starting at the baseline visit. The dose for both HMA-CD20 dosages willbe identical at the screening visit after the participant's eligibility has been established, and it will remain thesame for both infusions. The standard dose for HMA-CD20 is 1,000 mg per intravenous infusion on day 1 and day 15.\", 'interventionNames': ['Drug: Rituximab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rituximab', 'description': 'Rituximab will be studied in patients with HFrEF, and verify the patients safety.', 'armGroupLabels': ['Interventional Group']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of Rituximab Emergent Cardiovascular Adverse Events', 'description': 'The investigators analyze the safety of rituximab based on the occurrence of cardiovascular adverse events such as arrhythmia, worsening of symptoms and acute coronary syndromes.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% and an alpha score of 0.05 were considered.", "answer": 10, "answer_type": "ESTIMATED", "explanation": "Sample size\n We considered a convenience sample of 10 patients from our heart failure clinic since the previously reported incidence of acute coronary syndrome\u00c2\u00a0(ACS) and atrial and ventricular arrhythmias with the use of rituximab is\u00c2\u00a0<0.1% and 7.6%, respectively.8 Regarding the worsening of left ventricle ejection fraction\u00c2\u00a0(LVEF) attributed to rituximab, the incidence is limited to case reports only, wherefore it is impossible to precisely determine the incidence.9 Moreover, with the strategic safety measures that we will take before, during and following the rituximab administration, we aim to reduce the risk of potential cardiovascular adverse events\u00c2\u00a0(AEs). However, the sample size required; considering a power of 80% and an alpha score of 0.05, obtained by probabilistic methods, ranges from 321 to 26\u00e2\u0080\u0089091 subjects to enrol, which would, unfortunately, be out of our reach.", "id": 225, "split": "train"} +{"trial_id": "NCT03334006", "pmid": "30832742", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective, Randomized Trial of Personalized Medicine with Pentaglobin\u00ae After Surgical Infectious Source Control in Patients with Peritonitis\n\nIncluded conditions:\n- Peritonitis\n- Sepsis\n- Septic Shock\n\nStudy Armgroups:\n- {'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': 'Standard of Care treatment'}\n- {'label': 'Verum arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard of Care treatment + Pentaglobin\u00ae', 'interventionNames': ['Drug: Pentaglobin\u00ae/Standard of Care']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Pentaglobin\u00ae/Standard of Care', 'description': 'Standard of Care treatment + Pentaglobin\u00ae', 'armGroupLabels': ['Verum arm']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Multiple Organ Failure (MOF) score (measured in lung, heart, kidney, liver, blood) from baseline to day 7 after surgical infectious source control in the context of peritonitis.', 'description': 'The MOF score is determined in the morning. The following points are distributed per organ: Normal organ function: 0 points; organ dysfunction: 1 point; single organ failure: 2 points. A score \\\\> 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score was obtained are assigned a score of 10 points.', 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level \u03b1 = 0.05; power = 90%; randomization ratio verum:control 2:1; additional margin of ~13% for drop-outs", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size\n The following assumptions are made: significance level \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05; power\u00e2\u0080\u0089=\u00e2\u0080\u008990%; randomization ratio verum:control 2:1; in MOF score 3.0 (verum) vs 3.8 points (control), each with a standard deviation of 1.5 points. A t-test model led to N\u00e2\u0080\u0089=\u00e2\u0080\u0089114 in the active treatment group and 57 in the control group. To allow for drop-outs from the PP population, an additional margin of ~\u00e2\u0080\u008913% is allowed, giving N\u00e2\u0080\u0089=\u00e2\u0080\u0089133 in the active-treatment group and 67 in the control group (total 200).", "id": 226, "split": "train"} +{"trial_id": "NCT03335709", "pmid": "29780029", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Occupational Therapy Intervention Program \"A Better Everyday Life 1.0\" - a Protocol for a Feasibility Study\n\nIncluded conditions:\n- Activities of Daily Living\n\nStudy Armgroups:\n- {'label': 'ADL intervention', 'type': 'EXPERIMENTAL', 'description': 'The participants are assigned to an eight-week intervention program aiming at enhancing ADL ability. The program consists of a minimum of five and a maximum of eight sessions; Session one - First meeting and occupational therapy evaluation (mandatory), Session two - Goal setting and clarifying reasons for problems related to ADL (mandatory), Session three- seven - Interventions aiming at enhancing ADL ability (Number of sessions can vary. However, a minimum of two sessions are mandatory), Session eight - Re-evaluation (Mandatory)', 'interventionNames': ['Behavioral: ADL intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ADL intervention', 'description': 'Overall, an adaptational approach is being applied. The intervention sessions include changes related to the person, the environment and/or the occupation.', 'armGroupLabels': ['ADL intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Assessment of Motor and Process Skills (AMPS)', 'description': \"The Assessment of Motor and Process Skills (AMPS) is a standardized observation-based evaluation tool used by occupational therapists to measure a person's observed quality of ADL task performance in terms of physical effort and/or fatigue, efficiency, safety and independence. After the observation the quality of each skill is evaluated on a four point ordinal scale according to the scoring criteria in the AMPS manual.\\n\\nThe available AMPS software, based on Many-Faceted Rasch statistics, makes it possible to convert ordinal raw scores into overall linear ADL motor and ADL process ability measures adjusted for task challenge, skill item difficulty and rater severity. The measures are expressed in logits (log-odds probability units).\", 'timeFrame': 'Change from baseline at eight weeks.'}\n- {'measure': 'ADL-Interview (ADL-I)', 'description': \"The ADL-Interview (ADL-I) is developed to describe and measure the ADL ability based on self-report. Using the ADL-I, the participant is asked to report their perceived ADL ability (i.e. quality of ADL task performance) for each of the 47 ADL items using seven response categories.\\n\\nData will be used to (a) describe the self-reported quality of ADL task performance on each task for a single person or a group of people and (b) measure a single person's overall self-reported quality of ADL task performance. To create an overall measure of self-reported quality of ADL task performance Rasch measurement methods are applied in order to transform the ratings into an overall linear (interval scale) measure of self-reported quality of ADL task performance, adjusted for the difficulty of the ADL task.\", 'timeFrame': 'Change from baseline at eight weeks.'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated as this is a feasibility study.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Sample size\n As this study is a feasibility study, a sample size calculation is not required.44 45 However, the sample needs to be representative of the target population and to be large enough to provide information related to the feasibility and the potential outcome of the programme.45 Results from a recent study,44 using audit of sample sizes for pilot and feasibility studies conducted in the UK revealed sample sizes for feasibility studies from 10 to 300 participants. Hence, the results provide no clear guidelines on sample size estimations for future studies. In the present study, occupational therapists apply a new occupational therapy programme. As it may take some time for the occupational therapist to get experienced in applying the programme, several participants are needed. Consequently, the sample size is estimated to a total of 30 participants.", "id": 227, "split": "train"} +{"trial_id": "NCT03337360", "pmid": "32616489", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Impact of a Nutritional Supplement (Impryl\u00ae) on Male Fertility\n\nIncluded conditions:\n- Male Subfertility\n\nStudy Armgroups:\n- {'label': 'Impryl', 'type': 'ACTIVE_COMPARATOR', 'description': 'One tablet daily for 6 months', 'interventionNames': ['Dietary Supplement: Impryl']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'One tablet daily for 6 months', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Impryl', 'description': 'Food supplement with betaine, cystine, zinc, niacin, folic acid (5MTHF-glucosamine), Vitamin B12 (cobalamin), Vitamin B6, Vitamin B2 (riboflavin)', 'armGroupLabels': ['Impryl']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Inactive ingredients, placebo', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Ongoing pregnancy rate', 'description': 'Ongoing pregnancy \u226510-12 weeks of gestation', 'timeFrame': '15 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed as a superiority trial with a two-sided alpha of 5% and a beta of 24% (76% power). The expected increase in ongoing pregnancy rate is adjusted to 6.5% due to the duration of spermatogenesis. The number of participants lost to follow-up is expected to be minimal.", "answer": 1200, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n We aimed to recruit 1200 male participants as a part of an infertile couple, based on the following data and power calculation.\n Overall, the number of ongoing pregnancies in IVF and ICSI in the Netherlands was 19.8% and 21.5%, respectively, per started fresh cycle in 2015.32 The number of ongoing pregnancies in IUI is estimated to be around 5% to 13% per cycle, around 18% after three cycles and 20%to 30% after six cycles.33\u00e2\u0080\u009335 Based on Radboudumc data, the ongoing pregnancy rate in EM is estimated around 20% after 6 months.\n A Cochrane review estimated the increase in clinical pregnancy rates after use of antioxidants with an OR of 3.43 (95% CI 1.92 to 6.11) based on seven RCTs with a total of 522 men.36 However, this concerns low-quality evidence, and the included population in this Cochrane review was couples with male factor subfertility, whereas in our study, we also include couples with unexplained infertility. Therefore, we assumed a more conservative OR of 1.5. Assuming a 20% ongoing pregnancy rate in the placebo group, this reflects in an expected pregnancy rate of 27.3% in the Impryl group.\n The study is designed as a superiority trial. Based on the above mentioned data, we expect a 7.3% increase in ongoing pregnancy number when men are treated with Impryl compared with placebo. However, after randomisation, patients can directly start with both intervention and achieving a pregnancy, either spontaneously or with fertility treatment. In these first months, the effect of the intervention is expected to be suboptimal due to the duration of the spermatogenesis (72 days before whole renewal). Therefore, we adjusted the expected increase of 7.3% to a more realistic effect of 6.5%. We assume an equal increase in all fertility groups (meaning EM, IUI and IVF/ICSI) from 20% to 26.5%.\n To test the effect of Impryl on the probability of ongoing pregnancy, a sample size of 600 men per treatment group (1200 in total) is needed, assuming differences in ongoing pregnancy rates of 6.5% and an expected ongoing pregnancy rate of 20% in the placebo group, a two-sided alpha of 5% and a beta of 24% (ie, 76% power). As we expect the number of participants lost to follow-up to be minimal, we will allocate 600 patients to both the intervention and the placebo arm. Figure 1 shows the distribution of the number of participants for the three different types of fertility treatment (EM, IVF/ICSI and IUI).\n \n Figure 1\n \n Flowchart study design. ICSI, intracytoplasmic sperm injection; IUI, intrauterine insemination; IVF, in vitro fertilisation.", "id": 228, "split": "train"} +{"trial_id": "NCT03339557", "pmid": "31604440", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants\n\nIncluded conditions:\n- Osteoarthritis, Knee\n- Arthroplasty\n- Total Knee Replacement\n\nStudy Armgroups:\n- {'label': 'PFC Total Knee Replacement', 'type': 'ACTIVE_COMPARATOR', 'description': 'PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.', 'interventionNames': ['Device: NexGen', 'Device: Persona']}\n- {'label': 'NexGen Total Knee Replacement', 'type': 'ACTIVE_COMPARATOR', 'description': 'NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.', 'interventionNames': ['Device: Persona', 'Device: PFC']}\n- {'label': 'Persona Total Knee Replacement', 'type': 'ACTIVE_COMPARATOR', 'description': 'Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.', 'interventionNames': ['Device: NexGen', 'Device: PFC']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'NexGen', 'description': 'Comparing two conventional designs and one novel design', 'armGroupLabels': ['PFC Total Knee Replacement', 'Persona Total Knee Replacement']}\n- {'type': 'DEVICE', 'name': 'Persona', 'description': 'Comparing two conventional designs and one novel design', 'armGroupLabels': ['NexGen Total Knee Replacement', 'PFC Total Knee Replacement']}\n- {'type': 'DEVICE', 'name': 'PFC', 'description': 'Comparing two conventional designs and one novel design', 'armGroupLabels': ['NexGen Total Knee Replacement', 'Persona Total Knee Replacement']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in patient reported outcome measures scores (PROMs), Functional improvement', 'description': 'Oxford Knee Score (OKS)', 'timeFrame': 'preoperative, postoperative at 2-3 months, at 1 year and at 2 years'}\n\nPlease estimate the sample size based on the assumption: \nAlpha = 0.05, power = 0.8, 10% drop-out rate, and 10% addition due to skewness in the variable distribution.", "answer": 240, "answer_type": "ACTUAL", "explanation": "Sample size\n The power analyses will be calculated using both the OKS (primary outcome) and the FJS (secondary outcome). Of these, the FJS is more sensitive in differentiating patients at the upper end of the outcome scores and requires larger patient groups. With the OKS, the estimated sample size is 48 patients per arm. With the FJS in the range of 60 to 80 and a standard deviation of 25 points, the estimated sample size is 64 patients per arm (delta\u00e2\u0080\u0089=\u00e2\u0080\u008913, sd\u00e2\u0080\u0089=\u00e2\u0080\u008925, alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, power\u00e2\u0080\u0089=\u00e2\u0080\u00890.8). Allowing for a 10% drop-out rate and a 10% addition due to skewness in the variable distribution, the required arm size is 80. Therefore, with three comparison arms, the total number of patients recruited into the study will be 240.", "id": 229, "split": "train"} +{"trial_id": "NCT03342807", "pmid": "31215460", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Controlled, Multicenter Studies of the Effects of Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis\n\nIncluded conditions:\n- Pancreatitis, Acute\n- Hypertriglyceridemia\n\nStudy Armgroups:\n- {'label': 'Group Insulin', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Insulin']}\n- {'label': 'Group Aphesis', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Aphesis']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Insulin', 'description': 'Insulin infusion for subjects in Group Insulin.', 'armGroupLabels': ['Group Insulin']}\n- {'type': 'DEVICE', 'name': 'Aphesis', 'description': 'Aphesis for subjects in Group Aphesis.', 'armGroupLabels': ['Group Aphesis']}\n\nPrimary Outcomes:\n- {'measure': 'serum TG', 'description': 'Elimination of serum triglyceride.', 'timeFrame': 'every 4 hours in first 3 days'}\n\nPlease estimate the sample size based on the assumption: \ntwo-sided significance level of 5%, statistical power of 80%, 20% increase to account for drop-out and missing data", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The Bi-TPAI trial is a non-inferiority randomized controlled trial. Respective studies and series reported 60\u00e2\u0080\u009372% of cases with TG\u00e2\u0080\u0089<\u00e2\u0080\u00895.6\u00e2\u0080\u0089mmol/l after one or two sessions of plasmapheresis [4, 12]. A total of 176 participants (88 per group) is required to show non-inferiority of intensive insulin therapy compared to plasmapheresis therapy, with a two-sided significance level of 5% and statistical power of 80%. To account for drop-out and missing data, the sample size is increased by 20% to a final sample size of 220 participates (110 per group).", "id": 230, "split": "train"} +{"trial_id": "NCT03344887", "pmid": "33622960", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Innovative Trial Assessing Donor Sex on Recipient Mortality (iTADS)\n\nIncluded conditions:\n- Red Blood Cell Transfusion\n\nStudy Armgroups:\n- {'label': 'RBC Transfusion from male donor', 'type': 'ACTIVE_COMPARATOR', 'description': 'For the treatment of anemia', 'interventionNames': ['Other: RBC Transfusion from male donor']}\n- {'label': 'RBC Transfusion from female donor', 'type': 'ACTIVE_COMPARATOR', 'description': 'For the treatment of anemia', 'interventionNames': ['Other: RBC Transfusion from female donor']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'RBC Transfusion from male donor', 'description': 'Patients requiring an RBC transfusion for the treatment of anemia will receive products from a male donor at initial and any subsequent hospitalizations during the trial period.', 'armGroupLabels': ['RBC Transfusion from male donor']}\n- {'type': 'OTHER', 'name': 'RBC Transfusion from female donor', 'description': 'Patients requiring an RBC transfusion for the treatment of anemia will receive products from a female donor at initial and any subsequent hospitalizations during the trial period.', 'armGroupLabels': ['RBC Transfusion from female donor']}\n\nPrimary Outcomes:\n- {'measure': 'Survival', 'description': 'Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nA two-tailed \u03b1 of 0.05, a power (1\u2212\u03b2) of 0.80, an accrual time of 2 years, median survival time of 5 years, and an 11% non-compliance factor.", "answer": 8850, "answer_type": "ACTUAL", "explanation": "Sample size\n The overall mortality rate of hospitalised patients that receive RBC transfusions is high due to patient acuity. In our previous study, after a mean follow-up of 2.3 years (maximum follow-up of 7 years), 43% of patients had died.11 At 1-year follow-up, which is the expected median follow-up time for this study, mortality was 30%, and the median survival was 5 years. From our previous observational work, we expect our intervention to reduce the absolute risk of death by at least 5%.11 We proposed a minimally clinically important difference of 2% (applicable to the entire inpatient and outpatient population). Thus, sample size calculations based on a survival analysis comparing two survival curves using a two-tailed \u00ce\u00b1 of 0.05 and a 1\u00e2\u0088\u0092\u00ce\u00b2 of 0.80, an accrual time of 2 years, median survival time of 5 years, an absolute risk reduction of 2% (30%\u00e2\u0080\u009328%, corresponding HR of 0.93) and a 11% non-compliance factor require 8850 randomised and transfused patients. Our original estimate was a 3% non-compliance requiring 8000 patients. A revised 11% non-compliance estimate was informed by 1-year aggregate trial data. The 11% non-compliance at the patient level is predominantly due to the allocated donor sex not being available at time of RBC transfusion (first or repeat) or the need for the transfusion service to use expiring units.", "id": 231, "split": "train"} +{"trial_id": "NCT03350789", "pmid": "30651139", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Mechanism of Acupuncture on Patients With Chronic Sciatica Using fMRI: A Randomized, Patient-Assessor Blind, Sham-Controlled Clinical Trial\n\nIncluded conditions:\n- Chronic Sciatica\n\nStudy Armgroups:\n- {'label': 'Real acupuncture', 'type': 'EXPERIMENTAL', 'description': 'manual acupuncture + electroacupuncuture on acupoints, twice a week, for 4 weeks', 'interventionNames': ['Device: Real acupuncture']}\n- {'label': 'Sham acupuncture', 'type': 'SHAM_COMPARATOR', 'description': 'sham acupuncture (no skin penetration) + placebo electroacupuncture without electrical stimulation on acupoints, twice a week, for 4 weeks', 'interventionNames': ['Device: Sham acupuncture']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Real acupuncture', 'description': 'manual acupuncture(0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) (unilateral GB30) + electroacupuncture(0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) (unilateral EX-B2 (L4 \\\\& L5), BL25, BL23, BL40, GB34), twice a week, for 4 weeks, common approaches for the treatment of chronic sciatica used by doctors of Korean medicine in Korea today', 'armGroupLabels': ['Real acupuncture']}\n- {'type': 'DEVICE', 'name': 'Sham acupuncture', 'description': 'sham acupuncture without skin penetration(0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) (unilateral GB30) + placebo electroacupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) without electrical stimulation (unilateral EX-B2, BL25, BL23, BL40, GB34), twice a week, for 4 weeks', 'armGroupLabels': ['Sham acupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'Visual analogue scale for bothersomeness', 'description': 'change in visual analoge scale for bothersomeness \\\\[range: 0(better)-100(worse) mm\\\\]', 'timeFrame': 'baseline, 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, 4-1, 4-2, 5, and 8 weeks'}\n\nPlease estimate the sample size based on the assumption: \nUsing a two-sample t test model with a two-tailed test, 80% test power, 5% significance level, and a 20% dropout rate.", "answer": 68, "answer_type": "ESTIMATED", "explanation": "Sample size\n Referring to a previous study [52], an appropriately powered full-scale sample size was estimated using the mean difference of VAS for bothersomeness due to sciatica between groups in the primary endpoint. The researchers expect the mean difference will be 12.4\u00e2\u0080\u0089mm with a standard deviation (SD) of 16.2\u00e2\u0080\u0089mm between the two groups, which is not moderately clinically meaningful but represents a minimally important difference [53].\n Considering the mean comparison method of the two-sample t test model with a two-tailed test, 80% test power, and a 5% significance level, the total number of individuals required per group is 27. For equal allocation of the two groups, the total sample size required when considering a dropout rate of 20% is 68 subjects with 34 subjects in each group.\n Considering the nature of fMRI studies that use approximately 90,000 voxels to estimate the BOLD signal indirectly and for which conventional power calculations are meaningless, we determined 20 subjects in each group for fMRI scanning according to the trend of related neuroimaging studies [54\u00e2\u0080\u009358]. Most studies decided that 20 participants is an adequate sample size regarding the high cost of fMRI examinations.", "id": 232, "split": "train"} +{"trial_id": "NCT03351075", "pmid": "30612114", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness of a Modern Educational Intervention for Pain-related Disability After Breast Cancer Surgery: Randomized Controlled Trial\n\nIncluded conditions:\n- Breast Neoplasm\n- Pain\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Standard physical therapy program + Modern educational program', 'interventionNames': ['Other: Standard physical therapy program', 'Other: Modern educational program']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard physical therapy program + Traditional biomedical educational program', 'interventionNames': ['Other: Standard physical therapy program', 'Other: Traditional biomedical educational program']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Standard physical therapy program', 'description': 'Mobilisations, stretching, scar tissue treatment and exercises\\n\\n* Start immediately after surgery, sessions are individual and take 30 minutes\\n* Intensive phase (4 months): 1-2x/week\\n* Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery', 'armGroupLabels': ['Control group', 'Intervention group']}\n- {'type': 'OTHER', 'name': 'Modern educational program', 'description': 'This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.\\n\\n* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions\\n* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery', 'armGroupLabels': ['Intervention group']}\n- {'type': 'OTHER', 'name': 'Traditional biomedical educational program', 'description': \"Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective\\n\\n* Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions\\n* 3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery\", 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Self-reported Change in Pain-related Disability', 'description': \"Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain.\", 'timeFrame': 'Change between baseline and one year follow-up assessment'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level (alpha) of 0.05, and a drop-out rate of approximately 5%.", "answer": 184, "answer_type": "ACTUAL", "explanation": "Sample size\n A power calculation was performed by the Leuven Biostatistics and statistical bioinformatics Centre of KU Leuven (Katholieke Universiteit Leuven) for the primary outcome parameter \u00e2\u0080\u0098PDI after 1\u00e2\u0080\u0089year\u00e2\u0080\u0099. Sample size calculation was based on data available in\u00c2\u00a0the literature for the PDI.39 40 and calculated to detect with 80% power a difference of 20% in PDI after 1\u00e2\u0080\u0089year. Assuming a coefficient of variation (CV) equal to 0.5, 87 participants per group are needed based on a two-sample pooled t-test of a mean ratio with lognormal data and setting alpha equal to 0.05. The assumed CV is a conservative estimate, derived from the observed CV of 0.30 in a sample of normative data for women with chronic pain. To anticipate a drop-out rate of approximately 5%, 184 participants in total will be recruited. The drop-out rate is based on previous similar trials at our institution.24 25 29 To handle the potential missing measurements after 1\u00e2\u0080\u0089year, the comparison of the PDI will be based on a multivariate normal model for longitudinal measurements fitted on all repeated measures over time (preoperative, postoperative, 4, 6, 8, 12 and 18 months). A log-transformation will be applied if necessary to handle the right-skewed distribution of the PDI.", "id": 233, "split": "train"} +{"trial_id": "NCT03353974", "pmid": "34675018", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Role of Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients. A Pilot Randomized Controlled Trial.\n\nIncluded conditions:\n- Multiple Sclerosis\n\nStudy Armgroups:\n- {'label': 'Video game therapy', 'type': 'EXPERIMENTAL', 'description': 'Subjects belonging to the experimental group will receive a Video Game Therapy (VGT) protocol using the Xbox console. They will receive 12 sessions of treatment within 4 weeks (3 sessions per week); each session will last 1 hour. To manage possible absence lasting one or more treatment sessions, a potential window of 5 weeks will be set to ensure the achievement of all 12 sessions. Will be required to concentrate in games whose major purposes are increasing balance, selective attention and attention shifting. During sessions the patient will be carefully controlled by a researcher who will prevent the risk of falling', 'interventionNames': ['Device: Video game therapy']}\n- {'label': 'Balance platform therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects belonging to the control group will receive the same amount of therapy (12 sessions) using a balance platform (Biodex Medical Systems, Inc., Shirley, NY). Balance/rebalancing, postural stability and weight-shifting exercises ill be administered with and without visual feedback. During the first session, the tasks will be performed at an \"entry level,\" and the exercise progression will be adjusted over time according to the patients\\' functional level (intermediate and difficult level). Balance platform therapy offered visual feedback and knowledge of performance (augmented feedback). The physiotherapist, as during VGT, provided additional external feedback.', 'interventionNames': ['Device: Balance platform therapy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Video game therapy', 'description': 'Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).', 'armGroupLabels': ['Video game therapy']}\n- {'type': 'DEVICE', 'name': 'Balance platform therapy', 'description': 'Balance/rebalancing, postural stability and weight-shifting exercises with and without visual feedback will be administered using a balance platform (Biodex Medical Systems, Inc., Shirley, NY).', 'armGroupLabels': ['Balance platform therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Timed Up and Go (TUG) test', 'description': 'TUG measures balance and functional mobility.', 'timeFrame': 'Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha of 5%, 10% drop-out rate", "answer": 48, "answer_type": "ACTUAL", "explanation": "Sample size and power\n The primary outcome of this study is to highlight differences in the time used to perform the TUG test between PwMS who underwent VGT and BPT. Our preliminary results from an unpublished pilot study (n=6) shown a VGT effect size of 0.93 in people with MS and EDSS <6. Given equal allocation between treatment and control arms, and using 80% power and alpha of 5%, we would need 40 subjects to complete the study. Conservatively, we expect a 10% rate of drop-out. Thus the sample size will be increased by 10% to 48 subjects (24 per arm).", "id": 234, "split": "train"} +{"trial_id": "NCT03359915", "pmid": "30340648", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries\n\nIncluded conditions:\n- Chronic Obstructive Pulmonary Disease\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Patient education in use of a COPD self-management action plan supported by monthly visits from, and access to, a CHW who has been trained in the use of a COPD self-management action plan.', 'interventionNames': ['Behavioral: COPD Self-Management Plan']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': \"COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'COPD Self-Management Plan', 'description': 'Patient education in use of a COPD self-management action plan supported by monthly visits from, and access to, a CHW who has been trained in the use of a COPD self-management action plan.', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in SGRQ', 'description': 'Comparison of the change in SGRQ between baseline and 12 months, in the intervention compared to the control arm.\\n\\nb) Implementation Aim 1: Assess the appropriateness, acceptability and feasibility of using questionnaires and PEF to identify COPD cases from the perspective of local community members, community health workers, local health centre physicians and ministries of health.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on an 80% one-sided confidence interval that excludes a 4-point difference in SGRQ under the scenario of no difference in means.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size and data analysis\n \n Sample size\n We calculated the sample size required for this trial using a confidence interval approach justified and described elsewhere [36]. This approach aims to ensure an adequate sample size to help inform a decision about continuation of GECo2 to a main trial based on an indication of a treatment effect for the primary outcome. This SGRQ score has previously been shown to have a standard deviation of 25 points in a similar population and the clinically important difference is 4 points (a recent Cochrane Review on the use of COPD Action Plans found an average decrease of 4 points in SGRQ in three randomised trials) [16]. A sample of 112 participants with COPD will be needed to produce an 80% one-sided confidence interval that excludes a 4-point difference in SGRQ under the scenario of no difference in means. We expect to have sufficient subjects to enrol 240 participants from the GECo1 study.\n \n \n Analysis\n The primary analysis will be a comparison of SGRQ scores at 12\u00c2\u00a0months between the randomised groups. We will use multiple linear regression, initially with adjustments for baseline SGRQ score and country and in subsequent analysis with adjustments for other factors including age, gender and disease severity. We will estimate the difference in means with a one-sided 80% confidence interval. We will examine repeated measurements of SGRQ by treatment group and fit random effects models to consider the effect of the intervention over time. The main analysis will be by intention-to-treat (ITT), based on cases where the primary outcome is available and will, therefore, rely on an assumption that data is missing at random. We will describe the number (%) with missing primary outcome, look at reasons for missingness and consider characteristics of the patients excluded from the ITT analysis. Models will be rerun including adjustment for factors found to be related to missingness of the 12-month score. In pre-specified exploratory analysis we will examine differences by site, and by existing vs. new diagnosis of COPD.", "id": 235, "split": "train"} +{"trial_id": "NCT03359915", "pmid": "30340648", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Global Excellence in COPD Outcomes: Implementation and Effectiveness of COPD Self-Management Action Plans in Low and Middle Income Countries\n\nIncluded conditions:\n- Chronic Obstructive Pulmonary Disease\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Patient education in use of a COPD self-management action plan supported by monthly visits from, and access to, a CHW who has been trained in the use of a COPD self-management action plan.', 'interventionNames': ['Behavioral: COPD Self-Management Plan']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': \"COPD 'standard' care in local setting - Bhaktapur, Nepal; Lima, Peru; Nakaseke, Uganda\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'COPD Self-Management Plan', 'description': 'Patient education in use of a COPD self-management action plan supported by monthly visits from, and access to, a CHW who has been trained in the use of a COPD self-management action plan.', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in SGRQ', 'description': 'Comparison of the change in SGRQ between baseline and 12 months, in the intervention compared to the control arm.\\n\\nb) Implementation Aim 1: Assess the appropriateness, acceptability and feasibility of using questionnaires and PEF to identify COPD cases from the perspective of local community members, community health workers, local health centre physicians and ministries of health.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on an 80% one-sided confidence interval that excludes a 4-point difference in SGRQ under the scenario of no difference in means.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size\n We calculated the sample size required for this trial using a confidence interval approach justified and described elsewhere [36]. This approach aims to ensure an adequate sample size to help inform a decision about continuation of GECo2 to a main trial based on an indication of a treatment effect for the primary outcome. This SGRQ score has previously been shown to have a standard deviation of 25 points in a similar population and the clinically important difference is 4 points (a recent Cochrane Review on the use of COPD Action Plans found an average decrease of 4 points in SGRQ in three randomised trials) [16]. A sample of 112 participants with COPD will be needed to produce an 80% one-sided confidence interval that excludes a 4-point difference in SGRQ under the scenario of no difference in means. We expect to have sufficient subjects to enrol 240 participants from the GECo1 study.", "id": 236, "split": "train"} +{"trial_id": "NCT03362229", "pmid": "31514744", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Medial Malleolus: Operative or Non-operative - A Prospective Randomized Controlled Trial of Operative Versus Non-operative Management of Associated Medial Malleolus Fractures in Unstable Fracture Dislocations of the Ankle Joint'\n\nIncluded conditions:\n- Ankle Fracture - Medial Malleolus\n\nStudy Armgroups:\n- {'label': 'FIXATION', 'type': 'ACTIVE_COMPARATOR', 'description': 'Medial malleolus fixation, with the method of fixation left to the surgeons discretion.', 'interventionNames': ['Procedure: Fixation']}\n- {'label': 'NON-FIXATION', 'type': 'ACTIVE_COMPARATOR', 'description': 'A well reduced medial malleolus fracture is then left without fixation ie, non-operative management.', 'interventionNames': ['Procedure: Non-fixation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Fixation', 'description': \"A well reduced medial malleolus fracture will undergo internal fixation, guided by the surgeon's skill and expertise\", 'armGroupLabels': ['FIXATION']}\n- {'type': 'PROCEDURE', 'name': 'Non-fixation', 'description': 'A well reduced medial malleolus fracture will be left without fixation', 'armGroupLabels': ['NON-FIXATION']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Olerud & Molander Ankle Score (OMAS) over a one-year post-operative period', 'description': \"The OMAS is a functional rating scale developed in 1984, which has been used extensively as a research tool in foot and ankle surgery. It includes nine parameters: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living. The sub-score parameters are summated to generate a final score from 0 - 100, with '100' representing an excellent functional outcome and '0' being the worse possible outcome.\", 'timeFrame': '6 week, 3 months, 6 months and one year.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% (two-sided) significance level, 20% increase to account for loss to follow-up.", "answer": 154, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary outcome measure will be the OMAS. In total, 154 patients (77 per arm) will be required with 80% power and 5% (two-sided) significance to detect a clinically meaningful difference of 10 points on the OMAS scale at 12\u00e2\u0080\u0089months between the two groups [24\u00e2\u0080\u009326]. This assumes a standard deviation of 20 [27]. The sample size has been increased by 20% to account for any loss to follow-up.", "id": 237, "split": "train"} +{"trial_id": "NCT03369210", "pmid": "30717805", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients\n\nIncluded conditions:\n- Transfusion-dependent Anemia\n- Surgery\n- Anemia\n\nStudy Armgroups:\n- {'label': 'Liberal', 'type': 'EXPERIMENTAL', 'description': 'Liberal group (patients receive a RBC unit each time Hb falls \u2264 9 g/dl (\u2264 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)).', 'interventionNames': ['Drug: red blood cell transfusion trigger']}\n- {'label': 'Restrictive', 'type': 'ACTIVE_COMPARATOR', 'description': 'Restrictive group (patients receive a single RBC unit each time Hb falls \u2264 7.5 g/dl (\u2264 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l).', 'interventionNames': ['Drug: red blood cell transfusion trigger']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'red blood cell transfusion trigger', 'description': 'patients receive a RBC unit with different target ranges for the post-transfusion Hb levels', 'armGroupLabels': ['Liberal', 'Restrictive']}\n\nPrimary Outcomes:\n- {'measure': 'Occurrence of a composite endpoint', 'description': 'Composite of death and anaemia-associated events I. All-cause mortality defined as death from any cause. II. Acute myocardial infarction confirmed by a cardiologist III. Acute ischaemic stroke confirmed by a neurologist IV. Acute kidney injury (stage III) defined according to the Kidney Disease Improving Global Outcomes criteria: Increase of plasma creatinine level \u2265 3 times within a time window of 7 days or initiation of renal replacement therapy.\\n\\nV. Acute mesenteric ischaemia defined as ischaemia confirmed by intervention (abdominal surgery or mesenteric angiography).\\n\\nVI. Acute peripheral vascular ischaemia defined as a new non-thrombotic compromised circulation in a limb confirmed by angiography and/or leading to surgery.', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided significance level of 5%, power of 80%, and a dropout rate of up to 5% are assumed.", "answer": 2470, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n For the primary endpoint, we expect an overall composite complication rate (OCCR) of about 25% at 90\u00e2\u0080\u0089days after surgery. This guestimate is based on a subgroup of elderly patients included in a large observational study in the field of Patient Blood Management [29], which reported most of the endpoint components, and is also based on the assumption that about 25\u00e2\u0080\u009340% of registered patients will be randomised.\n The effect size to be detected is set to an odds ratio of OR\u00e2\u0080\u0089=\u00e2\u0080\u00890.765. The available evidence on treatment differences from randomised trials concerning the old age group is sparse and inconsistent. Therefore, we choose an effect size, which is relevant from a clinical perspective. Assuming an OCCR of 25%, an odds ratio of OR\u00e2\u0080\u0089=\u00e2\u0080\u00890.765, corresponding to a 5% reduction in OCCR from 27.5% to 22.5% or risk reduction of 18%, would justify switching to the liberal transfusion strategy.\n The target sample size is N\u00e2\u0080\u0089=\u00e2\u0080\u00892470 randomised patients. Randomisation of 2\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00891176\u00e2\u0080\u0089=\u00e2\u0080\u00892352 patients is required using a two-sided significance level of 5% and requiring power of 80% for a test of the null-hypothesis OR\u00e2\u0080\u0089=\u00e2\u0080\u00891 versus OR\u00e2\u0080\u0089=\u00e2\u0080\u00890.765 based on the normal approximation to log (OR). We allow for a dropout rate of up to 5%.", "id": 238, "split": "train"} +{"trial_id": "NCT03372694", "pmid": "32245480", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Study on the Effect of Comprehensive Rehabilitation Program Plus Chemotherapy Versus Chemotherapy on Quality of Life in Postoperative Non Small Cell Lung Cancer Patients With Stage IB-IIIA\n\nIncluded conditions:\n- Non-small Cell Lung Cancer\n\nStudy Armgroups:\n- {'label': 'Chemotherapy+Training+TCM', 'type': 'EXPERIMENTAL', 'description': 'Adjuvant Chemotherapy is performed within 6 weeks after operation. Rehabilitation training is mainly composed of gymnastic qigong, which will be started in one month after operation.\\n\\nPrescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.', 'interventionNames': ['Behavioral: Rehabilitation Training', 'Drug: TCM']}\n- {'label': 'Chemotherapy+Education+TCM', 'type': 'EXPERIMENTAL', 'description': 'Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training.\\n\\nPrescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe, detoxication and resolving masses recipe. Patients will take harmonizing stomach recipe granules for the first week after chemotherapy and syndrome differentiation granules in TCM for second weeks from the end of chemotherapy. The patient will take TCM granules for 3 months.', 'interventionNames': ['Drug: TCM', 'Other: Rehabilitation Education']}\n- {'label': 'Chemotherapy+Education+Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Adjuvant Chemotherapy is performed within 6 weeks after operation. Patients who received rehabilitation education will not accept rehabilitation training.\\n\\nPatients who received rehabilitation education will not accept rehabilitation training.\\n\\nWe compromise the raw materials for the placebo including food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages. The patient will take placebo granules for 3 months.', 'interventionNames': ['Other: Rehabilitation Education', 'Drug: placebo']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Rehabilitation Training', 'description': 'Patients will be trained in one month after operation. Rehabilitation training will be carried out between every two cycles of chemotherapy. Rehabilitation training is mainly composed of gymnastics qigong, which has long been regarded as a form of rehabilitation in Traditonal Chinese Medicine. According to the poor pulmonary function of patients with lung cancer after operation, Liu Zi Jue lung exercise is chosen to strengthen the pulmonary function of the human body in Chinese traditional health culture. Liu Zi Jue lung exercise intervention will be lead by an expert instructor, five times a week, 15 min/time.', 'armGroupLabels': ['Chemotherapy+Training+TCM'], 'otherNames': ['gymnastics qigong', 'Liu Zi Jue lung exercises']}\n- {'type': 'DRUG', 'name': 'TCM', 'description': 'four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe and detoxication and resolving masses recipe. Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.', 'armGroupLabels': ['Chemotherapy+Education+TCM', 'Chemotherapy+Training+TCM'], 'otherNames': ['Prescriptions from Professor Xu Ling']}\n- {'type': 'OTHER', 'name': 'Rehabilitation Education', 'description': 'General health education', 'armGroupLabels': ['Chemotherapy+Education+Placebo', 'Chemotherapy+Education+TCM'], 'otherNames': ['health education']}\n- {'type': 'DRUG', 'name': 'placebo', 'description': 'four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe and detoxication and resolving masses recipe\uff0cwith the same color, smell\uff0ctaste, weight and package', 'armGroupLabels': ['Chemotherapy+Education+Placebo'], 'otherNames': ['control']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in Quality of life (QOL)', 'description': 'QOL is assessed using European Organization for Research and Treatment of Cancer Quality of Life QuestionnaireLung Cancer 43 (EORTC QLQ-LC43).', 'timeFrame': 'Time Frame: baseline, at 4 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (1 - \u03b2) = 0.90, and a 20% dropout rate.", "answer": 354, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary outcome of the study will be the change in the QoL score assessed by the QLQ-C30 scale. According to the results of the JRB.10 study, 27% of lung cancer patients at stage Ib\u00e2\u0080\u0093IIIa after 3\u00e2\u0080\u0089months of adjuvant chemotherapy had lower QoL scores than at baseline [9]. Based on the validity assumptions and clinical experience of the past, it is estimated that 15% of patients had no deterioration in the QoL combined with a comprehensive rehabilitation program compared with treatment without a comprehensive rehabilitation program for patients receiving 3-month postoperative adjuvant chemotherapy. At an inspection level of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and 1\u00c2\u00a0\u00e2\u0080\u0093\u00c2\u00a0\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.90, the QoL score after 3\u00e2\u0080\u0089months decreased by 10% in the intervention group and by 27% in the control group compared with baseline. A sample size of 98 patients was obtained for each group, and a 20% cutoff rate was considered; therefore, 354 patients (n\u00e2\u0080\u0089=\u00e2\u0080\u0089118) will be observed in 3\u00e2\u0080\u0089years. It is suggested that comprehensive rehabilitation combined with chemotherapy can improve the QoL of NSCLC postoperative patients compared with chemotherapy alone.", "id": 239, "split": "train"} +{"trial_id": "NCT03372707", "pmid": "31326936", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients Pilot Trial\n\nIncluded conditions:\n- Laryngeal Edema\n\nStudy Armgroups:\n- {'label': 'Intervention Arm', 'type': 'EXPERIMENTAL', 'description': 'Patients randomized to the intervention arm will have the results of the Cuff Leak Test (CLT) (whether failed or passed) communicated to the treating physician; the treating physician will decide whether to proceed with extubation or not based on the CLT results. It is at the discretion of the treating physician to provide corticosteroids (4-5 mg of intravenous dexamethasone every six hours for up to 24 hours, with the last dose given one hour preceding extubation) and/or delay extubation by 24 hours should the patient fail the CLT.', 'interventionNames': ['Diagnostic Test: Cuff Leak Test']}\n- {'label': 'Control Arm', 'type': 'NO_INTERVENTION', 'description': 'In the control arm of this trial; the treating physicians and healthcare workers will be blinded to the results of the Cuff Leak Test (CLT); therefore, the Respiratory Therapist (RT) will proceed with extubation without delay or administering systemic steroid, regardless to the CLT results.'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Cuff Leak Test', 'description': 'The Respiratory Therapist (RT) will perform the CLT on all enrolled patients. The patients will first be switched to volume assist-control (V-AC) with a respiratory rate of 10 breaths/min (to allow patient assist), constant flow of 60 l/min, and tidal volume set to match the average tidal volume currently being delivered during supportive ventilation. The RT will document the average exhaled volume over 3-5 breaths after switching to V-AC. The test will be performed by deflating the ETT balloon cuff with a 10 cc syringe, and: a) auscultation with a stethoscope to identify audible air leak around the ETT, and b) measuring the difference between the average exhaled volume prior to cuff deflation and the average exhaled volume over 3-5 breaths after cuff deflation.', 'armGroupLabels': ['Intervention Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Consent Rate', 'description': 'A successful consent rate will be defined as 70% of substitute decision makers (SDMs) or patients approached to consent, choosing to participate in the trial. This will be calculated as the overall proportion of SDMs or patients consenting out of those approached (with 95% CI). Note that a mixed consent model will be obtained. In Canada and Saudi Arabia, a priori or deferred consent model will be used. In Poland, a waved consent model will be used.', 'timeFrame': '1 year'}\n- {'measure': 'Recruitment Rate', 'description': 'A successful recruitment rate will be defined as achieving enrollment of 40 patients, conventionally expressed as four patients per month over the duration of the trial. While the pilot trial is ongoing, recruitment will be reviewed weekly and the screening records will be reviewed monthly with the cases of missed eligible patients reviewed. If applicable, barriers to enrollment will be addressed to maximize recruitment. The recruitment metric will be measured and interpreted at the end of the pilot trial by calculating the mean number of recruited patients per active screening month.', 'timeFrame': '1 year'}\n- {'measure': 'Protocol Adherence', 'description': \"Successful adherence will be defined as \u226580%. The adherence will be calculated as the proportion of patients that were assigned to the control arm being extubated after CLT being performed and the portion of people that assigned to the intervention arm who are given the prescribed steroids for a failed CLT. As this pilot trial is ongoing, investigators will review adherence monthly and investigate the reasons for compliance failure. All reasons for either failure to extubate after a failed CLT in the control arm will be investigated. The RC will review the Respiratory Therapists' notes, and the medication profile to determine actual compliance. All reasons for non-compliance will be recorded for both groups using distinguishing clinical reasons (eg. Palliation, death, consent withdrawal, errors).\", 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size and justification\n We plan to enrol 100 patients for the pilot trial to ensure feasibility criteria will be appropriately examined.21 22", "id": 240, "split": "train"} +{"trial_id": "NCT03372954", "pmid": "30704414", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Retrograde Application of Bone Marrow Aspirate Concentrate (BMAC) Through Coronary Sinus in Patients With Congestive Heart Failure of Ischemic Etiology\n\nIncluded conditions:\n- Heart Failure\n\nStudy Armgroups:\n- {'label': 'Bone marrow autologous cells concentrate (BMAC)', 'type': 'EXPERIMENTAL', 'description': 'retrograde administration on non-selected BMAC via coronary sinus', 'interventionNames': ['Drug: BMAC']}\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'standard treatment o heart failure', 'interventionNames': ['Drug: BMAC']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'BMAC', 'description': 'retrograde administration on non-selected BMAC via coronary sinus', 'armGroupLabels': ['Bone marrow autologous cells concentrate (BMAC)', 'Control']}\n\nPrimary Outcomes:\n- {'measure': 'Left ventricular end-systolic diameter (LVESd)', 'description': 'Left ventricular end-systolic diameter', 'timeFrame': '12 month'}\n- {'measure': 'Left ventricular end-systolic volume (LVESV)', 'description': 'Left ventricular end-systolic volume', 'timeFrame': '12 month'}\n- {'measure': 'Left ventricular end-diastolic diameter (LVEDd)', 'description': 'Left ventricular end-diastolic diameter', 'timeFrame': '12 month'}\n- {'measure': 'Left ventricular end-diastolic volume (LVEDV)', 'description': 'Left ventricular end-diastolic volume', 'timeFrame': '12 month'}\n- {'measure': 'ejection fraction of left ventricle (EF LV)', 'description': 'ejection fraction of left ventricle', 'timeFrame': '12 month'}\n\nPlease estimate the sample size based on the assumption: \nType I error (\u03b1) is 5%, test strength (\u03b2) is 80%, and an expected loss of 10% of patients in the 12-month follow-up. Continuous variables with normal distribution will be compared using Student's t-test, non-normal distribution using Mann-Whitney U test, and categorical variables using \u03c72 or Fisher exact test. Odds ratios (OR) are expressed with 95% CI, and a p-value < 0.05 is considered significant.", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size and statistical analysis\n The statistical estimate of the size of the file was based on the data from previous studies in patients with congestive heart failure [6] in which was reached the difference of 13.0\u00e2\u0080\u0089+\u00e2\u0080\u008912.9\u00e2\u0080\u0089ml in LVESV between study and control groups. \u00ce\u00b1 type I error of 5%, and \u00ce\u00b2 test strength of 80% were used to determine the required group size of 17 patients per group. When including an expected loss of 10% of patients in the 12-month follow-up (including MRI drop out), the resulting size of our group was 40 patients (20 per arm).\n Continuous variables with normal distribution will be presented as mean and standard deviation (SD) and will be compared using Student 2-sample t test. Continuous variables with non-normal distribution will be presented as the median and range (minimum\u00e2\u0080\u0093maximum or lower and higher percentile) and will be compared using the nonparametric Mann\u00e2\u0080\u0093Whitney U test. Categorical variables will be presented as counts and percentages and will be compared using the \u00cf\u00872 or Fisher exact test. Odds ratios (OR) are expressed with 95% CI. A p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05 will be considered significant. All statistical analyses will be performed using IBM SPSS Statistics version 22.", "id": 241, "split": "train"} +{"trial_id": "NCT03373474", "pmid": "31277678", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Effectiveness Between Warm Acupuncture With Local-Distal Points Association and Local Distribution Points Association in Breast Cancer Related Lymphedema Patients: A Multicenter, Randomized, Controlled Clinical Trial\n\nIncluded conditions:\n- Breast Cancer Lymphedema\n\nStudy Armgroups:\n- {'label': 'local distribution points association', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive warm acupuncture with the local distribution acupoints association on the affected arm only.', 'interventionNames': ['Other: local distribution points association']}\n- {'label': 'local-distal points association', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive warm acupuncture with the local-distal acupoints association on the affected arm, unaffected arm, abdomen, and legs.', 'interventionNames': ['Other: local-distal points association']}\n- {'label': 'waiting-list', 'type': 'NO_INTERVENTION', 'description': 'Patients in the waiting-list group will not receive any acupuncture treatment during the study. However, for ethical consideration, 20 free acupuncture treatments will be offered after the study is completed.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'local distribution points association', 'description': 'Participants will receive acupuncture treatments using the local points set plus the local-addition points set (local distribution association) described below. Warming acupuncture will be applied at HT2, LI11, and TE9 if permitted.\\n\\nLocal points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Local-addition points set: LU5, PC3, SI7, TE4, TE3, HT2, TE10, LI15, and 2 other points according to the symptom on the affected arm.', 'armGroupLabels': ['local distribution points association']}\n- {'type': 'OTHER', 'name': 'local-distal points association', 'description': 'Participants will receive acupuncture treatments using the local points set plus the distal points set (local-distal association) described below. Warming acupuncture will be applied similarly to the local distribution group, with the addition of Ren6, Ren9, bilateral SP9, and LI11 on the unaffected arm.\\n\\nLocal points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Distal points set: TE5, LI11, HT3, TE13 on the unaffected arm; CV4, CV6, CV9, CV12, bilateral SP6 and SP9.', 'armGroupLabels': ['local-distal points association']}\n\nPrimary Outcomes:\n- {'measure': 'Upper extremity circumference', 'description': 'Various assessment methods are available but circumference measure is simple, convenient with low cost, and reliable. Therefore, the primary outcome measures will be the mean change in inter-limb circumference difference from baseline to the end of the 8-week intervention. The circumference will be measured by the measurement tape (Gulick Attachment, Baseline, America) at the wrist crease, 10 cm above the wrist crease, elbow crease, 10 cm above the elbow crease, where the lymphedema is most severe and its corresponding location on the unaffected limb.', 'timeFrame': '80 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (\u03b2) = 0.10, Number of groups (K) = 3, Degree of freedom V1 = 2, Degree of freedom V2 = N-1 (N assumed as \u221e), Critical value (\u03a8) = 2.52, Dropout rate = 20%", "answer": 108, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n According to the results of our preliminary trial (9 participants in the LDA group, 7 participants in the LA group, and 10 participants in the WL group), the biggest circumference difference after 20 treatments was 2.34\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.6\u00e2\u0080\u0089cm, 3.32\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.53\u00e2\u0080\u0089cm, and 3.74\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.1\u00e2\u0080\u0089cm in the LDA, LA, and WL groups, respectively. According to the formula:\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ \\mathrm{n}={\\Psi}^2\\left(\\sum \\left({Si}^2\\right)/K\\right)/\\left[\\sum {\\left(\\overline{Xi}-\\overline{X}\\right)}^2/\\left(\\mathrm{K}-1\\right)\\right] $$\\end{document}n=\u00ce\u00a82\u00e2\u0088\u0091Si2/K/\u00e2\u0088\u0091Xi\u00c2\u00af\u00e2\u0088\u0092X\u00c2\u00af2/K\u00e2\u0088\u00921\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.10K\u00e2\u0080\u0089=\u00e2\u0080\u00893\u00ce\u00a8: K\u00e2\u0080\u0089=\u00e2\u0080\u00893, degree of freedom V1\u00e2\u0080\u0089=\u00e2\u0080\u0089K\u00e2\u0080\u00931\u00e2\u0080\u0089=\u00e2\u0080\u00892; degree of freedom V2\u00e2\u0080\u0089=\u00e2\u0080\u0089N\u00e2\u0080\u00931, N is unknown, assume N as \u00e2\u0088\u009e, according to the T distribution critical values table when \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.10: \u00ce\u00a8 \u00ce\u00b1, \u00ce\u00b2, K\u00e2\u0080\u00931, \u00e2\u0088\u009e\u00e2\u0080\u0089=\u00e2\u0080\u00892.52\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ \\overline{Xi} $$\\end{document}Xi\u00c2\u00af and Si represent mean number (X1\u00e2\u0080\u0089=\u00e2\u0080\u00892.34, X2\u00e2\u0080\u0089=\u00e2\u0080\u00893.32, X3\u00e2\u0080\u0089=\u00e2\u0080\u00893.74) and standard deviation (S1\u00e2\u0080\u0089=\u00e2\u0080\u00891.6, S2\u00e2\u0080\u0089=\u00e2\u0080\u00891.53, S3\u00e2\u0080\u0089=\u00e2\u0080\u00891.1) of group i according to the preliminary trial.\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ \\overline{\\mathrm{X}} $$\\end{document}X\u00c2\u00af= (X1\u00e2\u0080\u0089+\u00e2\u0080\u0089X2\u00e2\u0080\u0089+\u00e2\u0080\u0089X3)/K\u00e2\u0080\u0089=\u00e2\u0080\u0089(2.34\u00e2\u0080\u0089+\u00e2\u0080\u00893.32\u00e2\u0080\u0089+\u00e2\u0080\u00893.74)/3\u00e2\u0080\u0089=\u00e2\u0080\u00893.13\n The result of calculation was 30 participants in each group. Assuming a 20% dropout rate, a total of 108 participants are required with 36 participants in each group.", "id": 242, "split": "train"} +{"trial_id": "NCT03374761", "pmid": "30782674", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Families First Positive Discipline for Everyday Parenting With Home Visiting Program in Indonesia\n\nIncluded conditions:\n- Child Abuse\n- Parent-Child Relations\n\nStudy Armgroups:\n- {'label': 'Families First Home Visiting Program', 'type': 'EXPERIMENTAL', 'description': '10 group sessions conducted weekly and 4 home visits for the duration of the program. Sessions and visits of the Families First Home Visiting Program cover child development, parenting skills, parent-child communications, and positive discipline practices. The intervention is delivered by para-professional community facilitators, trained in the program.', 'interventionNames': ['Other: Families First Home Visiting Program']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'The control group receives the standard, government run, services provided by community health workers in West Java. Once the evaluation of the intervention arm is completed, participants in the control arm will be offered the intervention.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Families First Home Visiting Program', 'description': '10 group sessions and 4 home visits with community facilitators emphasizing positive parenting', 'armGroupLabels': ['Families First Home Visiting Program']}\n\nPrimary Outcomes:\n- {'measure': 'Change in frequency of physical and emotional punishment at 3 and 6 months', 'description': 'Self-report frequency in the past month of use of physical discipline including harsh physical discipline, and verbal/emotional discipline.', 'timeFrame': 'Baseline, post-intervention (3 months), and 6 months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, 90% power, 0.02 intraclass correlation, and 80% participation rate.", "answer": 720, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size calculation\n The study is powered to detect a change considered to be both meaningful and plausible on the primary outcome. A sample size of 720 families will allow measuring a reduction of 15.2% in parent-reported use of violent discipline at home from the initial estimated prevalence of 30% (SKTA 2013)4 with an \u00ce\u00b1 level of 0.05% and 90% power, assuming 0.02 intraclass correlation73 74 and 80% participation rate.75 One child per family will be selected as the index child.", "id": 243, "split": "train"} +{"trial_id": "NCT03374800", "pmid": "37968012", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Re-EValuating the Inhibition of Stress Erosions: Prophylaxis Against Gastrointestinal Bleeding in the Critically Ill (The REVISE) Trial\n\nIncluded conditions:\n- Gastrointestinal Hemorrhage (Clinically Important, Upper)\n\nStudy Armgroups:\n- {'label': 'Placebo (0.9% saline)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Withholding Stress ulcer prophylaxis (intravenous 0.9% saline as placebo)', 'interventionNames': ['Drug: Placebo (0.9% saline)']}\n- {'label': 'Stress Ulcer Prophylaxis (Pantoprazole)', 'type': 'ACTIVE_COMPARATOR', 'description': 'pantoprazole 40mg powder for injection reconstituted with 0.9% saline', 'interventionNames': ['Drug: Pantoprazole']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Placebo (0.9% saline)', 'description': 'normal saline', 'armGroupLabels': ['Placebo (0.9% saline)'], 'otherNames': ['normal saline; NaCl 0.9%']}\n- {'type': 'DRUG', 'name': 'Pantoprazole', 'description': '40 mg powder for injection reconstituted with 0.9% saline', 'armGroupLabels': ['Stress Ulcer Prophylaxis (Pantoprazole)'], 'otherNames': ['Protonix']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of clinically important upper gastro-intestinal bleeding', 'description': 'Clinically important upper GI bleeding requires the presence of overt GI bleeding which is defined as one of the following;\\n\\n* Hematemesis\\n* Overt nasogastric bleeding\\n* Melena\\n* Hematochezia\\n\\nPLUS (in the absence of another cause), at least one of the following in the 24 hours following overt GI bleeding:\\n\\n* Haemodynamic change defined as a spontaneous decrease in invasively monitored mean arterial pressure or non-invasive systolic or diastolic blood pressure of 20 mmHg or more or an orthostatic increase in pulse rate of 20 beats/minute and a decrease in systolic blood pressure of 10 mmHg, with or without vasopressor initiation, or increase\\n* Vasopressor initiation\\n* A decrease in haemoglobin of \u2265 20 g/l in a 24-hour period or less,\\n* Transfusion of \u22652 units of packed red blood cells within 24 hours of bleeding to maintain stable haemoglobin or haemodynamics, or\\n* Need for therapeutic intervention (e.g. angiography, surgery or endoscopic treatment of bleeding).', 'timeFrame': '90 days (In ICU or resulting in ICU readmission, censored at 90 days after randomization)'}\n- {'measure': 'Primary Safety Outcome: 90 Day Mortality', 'description': 'Mortality status at day 90 post randomization', 'timeFrame': '90 days post randomization'}\n\nPlease estimate the sample size based on the assumption: \nThe study targets 85% power for detecting clinically important reductions in GI bleeding and at least 70% power for detecting effects on 90-day mortality. The sample size accounts for feasible enrollment over 4 years, including non-compliance and loss to follow-up.", "answer": 4800, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size of 4800 patients was chosen on the basis of plausible baseline risks of GI bleeding, plausible RR reductions, a target of 85% power and feasible enrolment. The best estimate of the GI bleeding event rate in the placebo arm ranging from 3% to 6% is based on the following: an international period-prevalence study (2.6%; 95% CI 1.6 to 3.6)1; the REVISE Pilot trial (placebo 6.1%; 95% CI 2.1 to 16.5)12; and the SUPICU trial placebo rate of 4.2%.3 The RR associated with pantoprazole was 0.6 in the SUPICU trial. Table 2 highlights sample size considerations for clinically important upper GI bleeding. The table presents combinations of RR reductions ranging from 30% to 50%, and baseline risks between 3% and 6% for which we will achieve 85% power. With a baseline risk of 3% and an RR reduction of 50%, the absolute benefit will be a 1.5% difference. Other highlighted cells correspond to absolute risk reduction of greater than 1.5%. In summary, across the range of plausible baseline risks, 4800 patients will provide at least 85% power to detect effects of pantoprazole as large as, or greater than, the smallest clinically important reduction in GI bleeding.\n \n Table 2\n \n Sample size with respect to clinically important bleeding outcome\n \n \n \n \n \n True underlying relative risk (PPI vs placebo)\n \n \n 0.7\n 0.6\n 0.5\n \n \n \n \n \nEvent rate in placebo group\n\n \n3%\n\n 47.1%\n 74.6%\n 92.6%\n \n \n \n4%\n\n 60.1%\n 86.6%\n 97.8%\n \n \n \n5%\n\n 70.7%\n 93.4%\n 99.4%\n \n \n \n6%\n\n 79.1%\n 96.9%\n 99.9%\n \n \n \n \n \n This table highlights consideration for clinically important gastrointestinal (GI) bleeding. It presents combinations of relative risk reductions ranging from 30% to 50%, and baseline risks between 3% and 6% for which we will achieve 85% power. With a baseline risk of 3% and a relative risk reduction of 50%, the absolute benefit of will be a 1.5% difference. Other highlighted cells correspond to absolute risk reduction of greater than 1.5%. In summary, across the range of plausible baseline risks in the shaded boxes, 4800 patients will provide at least 85% power to detect effects of pantoprazole as large as, or greater than, this small important reduction in clinically important GI bleeding. This sample size reflects feasible enrolment in an acceptable 4-year time frame, accounting for any non-compliance or loss to follow-up, in the context of hybrid serial funding for Re-Evaluating the Inhibition of Stress Erosions.\n \n \n PPI, proton pump inhibitor.\n \n \n \n \nTable 3 highlights sample size implications for 90-day mortality. The estimates of RR are informed by SUPICU in which the upper confidence limit around the increased mortality in the high-risk group (using the illness severity metric of the Simplified Acute Physiology Score (SAPS) II>53) included a value of 1.30. Among the first 25% of patients enrolled, the mortality rate was 44% across both groups in the comparable high risk of death group of concern (using the illness severity metric of the Acute Physiology and Chronic Health Evaluation (APACHE) II score>25). Our power calculations are based on the estimated 40% of REVISE patients who will fall in the high-risk group (~1920 patients). The table presents combinations of RRs ranging from 1.1 to 1.3, and baseline risks between 4% and 38%, demonstrating power of >70% for combinations of higher levels of baseline risk and RR increase. The RR of 1.13 is the point estimate in patients with high illness severity in SUPICU.3 In summary, across the range of higher baseline risks, 4800 patients will provide at least 70% power to detect effects of pantoprazole at levels that would likely preclude use of pantoprazole in patients at higher risk of death.\n \n Table 3\n \n Sample size with respect to 90-day mortality\n \n \n \n \n \n True underlying relative risk (PPI vs placebo)\n \n \n 1.1\n 1.13\n 1.2\n 1.3\n \n \n \n \n \nEvent rate in placebo group\n\n \n38%\n\n 38.0%\n 57.9%\n 91.5%\n 99.9%\n \n \n \n40%\n\n 40.9%\n 61.7%\n 93.7%\n >99.9%\n \n \n \n42%\n\n 43.9%\n 65.6%\n 95.5%\n >99.9%\n \n \n \n44%\n\n 47.1%\n 69.4%\n 96.9%\n >99.9%\n \n \n \n \n \n This table highlights sample size implications for 90-day mortality. The estimates of relative risk are informed by Stress Ulcer Prevention in the ICU (SUPICU) in which the upper confidence limit around the increased mortality in the high-risk group (SAPS II>53) included a value of 1.30. Among the first 25% of patients enrolled, the mortality rate was 44% across both groups in the comparable high-risk of death group of concern (APACHE II score>25). Our power calculations are based on the 40% of REVISE patients who will fall in the high-risk group (1920 patients). The table presents combinations of relative risks ranging from 1.1 to 1.3, and baseline risks between 38% and 44%, showing power of >70% for combinations of higher levels of baseline risk and relative risk increase. The relative risk of 1.13 is the observed point estimate in patients with high illness severity in the SUPICU Trial. In summary, across the range of higher baseline risks, 4800 patients will provide at least 70% power to detect effects of pantoprazole at levels that would preclude use of the drug in patients with high illness severity\u00e2\u0080\u0094those at higher risk of death.\n \n \n APACHE, Acute Physiology and Chronic Health Evaluation; PPI, proton pump inhibitor; SAPS, Simplified Acute Physiology Score;", "id": 244, "split": "train"} +{"trial_id": "NCT03374800", "pmid": "37644556", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Re-EValuating the Inhibition of Stress Erosions: Prophylaxis Against Gastrointestinal Bleeding in the Critically Ill (The REVISE) Trial\n\nIncluded conditions:\n- Gastrointestinal Hemorrhage (Clinically Important, Upper)\n\nStudy Armgroups:\n- {'label': 'Placebo (0.9% saline)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Withholding Stress ulcer prophylaxis (intravenous 0.9% saline as placebo)', 'interventionNames': ['Drug: Placebo (0.9% saline)']}\n- {'label': 'Stress Ulcer Prophylaxis (Pantoprazole)', 'type': 'ACTIVE_COMPARATOR', 'description': 'pantoprazole 40mg powder for injection reconstituted with 0.9% saline', 'interventionNames': ['Drug: Pantoprazole']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Placebo (0.9% saline)', 'description': 'normal saline', 'armGroupLabels': ['Placebo (0.9% saline)'], 'otherNames': ['normal saline; NaCl 0.9%']}\n- {'type': 'DRUG', 'name': 'Pantoprazole', 'description': '40 mg powder for injection reconstituted with 0.9% saline', 'armGroupLabels': ['Stress Ulcer Prophylaxis (Pantoprazole)'], 'otherNames': ['Protonix']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of clinically important upper gastro-intestinal bleeding', 'description': 'Clinically important upper GI bleeding requires the presence of overt GI bleeding which is defined as one of the following;\\n\\n* Hematemesis\\n* Overt nasogastric bleeding\\n* Melena\\n* Hematochezia\\n\\nPLUS (in the absence of another cause), at least one of the following in the 24 hours following overt GI bleeding:\\n\\n* Haemodynamic change defined as a spontaneous decrease in invasively monitored mean arterial pressure or non-invasive systolic or diastolic blood pressure of 20 mmHg or more or an orthostatic increase in pulse rate of 20 beats/minute and a decrease in systolic blood pressure of 10 mmHg, with or without vasopressor initiation, or increase\\n* Vasopressor initiation\\n* A decrease in haemoglobin of \u2265 20 g/l in a 24-hour period or less,\\n* Transfusion of \u22652 units of packed red blood cells within 24 hours of bleeding to maintain stable haemoglobin or haemodynamics, or\\n* Need for therapeutic intervention (e.g. angiography, surgery or endoscopic treatment of bleeding).', 'timeFrame': '90 days (In ICU or resulting in ICU readmission, censored at 90 days after randomization)'}\n- {'measure': 'Primary Safety Outcome: 90 Day Mortality', 'description': 'Mortality status at day 90 post randomization', 'timeFrame': '90 days post randomization'}\n\nPlease estimate the sample size based on the assumption: \nBaseline characteristics will be described, and multiple imputation will be performed for outcomes missing in more than 2% of patients. No adjustments for multiple comparisons will be made. Analyses will be performed using SAS version 9.4.", "answer": 4800, "answer_type": "ACTUAL", "explanation": "Sample size\n The cohort size is based on the number of patients with COVID-19 enrolled in REVISE. As of June 1, 2023, 484 patients with COVID-19 have been enrolled in REVISE, representing 10.1% of the sample size of 4800 patients. Acknowledging the inherent challenges in predicting the incidence of and the means\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u0089standard deviation (SD) or median (interquartile range [IQR]) of the continuous variables will be calculated. Baseline characteristics (e.g., age, sex, APACHE II Score, admission diagnostic category, comorbidities, COVID-19 vaccination status, and pre-hospital acid suppression) will be described. Table 1 presents the statistical analysis plans for the 3 study objectives, hypotheses, and outcomes.\n For any outcome that is missing for more than 2% of patients, we will perform multiple imputation. Adjustments for multiple comparisons will not be made for these exploratory analyses. All analyses will be performed using the statistical software SAS version 9.4 [21].", "id": 245, "split": "train"} +{"trial_id": "NCT03375918", "pmid": "33592827", "question": "Here is the design of a clinical trial:\n\nOfficial Title: COmmuNity-engaged SimULation Training for Blood Pressure Control\n\nIncluded conditions:\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Healthcare Trainees - Cluster 1', 'type': 'OTHER', 'description': 'Within each academic year, trainee clusters are randomized to 1 of 5 start date training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.', 'interventionNames': ['Other: CONSULT-BP Educational Intervention']}\n- {'label': 'Healthcare Trainees - Cluster 2', 'type': 'OTHER', 'description': 'Within each academic year, trainee clusters are randomized to 1 of 5 start date training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.', 'interventionNames': ['Other: CONSULT-BP Educational Intervention']}\n- {'label': 'Healthcare Trainees - Cluster 3', 'type': 'OTHER', 'description': 'Within each academic year, trainee clusters are randomized to 1 of 5 start date training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.', 'interventionNames': ['Other: CONSULT-BP Educational Intervention']}\n- {'label': 'Healthcare Trainees - Cluster 4', 'type': 'OTHER', 'description': 'Within each academic year, trainee clusters are randomized to 1 of 5 start date training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.', 'interventionNames': ['Other: CONSULT-BP Educational Intervention']}\n- {'label': 'Healthcare Trainees - Cluster 5', 'type': 'OTHER', 'description': 'Within each academic year, trainee clusters are randomized to 1 of 5 start date training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period.', 'interventionNames': ['Other: CONSULT-BP Educational Intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'CONSULT-BP Educational Intervention', 'description': 'The CONSULT-BP intervention includes two, 180-minute, in-persons sessions 5 weeks apart. Each session has 3 parts: 1. Pre-\"Clinical Practice Simulation\" Learning; 2. Trainee Self-Assessments of implicit bias; and 3. In-Person \"Clinical Practice Simulations\" to practice communication skills, trigger reflection, and frame group-based reflections on bias.', 'armGroupLabels': ['Healthcare Trainees - Cluster 1', 'Healthcare Trainees - Cluster 2', 'Healthcare Trainees - Cluster 3', 'Healthcare Trainees - Cluster 4', 'Healthcare Trainees - Cluster 5']}\n\nPrimary Outcomes:\n- {'measure': 'Blood pressure', 'description': 'Systolic and diastolic blood pressure reported in the EMR', 'timeFrame': 'up to 6 months after the intervention'}\n\nPlease estimate the sample size based on the assumption: \n>90% power, 3-year accrual period", "answer": 205, "answer_type": "ESTIMATED", "explanation": "4.6\n Sample size calculation\n For the primary outcome of BP change, we estimate that each resident will have at least 5 eligible patients per 5-week training block (assuming trainees see \u00e2\u0088\u00bc25 patients per outpatient rotation block, of whom \u00e2\u0088\u00bc40% have HTN (n\u00e2\u0088\u00bc10), and of whom \u00e2\u0088\u00bc45% are low income). Thus, each trainee will see \u00e2\u0088\u00bc10 eligible patients in the 3-block pre-intervention period, and \u00e2\u0088\u00bc20 eligible patients in the 4 block post-intervention period. We estimate there will be approximately 205 enrolled trainees over a 3 year accrual period, yielding \u00e2\u0088\u00bc205\u00e2\u0080\u008a\u00c3\u0097\u00e2\u0080\u008a10 pre-intervention observations (n\u00e2\u0080\u008a=\u00e2\u0080\u008a2050) and 205\u00c3\u009720 post-intervention observations (n\u00e2\u0080\u008a=\u00e2\u0080\u008a4100) for all patients with HTN, and fewer (control\u00e2\u0088\u00bc1025 and intervention \u00e2\u0088\u00bc2050) for participants with uncontrolled HTN (50%\u00e2\u0080\u009370% in minority and poor populations).[34] We will have >90% power to detect a 3 mmHg difference in patients at control and post-training periods.", "id": 246, "split": "train"} +{"trial_id": "NCT03376048", "pmid": "31266529", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Analgesic Efficacy of Local Wound Infiltration Plus Transversus Abdominis Plane Block and Local Wound Infiltration Only After Laparoscopic Colorectal Resection: a Randomized, Double-blind, Non-inferiority Trial\n\nIncluded conditions:\n- Colorectal Disorders\n\nStudy Armgroups:\n- {'label': 'Wound infiltration plus TAP', 'type': 'EXPERIMENTAL', 'description': 'Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon', 'interventionNames': ['Procedure: Wound infiltration plus TAP']}\n- {'label': 'Wound infiltration', 'type': 'ACTIVE_COMPARATOR', 'description': 'Wound infiltration placed by surgeon', 'interventionNames': ['Procedure: Wound infiltration']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Wound infiltration plus TAP', 'description': '1. TAP block: At the beginning of the main surgical procedure the surgeon will perform a TAP with ropivacaine infiltration, bilaterally in the anterior axillary line, between the costal margin and iliac crest in the intermuscular plane between the internal oblique and transversus abdominis muscles, the anesthesiologist under ultrasound guidance, the surgeon under laparoscopic guidance (two \"pops\" technique).\\n2. Wound infiltration : Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.', 'armGroupLabels': ['Wound infiltration plus TAP'], 'otherNames': ['ropivacaine']}\n- {'type': 'PROCEDURE', 'name': 'Wound infiltration', 'description': 'Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.', 'armGroupLabels': ['Wound infiltration'], 'otherNames': ['ropivacaine']}\n\nPrimary Outcomes:\n- {'measure': 'Pain numerical rating scale (NRS)', 'description': '1. Pain NRS during rest and cough\\n2. NRS scale 0-10: 0, \"no pain\"; 10, \"worst pain imaginable\"', 'timeFrame': 'within the first 6 hours after surgery'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided sample size calculation with 0.8 power, significance level of 0.05, and an estimated dropout rate of 8%.", "answer": 108, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The null hypothesis is that WI is inferior to WI plus L-TAP. To test the alternative hypothesis of noninferiority of WI compared with WI plus L-TAP, the sample size is calculated using the mean value of NRS. Considering our results with previously treated patients, the mean (standard deviation [SD]) pain intensity score according to NRS is 2.8 (1.9) for the WI plus TAP block group and 3.1 (1.9) for the WI group. These data have been used for the sample size calculation. The noninferiority limit of NRS 1 has been intended to be the largest difference that is clinically acceptable, so that a difference greater than 1 would matter in practice. A two-sided sample size calculation with 0.8 power and significance level of 0.05 reveals that 100 patients have to be included. With an estimated dropout rate of 8%, a sample size of 108 patients is required with 54 patients in the WI group and 54 patients in the WI plus L-TAP group. Patient recruitment is split between the two centers. Sample size has been calculated using PASS\u00c2\u00ae version 14.0.8 with a noninferiority test for the difference of two means.", "id": 247, "split": "train"} +{"trial_id": "NCT03377127", "pmid": "30143033", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PHARM-MD; An Open-Label, Randomized Controlled Phase II Study to Evaluate the Efficacy of a Pharmacist Managed Diabetes Clinic in High-Risk Diabetes Patients\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'Standard of Care (SOC)', 'type': 'ACTIVE_COMPARATOR', 'description': \"The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. Management per standard of care includes referrals to ophthalmology for dilated eye exam, nephrology for nephropathy management, cardiology for macrovascular complications management, neurology for neuropathy or neurologic complications, diabetic education, laboratory studies, and vaccinations and will be ordered or performed at the discretion of each patient's PCP\", 'interventionNames': ['Other: Standard of Care (SOC)']}\n- {'label': 'SOC and PMDC', 'type': 'EXPERIMENTAL', 'description': 'The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. Pharmacists have the discretion to make medication adjustments and initiate new medications pertinent to the management of diabetic comorbidities. The model is a collaborative practice agreement between the pharmacist and the primary care physician.', 'interventionNames': ['Behavioral: Pharmacy Managed Diabetes Clinic (PMDC)', 'Other: Standard of Care (SOC)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Pharmacy Managed Diabetes Clinic (PMDC)', 'description': 'The PMDC visit encounters will focus on patient identified goals for the management of their diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45 minutes.', 'armGroupLabels': ['SOC and PMDC']}\n- {'type': 'OTHER', 'name': 'Standard of Care (SOC)', 'description': 'Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations', 'armGroupLabels': ['SOC and PMDC', 'Standard of Care (SOC)']}\n\nPrimary Outcomes:\n- {'measure': 'Hemoglobin A1c at 6 Months', 'description': 'change from baseline in Hemoglobin A1c, measured in % DCCT (Diabetes Control and Complications Trial) units', 'timeFrame': '6 months'}\n- {'measure': 'Hemoglobin A1c at 12 Months', 'description': 'change from baseline in Hemoglobin A1c', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level of p < 0.05, and 20% attrition rate.", "answer": 86, "answer_type": "ACTUAL", "explanation": "Sample size\n Assigning an allocation of 1:1 that will result in equal sample sizes, we are expecting a mean difference of change in HbA1c of 1% between the two groups (intervention versus control) with standard deviation (SD) of 1.5%. The sample size was estimated to be 36 per arm or a total of 72 with 80% power at a p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05 significance. Adding 20% for attrition, the final sample size was estimated at 86 patients. We considered a HbA1c difference of 1% as being clinically significant in long-term reduction of stroke, myocardial infarction, and microvascular complications [3]. PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, UT, USA, ncss.com/software/pass was used for the sample size calculation.", "id": 248, "split": "train"} +{"trial_id": "NCT03382548", "pmid": "33986070", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Reducing Antibiotics Treatment Duration for Ventilator-Associated Pneumonia\n\nIncluded conditions:\n- Ventilator Associated Pneumonia\n- Pneumonia, Bacterial\n\nStudy Armgroups:\n- {'label': 'Short antibiotic treatment duration for VAP (7 days or less)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Reducing Antibiotics treatment duration']}\n- {'label': 'Long antibiotic treatment duration for VAP ( 8 days or more)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Standard Antibiotics treatment duration']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Reducing Antibiotics treatment duration', 'description': 'Antibiotics should be stopped from day 3 to 7 if respiratory cultures are negative and the patients fulfill a set of stringent clinical criteria signifying cardiopulmonary stability for 48 hours. If the respiratory cultures are positive, patients who fulfill the same set of clinical criteria should have their antibiotics stopped from day 5 to 7.', 'armGroupLabels': ['Short antibiotic treatment duration for VAP (7 days or less)']}\n- {'type': 'DRUG', 'name': 'Standard Antibiotics treatment duration', 'description': 'Participants in the control (long duration) arm will receive standard care, which is antibiotic treatment for at least 8 days with the exact duration decided by the primary physician.', 'armGroupLabels': ['Long antibiotic treatment duration for VAP ( 8 days or more)']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patients who suffered either death or pneumonia recurrence within 60(\u00b15) days of enrolment', 'timeFrame': '60 days'}\n\nPlease estimate the sample size based on the assumption: \nA group sequential design with boundaries proposed by Fleming-Harrington-O'Brien is used. The study aims for a power of 80% to conclude non-inferiority with a one-sided alpha risk of 5%. A loss to follow-up rate of up to 10% is anticipated.", "answer": 460, "answer_type": "ACTUAL", "explanation": "Sample size calculation and non-inferiority margin determination\n Mortality after sustaining an episode of VAP has been reported to be 14%\u00e2\u0080\u009343%\u00e2\u0080\u0089globally.8 32\u00e2\u0080\u009339 VAP recurrence rates range from 14% to 40%, with higher incidence in those caused by GNNF bacilli.33 40 41 Mortality observed in these recurrence episodes were 17%\u00e2\u0080\u009350%.32 33 Based on these, we expect the primary outcome (a composite binary outcome of mortality and VAP recurrence) to occur in 55% of the patients in the standard-of-care arm. We derived an absolute non-inferiority margin of 12% with the fixed-margin method, preserving at least 50% of the efficacy of standard treatment in VAP.42 43 Using a group sequential design adopting the boundaries proposed by Fleming-Harrington-O\u00e2\u0080\u0099Brien, a maximum of 412 patients will be required to achieve a power of 80% to conclude non-inferiority between the two groups with a one-sided \u00ce\u00b1 risk of 5%.44 As we anticipate a loss to follow-up of up to 10%, we plan to enrol a maximum of 460 patients.", "id": 249, "split": "train"} +{"trial_id": "NCT03383172", "pmid": "30832708", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mental Health Prevention Among Preschool Children: a Pilot Study of the Adaptation of the I Can Problem Solve (ICPS) Program to Chile\n\nIncluded conditions:\n- Mental Health\n- Aggressive Childhood Behavior\n- Problem Behavior\n- Social Behavior\n\nStudy Armgroups:\n- {'label': 'ICPS with internal school facilitator', 'type': 'EXPERIMENTAL', 'description': 'Schools with preschool students. All consented students in the class will participate in the ICPS preschool program, adapted to the Chilean reality and culture. The program is manualized and will be delivered by the early educator of the class, who is part of the school personnel.This internal facilitator will be trained in the program. Each of the 59 sessions lasts around 20 minutes, delivered 2 to 3 times a week, during 5 months. ICPS content includes vocabulary and concepts about emotions, and the development of problem-solving skills, practising alternative solutions, consequences and the sequential thought (solutions-consequences). Interactive techniques (e.g. games, role-playing, and the use of stories, illustrations and puppets), and guided discussion strategies are used to solve problems.', 'interventionNames': ['Behavioral: I Can Problem Solve (ICPS) Program']}\n- {'label': 'ICPS with external facilitator', 'type': 'ACTIVE_COMPARATOR', 'description': 'Schools with preschool students. All consented students in the class will participate in the ICPS preschool program, adapted to the Chilean reality and culture. The program is manualized and will be delivered by an external trained early educator, who is part of the research team. The early educator of the class, who is part of the school personnel, will also be trained to collaborate with all the program activities with the external facilitator. Each of the 59 sessions lasts around 20 minutes, delivered 2 to 3 times a week, during 5 months. ICPS content includes vocabulary and concepts about emotions, and the development of problem-solving skills, practising alternative solutions, consequences and the sequential thought (solutions-consequences). Interactive techniques (e.g. games, role-playing, and the use of stories, illustrations and puppets), and guided discussion strategies are used to solve problems.', 'interventionNames': ['Behavioral: I Can Problem Solve (ICPS) Program']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'School in the control group will continue to carry out their normal academic and prevention activities.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'I Can Problem Solve (ICPS) Program', 'description': 'The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.', 'armGroupLabels': ['ICPS with external facilitator', 'ICPS with internal school facilitator'], 'otherNames': ['Interpersonal Cognitive Problem Solving Program']}\n\nPrimary Outcomes:\n- {'measure': 'Acceptability', 'description': 'Acceptability of the intervention will be assessed using qualitative questionnaires', 'timeFrame': '5 months'}\n- {'measure': 'Feasibility', 'description': 'Feasibility will be assessed by looking at the number of students successfully completing the study', 'timeFrame': '5 months'}\n- {'measure': 'Parental report of psychological difficulties', 'description': 'The psychological difficulties will be assessed using the total subscale of difficulties of the Parents version of The Strengths and Difficulties Questionnaire (SDQ)', 'timeFrame': '8 months'}\n- {'measure': 'Parental report of psychological strengths', 'description': 'The psychological strengths will be assessed using the total subscale of difficulties of the Parents version of The Strengths and Difficulties Questionnaire (SDQ)', 'timeFrame': '8 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided contrast analysis with a 20% loss to follow-up rate is assumed. Despite evidence supporting a one-sided analysis, a two-sided analysis is chosen to align with common practices in randomized controlled trials.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Sample size\n Since this is a pilot study, it is not appropriate to calculate a sample size for establishing the effectiveness of the intervention [45]. However, we have calculated a suitable number of children for this study. According to some studies, we expect that the proportion of children who will have disruptive symptoms within 1\u00e2\u0080\u0089year in the waiting-list control group will be 30%, compared to 10% for those children in any of the intervention arms. For a loss to follow-up calculated at 20% and in a two-sided contrast analysis, 75 children will be required per arm and 225 children in total. Despite evidence to support a one-sided analysis for this case, since we assume that the intervention will not cause harm, we will conduct a two-sided analysis as is common in randomised controlled trials. This number is adequate according to recommendations for feasibility studies that propose a minimum of 30 participants per arm to estimate the parameters for future sample size calculations [46]. We have considered the selection of 12 educational institutions as an adequate size for this pilot study, with three arms: four schools in the control group and four in each of the two intervention groups. In one of the intervention groups, the ICPS programme facilitator will be the preschool educator of the educational establishment itself, while in the other group, the facilitator will be an external preschool educator hired by the research team. Since each of these educational institutions meet the aforementioned inclusion criteria, they may be considered to have similar characteristics. An average participation of 20 students is desired per course, so we hope to recruit a total of 20 students per school. Each arm of the study should have a total of 80 students for a total of 240 students, just above the expected sample size calculated.", "id": 250, "split": "train"} +{"trial_id": "NCT03384368", "pmid": "30696677", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Modified Placement of Two Additional Pedicle Screws at the Fracture Level for the Treatment of Thoracolumbar Burst Fractures--a Study Protocol of a Randomised Controlled Trial\n\nIncluded conditions:\n- Posterior Short-segment Pedicle Instrumentation\n\nStudy Armgroups:\n- {'label': 'Screw-Distraction (SD) group', 'type': 'PLACEBO_COMPARATOR', 'description': 'six pedicle screws were implanted firstly, then distraction was achieved.', 'interventionNames': ['Device: fractured level screws-distraction']}\n- {'label': 'Distraction-Screw (DS) group', 'type': 'EXPERIMENTAL', 'description': 'four pedicle screws were implanted firstly, then distraction was achieved, two additional screws were introduced at the fracture level at last.', 'interventionNames': ['Device: fractured level screws-distraction']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'fractured level screws-distraction', 'description': 'four pedicle screws were implanted into the upper vertebra and the lower vertebral body of the fractured vertebra. Then, immediate reduction and decompression were achieved by applying distraction of rod. Finally, two additional screws were introduced at fracture level', 'armGroupLabels': ['Distraction-Screw (DS) group', 'Screw-Distraction (SD) group']}\n\nPrimary Outcomes:\n- {'measure': 'compression ratio change of anterior border of vertebral body height', 'description': 'using X-ray fluorescence', 'timeFrame': 'preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively'}\n- {'measure': 'Depth of nail into injured vertebrae', 'description': 'using X-ray fluorescence', 'timeFrame': 'at postoperation immediately'}\n- {'measure': 'Kyphosis (Cobb) angle change', 'description': 'using X-ray fluorescence', 'timeFrame': 'preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nType I error probability of 5%, 80% power, and a 20% dropout rate.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n As no previous similar trial has been conducted using our RCT design, we performed a power analysis to determine the sample size required to show safety with a type I error probability of 5% and an 80% probability of avoiding a type II error. In related studies,18 19 the mean of the control group was 0.891 and the mean of the intervention group was 0.914 (\u00cf\u0083=3 was adopted). We carried out two independent\u00c2\u00a0samples t-tests using the Power Analysis and Sample Size software and obtained a result of 28. We propose to enrol 56 participants (28 randomised to each arm) and suggest recruitment of an effective sample size of at least 70 participants to allow for a 20% drop-out rate.", "id": 251, "split": "train"} +{"trial_id": "NCT03384680", "pmid": "31192960", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Study on Symptom Collection of Patients With Lung Cancer.\n\nIncluded conditions:\n- Lung Cancer\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Pattern identification', 'description': 'Pattern identification by Body constitution questionnaire(BCQ) BCQ(+) is a questionnaire that is comprised of nineteen questions with one-to-five rating scales, making the range of total score to be between nineteen and ninety-five points with the cut-off score of 30.5 points for Yang-Xu.\\n\\nBCQ(-) is composed of another set of nineteen questions with the same five-point Likert scales, with the cut-off score of 29.5 points for Yin-Xu.\\n\\nBCQ(s) consists of twenty-three questions with the same Likert scale cut-off score of 26.5 points for Stasis.', 'timeFrame': 'For 1 year'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated, as this is a preliminary trial.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "2.8\n Sample size\n As a preliminary trial for exploring proteomics approach based on pattern identification, we intend to enroll 100 participants.\n \n 2.8.1\n LCE groups (LCEX, LCES, and LCEG)\n At least 10 patients will be assigned to each group.\n \n \n 2.8.2\n LCR groups (LCRX, LCRS, and LCRG)\n All LCR groups must have the same number of samples. The number of samples in these 3 LCR groups will be set by setting all the control factors other than pattern identification constant.", "id": 252, "split": "train"} +{"trial_id": "NCT03385902", "pmid": "31501092", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact on Mortality of Timing of Dialysis Initiation in Patients With End-stage Renal Disease by a Novel Assessment Based on Fuzzy Mathematics\n\nIncluded conditions:\n- Chronic Kidney Disease\n\nStudy Armgroups:\n- {'label': 'optimal start dialysis group', 'type': 'EXPERIMENTAL', 'description': 'The DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE reaching to 30-35, which defined as the optimal start time.', 'interventionNames': ['Other: optimal start time']}\n- {'label': 'late start dialysis group', 'type': 'ACTIVE_COMPARATOR', 'description': 'the DIFE will be used as the assessment of initiation time of dialysis. Patients in this group will start dialysis when their results of the DIFE less than 30, which defined as late start time.', 'interventionNames': ['Other: late start time']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'optimal start time', 'description': 'patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.', 'armGroupLabels': ['optimal start dialysis group']}\n- {'type': 'OTHER', 'name': 'late start time', 'description': 'patients will start hemodialysis when their DIFE less than 30', 'armGroupLabels': ['late start dialysis group']}\n\nPrimary Outcomes:\n- {'measure': 'all-cause mortality', 'description': 'proportion of patients who die from any cause', 'timeFrame': 'from the date of enrollment until the end of study, assessed up to 3 years'}\n- {'measure': 'cerebro-cardiovascular mortality', 'description': 'proportion of patients who die from cerebro-cardiovascular disease', 'timeFrame': '3 years, from the date of enrollment until the end of study'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate of 5%, 80% power, two-sided test, with p<0.05 considered statistically significant. Assumes 20% withdrawal or dropout rate.", "answer": 388, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size estimate is mainly based on the primary endpoint of the 3-year all-cause mortality from the previous retrospective cohort DIFE study, which showed that the 3-year mortality of the optimal start dialysis group was 8.38% and that of the late start dialysis group was 19.4%.21 Using PASS V.15 of the Power and Sample Size Calculation program (NCSS, LLC), we estimated a sample size of 154 per group (assuming a type I error rate of 5% with 80% power, two-sided test, with p<0.05 considered statistically significant). Assuming that 20% of the participants would withdraw or drop out, the target sample size was estimated as 388 participants, meaning that 194 participants in each group will be recruited.", "id": 253, "split": "train"} +{"trial_id": "NCT03395431", "pmid": "30385451", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Feasibility of Fingerprick Autologous Blood (FAB) As a Novel Treatment for Severe Dry Eye Disease (DED)\n\nIncluded conditions:\n- Dry Eye Syndromes\n\nStudy Armgroups:\n- {'label': 'FAB group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Arm A - Finger prick autologous blood (FAB) plus conventional treatment The patients will use FAB alongside conventional therapy as recommended by their treating ophthalmologist. A fingertip of the hand will be wiped with an alcohol steret and self-pricked using a standard diabetic lancet. The drop of blood is produced as normal and applied to the lower fornix of the affected eye(s) with the lower lid pulled down slightly by the patient. The blood will be applied 4 times a day. A fresh finger should be used for each eye. FAB should be applied at least 15 minutes after any artificial tears and no other drops applied for at least half an hour afterwards', 'interventionNames': ['Other: Fingerprick autologuos blood (FAB)']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Arm B - Conventional treatment only The patients will use conventional therapy (artificial tears, cyclosporin drops and punctal plugs/cautery) as recommended by their treating ophthalmologist'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Fingerprick autologuos blood (FAB)', 'description': 'Intervention involves the instillation of whole blood obtained from the prick of a clean finger 4 times a day.', 'armGroupLabels': ['FAB group'], 'otherNames': ['FAB']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients recruited into the study within the specified time frame', 'description': 'This will involve specifically assessing the number of eligible patient in study population consented and randomized.', 'timeFrame': '12 months'}\n- {'measure': 'Number of patients who adhere to trial protocol', 'description': 'Measured by self-reported adherence to trial protocol', 'timeFrame': '12months'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to estimate parameters such as the standard deviation for a subsequent full-scale trial. A conservative attrition rate of 10% is assumed.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n As this is a feasibility trial, there were no formal sample size calculations.23 The aim of the study is to recruit a\u00c2\u00a0sufficient number of patients to evaluate the acceptability and feasibility of the intervention. An outcome of this study will be to estimate parameters such as the SD for a sample size calculation of a subsequent full-scale trial. A sample of 52 patients (26 in each arm) is considered adequate for obtaining reliable sample size estimates.24 25 To allow for a conservative attrition rate of 10%, we aim to recruit 60 patients into the trial.", "id": 254, "split": "train"} +{"trial_id": "NCT03398291", "pmid": "31818843", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy\n\nIncluded conditions:\n- Pancreatic Cancer\n- Liver Metastases\n- Surgery\n\nStudy Armgroups:\n- {'label': 'Standard treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients continue to receive standard chemotherapy.', 'interventionNames': ['Drug: Standard chemotherapy']}\n- {'label': 'Surgical exploration', 'type': 'EXPERIMENTAL', 'description': 'Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed.', 'interventionNames': ['Procedure: Synchronous resection of primary pancreatic cancer and liver oligometastasis']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Synchronous resection of primary pancreatic cancer and liver oligometastasis', 'description': 'Patients undergo surgical exploration. If no extensive metastatic sites are found, the synchronous resection of primary pancreatic cancer and liver metastatic sites will be performed. Adjuvant chemotherapy was recommended, and the regimen selection is recommended to be based on the preoperative chemotherapy.', 'armGroupLabels': ['Surgical exploration']}\n- {'type': 'DRUG', 'name': 'Standard chemotherapy', 'description': 'Patients continue to receive standard chemotherapy including folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus nab-paclitaxel, or gemcitabine plus S-1', 'armGroupLabels': ['Standard treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Real overall survival', 'description': 'Including the time of induction chemotherapy', 'timeFrame': 'Up to 2 years'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided log-rank test, significance level 0.05, power 80%, and a 10% drop-out rate.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Study design and sample size\n CSPAC-1 is an open-label, multicentre, prospective, randomised phase III trial evaluating the efficacy and safety of simultaneous resection of the primary tumour and liver metastases after conversion chemotherapy versus standard therapy in pancreatic cancer with liver oligometastasis. The primary endpoint of this study is rOS. Our null hypothesis is that there is no differences in rOS between the operation arm and the control arm. The alternative hypothesis is that there is a difference between the operation arm and the control arm. Based on previous small-sample study results (the expected median survival times are 20.3 months and 14.0 months in the operation arm and the control arm, respectively), the assumption that enrolment will require 60 months and the requirement that the last patient be followed for at least 24 months, a total of 268 patients (134 vs 134) is needed according to PASS 11.0 software (two-sided log-rank test, significance 0.05; power 80%). Considering a 10% drop-out rate, 298 patients are needed. Therefore, we plan to enrol 300 patients (150 per group), which will be sufficient to meet the needs for sample size.", "id": 255, "split": "train"} +{"trial_id": "NCT03398915", "pmid": "31501123", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The European Robotic Spinal Instrumentation (EUROSPIN) Study: A European Prospective Multicenter Multinational Pragmatic Trial on Robot-guided Versus Navigated Versus Freehand Pedicle Screw Fixation\n\nIncluded conditions:\n- Degenerative Disc Disease\n- Spondylolisthesis\n- Spinal Stenosis\n- Recurrent Disc Herniation\n- Spondylodiskitis\n- Spinal Tumor\n- Spinal Metastases\n\nStudy Armgroups:\n- {'label': 'Robot-Guided Transpedicular Instrumentation', 'description': 'This arm will comprise all patients that receive transpedicular instrumentation by use of a robotic guidance system (SpineAssist or Renaissance, Mazor Robotics, Ltd., Caesarea, Israel or ROSA Spine, Medtech, Montpellier, France).', 'interventionNames': ['Procedure: Transpedicular Instrumentation']}\n- {'label': 'Navigated Transpedicular Instrumentation', 'description': 'This arm will comprise all patients that receive transpedicular instrumentation by use of navigation (computer assistance using CT, O-arm or 3D-fluoroscopic imaging).', 'interventionNames': ['Procedure: Transpedicular Instrumentation']}\n- {'label': 'Freehand Transpedicular Instrumentation', 'description': 'This arm will comprise all patients that receive transpedicular instrumentation by use of the conventional freehand technique.', 'interventionNames': ['Procedure: Transpedicular Instrumentation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Transpedicular Instrumentation', 'description': 'Transpedicular screw placement and instrumentation', 'armGroupLabels': ['Freehand Transpedicular Instrumentation', 'Navigated Transpedicular Instrumentation', 'Robot-Guided Transpedicular Instrumentation']}\n\nPrimary Outcomes:\n- {'measure': 'Revision surgery for a malpositioned pedicle screw', 'description': 'We defined the primary endpoint as required revision surgery for a malpositioned or loosened pedicle screw within the first postoperative year.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, significance level of 0.05, and a low dropout rate.", "answer": 615, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n It was determined that, to detect an absolute intergroup difference of 5% in the primary endpoint, 205 patients are required per group to achieve a power of 1 - \u00ce\u00b2=0.8 at \u00ce\u00b1=0.05.47 Recruitment for a specific arm is stopped once the 205 patients have been included. The incidence rates are based on the published literature, with an approximated incidence rate of the primary endpoint of ~0% for the intervention and 5% for the control group.5 6 Because the study protocol is in line with the normal clinical follow-up protocol of most centres, a low dropout rate is expected. This leads to a minimum total sample size of 615 patients.", "id": 256, "split": "train"} +{"trial_id": "NCT03405454", "pmid": "32591370", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicentre Phase II Randomised Trial of Durvalumab (MEDI4736) Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas (MOCCA)\n\nIncluded conditions:\n- Ovarian Clear Cell Carcinoma\n\nStudy Armgroups:\n- {'label': 'standard chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': \"Patients on physician's choice of chemotherapy are allowed to receive any systemic chemotherapy either as a single agent or in combination. However, biologics( including bevacizumab) and oral tyrosine kinase inhibitors will not be allowed for patients on this arm\", 'interventionNames': ['Drug: standard chemotherapy']}\n- {'label': 'durvalumab', 'type': 'EXPERIMENTAL', 'description': 'Patients on durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months', 'interventionNames': ['Drug: durvalumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'durvalumab', 'description': 'Durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months or until the appearance of significant treatment-related toxicity or disease progression', 'armGroupLabels': ['durvalumab']}\n- {'type': 'DRUG', 'name': 'standard chemotherapy', 'description': 'chemotherapy treatment will be administered as per local institutional guidelines', 'armGroupLabels': ['standard chemotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Progression free survival', 'description': 'Progression free survival (PFS) is defined as the time from the first day of treatment to the first observation of radiological or clinical disease progression or death due to any cause or last follow-up. The progression will be defined by RECIST criteria v1.1 for patients on the chemotherapy arm which includes first instance of more than 20% increase in the sum of diameters or unequivocal progression in non-target disease. The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) is calculated at baseline and at each tumor assessment.', 'timeFrame': '4 years'}\n\nPlease estimate the sample size based on the assumption: \n", "answer": 46, "answer_type": "ESTIMATED", "explanation": "Sample size\n The target sample size was 46 patients.", "id": 257, "split": "train"} +{"trial_id": "NCT03405454", "pmid": "32591370", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicentre Phase II Randomised Trial of Durvalumab (MEDI4736) Versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinomas (MOCCA)\n\nIncluded conditions:\n- Ovarian Clear Cell Carcinoma\n\nStudy Armgroups:\n- {'label': 'standard chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': \"Patients on physician's choice of chemotherapy are allowed to receive any systemic chemotherapy either as a single agent or in combination. However, biologics( including bevacizumab) and oral tyrosine kinase inhibitors will not be allowed for patients on this arm\", 'interventionNames': ['Drug: standard chemotherapy']}\n- {'label': 'durvalumab', 'type': 'EXPERIMENTAL', 'description': 'Patients on durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months', 'interventionNames': ['Drug: durvalumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'durvalumab', 'description': 'Durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months or until the appearance of significant treatment-related toxicity or disease progression', 'armGroupLabels': ['durvalumab']}\n- {'type': 'DRUG', 'name': 'standard chemotherapy', 'description': 'chemotherapy treatment will be administered as per local institutional guidelines', 'armGroupLabels': ['standard chemotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Progression free survival', 'description': 'Progression free survival (PFS) is defined as the time from the first day of treatment to the first observation of radiological or clinical disease progression or death due to any cause or last follow-up. The progression will be defined by RECIST criteria v1.1 for patients on the chemotherapy arm which includes first instance of more than 20% increase in the sum of diameters or unequivocal progression in non-target disease. The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) is calculated at baseline and at each tumor assessment.', 'timeFrame': '4 years'}\n\nPlease estimate the sample size based on the assumption: \n", "answer": 46, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was estimated based on the primary endpoint of progression-free survival. A retrospective analysis of median progression-free survival in patients with ovarian clear cell carcinoma was 11 weeks.13 Hence, a HR of 0.50 was postulated assuming a median progression-free survival of 10 weeks in the chemotherapy arm and 20 or more weeks in the durvalumab arm. Based on a 6-month progression-free survival probability of 15% in the chemotherapy arm,13 a 2:1 treatment allocation, a one-sided 10% significance level, and a power of 80%, a sample size of 31 patients in the durvalumab arm and 15 patients in the chemotherapy arm was required, giving a total sample size of 46 patients.", "id": 258, "split": "train"} +{"trial_id": "NCT03412721", "pmid": "30572467", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Split-mouth Clinical Study on the Effectiveness of Er:YAG Pulse Therapy for Achieving Pre-emptive Dental Analgesia in Children\n\nIncluded conditions:\n- Caries, Dental\n\nStudy Armgroups:\n- {'label': 'Laser analgesia', 'type': 'EXPERIMENTAL', 'description': 'Procedure: Laser analgesic procedure Performing protocol for pre-emptive laser analgesia with Er:YAG laser (Litetouch, Syneron) switched on.', 'interventionNames': ['Procedure: Laser analgesic procedure']}\n- {'label': 'Placebo analgesia', 'type': 'PLACEBO_COMPARATOR', 'description': 'Procedure: Placebo analgesic procedure Performing imitation of laser analgesic protocol with Er:YAG laser (Litetouch, Syneron) switched off - no pulse energy applied.', 'interventionNames': ['Procedure: Placebo analgesic procedure']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Laser analgesic procedure', 'description': 'Water mist spray set to \"maximum\", non-contact handpiece with sapphire tip. Tip-to-tissue distance 10 mm from the tooth neck, achieved by using a spacer. Energy is delivered to the enamel above the gingival margin adjacent to the cemento-enamel junction (perpendicularly towards the dental pulp) on each of the four line angles of the tooth for 30s, moving the laser handpiece in a sweeping action. Pulse energy - 0.2 W/ 10 Hz/ 20 mJ. Follows increase of energy and repetition of protocol - 0.6 W/ 15 Hz/ 40 mJ. Total duration of LA-induction - 240s.', 'armGroupLabels': ['Laser analgesia']}\n- {'type': 'PROCEDURE', 'name': 'Placebo analgesic procedure', 'description': 'Performing imitation of laser analgesic procedure. No pulse energy applied, non-contact handpiece with sapphire tip. Moving the laser handpiece in a sweeping action towards the cemento-enamel junction (pointing perpendicularly towards the dental pulp) on each of the four line angles of the tooth. Total duration of placebo analgesia induction - 240s.', 'armGroupLabels': ['Placebo analgesia']}\n\nPrimary Outcomes:\n- {'measure': 'Pain felt during treatment according to a visual analogue scale', 'description': \"Reported by the patient at the end of the dental treatment session on a VAS (visual analogue scale), which contains a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, which includes pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.\", 'timeFrame': '1 hour'}\n\nPlease estimate the sample size based on the assumption: \nThe error was set at 5%, the power test at 95%, and a 10% drop-out rate was conservatively allowed.", "answer": 41, "answer_type": "ACTUAL", "explanation": "2.3.4\n Sample size calculation\n Given the lack of comparable research and the unknown population standard deviation we conducted a pretest with 20 subjects and considered the behavior of this subgroup as population estimate. To estimate sample size for the primary outcome\u00e2\u0080\u0094pain felt during laser ablation of moderate carious lesion, according to the VAS scale\u00e2\u0080\u0094we applied a t test for paired groups (G\u00e2\u0088\u0097 Power software version 3.1),[13] since we have 2 groups (first upper molar in right and left quadrant) on the same patient.\n The effect size was determined using the formula\u00c2\u00a0\n Where SD is the pooled standard deviation\u00e2\u0080\u0094an average of the standard deviations of the experimental and control groups. The error was set at 5% and the power test at 95%. According to the calculation, a sample of 37 patients will be necessary to detect differences in pain. Since drop-outs are unavoidable when collecting follow-up data, this number needs to be adjusted for the estimated drop-out rate. During the pre-test, we had a drop-out rate of 5% for collecting the follow-up data and if we anticipated a higher drop-out rate for this study, we conservatively allowed for a 10% drop-out rate. Adjusting the sample size for this drop-out rate results in a sample of 41 patients needing to be recruited.", "id": 259, "split": "train"} +{"trial_id": "NCT03413410", "pmid": "31806613", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome\n\nIncluded conditions:\n- ACS - Acute Coronary Syndrome\n\nStudy Armgroups:\n- {'label': 'Metoprolol interventional group', 'type': 'EXPERIMENTAL', 'description': 'This is a multi-center, prospective, open label, single-arm interventional study.\\n\\nPatients hospitalized for ACS, fulfilling all of the inclusion criteria and none of the exclusion criteria can be enrolled in this study.', 'interventionNames': ['Drug: Metoprolol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Metoprolol', 'description': 'Patients with acute coronary syndrome take metoprolol during hospital and after discharge in the optimal dosing pathway.', 'armGroupLabels': ['Metoprolol interventional group']}\n\nPrimary Outcomes:\n- {'measure': 'percentage of patients achieving target dose', 'description': 'The percentage of patients achieving target dose of 95mg/d at the time of discharge', 'timeFrame': '1 month'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 95% confidence interval (Z=1.96), and the precision (half-length of 95% CI) is between 2.5% to 1.9%.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "\u00e2\u0080\u008bSample size justification\n This is a study to investigate the percentage of patients achieving target dose during hospitalisation. Assuming the percentage of patients achieving target dose during hospitalisation to be around 80%\u00e2\u0080\u009390%, 1000 patients will allow it to be estimated with a precision (ie, half-length of 95% CI) of 2.5% to 1.9%. A simple formula14 can be used for sample size calculation for the study estimating population prevalence as follows:\n \nn=Z2P(1-P)d2\n\n where n=sample\u00e2\u0080\u0089size, Z=Z statistic for a level of confidence (Z=1.96 for 95% CI), P-=expected prevalence or proportion, d=precision.", "id": 260, "split": "train"} +{"trial_id": "NCT03418181", "pmid": "32792431", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Does Incremental Initiation of Haemodialysis Preserve Native Kidney Function? A Multicentre Feasibility Randomised Controlled Trial\n\nIncluded conditions:\n- Kidney Failure\n- Dialysis\n\nStudy Armgroups:\n- {'label': 'Standard Haemodialysis', 'type': 'OTHER', 'description': 'Thrice weekly dialysis (control arm) - dialysis dose will not be adjusted according to Residual Kidney Function and subjects will be dialysed initially for 3.5-4 hours thrice weekly to ensure a target minimum eKt/V of 1.2.', 'interventionNames': ['Procedure: Standard Haemodialysis']}\n- {'label': 'Incremental dialysis', 'type': 'EXPERIMENTAL', 'description': 'Twice weekly dialysis - dialysis dose will be adjusted according to Residual Kidney Function.\\n\\nPatients will commence dialysis for 3.5-4 hours twice weekly and have residual renal urea clearance formally measured by interdialytic urine collection at the end of the week following dialysis initiation. Subsequent to this, dialysis dose will be adjusted.', 'interventionNames': ['Procedure: Incremental dialysis']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Standard Haemodialysis', 'description': 'Thrice weekly dialysis.', 'armGroupLabels': ['Standard Haemodialysis']}\n- {'type': 'PROCEDURE', 'name': 'Incremental dialysis', 'description': 'Individualised dialysis dose according to native kidney function.', 'armGroupLabels': ['Incremental dialysis']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitability', 'description': 'Number of patients potentially eligible for screening during the study period', 'timeFrame': '12 months'}\n- {'measure': 'Recruitability', 'description': 'Proportion of screened patients who fulfil study criteria.', 'timeFrame': '12 months'}\n- {'measure': 'Recruitability', 'description': 'Proportion of patients approached who agree to participate in the study.', 'timeFrame': '12 months'}\n- {'measure': 'Retainability', 'description': 'Proportion of patients randomised who withdraw from the study and the reasons for their withdrawal.', 'timeFrame': '12 months'}\n- {'measure': 'Protocol Adherence', 'description': 'Proportion of patients who adhere to protocol dialysis frequency.', 'timeFrame': '12 months'}\n- {'measure': 'Incidence of hospital admissions due to hyperkalemia, fluid overload, lower respiratory tract infection [Safety of the study]', 'description': 'Frequency of hospital admission due to hyperkalemia and fluid overload, and lower respiratory tract infection (LRTI).', 'timeFrame': '12 months'}\n- {'measure': 'Effect size', 'description': 'Rate of change (mean) of RKF in the first 6 months after randomisation.', 'timeFrame': '6 months after randomisation'}\n- {'measure': 'Dialysis dose', 'description': 'Dialysis dose measured by eKT/V', 'timeFrame': '6 months after randomisation'}\n- {'measure': 'Residual kidney function', 'description': 'Residual kidney function measured by eKT/V', 'timeFrame': '6 months after randomisation'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level and power are not explicitly mentioned. Assumes a retention rate of 75% over 6 months and a 40% eligibility rate among the incident HD population.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n Retrospective studies suggest that decline of RKF may be attenuated in patients who receive twice weekly dialysis compared with thrice weekly, and that this effect occurs early such that a difference in RKF at 6 months is likely to be an optimal time point for the basis of a power analysis. Our initial power analysis, based on our own retrospective data,28 indicated an effect size (Cohen\u00e2\u0080\u0099s d) of 0.37 calculated from mean and SD of urea clearance slopes in the first 6 months after HD initiation between two groups of patients, one initiating HD twice weekly and the other thrice weekly. Based on this, the sample size for the proposed definitive RCT would be 180 (90 each arm). If the definitive study were to be carried out using the same four centres, the available incident HD population would be around 600 annually or 1200 over a proposed 2-year recruitment period. We anticipate that 40% of these patients will meet the eligibility criteria, that is, 480 patients. To achieve 180 analysable patients at 6 months following randomisation, we will need to recruit 50% of eligible patients assuming a retention rate of 75% over 6 months.\n This feasibility study will test these assumptions on effect size, the proportion of incident patients who can be prescreened who are eligible to be approached for study consent, the proportion of patients approached for screening who consent, pass formal screening and undergo randomisation (recruitability), and the retention rate during the 6 months after randomisation (retainability). Sample sizes between 24 and 50 have been recommended for feasibility studies.29 30 Initially, we chose a sample size of 50 but, because of a higher than anticipated recovery of renal function in the first few weeks of recruitment, increased this to 54. A sample of this size will enable us to estimate eligibility, recruitability, screen-failure rate and retainabililty rate to within a 95% CI 11% to 14%.", "id": 261, "split": "train"} +{"trial_id": "NCT03418779", "pmid": "31907076", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of End-stage Renal Disease (TCM-WINE)\n\nIncluded conditions:\n- IgA Nephropathy at High Risk of Developing ESRD\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'EXPERIMENTAL', 'description': 'Optimized supportive care, YQF placebo (oral granule), immunosuppression therapy comprises oral prednisolone plus intravenous cyclophosphamide.', 'interventionNames': ['Drug: Immunosuppressants', 'Other: Optimized Supportive Care', 'Other: Yi-Qi-Qing-Jie herbal compound placebo']}\n- {'label': 'YQF Group', 'type': 'EXPERIMENTAL', 'description': 'Optimized supportive care, YQF (oral granule), immunosuppression therapy comprises oral prednisolone plus intravenous cyclophosphamide.', 'interventionNames': ['Drug: The Yi-Qi-Qing-Jie herbal compound', 'Drug: Immunosuppressants', 'Other: Optimized Supportive Care']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'The Yi-Qi-Qing-Jie herbal compound', 'description': 'The compounds are blends of individual herbal extracts from YQF (consisting of Astragalus membranaceus, Saposhnikovia divaricata (turcz.) Schischk, Flos lonicerae, Angelica sinensis, Dioscorea nipponica, Hedyotis diffusa Willd, rhubarb, Spatholobus suberectus, with the effect of reinforcing Qi and activating blood, clearing away heat and poison, dissolving dampness and downbearing turbid) dissolved in 150 ml boiled water and taken orally twice a day for the duration of the treatment and follow-up phases.', 'armGroupLabels': ['YQF Group']}\n- {'type': 'DRUG', 'name': 'Immunosuppressants', 'description': 'Immunosuppression therapy comprises oral prednisolone (0.5-0.8 mg/kg/day; exact dose decided by the investigator, maximum dose not exceeding 60 mg/day) for 8 weeks, then tapered by 5-10 mg/day every 4 weeks, with a total treatment period of 24-32 weeks. Participants with persistent proteinuria \u2265 1 g/day after 8 weeks of corticosteroid monotherapy will receive 0.8-1.0 g of intravenous cyclophosphamide (CTX) every 4 weeks, total dose of not exceeding 8 g (exact dose decided by the site investigator). If severe CTX-related adverse events occur, such as alanine transaminase (ALT) exceeding the upper limit of two times, infections requiring hospitalization, granulocytes \\\\< 3.0 \u00d7 109/L and platelets \\\\< 50.0 \u00d7 109/L, CTX will stop being administered, symptoms will be treated, and adverse events recorded. Also, the frequency of detection will be increased to once every 2 weeks and the affected participant will be withdrawn if persistent infection or myelosuppression occurs.', 'armGroupLabels': ['Control Group', 'YQF Group'], 'otherNames': ['prednisolone', 'cyclophosphamide']}\n- {'type': 'OTHER', 'name': 'Optimized Supportive Care', 'description': 'The optimized supportive care included:\\n\\n1. Lifestyle: low-salt, restricted protein dietary with sufficient calorie supply, smoking cessation, moderate alcohol consumption and keeping a healthy weight\\n2. The use of renin-angiotensin system blockade: lowering blood pressure to a target below 135/85 mmHg, during which treatment was adjusted to ensure that patients were receiving the maximum labelled or tolerated dose of RAS blockade\\n3. Patients with Diabetes Mellitus received insulin or oral hypoglycemic agents to achieve HbA1c\u2264 7.0%\\n4. Received uricosuric agents or xanthine oxidase inhibitors as necessary to achieve serum uric acid \\\\<6 mg/dL in female, \\\\<7 mg/dL in male', 'armGroupLabels': ['Control Group', 'YQF Group']}\n- {'type': 'OTHER', 'name': 'Yi-Qi-Qing-Jie herbal compound placebo', 'description': 'Patients will receive Yi-Qi-Qing-Jie herbal compound placebo instead for the duration of the treatment and follow-up phases. The major component of the placebo is malt dextrin which looks, smells and tastes like YQF compound, and it comes in packaging with a similar appearance to YQF compound; it is also dissolved in 150 ml boiled water and taken orally twice a day.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'First occurrence of 40% decrease in eGFR from baseline', 'timeFrame': 'Baseline, until the first occurrence or 3 years'}\n- {'measure': 'First occurrence of progression to continuous renal replacement', 'timeFrame': 'Until occurrence or 3 years'}\n- {'measure': 'Death due to renal disease', 'timeFrame': 'Until occurrence or 3 years'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is 0.05, the power (1-\u03b2) is 0.9, and the dropout rate is assumed to be 25%.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n On the basis of our recent trial [22], where eGFR slope after 12 months of treatment was the primary endpoint, we define \u00ce\u00b4\u00e2\u0080\u0089=\u00e2\u0080\u0089(\u00ce\u00bc1 \u00e2\u0088\u0092 \u00ce\u00bc2)/\u00cf\u0083, where \u00cf\u0083 is the pooled standard deviation (for sample size calculation, see Additional\u00c2\u00a0file\u00c2\u00a04) and \u00ce\u00bc is the treated mean. We calculate \u00ce\u00b4\u00e2\u0080\u0089=\u00e2\u0080\u00890.994, approximately equivalent to 1.0, according to the look-up table of counts (Medical Statistics Method, PH Jin, Shanghai Medical College Press; Additional\u00c2\u00a0file\u00c2\u00a03), and using \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.1, we require a sample size of 46 participants. Assuming 25% dropout and in view of n\u00e2\u0080\u0089=\u00e2\u0080\u008930 as a rule of thumb for a small size clinical trial, we plan to recruit 60 patients for this study (30 patients per group).", "id": 262, "split": "train"} +{"trial_id": "NCT03423797", "pmid": "29973256", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Biannual Application of Silver Nitrate Solution Followed by Sodium Fluoride Varnish With or Without Functionalized Tricalcium Phosphate in Arresting Caries in Preschool Children\n\nIncluded conditions:\n- Early Childhood Caries\n\nStudy Armgroups:\n- {'label': 'NaF without fTCP', 'type': 'ACTIVE_COMPARATOR', 'description': '25% AgNO3 solution followed by 5% NaF.', 'interventionNames': ['Drug: 25% AgNO3 solution followed by 5% NaF']}\n- {'label': 'NaF with fTCP', 'type': 'EXPERIMENTAL', 'description': '25% AgNO3 solution followed by 5% NaF with fTCP.', 'interventionNames': ['Drug: 25% AgNO3 solution followed by 5% NaF with fTCP']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '25% AgNO3 solution followed by 5% NaF', 'description': 'Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF: 11.6mg (F-)/0.5ml (max dose).', 'armGroupLabels': ['NaF without fTCP'], 'otherNames': ['5% NaF without fTCP']}\n- {'type': 'DRUG', 'name': '25% AgNO3 solution followed by 5% NaF with fTCP', 'description': 'Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF with fTCP: 11.6mg (F-)/0.5ml (max dose).', 'armGroupLabels': ['NaF with fTCP'], 'otherNames': ['5% NaF with fTCP']}\n\nPrimary Outcomes:\n- {'measure': 'The hardness of cavity on tooth by probing', 'description': 'The effectiveness of adjunctive application of 25% AgNO3 solution and 5% NaF varnish with or without fTCP is expected to be equivalent in arresting dentine caries of primary teeth.', 'timeFrame': 'The follow-up oral examinations will be conducted every 6 months for 30 months totally'}\n\nPlease estimate the sample size based on the assumption: \nThe power of the study is set at 90% (\u03b2 = 0.1) and a two-sided 95% confidence interval (\u03b1 = 0.05). The anticipated dropout rate is 15%.", "answer": 408, "answer_type": "ACTUAL", "explanation": "Sample size and power calculation\n The results of previous clinical trials showed that around 70% of the active dentine caries became arrested after 30\u00c2\u00a0months [18]. The anticipated caries-arresting rates of group B would be 80%. An absolute difference of 10% for the caries-arresting rates between treatment groups is considered to be clinically significant. The sample size calculation is based on the expected proportion of caries that become arrested, with the power of the study set at 90% (\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.1) and a two-sided 95% confidence interval (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05) as the statistical significance level by using the G*Power Version 3.1.9.2 (Franz Faul, Universit\u00c3\u00a4t Kiel, Germany). Therefore, at least 820 active carious tooth surfaces need to be included, or 410 in each study group. Based on the results of epidemiological surveys, we anticipate that the mean number of active caries tooth surfaces of 3-year-old children in Hong Kong is approximately three [25]. The intraclass correlation coefficient for dental caries data at the surface level within the individual would be approximately 0.13 [26]. Following the equation for the required sample size in a multilevel study [27], the design effect will be 1.26. Thus, the estimated sample size would be at least 346 children, or 173 per group. The anticipated dropout rate is 15% [24]; thus, 408 children (204 children in each group) will be needed at baseline.", "id": 263, "split": "train"} +{"trial_id": "NCT03424616", "pmid": "30765398", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Deep Brain Stimulation of Nucleus Accumbens for Opioid Relapse Prevention:A Multicenter Randomized Double-Blind Sham-stimulation Controlled Clinical Trial\n\nIncluded conditions:\n- Addiction\n\nStudy Armgroups:\n- {'label': 'Postoperative immediate Deep brain stimulation', 'type': 'EXPERIMENTAL', 'description': 'The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray\u00ae DBS System) was turned on 1-2 weeks postoperatively.', 'interventionNames': ['Device: Suzhou Sceneray\u00ae DBS System']}\n- {'label': 'Postoperative delayed Deep brain stimulation', 'type': 'SHAM_COMPARATOR', 'description': 'The addicts undergone the deep brain stimulation while the stimulation (Suzhou Sceneray\u00ae DBS System) was off until 25 months postoperatively, during which the following up was kept, then the the stimulation was turned on 25 months postoperatively.', 'interventionNames': ['Device: Suzhou Sceneray\u00ae DBS System']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Suzhou Sceneray\u00ae DBS System', 'description': 'We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations.', 'armGroupLabels': ['Postoperative delayed Deep brain stimulation', 'Postoperative immediate Deep brain stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'The abstinent rate at 25 weeks after DBS stimulation on \uff08Urine Tests\uff09', 'description': 'If the participants or their families report no less than 2 times of the drug use in each of two consecutive weeks, or the consecutive 2 times of urine tests showed positive, or lost of follow-up, the case was defined as relapse', 'timeFrame': 'At 25 weeks after DBS stimulation on'}\n\nPlease estimate the sample size based on the assumption: \nA two-sample test with a two-sided significance level of 5%, statistical power of 80%, and a 15% drop-out rate.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n In order that more patients can be allocated to the early stimulation group (receiving \u00e2\u0080\u0098true\u00e2\u0080\u0099 but not \u00e2\u0080\u0098sham\u00e2\u0080\u0099 intervention), which make trial representing more ethical considerations and make recruitment more easier (patients were informed that they have more chance to be allocated into the early stimulation group), the statistical experts decided the sample ratio to be 2:1 for treatment group:control group, which has been applied for most previous similar trials. Calculation of the sample size was further done by statistical experts designated by China Food and Drug Administration that was in charge of the quality control and approval for clinical trials, based on the primary outcome of the abstinence rate reported by previous literatures.24 43 Based on retrospective analysis of our previous data, the abstinence rate from baseline to 25 weeks after DBS surgery was 70% in 11 patients with opioid dependence, and previous studies showed that the abstinence rate of patients with opioid dependence who do not receive any treatment is around 30%.4 5 A two-sample test will be used to determine if the mean of the treatment group (\u00ce\u00bcA) is different from that of the control group (\u00ce\u00bcB). The hypotheses are: H0: \u00ce\u00bcA\u00e2\u0088\u0092\u00ce\u00bcB=0, H1: \u00ce\u00bcA\u00e2\u0088\u0092\u00ce\u00bcB\u00e2\u0089\u00a00. The sample size will be calculated using the PASS V.11 sample size calculation software (NCSS, USA). Based on tests for two means, with a two-sided significance level of 5% and statistical power at 80%, allowing for a 15% drop-out rate, a sample size of 60 patients will be needed to test the hypothesis with the two-sided test. This will consist of 40 patients for the treatment group and 20 patients for the control group.", "id": 264, "split": "train"} +{"trial_id": "NCT03425487", "pmid": "31597650", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services: A Randomized Controlled Trial\n\nIncluded conditions:\n- Anxious-Depressive\n\nStudy Armgroups:\n- {'label': 'MBSR+TAU', 'type': 'EXPERIMENTAL', 'description': 'Mindfulness based Intervention (MBSR) + Usual specialized treatment in mental health. MBSR consists of 8 weekly groupal sessions of 150 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.', 'interventionNames': ['Behavioral: Mindfulness based Intervention']}\n- {'label': 'ABCT+TAU', 'type': 'EXPERIMENTAL', 'description': 'Compassion based Intervention (ABCT) + Usual specialized treatment in mental health. ABCT consists of 8 weekly groupal sessions of 120 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.', 'interventionNames': ['Behavioral: Compassion based Intervention']}\n- {'label': 'TAU', 'type': 'ACTIVE_COMPARATOR', 'description': 'Usual specialized treatment in mental health (psychological or/and psychiatric)', 'interventionNames': ['Other: TAU']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness based Intervention', 'description': 'MBSR consists of 8 weekly groupal sessions of 150 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months', 'armGroupLabels': ['MBSR+TAU']}\n- {'type': 'BEHAVIORAL', 'name': 'Compassion based Intervention', 'description': 'ABCT consists of 8 weekly groupal sessions of 120 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.', 'armGroupLabels': ['ABCT+TAU']}\n- {'type': 'OTHER', 'name': 'TAU', 'description': 'Usual specialized treatment in mental health (psychological or/and psychiatric)', 'armGroupLabels': ['TAU']}\n\nPrimary Outcomes:\n- {'measure': 'Depression Anxiety Stress Scales', 'description': 'In the MBSR based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.', 'timeFrame': 'Baseline'}\n- {'measure': 'Depression Anxiety Stress Scales', 'description': 'In the ABCT based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.', 'timeFrame': 'Baseline'}\n- {'measure': 'Depression Anxiety Stress Scales', 'description': 'In the TAU control group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.', 'timeFrame': 'Baseline'}\n- {'measure': 'Depression Anxiety Stress Scales', 'description': 'In the MBSR based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.', 'timeFrame': 'Post-treatment 8 weeks from baseline in 8 weeks MBSR intervention group'}\n- {'measure': 'Depression Anxiety Stress Scales', 'description': 'In the ABCT based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.', 'timeFrame': 'Post-treatment 8 weeks from baseline in 8 weeks ABCT intervention group'}\n- {'measure': 'Depression Anxiety Stress Scales', 'description': 'In the TAU control group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.', 'timeFrame': 'Post-treatment 8 weeks from baseline in TAU control group'}\n- {'measure': 'Depression Anxiety Stress Scales', 'description': 'In the MBSR based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.', 'timeFrame': 'Six-months follow-up'}\n- {'measure': 'Depression Anxiety Stress Scales', 'description': 'In the ABCT based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.', 'timeFrame': 'Six-months follow-up'}\n- {'measure': 'Depression Anxiety Stress Scales', 'description': 'In the TAU control group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.', 'timeFrame': 'Six-months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, beta risk <0.2 (power of 80%), and a patient attrition rate at follow-up of approximately 15%-20%.", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size\n Sample size has been estimated considering the main hypothesis (\u00e2\u0080\u0098ABCT+TAU\u00e2\u0080\u0099 will be more effective than \u00e2\u0080\u0098MBSR +TAU\u00e2\u0080\u0099 for treating depressive, anxiety or adjustment disorders). There are no references on previous direct comparisons between ABCT and MBSR groups, so we will perform an exploration in this respect. According to the literature and considering the TAU active control comparator used, we assume a large effect of ABCT and a small effect of MBSR in the primary outcome of general affective distress.28 36 51 73 Therefore, with an equal 1:1:1 allocation rate, supposing a large difference between ABCT and MBSR conditions, with an ES of roughly d=0.80, accepting an alpha of 0.05 and a beta risk <0.2 in a bilateral contrast, we will need approximately 75 patients: 25 in the MBSR condition, 25 in the ABCT group and 25 in the TAU condition. Assuming a patient attrition rate at follow-up of approximately 15%\u00e2\u0080\u009320%, the total sample size needed will be established at 90 patients (30 in each group).", "id": 265, "split": "train"} +{"trial_id": "NCT03426137", "pmid": "31719077", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Relieving Acute Pain (RAP): A Pilot Study\n\nIncluded conditions:\n- Trauma\n- Opioid Use\n- Spine Fusion\n\nStudy Armgroups:\n- {'label': 'Full Dose (FD)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the FD arm will receive NSAIDs and Oxycodone (5mg).dosed in accordance with the Guidelines for Use from University of Maryland Shock Trauma Center.', 'interventionNames': ['Drug: Oxycodone', 'Drug: Ketorolac']}\n- {'label': 'PR (Partial Reinforcement)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants in this group will receive NSAIDs, Oxycodone (5mg), and placebo pills to reach a 50% reduction of the total intake of opioids.', 'interventionNames': ['Drug: Oxycodone', 'Drug: Ketorolac', 'Other: Placebo']}\n- {'label': 'C (Control)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants in this group will receive NSAIDs and placebo pills', 'interventionNames': ['Drug: Ketorolac', 'Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oxycodone', 'description': '5mg Oxycodone in oral solution given every 3 hours', 'armGroupLabels': ['Full Dose (FD)', 'PR (Partial Reinforcement)'], 'otherNames': ['Oxycodone Hydrochloride']}\n- {'type': 'DRUG', 'name': 'Ketorolac', 'description': 'toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.', 'armGroupLabels': ['C (Control)', 'Full Dose (FD)', 'PR (Partial Reinforcement)'], 'otherNames': ['Toradol']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet', 'armGroupLabels': ['C (Control)', 'PR (Partial Reinforcement)'], 'otherNames': ['OraSweet']}\n\nPrimary Outcomes:\n- {'measure': 'Pain Self-reports', 'description': 'Collected on a visual analogue scale, with 0 being \"no pain\" and 100 being \"maximum pain tolerable\"', 'timeFrame': 'Day 1-7, Week 2, Months 1, 3 and 6'}\n\nPlease estimate the sample size based on the assumption: \nAlpha set at 0.05, F equal to 3.054, and account for 20% participant withdrawal.", "answer": 3, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n This study will enrol a total of 159 participants with 53 participants assigned to each of the three arms. We predict in the FD group that patients will take a maximum of 90\u00e2\u0080\u0089mg (5\u00e2\u0080\u0089mg every 4\u00e2\u0080\u0089hours for 3\u00e2\u0080\u0089days) and in PR group that patients will take a maximum dose of 45\u00e2\u0080\u0089mg (5\u00e2\u0080\u0089mg every 4\u00e2\u0080\u0089hours for the first 24\u00e2\u0080\u0089hours and then estimated every 6\u00e2\u0080\u0089hours for 2\u00e2\u0080\u0089days) with an overall reduction of opioids in the hospitalisation window of approximately 50%. We expect a small change in pain report (0.25%), and account for 20% participant withdrawal. Therefore, we will need to recruit 159 participants, with 53 participants per group, to achieve a significant difference across groups (alpha set at 0.05 and F equal to 3.054).", "id": 266, "split": "train"} +{"trial_id": "NCT03434314", "pmid": "30837256", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With 'Minimally-Invasive Segmental Artery Coil-Embolization': A Randomized Controlled Multicentre Trial - PAPAartis\n\nIncluded conditions:\n- Aortic Aneurysm, Thoracoabdominal\n\nStudy Armgroups:\n- {'label': 'MISACE arm', 'type': 'EXPERIMENTAL', 'description': 'Minimally-Invasive Segmental Artery Coil-Embolization\\n\\nMISACE procedure prior to aneurysm repair\\n\\nsegmental arteries are occluded with coils or plugs in one to three MISACE sessions (staged procedure)', 'interventionNames': ['Procedure: Minimally-Invasive Segmental Artery Coil-Embolization']}\n- {'label': 'control arm', 'type': 'NO_INTERVENTION', 'description': 'receives treatment of aneurysm as usual: open surgical repair or endovascular repair without MISACE'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Minimally-Invasive Segmental Artery Coil-Embolization', 'description': 'During one single MISACE session 3-7 segmental arteries will be occluded. The procedure is conducted through a peripheral artery access in local anaesthesia. Microcoils or vascular plugs will be used for the occlusion itself.', 'armGroupLabels': ['MISACE arm']}\n\nPrimary Outcomes:\n- {'measure': 'The primary objective is to greatly reduce incidence of ischaemic spinal cord injury and mortality.', 'description': 'Successful treatment of the aneurysm is a binary variable. All of the following criteria must be met for this composite endpoint to count as a success:\\n\\n* The patient is alive and without substantial spinal cord injury 30 days after treatment, and\\n* the aneurysm did not rupture and has been excluded within six months of randomization. Substantial spinal cord injury will be determined with a modified Tarlov scale (see below).', 'timeFrame': '30 days after TAAA repair'}\n\nPlease estimate the sample size based on the assumption: \nGroup-sequential design with two interim analyses, power of just over 87%, very few dropouts expected, and loss to follow-up not expected to be a major factor.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Sample size and recruitment\n Estimates of effect size are difficult for several reasons. Foremost, there are large discrepancies between outcome rates quoted in the literature. Moreover, the impact of recent improvements in techniques on outcomes cannot yet be quantified accurately, and finally, the effect size depends on the improvement due to the trial intervention which, in turn, depends on anatomy, postrepair management and other complex factors. Taking a random effects model of the data from large recent publications for open10 28\u00e2\u0080\u009330 and endovascular repair,31\u00e2\u0080\u009333 one finds an estimated incidence of 18% (95% prediction interval 15% to 23%) for open repair and a very uncertain 24% (2% to 79%) for endovascular repair. The prediction interval as opposed to the CI provides the correct bounds for what can be expected in the trial.34 The resources and time available to the study allow for the recruitment of 500 patients. Assuming success rates of 80% in the control arm and 90% in the intervention arm and using a group-sequential design35 with two interim analyses, this then implies a power of just over 87%.36 The definitions of the primary endpoint and the full analysis set imply that only very few dropouts are to be expected for this analysis and that compliance will not be a problem. The severity of the therapy and recovery times mean that loss to follow-up is not expected to be a major factor.\n The planned recruitment is between 8 and 9 patients per site per year. This is roughly half the number of patients that meet the inclusion criteria. However, slow recruitment plagues many trials and mitigation strategies have already been developed. A list of interested recruitment sites (n>10) is being collected to expand the consortium. Statistical monitoring will be used to identify reasons for screened patients not being included in the trial so that minor and clinically justified amendments to the trial protocol can address these issues, for example, through adjustments to the inclusion and exclusion criteria. Finally, a newsletter including recruitment by site will be distributed at regular intervals to spawn healthy competition among the team members.", "id": 267, "split": "train"} +{"trial_id": "NCT03435809", "pmid": "33737427", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Control Study on the Impact of a Pozzi Tenaculum Forceps Use on the Success Rate of Intrauterine Insemination (IUI)\n\nIncluded conditions:\n- Infertility\n- Insemination\n\nStudy Armgroups:\n- {'label': 'Pozzi for intrauterine insemination', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treatment done with a pozzi tenaculum forceps', 'interventionNames': ['Procedure: Intrauterine insemination']}\n- {'label': 'No Pozzi for intrauterine insemination', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treatment done without a tenaculum forceps', 'interventionNames': ['Procedure: Intrauterine insemination']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Intrauterine insemination', 'description': 'Obligatory use of a Pozzi forceps tenaculum during intrauterine insemination', 'armGroupLabels': ['No Pozzi for intrauterine insemination', 'Pozzi for intrauterine insemination']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of live births', 'description': 'Live born delivery resulting from an intrauterine insemination cycle', 'timeFrame': '10 months after positive pregnancy test'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05, power of 63% for 400 cases and 80% for 800 cases using Fisher's exact test; power of 43% for 400 cases and 80% for 800 cases using GEE logistic model; 1-3 cycles of inseminations; bootstrap resampling with 1000 samples; SAS V.9.4 used for estimation", "answer": 800, "answer_type": "ESTIMATED", "explanation": "Sample size\n The total sample of 400 cases at the time of the interim analysis provides 63% power of Fisher\u00e2\u0080\u0099s exact test to detect 17.7% of pregnancy following the use of Pozzi forceps compared with 10.7% of pregnancy without the use of forceps. The same estimation with 800 cases provides 80% of the power. All power was estimated using GPower V.3.1 with a significance level of 0.05.\n To estimate the power of a generalised estimating equation (GEE) logistic model that takes into account 1\u00e2\u0080\u00933 cycles of inseminations, a sample of 400 simulated cases was created with a 17.7% pregnancy prevalence following the use of Pozzi forceps and 10.7% prevalence of pregnancy without the use of Pozzi forceps. A total of 1000 samples were resampled using bootstrap unrestricted random sampling from the simulated database. The power of the GEE logistics model was 43% for a total sample of 400 cases. The same procedure for a total sample of 800 cases provides 80% power for GEE logistic regression model. All estimation was done using SAS V.9.4.\n Finally, this sample size estimation (\u00e2\u0089\u00a5180 cases by group) is in agreement with the recommendations of Rochon for GEE logistic regression with three repeated measurements (new).10", "id": 268, "split": "train"} +{"trial_id": "NCT03436290", "pmid": "31829237", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Surgery for Cancer With Option of Palliative Care Expert: A Randomized Trial of an Early Palliative Care Intervention for Patients Undergoing Surgery for Cancer\n\nIncluded conditions:\n- Cancer\n\nStudy Armgroups:\n- {'label': 'Palliative Care Intervention', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: Palliative Care Intervention']}\n- {'label': 'Standard of Care', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Palliative Care Intervention', 'description': 'These patients will receive the palliative care intervention.', 'armGroupLabels': ['Palliative Care Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Physical and Functional Quality of Life as Measured by the FACT-G TOI', 'description': 'FACT-Gastric Trial Outcome Index (TOI) is an efficient summary index of physical/functional outcomes and is comprised of two subscales from the FACT-Gastric Score: the physical wellbeing subscale (7 questions) and the functional wellbeing scale (7 questions). Each question uses a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Total scores on the FACT-TOI range from 0-56. The higher the score, the better the quality of life.', 'timeFrame': '90 days after operation'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate of 5%, common standard deviation of 9 in FACT-G TOI score and 18.1 in FACT-G total score, 80% power, 20% loss to follow-up, normal distribution for primary outcome, two-sample t test.", "answer": 236, "answer_type": "ACTUAL", "explanation": "Sample size calculation and statistical analysis\n Previous studies have demonstrated a moderate effect (effect size approximately\u00e2\u0080\u00890.4) of early palliative care on TOI, the primary outcome of the SCOPE Trial [1]. Assuming a type I error rate of 5% and a common standard deviation of 9 in the FACT-G TOI score and 18.1 in the FACT-G total score in each group [12], enrolling 98 participants in each group (total N\u00e2\u0080\u0089=\u00e2\u0080\u0089196) would provide at least 80% power to detect a change of 3.6 points for TOI and 7.24 for total FACT-G (an effect size of 0.4). Minimally important difference for the total FACT-G is estimated to be 3\u00e2\u0080\u00937 points and 2\u00e2\u0080\u00933 points for each subscale [12], so the trial should be adequately powered to detect a clinically meaningful difference. The sample size computations were performed assuming a normal distribution for the primary outcome and using two-sample t test. Allowing for 20% loss to follow-up (we expect mortality to be very low at 90 days), we plan to enroll 236 patients to ensure an adequately powered study. Based on the mix of malignancies included in the study, we expect median survival to be approximately 36\u00e2\u0080\u0089months, so a substantial portion of patients should be alive at later time points, which will enable exploratory analyses with the long-term outcomes.\n Closer to the completion of the trial, the investigators and biostatisticians will develop a comprehensive statistical analysis plan (SAP) that will be made publicly available and will be time-stamped. The SAP will describe the analytic strategies used for the study and any prespecified subgroup analyses. The SAP will be completed while the biostatisticians remain blinded to the participants\u00e2\u0080\u0099 group assignment, and any subsequent changes will be publicly noted to have occurred after the blind was broken. In developing our SAP, we will be ready to adopt novel statistical methods that are developed while the trial is ongoing. In what follows, we present a tentative outline for the approach that we will develop in detail in the SAP.\n The demographic and clinical characteristics of patients will be described using descriptive statistics. For continuous variables, median and interquartile range will be used while categorical variables will be described using frequency (percentage).\n For our primary analysis, we will perform multivariable regression to adjust for a priori-selected potential confounders, including age, frailty, cancer type, insurance status, education level, and degree of religious involvement. We will choose the type of multiple regression by carefully examining the distribution of the data. In the case of non-normally distributed outcomes, we will use a multivariable proportional odds regression model. For normally distributed outcomes, a linear regression model will be used. Cox proportional hazards regression will be used to analyze the adjusted effect of intervention on time-to-event outcomes such as survival, with censoring as appropriate based on the outcome and time point (for instance, the analysis of overall survival at 1 year will have censoring at 1 year for patients who have not died).\n For all primary analyses, we will adhere to intention-to-treat principles. Missing data will be imputed using standard model-based imputation methods, i.e., regression imputation where a model is fitted on the observed data and subsequently used to generate imputations for the missing values. Imputation of data will only be performed for baseline characteristics and not for outcomes, and the covariates will include only those obtained at baseline. The SAP will provide further details on the plans for missing data imputation. Non-linear effects of continuous variables will be fit using restricted cubic splines, and modern regression model building techniques will be used [23]. For long-term outcomes, missing data are common due to death and loss to follow-up. We will deal with this potential bias by estimating the principal stratum causal effect (i.e., survivor average causal effect) defined as the average causal effect among participants who would survive under either treatment [24]. Since the analysis of survivors with assessments may be susceptible to survivor bias, we will use an unadjusted composite endpoint approach as described by Lachin [25], where the composite endpoint will be defined as days between surgery and death if the patient dies prior to assessment, but if the patient survives and is successfully assessed, the outcome will be days between surgery and the assessment plus the assessment score. All covariates included in the adjusted models will be selected a priori and the model complexity will be based on the general rule that a model must fit no more than m/10 parameters to allow for proper multivariable analysis and to be generalizable to future patients, where m is the effective sample size [23].\n Graphical techniques will be used to perform model diagnostics and evaluate assumptions. Multicollinearity will be assessed using variance inflation factors and in the event of highly collinear variables, principal component analysis will be used. All models will be validated using the bootstrap internal validation approach and the cross-validation approach. No adjustment will be made for multiple comparisons when examining secondary a priori-defined outcomes [26, 27]. Caution will be exercised in the interpretation of results by noting the number of nominally significant tests that would be expected to occur by chance alone [28].\n Secondary and subgroup analyses will be prespecified and fully described in the SAP, and at the time of drafting it we will conduct a further review of the literatureto determine which prespecified subgroups are important to study. To alleviate issues caused by multiple testing, our planned subgroup analysis will purely be exploratory in nature and used to inform the design of future studies. Caution will be exercised in the interpretation of results by noting the number of nominally significant tests that would be expected to occur by chance alone [28]. P values will not be provided, instead effect sizes will be quantified, and confidence intervals will be provided. Results of subgroup analysis will be graphically illustrated. Currently, we plan to conduct exploratory analyses of the interaction of baseline age, frailty, and cognitive impairment with group assignment because older patients or those with frailty or cognitive impairment may be at increased risk for adverse outcomes and therefore more likely to benefit from the intervention. Such results could inform the design of future studies. Since the control group may receive additional palliative care consults at providers\u00e2\u0080\u0099 discretion and some patients in the intervention group may receive fewer visits than others due to missed appointments, palliative care consults for both groups will be monitored and described. Additionally, sensitivity analysis will be considered where dose of palliative care (i.e., number of visits/telephone calls completed) will be considered as an interaction term with treatment group. In these sensitivity analyses, palliative care will be included as a time-varying covariate. The details of these sensitivity analyses will be described in the SAP.", "id": 269, "split": "train"} +{"trial_id": "NCT03437148", "pmid": "31133575", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Shunt Quantification in Atrial Septal Defect Using Inert Gas Rebreathing and Thoracic Bioimpedance: Comparison With the Gold Standard Method\n\nIncluded conditions:\n- Congenital Heart Diseases\n- Hemodynamic\n- Cardiac Output\n\nStudy Armgroups:\n- {'label': 'patients with Atrial septal defect type Ostium Secundum', 'type': 'EXPERIMENTAL', 'description': 'patients with Atrial septal defect type Ostium Secundum, eligible for an interventional closure', 'interventionNames': ['Device: Innocor\u00ae', 'Device: Physioflow\u00ae']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Innocor\u00ae', 'description': 'Inert gas rebreathing device: Innocor\u00ae (Innovision, Odense, Denmark)', 'armGroupLabels': ['patients with Atrial septal defect type Ostium Secundum']}\n- {'type': 'DEVICE', 'name': 'Physioflow\u00ae', 'description': 'Bioimpedance cardiograph: Physioflow\u00ae (Manatec, France)', 'armGroupLabels': ['patients with Atrial septal defect type Ostium Secundum']}\n\nPrimary Outcomes:\n- {'measure': 'shunt fraction', 'description': 'Accuracy of Qp/Qs ratio measurements by the double non-invasive technique and the gold standard method (non-invasive: Echocardiography Doppler; invasive: direct Fick method) before interventional closure of ASD', 'timeFrame': 'at 1 hour'}\n\nPlease estimate the sample size based on the assumption: \npower of 90%, two-sided type I error at 5%, sequential exploratory analysis every 10 patients without correction of type I error", "answer": 10, "answer_type": "ACTUAL", "explanation": "Estimation of sample size\n To evaluate the agreement between the double non-invasive approach and the gold standard technique, a sample size of 30 subjects would provide a power of 90% to highlight an agreement of 0.8 (Lin\u00e2\u0080\u0099s concordance coefficient) for a two-sided type I error at 5%. A sequential exploratory analysis will be proposed each 10 patients without correction of type I error.", "id": 270, "split": "train"} +{"trial_id": "NCT03438526", "pmid": "32354780", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Better Outcome With Melatonin Compared to Placebo Administered to Normalize Sleep-wake Cycle and Treat Hypoactive ICU Delirium The Basel BOMP-AID Randomized Trial\n\nIncluded conditions:\n- Hypoactive Delirium\n\nStudy Armgroups:\n- {'label': 'Melatonin (Circadin \u00ae)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Melatonin (Circadin \u00ae)']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Melatonin (Circadin \u00ae)', 'description': '4 mg of oral melatonin at 8 p.m. for the length of the duration of the hypoactive delirium', 'armGroupLabels': ['Melatonin (Circadin \u00ae)']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Lactose monohydrate, cellulose powder, magnesium stearate (Ph. Eur.), mocrocristalline cellulose', 'armGroupLabels': ['Placebo'], 'otherNames': ['Oral tablet']}\n\nPrimary Outcomes:\n- {'measure': 'Duration of hypoactive delirium', 'description': 'Duration of hypoactive delirium in the ICU in 8-hour shifts', 'timeFrame': 'From study inclusion to delirium resolution, assessed daily until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 28 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) is 5%. Power (1-beta) is 90%. Dropout rate is 5%. A Wilcoxon rank-sum test was used for statistical testing.", "answer": 190, "answer_type": "ESTIMATED", "explanation": "Determination of sample size\n Sample size was estimated to be able to show the superiority of melatonin compared with placebo regarding the duration of delirium (in number of shifts).\n The sample size calculation was based on an expected duration of delirium of 15 shifts (5 days) for patients treated with placebo (in line with \u00ef\u00ac\u0081ndings of Page et al,28 a reduction of the duration of delirium by \u00ce\u00b4=3 shifts (1\u00e2\u0080\u0089day), and an SD in both arms of 6 shifts (2 days).\n Sample size was calculated with a resampling method. Each sample size, ni=1,\u00e2\u0080\u00a6,49=10,\u00e2\u0080\u00a6, 298, was evaluated by sampling 999 times ni/2 individual patients from a normal distribution with a mean of 15 (placebo arm) and ni/2 with a mean of 12 (melatonin arm), both with an SD of 6. In addition, different effect sizes for melatonin versus placebo, ranging from 1 to 6 shifts were applied to assess the sensitivity of the sample size with regard to the expected effect size. Because the number of shifts can only be positive negative simulated values (which rarely occurred) were replaced by zero. A Wilcoxon rank-sum test was used to test for a difference between trial arms. Sample size was set to ensure at least 90% power (1\u00e2\u0080\u0093\u00ce\u00b2=0.9) at a signi\u00ef\u00ac\u0081cance level of 5% (\u00ce\u00b1=0.05).\n For this study, assuming a difference in duration of delirium of 3 shifts and a SD of 6 shifts, 190 patients should be recruited to ensure 180 evaluable patients, considering a dropout rate of 5%. Figure 1 shows the sensitivity of the sample size is with respect to the expected effect size.\n \n Figure 1\n \n Total sample size (number of patients, not including dropouts) needed to be able to show the superiority of melatonin to placebo with respect to delirium duration (number of shifts), assuming an SD of 6 shifts, depending on the expected effect size. The numbers on the curves show the corresponding power. An example is shown for an effect size of 3 shifts and a power of 90%. The curves are smoothed and for illustration only.", "id": 271, "split": "train"} +{"trial_id": "NCT03440346", "pmid": "31694844", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Biomarker Research in ADHD: the Impact of Nutrition (BRAIN). An Open-label Trial to Investigate the Mechanisms Underlying the Effects of a Few-foods Diet on ADHD Symptoms in Children\n\nIncluded conditions:\n- Attention Deficit-Hyperactivity Disorder\n\nStudy Armgroups:\n- {'label': 'Few-foods diet intervention', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Few-foods diet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Few-foods diet', 'description': \"The few-foods diet (FFD) is followed for 5-weeks preceded by a 1-week transition period during which the child's eating pattern will be gradually adjusted. The diet consists of rice, meat (turkey and lamb), a range of vegetables, pear, rice milk with added calcium and water, and is complemented with foods such as potatoes, fruits, corn, some sweets and wheat, which are allowed in small quantities only. Normal quantities of vegetables, rice and meat are allowed every day. If necessary the diet will be adjusted to avoid foods that the child dislikes or has cravings for. If the child does not respond to the initial FFD, i.e. no change in behaviour after the first two weeks, interim adjustments to the FFD will be made in consultation with the parents.\", 'armGroupLabels': ['Few-foods diet intervention'], 'otherNames': ['Restricted Elimination Diet']}\n\nPrimary Outcomes:\n- {'measure': 'Change in neural activation patterns during execution of tasks', 'description': 'Using fMRI, blood oxygen-level-dependent (BOLD) signal changes will be measured whilst performing cognitive tasks that assess inhibitory control and selective attention, i.e. a stop-signal task (response inhibition) and a Flanker task (response conflict and associated error monitoring). fMRI BOLD responses will be assessed between variable task-elements and performance. Region of interest (ROI; anatomically defined regions in the brain) analyses of the BOLD responses will be performed.', 'timeFrame': 'Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)'}\n- {'measure': 'Change in peripheral blood metabolite concentrations', 'description': 'Global metabolite profiles will be examined in plasma (or alternatively serum) obtained from whole blood using mass-spectrometry profiling. Phenylalanine and tyrosine plasma levels represent primary outcomes.', 'timeFrame': 'Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)'}\n- {'measure': 'Change in functional composition of the gut microbiota', 'description': 'Metagenome profiling will be performed on stool samples, leveraging Illumina next-generation sequencing technology. Sequence read data will be used for abundance profiling of microbiota genes that encode enzymes directly involved in the production or degradation of the dopamine and noradrenaline precursors phenylalanine and tyrosine.', 'timeFrame': 'Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)'}\n- {'measure': 'Change in ADHD symptom scores', 'description': 'ADHD symptoms will be scored using the 18-item ADHD rating scale, which is based on the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV and consists of 9 items that assess inattention and 9 items that focus on hyperactivity and impulsivity.', 'timeFrame': 'Before and at the end of the FFD intervention (i.e. at the end of week 2 and at the end of week 8)'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to achieve at least 80% power with a Bonferroni-adjusted error probability of 0.002 (0.05/25) and an outcome allocation ratio of 2.2. Sample size calculations were conducted using t statistics and comparing two-sample independent means (two-tailed).", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n This study aims to assess the effects of an FFD on brain and MGB axis parameters in relation to ADHD symptoms. FFD responders are defined as children showing at least 40% reduction on the ARS at T2, compared with T1.26 It is assumed that 55% of the children will respond to the FFD, 25% will not respond to the FFD (nresponder/nnon-responder=2.2), and 20% will drop out.26\n\n To our best knowledge, no studies have been published that were conducted on a cohort of ADHD patients and that investigated the effect of an FFD on the brain and MGB axis parameters in relation to ADHD symptoms. Consequently, due to the lack of data on the amplitude and variability in MGB axis parameters induced by an FFD, it is not straightforward to estimate the required sample size to obtain adequate levels of statistical power. Therefore, we based our sample size estimates for primary study outcome parameters on publicly available datasets serving as a proxy for the expected differences and variation.\n Sample size calculations were conducted in G*Power87 (V.3.1.9.2), using t statistics and comparing two-sample independent means (two tailed). To have a sufficient likelihood of detecting a difference between FFD responders and non-responders for the primary study outcomes, we aim to achieve at least 80% power with a Bonferroni-adjusted error probability of 0.002 (0.05/25) and an outcome allocation ratio (nresponder/nnon-responder) of 2.2. Based on the sample size estimates per outcome variable, as specified below, we will include 100 participants. Of note, this sample size calculation is conservative, since it is based on a simple Student\u00e2\u0080\u0099s t-test comparing the primary measurements between responders and non-responders. The actual analysis (eg, multiple linear regression analysis) will most likely provide additional power.\n \n \n Neural activation: In a study on striatal activation during task performance in boys with ADHD (n=10; 8\u00e2\u0080\u009313\u00e2\u0080\u0089years) and healthy controls (n=6; 8\u00e2\u0080\u009312\u00e2\u0080\u0089years), activation was higher in controls than in boys with ADHD (Cohen\u00e2\u0080\u0099s d: 1.33\u00c2\u00b10.13).88 The required sample size to detect this difference in striatal activation is 46 (nresponder=32; nnon-responder=14). We expect a comparable difference between FFD responders and non-responders, as the response to the FFD can be to such extent, that responders no longer meet the criteria for ADHD.26\n\n \n \n Phenylalanine and tyrosine plasma levels: In a study on the effect of a diet intervention trial in 66 healthy adults (31 male and 35 female; 18\u00e2\u0080\u009370\u00e2\u0080\u0089years), baseline plasma metabolites were used to predict outcome (liver dysfunction or no dysfunction; Cohen\u00e2\u0080\u0099s d: 1.03\u00c2\u00b10.24).89 The required sample size to detect these differences in metabolites is 74 (nresponder=51\u00e2\u0080\u0089and nnon-responder=23).\n \n \n Gene abundance in stool microbiota related to phenylalanine and tyrosine metabolism: As no suitable, publicly available dataset was present at the time of writing this protocol, it was anticipated that gene abundance differences between FFD responders and non-responders will be 25%, with a variance of 25% (Cohen\u00e2\u0080\u0099s d: 1.00\u00c2\u00b10.25). To detect this difference, a sample size of 70 is required (nresponder=48\u00e2\u0080\u0089and nnon-responder=22).", "id": 272, "split": "train"} +{"trial_id": "NCT03440606", "pmid": "31287010", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Development and Evaluation of a Novel Mindful-Compassion Art Therapy (MCAT) Supervision for Self-Care and Collegial Support Among End-of-Life Care Professionals in Singapore\n\nIncluded conditions:\n- End-of-life Care\n\nStudy Armgroups:\n- {'label': 'MCAT Supervision Group', 'type': 'EXPERIMENTAL', 'description': 'The 6-week 3-hour Mindful-Compassion Art Therapy (MCAT) supervision will include intervention elements of brief psycho-education, weekly mindfulness mediation that serve as a foundation to foster creative art making, reflective writing, group sharing and discussion.', 'interventionNames': ['Behavioral: Mindful-Compassion Art Therapy Supervision']}\n- {'label': 'Waitlist Control Group', 'type': 'EXPERIMENTAL', 'description': 'Those assigned to the waitlist control group will not receive Mindful-Compassion Art Therapy (MCAT) supervision until approximately 1.5 month later; equivalent intervention and assessment procedures will be administered.', 'interventionNames': ['Behavioral: Mindful-Compassion Art Therapy Supervision']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindful-Compassion Art Therapy Supervision', 'description': 'Each \"Mindful-Compassion Art Therapy Supervision\" group will focus on 3 major areas that cultivate self-care, resilience and communal support. The specific structure include: (1) Self-care and Stress Management in Week 1 and 2 (i.e., concept of mindfulness and art, the symbol of the mandala and its use in self-care, mindfulness practice and art); (2) Sharing of Clinical Expertise and Experiences in Week 3 and 4 (i.e., Create mindful art about one meaningful and one challenging patient/client interaction with small group discussion); and (3) Understanding Grief and Meaning-Making in Week 5 and 6 (i.e., Create mindful art representing a clinical encounter of mortality, and meaning-making from reflection on grief).', 'armGroupLabels': ['MCAT Supervision Group', 'Waitlist Control Group']}\n\nPrimary Outcomes:\n- {'measure': \"Change from Baseline 'Maslach Burnout Inventory- General Survey (MBI-GS)' at immediate after intervention [T2] and 4 weeks follow-up [T3].\", 'description': 'This tool measures changes in level of burnout.', 'timeFrame': 'It will be assessed at baseline [T1], immediately after intervention [T2], and four weeks post intervention [T3].'}\n\nPlease estimate the sample size based on the assumption: \n15% attrition rate, 80% power, 5% significance level, two-tailed test", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Given an attrition rate of 15% at follow-ups, a sample of 60 (N = 60) will provide 80% power to detect an effect size of 0.8 (referencing highly effective psychotherapy studies) [31] on the primary outcome measure of the Maslach Burnout Inventory\u00e2\u0080\u0093General Survey (MBI-GS) [4] between the intervention and control groups at a (two-tailed test) 5% level of significance.", "id": 273, "split": "train"} +{"trial_id": "NCT03444103", "pmid": "30635033", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety, Tolerability and Efficacy of Anti-IL-6 Antibody Clazakizumab in Late Antibody-Mediated Rejection After Kidney Transplantation - a Pilot Trial\n\nIncluded conditions:\n- Antibody-mediated Rejection\n\nStudy Armgroups:\n- {'label': 'Clazakizumab / Clazakizumab', 'type': 'ACTIVE_COMPARATOR', 'description': 'Monthly subcutaneous injections of 25mg clazakizumab for three months (after completion of part A, monthly injection of 25mg clazakizumab for nine months).', 'interventionNames': ['Drug: Clazakizumab / Clazakizumab']}\n- {'label': 'Placebo / Clazakizumab', 'type': 'PLACEBO_COMPARATOR', 'description': 'Monthly subcutaneous injections of placebo (saline) for three months (after completion of part A, monthly injection of 25mg clazakizumab for nine months).', 'interventionNames': ['Drug: Placebo / Clazakizumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Clazakizumab / Clazakizumab', 'description': 'Humanized monoclonal anti-IL-6 antibody', 'armGroupLabels': ['Clazakizumab / Clazakizumab'], 'otherNames': ['Anti-IL-6 antibody']}\n- {'type': 'DRUG', 'name': 'Placebo / Clazakizumab', 'description': '0.9% Saline', 'armGroupLabels': ['Placebo / Clazakizumab'], 'otherNames': ['Saline']}\n\nPrimary Outcomes:\n- {'measure': \"Number of adverse events and severe adverse events (AE's, SAE's)\", 'description': 'Serious and Non-Serious adverse events probably or possibly attributable to clazakizumab', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe primary endpoint will be safety and tolerability. Preliminary assessment of efficacy outcomes will be conducted.", "answer": 20, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n For this pilot study, no exact sample size estimation has been performed, because the effect size is unknown (there is no prior information to base a sample size on). The primary endpoint will be safety and tolerability. A preliminary assessment of efficacy outcomes in 20 kidney transplant recipients with late ABMR will provide first data on the effect of clazakizumab on clinical, morphological, immunological, and molecular endpoints. The respective results (e.g. comparison between clazakizumab and placebo with respect to microcirculation inflammation and molecular rejection scores), including an assessment of variability, can be expected to provide a valuable foundation of the design of future trials.", "id": 274, "split": "train"} +{"trial_id": "NCT03444896", "pmid": "31601583", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy and Neural Mechanism of Acupuncture Treatment in Older Adults With Subjective Cognitive Decline: a Randomized Controlled Trial\n\nIncluded conditions:\n- Subjective Cognitive Decline\n- Subjective Cognitive Complaint\n\nStudy Armgroups:\n- {'label': 'Acupuncture group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Acupuncture group']}\n- {'label': 'Sham acupuncture group', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Device: Sham acupuncture group']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Acupuncture group', 'description': 'Acupuncture needles were placed at acupoints Baihui (DU20), Shenting (DU24), Fengfu (DU16), Fengchi (GB20), Danzhong (RN17), Zhongwan (RN12), Qihai (RN6), Neiguan (PC6), Zusanli (ST36), Xuehai (SP10), Xinshu (BL15), Yixi (BL45), Tongli (HT5), and Zhaohai(KI6). Electrodes were attached the needle holders of the Baihui (DU20) and Shenting (DU24). The acupuncture needles are inserted through the adhesive pads and are retained for 20 minutes in every course. Treatment will be conducted over a period of 3 months, at a frequency of two times per week.', 'armGroupLabels': ['Acupuncture group']}\n- {'type': 'DEVICE', 'name': 'Sham acupuncture group', 'description': 'Sham acupoint (SA) 1 located in the midpoint of Shuaigu and Touwei. SA2 located in the midpoint of Touwei and Yangbai. SA3 located in the midpoint of Tianyou and Tianrong. SA4 located in 4 cun above umbilicus and 1 cun right of umbilical midline (UM). SA5 located in 2 cun below umbilicus and 1 cun right of UM. SA6 1 cun outside the point 1/4 of the line between Shenmen and Shaohai. SA7 located in 1 cun outside the midpoint of Shaohai and Tongli. SA8 located in 6 cun above mediosuperior border of the patella. SA9 located in 3 cun below the Yanglingquan and middle of the gallbladder and bladder channels. SA10 located in midpoint between Jiexi and Qiuxu. SA11 and SA12 located in 2 cun from the lower border of spinous process of fifth or sixth thoracic vertebra. Electrodes were attached the needle holders of the bilateral SA 2. Procedures, and other treatment settings were the same in the acupuncture group but with no skin penetration, electricity output, or needle manipulation for de qi.', 'armGroupLabels': ['Sham acupuncture group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in cognitive function', 'description': 'A composite score will be computed by averaging z-scores from Animal Fluency Test, Digit Symbol Substitution Test, Trail-Making Test Parts A and B, Stroop Color Word Test C, Digit Span Test, Boston Naming Test, Clock Drawing Test and Auditory Verbal Learning Test delayed recall and delayed recognition.', 'timeFrame': 'Changes from baseline at 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level (alpha) of 0.05 for single voxel level, stricter alpha of 0.000002, type I error of alpha=0.005, estimated dropout rate and loss of data due to head motion.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size and blinding\n Task fMRI studies characteristically include small sample size41 and thus have a low statistical power. The statistically underpowered study by definition means that a study will have less of a chance for detecting significant effects.42 Therefore, power-based sample size will be calculated prior to fMRI data collection.43 Fortunately, approaches for sample size calculations in studies using fMRI have been developed.\n By using the non-central random field theory, Hayasaka et al estimated that at least 12 subjects would be required to detect signals in either of the auditory cortices with at least 80% power.44 They also found that approximately 13 subjects would be required to detect signals in the auditory cortices with 80% power, when generated a sample size map based on the mock pilot analysis.44 Adopting a simulation-based method to calculate statistical power for group-level fMRI studies, Desmond and Glover found a minimum of 12 subjects are required to achieve 80% power at \u00ce\u00b1=0.05 at the single voxel level.45 For a more realistic threshold, twice as many subjects are recommended to maintain this level of power after correcting for multiple comparisons. For a stricter alpha of 0.000002, approximately 25 subjects are needed. Mumford and Nichols recommended 20 subjects and a type I error of \u00ce\u00b1=0.005 should probably be used, and this power calculation is based on a non-central T or F distribution.46 We used the largest sample size of 25 for each group with an estimated dropout rate and loss of data due to head motion, then we planned to enrol 60 participants in the two groups.\n Eligible patients will be randomly assigned into either the acupuncture or sham acupuncture group after signing written informed consent forms via a randomisation digital table with a 1:1 ratio. Blocked randomisation with a block size of 6 will be employed to ensure balance within the two groups. The randomisation sequence will be generated by a third-party professional statistician using computer-generated randomisation digital table by using SAS V.9.2 (SAS Institute). The randomisation list will be stored by a non-involved investigator and out of reach and sight of the involved investigators. The allocation schedule will be using a telephone randomisation procedure. The randomisation list was restricted to this research coordinator and was concealed from other study personnel. The patients, outcome assessors and statisticians will be blinded to treatment allocation. Patients are told that they will receive one of two effective interventions randomised after enrolment. During the acupuncture treatment, the adhesive pads are pasted on the acupoints or sham acupoints after skin disinfection. The true or sham needles with a blunt tip will be placed in the adhesive pads. Patients in different groups will be assigned into separate cubicles to refrain from communication.", "id": 275, "split": "train"} +{"trial_id": "NCT03445039", "pmid": "30217227", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Evaluation of Modified Transalveolar Sinus Floor Elevation and Osteotome Sinus Floor Elevation in Posterior Maxillae\n\nIncluded conditions:\n- Dental Implant\n- Sinus Floor Augmentation\n\nStudy Armgroups:\n- {'label': 'TSFE using osteotomes with bone grafting', 'type': 'EXPERIMENTAL', 'description': 'The patients in this group will receive transalveolar sinus floor elevation with osteotomes and mallet. The bone substitute is placed in this group.The interventions in the arm are bone grafting and the TSFE will be performed by osteotomes.', 'interventionNames': ['Device: traditional TSFE', 'Procedure: bone grafting materials']}\n- {'label': 'TSFE using osteotomes without bone grafting', 'type': 'EXPERIMENTAL', 'description': 'The patients in this group will receive transalveolar sinus floor elevation with osteotomes and mallet. The bone substitute will not be placed in this group.The intervention in the arm is the TSFE will be performed by osteotomes.', 'interventionNames': ['Device: traditional TSFE', 'Procedure: without bone grafting materials']}\n- {'label': 'modified TSFE with bone grafting', 'type': 'EXPERIMENTAL', 'description': 'The patients in this group will receive modified transalveolar sinus floor elevation with the Dask drills. The cortical plate of the sinus floor is grinded or removed by the dome like drills. And the membrane is elevated by the surgical instruments. The bone substitute is placed before the implant placement.Interventions in the arm are bone grafting and the TSFE will be performed by dask drills.', 'interventionNames': ['Procedure: bone grafting materials', 'Device: TSFE by DASK drills']}\n- {'label': 'modified TSFE without bone grafting', 'type': 'EXPERIMENTAL', 'description': 'The patients in this group will receive modified transalveolar sinus floor elevation with the Dask drills. The cortical plate of the sinus floor is grinded or removed by the dome like drills. And the membrane is elevated by the surgical instruments. The bone substitute will not be placed in this group.The intervention in the arm is the TSFE will be performed by dask drills.', 'interventionNames': ['Device: TSFE by DASK drills', 'Procedure: without bone grafting materials']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'traditional TSFE', 'description': 'The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.', 'armGroupLabels': ['TSFE using osteotomes with bone grafting', 'TSFE using osteotomes without bone grafting']}\n- {'type': 'PROCEDURE', 'name': 'bone grafting materials', 'description': 'The bone substitute is placed into the siuns under the membrane before the implant placement', 'armGroupLabels': ['TSFE using osteotomes with bone grafting', 'modified TSFE with bone grafting']}\n- {'type': 'DEVICE', 'name': 'TSFE by DASK drills', 'description': 'The TSFE procedure is performed by DASK(Dentium Advanced Surgical Kits) drills (Dentium, Korea), the residual cortical plate of the sinus floor is grinded by the drills.', 'armGroupLabels': ['modified TSFE with bone grafting', 'modified TSFE without bone grafting']}\n- {'type': 'PROCEDURE', 'name': 'without bone grafting materials', 'description': 'The bone substitute will not be placed into the sinus before the implant placement.', 'armGroupLabels': ['TSFE using osteotomes without bone grafting', 'modified TSFE without bone grafting']}\n\nPrimary Outcomes:\n- {'measure': 'implant survival rate', 'description': 'whether the implant has osseointegrated and functional', 'timeFrame': 'the implant status will be inspected and calculated at 1 year revisit'}\n- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '2 weeks after implant placement'}\n- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '4 weeks after the implant placement'}\n- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '8 weeks after the implant placement'}\n- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '12 weeks after the implant placement'}\n- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '16 weeks after the implant placement'}\n- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '26 weeks after the implant placement'}\n- {'measure': 'implant stability', 'description': 'the implant stability is gauged by the RFA( resonance frequency analysis)', 'timeFrame': '52 weeks after the implant placement'}\n- {'measure': 'marginal bone remodeling around the implant', 'description': 'use CBCT to access the marginal bone changes between the 26 weeks after the implant placement and baseline (the day the implant is placed).', 'timeFrame': '26 weeks after the implant placement'}\n- {'measure': 'marginal bone remodeling around the implant', 'description': 'use CBCT to access the marginal bone changes between the 52 weeks after the implant placement and baseline (the day the implant is placed).', 'timeFrame': '52 weeks after the implant placement'}\n- {'measure': 'post operative pain accessed by the patient', 'description': 'The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No pain\" and \"worst imaginable pain\". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '1 day after the surgery'}\n- {'measure': 'post operative pain accessed by the patient', 'description': 'The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No pain\" and \"worst imaginable pain\". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '2 days after the surgery'}\n- {'measure': 'post operative pain accessed by the patient', 'description': 'The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No pain\" and \"worst imaginable pain\". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '3 days after the surgery'}\n- {'measure': 'post operative pain accessed by the patient', 'description': 'The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No pain\" and \"worst imaginable pain\". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '4 days after the surgery'}\n- {'measure': 'post operative pain accessed by the patient', 'description': 'The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No pain\" and \"worst imaginable pain\". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '5 days after the surgery'}\n- {'measure': 'post operative pain accessed by the patient', 'description': 'The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No pain\" and \"worst imaginable pain\". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '6 days after the surgery'}\n- {'measure': 'post operative pain accessed by the patient', 'description': 'The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No pain\" and \"worst imaginable pain\". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '7 days after the surgery'}\n- {'measure': 'post operative pain accessed by the patient', 'description': 'The post operative pain is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No pain\" and \"worst imaginable pain\". The patient will mark on the line to represent their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no pain\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '14 days after the surgery'}\n- {'measure': 'post operative swelling accessed by the patient', 'description': 'The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No swelling\" and \"worst imaginable swelling\". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no swelling\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '1 day after the surgery'}\n- {'measure': 'post operative swelling accessed by the patient', 'description': 'The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No swelling\" and \"worst imaginable swelling\". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no swelling\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '2 days after the surgery'}\n- {'measure': 'post operative swelling accessed by the patient', 'description': 'The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No swelling\" and \"worst imaginable swelling\". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no swelling\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '3 days after the surgery'}\n- {'measure': 'post operative swelling accessed by the patient', 'description': 'The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No swelling\" and \"worst imaginable swelling\". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no swelling\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '4 days after the surgery'}\n- {'measure': 'post operative swelling accessed by the patient', 'description': 'The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No swelling\" and \"worst imaginable swelling\". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no swelling\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '5 days after the surgery'}\n- {'measure': 'post operative swelling accessed by the patient', 'description': 'The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No swelling\" and \"worst imaginable swelling\". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no swelling\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '6 days after the surgery'}\n- {'measure': 'post operative swelling accessed by the patient', 'description': 'The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No swelling\" and \"worst imaginable swelling\". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no swelling\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '7 days after the surgery'}\n- {'measure': 'post operative swelling accessed by the patient', 'description': 'The post operative swelling is access by the patient via visual analog scales. The VAS questionnaire consists a 100mm long and two anchors, one at each end. The anchors are verbal \"No swelling\" and \"worst imaginable swelling\". The patient will mark on the line to represent their swelling intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the \"no swelling\" anchor and the patient\\'s mark, providing a range of scores from 0-100.', 'timeFrame': '14 days after the surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is set at 0.05, the power of the test (\u03b2) is set at 90%, and the loss to follow-up rate is around 10%.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size of the current trial is calculated based on the formula: n = 2(t\u00ce\u00b1 + t1-\u00ce\u00b2)2\u00cf\u00832/\u00ce\u00b42. According to the preliminary experiment results and data analysis from currently published articles, the difference of the bone remodeling with and without bone grafting groups (\u00ce\u00b4) is around 0.8 mm, the difference of the bone remodeling between the original TSFE groups and modified TSFE groups is around 0.5 mm, and the standard deviation in groups (\u00cf\u0083) is around 1 mm.\n Thus, if the inspection level (\u00ce\u00b1) is set at 0.05 and the power of test (\u00ce\u00b2) is set at 90%, then 27 participants will be required for each group. Given a loss to follow-up rate of around 10%, the study would be anticipated to require 30 participants for each group. As a result, this trial will require at least 120 participants in its current setup.", "id": 276, "split": "train"} +{"trial_id": "NCT03445182", "pmid": "31270121", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of DentalVibe Comfort System in Reducing Injection Pain and Anxiety During Local Anaesthesia in Paediatric Patients\n\nIncluded conditions:\n- Pain Management\n- Local Anaesthesia\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Local anaesthesia with conventional syringe', 'interventionNames': ['Procedure: Local anaesthesia with conventional syringe']}\n- {'label': 'DentalVibe group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Local anaesthesia with conventional syringe + DentalVibe', 'interventionNames': ['Device: Local anaesthesia with conventional syringe + Dentalvibe']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Local anaesthesia with conventional syringe', 'description': 'Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.\\n\\nLocal anaesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL', 'armGroupLabels': ['Control group']}\n- {'type': 'DEVICE', 'name': 'Local anaesthesia with conventional syringe + Dentalvibe', 'description': 'Buccal infiltration in posterior maxillary region. The tip of the DentalVibe device is placed in the mucobuccal fold above the tooth to be anesthetized. The device is activated for 5 s. A 27 gauge short needle is inserted as close as possible to the inner side of the prong while the vibration is still on.\\n\\nLocal anaesthetic infiltration speed 1ml/min. After injection the needle is withdrawn and vibration continues for another 5 s.\\n\\nDrug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL', 'armGroupLabels': ['DentalVibe group']}\n\nPrimary Outcomes:\n- {'measure': 'Pain felt during injection using visual analogue scale', 'description': \"Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.\", 'timeFrame': 'Immediately after local anaesthetic delivery'}\n\nPlease estimate the sample size based on the assumption: \nThe error was set at 5% (significance level) and the power test at 95%. A dropout rate of 10% was anticipated.", "answer": 41, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Given the lack of fully comparable research and the unknown population SD, we conducted a pretest with 20 subjects and considered the behaviour of this subgroup as population estimate. To estimate sample size for the primary outcome\u00e2\u0080\u0094self-reported pain felt during injection, according to the VAS\u00e2\u0080\u0094we applied a t-test for paired groups (G* Power software V.3.1,6 since we have two groups (primary molar in the\u00c2\u00a0right and left quadrants of upper jaw) on the same patient.\n The effect size was determined using the formula\n \nES=Control\u00e2\u0088\u0092TreatedSDpooled=2.33\u00e2\u0088\u00920.333.25=0.62,\n where SD is the pooled SD,\u00c2\u00a0an average of the SD of the experimental and control groups. The error was set at 5% and the power test at 95%. According to the calculation, a sample of 37 patients will be necessary to detect differences in pain. Since dropouts are unavoidable when collecting follow-up data, this number needs to be adjusted for the estimated dropout rate. During the pretest, we had a dropout rate of 5% for collecting the follow-up data, and if we anticipated a higher dropout rate for this study, we conservatively allowed for a 10% dropout rate. Adjusting the sample size for this dropout rate results in a sample of 41 patients needing to be recruited.", "id": 277, "split": "train"} +{"trial_id": "NCT03449316", "pmid": "30696670", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Inhaler Technique Education in Elderly Patients With Asthma or COPD: Impact on Disease Exacerbations - a Protocol for a Single-blinded Randomised Controlled Trial\n\nIncluded conditions:\n- Asthma\n- COPD\n\nStudy Armgroups:\n- {'label': 'Inhaler technique education', 'type': 'EXPERIMENTAL', 'description': 'This group will receive a structured and regular follow-up plan, with education on inhaler technique. Patients will be trained by a Family Doctor (the primary investigator) in terms of the inhaler technique using placebo devices similar to their own devices. A teach-to-goal approach will be used, repeating all correct steps as many times as needed in order for patients to perform them correctly at each evaluation. There will be visits at baseline and after 3, 6 and 12 months to assess outcomes. In each visit, and prior to the main intervention with the primary investigator, assessment of the inhaler technique and application of all questionnaires (clinical control, treatment adhesion and quality of life) will be performed by a secondary blinded investigator.', 'interventionNames': ['Behavioral: Inhaler technique education']}\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'This group will receive usual care from their own Family doctors, with no specific intervention. Each doctor will perform the necessary consultations according to his real life judgment. Besides this, this group will perform visits at baseline and after 3, 6 and 12 months to assess secondary outcomes. At each visit, assessment of the inhaler technique and application of all questionnaires (clinical control, treatment adhesion and quality of life) will be performed by a secondary blinded investigator. At any appointment, if the patient asks for or if the clinician decides to teach inhaler technique, that will be recorded.\\n\\nIf any adjustments are made in drug classes or device types in every participants, this information will be recorded.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Inhaler technique education', 'description': 'Teaching of inhalers use with placebo devices in real training', 'armGroupLabels': ['Inhaler technique education']}\n\nPrimary Outcomes:\n- {'measure': 'Adverse events', 'description': 'This outcome will be quantifyed as \"time to event\"\\n\\nFor Asthma, an event will be defined as increased respiratory clinical symptoms leading the patient to search for medical care, and resulting in any of the following:\\n\\n* Need for increased inhaled corticosteroid dose of at least 4x the regular dose\\n* Need for increase of short-acting \u03b22 agonists on a daily basis\\n* Need for oral corticosteroids\\n* Need for oral antibiotics\\n* Hospitalization or Emergency Room (ER) visit with increased respiratory clinical symptoms.\\n\\nFor COPD, an event will be defined as increased respiratory clinical symptoms inducing the patient to search for medical care, and resulting in any of the following:\\n\\n* Need for increase of long-acting \u03b22 agonists on a daily basis\\n* Need for oral corticosteroids\\n* Need for oral antibiotics\\n* Hospitalization or ER visit with increased respiratory clinical symptoms. Respiratory-related mortality and all-cause mortality will also be considered an adverse event.', 'timeFrame': 'Evaluation at 12 months.'}\n\nPlease estimate the sample size based on the assumption: \n95% CI, power of 80%, alpha level of 5%, ratio of cases/controls of 1:1, and 20% loss rate", "answer": 146, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size was estimated using the \u00cf\u0087\u00c2\u00b2 independent group proportions approach of STATA Statistical Package, considering the event proportion in control group of 50% (0.5 annual rate) as reported in other previous studies21 22 44 and estimating a reduction of event rate in the intervention group to 25% (0.25 annual rate) as reported in similar studies. A 95% CI, with \u00ce\u00b2 value (power) of 80%, an alpha level of 5% and a ratio of cases/controls of 1:1 were established. Finally, the sample size was readjusted upward, considering an estimated proportion of full compliance of the study of 80% (20% losses). The estimated sample size was 116, readjusted to a total of 146 individuals (73 in each arm).", "id": 278, "split": "train"} +{"trial_id": "NCT03455608", "pmid": "34645411", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PRO-ACTIVE: Comparing The Effectiveness of Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer\n\nIncluded conditions:\n- Dysphagia\n\nStudy Armgroups:\n- {'label': 'RE-ACTIVE', 'type': 'ACTIVE_COMPARATOR', 'description': 'Reactive intervention started promptly if/when dysphagia is identified (RE-ACTIVE)', 'interventionNames': ['Behavioral: RE-ACTIVE']}\n- {'label': 'PRO-ACTIVE EAT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Early low intensity proactive intervention started before RT commences', 'interventionNames': ['Behavioral: PRO-ACTIVE EAT']}\n- {'label': 'PRO-ACTIVE EAT + EXERCISE', 'type': 'ACTIVE_COMPARATOR', 'description': 'Early high intensity proactive intervention started before RT commences', 'interventionNames': ['Behavioral: PRO-ACTIVE EAT + EXERCISE']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'RE-ACTIVE', 'description': 'Reactive intervention started promptly if/when dysphagia is identified', 'armGroupLabels': ['RE-ACTIVE']}\n- {'type': 'BEHAVIORAL', 'name': 'PRO-ACTIVE EAT', 'description': 'Early low intensity proactive intervention started before RT commences', 'armGroupLabels': ['PRO-ACTIVE EAT']}\n- {'type': 'BEHAVIORAL', 'name': 'PRO-ACTIVE EAT + EXERCISE', 'description': 'Early high intensity proactive intervention started before RT commences', 'armGroupLabels': ['PRO-ACTIVE EAT + EXERCISE']}\n\nPrimary Outcomes:\n- {'measure': 'Duration of feeding tube dependence', 'description': 'Effectiveness will be measured based on duration of feeding tube dependency (count of days from end of radiotherapy to last feeding tube use within the 12-month study period)', 'timeFrame': 'Baseline - 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe type 1 error probability is set at 0.05 (two-sided) for all comparisons. The power is set at 80% for detecting the specified effect sizes. The attrition factor is set at 5% for the primary endpoint and feeding tube dependence at 3-months, and 26% for secondary analyses requiring clinical visits and survey responses.", "answer": 952, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Sample size calculations, based on a 2-sample t-test, assume 952 patients enrolled with 1:4 allocation to RE-ACTIVE (Arm 1, n\u00c2\u00a0=\u00e2\u0080\u0089190) and PRO-ACTIVE arms (Arms 2 and 3, n\u00c2\u00a0=\u00e2\u0080\u0089381 per group). The attrition factor is set at 5% because the primary endpoint can be ascertained without clinical encounter. Thus, the resultant sample size estimated is 180 in Arm 1, 361 in Arm 2, and 361 in Arm 3. For the primary comparison (Hyp 1.1) of Arm 1 (n\u00c2\u00a0=\u00e2\u0080\u0089180) versus the combined Arms 2 and 3 (n\u00c2\u00a0=\u00e2\u0080\u0089722), assuming ITT analysis with type 1 error probability of 0.05 (two-sided) yields 80% power to detect a small effect size of .23 SD for duration of feeding tube use. For the analysis of Hyp 1.2 in the gate-keeper approach, we will compare intensity of PRO-ACTIVE therapies (Arm 2 versus Arm 3, n\u00c2\u00a0=\u00e2\u0080\u0089361 per group), assuming type 1 error probability of 0.05 (two-sided), we have 80% power to detect again a small effect size of 0.21 SD for the primary endpoint of feeding tube duration. We expect the t-test will not be sufficient as the primary analysis given it does not allow for covariate adjustment. Therefore, we will apply the multiple linear regression model as the primary analysis for Aim 1. The power calculation conducted assuming t-tests for analysis of hypotheses 1.1 and 1.2 and deriving a sample of 952 patients remain sufficient for the linear model because by adjusting for variables associated with the mean response, the distribution of the residuals is expected to improve. Therefore, the power for the same hypothesized difference in the primary outcome attributed to treatment in the regression framework will be at least as much as for that for the t-test.\n For the secondary analysis (Aim 2) in the gate-keeper approach, we will compare intensity of PRO-ACTIVE therapies (Arm 2 versus Arm 3, n\u00c2\u00a0=\u00e2\u0080\u0089361 per group), assuming type 1 error probability of 0.05 (two-sided), we have 80% power to detect again a small effect size of 0.24 SD for PROs and VFS measures. The attrition factor for the secondary analysis is set at 26% because they are more prone to attrition due to required clinical visits and survey responses required from participants. As an exception, feeding tube dependence at 3-months uses an attrition factor of 5%, for the same rationale as the primary endpoint.", "id": 279, "split": "train"} +{"trial_id": "NCT03463772", "pmid": "32295778", "question": "Here is the design of a clinical trial:\n\nOfficial Title: In Vitro Maturation Versus Standard in Vitro Fertilization in Infertile Patients Diagnosed With Polycystic Ovaries Syndrome: a Study Protocol for a Single-center Prospective, Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- PCOS\n\nStudy Armgroups:\n- {'label': 'standard IVF', 'type': 'ACTIVE_COMPARATOR', 'description': 'On the Day2/3 of the menstrual cycle, qualified participants will be randomized into either of two groups. Participants in group A will receive standard IVF procedure. Other standard assisted reproductive treatments are similar and parallel between two groups.', 'interventionNames': ['Procedure: standard IVF']}\n- {'label': 'In vitro maturation', 'type': 'ACTIVE_COMPARATOR', 'description': 'On the Day2/3 of the menstrual cycle, qualified participants will be randomized into either of two groups. Participants in group B will receive IVM procedure.Other standard assisted reproductive treatments are similar and parallel between two groups.', 'interventionNames': ['Drug: In vitro maturation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'standard IVF', 'description': 'Ovarian stimulation will be performed by a standard protocol using gonadotrophin-releasing hormone antagonist (GnRH-ant) in association with recombinant FSH (rFSH) and human chorionic gonadotrophin (hCG).Oocyte retrieval is scheduled for 36 (\u00b12) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be inseminated using ICSI or conventional IVF according to the seman analysis. All embryos will be cultured to blastocyst stage and be vitrified.', 'armGroupLabels': ['standard IVF']}\n- {'type': 'DRUG', 'name': 'In vitro maturation', 'description': 'Controlled ovarian stimulation protocol will not performed in this group patients. Transvaginal ultrasound scanning was examined on natural cycle to monitor the follicle size in group B participants. Oocyte retrieval was scheduled once the endometrium had reached at least 6 mm in thickness and there was no follicle larger than 10 mm. After oocyte retrieval, the COCs will be cultured for 28-32h in special IVM media in order to get the matured oocytes. All the metaphase II (MII) oocytes were inseminated by means of intracytoplasmic sperm injection (ICSI). All embryos will be cultured to blastocyst stage and be vitrified.', 'armGroupLabels': ['In vitro maturation'], 'otherNames': ['IVM']}\n\nPrimary Outcomes:\n- {'measure': 'the proportion of ongoing pregnancy leading to live birth', 'description': 'number of ongoing pregnancy leading to live birth resulting from the first oocyte retrieval cycle after the randomization ( 6 month) divided by the number of patients with oocyte retrieval', 'timeFrame': 'after 22 weeks of gestation'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, one-sided significance level (\u03b1) of 0.025, and a dropout rate of 10%.", "answer": 350, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The primary hypothesis of this study is that the experimental group (IVM) is non-inferior to the control group (IVF) in terms of ongoing pregnancy leading to live birth. On the basis of actual data on the women with PCOS who underwent IVM or IVF-ET in our reproductive medicine centre, we assume that after IVF the proportions of ongoing pregnancy leading to live birth for the PCOS women are 35% per transferred cycle.22 23 With a non-inferiority margin of 15%, power of 80% and one-sided \u00ce\u00b1 0.025, we will need to enrol 159 participants in each group (the ratio between groups will be 1:1). Taking consideration of dropout rate as 10% (such as cancellation during trial procedures), each group will include 175 participants (a total of 350 participants).", "id": 280, "split": "train"} +{"trial_id": "NCT03469726", "pmid": "32778061", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Diagnostic Accuracy of Contrast-enhanced Diffusion-weighted MRI for Liver Metastases of Pancreatic Cancer: Towards Adequate Staging and Follow-up of Pancreatic Cancer\n\nIncluded conditions:\n- Pancreatic Neoplasms\n\nStudy Armgroups:\n- {'label': 'Patients with (suspected) PDAC', 'type': 'OTHER', 'description': 'Patients with (suspected) pancreatic cancer will undergo additional Contrast-enhanced Diffusion-weighted MRI (CE-DW-MRI) within two weeks from the CECT.\\n\\nSuspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months.', 'interventionNames': ['Diagnostic Test: Contrast-enhanced Diffusion-weighted MRI']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Contrast-enhanced Diffusion-weighted MRI', 'description': 'An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values', 'armGroupLabels': ['Patients with (suspected) PDAC']}\n\nPrimary Outcomes:\n- {'measure': 'Diagnostic accuracy of CE-DW-MRI', 'description': 'Sensitivity and Specificity of CE-DW-MRI for the detection of liver metastases in patients with pancreatic cancer compared to CECT.', 'timeFrame': 'Baseline'}\n\nPlease estimate the sample size based on the assumption: \nConfidence interval of 95% (Z = 1.96), \u03b1 = 0.05, expected percentage of patients with liver metastases is approximately 40%, and an expected inclusion rate of 80% (assuming 20% dropout rate).", "answer": 465, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size for the study was calculated for the primary endpoint (sensitivity and specificity of MRI for the detection of liver metastases).\n The sample size is calculated based on a method for power calculations for diagnostic studies described by Jones et al. [30]. Based on literature and our previously performed retrospective study [9, 31\u00e2\u0080\u009335] we estimate the sensitivity of MRI will be approximately 90%. In literature the specificity for MRI is usually higher than the sensitivity, therefore we based our sample size calculation on the sensitivity only. With an expected sensitivity of 90%, confidence interval of 95% (Z\u00e2\u0080\u0089=\u00e2\u0080\u00891.96) and \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, 138 patients with metastasis are required for analysis. Based on literature the expected percentage of patients with liver metastases is approximately 40% [3, 36]. With an expected inclusion rate of 80% (assuming 20% cannot be analyzed optimally, e.g. because no representative liver biopsies could be acquired, mortality before first follow-up or withdrawal) we need approximately 433 patients. In case the proportion of patients with metastases is not equal to 40% in our cohort, we will include until we reach 138 patients with liver metastasis or up to a maximum total of 465 patients.", "id": 281, "split": "train"} +{"trial_id": "NCT03471247", "pmid": "37355270", "question": "Here is the design of a clinical trial:\n\nOfficial Title: CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients\n\nIncluded conditions:\n- Intensive Care Unit Acquired Weakness\n- Critical Care\n- Mechanical Ventilation\n- Respiratory Failure\n\nStudy Armgroups:\n- {'label': 'In-Bed Cycle Ergometer + Routine PT', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive 30 minutes of in-bed cycling once per day, 5 days per week, while they remain in the ICU, for up to a maximum of 28 days. They will also receive routine physiotherapy.', 'interventionNames': ['Device: In-Bed Cycle Ergometer', 'Other: Routine PT']}\n- {'label': 'Routine PT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive routine physiotherapy interventions per current institutional practice', 'interventionNames': ['Other: Routine PT']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'In-Bed Cycle Ergometer', 'description': \"Physiotherapists will place the patient's legs in a specialized in-bed cycle ergometer allowing for gentle leg exercise. Exercise can performed in passive, active-assisted, or active mode.\", 'armGroupLabels': ['In-Bed Cycle Ergometer + Routine PT'], 'otherNames': ['Restorative Therapies RT300 Supine']}\n- {'type': 'OTHER', 'name': 'Routine PT', 'description': \"Includes, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out- of bed mobility, ambulation, and assistance with optimizing airway clearance and respiratory function.\", 'armGroupLabels': ['In-Bed Cycle Ergometer + Routine PT', 'Routine PT']}\n\nPrimary Outcomes:\n- {'measure': 'Physical Function Test for ICU-scored (PFIT-s)', 'description': 'Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function.', 'timeFrame': '3 days after ICU discharge'}\n\nPlease estimate the sample size based on the assumption: \nBased on a SD of 2.5 points at ICU discharge, 90% power, 0.05 significance level, 25% ICU mortality, 1% mortality in the first 3 days post-ICU discharge, 5% missed primary outcome assessments at 3 days post-ICU, and 5% unblinded assessments.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size of 360 patients (180 patients per group) is based on identifying a 1.0 point mean difference between the Cycling and Routine groups for the PFIT-s 3\u00e2\u0080\u0089days after ICU discharge,49 corresponding to the minimal clinically important difference identified in psychometric studies.31 50 By logistic regression, the analysis of patients enrolled in two of our previous pilot studies identified that each 1.0 point increase in PFIT-s at ICU discharge was associated with a 40% reduction in the composite outcome of death, readmission to ICU or need for paid assistance after hospital discharge.49 Based on a SD of 2.5 points at ICU discharge,15 51 a 1.0-point difference between groups31 49 50 and 90% power (0.05 \u00ce\u00b1), we need to randomise and analyse 266 patients (133 per group). Based on pilot data, we anticipate 25% ICU mortality and 1% mortality in the first 3\u00e2\u0080\u0089days post-ICU discharge. Among ICU survivors, we anticipate 5% missed primary outcome assessments at 3\u00e2\u0080\u0089days post-ICU, and 5% unblinded assessments; thus, we will recruit 360 patients overall.", "id": 282, "split": "train"} +{"trial_id": "NCT03471858", "pmid": "31699720", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MEchanical DIlatation of the Cervix in a Scarred Uterus (MEDICS)\n\nIncluded conditions:\n- Pregnancy Related\n- Labor Complication\n- Cesarean Section; Dehiscence\n\nStudy Armgroups:\n- {'label': 'Cervical Balloon', 'type': 'ACTIVE_COMPARATOR', 'description': 'Transcervical 2-way 18 French (18F) single balloon Foley catheter, applied using a sponge-holding forceps into the cervical canal with the balloon inflated to a minimum of 30ml and maximum of 60ml with sterile water or saline \\\\[1\\\\]. This will be administered once during the study and will be retained for a maximum of 12 hours within the 24 hour study period.', 'interventionNames': ['Device: Cervical balloon']}\n- {'label': 'Prostaglandin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Prostaglandin E2 (Prostin\u00ae) 3mg tablet, placed high in the vaginal fornix. This will be administered per vaginum once in the first 6 hours; a second dose is administered at the discretion of the clinician / clinical team 6 hours after the first pessary, for a cumulative total of 6mg within the 24 hour study period.', 'interventionNames': ['Drug: Prostaglandins']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Cervical balloon', 'description': 'To assess if a cervical balloon catheter (foleys catheter) for mechanical induction of labour is comparable to prostaglandin usage for induction of labour in women who have had a previous caesarean section.', 'armGroupLabels': ['Cervical Balloon'], 'otherNames': ['Foley Balloon Catheter']}\n- {'type': 'DRUG', 'name': 'Prostaglandins', 'description': 'Prostin will be used in the control arm.', 'armGroupLabels': ['Prostaglandin'], 'otherNames': ['Prostin']}\n\nPrimary Outcomes:\n- {'measure': 'Improvement in Bishops score', 'description': 'Assess for increase in Bishops score from baseline of \\\\<5 (Unfavourable) to \\\\>6', 'timeFrame': '24hours'}\n\nPlease estimate the sample size based on the assumption: \nUsing \u03b1=0.05 and 80% power, with an anticipated attrition rate of 20%.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Statistical analysis plan and sample size estimation\n We deliver ~4000 pregnancies annually, of which 10%\u00e2\u0080\u009315% are of patients with a single previous CS. Of these, ~60% attempt TOLAC (20 per month) and 20%\u00e2\u0080\u009325% undergo IOL (5 per month). At our centre, the current VBAC success rate is ~40%\u00e2\u0080\u009355%, with the remaining patients undergoing emergency CS. The variance applied to our population is derived from a retrospective cohort study from Hong Kong using the DBC in 24 women with one previous CS in which the median improvement in BS was 3 units with an IQR of 2.50 Assuming a normal distribution we derive a variability of \u00ce\u00b4=1.5. Postulating that the difference in modified BS between the two groups at 12\u00e2\u0080\u009324\u00e2\u0080\u0089hours is 1 point with a range of 2\u00e2\u0080\u00938 points (SD=1.5),64 using \u00ce\u00b1=0.05% and 80% power we calculate that we require 40 patients in each arm. Anticipating an attrition rate of 20%, a total of 100 subjects will be randomised equally into the two groups. A general linear model will be used to compare numerical outcome variables between both groups, while Poisson regression will be used to compare binary outcomes and derive relative estimates. All analyses will be performed using SPSS V.25.0 and GraphPad Prism V.6.07.", "id": 283, "split": "train"} +{"trial_id": "NCT03473821", "pmid": "34674738", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Motor Imagery to Facilitate Sensorimotor Relearning (MOTIFS) After ACL Injury: A Randomized Controlled Trial\n\nIncluded conditions:\n- Anterior Cruciate Ligament Injury\n\nStudy Armgroups:\n- {'label': 'Neuromuscular Training', 'type': 'NO_INTERVENTION', 'description': 'Participants in this group will undergo rehabilitation for ACL injury consisting of neuromuscular training according to care-as-usual treatment common to physical therapy professionals.'}\n- {'label': 'MOTIFS', 'type': 'EXPERIMENTAL', 'description': 'Participants in this group will receive an intervention that has been developed according to our new training model, known as MOTor Imagery to Facilitate Sensorimotor re-learning (MOTIFS). In this intervention, patients will receive a neuromuscular training rehabilitation program with integrated dynamic motor imagery.', 'interventionNames': ['Behavioral: MOTIFS']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'MOTIFS', 'description': 'o MOTor Imagery to Facilitate Sensorimotor re-learning (MOTIFS) is an individualized and physical activity-specific integrated model that includes aspects of both neuromuscular training, as used in rehabilitation practices, and Dynamic Motor Imagery (DMI). DMI is a form of mental training in which the participant images him-/herself performing a task from a first-person perspective in order to maximize functional equivalence to the task in question. This includes dynamic, physical movement, as well as mental imaging. The intervention provides a framework for designing individualized, physical activity-specific rehabilitation exercises for knee-injured people.', 'armGroupLabels': ['MOTIFS'], 'otherNames': ['Neuromuscular Training Plus Mental Training', 'Train the Brain Model']}\n\nPrimary Outcomes:\n- {'measure': 'Side Hop', 'description': 'Change in hop performance on the injured leg from baseline to 12 weeks, expressed in number of hops completed', 'timeFrame': '12 weeks'}\n- {'measure': 'Anterior Cruciate Ligament Return to Sport After Injury Scale', 'description': '12 question self-reported outcome scale measuring readiness to return to sport. Scale ranges from 0-10 for each question. Scores summed from 0 (worst) - 100 (best).', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level set at p<0.025, power of 0.80, and an estimated 20% drop-out rate. Adjustments for clustering effects using observed within- and between-cluster variance to more accurately estimate ICC.", "answer": 106, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on previous studies examining ACL-RSI [49] and side-hop function [50], a preliminary sample size was estimated, to be used in the first phase of this adaptive RCT, which resulted in n=106 participants. This included adjustments for potential cluster effects using a preliminary Intra-Cluster Correlation Coefficient (ICC). An approximation is required as comparable studies are unavailable to reliably perform a sample size estimation. This is necessary in this phase in order to evaluate whether an intervention effect is detectable and within practical limitations, which will thereafter inform more accurate sample-size estimations.\n A new sample size will be calculated by a blinded third-party member of the data management committee using collected data from an interim analysis, therefore allowing for more accurate between-group differences in the main outcomes. Observed within- and between-cluster variance will also be calculated in order to more accurately estimate an Intra-Cluster Correlation Coefficient (ICC, denoted as \u00cf\u0081). This will be performed using the formula \\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ \\rho =\\frac{s_b^2}{s_b^2+{s}_w^2} $$\\end{document}\u00cf\u0081=sb2sb2+sw2 [51] in order to adjust for the fact that different clinics are included in the trial (i.e., potential clustering effects). The adjusted sample size will therefore be calculated using the formula \\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ \\frac{n_ik\\left(1-\\rho \\right)}{k-{n}_i\\rho } $$\\end{document}nik1\u00e2\u0088\u0092\u00cf\u0081k\u00e2\u0088\u0092ni\u00cf\u0081 [52], along with an estimated 20% drop-out rate, in order to reach a power of 0.80, with significance set at p<0.025. As an estimated sample size has been calculated, the new sample size will only be adjusted up; that is, the number of participants included will not be less than n=106 required in the original sample-size estimation.", "id": 284, "split": "train"} +{"trial_id": "NCT03477344", "pmid": "35396310", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dexmedetomidine After Cardiac Surgery for Prevention of Delirium: The Exactum Study a Randomised Double Blind Controlled Trial\n\nIncluded conditions:\n- ICU Delirium\n\nStudy Armgroups:\n- {'label': 'Dexm\u00e9d\u00e9tomidine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment.', 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'Sodium Chloride 0,9%', 'type': 'PLACEBO_COMPARATOR', 'description': 'Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group.', 'interventionNames': ['Drug: Sodium chloride 0.9%']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment.', 'armGroupLabels': ['Dexm\u00e9d\u00e9tomidine']}\n- {'type': 'DRUG', 'name': 'Sodium chloride 0.9%', 'description': 'Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group.', 'armGroupLabels': ['Sodium Chloride 0,9%']}\n\nPrimary Outcomes:\n- {'measure': 'Delirium', 'description': 'Occurrence of delirium diagnosed by the Confusion Assessment Method (CAM ICU) at any time in the first seven days after surgery', 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided alpha=0.05, 90% power, and a 5% loss-to-follow-up rate.", "answer": 348, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n In three randomised controlled trials on postoperative delirium in elderly patients undergoing cardiac surgery, delirium incidence varied from 13.7% to 34.0%.18\u00e2\u0080\u009320 Based on this literature, we hypothesised a delirium incidence of 25% in the population studied. In two of the three studies, the magnitude of the treatment effect was a 50% decrease of postoperative delirium and subsyndromal delirium.18 19 Therefore, a 50% decrease in incidence of delirium was chosen to remain in line with the previous publications. Using a one-sided alpha=0.05% and 90% power, a sample size of 332 is needed. Considering a loss-to-follow-up rate of 5%, we plan to enrol 348 patients.\n A one-sided alpha was chosen because no publication reported any worsening of the patient\u00e2\u0080\u0099s outcome compared with placebo. A two-sided alpha estimate is more robust but requires a bigger sample size.", "id": 285, "split": "train"} +{"trial_id": "NCT03477890", "pmid": "31911341", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Angina in Patients Without Obstructive Coronary Disease As Revealed by CT Coronary Angiography (Cor-CTCA): an Observational Cohort Study Involving Coronary Function Tests and a Nested Randomised Trial\n\nIncluded conditions:\n- Angina, Stable\n- Angina Pectoris, Variant\n- Microvascular Angina\n\nStudy Armgroups:\n- {'label': 'Intervention group (coronary function test results disclosed)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Coronary function tests are measured and disclosed to the clinician for re-evaluation of the initial diagnosis and treatment as compared with initial angiography. The intervention involves measurement of FFR, CFR, IMR and RRR in a major coronary artery followed by reactivity testing using incremental doses of acetylcholine (10-4 Molar (M), 10-5 M, 10-6 M) to assess endothelial function, bolus of ACh (10-4 M; 100 micrograms) for vasospasm, followed by glyceryl trinitrate (300 micrograms). FFR will be measured in all arteries with a diameter \\\\>=2.5 mm and a stenosis 40% to 90% in severity. Endotypes are based on criteria for abnormal coronary vasodilator function, vasospasm and microvascular resistance. The endotypes (diagnostic strata) are: obstructive CAD, vasospastic angina, microvascular angina, mixed (ie both vasospastic and microvascular disorders), endothelial dysfunction (no angina), normal (non-cardiac). A diagnosis may be ruled-in or ruled-out based on the test results.', 'interventionNames': ['Diagnostic Test: Stratified medicine involving a diagnostic intervention']}\n- {'label': 'Usual care group (coronary function results not disclosed)', 'type': 'SHAM_COMPARATOR', 'description': 'Coronary function tests are measured but not disclosed to the attending clinician or the participant. The same coronary function tests are undertaken as in the intervention group. Masking is achieved by obscuring the catheter laboratory monitors from the attending clinician and participant. The effectiveness of masking and protocol adherence is prospectively monitored.', 'interventionNames': ['Diagnostic Test: Stratified medicine involving a diagnostic intervention']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Stratified medicine involving a diagnostic intervention', 'description': 'Adjunctive tests of coronary artery lesion severity (fractional flow reserve) and function at the time of invasive coronary angiography. Diagnostic groups: stable coronary syndromes in patients with obstructive coronary artery disease (mis-classified by non-invasive CTCA) or no-obstructive coronary disease including the following sub-groups (coronary artery vasospasm, microvascular spasm, impaired vasorelaxation due to (1) endothelial dysfunction and/or (2) non-endothelial dysfunction, or unaffected (normal test results).\\n\\nMedical management is linked to contemporary clinical guidelines for the management of patients with stable coronary artery disease (European Society of Cardiology (2013), Scottish Intercollegiate Guideline Network (SIGN), 2017).', 'armGroupLabels': ['Intervention group (coronary function test results disclosed)'], 'otherNames': ['Adjunctive tests of coronary disease severity and function (disclosed)']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Stratified medicine involving a diagnostic intervention', 'description': 'Adjunctive tests of coronary artery lesion severity (fractional flow reserve) and function at the time of invasive coronary angiography. Diagnostic groups: stable coronary syndromes in patients with obstructive coronary artery disease (mis-classified by non-invasive CTCA) or non-obstructive coronary disease including the following sub-groups (coronary artery vasospasm, microvascular spasm, impaired vasorelaxation due to (1) endothelial dysfunction and/or (2) non-endothelial dysfunction, or unaffected (normal test results).\\n\\nMedical management is linked to contemporary clinical guidelines for the management of patients with stable coronary artery disease (European Society of Cardiology (2013), Scottish Intercollegiate Guideline Network (SIGN), 2017).', 'armGroupLabels': ['Usual care group (coronary function results not disclosed)'], 'otherNames': ['Adjunctive tests of coronary disease severity and function (not disclosed, sham control)']}\n\nPrimary Outcomes:\n- {'measure': 'Final diagnosis', 'description': 'The between-group difference in the reclassification rate of the initial diagnosis based on CTCA vs. final diagnosis after the invasive procedure involving coronary function tests in a a major coronary artery using logistic regression, adjusted for baseline factors associated with the likelihood of reclassification of the initial diagnosis.', 'timeFrame': 'Day 1'}\n\nPlease estimate the sample size based on the assumption: \n80% power to detect a 15% difference, 90% power to detect a 20% difference, adjusted for baseline characteristics such as sex and smoking status, with allowance for missing data.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and statistical analysis for the diagnostic study\n The primary analysis will be the between-group comparison of the reclassification rate using logistic regression, adjusted for baseline characteristics associated with the likelihood of reclassification of the initial diagnosis. Prespecified baseline characteristics are anticipated to include sex and smoking status. If this is not possible because of small numbers, logistic regression with fewer adjustment variables or Fisher exact test will be used as appropriate. A sample size of 115 per group will have 80% power to detect a between-group difference of 15%, or 90% power to detect a difference of 20%, in the proportion of patients whose diagnosis is reclassified. To allow for any missing data, 250 patients will be randomized (Table II). If the coronary function test results are disclosed in the usual-care group (operator preference; protocol deviation), the plan before disclosure will be recorded.Table IISample size calculations for the diagnostic studyTable IISample size calculation: change in diagnosis (% of patients)Power, %Group size, nDisclosed groupUsual-care group100.1\u00e2\u0081\u008e9094\u00e2\u0080\u00a0200.1\u00e2\u0081\u008e9045\u00e2\u0080\u00a020590114255907525108011330109092\u00e2\u0081\u008eApproximately 0%-1% reclassification.\u00e2\u0080\u00a0Calculation based on Fisher exact test.", "id": 286, "split": "train"} +{"trial_id": "NCT03480893", "pmid": "33028548", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cost-effectiveness of Small Size Interarcuair Decompression Versus Extended Decompression in Patients With Intermittent Neurogenic Claudication (Size-study): a Multi-center, Double-blinded Randomized Controlled Trial\n\nIncluded conditions:\n- Stenoses, Spinal\n\nStudy Armgroups:\n- {'label': 'Small size interarcuair decompression', 'type': 'EXPERIMENTAL', 'description': 'Patients will undergo small size interarcuair decompression', 'interventionNames': ['Procedure: small size interarcuair decompression']}\n- {'label': 'Laminectomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will undergo laminectomy', 'interventionNames': ['Procedure: Laminectomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'small size interarcuair decompression', 'description': \"A median lumbar incision is made and the paravertebral muscles are dissected subperiosteally and retracted unilaterally or bilaterally. Decompression will be applied via decompression of the ligamentum flavum. The lateral recess will be opened bilaterally and a medial facetectomy will be performed in order maintain stability of the segments. Posterior ligaments will be spared. The wound will be closed in layers with or without a suction drain. Patients will be operated with a loupe magnification or microscope depending on the surgeon's preference.\", 'armGroupLabels': ['Small size interarcuair decompression']}\n- {'type': 'PROCEDURE', 'name': 'Laminectomy', 'description': \"A median lumbar incision is made over the spinous processes, the laminae of the affected level(s) are exposed subperiosteally, and the supraspinous ligament will be incised. The spinous process is removed. The supra and interspinous ligament of the affected level is removed by drill or Kerrison punches. The lamen is removed of the affect level, leaving the facet joint intact. The lateral recess will be opened bilaterally and medial facetectomy will be performed in order to maintain stability of the segments. When a single level stenosis is present (e.g. L4-L5) both laminae L4 and L5 will be removed. The wound will be closed in layers with or without a suction drain. Patients will be operated with loupe magnification or microscope depending surgeon's preference.\", 'armGroupLabels': ['Laminectomy']}\n\nPrimary Outcomes:\n- {'measure': 'Change on the Modified Roland-Morris Disability Questionnaire', 'description': 'This is a 24-point Dutch questionnaire that is designed to assess the physical disability in patients, due to lower back pain.', 'timeFrame': 'baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months, 18 months, 24 months, 36 months and 48 months after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a significance level (alpha) of 0.05, a power of 90%, and accounts for a 20% loss in follow-up.", "answer": 174, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size of this study is calculated for the primary endpoint of group difference in the RMDQ at 12 months. According to literature, results obtained after interarcuair decompression should be 3 points lower on the RMDQ compared with those for the laminectomy group in order to detect superiority.45\n\n Hence, the sample size of this study is based on a superiority design, using a delta of 3, an assumed true mean difference of 0 and a pooled SD of 6. Using an alpha of 0.05, and a power of 90%, we calculated a sample size of 69 patients per group. Accounting for a 20% loss in follow-up, we will therefore enrol 174 patients (87 patients per group).", "id": 287, "split": "train"} +{"trial_id": "NCT03483740", "pmid": "31676660", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Remediation Group Therapy to Improve Older Adults' Ability to Cope With HIV-Associated Neurocognitive Disorder (HAND)\n\nIncluded conditions:\n- HIV/AIDS\n- Aging\n- Mild Cognitive Impairment\n- Group, Peer\n\nStudy Armgroups:\n- {'label': 'Cognitive remediation group therapy', 'type': 'EXPERIMENTAL', 'description': '8 weekly 3-hour sessions of CRGT', 'interventionNames': ['Behavioral: CRGT']}\n- {'label': 'Mutual aid support group', 'type': 'ACTIVE_COMPARATOR', 'description': '8 weekly 3-hour sessions of HIV group therapy', 'interventionNames': ['Behavioral: HIV group therapy']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'CRGT', 'description': 'Cognitive remediation group therapy (CRGT) will be comprised of 1/3 brain training exercises on tablets using PositScience software by BrainHQ and 2/3 mindfulness-based stress reduction (MBSR) involving various activities such as meditation, breathing exercises, etc. Intervention will comprise of 8 weekly 3-hour sessions.', 'armGroupLabels': ['Cognitive remediation group therapy']}\n- {'type': 'BEHAVIORAL', 'name': 'HIV group therapy', 'description': 'These groups use a model of mutual aid to encourage peer-based discussion on the effects of living with HIV. Topics are determined by the group; facilitators ensure that safety is maintained throughout and make connections between participants as appropriate. Intervension will comprise of 8 weekly 3-hour sessions.', 'armGroupLabels': ['Mutual aid support group']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility - Session Attendance', 'description': 'Number of Participants who Attended at least 80% of the Group Sessions.', 'timeFrame': 'Three months'}\n- {'measure': 'Acceptability - Participant Satisfaction With Group Sessions', 'description': 'Participants will complete the Helping Characteristics of Self-Help and Support Groups Measure that will be complemented by questions about session length, number of sessions, activities used, and evaluation of facilitators.\\n\\nThe Helping Characteristics of Self-Help and Support Group Measure contains 22 items that are scored on a 5-point-Likert style scale for a minimum score of 22 and a maximum score of 110. Higher scores indicate better outcome (outcome being satisfaction with support group). There are no subscales.', 'timeFrame': 'Three months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated, but the sample size is based on the ideal size for 8 weeks of group therapy and the proportion of the sampling frame.", "answer": 12, "answer_type": "ACTUAL", "explanation": "Sample size\n A sample size of 12\u00e2\u0080\u009316 participants (6\u00e2\u0080\u00938 in each study arm) has been selected as (1) 6\u00e2\u0080\u00938 participants have been found to be an ideal size for 8\u00e2\u0080\u0089weeks of group therapy40; and (2) this number can provide preliminary insight into the feasibility and acceptability of the novel CRGT arm before initiating a larger study. Further, 12\u00e2\u0080\u009316 participants are 30% to 40% of the sampling frame (n=40). So, if this pilot\u00e2\u0080\u0099s results prove promising, scale-up to a larger study with similar recruitment proportions would feasibly require a sample of 90\u00e2\u0080\u0093120 from approximately 300 potential participants.", "id": 288, "split": "train"} +{"trial_id": "NCT03485378", "pmid": "31829203", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease (ASPIRE-ILD): A Phase II Trial\n\nIncluded conditions:\n- Non Small Cell Lung Cancer\n- Interstitial Lung Disease\n\nStudy Armgroups:\n- {'label': 'Treatment Arm: Stereotactic Ablative Radiotherapy', 'type': 'EXPERIMENTAL', 'description': 'Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease', 'interventionNames': ['Radiation: Stereotactic Ablative Radiotherapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Stereotactic Ablative Radiotherapy', 'description': 'Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease', 'armGroupLabels': ['Treatment Arm: Stereotactic Ablative Radiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Overall Survival', 'description': 'Time from enrollment to death from any cause', 'timeFrame': '4 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a one-sample, one-sided binomial test at the 0.05 significance level, with >80% power and assumes a 10% dropout or loss to follow-up rate before one year.", "answer": 39, "answer_type": "ESTIMATED", "explanation": "Statistical design and sample size\n The primary endpoint of this study is overall survival in patients able to be treated with a dose of 50\u00e2\u0080\u0089Gy in 5 fractions, with a comparison to historical controls of untreated medically inoperable patients stage I NSCLC, which consistently have survivals of less than 1\u00e2\u0080\u0089year, as described in the Background section. Demonstration in this study that median OS after SABR is statistically greater than a historical control of <\u00e2\u0080\u008912\u00e2\u0080\u0089months would indicate that SABR is worthwhile in this population of ILD patients, if toxicity is within acceptable limits.\n A sample size of 39 patients provides >80% power to detect an OS improvement of >20% at 1\u00e2\u0080\u0089year, compared to a historical control of <50% (i.e. 70% vs. 49%), using a one-sample, one sided binomial test at the 0.05 significance level, assuming 10% dropout or loss to follow-up before one year. All cohorts will be combined for this primary analysis.\n SABR will be considered worthwhile if OS is >\u00e2\u0080\u00891\u00e2\u0080\u0089year, the risk of grade 3 or 4 pulmonary toxicity is <\u00e2\u0080\u008935%, and the risk of treatment-related mortality is <\u00e2\u0080\u008915%.", "id": 289, "split": "train"} +{"trial_id": "NCT03492983", "pmid": "30552275", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of High Cocoa Content Chocolate on Vascular Function, Body Composition, Health-related Quality of Life and Cognitive Performance in Postmenopausal Women.\n\nIncluded conditions:\n- Postmenopausal Women\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'No intervention'}\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Addition of 10 g/day of high cocoa content chocolate to the usual diet for six months', 'interventionNames': ['Dietary Supplement: Intervention group']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Intervention group', 'description': '10 g/day of high cocoa content chocolate for six months.', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Blood pressure', 'description': 'Measurement by oscillometric method (mmHg)', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, beta risk of 0.20, standard deviation (SD) of 5.8 mm Hg, and a predicted drop-out rate of 10%.", "answer": 140, "answer_type": "ACTUAL", "explanation": "Sample size\n The size of the sample has been estimated based on the potential modification of the main variable, systolic blood pressure (SBP). Given alpha and beta risks of 0.05 and 0.20 respectively in bilateral contrast and an SD of 5.8\u00e2\u0080\u0089mm\u00c2\u00a0Hg, 140 participants (70 per group) will be necessary to detect a minimum difference of 2.9\u00e2\u0080\u0089mm\u00c2\u00a0Hg in the SBP between the two groups. A predicted drop-out rate of 10% during follow-up has been taken into account. This estimate has considered the results obtained in a similar study in which a decrease in SBP of 6.5 was observed \u00c2\u00b15.8\u00e2\u0080\u0089mm Hg.14", "id": 290, "split": "train"} +{"trial_id": "NCT03497546", "pmid": "34268680", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Supervised Exercise Following Bariatric Surgery in the Treatment of Severe/Morbid Obesity: a Randomized Controlled Trial\n\nIncluded conditions:\n- Obesity, Morbid\n- Bariatric Surgery Candidate\n\nStudy Armgroups:\n- {'label': 'Exercise', 'type': 'EXPERIMENTAL', 'description': 'Usual care PLUS concurrent (aerobic and strength) supervised exercise program of 16 weeks (3 sessions/week, 60 min/session, progressively increasing in volume and intensity). The program will be conducted by certified Exercise Science professionals.', 'interventionNames': ['Other: Exercise']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Usual care routinely delivered after bariatric surgery, based on national (Spanish) and international recommendations, focused on nutritional status monitoring and diet/physical activity counseling.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Exercise', 'description': 'Concurrent (aerobic and strength) supervised exercise program: the program comprises 3 sessions/week (60 min/session) of aerobic and strength exercises of progressive volume and intensity. The program will follow the Consensus on Exercise Reporting Template (CERT) guidelines.', 'armGroupLabels': ['Exercise'], 'otherNames': ['Exercise training']}\n\nPrimary Outcomes:\n- {'measure': 'Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA]', 'description': '%TWL = \\\\[(pre-surgery weight - post-surgery weight) / (pre-surgery weight)\\\\] x 100', 'timeFrame': 'Changes from baseline to 4-month and 1-year follow-up'}\n\nPlease estimate the sample size based on the assumption: \nAlpha error of 0.05, power of 80%, and a potential follow-up loss of up to 20%.", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample Size\n Assuming an alpha error of 0.05 and a power of 80%, a total of 66 patients (n=33 patients per group) are needed to detect an effect (between group difference) of at least 0.7 standard deviations [16] in the % of total weight loss (% TWL). Anticipating a potential follow-up loss of up to 20%, a total of 80 patients will be recruited (i.e., 40 per group). Based on previous literature and our surgical team\u00e2\u0080\u0099s experience, 60\u00e2\u0080\u009380% of the recruited participants are expected to be women.", "id": 291, "split": "train"} +{"trial_id": "NCT03505619", "pmid": "31345964", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of an Intervention Program Addressing Reablement Services in a Swedish Context (ASSIST 1.0) - A Protocol for a Feasibility Study\n\nIncluded conditions:\n- Older Adults\n- Participation\n\nStudy Armgroups:\n- {'label': 'ASSIST 1.0', 'type': 'EXPERIMENTAL', 'description': \"A ten-week intervention program using a person-centred approach to support the older person to set up goals to perform daily activities that he/she wants or needs to do. The activity goals will target improvements in quality of life, physical health, mental well-being, and conditions for social community. The focus will be on supporting the older person's activities in everyday life that are considered meaningful for the individual. During the intervention, a specially designed application will send reminders and feedback related to the older adults' activity goals of doing their prioritized everyday activities both to the older adults and to the home care providers via mobile phones, tablet etc. The home care providers will participate in coaching sessions supporting the intervention held by the team of researchers.\", 'interventionNames': ['Behavioral: ASSIST 1.0']}\n- {'label': 'Ordinary home care services', 'type': 'NO_INTERVENTION', 'description': 'The home care providers in the control group (CG) will provide services as usual to older adults participating in the control group. They will however, identify potential older persons to participate in the control group according to the same procedure and criteria as the intervention group.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ASSIST 1.0', 'description': '10 weeks intervention applying a person-centred approach by using goal setting and smart products.', 'armGroupLabels': ['ASSIST 1.0']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Canadian Occupational Performance Measure (COPM)', 'description': \"Measuring the older adults' self-perception of activity performance and satisfaction within the areas of self care, productivity and leisure, measured on a 1-10 scale, where 10 represents most satsified and highest performance ranking.\", 'timeFrame': 'Change between baseline and 8 to 10 weeks post baseline.'}\n\nPlease estimate the sample size based on the assumption: \nStatistics and tests will be reported in accordance with the CONSORT 2010 statement and its extensions for non-pharmacological treatment trials.", "answer": 20, "answer_type": "ACTUAL", "explanation": "Sample size and power considerations\n As this study is a feasibility study, a sample size calculation is not required.51 52 However, the sample should be representative of the target population and be large enough to provide information related to the feasibility and the potential outcome of the programme.52 If the programme is feasible and reveals positive outcomes, the intention is to evaluate the outcomes of the programme in a future large-scale RCT. Initially, such a study will include a pilot period. If no adjustments of the ASSIST programme are required, the data from the pilot period might be included in the large-scale RCT (internal pilot).53 Furthermore, the results of the feasibility study and the pilot period will be the basis for a power calculation for the future large-scale study and thereafter, a sample size justification should51 be presented for phase III\u00e2\u0080\u0094the RCT design in this project (figure 1).\n All statistics and tests will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement54 in conjunction with the CONSORT 2010 extensions for randomised trials of non-pharmacological treatment.55 56", "id": 292, "split": "train"} +{"trial_id": "NCT03507608", "pmid": "38104131", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Trial Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'flutamide', 'type': 'EXPERIMENTAL', 'description': '50mg flutamide prior to brachytherapy and prostatic biopsy', 'interventionNames': ['Drug: Flutamide']}\n- {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'placebo prior to brachytherapy and prostatic biopsy', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Flutamide', 'description': '50mg flutamide prior to brachytherapy and prostatic biopsy', 'armGroupLabels': ['flutamide']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'placebo prior to brachytherapy and prostatic biopsy', 'armGroupLabels': ['placebo']}\n\nPrimary Outcomes:\n- {'measure': 'DNA double strand break formations', 'description': 'To confirm DNA double strand breaks occur in prostate cancer tissue following pulse-dose flutamide administration in patients who are androgen suppressed, as compared to control patients receiving placebo. Extent of Gamma H2Ax as a measure of DNA double strand break formation.', 'timeFrame': 'Post Flutimide exposure up to 12 hours'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a Bayesian monitoring rule with a significance level of 50% for feasibility. The confidence intervals for the treatment group range from 0.35 to 0.42, and for the control group, it is less than 0.5. The dropout and non-evaluable rate is estimated at 20%.", "answer": 24, "answer_type": "ACTUAL", "explanation": "Sample size justification and accrual\n This trial will be utilized to design a larger study to establish measures for such parameters with a reasonable level of precision. We will enroll 30 patients in the trial, with a goal of at least 24 evaluable patients accrued.\n In the run-in phase, a total of 6 evaluable patients will be accrued to receive Flutamide administration. We will use a Bayesian monitoring rule to determine if the study is feasible. Specifically, we would consider it \u00e2\u0080\u009cinfeasible\u00e2\u0080\u009d if the probability of not observing greater than or equal to 5% of prostate cancer cells having \u00ce\u00b3H2Ax foci is more than 50%. Based on the Bayesian monitoring rule in Section 6.3, if there is less than or equal to 1 out of 6 cases with detectable DNA double-strand breaks (i.e., greater than or equal to 5% of prostate cancer cells having \u00ce\u00b3H2Ax foci on patient level), the study will be considered as infeasible and will not proceed into the randomization part.\n If the study proceeds into the randomization part, a total of 18 evaluable patients will be randomized in a 2:1 ratio to either receive flutamide (12 patients) or not (6 patients). A simple randomization method will be utilized. A total of 18 patients treated with flutamide (6 from run-in and 12 from randomization) will produce a two-sided 90% confidence interval with a width ranging from 0.35 to 0.42 (if the true proportion of prostate cancer cells having \u00ce\u00b3H2Ax foci is 30%-80%). A total of 6 patients in control will produce a two-sided 90% confidence interval with a width approximately less than 0.5 (if the true proportion of prostate cancer cells having \u00ce\u00b3H2Ax foci is less than 10%).\n All eligible patients will be offered enrollment in the study, and we estimate a 20% dropout and non-evaluable rate. Patients who drop out prior to the biopsy/brachytherapy procedure will be replaced; patients who drop out after the biopsy/brachytherapy will not be replaced. In order to ensure at least 24 evaluable patients are available, we plan to enroll ~30 patients in this trial. Given the minimal addition to standard therapy and effort requirement from patients, we expect to accrue at least 2\u00e2\u0080\u00933 patients/month, and the full accrual will be completed in 2 years.\n The feasibility of detecting DNA double-strand breaks will be based on the proportion of patients in whom \u00ce\u00b3H2Ax foci are observed in \u00e2\u0089\u00a55% of prostate cancer cells. Conversely, the trial will be considered \u00e2\u0080\u009cinfeasible\u00e2\u0080\u009d if the probability of failure to observe DNA double-strand breaks is more than 50% and with more than 70% posterior probability. We assume there will only be a smaller proportion of cases in which DNA double-strand breaks cannot be observed, e.g., on average only 10% of patients will not have detectable DNA double-strand breaks and there will be about 16% chance that the risk will be 20% or more. This corresponds to a Beta (0.1, 0.9) prior distribution. Table 1 summarizes the continuous termination rule for the 18 evaluable patients treated with flutamide. The feasibility termination rule calls for the conclusion of the study without proceeding into the randomization part if there is less than or equal to 1 patient with detectable DNA double-strand breaks within the first 6 patients (in the run-in phase). If the trial enters the randomization phase, the feasibility-stopping rule calls for accrual suspension if the number of patients with detectable DNA double-strand breaks is too low.Table 1Stopping rule for feasibility# patients without detectable DNA double-strand breaks567891011Out of the total # evaluable patients6\u00e2\u0080\u009378\u00e2\u0080\u009391112\u00e2\u0080\u00931314\u00e2\u0080\u00931516\u00e2\u0080\u00931718\n Table 2 summarizes the operating characteristics based on 5000 simulations with 18 evaluable patients in terms of how frequently the study would stop based on the stopping rule under different hypothetical feasibility rates, as well as the average sample sizes.Table 2Operating characteristics of the stopping rule for feasibilityUnderlying proportion without detectable DNA double-strand breaks0.40.50.60.70.8% of the time study stops19.3%44%74.8%92.4%99.4%Expected sample size16.314.111.18.76.9", "id": 293, "split": "train"} +{"trial_id": "NCT03508895", "pmid": "32326966", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Double-blind, Randomized, Cross-over Trial of Whole Hemp Seed Protein and Hemp Seed Protein Hydrolysate Derived Bioactive Peptide Consumption for Hypertension\n\nIncluded conditions:\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Whole hemp seed protein', 'type': 'EXPERIMENTAL', 'description': '25 grams of hemp seed protein powder, twice a day', 'interventionNames': ['Other: Whole hemp seed protein']}\n- {'label': 'Whole hemp seed protein plus bioactive peptides', 'type': 'EXPERIMENTAL', 'description': '22.5 grams of hemp seed protein and 2.5 grams of hemp seed protein hydrolysate derived bioactive peptides, twice a day', 'interventionNames': ['Other: Whole hemp seed protein plus bioactive peptides']}\n- {'label': 'Casein protein', 'type': 'ACTIVE_COMPARATOR', 'description': '25 grams of protein powder, twice a day', 'interventionNames': ['Other: Casein protein']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Whole hemp seed protein', 'description': 'The intervention was provided in the form of a smoothie.', 'armGroupLabels': ['Whole hemp seed protein']}\n- {'type': 'OTHER', 'name': 'Whole hemp seed protein plus bioactive peptides', 'description': 'The intervention was provided in the form of a smoothie.', 'armGroupLabels': ['Whole hemp seed protein plus bioactive peptides']}\n- {'type': 'OTHER', 'name': 'Casein protein', 'description': 'The intervention was provided in the form of a smoothie.', 'armGroupLabels': ['Casein protein']}\n\nPrimary Outcomes:\n- {'measure': 'Change in 24 hour ambulatory blood pressure', 'description': 'Participants were fitted with an ambulatory blood pressure monitor (ABPM) for 24 hours. Continuous diastolic and systolic blood pressure were measured over 24 hours.', 'timeFrame': 'Measured at day 1 of phase 1 (baseline) and change from baseline ABP at week 6 of phase 1, 2 and 3'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80 and significance level (\u03b1) of 0.05, with an allowance for potential participant dropout", "answer": 35, "answer_type": "ACTUAL", "explanation": "Sample size\n A total sample size of 30 participants was calculated as required to detect a change in 4\u00e2\u0080\u0089mmHg in SBP with the proposed crossover design, using an estimated within-participant standard deviation of 5.45\u00e2\u0080\u0089mmHg and a power of 0.80 and \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 [13]. A recruitment goal of 35 participants has been set to account for the potential participant drop out.", "id": 294, "split": "train"} +{"trial_id": "NCT03509428", "pmid": "36247802", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Pragmatic Factorial Design Randomised Controlled Study to Assess the Efficacy of the Implementation of a Prehabilitation Programme in Patients Undergoing Elective Major Intra - Cavity Cancer Surgery in Wessex\n\nIncluded conditions:\n- Cancer\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Usual care plus additional monitoring'}\n- {'label': 'SRETP', 'type': 'EXPERIMENTAL', 'description': 'Structured Responsive Exercise Training Programme (SRETP) prior to surgery', 'interventionNames': ['Behavioral: SRETP']}\n- {'label': 'Psychological support', 'type': 'EXPERIMENTAL', 'description': 'Psychological support prior to surgery', 'interventionNames': ['Behavioral: Psychological support']}\n- {'label': 'SRETP and psychological support', 'type': 'EXPERIMENTAL', 'description': 'Structured Responsive Exercise Training Programme (SRETP) and psychological support prior to surgery', 'interventionNames': ['Behavioral: SRETP', 'Behavioral: Psychological support']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'SRETP', 'description': 'SRETP will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. Exercise intensities during the interval exercise-training program are specific to each patient and derived from CPET. Moderate intensity exercise is below the anaerobic threshold (AT). Patients will exercise at 80% of oxygen uptake (VO2) obtained at the anaerobic threshold (80%AT) for moderate intensity exercise - 3 minutes. Severe exercise intensity is recognised as 50% of the difference between the VO2 AT and VO2 Peak (50%\u2206) - 2 minutes.', 'armGroupLabels': ['SRETP', 'SRETP and psychological support']}\n- {'type': 'BEHAVIORAL', 'name': 'Psychological support', 'description': 'Support sessions will be patient-centred, giving the patient an opportunity to raise any issues/concerns they are having, this may include (but will not be limited to) ways of coping with their reactions to cancer, family and relationship issues, exploring personal issues and dealing with practical issues. Patients will have access to other resources available at the cancer centres including but not restricted to further information about their condition and how to access financial support. These processes reflect the best practice currently being delivered by cancer support centre staff in the Wessex region. Any patient deemed at risk (i.e. from suicidal ideation or self harm) will be reported to their GP, followed up by a letter.', 'armGroupLabels': ['Psychological support', 'SRETP and psychological support']}\n\nPrimary Outcomes:\n- {'measure': 'Post-operative length of hospital stay', 'description': 'Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS).', 'timeFrame': 'up to 1 year'}\n\nPlease estimate the sample size based on the assumption: \n85% power, alpha = 0.05, and a 20% drop-out rate.", "answer": 1560, "answer_type": "ESTIMATED", "explanation": "Estimation of sample size\n From previous studies, the median length of stay in the control group is estimated to be 7 days. To detect a clinically meaningful difference of a (significance level to detect a hazard ratio of 1.17 when the control group median in-patient time is 7 days) 1 day reduction in LOS with 85% power, alpha = 0.05, a sample size of 1560 participants will need to be recruited over 3 years, with a one year follow-up period. The sample size allows for a 20% drop-out.\n Sample size calculations for 2\u00c3\u00972 designs are based on the two main comparisons (i.e. exercise vs. no exercise and psychological support vs. no support). The trial sample size is the larger of these 2 comparisons, so in this case, the sample size calculation is powered on the psychological support comparison. The sample size calculation assumes that there is no interaction between the interventions.", "id": 295, "split": "train"} +{"trial_id": "NCT03510650", "pmid": "31666276", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Diagnostic Biomarkers for Adult Hemophagocytic Lymphohistiocytosis in Critically Ill Patients (HEMICU)\n\nIncluded conditions:\n- Hemophagocytic Lymphohistiocytosis\n\nStudy Armgroups:\n- {'label': 'Patients', 'description': '50 patients with sepsis versus 50 patients with HLH \\\\[anticipated\\\\]'}\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Incidence of HLH in intensive care units based on HLH-2004 criteria', 'description': 'HLH patients are followed up until the end of hospital stay or death.', 'timeFrame': 'Up to 180 days'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided 95.0% confidence interval, large sample normal approximation, CI will extend 0.1 from the observed proportion.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size\n The true incidence of adult HLH in ICU is unknown. According to our own research9 and the annual number of patients admitted to our ICU, we expect to see about 200 patients with diagnosed HLH over 2\u00e2\u0080\u0089years and about 400 with suspected HLH. Of these, we hope to include at least 100 patients with suspected HLH into the study, of whom about 50 patients are expected to be diagnosed with HLH. When the sample size is 100, a two-sided 95.0% CI for a single proportion using the large sample normal approximation will extend 0.1 from the observed proportion for an expected proportion of 0.5 (nQuery Advisor V.7.0).", "id": 296, "split": "train"} +{"trial_id": "NCT03512015", "pmid": "30772862", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Mobile Supportive Care App for Patients With Metastatic Lung Cancer: a Pilot Randomized Controlled Trial - The Lung Cancer App (LuCApp) Study\n\nIncluded conditions:\n- Nonsmall Cell Lung Cancer\n- Small Cell Lung Carcinoma\n\nStudy Armgroups:\n- {'label': 'LuCApp + Standard Care', 'type': 'EXPERIMENTAL', 'description': 'LuCApp (Lung Cancer App) is an application developed by researchers and lung cancer clinicians to gather symptom data in real time and to share it with healthcare professionals.\\n\\nLuCApp allows daily monitoring and grading of a list of symptoms which trigger alerts to the physicians in case predefined severity thresholds are met.', 'interventionNames': ['Other: The Lung Cancer App - LuCApp']}\n- {'label': 'Standard Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Usual care will consist of standard procedures currently available at participating centers for monitoring and documenting symptoms. These therapeutical procedures are based on the guidelines developed by the National Comprehensive Cancer Network (NCCN) and the Associazione Italiana di Oncologia Medica (AIOM). Symptoms for control arm patients will be discussed and registered during scheduled clinical visits with the oncologists. Standard-of-care patients will fill out their PROMs following the same schedule identified for LuCApp patients with paper questionnaires during clinic visits, or at home (having received paper questionnaires during the previous visit) or via telephonic interviews with the research team.', 'interventionNames': ['Other: Standard care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'The Lung Cancer App - LuCApp', 'description': 'The Intervention Arm receiving LuCApp (The Lung Cancer App) in addition to standard care', 'armGroupLabels': ['LuCApp + Standard Care']}\n- {'type': 'OTHER', 'name': 'Standard care', 'description': 'The Standard-of-Care patients receiving following the same schedule identified for LuCApp patients with paper questionnaires during clinic visits, or at home (having received paper questionnaires during the previous visit) or via telephonic interviews with the research team.', 'armGroupLabels': ['Standard Care']}\n\nPrimary Outcomes:\n- {'measure': 'The primary outcome is the change in the score of the Trial Outcome Index (TOI) in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks.', 'description': 'FACT-L questionnaire contains four general and one lung cancer symptom-specific subscales. General subscales include: Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The Lung Cancer Subscale (LCS) assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath; loss of weight; tightness in chest). The TOI is derived by adding scores on the PWB and FWB subscales to the LCS. Because they contain the most relevant questions about symptoms and physical functioning, the LCS and TOI were selected as the primary focus of this analysis.', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 20% attrition rate, 90% power, a two-sided significance level (\u03b1) of 0.05, and a pooled standard deviation (SD) of 15.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The change in the Trial Outcome Index (TOI) of the FACT-L questionnaire from baseline to 12 weeks was used as primary end\u00c2\u00a0point for this study. FACT-L questionnaire contains four general and one lung cancer symptom-specific subscales. General subscales include: Physical Well-Being (PWB), Social/family Well-Being, Emotional Well-Being and Functional Well-Being (FWB).42 The LCS assesses symptoms commonly reported by patients with lung cancer (eg, shortness of breath; loss of weight; tightness in chest). The TOI is derived by adding scores on the PWB and FWB subscales to the LCS. Because they contain the most relevant questions about symptoms and physical functioning, the LCS and TOI were selected as the primary focus of this analysis. All FACT-L questions are rated on 5-point Likert-type scales ranging from 0 (\u00e2\u0080\u0098not at all\u00e2\u0080\u0099) to 4 (\u00e2\u0080\u0098very much\u00e2\u0080\u0099). TOI scores range from 0 to 84 where higher scores represent better HRQoL or fewer symptoms. After accounting for about 20% attrition rate, we estimated that with 120 patients allocated 1:1 between LuCApp and usual care groups, the study would have 90% power with a two-sided \u00ce\u00b1 of 0.05 to detect a significant between-group difference of 5 points43 in the change in the TOI score from baseline to 12 weeks, given a pooled SD of 15.44", "id": 297, "split": "train"} +{"trial_id": "NCT03512158", "pmid": "36787974", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Non-invasive Respiratory Support in Preterm Infants: a Multicentre Pilot Randomized Controlled Trial\n\nIncluded conditions:\n- Preterm Infant\n- Respiratory Insufficiency Syndrome of Newborn\n- Bronchopulmonary Dysplasia\n\nStudy Armgroups:\n- {'label': 'High NCPAP', 'type': 'EXPERIMENTAL', 'description': 'Administration of high NCPAP (\\\\> 8 cmH2O) following either failure of traditional NCPAP pressures (\u2264 8 cmH2O) OR post-extubation from high endotracheal mechanical ventilation settings (defined as mean airway pressure \u226510 cmH2O)', 'interventionNames': ['Other: Non-invasive respiratory support mode']}\n- {'label': 'NIPPV', 'type': 'ACTIVE_COMPARATOR', 'description': 'Administration of NIPPV following either failure of traditional NCPAP pressures (\u2264 8 cmH2O) OR post-extubation from high endotracheal mechanical ventilation settings (defined as mean airway pressure \u226510 cmH2O)', 'interventionNames': ['Other: Non-invasive respiratory support mode']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Non-invasive respiratory support mode', 'description': 'A mode of providing respiratory support via nasal masks or prongs', 'armGroupLabels': ['High NCPAP', 'NIPPV']}\n\nPrimary Outcomes:\n- {'measure': 'Ability to enroll a minimum of 10% of all eligible neonates per year at each site', 'description': 'Ability to enroll a minimum of 30% of all admitted neonates \\\\< 29 weeks GA who do not meet exclusion criteria AND ability to randomize a minimum of 33% of all enrolled patients per year at each site \\\\[i.e. randomize a minimum of 10% of all eligible neonates\\\\]', 'timeFrame': 'Through study completion (total 42 months)'}\n- {'measure': 'Fewer than 20% randomized subjects with protocol violations in High CPAP arm', 'description': 'Defined as any use of NIPPV', 'timeFrame': 'Through study completion (total 42 months)'}\n- {'measure': 'Fewer than 20% randomized subjects with protocol violations in NIPPV arm', 'description': 'Defined as any use of high NCPAP \\\\> 8 cmH2O', 'timeFrame': 'Through study completion (total 42 months)'}\n- {'measure': 'Fewer than 20% of enrolled (consented, but pre-randomization) subjects with protocol violations', 'description': 'Defined as post-consent initiation of high NCPAP or NIPPV for \\\\>4 hours without randomization', 'timeFrame': 'Through study completion (total 42 months)'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated; this is a pilot trial to inform future studies.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n For this multicentre pilot trial, a sample size of 100 subjects was determined based on the feasibility outcome outlined earlier (ie, ability to randomise a minimum of 10% of all patients <29\u00e2\u0080\u0089week\u00e2\u0080\u0099s GA who do not meet exclusion criteria), as shown in online supplemental file. Analysis of secondary outcomes from this study will help inform the design and sample size for a larger, definitive trial.", "id": 298, "split": "train"} +{"trial_id": "NCT03513614", "pmid": "30514362", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS). A Multicenter Randomized Phase III Trial (OPBC-03/ SAKK 23/16 /IBCSG 57-18 / ABCSG-53 / GBG-101)\n\nIncluded conditions:\n- Node-positive Breast Cancer\n\nStudy Armgroups:\n- {'label': 'ALND', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tailored axillary surgery followed by axillary lymph node dissection (ALND) and regional nodal irradiation excluding the dissected axilla.', 'interventionNames': ['Procedure: Tailored axillary surgery - both Arms', 'Radiation: Radiotherapy - Arm A']}\n- {'label': 'No ALND', 'type': 'ACTIVE_COMPARATOR', 'description': 'Tailored axillary surgery followed by regional nodal irradiation including the full axilla.', 'interventionNames': ['Procedure: Tailored axillary surgery - both Arms', 'Radiation: Radiotherapy - Arm B']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Tailored axillary surgery - both Arms', 'description': 'Axillary lymph node dissection - Arm A', 'armGroupLabels': ['ALND', 'No ALND']}\n- {'type': 'RADIATION', 'name': 'Radiotherapy - Arm A', 'description': 'Regional nodal irradiation excluding the dissected axilla - Arm A', 'armGroupLabels': ['ALND']}\n- {'type': 'RADIATION', 'name': 'Radiotherapy - Arm B', 'description': 'Regional nodal irradiation including the full axilla - Arm B', 'armGroupLabels': ['No ALND']}\n\nPrimary Outcomes:\n- {'measure': 'Disease-free survival (DFS)', 'description': 'The primary endpoint of this trial is DFS, defined as time from randomization until one of the following events, whichever comes first:\\n\\n* Local recurrence, regional recurrence, distant recurrence\\n* Second breast cancer\\n* Death from any cause Patients not experiencing an event will be censored at the date of the last available assessment.', 'timeFrame': 'at the occurrence of the event or latest 20 years after randomization of the last patient'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 5%, power of 80%, one interim analysis for efficacy/futility after 20% of the required events, and analysis based on the per-protocol set.", "answer": 1500, "answer_type": "ESTIMATED", "explanation": "Sample size considerations and statistical analyses\n The sample size is based on the primary endpoint DFS. With a type I error of 5% and a power of 80%, 385 events will be needed to show non-inferiority of TAS and axillary RT in comparison to ALND with a non-inferiority hazard ratio of 1.289 (corresponding to a DFS at 5\u00c2\u00a0years of 80% in the ALND arm and 75% in the TAS and axillary RT arm). The sample size needed is 1500 patients (750 per arm). One interim analysis for efficacy/futility is foreseen after 20% of the required events have occurred. A report including the interim efficacy results as well as patient characteristics, treatment administration and safety results (AEs, SSI, and serious AEs) will be presented to an independent Data Monitoring Committee appointed by the SAKK Board. The SAKK Board will decide on the continuation/modification/early stopping of the trial based on the recommendations of the committee. All efficacy endpoints will be analyzed based on the per-protocol set. For the primary endpoint, DFS, the hazard ratio and one-sided 95% confidence interval will be calculated using a Cox regression model with the treatment arm as independent variable and the stratification factors as strata. The median DFS and the corresponding 95% confidence intervals using the Kaplan-Meier method will be presented for each treatment arm.\n Planned subgroup analyses for the primary endpoint:Type of positive node detection at first diagnosis: cN1 vs. iN1Neoadjuvant vs. adjuvant systemic treatment vs. bothycN1 vs. ycN0BMI <\u00e2\u0080\u008925 kg/m2 vs \u00e2\u0089\u00a5\u00e2\u0080\u008925 kg/m2Normofractionation vs. hypofractionationBreast-conserving surgery vs. mastectomyTriple-negative vs. HER2+ vs. ER- and/or PR-positive, and HER2-", "id": 299, "split": "train"} +{"trial_id": "NCT03516851", "pmid": "30898819", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multimodal Neuronavigation Guiding Precision Bypass in Adult Ischemic Patients With Moyamoya Disease\n\nIncluded conditions:\n- Moyamoya Disease\n\nStudy Armgroups:\n- {'label': 'Precision bypass group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Using ICG with Flow800 software and multimodal neuronavigation to choose the recipient vessel', 'interventionNames': ['Procedure: Precision bypass group']}\n- {'label': 'Empirical group', 'type': 'NO_INTERVENTION', 'description': \"choosing the recipient vessel by the surgeon's own experience\"}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Precision bypass group', 'description': 'With the brain cortex exposed after craniotomy, an initial ICG fluorescence angiography will be performed. ICG fluorescence angiography using Flow800 software to determine blood flow velocity and cortical perfusion in different candidate receptors. And electromagnetic neuronavigation system is used to evaluate the cerebral flow under different candidate recipient vessels. The treatment planning station will be situated based on the multimodal neuronavigation data. The vessel was chose as the receptor with lower flow velocity and lower cerebral perfusion area to perform anastomosis. Then a direct bypass surgery will be performed just like in the empirical direct bypass surgery group.', 'armGroupLabels': ['Precision bypass group']}\n\nPrimary Outcomes:\n- {'measure': 'ischemic events', 'description': 'All strokes \\\\& death within 30 days post-surgery and ipsilateral infarctions afterwards', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nProspective, exploratory, randomised controlled trial", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size\n Because this trial is a prospective, exploratory, randomised controlled trial, there is no previous data for multimodal neuronavigation-guided precise bypass procedure, the sample size for this trial can\u00e2\u0080\u0099t be calculated from the formula. Finally, 100 patients are randomised (1:1) to two groups, 50 of them will undergo direct bypass guided by multimodal neuronavigation, while others will undergo empirical direct bypass procedure.", "id": 300, "split": "train"} +{"trial_id": "NCT03517098", "pmid": "31640757", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Enhanced Recovery After Surgery (ERAS) Pathway for Primary Hip and Knee Arthroplasty: a Prospective, Controlled, Randomized Clinical Trial\n\nIncluded conditions:\n- Arthroplasty, Replacement, Hip, Knee\n\nStudy Armgroups:\n- {'label': 'The ERAS group', 'type': 'EXPERIMENTAL', 'description': 'Patients will be treated with the ERAS pathway', 'interventionNames': ['Procedure: The ERAS group']}\n- {'label': 'The non-ERAS group', 'type': 'OTHER', 'description': 'Patients undergoing THA or TKA will receive conventional care.', 'interventionNames': ['Procedure: The non-ERAS group']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'The ERAS group', 'description': 'ERAS pathway for orthopedic surgeons:\\n\\n1. Shortened preoperative fasting from intake.\\n2. Preoperative tranexamic acid administration.\\n3. No indwelling catheters.\\n4. No tourniquet used for TKA.\\n5. No drainage tube.\\n6. Application of the low molecular heparin 6 hours after the operation.\\n\\nERAS pathway for anesthesiologist:\\n\\n1. Intravenous 20 mg of dexamethasone before anesthetic induction.\\n2. Anesthesia will be induced with small dose of long-acting opioids such as sulfentanil, or without long-acting opioids at all.\\n3. Laryngeal mask for airway.\\n4. Anesthesia will be maintained with short-acting anesthetic agents such as desflurane, sevoflurane, or propofol, with continuous remifentanil , and BIS value will be kept between 40 to 60 during procedure.\\n5. Incision infiltration with 40-50ml of 0.2% ropivacaine, and no patient controlled intravenous analgesia devices will be applied.', 'armGroupLabels': ['The ERAS group']}\n- {'type': 'PROCEDURE', 'name': 'The non-ERAS group', 'description': \"Patients undergoing THA or TKA will receive conventional care according to different participating center, and there's no standard protocol for pre-operative management, anesthetic technique or medication choice, postoperative analgesia or food intake, or catheters indwelling.\", 'armGroupLabels': ['The non-ERAS group']}\n\nPrimary Outcomes:\n- {'measure': 'Length of stay (LOS) in hospital', 'description': 'Time from the day on arrival at hospital to discharge from the hospital (unit: days).', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nA 5% significance level, a power of 0.90, and a 20% dropout rate.", "answer": 640, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Our primary hypothesis is that the application of the ERAS pathway would reduce the LOS in hospital when compared to the current non-ERAS practice in total joint arthroplasty (TJA). According to retrospective analysis of LOS of in hospital of TJA in 2014 (when the ERAS pathway was just proposed) and 2016 (when the ERAS pathway was applied in about 50% of patients) in the Department of Orthopedics, West China Hospital of Sichuan University, the mean LOS of THA was 10\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.5\u00e2\u0080\u0089days in 2014 and 8.6\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.1\u00e2\u0080\u0089days in 2016; the mean LOS of TKA was 12.1\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00892.1\u00e2\u0080\u0089days in 2014 and 8.9\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.5\u00e2\u0080\u0089days in 2017. For THA, assuming the difference between the two groups was a 5% significance level and a power of 0.90, 17 patients in each group are required; for TKA, assuming the difference between two groups was a 5% significance level and a power of 0.90, only seven patients in each group are required for a comparison within the group. Considering an estimated 20% dropout rate, there should be 42 patients in each group for THA and 20 patients in each group for TKA; a total of 62 patients are required for this study [10]. For a better application of the ERAS pathway for orthopedic surgeons and anesthesiologists, we increased the sample size to 160 individuals in each group for THA and TKA, and a total of 640 individuals will be included. We plan to enroll 320 patients undergoing TKA to participate in this trial in the first stage and enroll 320 patients undergoing THA after completion. A primary comparison will be performed separately for TKA and THA.", "id": 301, "split": "train"} +{"trial_id": "NCT03524352", "pmid": "32493442", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis\n\nIncluded conditions:\n- Pouchitis\n\nStudy Armgroups:\n- {'label': 'fecal microbiota', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: fecal microbiota']}\n- {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'fecal microbiota', 'description': 'fecal microbiota in suspension', 'armGroupLabels': ['fecal microbiota']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'sterile saline', 'armGroupLabels': ['placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Number of days between the date of transplantation and the date of relapse according to physiological and endoscopic parameter (pochitis disease activity index)', 'timeFrame': '106 weeks'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, 48-month enrollment period, 24-month follow-up period, and interim analysis at the first 16 observed events.", "answer": 42, "answer_type": "ESTIMATED", "explanation": "Sample size evaluation\n This superiority study is designed to have a statistical power of 80% to detect a significant treatment effect on the first onset of pouchitis. We estimate a survival rate of 25% in the control group versus 60% in the treatment group at 6 months (hazard ratio\u00e2\u0080\u0089=\u00e2\u0080\u00890.3685).\n These figures are based on the work on probiotics of Gionchetti and Mimura [18, 19].\n A total of 32 events are needed to ensure a statistical power of 80%. For a 48-month enrollment period and 24-month follow-up period, 40 patients are needed to observe 32 events. To ensure this statistical power, a total of 42 patients will be randomized.\n This sample size calculation takes into account the interim analysis planned at the first 16 observed events.", "id": 302, "split": "train"} +{"trial_id": "NCT03526692", "pmid": "30696475", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Effects Between SMR/Delta Ratio and beta1/Theta Ratio Neurofeedback Trainings for Older Adults With Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Mild Cognitive Impairment\n\nStudy Armgroups:\n- {'label': 'Sensorimotor/delta NF training group', 'type': 'EXPERIMENTAL', 'description': 'Three interventions will be administered:\\n\\n* An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system.\\n* The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours.\\n* The third intervention is the neurofeedback training sensorimotor/delta ratio that will be recorded at channel Cz according to the International 10-20 system.', 'interventionNames': ['Behavioral: Neurofeedback']}\n- {'label': 'Beta1/theta NF training group', 'type': 'EXPERIMENTAL', 'description': 'Three interventions will be administered:\\n\\n* An electroencephalography recording (EEG) for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system.\\n* The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours.\\n* The third intervention is the neurofeedback training Beta1/theta ratio that will be recorded at channel Fz according to the International 10-20 system.', 'interventionNames': ['Behavioral: Neurofeedback']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Three interventions will be administered:\\n\\n* An electroencephalography recording for 30 minutes.We will use an electrocap of 19 scalp locations according to the International 10-20 EEG placement system.\\n* The second intervention is the neuropsychological assessments and questionnaires. They will be done in one session for approximately 2 hours.\\n* The psychopedagogical care : Each session will be organized using the same video material than for the NF training sessions.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Neurofeedback', 'description': 'Neurofeedback experiment will consist of 30 sessions of neurofeedback training, twice or three times a week during maximum 4 months. The two experimental groups will undergo questionnaires, EEG recording and neuropsychological assessments in three-time points, pre-training (T0), post-training (T1) and 3 months follow-up (T2). Electroencephalography will be recorded by a technician in EEGFor each participant, EEG power spectrum will be calculated in pre (T0) and post neurofeedback training/psycho-pedagogical care at T2 and T3.', 'armGroupLabels': ['Beta1/theta NF training group', 'Sensorimotor/delta NF training group'], 'otherNames': ['Electroencephalography']}\n\nPrimary Outcomes:\n- {'measure': 'Change on attention test, TMTB-TMA', 'description': 'assessment of the Trail Making Test B and A, calculation of subtraction', 'timeFrame': 'Baseline Assessment in 2 weeks period before intervention, change from baseline at immediately after the end of the intervention and after 3-months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe total sample of 60 subjects has a power of 80% to detect differences between means using an F test with a significance level of 0.05.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was estimated on the basis of our feasibility study evaluating the effects of NF training on cognitive performances in MCI subjects (registered at ClinicalTrials.gov under the identifier: NCT03526692, on 16 May 2018). In an analysis of covariance study (ANCOVA), sample sizes of 20 are obtained for each of the three groups whose expected averages of TMT B are 140 in the control group and 105\u00e2\u0080\u0089s in two intervention groups with a standard deviation of 45. The supposed R-squared of the model is 0.20. The total sample of 60 subjects has a power of 80% to detect differences between means using an F test with a significance level of 0.05.", "id": 303, "split": "train"} +{"trial_id": "NCT03527433", "pmid": "32616017", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Controlled Trial Comparing Wound COmplications in Elective Midline Laparotomies After FAscia Closure Using Two Different Techniques of Running Sutures: COFACTOR-trial\n\nIncluded conditions:\n- Wound Complication\n\nStudy Armgroups:\n- {'label': 'Standard arm', 'type': 'NO_INTERVENTION', 'description': 'In the standard arm, an average of one suture will be placed at each cm length of the wound, thus the number of sutures placed should be equal to the length of the wound in cm.'}\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'The intervention arm will undergo the alternative/new closure technique with small and close fascia sutures, where each suture will be placed only 5 mm away from the fascia edge and 5 mm apart from the adjacent fascia suture.', 'interventionNames': ['Procedure: New closure technique']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'New closure technique', 'description': 'In the intervention arm, an average of two sutures will be placed at each cm length of the wound, thus the number of sutures placed should be equal to at least double the length of the wound in cm.The aim is to have a ratio of 4:1 between the overall lengths of the suture to the length of the wound being closed', 'armGroupLabels': ['Intervention arm'], 'otherNames': ['Alternative closure technique']}\n\nPrimary Outcomes:\n- {'measure': 'Incisional hernia', 'description': 'We will define incisional hernia according to the European Society of Hernia: \"any abdominal wall gap with or without bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging\". (7) Using both clinical exam and imaging if performed, these hernias will be described according to their location along the midline, size of the defect using vertical and transverse measurements, and reducibility of any protruding viscera upon lying down or following gentle pressure by the examining hand. Also, we will collect information whether the hernia is causing any pain, discomfort, decrease in mobility, or any incidence of incarceration where the hernia contents protrude and does not reduce to the abdomen upon gentle pressure.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 5%, power of 80%, and a 30% loss to follow-up rate.", "answer": 274, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Millbourn et al. compared long to short continuous stitches and found a drop in incisional hernia rate at 1\u00e2\u0080\u0089year from 18 to 6% and a drop of SSI from 10 to 5% [6].\n In order to detect a drop of 12% in the incidence of incisional hernia, with an alpha of 5%, we will need to recruit 114 patients per arm to detect this difference with an\u00c2\u00a080% power thus a total of 228 patients\u00c2\u00a0need to be recruited into the trial. We are expecting a 30% loss to follow-up, so our adjusted target recruitment will be 274 subjects in total.\n After a thorough discussion with our institution\u00e2\u0080\u0099s admitting officers as well as clinicians and surgeons regarding follow-up visit rate, we reached the conclusion that approximately 30% of patients do not present for follow-up by 12\u00e2\u0080\u0089months.", "id": 304, "split": "train"} +{"trial_id": "NCT03528434", "pmid": "31349866", "question": "Here is the design of a clinical trial:\n\nOfficial Title: for Infection Prevention in Sickle Cell Anemia (ZIPS)\n\nIncluded conditions:\n- Sickle Cell Disease\n\nStudy Armgroups:\n- {'label': 'Zinc', 'type': 'EXPERIMENTAL', 'description': 'Dietary Supplement: Zinc 10mg dispersible zinc sulfate tablet', 'interventionNames': ['Dietary Supplement: Zinc']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Dispersible tablet with inert ingredients, identical to zinc in appearance', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Zinc', 'description': '10mg dispersible zinc sulfate tablet', 'armGroupLabels': ['Zinc']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Dispersible tablet with inert ingredients, identical to zinc in appearance', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of infection', 'description': 'The investigators will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.025 for a one-sided test or 0.05 for a two-sided test, 80% power, and a 10% loss to follow-up.", "answer": 250, "answer_type": "ACTUAL", "explanation": "Sample size and power calculation\n We will assess reduction in incidence of severe or invasive infections, with or without culture or PCR confirmation. Sample size is based on incidence of severe or invasive infections, using a baseline rate of 0.71 infections/child/year, derived from data of children from the NOHARM study [5]. Power calculations assume an alpha of 0.025 for a one-sided test or 0.05 for a two-sided test. With an incidence of 0.71 severe or invasive infections/year in the placebo group, a sample size of 250 children (with a 10% loss to follow-up) will have 80% power to detect a decrease of \u00e2\u0089\u00a5\u00e2\u0080\u008940% in severe or invasive infection incidence over the 12-month study period. This decrease is smaller than the 47\u00e2\u0080\u009388% reduction in clinical infection incidence in adolescents and adults in previous studies [40\u00e2\u0080\u009342], so the study sample size should allow us to detect the expected effects of zinc on infection incidence.", "id": 305, "split": "train"} +{"trial_id": "NCT03530852", "pmid": "36857339", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A 90 Day, Phase 3, Open Labeled Exploratory Study of RELiZORB to Evaluate Safety, Tolerability, and Nutrient Absorption in Children With Short Bowel Syndrome Who Are Dependent on Parenteral Nutrition\n\nIncluded conditions:\n- Short Bowel Syndrome\n- Malabsorption\n\nStudy Armgroups:\n- {'label': 'Relizorb treatment', 'type': 'EXPERIMENTAL', 'description': 'Patients will have tube feeds placed through chamber and evaluate wean from parenteral nutrition', 'interventionNames': ['Device: Relizorb']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Relizorb', 'description': 'Tube feeds run across device to digest fats.', 'armGroupLabels': ['Relizorb treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition based on PN calories', 'description': 'To determine the effectiveness of the RELiZORB enzyme cartridge on the absorption of enteral nutrition when used daily for a total 90 days of treatment, in pediatric subjects with SBS who are PN dependent, aged 2 years - 18 years, by measuring the change in PN calories from baseline, assessed at days 7, 14, 28, 60, and day 90. Each subject will be on the study for a total of 90 days.', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided alpha of 0.05 and 80% power were used. The standard deviation (SD) was considered to be 0.14, but a conservative estimate doubled the SD to 0.28. The confidence interval (CI) for a 20% reduction with SD = 0.14 was (0.75, 0.85), and with SD = 0.28 was (0.7, 0.9).", "answer": 32, "answer_type": "ESTIMATED", "explanation": "Sample size\n Precision-based power calculations were determined using nQuery Advisor 7.0 (GraphPad Software DBA Statistical Solutions, San Diego, CA). The primary outcome is the change in PN calories from baseline, assessed weekly at 13 assessments (study days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, and 90) using a baseline-adjusted time-weighted average (AUC7-90). In adults receiving teduglutide intended to improve enteral absorption in PN dependent patients with intestinal failure, an aim of 20% reduction was used to assess efficacy [9]. When adapted for a pediatric intestinal failure population, a \u00e2\u0089\u00a510% reduction was considered a valid pharmacodynamics (PD) marker of increased intestinal absorptive capacity. Based on the design of the teduglutide studies it was felt that the data provide similar support for a \u00e2\u0089\u00a510% reduction at Day 90 as a predictor of pharmacodynamic effect with the use of the RELiZORB device.\n A reliable estimate for the standard deviation (SD) of AUC7-90 for the primary outcome in this patient population is unavailable. Unpublished data for seven patients are available, but at least four of these would not meet the eligibility criteria for this study (ages 1\u00e2\u0080\u009310; one had a STEP procedure; three have pancreatic involvement). Nevertheless, the mean \u00c2\u00b1 SD reduction (AUC7-90) for these seven patients was 0.81\u00c2\u00b10.14, representing a 19% decrease over 90 days. Using this SD with a sample size of n = 32, a 20% observed reduction in outcome would provide a 95% confidence interval (CI) = (0.75, 0.85), ruling out a true mean population reduction smaller than 15%. Conservatively, if the SD was doubled (SD = 0.28), the 95% CI = (0.7, 0.9), excluding a true mean population reduction smaller than 10%, our target threshold. In general, for any continuous outcome, a sample size of n = 32 with two-side alpha = 0.05 will provide 80% power to detect an effect size (mean/SD) as small as 0.51, considered a medium-sized effect [16].", "id": 306, "split": "train"} +{"trial_id": "NCT03535935", "pmid": "33436470", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy, Safety and Response Predictors of Adjuvant Astragalus Therapy for Diabetic Kidney Disease (READY) - An Open-label Randomised Controlled Trial With Responder Regression Analysis\n\nIncluded conditions:\n- Diabetic Nephropathies\n- Diabetic Kidney Disease\n\nStudy Armgroups:\n- {'label': 'Standard medical care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Angiotensin converting enzyme inhibitor or angiotensin receptor blocker and oral hypoglycemic agents or insulin', 'interventionNames': ['Other: Routine medical care (active comparator)']}\n- {'label': 'Add on astragalus powder', 'type': 'EXPERIMENTAL', 'description': '3 grams of water soluble astragalus sachets (equivalent to 15g raw herbs) administrated orally on top of standard medical care for 48 weeks.', 'interventionNames': ['Drug: Astragalus Powder', 'Other: Routine medical care (active comparator)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Astragalus Powder', 'description': '3 grams of water soluble astragalus sachets (equivalent to 15g raw herbs) administrated orally on top of standard medical care for 48 weeks.\\n\\nPatients will have 5 days of medicine per week and will be advised to take the medicine once daily dissolved in boiling water in the first 5 days of the week.', 'armGroupLabels': ['Add on astragalus powder']}\n- {'type': 'OTHER', 'name': 'Routine medical care (active comparator)', 'description': 'Angiotensin converting enzyme inhibitor or angiotensin receptor blocker', 'armGroupLabels': ['Add on astragalus powder', 'Standard medical care']}\n\nPrimary Outcomes:\n- {'measure': 'Change in estimated GFR', 'description': 'Efficacy and safety', 'timeFrame': 'From baseline to 48 weeks after treatment'}\n- {'measure': 'Change in spot urine albumin-to-creatinine ratio', 'description': 'Efficacy and safety', 'timeFrame': 'From baseline to 48 weeks after treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to be 95% confident (two-sided) that the main study achieves a power of 70% with a nominal power set at 80% (10% power forfeit). An inflation factor (IF) of less than 1.13 is needed. A 15% attrition rate is considered.", "answer": 118, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Since the primary objective of this trial is to evaluate key clinical outcomes and to perform a preliminary analysis on potential response predictors, we calculated the sample size based on the control of inflation factor (IF) to the estimation of sample size for the subsequent large-scale studies.39 40 One hundred and eighteen patients (around 60 per group) are needed.\n \n \n \n \n \n I\n F\n =\n \n S\n \n u\n c\n l\n \n \n \n /\n \n \n S\n \n o\n b\n s\n \n \n =\n s\n q\n r\n t\n [\n (\n n\n \u00e2\u0088\u0092\n 1\n )\n \n /\n \n \n x\n \n 1\n \u00e2\u0088\u0092\n \u00ce\u00b1\n ,\n n\n \u00e2\u0088\u0092\n 1\n \n \n 2\n \n \n ]\n \n \n \n \n \n \n \n \n \n \n \n N\n \n a\n d\n j\n \n \n \n /\n \n \n N\n \n u\n n\n a\n d\n j\n \n \n \u00e2\u0089\u0088\n I\n \n F\n \n 2\n \n \n \u00e2\u0089\u0088\n \n n\n \n u\n n\n a\n d\n j\n \n \n \u00c3\u0097\n I\n \n F\n \n 2\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n N\n \n \n \u00e2\u0089\u0088\n [\n 2\n (\n \n Z\n \n 1\n \u00e2\u0088\u0092\n \u00ce\u00b1\n \n /\n \n 2\n \n \n +\n \n Z\n \n 1\n \u00e2\u0088\u0092\n \n \u00ce\u00b2\n \u00e2\u0080\u00b2\n \n \n \n \n )\n 2\n \n (\n I\n F\n \u00e2\u0088\u0097\n s\n \n )\n 2\n \n ]\n \n /\n \n (\n \n \u00ce\u00bc\n \n 1\n \n \n \u00e2\u0088\u0092\n \n \u00ce\u00bc\n \n 2\n \n \n \n )\n 2\n \n ]\n \n \n \n \n \n =\n [\n 2\n (\n \n Z\n \n 1\n \u00e2\u0088\u0092\n \u00ce\u00b1\n \n /\n \n 2\n \n \n +\n \n Z\n \n 1\n \u00e2\u0088\u0092\n \u00ce\u00b2\n \n \n )\n \n s\n 2\n \n ]\n \n /\n \n (\n \n \u00ce\u00bc\n \n 1\n \n \n \u00e2\u0088\u0092\n \n \u00ce\u00bc\n \n 2\n \n \n \n )\n 2\n \n ]\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n Z\n \n 1\n \u00e2\u0088\u0092\n \n \u00ce\u00b2\n \u00e2\u0080\u00b2\n \n \n \n =\n \n Z\n \n 1\n \u00e2\u0088\u0092\n \u00ce\u00b1\n \n /\n \n 2\n \n \n (\n I\n \n F\n \n \u00e2\u0088\u0092\n 1\n \n \n \u00e2\u0088\u0092\n 1\n )\n +\n \n Z\n \n 1\n \u00e2\u0088\u0092\n \u00ce\u00b2\n \n \n \u00e2\u0088\u0097\n I\n \n F\n \n \u00e2\u0088\u0092\n 1\n \n \n \n \n \n \n \n where\n IF=Inflation factor.\n Sucl=SD of upper CI.\n Sobs=Observed SD in pilot study.\n \u00ce\u00b1=Chosen confidence level.\n \u00e1\u00ba\u009e=Nominal power set for main study.\n \u00e1\u00ba\u009e\u00e2\u0080\u00b2=Actual power achieved for main study by using pilot SD for sample size calculation.\n n=Sample\u00e2\u0080\u0089size of pilot study.\n N=Sample\u00e2\u0080\u0089size of main study.\n Nunadj=Sample\u00e2\u0080\u0089size of main study with no adjustment on SD.\n Nadj=Sample\u00e2\u0080\u0089size of main study with adjustment on SD.\n The SD used for sample size calculation for large-scale main studies is often underestimated by small-scale pilot studies; therefore, an IF is needed for adjustment in sample size calculation.39 40 IF is calculated based on the size of pilot study and the confidence level of achieving at least the desired power in subsequent main studies. Therefore, the actual achieved power of the main studies depends on the nominal power set for the main study and the IF.\n In order to be 95% confident (two-sided) that the main study achieves a power of 70% with nominal power set at 80% (ie, a 10% power forfeit), the IF should be controlled to less than 1.13. At IF=1.13, a sample size of 100 is therefore needed to attain 95% one-sided confidence that the main studies will achieve the nominal power to test the hypothesis of add-on astragalus could be more effective in stabilising the GFR among patients with DKD when compared with standard care. To allow a 15% attrition rate, a sample size of 118 patients is therefore needed for this pilot study.\n Currently, there is limited evidence on the symptom-based response predictors of astragalus. A general recommendation for power estimation is to have 10 events per variable.41 From the previous systematic review, we estimate that around 60% of patients will have stabilised GFR after receiving astragalus.31 One hundred and eighteen subjects with 15% attrition will power up to six variables for the screening of predictors. A univariable screening on the 11 prespecified potential symptom-based predictors will be conducted to reduce the number of predictors for the subsequent multivariable regression analysis, in order to maximise the power of the regression analysis.", "id": 307, "split": "train"} +{"trial_id": "NCT03538678", "pmid": "30808389", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Just Kwit: Mobile Intervention for Tobacco Cessation\n\nIncluded conditions:\n- Smoking Cessation\n\nStudy Armgroups:\n- {'label': 'Kwit app', 'type': 'EXPERIMENTAL', 'description': 'Use of Kwit smartphone app', 'interventionNames': ['Other: Kwit smartphone app']}\n- {'label': 'Standard of care', 'type': 'NO_INTERVENTION', 'description': 'Patient initiated follow-up post discharge'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Kwit smartphone app', 'description': 'Kwit smarphone app', 'armGroupLabels': ['Kwit app']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility - Helpfulness and Ease of Use of the Intervention Smartphone App', 'description': 'Assessment of feasibility - Descriptive statistics that will be obtained via a follow up survey will be used to assess feasibility. The follow up survey will be administered one month after discharge via email, phone or in-person, determined by the preference of the participant. Specific questions will be asked asking participants to rate the Kwit smartphone application based on helpfulness, ease of use, and to list frustrations and helpful aspects of the application.\\n\\nHow helpful was the Kwit app? Very helpful Somewhat helpful Neutral Not very helpful Not at all helpful\\n\\nWas the app easy to use? Very Somewhat Neutral Not much Not at all\\n\\nWas it frustrating to use? Very Somewhat Neutral Not much Not at all\\n\\nWhat, if anything, was helpful about the app? What, if anything, was not helpful about the app?', 'timeFrame': '1-month'}\n- {'measure': 'Feasibility - Frequency of Use', 'description': 'Assessment of feasibility - Descriptive statistics that will be obtained via a follow up survey will be used to assess feasibility. The follow up survey will be administered one month after discharge via email, phone or in-person, determined by the preference of the participant. Specific questions will be asked asking participants to rate the Kwit smartphone application based on frequency of use.', 'timeFrame': '1-month'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated; formal sample size calculation is not appropriate.", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size\n Given this is a feasibility trial, a formal sample size calculation is not appropriate [17]. For the current study, we are informed by quantitative usability-testing recommendations that suggest a sample size of 20 [19]. Because we wish to stratify by birth sex, we obtained our sample size of 40 individuals. While we expect this to be more than sufficient, we will remain flexible in our approach and will recruit additional individuals if necessary.", "id": 308, "split": "train"} +{"trial_id": "NCT03542903", "pmid": "33858488", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia\n\nIncluded conditions:\n- Schizophrenia\n- Electroconvulsive Therapy\n\nStudy Armgroups:\n- {'label': 'Short ECT arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the short arm, bitemporal ECT is administered twice a week during the first 6 weeks. Afterwards, it is administered once a week during 4 weeks. After that, the patients will have one ECT every 3 weeks during 6 weeks. Lastly, patients will receive one ECT each month during 2 months.', 'interventionNames': ['Device: Electroconvulsive therapy']}\n- {'label': 'Long ECT arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the long arm, bitemporal ECT is administered twice a week during the first 12 weeks. Afterwards, it is administered once a week during 8 weeks. After that, the patients will have one ECT every 3 weeks during 12 weeks. Lastly, patients will receive one ECT each month during 4 months.', 'interventionNames': ['Device: Electroconvulsive therapy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Electroconvulsive therapy', 'description': \"Electroconvulsive therapy is administered through electrodes positioned bilaterally (for quicker efficacy) on the frontotemporal region.\\n\\nThe stimulation dose is determined by titration method, during the first ECT session.\\n\\nThe dose for therapeutic stimulation will be twice the seizure threshold. This dose may be increased as the crisis does not meet the effectiveness criteria, as is recommended.\\n\\nFor patients undergoing ECT, an intravenous injection of etomidate (between 0.1 and 0.7 mg/kg) and suxamethonium chloride (0.8 and 1.2 mg/kg) is performed. The required doses are adapted according to each patient by the anaesthetist and they are documented in the patients' files. A mixture of etomidate and propofol can be used in second-line or just propofol in third-line (no more than 2mg/kg).\", 'armGroupLabels': ['Long ECT arm', 'Short ECT arm']}\n\nPrimary Outcomes:\n- {'measure': 'The response rate (a 30% decrease in the Positive and Negative Syndrome Scale (PANSS)) at 15th month', 'description': 'The response rate (a 30% decrease in the PANSS, ranging from 30, the minimum, to 210, the most severe score) at 15th month', 'timeFrame': 'three months after the end of the treatment (i.e. 9 and 15 months)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk (significance level) is 0.05, power is 0.80, and the estimated dropout rate is 20%.", "answer": 64, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The aim of this trial is to compare the response rates between short and long ECT protocols. According to the meta-analysis of Lally et al. [7], the proportion of patients with treatment-resistant schizophrenia that responds to ECT augmentation of clozapine was 61.79% (Table 1: 55/89 cases). However, the relapse following ECT cessation is very high: the relapse rate has been estimated at 62.5% by Kho et al. [18]. On the other hand, Braga et al. [19] suggested that ECT were effective as a continuation strategy to prevent relapse after an acute course of ECT. During the 6-month maintenance period, no patient presented with clinically worsening symptoms. From this literature data, we postulate that the responder rates would be 61.79% in the long ECT protocol and 23.25% in the short ECT protocol (62%\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089(1\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.625)\u00e2\u0080\u0089=\u00e2\u0080\u008923.25%). Assuming an alpha risk of 0.05 and a power of 0.80, we estimated the need to include 25 patients per group. To overcome an estimated 20% drop-out, the required number of patients increased to 32 patients per group. As a result, the total number of participants required for the study is 64 patients.", "id": 309, "split": "train"} +{"trial_id": "NCT03545334", "pmid": "31689874", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Diagnostic Sensitivity Study Comparing Intradermal ICG and NIRFI With Intradermal Technetium 99m and Traditional Lymphoscintigraphy for Transcutaneous Identification of Sentinel Lymph Nodes in Malignant Melanoma\n\nIncluded conditions:\n- Malignant Melanoma\n- Merkel Cell Carcinoma\n\nStudy Armgroups:\n- {'label': 'Comparison result lymphoscintigraphy with ICG lymphography', 'type': 'EXPERIMENTAL', 'description': 'The patient first receives a standard Tc-99m-based lymphoscintigraphy. The identified lymph nodes are not marked in the patients, so that the surgeons are not affected in lymph node identification during ICG and near infrared fluorescence imaging. The surgeon also has no access to lymphoscintigraphy images.\\n\\nTranscutaneous ICG lymphography is then performed by intradermal injection of ICG around the scar of the primary tumor excision and transcutaneous fluorescence evaluation with the Visionsense\u2122 VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD) and results are compared.', 'interventionNames': ['Diagnostic Test: Visionsense\u2122 VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD)']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Visionsense\u2122 VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD)', 'description': 'Injection of ICG intradermally around the scar of the primary excision of the tumour and transcutaneous assessment of fluorescence with the VS3-3DHD camera (Visionsense\u2122 VS3 - Stereoscopic High Definition Visualisation System ).', 'armGroupLabels': ['Comparison result lymphoscintigraphy with ICG lymphography'], 'otherNames': ['Indocyanin green (ICG)']}\n\nPrimary Outcomes:\n- {'measure': 'Correlation of sentinel lymph nodes identified by lymphoscintigraphy vs. VisionSense near-infrared-fluorescence-imaging.', 'description': 'To determine whether the VisionSense NIRFI technology can transcutaneously identify SLNs as effectively as LS.', 'timeFrame': 'one hour'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence interval with a maximum clinically acceptable width of 10% (50%-70%).", "answer": 93, "answer_type": "ACTUAL", "explanation": "2.8\n Statistical analysis and sample size calculation\n The statistical analysis will be performed by a statistician at the end of the study (ie, when all patients are included). Baseline characteristics will be reported as mean and standard deviation or median and interquartile range, and number and percentage of patients for continuous and categorical variables, respectively.\n The sensitivity (ie, the proportion of NIRFI and LS positive LN among LS positive LN) will be reported with a 95% confidence interval (CI) and adjusted for multiple observations per patients using generalized estimating equations[19] or the method by Rao and Scott.[20] The number of LS-negative LNs that are NIRFI positive will be reported.\n Data relating to the ability of SLNs to be successfully identified transcutaneously by NIRFI will be grouped anatomically and according to patients\u00e2\u0080\u0099 characteristics (eg, BMI, sex, and age) and afterward analyzed to determine if certain anatomical regions or patient groups have different sensitivity rates.\n Only patients with positively identified LNs in LS will be included in the study and there will be no missing data from the LS. We do not expect any or only a small number of missing NIRFI data. However, patients with missing data in NIRFI will be excluded from the main analysis. For a sensitivity analysis, we will assume that all missing NIRFI results will be negative. The number of missing data will be reported together with the reasons behind their absence.\n All of the patients will have at least 1 positive LN in LS, but there could also be cases with more than 1 LN per patient, increasing the precision of the sensitivity estimate. As it is not possible to make a reasonable assumption about the number of LNs per patient and the correlations of the measurements within a patient, we will recruit 93 patients. Sample size at the required absolute precision level for sensitivity was calculated with Buderer formula.[19,20] We assumed a sensitivity of 60% (based on Namikawa et al \u00e2\u0080\u0093 identification rate with ICG of 63.4% before skin incision[16]) and a maximum clinically acceptable width of the 95% CI of 10% (ie, 50%\u00e2\u0080\u009370%), for a total of 93 LNs identified by LS.", "id": 310, "split": "train"} +{"trial_id": "NCT03547661", "pmid": "32071176", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial\n\nIncluded conditions:\n- Premenstrual Syndrome\n\nStudy Armgroups:\n- {'label': 'Treatment as Usual', 'type': 'NO_INTERVENTION', 'description': 'The treatment as usual (TAU) group will control for regression to the mean, spontaneous remission, natural course of disease, and the participants-provider interaction. Participants of the TAU group are allowed to continue their usual medication intake, given they are already on a stable dose (at least 30 days of intake) and the medication is not listed in the exclusion criteria.'}\n- {'label': 'Integrative Open-Label Placebo', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention will encompass an integrative administration of \"P-Dragees rosa Lichtenstein\", which are pink placebo drag\u00e9es without any active ingredient. Each drag\u00e9e contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000.\\n\\nAll participants will be informed that the administered drag\u00e9es are placebo drag\u00e9es and participants will be instructed to take two drag\u00e9es a day for six weeks. (Amendment regarding dosage since 08/18)', 'interventionNames': ['Other: P-Dragees rosa Lichtenstein']}\n- {'label': 'Open-Label Placebo', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention will encompass an administration of \"P-Dragees rosa Lichtenstein\", which are pink placebo drag\u00e9es without any active ingredient. Each drag\u00e9e contents the following substances: lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; highly dispersed silicon dioxide; white clay, macrogol glycerolhydroxy stearate (Ph. Eur.); Arabic gum; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); erythrosine; aluminium salt (E 127); calcium carbonate; sucrose; glucose syrup; maize starch; macrogol 6000.\\n\\nAll participants will be informed that the administered drag\u00e9es are placebo drag\u00e9es and participants will be instructed to take two drag\u00e9es a day for six weeks. (Amendment regarding dosage since 08/18)', 'interventionNames': ['Other: P-Dragees rosa Lichtenstein']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'P-Dragees rosa Lichtenstein', 'description': 'Placebo drag\u00e9es', 'armGroupLabels': ['Integrative Open-Label Placebo', 'Open-Label Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'PMS symptom intensity assessed by a PMS symptom diary sub sum score', 'description': 'Symptom intensity will be assessed by an intensity sub scale of the PMS symptom diary. Intensity will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of symptom intensity and 6 the highest.', 'timeFrame': 'Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)'}\n- {'measure': 'PMS symptom interference assessed by a PMS symptom diary sub sum score', 'description': 'Symptom interference will be assessed by an interference sub scale of the PMS symptom diary. Interference will be rated by means of a six-level Likert scale, whereat 1 is the lowest rating of interference and 6 the highest.', 'timeFrame': 'Continuous measurement, starting from day 1 of the menstrual cycle (length of each cycle is on average 28 days) until the individual last day of the third menstrual cycle of each participant (assessment across three menstrual cycles in total)'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) is set at 0.05. Power is considered at 0.8 and 0.9. A multilevel approach is adopted for more precise estimations. Correlation among different time points is assumed to be 0.5.", "answer": 150, "answer_type": "ACTUAL", "explanation": "Sample size and statistical analysis of data\n \n Data management\n For data management, Microsoft Excel and LabKey, which is hosted by the University of Basel, is used. Study data are collected at the web server-based software LimeSurvey. Only authorised study team members are able to view and export data. Entries and actions are marked with the initials of the respective study member.\n \n \n Sample size\n A calculation with a power analysis on the basis of an F-test and an analysis of covariance for three groups, using the statistical software G*Power, indicated a total sample size of 206 participants needed for a power of 0.9 and a total sample size of 158 participants for a power of 0.8 to detect a medium effect size of f=0.25 (equals d=0.5) with an alpha-level of 0.05.\n Since we will adopt a multilevel approach which enables more precise estimations, we also conducted a power analysis on a repeated-measures analysis of variance, using G*Power, whereby we are interested in the interaction between time (menstrual cycles, 3 levels) and study groups (3 levels). If the correlation for the outcome among the different time points (1\u00e2\u0080\u00933 cycles) is assumed to be 0.5, then based on an alpha-level of 0.05, a power of 0.8 and a medium effect size of f=0.25, the required samples size is 36 (12 per group). Accordingly, for the main effect of menstrual cycle, we would need 30 participants (10 per group), and for the main effect of study group we would need 108 participants (36 per group). On this basis, we chose a conservative total sample size of 150 participants (50 per group). It is worth noting that most OLP studies reported effect sizes that are generally higher than d=0.5 (eg, chronic low back pain: d=0.771; irritable bowel syndrome: d=0.79).2 However, in another OLP study for patients suffering from major depressive disorder,5 the authors reported an effect size of d=0.54 while stating that the study was limited by low statistical power (ie, the findings did not support the hypothesis that OLPs are effective in depression). Since PMS is not only characterised by physical complaints, yet also by psychological symptoms such as depressive mood, and since there is no specific research on OLP effects and effect sizes in PMS, we considered a conservative medium effect size as more appropriate. This resulted in a more conservative sample size.\n \n \n Statistical analysis\n For the testing of the primary hypotheses, the daily data from three menstrual cycles of a symptom diary is examined. Because of the hierarchical structure of the data (menstrual cycles as level-1 are nested within participants as level-2) and given our aim to predict post-interventional changes between menstrual cycles as the primary outcome, a multilevel modelling approach will be adopted. Multilevel models take care of the interdependence of the hierarchical data that arises due to the fact that observations within the same individual are typically more similar to each other compared to observations between individuals.30 31 Here, we will analyse temporal changes across menstrual cycles of symptom intensity and interference among the different study groups. To compare a TAU group with two intervention groups and to evaluate the effect of the applied treatment rationale, the following linear a priori contrast will be tested for the factor study group: TAU\u00e2\u0080\u0089100 mmHg) and pulmonary vs. extrapulmonary ARDS.\n All analyses will be performed using the R software and subgroups will be evaluated using the chi-square test for homogeneity, we will employ the statistical software R Project Version 4.1.3 for Windows to carry out the analyses.\n \n \n Data monitoring committee\n A Data Monitoring Committee comprising independent epidemiologists and intensivists will be established to oversee the study. The committee will be responsible for assessing the potential risks and benefits associated with the research, and will provide recommendations on whether to continue with the planned study or cease recruitment. This decision will be based on evidence indicating a higher mortality rate in the experimental group compared to the control group. Any safety-related adverse events will be promptly reported to the site\u00e2\u0080\u0099s Institutional Review Board (IRB). Site investigators will be informed of the event and will subsequently submit a comprehensive written report to the local IRB. Sites will notify the research team of any related adverse events within a week of their discovery and complete the appropriate eCRF. The research team will provide the Data Monitoring Committee with summaries of all reports at least biannually. The Committee will convene via teleconference or in-person meetings at 25%, 50%, and 75% of enrollment, or earlier if necessary, to review adverse events.\n \n \n Ethics and dissemination\n The protocol has received approval from the Ethics Committee of West China Hospital of Sichuan University (approval number 2019\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u0089337). Additionally, approvals for the protocol and informed consent documents are obtained from the Institutional Review Board of each participating institution before enrolling study participants. Written informed consent is required and obtained from legally authorized representatives at the respective study site. Trial methods and results will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines [42]. The primary outcome of the study will be published as the first article and additional results extrapolated from the data could be published in separate articles. The findings of this study will be disseminated in peer-reviewed journals, presented at scientific conferences, and shared with the practice.\n \n \n Protocol amendments\n Any modifications to the study will prompt simultaneous protocol adjustments, which will be promptly submitted for approval to the institutional review board. The changes will only be executed following the endorsement of the ethical committee. Upon approval, the amendments will be disseminated to other participating sites, and ClinicalTrials.gov will be promptly updated regarding any significant changes. If required, the study team will provide protocol training for the amendments.", "id": 313, "split": "train"} +{"trial_id": "NCT03549910", "pmid": "38783268", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter, Random Control Study: Early Use of Airway Pressure Release Ventilation Updated (APRVplus) Protocol in Acute Respiratory Disease Syndrome (ARDS)\n\nIncluded conditions:\n- Acute Respiratory Distress Syndrome\n\nStudy Armgroups:\n- {'label': 'Early use of APRVplus protocol in ARDS', 'type': 'EXPERIMENTAL', 'description': 'physiology-driven APRVplus protocol', 'interventionNames': ['Procedure: APRVplus protocol']}\n- {'label': 'Low tidal volume ventilation', 'type': 'OTHER', 'description': 'Low tidal volume lung protective ventilation', 'interventionNames': ['Procedure: Low tidal volume ventilation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'APRVplus protocol', 'description': 'Physiology-driven APRVplus protocol', 'armGroupLabels': ['Early use of APRVplus protocol in ARDS']}\n- {'type': 'PROCEDURE', 'name': 'Low tidal volume ventilation', 'description': 'Low tidal volume lung protective ventilation', 'armGroupLabels': ['Low tidal volume ventilation']}\n\nPrimary Outcomes:\n- {'measure': 'mortality', 'description': 'mortality at Day28', 'timeFrame': 'Day 28'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-sided significance level of 0.05, and approximately 10% loss in follow-up.", "answer": 840, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on previous research indicating a 37% mortality rate at ICU 28 days among moderate-severe ARDS patients receiving low tidal volume ventilation strategy [41], we postulated a 10% reduction in ICU 28-day mortality following the implementation of the early pathophysiology-directed APRV ventilation strategy compared to low tidal volume lung protective ventilation. Considering a hazard ratio of 0.66, a 90% power, and a two-sided significance level of 0.05, it is estimated that 762 patients are required to detect this difference. Accounting for approximately 10% loss in follow-up, enrollment of 840 patients (420 in each group) is necessary. An interim analysis will be conducted once 50% of the sample size is reached.\n \nTable 2Overview of the schedule of enrolment, interventions and assessmentsAPRV airway pressure release ventilation, LTV low tital ventilation", "id": 314, "split": "train"} +{"trial_id": "NCT03553355", "pmid": "31441863", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients\n\nIncluded conditions:\n- Cancer-related Fatigue\n\nStudy Armgroups:\n- {'label': 'Infrared Laser Moxibustion Therapy', 'type': 'EXPERIMENTAL', 'description': 'Each patient will receive this treatment twice per week for six weeks (12 sessions total).', 'interventionNames': ['Device: Infrared Laser Moxibustion']}\n- {'label': 'Sham Infrared Laser Moxibustion Therapy', 'type': 'SHAM_COMPARATOR', 'description': 'The patients will receive treatment from sham laser moxibustion instrument.', 'interventionNames': ['Device: Sham Infrared Laser Moxibustion']}\n- {'label': 'Waitlist Controls', 'type': 'NO_INTERVENTION', 'description': 'The patients maintain their usual treatment and self-care,'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Infrared Laser Moxibustion', 'description': 'We will use SX10-C1 laser moxibustion devices (Shanghai Wonderful Opto-Electrics Tech Co Ltd, Shanghai, China) for the ILM and SILM groups. Four laser probes will be synchronously aligned with 4 points (tST36 (bilateral), CV4, and CV6 acupoints) and we will irradiate each acupoint 2 cm away from the skin surface for 20 minutes. Each patient will receive this treatment twice per week for six weeks (12 sessions total).', 'armGroupLabels': ['Infrared Laser Moxibustion Therapy']}\n- {'type': 'DEVICE', 'name': 'Sham Infrared Laser Moxibustion', 'description': 'The sham laser moxibustion instrument appears to be identical as the real one.', 'armGroupLabels': ['Sham Infrared Laser Moxibustion Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Chinese version of the Brief Fatigue Inventory (BFI-C)', 'description': 'The Chinese version of the Brief Fatigue Inventory (BFI) : It uses 10-point numeric descriptions: scores of 1 to 3 represent mild levels of fatigue, scores of 4 to 6 represent moderate levels of fatigue, and scores of 7 to 10 represent severe levels of fatigue.', 'timeFrame': 'Change from Baseline BFI-C at 6 weeks'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 5%, power of 80%, and a 20% attrition rate.", "answer": 140, "answer_type": "ACTUAL", "explanation": "3.15\n Statistical analysis and sample size calculation\n Standard descriptive statistics will be used to analyze baseline participant characteristics. We will produce summary statistics such as means, medians, standard deviations, and ranges for measured variables. We will tabulate frequencies for categorical and ordinal variables. We will use graphical methods extensively to examine distributions, identify potentially influential points, and guide data transformations if warranted. For continuous variables with markedly non-normal or skewed distributions, appropriate transformation may be required, such as natural logarithms, which we will apply as necessary and appropriate.[43] In the sections below, we will assume, when discussing particular outcomes, that the appropriately transformed variables will be used. We will perform analysis according to the intention-to-treat (ITT) principle (i.e., subjects will be analyzed according to the treatment group to which they will be randomly allocated regardless of drop-out).\n To determine the effects of ILM on fatigue, we will use mixed effects models.[44] This statistical procedure takes into account within-subject correlations from repeated measurements in the same subjects and allows estimation of between-group difference without necessitating that the last observation is carried forward or exclusion of participants with missing data. Tests of ITT differences between intervention arms with respect to change in BFI-C will be based on time-intervention interactions in the mixed-effects models. Although randomization theoretically balances the potential confounders between treatment groups, occasional unequal distribution can be seen. Should this happen, the effect of confounding will be evaluated by including the potential confounders as co-variates in the models.[43] For secondary outcomes, we will use similar analytical strategies for co-morbid symptoms. To evaluate the long-term durability of treatment effect, we will display long-term data descriptively. It is possible that the long-term outcome may display different patterns from short-term therapeutic effect. If this occurs, we may need to create piece-wise linear mixed-effects models to fit the data and test for statistical significance on outcome change among treatment groups.\n We have based our sample size calculation on our preliminary study. We plan to enroll and randomize 140 participants (2:2:1) to ILM, SILM, and WLC. Assuming a 20% attrition rate, we will have 45 participants in each of the ILM and SILM groups and 22 participants in the WLC group who will provide evaluable outcomes. In our previous study, we found that ILM produced a greater reduction in BFI-C intensity at the end of intervention (Week 4 from baseline) at a magnitude of 0.60 SD (Standard Deviation) as compared to SILM. Given an alpha of 5%, with 45 subjects in each of the ILM and SILM groups, we will be able to detect a between-group difference of reduction in BFI-C of 0.60 SD with 80% power. With 45 subjects each in the ILM and SILM groups and 22 participants in the WLC group, a power of 80% and two-sided alpha of 0.05, we will be able to detect an effect size of 0.71 SD (i.e., difference of reduction in BFI-C) between ILM and WLC or SILM and WLC groups. This is a conservative way to estimate sample size since the longitudinal analysis using all repeated measures with the mixed-effects model specified in the analysis plan will provide higher power than a t test.", "id": 315, "split": "train"} +{"trial_id": "NCT03553979", "pmid": "30021551", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Project Grip&Health: A Behavioural Intervention Which Uses an Integral Approach to Reduce Stress, Smoking, Improve Financial Health and Self-perceived Health of Low SES-residents in Rotterdam\n\nIncluded conditions:\n- Smoking Cessation\n- Smoking, Cigarette\n- Smoking\n- Stress\n- Stress, Psychological\n- Health Behavior\n- Smoking, Tobacco\n\nStudy Armgroups:\n- {'label': 'Stress management program (SM)', 'type': 'EXPERIMENTAL', 'description': 'The stress management program (SM) is a program which has been tailored to meet the specific needs of low-SES participants. The SM consists of 4-weekly sessions (1.5hours/session) and a follow-up session 8 weeks later. A core element of SM is its group-based format in which psycho-educative topics on stress responses and coping and motivation to stop smoking link up with cognitive and behavioural technique activities.', 'interventionNames': ['Behavioral: Stress management program (SM)']}\n- {'label': 'Stress management + Buddy program (SM-B)', 'type': 'EXPERIMENTAL', 'description': 'The stress management + buddy program (SM-B) includes the same psycho-educative topics and exercises, cognitive and behavioural technique activities as the SM condition. The SM-B in addition to SM utilises one-to-one support through a buddy selected by a participant. A buddy, 18 year or older is a student or a volunteer who is recruited and trained by Indigo Rijnmond. The buddy pairs up with a participant and provides the following: supports participant in managing and filling in tax/welfare papers; 2) helps a participant to get a grip over his/her personal finances; and 3) helps a participant to overcome daily barriers (eg. arranging childcare). Over the duration of the course, the buddy meets up 6 times with a participant every second week in a public area.', 'interventionNames': ['Behavioral: Stress management + Buddy program (SM-B)']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control condition are instructed to continue with their normal daily behaviour. They will be invited to complete the questionnaires and objective measurements at the equivalent times as the intervention groups, thus at baseline, 4 weeks after baseline and 12 weeks after baseline. After the control period, participants in the control condition will be offered the intervention.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Stress management program (SM)', 'description': 'Participants follow the SM program.', 'armGroupLabels': ['Stress management program (SM)']}\n- {'type': 'BEHAVIORAL', 'name': 'Stress management + Buddy program (SM-B)', 'description': 'In addition to receiving the SM, participants in the SM-B will also receive one-to-one support through a buddy.', 'armGroupLabels': ['Stress management + Buddy program (SM-B)']}\n\nPrimary Outcomes:\n- {'measure': 'Self-reported Stress', 'description': 'Change in self-reported Stress.\\n\\nThe Depression, Anxiety and Stress (DASS) questionnaire will be used to measure change in self-reported stress from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2).\\n\\nThe DASS is a 21-item questionnaire with three self-report scales (Depression, Anxiety and Stress). Scores for depression, anxiety and stress are determined by summing the scores of the 21 items. Ranges for depression, anxiety and stress are 0-28, 0-20, and 0-33, respectively. Lower scores indicate less severity.\\n\\nIn this study participants will be asked to complete the DASS-21 questionnaire at three different time points (T0, T1 and T2). This is done so the investigators can assess the change in scores of self-reported stress across time points (T0, T1 and T2).', 'timeFrame': 'at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)'}\n- {'measure': 'Objective Stress', 'description': \"Change in objective evaluations of stress based on heart rate variability (HRV) from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2).\\n\\nHRV indicates variability of time intervals between two consecutive heartbeats with each heartbeat having a R-wave which peaks in the R peak. The variations between two RR intervals are defined as HRV. A higher HRV value reflects a greater variation of the RR whereas a lower HRV indicates small variation.\\n\\nParticipants beat-to-beat heart rate is measured using wrist wearables provided by Philips. During the measurements, the wearables are mounted on a participant's wrist and the participant is instructed to sit in a resting state for five minutes while the beat-to-beat heart rate is recorded. HRV analysis is derived from the recorded data using an appropriate software program. To assess change over time points (T0, T1 and T2), participants's beat-to-beat heart rate will be measured at three time points\", 'timeFrame': 'at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)'}\n- {'measure': 'Self-reported Smoking', 'description': 'Change in self-reported Smoking.\\n\\nThe Global Adult Tobacco Survey (GATS) questionnaire will be used to measure change in self-reported smoking from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2).\\n\\nParticipants will be asked to complete the questionnaire at three time points (T0, T1 and T2). This is done so the investigators can assess the change in self-reported smoking across time points.', 'timeFrame': 'at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)'}\n- {'measure': 'Dependence of nicotine', 'description': \"Fagerstrom Test for Nicotine Dependence (FTND) questionnaire will be used to measure change in level of nicotine dependence from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2).\\n\\nThe FTND test is used to assess the intensity of physical addiction to nicotine. The test is designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluates the quantity of cigarette consumption, the compulsion to use and dependence. Yes/No items on FTND are scores from 0-1 and multiple choice items are scores from 0-3. The items are summed to yield a total score of 0-10. The higher the FTND, the more intense a participant's physical dependence on nicotine.\\n\\nIn this study, participants will be asked to complete the FTND at three time points (T0, T1 and T2). This is done so the investigators can assess the change in the level of nicotine dependence across time points.\", 'timeFrame': 'at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)'}\n- {'measure': 'Carbon Monoxide breath test', 'description': \"Change in exhaled Carbon Monoxide (CO) levels from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2).\\n\\nThe CO breath test is a biological method used to verify smoking or non-smoking status of participants.\\n\\nIn this study, participants's exhaled CO levels will be measured (Micro SmokeLyzer; Bedfont, UK). A CO level \u226510 ppm reflects a heavy smoker. During the measurements, participants are instructed to hold their breath for 15 seconds and subsequently to slowly exhale into a mouthpiece connected to the SmokeLyzer device until their lungs are empty.\\n\\nParticipants CO levels will be recorded at three time points (T0, T1 and T2). This is done so the investigators can assess the change in C0 levels across time points.\", 'timeFrame': 'at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)'}\n- {'measure': 'Self-perceived health', 'description': 'The Short Form Health Survey version 2 (SF-12v2) questionnaire will be used to measure change in self-perceived health from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2).\\n\\nThe SF-12v2 is a 12-item with three dimensions both for functioning (physical, social and role) and for wellbeing (mental health, general health perceptions and pain). In this study, participants will be asked to rate their general health on a Likert-type scale (1=poor, 2=fair, 3= good, 4= very good, and 5=excellent). Low scores (poor) on the general health scale represent a person who believes his/her health to be poor and high score (excellent) represents someone who sees his/her health as excellent.\\n\\nParticipants will be asked to complete the SF-12v2 questionnaire at three time points (T0, T1 and T2). This is done so the investigators can assess the change in health perceptions across time points.', 'timeFrame': 'at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)'}\n- {'measure': 'Financial health', 'description': \"Change in participant's's financial health will be measured from baseline (T0), at 4 weeks after baseline (T1) and at 12 weeks after baseline (T2).\\n\\nIn this study, participants's financial health will be measured by asking them to report: 1) their total monthly income; 2) their spouse/partner's total monthly income; and 3) money shortages experienced in the past month.\\n\\nParticipants will be asked to fill this questionnaire in at three time points (T0, T1 and T2). This is done to assess changes in financial health across time points.\", 'timeFrame': 'at baseline (T0), 4 weeks after baseline (T1) and 12 weeks after baseline (T2)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha error of 0.05, power of 0.80, and an expected attrition rate of 10%.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Sample size calculations are based on the primary outcome measures (stress, smoking, and perceived health). To the best of our knowledge, no previous studies have evaluated a similar intervention in low-SES groups. Therefore, it is challenging to determine a prior the necessary sample size for multicomponent behavioral interventions. Previous studies that have evaluated similar components on other outcome measures recommend to aim for a sample size of 20-500 participants per intervention condition with an alpha error of 0.05 and a power of 0.80. to detect the expected effect. Assuming expected attrition of 10%, an initial sample of 300 participants are needed, thus 150 in each intervention condition. All power calculations are done using G*Power [76].", "id": 316, "split": "train"} +{"trial_id": "NCT03558178", "pmid": "31079083", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: A Multi-center Randomized Controlled Trial\n\nIncluded conditions:\n- Chronic Neck Pain\n\nStudy Armgroups:\n- {'label': 'Doin with Acupuncture', 'type': 'EXPERIMENTAL', 'description': 'An acupuncture physician will administer acupuncture at a total 6-12 acupoints in the upper and middle trapezius areas (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels). Cervical Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise as indicated.', 'interventionNames': ['Procedure: Doin with acupuncture', 'Device: Acupuncture']}\n- {'label': 'Acupuncture', 'type': 'ACTIVE_COMPARATOR', 'description': 'An acupuncture physician will administer acupuncture at a total 6-12 acupoints in the upper and middle trapezius areas (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels).', 'interventionNames': ['Device: Acupuncture']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Doin with acupuncture', 'description': 'Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise as indicated. Doin sessions will be conducted 2 times a week for 5 weeks (total 10 sessions).', 'armGroupLabels': ['Doin with Acupuncture'], 'otherNames': ['Doin Exercise with acupuncture', 'Do-in Exercise with acupuncture', 'Conduction Exercise with acupuncture']}\n- {'type': 'DEVICE', 'name': 'Acupuncture', 'description': 'Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks (total 10 sessions).', 'armGroupLabels': ['Acupuncture', 'Doin with Acupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'Difference between visual analogue scale (VAS) of neck pain for the past 3 days at 5 weeks post-baseline and baseline', 'description': \"VAS uses a 10cm line labeled at each end with scale anchors. In pain measurement using VAS, patients are asked to mark a point that represents their pain between the anchors of 'no pain' and 'worst pain possible' (labels may vary by study). Scores are recorded in millimeters with a total range of 0-100 millimeters.\", 'timeFrame': 'Week 5 post-baseline (screening)'}\n\nPlease estimate the sample size based on the assumption: \nLevel of significance, \u03b1=0.05; type II error (\u03b2) set to 0.2, with power set to 80%. The correlation coefficient (CC) between the baseline value and the mean difference value is approximately 0.24. Considering a 20% dropout rate.", "answer": 124, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n In order to estimate the number of eligible patients, we used the results of unpublished data from a pilot study with the following assumptions: level of significance, \u00ce\u00b1=0.05; type II error (\u00ce\u00b2) set to 0.2, with power set to 80%. According to unpublished data from a pilot study using VAS as the main evaluation tool for acupuncture with Doin therapy in neck pain patients, the effect size in comparison to that of controls was 0.55 based on 80% compliance (predicted rate of completing\u00c2\u00a0>6 sessions during the 5-week treatment period); sample size was calculated using G*Power 3.1.7. The effect size resulting from a sample size of 106 participants (53 in each group) was calculated. In this study, analysis of covariance (ANCOVA), which adjusts the baseline pain scores, is the main analysis. Thus, in the preliminary study, the correlation coefficient (CC) between the baseline value and the mean difference value is approximately 0.24, and adjusting this with 1\u00e2\u0080\u0093CC2 and considering 20% dropout rate the appropriate sample size for this study will be 124.36", "id": 317, "split": "train"} +{"trial_id": "NCT03564652", "pmid": "32873314", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Nutritional Support for Lactating Women and Azithromycin to Infants to Improve Growth Outcomes in Peri-urban Slums of Karachi, Pakistan - Randomized Controlled Trial\n\nIncluded conditions:\n- Undernutrition\n\nStudy Armgroups:\n- {'label': 'Arm A', 'type': 'NO_INTERVENTION', 'description': 'Control arm: Lactating women (LW) randomized in this arm will only receive standard of care which comprises of standard nutritional counseling, key messages of exclusive breastfeeding, essential newborn and infant care and immunization.'}\n- {'label': 'Arm B', 'type': 'EXPERIMENTAL', 'description': \"Intervention arm B: Lactating women (LW) randomized in this arm will receive ready-to-use nutritional supplement, 'Balanced energy-protein (BEP)' for next 6 months to be consumed in a dose of 2 sachets of 75 grams per day. Further, LW will also receive standard of care which comprises of standard nutritional counseling, key messages of exclusive breastfeeding, essential newborn and infant care and immunization.\", 'interventionNames': ['Dietary Supplement: Balanced energy-protein (BEP)']}\n- {'label': 'Arm C', 'type': 'EXPERIMENTAL', 'description': \"Intervention arm B: Lactating women (LW) randomized in this arm will receive ready-to-use nutritional supplement, 'Balanced energy-protein (BEP)' for next 6 months to be consumed in a dose of 2 sachets of 75 grams per day. Further, the same infant of LW will receive a single dose of Azithromycin (20mg/kilogram) at day 42 of age. Further, LW will also receive standard of care which comprises of standard nutritional counseling, key messages of exclusive breastfeeding, essential newborn and infant care and immunization.\", 'interventionNames': ['Dietary Supplement: Balanced energy-protein (BEP)', 'Drug: Azithromycin']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Balanced energy-protein (BEP)', 'description': 'Lactating women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.', 'armGroupLabels': ['Arm B', 'Arm C'], 'otherNames': ['RUSF']}\n- {'type': 'DRUG', 'name': 'Azithromycin', 'description': 'A single prophylaxis dose of 20 mg/kg in suspension form, reconstituted by trial staff before dose administration by the same.', 'armGroupLabels': ['Arm C'], 'otherNames': ['Suspension']}\n\nPrimary Outcomes:\n- {'measure': \"Length velocity at 6 months of infant's age\", 'description': 'Mean difference in length velocity of \\\\>0.12 cm /month to look at comparisons between multiple arms', 'timeFrame': '6 months of infant age, after birth and enrollment through monthly assessment'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a 1-sided test with a power of 80% and an alpha of 0.025 to account for multiple comparisons. A drop-out rate of 14% is assumed, including 10% loss to follow-up and 4% infant mortality rate.", "answer": 957, "answer_type": "ACTUAL", "explanation": "Sample size\n There are limited data available on the impact of BEP on length velocity over the first 6\u00e2\u0080\u0089months of life in infants. However, in one of the studies, the mothers received only perinatal supplement, and the overall increase in length (cm/month) was b\u00e2\u0080\u0089=\u00e2\u0080\u00893.289 among the LNS group and b\u00e2\u0080\u0089=\u00e2\u0080\u00893.346 among the MMN group [15]. However, the women in this trial received supplements with smaller doses/energy than the women in our study will receive, and the intervention time was also different, i.e., the perinatal period rather than the infancy period. Another study showed that the difference in length velocity (cm/month) was 0.02 between the MMN and IFA groups over a period of 0\u00e2\u0080\u009318\u00e2\u0080\u0089months [17]. Therefore, in the absence of clear evidence on the impact of these interventions, we hypothesized the effect size to be 0.12\u00e2\u0080\u0089cm/month. This is also based on learning through field experience; when severely malnourished lactating women (MUAC <\u00e2\u0080\u008919.0\u00e2\u0080\u0089cm) were provided with chickpea-based ready-to-eat supplements (100\u00e2\u0080\u0089g/day for 3\u00e2\u0080\u0089months), the difference was 0.06\u00e2\u0080\u0089cm/month at 3\u00e2\u0080\u0089months of age between these women and women who did not receive any supplements (unpublished data that was used purely for implementation and was not included in a study).\n The null hypothesis for this trial is that the mean difference in length velocity between an infant of a lactating woman receiving standard breastfeeding counseling with BEP alone (intervention arm 1) for 6\u00e2\u0080\u0089months or in combination with a single prophylactic dose of azithromycin at 42\u00e2\u0080\u0089days of age (intervention arm 2) and an infant of a lactating woman receiving standard breastfeeding counseling alone (control arm) is equal or less than 0.12\u00e2\u0080\u0089cm/month (primary outcome). Due to the absence of evidence of such interventions on length velocity, we based this hypothesis on our local experience and field data from our field sites. The alternate hypothesis for this trial is that an infant of a lactating woman receiving BEP alone for 6\u00e2\u0080\u0089months or in combination with a single prophylactic dose of azithromycin at 42\u00e2\u0080\u0089days of age has a mean length velocity is greater than 0.12\u00e2\u0080\u0089cm/month that of an infant of a lactating woman not receiving an intervention at 6 months. The sample size takes multiple comparisons into account and is based on the primary outcome of length velocity with an effect size difference of at 0.12\u00e2\u0080\u0089cm per month between the arms, a 1-sided test, power of 80% and an alpha of 0.025 to account for multiple comparisons (the lower alpha). A drop-out rate of 14% (i.e., 10% loss to follow-up and infant mortality rate of 4%) is assumed in the study, so the minimum total sample size required is 957 (319 lactating women in each arm).", "id": 318, "split": "train"} +{"trial_id": "NCT03573453", "pmid": "33228772", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients. Effect on Energy and Protein Target Achievement, Tolerance and Incidence of Complications. Monocentric Prospective Randomised Study.\n\nIncluded conditions:\n- Nutrition Disorders\n\nStudy Armgroups:\n- {'label': 'Intermittent', 'type': 'EXPERIMENTAL', 'description': 'enteral nutrition will be administered via enteral feeding pump as 30-60minutes lasting bolus 6 times per day volume of initial bolus will be 80ml. The volume of bolus will be increased gradually according to tolerance, till the estimated target rate will be reached', 'interventionNames': ['Other: enteral nutrition']}\n- {'label': 'Continuous', 'type': 'EXPERIMENTAL', 'description': 'enteral nutrition will be administered via enteral feeding pump for at least 16 hours par day initial rate will be 25ml/hour. The rate will be increased gradually according to tolerance, till the estimated target rate will be reached', 'interventionNames': ['Other: enteral nutrition']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'enteral nutrition', 'description': 'administration of enteral nutrition', 'armGroupLabels': ['Continuous', 'Intermittent']}\n\nPrimary Outcomes:\n- {'measure': 'Energy target', 'description': 'Daily assessment of energy intake in critically ill patients with enteral nutrition.Energy target will be achieved if at least 80% of calculated energy intake will be delivered.', 'timeFrame': '5 days from initiation of enteral nutrition'}\n\nPlease estimate the sample size based on the assumption: \nAlpha set to 5%, power set to 80%, and accounting for potential drop-out.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Studies focused on the primary target of our study are lacking. However, we have identified several studies comparing bolus and continuous administration of enteral feeding. These studies included small numbers of patients, were conducted in different patient populations, and did not assess the time to reach the nutritional targets as a primary outcome. However, for calculation of the sample size, we hypothesized a difference of 1\u00e2\u0080\u0089day between groups (target being reached on day 2 and day 3, respectively). The alpha was set to 5%, and the power was set to 80%. The estimated sample size was 122 patients per arm. To account for potential drop-out, we increased the sample size to 300 participants in total, with 150 patients in each study arm.\nTable 3Participant timelineStudy periodFollow-upTime pointScreeningD0D1D2D3D4D5D28Number of visits12345678Eligibility criteriaxInformed consentxAllocationxDemographic dataxAPACHE IIxSOFA scorexLaboratory tests (total serum protein, albumin, prealbumin)xxEstimation of energy and protein targetxAdministration of enteral nutritionxxxxxAssessment of tolerance (diarrhea, vomiting, GRV, postpyloric nutrition)xxxxxAssessment of complicationsxxxxxAssessment of energetic and protein targetsxxxxxAssessment of hospital LOS, ICU LOS, and mortalityx", "id": 319, "split": "train"} +{"trial_id": "NCT03574454", "pmid": "36198471", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Development of a Machine Learning Support for Reading Whole Body Diffusion Weighted Magnetic Resonance Imaging (WB-DW-MRI) in Myeloma for the Detection and Quantification of the Extent of Disease Before and After Treatment\n\nIncluded conditions:\n- Myeloma\n\nStudy Armgroups:\n- {'label': 'Phase 1 - Mixed Scan Data Training Set', 'type': 'OTHER', 'description': 'Machine learning (ML): A mixed data set of 200 WB-MRI scans comprising scans obtained from 40 healthy volunteers (scanned for the purposes of the study), 40 previously acquired inactive myeloma WB-MRI scans and 120 previously acquired active myeloma WB-MRI scans, in which machine learning and convolutional neural networks will be trained to recognise healthy marrow, treated inactive previous myeloma and active myeloma. An algorithm will be developed for testing in phase 2.', 'interventionNames': ['Other: Machine Learning (ML)']}\n- {'label': 'Phase 2 - Mixed Scan Data Validation Set', 'type': 'OTHER', 'description': 'Machine Learning (ML): A mixed data set of 353 WB-MRI scans as that comprising 50 healthy volunteers (scanned for the purposes of the study), and previously acquired scans from 303 myeloma patients, 100 of whom have inactive disease and 203 of whom have active myeloma. The scans will be read by radiologists in random order either with or without the support of for the detection of active myeloma. The diagnostic performance of the radiology reads with or without the machine learning support will be measured against an expert panel reference standard.', 'interventionNames': ['Other: Machine Learning (ML)']}\n- {'label': 'Phase 3 - Disease Burden Paired Data Set', 'type': 'OTHER', 'description': 'Machine Learning (ML): Approximately 200 paired WB-MRI scans from 100 patients (scanned at baseline with active disease and then post treatment) will be used to develop a machine learning tool to quantify the burden of disease. The machine learning algorithm will then be tested on a further additional set of 60 patients who previously had two WB-MRI scans comprising paired baseline (with active disease) and post treatment scans. The agreement of radiology readers to evaluate the burden of disease will be measured against the reference standard (expert panel) with and without machine learning support.', 'interventionNames': ['Other: Machine Learning (ML)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Machine Learning (ML)', 'description': 'Application of ML support algorithm to accelerate and enhance human interpretation of WB-MRI scans in patients with myeloma', 'armGroupLabels': ['Phase 1 - Mixed Scan Data Training Set', 'Phase 2 - Mixed Scan Data Validation Set', 'Phase 3 - Disease Burden Paired Data Set'], 'otherNames': ['Algorithm', 'Software', 'Decision support tool', 'Convolutional neural network']}\n\nPrimary Outcomes:\n- {'measure': 'Sensitivity of Machine Learning Algorithm to detect Myeloma', 'description': 'Sensitivity for the detection of active myeloma on WB-MRI with and without ML support versus the reference standard', 'timeFrame': '20 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 80% power with a two-sided alpha of 0.05. The estimated proportion of discordant pairs is 0.154. Specificity is assumed to be unchanged. Non-inferiority limit is set at 10%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n Phase 1\n We will train the ML algorithm on a set of scans without and with active disease that will reflect the categories of disease that may be encountered in clinical practice. The number of cases used for training are arbitrarily chosen reflecting the knowledge that a large number of training data sets will improve training accuracy, counterbalanced with the resources needed to curate and annotate a large number of data sets.\n \n \n Phase 2\n The study is powered on the primary outcome of sensitivity.\n In a meta-analysis, Wu et al have reported a pooled sensitivity of 88% and a pooled specificity of 86% (0.86 for WB-MRI with DW-MRI).8 We anticipate that the addition of ML could increase this by at least 7.5%, from 88% to 95.5%. There is no background data to indicate the expected proportion of discordant pairs, so we have estimated this as (1\u00e2\u0080\u00930.955)\u00c3\u00970.88+0.955\u00c3\u0097(1\u00e2\u0080\u00930.88), which is equal to 0.154. To achieve 80% power using a two-sided alpha of 0.05 would require a total of 203 patients positive for myeloma using the gold standard.\n If it is assumed that the specificity will be unchanged using ML, a total number of cases with no active disease of 150 (50 HV, 100 inactive treated myeloma) will give 80% power to show that the difference is above a non-inferiority limit of 10%.\n \n \n Phase 3 training\n Approximately 200 cases that have at least two time points will be taken from phases 1 and 2, with active disease present at least at one time point, and used for training and validation for burden of disease; this will ensure efficient use of all data and segmentations.\n \n \n Phase 3 clinical testing\n This sample size is fixed at 60 patients, the full sample size of the iTIMM study, each of whom has a baseline and one post-treatment scan.", "id": 320, "split": "train"} +{"trial_id": "NCT03576235", "pmid": "31779697", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Efficacy of PG102P for the coNtrol of prUritus in Patients underGoing Hemodialysis (SNUG Trial): Study Protocol for a Randomized Control Trial\n\nIncluded conditions:\n- Uremic Pruritus\n\nStudy Armgroups:\n- {'label': 'a treatment group', 'type': 'EXPERIMENTAL', 'description': 'PG102P 1.5 g/day', 'interventionNames': ['Drug: PG102P']}\n- {'label': 'a control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'PG102P', 'description': 'Daily dose of 1.5g', 'armGroupLabels': ['a treatment group']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Daily dose of placebo', 'armGroupLabels': ['a control group']}\n\nPrimary Outcomes:\n- {'measure': 'VAS change from baseline', 'description': 'The primary endpoint is the change in VAS', 'timeFrame': 'the change in VAS between visit 2 (week 0) and visits 3, 4, 5, and 6 (weeks 2, 4, 8, 10)'}\n\nPlease estimate the sample size based on the assumption: \n0.9 power, two-sided, 0.05 alpha, 30% dropout rate", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size calculations\n The enrolled participants will be randomly divided into two groups by at a 1:1 ratio. Under the assumption of 2.1\u00e2\u0080\u0089cm (with a pooled standard deviation of 2.4\u00e2\u0080\u0089cm) in the mean change difference in VAS values between the PG102P and placebo groups in a preceding pilot study with 0.9 of power, two-sided, and 0.05 of alpha, 28 participants will be allocated to each group. Considering a dropout rate of 30%, 80 participants will be needed (40 participants per group).", "id": 321, "split": "train"} +{"trial_id": "NCT03577132", "pmid": "33060077", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy of Neoadjuvant Atezolizumab Treatment in Patients With Advanced Urothelial Bladder Cancer According to the BASQ Classification\n\nIncluded conditions:\n- Urothelial Carcinoma\n\nStudy Armgroups:\n- {'label': 'Luminal type', 'type': 'EXPERIMENTAL', 'description': 'Luminal type in previous transurethral resection of bladder tumor pathology. Luminal type in Immunohistochemistry (KRT5/6-KRT14-FOXA1+GATA3+)', 'interventionNames': ['Drug: Neoadjuvant atezolizumab']}\n- {'label': 'Basal typr', 'type': 'EXPERIMENTAL', 'description': 'Basal type in previous transurethral resection of bladder tumor pathology. Basal type in Immunohistochemistry (KRT5/6+KRT14+FOXA1-GATA3-)', 'interventionNames': ['Drug: Neoadjuvant atezolizumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Neoadjuvant atezolizumab', 'description': 'Atezolimumab\\n\\n* At a fixed dose of 1200 mg as a 60-minute intravenous infusion (1st), then as a 30-minute intravenous infusion (2nd and 3rd)\\n* Every 3 weeks, for a total of 3 cycles prior to radical cystectomy', 'armGroupLabels': ['Basal typr', 'Luminal type']}\n\nPrimary Outcomes:\n- {'measure': 'objective pathological responses (pT0 change)', 'description': 'Final pathology of bladder after operation (radical cystectomy)', 'timeFrame': '4weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, consideration of patient refusal and dropout rates.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size consideration\n The efficacy of atezolizumab as a neoadjuvant chemotherapy for radical cystectomy has not yet been published and is still under study. This study is a pilot study concept. To maximise its excellence in research progress and feasibility, we set the number of patients prospectively to 40, divided into two groups of 20. To detect a difference with 80% power and 5% significance level, we needed at least about 15 patients per cohort. About 80\u00e2\u0080\u0093100 patients had undergone radical cystectomy in our institution. We considered the number of patients diagnosed with MIBC who had undergone TURB in our institution and who could have a BASQ classification. Considering patients\u00e2\u0080\u0099 refusal to take part in the study and drop out of the study, about 40 patients are considered to be able to participate in the study for about 3\u00e2\u0080\u00934 years.", "id": 322, "split": "train"} +{"trial_id": "NCT03580265", "pmid": "31348263", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Laser Acupuncture for Carpal Tunnel Syndrome\n\nIncluded conditions:\n- Carpal Tunnel Syndrome\n\nStudy Armgroups:\n- {'label': 'Six-sessions of laser acupuncture', 'type': 'EXPERIMENTAL', 'description': 'Laser acupuncture was given three times a week for 2 weeks.', 'interventionNames': ['Device: laser phototherapy device with low level laser']}\n- {'label': 'Six-sessions of sham laser acupuncture', 'type': 'SHAM_COMPARATOR', 'description': 'Sham laser acupuncture was given three times a week for 2 weeks.', 'interventionNames': ['Device: laser phototherapy device with low level laser']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'laser phototherapy device with low level laser', 'description': 'The wavelength of low level laser is 808nm and the power output of low level laser is 300mW.', 'armGroupLabels': ['Six-sessions of laser acupuncture', 'Six-sessions of sham laser acupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline of severity of symptoms and functional status on 2th, 4th, 8th and 12th weeks after treatment by using Boston Carpal Tunnel Questionnaire (BCTQ).', 'description': 'The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. One is the minimum score and five is the maximum score in each symptom severity scale (11 items). The total score range of symptom severity scale is 11 to 55. One is the minimum score and five is the maximum score in each functional status scale (8 items). The total score range of functional status scale is 8 to 40.\\n\\nUsing the Boston Carpal Tunnel Questionnaire to measure the symptoms and functional status of carpal tunnel syndrome before treatment and multiple time frame after treatment.', 'timeFrame': 'baseline, 2th, 4th, 8th and 12th weeks after treatment'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80% (1 - \u03b2 = 0.8), statistical significance (\u03b1 = 0.05) of 95%, and a dropout rate of 20%.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "2.4.1\n Sample size\n The necessary number of subjects required for our study is based on a previous study of the effects of LLLT for CTS.[22] The sample size was calculated with a power of 80% (1 \u00e2\u0080\u0093 \u00ce\u00b2\u00e2\u0080\u008a=\u00e2\u0080\u008a0.8), statistical significance (\u00ce\u00b1\u00e2\u0080\u008a=\u00e2\u0080\u008a0.05) of 95% and a dropout rate of 20%. As a result, this study will require at least 40 wrists.", "id": 323, "split": "train"} +{"trial_id": "NCT03581123", "pmid": "37231386", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back\n\nIncluded conditions:\n- Acute Pain\n- Low Back Pain, Mechanical\n\nStudy Armgroups:\n- {'label': 'Supported-Self management (SSM)', 'type': 'EXPERIMENTAL', 'description': 'Supported-Self management', 'interventionNames': ['Behavioral: Supported-Self Management (SSM)']}\n- {'label': 'Spinal Manipulation Therapy (SMT)', 'type': 'EXPERIMENTAL', 'description': 'Spinal Manipulation Therapy', 'interventionNames': ['Other: Spinal Manipulation Therapy (SMT)']}\n- {'label': 'SMT + SSM', 'type': 'EXPERIMENTAL', 'description': 'Spinal Manipulation Therapy + Supported Self-Management', 'interventionNames': ['Combination Product: SMT + SSM']}\n- {'label': 'Standard Medical Care (SMC)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard Medical Care', 'interventionNames': ['Drug: Standard Medical Care (SMC)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Supported-Self Management (SSM)', 'description': 'Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.', 'armGroupLabels': ['Supported-Self management (SSM)']}\n- {'type': 'OTHER', 'name': 'Spinal Manipulation Therapy (SMT)', 'description': 'SMT will address the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine.', 'armGroupLabels': ['Spinal Manipulation Therapy (SMT)']}\n- {'type': 'COMBINATION_PRODUCT', 'name': 'SMT + SSM', 'description': 'Combination Treatment', 'armGroupLabels': ['SMT + SSM']}\n- {'type': 'DRUG', 'name': 'Standard Medical Care (SMC)', 'description': \"Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.\", 'armGroupLabels': ['Standard Medical Care (SMC)']}\n\nPrimary Outcomes:\n- {'measure': 'Average pain intensity over one year post-randomization', 'description': 'Measured using the 0-10 numerical rating scale (0=no LBP, 10=the worst LBP possible).', 'timeFrame': 'Weekly from enrollment - 52 weeks'}\n- {'measure': 'Average disability over one year post-randomization', 'description': 'Measured using the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire that measures the degree to which a low back problem restricts daily activities.', 'timeFrame': 'Measured monthly from enrollment - 52 weeks'}\n- {'measure': 'Prevention of chronic low back pain (LBP) that is impactful at 10-12 months follow-up', 'description': 'Measured by the LBP impact scale which includes measures of pain intensity, pain interference, and physical function from the PROMIS-29 Profile v2.0. The scale ranges from 8 (least impact) to 50 (greatest impact).', 'timeFrame': 'Months 10 -12'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at alpha = 0.05 with a multiple comparison correction for the two primary outcomes. The power is calculated based on 5000 simulations per scenario, with adjustments for period and site, and accounting for group imbalance. The trial assumes a 90% follow-up rate from an initial enrollment of 1000 participants.", "answer": 1000, "answer_type": "ACTUAL", "explanation": "Sample size and power\n The trial focuses on two separate effectiveness research questions with different time frames. First, we consider the overall time-averaged patient status for both pain and disability over the full 12 months of follow-up. We recognize the importance of considering multiple comparisons when evaluating both average pain and average function over one year, and we therefore adopt a multiple comparison correction for these two outcomes. Second, we consider the long-term impact of LBP using an assessment of impact over months 10\u00e2\u0080\u009312. However, given the different focus of the major questions and the timing of assessments further adjustment for multiple comparisons across the two questions is not indicated. Sample size and power for the trial is based on these two effectiveness research questions. To characterize the power of our primary analyses (an overall ANOVA F-test) a summary table is provided that considers potential standardized mean differences comparing the individual intervention arms to medical care (see Table\u00c2\u00a05). For a small effect size (Cohen\u00e2\u0080\u0099s d of 0.2) and an additive effect we have greater than 88% power to reject the null. However, additivity may not hold so we also consider sub-additive scenarios, in addition to scenarios where only one intervention is effective. For small to moderate effect size differences (0.25\u00e2\u0080\u00930.35) we have >\u00e2\u0080\u008980% power for all scenarios for LBP impact and most scenarios for pain and disability. We assume n\u00e2\u0080\u0089=\u00e2\u0080\u00891000 enrolled with 90% follow-up that yields 900 evaluated participants. Power is based on 5000 simulations per scenario with adjustment for period (4-arm, 2-arm) and site, and accounting for the group imbalance that results from our temporary restriction to 2-arm randomization (see trial modifications due to Covid page 11).\n \nTable 5Standardized mean differences relative to medical care and powerScenarioSMT AloneSSM AloneSSM\u00e2\u0080\u0089+\u00e2\u0080\u0089SMTPowerAverage pain intensity & disability over 12 months post-randomization(alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05/2)Chronicity based on LBP impact averaged over months 10\u00e2\u0080\u009312(alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05)\nAdditive\n0.200.200.4088%93%\nSub-Additive 1\n0.250.250.3585%91%\nSub-Additive 2\n0.300.300.3089%94%\nSub-Additive 3\n0.250.250.2574%81%\nSingle effect 1a\n00.300.3096%98%\nSingle effect 1b\n0.3000.3088%94%\nSingle effect 2a\n00.250.2583%91%\nSingle effect 2b\n0.2500.2571%80%LBP\u00e2\u0080\u0089=\u00e2\u0080\u0089Low Back Pain; SMT\u00e2\u0080\u0089=\u00e2\u0080\u0089Spinal Manipulation Therapy; SSM\u00e2\u0080\u0089=\u00e2\u0080\u0089Supported Self-Management", "id": 324, "split": "train"} +{"trial_id": "NCT03587402", "pmid": "33509164", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation on Urinary Incontinence After Radical Prostatectomy\n\nIncluded conditions:\n- Urinary Incontinence\n- Radical Prostatectomy\n- Pelvic Floor\n\nStudy Armgroups:\n- {'label': 'Transcutaneous perineal stimulation', 'type': 'EXPERIMENTAL', 'description': 'Patient is asked to lie down with legs slightly bend and two adhesive electrodes are attached transcutaneous on base of penis and on perineum. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.', 'interventionNames': ['Other: Transcutaneous perineal stimulation']}\n- {'label': 'Anal stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patient is asked to lie down with legs slightly bend and an electrical probe is inserted into the anus. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.', 'interventionNames': ['Other: Anal stimulation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Transcutaneous perineal stimulation', 'description': 'Surface stimulation', 'armGroupLabels': ['Transcutaneous perineal stimulation']}\n- {'type': 'OTHER', 'name': 'Anal stimulation', 'description': 'Intra-cavitary stimulation', 'armGroupLabels': ['Anal stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'Effects of transcutaneous perineal stimulation compared to anal stimulation', 'description': 'A change of the urine grams last in 24 hours', 'timeFrame': 'Baseline, 6 and 10 weeks'}\n\nPlease estimate the sample size based on the assumption: \nAlpha value of 5%, beta of 20% (power of 80%), and a 10% increase to account for losses to follow-up.", "answer": 70, "answer_type": "ACTUAL", "explanation": "Sample size\n To estimate the sample size, we use the randomisation and online databases for clinical trials program of the online computer software Sealed Envelope Ltd. 2001\u00e2\u0080\u00932015 (https://www.sealedenvelope.com/power/continuous-equivalence/).\n For this estimate, alpha values of 5% and beta of 20% (power of 80%) were taken into account. Based on data published in the literature [10, 12], and considering an expected difference in the 24-h Pad Test between the two studied groups of 22\u00c2\u00a0g, 32 patients are needed in each arm of the study. The interpretation is as follows: \u00e2\u0080\u009cif there is truly no difference between the control (ES by intra-anal probe) and intervention (ES by surface electrodes) treatment, then 64 patients are required to be 80% sure that the limits of a two-sided 90% confidence interval will exclude a difference in means of more than 22\u00c2\u00a0g\".\n Assuming that there could be losses to follow-up, the number of individuals to be recruited will be increased by 10% until reaching 70 patients (35 patients per group).", "id": 325, "split": "train"} +{"trial_id": "NCT03590119", "pmid": "32024533", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intra-arterial Lutetium-177-dotatate for Treatment of Patients With Neuro-endocrine Tumor Liver Metastases\n\nIncluded conditions:\n- Neuroendocrine Tumors\n- Liver Metastases\n\nStudy Armgroups:\n- {'label': 'Intra-arterially treated liver lobe', 'type': 'EXPERIMENTAL', 'description': 'Depending on the allocation after randomization, Lu-177-dotatate will be infused in either the left or the right hepatic artery, following catheterization using the Seldinger-technique.', 'interventionNames': ['Drug: Lutetium Lu 177-DOTATATE']}\n- {'label': \"'Intravenously' treated liver lobe\", 'type': 'ACTIVE_COMPARATOR', 'description': 'The lobe that is not treated intra-arterially, will act as the intravenously treated lobe, due to the first-pass effect.', 'interventionNames': ['Drug: Lutetium Lu 177-DOTATATE']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lutetium Lu 177-DOTATATE', 'description': 'Intra-arterial infusion of Lu-177-DOTATATE', 'armGroupLabels': [\"'Intravenously' treated liver lobe\", 'Intra-arterially treated liver lobe'], 'otherNames': ['Lutathera']}\n\nPrimary Outcomes:\n- {'measure': 'The difference in post-treatment tumor-to-non-tumor (T/N) activity concentration ratio on SPECT/CT between the intra-arterial treated liver lobe and the intravenous treated liver lobe.', 'description': 'To assess if there is a difference in post-treatment tumor-to-non-tumor (T/N) activity concentration ratio on SPECT/CT between the intra-arterial treated liver lobe and the intravenous treated liver lobe. The T/N activity concentration will be measured on SPECT/CT. The primary endpoint will be assessed after the first treatment cycle. For each liver lobe up to three tumors (i.e. all \\\\>3 cm) will be selected based on size (i.e. the largest lesions without central necrosis). The weighted average activity per voxel of these lesions will be divided by the normal liver tissue mean activity per voxel (i.e. a VOI with 3 cm diameter will be placed in the normal liver tissue) to calculate the T/N ratio. The T/N activity ratios of the second, third, and final treatment cycle will be assessed as secondary endpoint. Intra- and inter-patient differences will be studied.', 'timeFrame': '24 hours'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided significance level (\u03b1) of 0.025, power of approximately 0.9, using a sequential testing procedure with an O'Brien-Fleming type error spending function, and futility boundary values of T1 = -0.1045056 and T2 = 2.045732", "answer": 26, "answer_type": "ACTUAL", "explanation": "Sample size assessment\n The intended sample size is calculated using a paired samples t test on the difference in T/N uptake ratio between the IA-treated and contralateral lobes, which is equivalent to a one-sample t test on the within-patient difference scores. Assuming a moderate to large effect (i.e., \\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$\\text{d}_{z}={\\mu}_{diff}/{\\sigma}_{diff}= 0.65 $$\\end{document}Cohen'sdz=\u00ce\u00bcdiff/\u00cf\u0083diff=0.65), a one-sided \u00ce\u00b1 of 0.025, and using a sequential testing procedure with an O\u00e2\u0080\u0099Brien-Fleming type error spending function, a power of approximately 0.9 is obtained with futility boundary values equal to T1\u00c2\u00a0=\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.1045056 and T2\u00c2\u00a0=\u00e2\u0080\u00892.045732 for an interim analysis at n1\u00c2\u00a0=\u00e2\u0080\u008910 and final analysis at n2\u00c2\u00a0=\u00e2\u0080\u008926. Interim analysis will therefore be performed after ten patients have been treated, and final analysis will be performed after 26 patients have been treated.", "id": 326, "split": "train"} +{"trial_id": "NCT03591848", "pmid": "32047010", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of an Online Decision Support Tool for Young Women With Breast Cancer During the Proposal for Preservation of Fertility\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'DECISIF', 'type': 'EXPERIMENTAL', 'description': 'Exposed to an online support decision tool, in addition of the standard oral information', 'interventionNames': ['Behavioral: Online support decision tool', 'Behavioral: standard oral information']}\n- {'label': 'IRIS', 'type': 'ACTIVE_COMPARATOR', 'description': 'Exposed to a standard oral information', 'interventionNames': ['Behavioral: standard oral information']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Online support decision tool', 'description': 'Online support decision tool, in addition of the standard oral information', 'armGroupLabels': ['DECISIF']}\n- {'type': 'BEHAVIORAL', 'name': 'standard oral information', 'description': 'standard oral information', 'armGroupLabels': ['DECISIF', 'IRIS']}\n\nPrimary Outcomes:\n- {'measure': 'Multidimensional Measure of Informed Choice (MMIC)', 'description': 'Measure of patient autonomy for making decision, according to the Multidimensional Measure of Informed Choice (MMIC).\\n\\nA series of closed questions (based on the Osgoog\\'s scale) on their feelings about this fertility preservation approach, describing attitudes in regards to \"good / bad\", \"important / unimportant\", \"unhelpful\" good thing / bad thing, \"\" pleasant / unpleasant \"and\" useful / useless \". Responses go from \"very positive\" (1) to \"very negative\" (7).', 'timeFrame': '1 day (During the PF consultation)'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided test, significance level of 0.05%, 80% power.", "answer": 186, "answer_type": "ACTUAL", "explanation": "Sample size and sampling design\n A sample size of 186 participants, that is, 93 in each arm, is planned. The required sample size was calculated in order to detect a difference of 20% (50%\u00e2\u0080\u009370%) in the informed choice among women included in the IRIS and DECISIF groups and by using a two-sided test at a significance level of 0.05% and 80% power. Based on our experience, we estimate that half of the patients seen in fertility counselling today make an informed decision. We believe that a 20% increase in the number of patients who make an informed choice with the PDA would be acceptable in this context.", "id": 327, "split": "train"} +{"trial_id": "NCT03594786", "pmid": "32358359", "question": "Here is the design of a clinical trial:\n\nOfficial Title: To Assess Hemodynamic Disturbances to the Ostia of the Renal Arteries Generated by the Implantation of EVAR With a Suprarenal Fixation\n\nIncluded conditions:\n- Aortic Aneurysm, Abdominal\n- Endovascular Procedures\n- Renal Artery Stenosis\n\nStudy Armgroups:\n- {'label': 'endovascular aneurysm repair (EVAR) arm', 'type': 'EXPERIMENTAL', 'description': 'every patients are in the same arm and have EVAR with supra-renal fixation', 'interventionNames': ['Device: endovascular aneurysm repair (EVAR)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'endovascular aneurysm repair (EVAR)', 'description': 'Patient will be enrolled when the decision of an endovascular procedure with supra renal fixation is required. Before the intervention, Duplex scan will be necessary to evaluate renal arteries ostia. This exam will be realised in the month after the intervention and one year later.', 'armGroupLabels': ['endovascular aneurysm repair (EVAR) arm']}\n\nPrimary Outcomes:\n- {'measure': 'systolic maximum speed at the ostia of the renal arteries', 'description': 'Quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of a suprarenal fixation aortic stent immediately postoperatively.', 'timeFrame': 'one month'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha risk of 5% and an absolute precision of 10% are assumed. The sample size also accounts for potential loss to follow-up.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "3.8\n Sample size calculation\n The main objective was to evaluate the proportion of patients with hemodynamic disturbances. We assume that the maximum proportion of these patients is 20%. At an alpha risk of 5%, with an absolute precision of 10%, the number of subjects required is 62. We will include 70 patients to take into account any patients who are lost to follow-up.[20]", "id": 328, "split": "train"} +{"trial_id": "NCT03595098", "pmid": "35305587", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents With Obsessive Compulsive Disorder\n\nIncluded conditions:\n- Obsessive-Compulsive Disorder in Children\n- Obsessive-Compulsive Disorder in Adolescence\n\nStudy Armgroups:\n- {'label': 'FCBT', 'type': 'EXPERIMENTAL', 'description': 'The Family Based Cognitive Behavioural Therapy (FCBT)', 'interventionNames': ['Behavioral: Family Based Cognitive Behavioural Therapy']}\n- {'label': 'FPRT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Family-based Psychoeducation /Relaxation Training (FPRT)', 'interventionNames': ['Behavioral: Family Based Psychoeducation/Relaxation Training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Family Based Cognitive Behavioural Therapy', 'description': 'Family Based Cognitive Behavioural Therapy (FCBT) focuses on the interrelation between thought, emotion, and behaviour, Exposure and Response Prevention, family involvement, homework assignments, and formulating of specific goals for the child. The important, active components is Exposure and Response Prevention. It involves exposing the child to a feared object, situation or thought, and preventing the child from carrying out compulsions to show the child that distress/anxiety can decrease or disappear without performing rituals.', 'armGroupLabels': ['FCBT']}\n- {'type': 'BEHAVIORAL', 'name': 'Family Based Psychoeducation/Relaxation Training', 'description': 'Family-based Psychoeducation/Relaxation Training (FPRT) as an active control matches the experimental intervention as closely as possible, many elements of the control intervention are similar to FCBT. The main and intended difference between the two approaches is the absence of the Exposure and Response Prevention component, which is deemed the most effective treatment for OCD.', 'armGroupLabels': ['FPRT']}\n\nPrimary Outcomes:\n- {'measure': \"Change in Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score\", 'description': \"Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD). Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.\", 'timeFrame': 'Week 0, 4, 8, 16 and 40'}\n\nPlease estimate the sample size based on the assumption: \nUsing a power of 80%, a two-sided alpha of 5%, and expecting a standard deviation (SD) of 8 on the CY-BOCS total score. To account for drop-outs and missing data, the power is increased to 85.7% by including up to 20 extra participants.", "answer": 128, "answer_type": "ESTIMATED", "explanation": "Sample size estimation and feasibility of recruitment\n The sample size is based on the primary outcome, the CY-BOCS score (continuous variable) measuring severity of OCD symptoms on 10 items which can be rated 0 to 4 points (total score range 0 to 40). Using a power of 80%, a two-sided alpha of 5%, and expecting a SD of 8 on the CY-BOCS total score based on reports in similar patient groups [13], the required sample size necessary to detect or reject a minimal relevant difference of at least 4 points on CY-BOCS total score was estimated to be 64 participants in each intervention group, a total of 128 [13, 47]. Power calculations for secondary outcomes (KIDSCREEN-52 and NEQ) will follow in a detailed statistical analysis plan (see below).\n To estimate the expected recruitment potential of OCD patients in CAMHC we drew on the available hospital statistics in the planning phase of the trial before initiation in 2018. In the year 2016, 108 patients aged 8\u00e2\u0080\u009317\u00e2\u0080\u0089years were referred to and treated in CAMHC for OCD. We therefore estimated that around 324 patients would be eligible for participation in the TECTO trial within our recruitment period of 3 years (ultimo 2018 to ultimo 2021). With a target sample size of 128, we considered it feasible to recruit 40% of all referred patients. Randomised clinical trials with psychiatric patients are prone to drop-outs and missing data [48]. Thus, we aim to include and randomise up to 20 extra participants, i.e. up to 148 participants in total (74 in each group), which will increase our power for our primary outcome to 85.7%.", "id": 329, "split": "train"} +{"trial_id": "NCT03595787", "pmid": "38553062", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility Study of Tripartite Prehabilitation of Patients With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndromes During Intensive Chemotherapy Before Allogenic Haematopoietic Stem Cell Transplantation: the COHABILIT Protocol\n\nIncluded conditions:\n- Acute Myeloid Leukemia\n- Myelodysplastic Syndromes\n\nStudy Armgroups:\n- {'label': 'Prehabilitation program', 'type': 'EXPERIMENTAL', 'description': 'Program based on nutritional support, physical activity program and coaching. Home-based monitoring will be done thanks to connected watches (step counter pedometer) and a connected body fat weight scale', 'interventionNames': ['Procedure: Coaching and Habilitation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Coaching and Habilitation', 'description': 'nutritional support, adapted physical activity and coaching', 'armGroupLabels': ['Prehabilitation program']}\n\nPrimary Outcomes:\n- {'measure': 'feasibility to the adapted multidisciplinary program', 'description': 'proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nA power of at least 80% using a one-tailed exact test for binary data with a statistical significance level of 5%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to standard design criteria, a sample of 37 allotransplant patients is judged necessary to demonstrate that the proportion of patients with more than 50% of their programmed sessions validated by the coach is greater than the theoretical proportion of 50%, which is considered insufficient. This sample size was determined to ensure a power of at least 80% using a one-tailed exact test for binary data with a statistical significance level of 5%, assuming a minimal true proportion of at least 70%.\n Given an expected proportion of 40% allotransplant patients, it is planned to include 50 patients in order to recruit 37 allotransplant patients.", "id": 330, "split": "train"} +{"trial_id": "NCT03607799", "pmid": "37130668", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Culturally-tailored Personalized Nutrition Intervention in South Asian Women at Risk of Gestational Diabetes Mellitus\n\nIncluded conditions:\n- Diabetes, Gestational\n\nStudy Armgroups:\n- {'label': 'Dietary Intervention', 'type': 'EXPERIMENTAL', 'description': 'A personalized nutrition plan will be developed for each woman and will respect faith-based food choices and regional preferences. The plan will be delivered by a culturally congruent health coach, and consider baseline dietary intake, energy balance for recommended gestational weight gain, personal values and preferences, through setting 2-4 \"SMART\" goals. Participants assigned to the intervention group will receive text messages. Participants assigned to the intervention group will be given a Fitbit to track their steps and will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.', 'interventionNames': ['Behavioral: Dietary Intervention']}\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the control group will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.', 'interventionNames': ['Behavioral: Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Dietary Intervention', 'description': 'Individualized diet advice will be developed for each participant by a dietitian familiar with South Asian foods.', 'armGroupLabels': ['Dietary Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'Control group participants will be provided with PDFs, website links to encourage healthy eating, physical activity, and other lifestyle factors during pregnancy. They will also receive weekly text messages aimed at increasing walking.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Glucose area-under-the-curve (glucose AUC)', 'description': 'A measure of glycemic response, glucose AUC is a continuous measure of the response to a 75-g oral glucose tolerance test, and is calculated by the trapezoidal method using the fasting, 1-h, and 2-h glucose.', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 90% power, a 10% loss to follow-up, and 70% adherence to the intervention. The significance level is not explicitly mentioned but is typically assumed to be 0.05 in clinical trials.", "answer": 190, "answer_type": "ESTIMATED", "explanation": "Sample size\n With 86 participants per group (total n=172), the study will have 90% power to detect at least a 15% between-group difference in AUC glucose, the primary outcome, assuming 70% adherence to the intervention (ie, goal setting, health coach contacts, food tracking) and SD of AUC glucose=173\u00e2\u0080\u0089mmol/min.14 A change in glucose of at least this magnitude has been observed in trials of similar design to test fibre supplements,30 high-protein31 or high-fat diets.32 A 10% loss to follow up is assumed, which is low for dietary interventions; however, given the frequent expected contact with healthcare providers during pregnancy, the virtual nature of our intervention and our pilot data,33 it is believed to be feasible. The sample size has been inflated to 95 per group (total n=190) to account for the expected high lost to follow up. The study will have low power to detect a moderate treatment effect on the secondary outcome of GDM (ie, 20%\u00e2\u0080\u009330%\u00e2\u0080\u0089between-treatment difference) and higher power to detect very large treatment effects in GDM (ie, 80% power to detect a 61% relative risk reduction). The study will look to see if GDM incidence, measured as a dichotomous outcome, is nominally improved.", "id": 331, "split": "train"} +{"trial_id": "NCT03609697", "pmid": "32273317", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Community-based Weight Loss Programme Targetting Chinese Overweight Adults With Pre-diabetes: A Randomized Controlled Trial\n\nIncluded conditions:\n- Pre-diabetes\n\nStudy Armgroups:\n- {'label': 'Community-based lifestyle intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will attend 7 community-based group intervention sessions plus 2 individual face-to-face dietician consultation sessions during the first 6 months, followed by a 6-month maintenance phase which they will receive monthly phone support from the research team.', 'interventionNames': ['Behavioral: group-based lifestyle intervention']}\n- {'label': 'Minimal intervention (SMS intervention)', 'type': 'OTHER', 'description': 'Participants will receive one SMS per month during the first 6 months, followed by a 6-month maintenance phase which participants will receive one SMS every 2 months.', 'interventionNames': ['Behavioral: Minimal intervention (SMS intervention)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'group-based lifestyle intervention', 'description': 'Involve education about pre-diabetes self-management, weight loss, behavioural modification skills, nutrition and physical activity.', 'armGroupLabels': ['Community-based lifestyle intervention'], 'otherNames': ['individual dietitian consultation', 'Telephone support', 'community-based intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Minimal intervention (SMS intervention)', 'description': 'Text message related to general information about T2DM, pre-diabetes, and lifestyle modification.', 'armGroupLabels': ['Minimal intervention (SMS intervention)']}\n\nPrimary Outcomes:\n- {'measure': 'Percent weight change', 'description': '% weight change from baseline', 'timeFrame': '% weight change from baseline at 6-month and 12-months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, 35% dropout rate.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size\n The estimated minimum required sample size was based on the primary outcome: the proportion of participants achieving 5%\u00e2\u0080\u0089weight loss between the baseline assessment and 12 months. Previous lifestyle intervention trials have reported that around 50% of participants had lost at least 5% of their baseline body weight at 12 months.16 We predicted that weight loss in the control group (receiving minimal intervention) would be half of that in the intervention group; that is, 25% of participants in the control group may lose at least 5% of their baseline body weight at 12 months. To detect this difference in the proportion of participants achieving 5%\u00e2\u0080\u0089weight loss between the intervention and control groups, 58 participants were required in each group, to ensure 80% power at a 5% significance level. To accommodate a 35% dropout rate,14 we therefore needed to recruit 90 participants in each intervention group (180 in total). This was based on a conservative estimate: if fewer than 25% of participants in the control group achieve 5%\u00e2\u0080\u0089weight loss, the required sample size will be less than 180.", "id": 332, "split": "train"} +{"trial_id": "NCT03609762", "pmid": "33323434", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Routine Measurement of Health-Related Quality of Life in Improving the Outcomes of Patients With Musculoskeletal Problems - A Randomized Controlled Trial\n\nIncluded conditions:\n- Quality of Life\n- Musculoskeletal Disease\n- Outcome\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'EQ-5D-5L HRQOL results be available to the attending doctor', 'interventionNames': ['Behavioral: EQ-5D-5L HRQOL results be available to the attending doctor']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'usual care. All subjects attending the control clinics will not need to complete the electronic EQ-5D-5L before seeing the doctor during their follow-up visits. The doctor will manage the patient as usual, based on the usual clinical information. The doctor will complete the clinician-reported follow-up clinical data form (CRF) for each subject at the end of the consultation.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'EQ-5D-5L HRQOL results be available to the attending doctor', 'description': 'all subjects attending the intervention clinics will complete the electronic EQ-5D-5L before seeing the doctor during each follow-up visit for the musculoskeletal problem, a print out of the longitudinal EQ-5D-5L data (Table 1) since recruitment will be given to the patients to show to the attending doctors during the consultation. The doctors will provide the management based on the usual clinical information and the additional EQ-5D-5L HRQOL results. The doctor will complete the clinician-reported follow-up clinical data form (CRF) of each eligible patient at the end of the consultation.', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'The change in HRQOL measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) global score', 'description': 'The WOMAC is a widely used condition specific HRQOL measure to assess pain, stiffness and physical function of patients with MS problems. It has been applied to patients with hip and/or knee osteoarthritis, low back pain, rheumatoid arthritis and fibromyalgia. It consists of 24 items on 3 domains: pain (5 items), stiffness (2 items) and physical function (17 items). Each question is rated on a 5-point Likert scale from 0 to 4, with lower scores indicating lower levels of symptoms or impairment. The item scores in each domain subscale are summated to a domain score. The global WOMAC score is calculated by summating the three domain scores. A Chinese version of WOMAC is available and has been shown to be valid, reliable and sensitive in Chinese patients.', 'timeFrame': 'At baseline, and 3 months, 6 months and 12 months after baseline'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes 80% power, a 5% significance level, and a 20% attrition rate. The calculation also adjusts for an intracluster correlation coefficient (ICC) of 0.0321 due to clustering from six clinics.", "answer": 1374, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size calculation was based on the primary outcome of a difference in WOMAC total score between the intervention and control groups. A previous RCT study evaluating a rehabilitation programme integrating exercise, self-management and active coping strategies for patients with chronic knee pain showed that the average change in WOMAC total score at 6 months after baseline for the intervention and control groups was \u00e2\u0088\u00923.4 (mean: 35; SD: 16 at 6 months) and \u00e2\u0088\u00928 (mean: 30.4; SD: 17 at 6 months), respectively,20 indicating an effect size of 0.3. Using this, a minimum of 380 (190 in each group) patients are needed to achieve 80% power at 5% significant level, by two-sample t-test. There were no studies that provided an intracluster correlation (ICC) coefficient for WOMAC scores, but a review showed the ICC coefficient of pain outcome was 0.0321; to adjust for the clustering effect from six clinics, a larger sample size of 1098 (549 patients per group, and 183 subjects per clinic) will be required. We plan to recruit 1374 (687 in each group) subjects to allow for a 20% attrition rate.", "id": 333, "split": "train"} +{"trial_id": "NCT03611036", "pmid": "32957334", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Different Form of Upper Limb Muscles Training on Dyspnea in COPD\n\nIncluded conditions:\n- COPD\n\nStudy Armgroups:\n- {'label': 'Strength', 'type': 'EXPERIMENTAL', 'description': 'Patients will follow the pulmonary rehabilitation program associated with upper limbs strength training for a duration of 4 weeks', 'interventionNames': ['Other: Strength training']}\n- {'label': 'Endurance', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will follow the pulmonary rehabilitation program associated with upper limbs endurance training for a duration of 4 weeks', 'interventionNames': ['Other: Endurance training']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Strength training', 'description': 'Upper limbs Strength training; done with dumbbells whose weight corresponds to 60-80% of the maximal voluntary force in abduction measured initially, during 4 weeks', 'armGroupLabels': ['Strength']}\n- {'type': 'OTHER', 'name': 'Endurance training', 'description': 'Upper limbs Endurance training of the ; done with dumbbells whose weight corresponds to 30% of the maximum voluntary force in abduction measured initially, during 4 weeks', 'armGroupLabels': ['Endurance']}\n\nPrimary Outcomes:\n- {'measure': 'Compare the effect of upper limbs strength training versus the effect of upper limb endurance training on dyspnea in patients with COPD during a pulmonary rehabilitation program.', 'description': 'Measurement of dyspnea using the London Chest Daily Activity Living (LCADL) questionnaire.\\n\\nThis 15-item, self-administered questionnaire allows an evaluation of dyspnea in patients with COPD during daily activities divided into four components: self-care, domestic, physical, and leisure. Patients could score from 0: \"I would not do anyway\" to 5: \"I need someone else to do this\". LCADL score is calculated by aggregating the points assigned to each question, with a higher score representing maximal disability.', 'timeFrame': 'Change from inclusion at 4 week'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1-error of 5% and \u03b2-error of 10%.", "answer": 280, "answer_type": "ACTUAL", "explanation": "2.7\n Sample size calculation\n A previous study[29] (EMI2) reported a standard deviation of 10 points for the LCADL score. A 4-point improvement for LCADL during a pulmonary rehabilitation program would be clinically significant.[24,25]\n With these assumptions, for an \u00ce\u00b1-error of 5% and \u00ce\u00b2-error of 10%, the expected sample size would therefore be 133 patients per group. In order to anticipate loss to follow-up or withdrawals of consent, 140 patients per group will be included, or 280 in total.", "id": 334, "split": "train"} +{"trial_id": "NCT03614325", "pmid": "31882015", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia\n\nIncluded conditions:\n- Anesthesia, Intravenous\n- Pain, Postoperative\n- Delayed Recovery From Anesthesia\n- Satisfaction\n- Relaxation Therapy\n\nStudy Armgroups:\n- {'label': 'Usual Anesthesia Care', 'type': 'NO_INTERVENTION', 'description': 'Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery.'}\n- {'label': 'Virtual Reality Immersive Relaxation', 'type': 'EXPERIMENTAL', 'description': 'Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness.\\n\\nThroughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence.', 'interventionNames': ['Other: Virtual Reality Immersive Relaxation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Virtual Reality Immersive Relaxation', 'description': 'The software developed by VRHealth allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.', 'armGroupLabels': ['Virtual Reality Immersive Relaxation']}\n\nPrimary Outcomes:\n- {'measure': 'Intraoperative Propofol Dose', 'description': 'Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.', 'timeFrame': '60 minutes'}\n\nPlease estimate the sample size based on the assumption: \ntwo-sided \u03b1 of 0.05, 80% power, and accounting for anticipated drop-out", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Based on preliminary data from a related study evaluating the use of VR immersion for major joint surgery, we anticipate that we may be able to achieve a 30% reduction in intraoperative propofol dose between groups [15]. Using a two-sided \u00ce\u00b1 of 0.05, 80% power, an effect size of 30%, with mean propofol doses of 155\u00e2\u0080\u0089mg/h (standard deviation (SD) 45\u00e2\u0080\u0089mg/h) and 108.5\u00e2\u0080\u0089mg/h (SD 45\u00e2\u0080\u0089mg/h) we anticipate needing a sample size of 32 patients. To account for anticipated drop-out, we will add 8 patients to the calculated sample size for a total planned enrollment of 40 patients, with 20 in each of the two groups.", "id": 335, "split": "train"} +{"trial_id": "NCT03615638", "pmid": "33573664", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Community-based Post-operative Rehabilitation and Fall Prevention Program Following Total Knee Arthroplasty - a Randomized Controlled Trial\n\nIncluded conditions:\n- Knee Osteoarthritis\n- Fall\n\nStudy Armgroups:\n- {'label': 'Fall prevention group', 'type': 'EXPERIMENTAL', 'description': 'Fall prevention program', 'interventionNames': ['Other: Fall prevention program']}\n- {'label': 'Usual care group', 'type': 'NO_INTERVENTION', 'description': 'Usual postoperative care'}\n- {'label': 'Asymptomatic control', 'type': 'NO_INTERVENTION', 'description': 'No intervention'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Fall prevention program', 'description': '12-week fall prevention program (including warm-up, cool-down, education, Tai Chi, and lower limb strengthening)', 'armGroupLabels': ['Fall prevention group']}\n\nPrimary Outcomes:\n- {'measure': 'Chinese version of Knee Injury and Osteoarthritis Outcome Scale', 'description': 'A 42-item questionnaire with 5 subscales to assess pain, symptoms, activities of daily living, sports and recreation function, and knee-related quality of life', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nNo formal statistical assumptions were made. The study aims to evaluate feasibility, recruitment, retention rates, and acceptability.", "answer": 78, "answer_type": "ESTIMATED", "explanation": "Sample size\n No formal sample size calculation was performed for this feasibility study. However, a minimum sample size for a pilot study to evaluate the feasibility of conducting a full-scale trial is suggested to be 50 per study [18, 19]. A total of 78 patients (26 per arm) were deemed an appropriate sample size for this trial to estimate the recruitment and retention rates and explore the acceptability of the intervention.", "id": 336, "split": "train"} +{"trial_id": "NCT03616444", "pmid": "31374049", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Evidence-based Evaluation of the Efficacy of Shenbai Granules in Preventing Recurrent Colorectal Adenomas After Polypectomy and Its Therapeutic Mechanism\n\nIncluded conditions:\n- Gastroenterology\n\nStudy Armgroups:\n- {'label': 'TCM-Shenbai Granules', 'type': 'EXPERIMENTAL', 'description': 'Shenbai Granules: Hedyotis diffusa 10g, Sophorae flavescentis radix 4.5g, Codonopsis radix 7.5g, Atractylodis macrocephalae rhizoma 6g, Mume fructus 4.5g, Coptidis rhizoma 1.5g, Zingiberis rhizome praeparatum 3g, Coicis semen 10g.\\n\\nOrally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day.', 'interventionNames': ['Drug: Shenbai Granules']}\n- {'label': 'TCM-Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'It contains 5% SBG content, and the remaining ingredients are flavoring agents, starch and coloring agents. It is the same with SBG in appearance, smell and dosage form.\\n\\nOrally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day.', 'interventionNames': ['Drug: Shenbai Granules']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Shenbai Granules', 'description': 'In the first year, the trial granules will be started after enrollment for 3 months; In the second year, the trial granules will be started in the first 3 months; Each participant should have completed 6 months of trial granules.', 'armGroupLabels': ['TCM-Placebo', 'TCM-Shenbai Granules'], 'otherNames': ['placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Adenoma detection rate', 'description': 'The ratio of the number of patients with new adenoma detected by colonoscopy to the total number of cases in this group during follow-up.', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nA 2-sided significance level of 0.05 and power of 90% (\u03b1 = 0.05, \u03b2 = 0.1) with a 20% loss to follow-up.", "answer": 400, "answer_type": "ACTUAL", "explanation": "2.4\n Sample size\n According to the literature search, new CAP occurrence in post-polypectomy was used as the scoring criteria for the treatment of polypectomy under colonoscopy. The new CAP occurrence rate under colonoscopy treatment was about 30% (P0), and the new CAP occurrence after the intervention with Xiaoai Jiedu Decoction was about 16.4% (P1). According to the 1:1 parallel control principle, for a 2-sided significance level of .05 and power of 90% (\u00ce\u00b1\u00e2\u0080\u008a=\u00e2\u0080\u008a0.05, \u00ce\u00b2\u00e2\u0080\u008a=\u00e2\u0080\u008a0.1), the sample size is calculated using the formula:\u00c2\u00a0\n Considering a 20% loss to follow-up, the sample size is 400 cases (n\u00e2\u0080\u008a=\u00e2\u0080\u008a200 in each group).", "id": 337, "split": "train"} +{"trial_id": "NCT03618082", "pmid": "35468803", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Targeted Analgesia to ANI (Analgesia/ Nociception Index) During General Anesthesia on Immediate Postoperative Pain and Perioperative Hemodynamic: Multicenter Randomized Controlled Study\n\nIncluded conditions:\n- Immediate Severe Postoperative Pain\n- Perioperative Hemodynamic\n\nStudy Armgroups:\n- {'label': 'usual practice', 'type': 'ACTIVE_COMPARATOR', 'description': 'control group (usual practice): patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance. The dosage of the anesthetic agent, as well as the prophylactic administration of morphine at the end of the intervention, will be decided by the anesthesiologist.', 'interventionNames': ['Drug: Anesthesic agent guided by ANI (Interventional Group)', 'Drug: Administration of the lowest effective concentration of desflurane (Interventional Group)']}\n- {'label': 'targeted analgesia to ANI', 'type': 'EXPERIMENTAL', 'description': 'experimental group: patients receiving a general anesthesia with propofol, ketamine and remifentanil with or without curare for the induction, and desflurane and remifentanil (with or without curare) for the maintenance, as well as the prophylactic administration of morphine at the end of the intervention, will be administered according to the ANI.\\n\\n- In addition, desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC).', 'interventionNames': ['Drug: Anesthesic agent guided by ANI (Interventional Group)', 'Drug: Administration of the lowest effective concentration of desflurane (Interventional Group)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Anesthesic agent guided by ANI (Interventional Group)', 'description': 'Anesthesic agent guided by ANI (Interventional Group) The remifentanil administration will be piloted by the ANI, as well as the prophylactic administration of morphine at the end of the intervention.', 'armGroupLabels': ['targeted analgesia to ANI', 'usual practice']}\n- {'type': 'DRUG', 'name': 'Administration of the lowest effective concentration of desflurane (Interventional Group)', 'description': 'Administration of the lowest effective concentration of desflurane (Interventional Group) Desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC).', 'armGroupLabels': ['targeted analgesia to ANI', 'usual practice']}\n\nPrimary Outcomes:\n- {'measure': 'immediate maximum postoperative pain in recovery room defined by a score > 3 on a verbally administered numeric rating scale (NRS) variating from 0 to 10.', 'description': 'Once the patient transferred to the recovery room, the assessment of the primary outcome (verbally administered NRS) will be done by the nurse responsible for the patient, when the patient arrives, during the stay and when the patient leaves the recovery room', 'timeFrame': 'From day 0 to day 28'}\n\nPlease estimate the sample size based on the assumption: \n90% power, bilateral test with a p value of 5%, interim analysis with a p value of 0.003 using O\u2019Brien-Fleming alpha-spending function", "answer": 380, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Given the fact that immediate postoperative pain can affect 30% of patients [1], a total of 161 patients per group (322 patients) will give 90% power using a bilateral test with a p value of 5% to detect a 50% reduction in the incidence of immediate postoperative pain (NRS \u00e2\u0089\u00a4 3) in patients guided by ANI. Given the specific features of this protocol (essentially the direct transfer from operating theater to continuous monitoring or ICU, use of continuous vasopressors), the final decision is to include a total of 380 patients (190 per group). An interim analysis will be scheduled halfway through the enrolment period (95 patients per group). The p value used to decide withdrawal from the trial on efficacy grounds is set at 0.003 (correction of the O\u00e2\u0080\u0099Brien-Fleming alpha-spending function).", "id": 338, "split": "train"} +{"trial_id": "NCT03618173", "pmid": "32998920", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficiency of IV Dexamethasone Compared to Placebo, Administrated After a Lower Limb Blockade is Done, on the Post Operative Pain in Children : a Controled, Randomised, Double Blind Study\n\nIncluded conditions:\n- IV Drug Usage\n\nStudy Armgroups:\n- {'label': 'dexamethasone', 'type': 'EXPERIMENTAL', 'description': 'IV dexamethasone group : dexamethasone administrated at the induction of general anesthesia, at the dose of 0,2mg/kg (= 0,2mL/kg of a syringe with a 1mg/mL concentration) maximum 8mg (=8mL).', 'interventionNames': ['Drug: Dexamethasone']}\n- {'label': 'Placebos', 'type': 'PLACEBO_COMPARATOR', 'description': 'IV placebo group : saline serum is administrated at the induction of general anesthesia, at the dose of 0,2mL/kg, maximum 8mL.', 'interventionNames': ['Drug: Placebos']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'IV dexamethasone at the dose of 0,2mg/kg = 0,2mL/kg of a solution of 1mg/mL max 8mg', 'armGroupLabels': ['dexamethasone'], 'otherNames': ['IV dexamethasone']}\n- {'type': 'DRUG', 'name': 'Placebos', 'description': 'IV saline serum at the dose of 0,2mL/kg maximum 8mL', 'armGroupLabels': ['Placebos'], 'otherNames': ['IV saline serum']}\n\nPrimary Outcomes:\n- {'measure': 'Morphinic consumption in the post operative 24H', 'description': 'total morphinic consumption in morphine equivalent in mg', 'timeFrame': 'within 24 hours after dexamethasone or saline serum administration'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha risk of 5% and a power of 80% are considered. The analysis is based on a two-sample independent t-test. A p value of <0.05 for two-sided tests is considered significant. All analyses are performed according to the intention-to-treat principle.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size calculation\n \n Sample size estimation\n Based on our practices and published results in adult,28 we estimate that the mean morphine doses administered in the placebo group is 0.7\u00c2\u00b10.6\u00e2\u0080\u0089mg/kg for the 24 first hours and that dexamethasone would reduce these doses by 50% (0.3 mg/kg/day of morphine in the dexamethasone group). Considering an alpha risk of 5% and a power of 80%, and based on the two-sample independent t-test, it is necessary to include 36 patients per group to demonstrate a statistically significant difference.\n As a safety measure and to take into account possible premature stoppages and/or unusable results, we plan to include 40 patients in each group (according to parametric vs non-parametric statistics in the analysis of randomised trials with non-normally distributed data, BMC Medical Research Methodology, 2005).\n \n \n Statistical analysis\n The analysis of the results is performed using SAS software V.9.4 (SAS Institute, Cary, North Carolina, USA).\n A descriptive analysis and a comparison of the main sociodemographic and medical characteristics between the two study groups is scheduled, using a \u00cf\u00872 test for qualitative variables and a Student\u00e2\u0080\u0099s t-test for quantitative variables. Then, the total amount of nalbuphine or morphine\u00e2\u0080\u0094in morphine equivalent\u00e2\u0080\u0094administered during the first 24\u00e2\u0080\u0089hours, as well as the three secondary outcomes, are compared between the two groups by using a Mann-Whitney U test or a generalised linear model with adjustment for the patients\u00e2\u0080\u0099 characteristics if they differ between groups.\n A p value of <0.05 for two-sided tests is considered significant. All analyses are performed according to the intention-to-treat principle. In case of unblinding or for patients quitting the study before the end of follow-up, the measurements will be continued (if possible).", "id": 339, "split": "train"} +{"trial_id": "NCT03618173", "pmid": "32998920", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficiency of IV Dexamethasone Compared to Placebo, Administrated After a Lower Limb Blockade is Done, on the Post Operative Pain in Children : a Controled, Randomised, Double Blind Study\n\nIncluded conditions:\n- IV Drug Usage\n\nStudy Armgroups:\n- {'label': 'dexamethasone', 'type': 'EXPERIMENTAL', 'description': 'IV dexamethasone group : dexamethasone administrated at the induction of general anesthesia, at the dose of 0,2mg/kg (= 0,2mL/kg of a syringe with a 1mg/mL concentration) maximum 8mg (=8mL).', 'interventionNames': ['Drug: Dexamethasone']}\n- {'label': 'Placebos', 'type': 'PLACEBO_COMPARATOR', 'description': 'IV placebo group : saline serum is administrated at the induction of general anesthesia, at the dose of 0,2mL/kg, maximum 8mL.', 'interventionNames': ['Drug: Placebos']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'IV dexamethasone at the dose of 0,2mg/kg = 0,2mL/kg of a solution of 1mg/mL max 8mg', 'armGroupLabels': ['dexamethasone'], 'otherNames': ['IV dexamethasone']}\n- {'type': 'DRUG', 'name': 'Placebos', 'description': 'IV saline serum at the dose of 0,2mL/kg maximum 8mL', 'armGroupLabels': ['Placebos'], 'otherNames': ['IV saline serum']}\n\nPrimary Outcomes:\n- {'measure': 'Morphinic consumption in the post operative 24H', 'description': 'total morphinic consumption in morphine equivalent in mg', 'timeFrame': 'within 24 hours after dexamethasone or saline serum administration'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha risk of 5% and a power of 80% are considered. The analysis is based on a two-sample independent t-test. A p value of <0.05 for two-sided tests is considered significant. All analyses are performed according to the intention-to-treat principle.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Based on our practices and published results in adult,28 we estimate that the mean morphine doses administered in the placebo group is 0.7\u00c2\u00b10.6\u00e2\u0080\u0089mg/kg for the 24 first hours and that dexamethasone would reduce these doses by 50% (0.3 mg/kg/day of morphine in the dexamethasone group). Considering an alpha risk of 5% and a power of 80%, and based on the two-sample independent t-test, it is necessary to include 36 patients per group to demonstrate a statistically significant difference.\n As a safety measure and to take into account possible premature stoppages and/or unusable results, we plan to include 40 patients in each group (according to parametric vs non-parametric statistics in the analysis of randomised trials with non-normally distributed data, BMC Medical Research Methodology, 2005).", "id": 340, "split": "train"} +{"trial_id": "NCT03623893", "pmid": "34593022", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.\n\nIncluded conditions:\n- Inguinal Hernia\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'OTHER', 'description': 'Unilateral inguinal hernia repair with contralateral exploration.', 'interventionNames': ['Procedure: Contralateral exploration']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Unilateral inguinal hernia repair.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Contralateral exploration', 'description': \"Surgery eventually performed when a patent processus vaginalis or hernia exists on the other side than the side on which the child has to be operated on, will be exactly the same as the inguinal hernia repair on the 'symptomatic' side. Exploration of the contralateral side will increase anaesthesia time by 10-15 minutes.\", 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of infants that undergo a second operation', 'description': 'The number of infants that undergo a second operation related to unilateral inguinal hernia within one year after primary inguinal hernia repair', 'timeFrame': 'One year after primary hernia repair'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a power of 0.80 and a two-sided alpha of 0.05. A 10% loss to follow-up is also considered.", "answer": 416, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Data from the latest systematic review shows that the incidence of infants younger than 6 months of age who develop MCIH is 12.4% [4]. Retrospective data from the Emma Children\u00e2\u0080\u0099s Hospital AMC, where in 2000/2001 contralateral exploration was routinely performed, shows similar results: 8/92 patients did not undergo contralateral exploration and subsequently one patient (12.5%) developed MCIH. Eighty-four patients underwent unilateral hernia repair with contralateral exploration of which one patient (1.2%) developed MCIH.\n The expected percentage of children requiring one or more reoperations because of MCIH in the first year following hernia repair is approximately 10%. We consider a reduction of children requiring reoperation from 10 to 2.5% as clinically relevant. A total sample size of 378 patients is needed to detect such a reduction with a power of 0.80 at a two-sided alpha of 0.05 (nQuery Advisor 7.0) [29]. Taking into account 10% loss to follow-up, we need to include 416 children.", "id": 341, "split": "train"} +{"trial_id": "NCT03624283", "pmid": "31217316", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Vestibular Exercise, With or Without Medication, in Managing Residual Dizziness After Successful Repositioning Maneuvers in Patients With Benign Paroxysmal Positional Vertigo\n\nIncluded conditions:\n- Vestibular Disorder\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'EXPERIMENTAL', 'description': 'Group A will be provided with Exercise-based vestibular rehabilitation (VR) twice per day for a period of 4 weeks;', 'interventionNames': ['Behavioral: Exercise-based vestibular rehabilitation']}\n- {'label': 'Group B', 'type': 'EXPERIMENTAL', 'description': 'Group B will be prescribed with Betahistine 12mg, twice daily for 7 days;', 'interventionNames': ['Drug: Betahistine']}\n- {'label': 'Group C', 'type': 'EXPERIMENTAL', 'description': 'Group C will receive an combination of Exercise-based VR plus Betahistine.', 'interventionNames': ['Drug: Betahistine', 'Behavioral: Exercise-based vestibular rehabilitation']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Betahistine', 'description': 'Betahistine is used in the treatment of and vertigo.', 'armGroupLabels': ['Group B', 'Group C']}\n- {'type': 'BEHAVIORAL', 'name': 'Exercise-based vestibular rehabilitation', 'description': 'Exercise-based vestibular rehabilitation (VR) has proven to be an effective way for managing dizziness by relieving symptoms and improving balance and postural stability.', 'armGroupLabels': ['Group A', 'Group C']}\n\nPrimary Outcomes:\n- {'measure': 'Balance function', 'description': 'Balance function, measured by computerized dynamic posturography.', 'timeFrame': 'Change from baseline, at 4 weeks, 8 weeks and 12 weeks postrandomisation'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha level of 0.05 (two-tailed test), 20% loss during follow-up period.", "answer": 183, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The study sample size was based on the VAP measure (one of the primary outcomes), which is a useful clinical tool for assessing a patient\u00e2\u0080\u0099s limitations in activities and participation due to vertigo, dizziness and unsteadiness. The validation of VAP in patients who complained of dizziness or imbalance showed the minimum detectable change (MDC) for the VAP was 0.58, with an SE of 0.21.39 In this study, a VAP difference of 0.6 will be considered clinically meaningful. Thus, to detect an MDC of 0.6 for the VAP with 80% power (alpha level of 0.05, two-tailed test), 55 subjects per group will be required. Although there are three groups in this study, controlling for the type I error rate is not needed because our hypotheses are: (1) VR will be superior to betahistine (Group A vs Group B) and (2) VR will be non-inferior to VR plus betahistine (Group A vs Group C); therefore, only two comparisons will be executed. Allowing for a 20% loss during the follow-up period, a total sample of 183 (61 per group) will be required for the current study.", "id": 342, "split": "train"} +{"trial_id": "NCT03629457", "pmid": "30727962", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of a Training Program in Mindfulness and Self-Compassion of 4 Sessions in Front of the 8 Sessions to Reduce Work Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD Project)\n\nIncluded conditions:\n- Stress\n- Burnout Syndrome\n\nStudy Armgroups:\n- {'label': 'Intervention group 4s (mindfulness)', 'type': 'EXPERIMENTAL', 'description': 'Abbreviated program of 4 weeks: will consist of 4 weekly sessions of 2 hours. Participants must practice at home for 15 minutes a day', 'interventionNames': ['Behavioral: Mindfulness and Mindful Self-Compassion']}\n- {'label': 'Intervention group 8s (mindfulness)', 'type': 'EXPERIMENTAL', 'description': 'Program of 8 weeks: The format will be 8 weekly sessions of 2 hours. Participants must practice at home for 30 minutes a day', 'interventionNames': ['Behavioral: Mindfulness and Mindful Self-Compassion']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'The participants will only receive a one-hour information session and will be invited to complete the questionnaires provided in two moments of the time (coinciding with the interventions in the experimental groups)'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness and Mindful Self-Compassion', 'description': 'Mindfulness Based Stress Reduction (MBSR) and Mindful Self-Compassion', 'armGroupLabels': ['Intervention group 4s (mindfulness)', 'Intervention group 8s (mindfulness)']}\n\nPrimary Outcomes:\n- {'measure': 'Degree of occupational stress', 'description': 'An ordinal scale that ranges from 0 (no degree of stress) to 10 (maximum degree of stress) stress, will be used', 'timeFrame': 'Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)'}\n- {'measure': 'Degree of occupational stress', 'description': 'PSQ questionnaire (Perceived Stress Questionnaire). It consists of 30 items that can be scored using a Likert scale (1 to 4). Higher total values indicate more stress.', 'timeFrame': 'Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)'}\n- {'measure': 'Degree of burnout', 'description': 'Maslach Burnout Inventory-General Survey (MBI). Spanish version of the MBI-HSS25. It consists of 22 scoring items from 0 to 6 that measure the three dimensions of the syndrome: emotional fatigue (CE), 9 items and a maximum score of 54 points; depersonalization (DP), 5 items and maximum score of 30 points; personal fulfillment (RP), 8 items and maximum score of 48 points. The cut points used were: emotional fatigue under \\\\<19, moderate 19-26, high\\\\> 26. Depersonalization under \\\\<6, moderate 6-9, high\\\\> 9. Personal performance under\\\\> 39, moderate 39-34, high \\\\<34 .', 'timeFrame': 'Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)'}\n- {'measure': 'Degree of Self-Compassion', 'description': 'Self-compassion questionnaire. The short scale of the Spanish version, validated by Garc\u00eda-Campayo et al, will be used, with 12 items scored using a Likert scale (1 to 5) that measures how the subject usually acts towards himself in difficult moments. It consists of six subscales: self-friendliness, common humanity, mindfulness, and their opposites: self-judgment, isolation and over-identification. Higher total values indicate more self-pity.', 'timeFrame': 'Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, beta risk of 0.2 (power of 80%), and a loss/withdrawal rate of 25%. The design effect for cluster randomisation is considered with a factor of 1.7 based on an intra-cluster correlation coefficient (ICC) of < 0.05 for a cluster size of 15.", "answer": 132, "answer_type": "ACTUAL", "explanation": "Sample size\n To calculate the sample size, we have drawn on a previous study [25], using as an outcome variable the mean FFMQ score [31]; accepting an alpha risk of 0.05 and a beta risk of 0.2, in a bilateral contrast, 38 subjects are required in each group to detect a difference\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008915 points in the FFMQ scale between both experimental groups (EG4 and EG8) and the CG. It is assumed that the common standard deviation is 20. A loss or withdrawal rate of 25% has been estimated [43]. Because this is a cluster randomisation study, we have considered the design effect. The design effect multiplies the sample size by a factor ranging from 1.5 to 3 to achieve the same power, depending on the relationship between intra- and intergroup variance [44]. Estimates of the intra-cluster correlation coefficient (ICC) in randomised clinical trials in AP are generally <\u00e2\u0080\u00890.05 [45]. This ICC, for a cluster size of 15, results in a design effect corresponding to a factor of 1.7. Assuming this value, the final study sample size would be at least 130 subjects. One hundred and thirty-two (132) professionals will be included, 44 in each comparison group, 22 for each teaching unit.", "id": 343, "split": "train"} +{"trial_id": "NCT03632096", "pmid": "32311925", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of Photobiomodulation in Salivary Production of Patients With Xerostomy Induced by Anti-hypertensive Drugs\n\nIncluded conditions:\n- Xerostomia\n\nStudy Armgroups:\n- {'label': 'Photobiomodulation group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive 3 applications of low intensity light directly in the region of the three pairs of salivary glands already described. The ArGaAl diode laser, DMC 808nm 4J/point equipment will be used. The parameters that will be used are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2. The first application will be after the stimulated collection of saliva and the following applications will be given once a week for another 2 weeks.', 'interventionNames': ['Radiation: Photobiomodulation']}\n- {'label': 'Sham group', 'type': 'SHAM_COMPARATOR', 'description': 'The placebo group will have a simulation of application of the laser, following the same technique as the active group, but with the device turned off. Because it is an infrared light, it is invisible and this will not induce the patient to notice that the device is turned off.', 'interventionNames': ['Radiation: Sham']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Photobiomodulation', 'description': 'The parameters are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2.', 'armGroupLabels': ['Photobiomodulation group']}\n- {'type': 'RADIATION', 'name': 'Sham', 'description': 'The sham group will have a simulation of laser application, following the same procedures as the active group, but with the device switched off.', 'armGroupLabels': ['Sham group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline Sialometry (measurement of the amount of produced saliva before and after treatment)', 'description': 'The patient will be instructed to keep the head forward allowing all saliva to passively pass through the collection tube, resting on the lower lip, for five minutes. In the last second, the patient will be instructed to spit out all the accumulated saliva in the collection tube. The amount of saliva and foam will be evaluated and properly recorded. Then, the dimethicone (removal of the air bubbles) will be used to obtain the final result. At the end of the photobiomodulation sessions a sample of saliva will be collected to be compared to the initial sample. The measurement will be made as follows: milliliters of saliva produced per minute. For stimulate sialometry, a sialogogue will be used. The quantity will be classified as follows: Production of normal saliva: 1.5 to 3.0 ml/minute; Light hyposalivation: from 1.05 to 1.45 ml/minute; Moderate hyposalivation: 0.55 to 1.0 ml/minute; Severe hyposalivation: from 0.05 to 0.50 ml/minute; Sialorrhea: above 3.0 ml/min.', 'timeFrame': 'One month.'}\n\nPlease estimate the sample size based on the assumption: \nA 2-tailed t test with a significance level of 0.05 was assumed. The test power was set to be greater than 0.80.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "2.3\n Sample size\n It is known from published studies that the salivary volume (primary outcome) presents a normal distribution of probabilities, and with a variation coefficient of around 50%. Meanwhile the literature lacks information on the salivary flow difference between irradiated and non-irradiate subjects. Due to the lack of similar published works, the sample size was calculated using estimated effect size and test power as shown in Figure 3.\n \n Figure 3\n \n Statistical power of the hypothesis test as a function of the sample size. Each line was calculated for a different effect size.\n \n \n \n For the sample size analysis we assumed a 2-tailed t test with significant level of 0.05. Figure 4 shows that, for medium (0.750) and large (1000\u00e2\u0080\u00931250) effect sizes, a minimum of 30 patients per group is sufficient to control statistical variance, ensuring a test power >0.80.\n \n Figure 4\n \n Sites of irradiation: parotid, submandibular, and sublingual salivary gland.\n \n \n \n \n 2.3.1\n Inclusion criteria\n Patients over 18 years of age, hypertensive patients taking antihypertensive drugs and those who are associated with xerostomia, will be included, except for any other cause for the condition and provided they sign the free consent form. Patients with a serum level of LDL <160\u00e2\u0080\u008amg/dL and stage 3 renal disease whose renal function reduced their total capacity by 30% to 60%, but without oral repercussion, may be part of this group.\n \n \n 2.3.2\n Exclusion criteria\n Patients with cancer in the oral region, patients in radiotherapy, patients with Sj\u00c3\u00b6gren syndrome, diabetics, patients with stage 4 and 5 renal failure, pregnant women, infants, children under 18 years old, and those with any type of photosensitivity.", "id": 344, "split": "train"} +{"trial_id": "NCT03632590", "pmid": "31138315", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Magnesium Salts on Vascular Stiffness: A Randomized Controlled Trial in Healthy Overweight and Slightly Obese Men and Women\n\nIncluded conditions:\n- Vascular Stiffness\n- Blood Pressure\n\nStudy Armgroups:\n- {'label': 'Magnesium Citrate', 'type': 'EXPERIMENTAL', 'description': '450 mg of Magnesium Citrate per day', 'interventionNames': ['Dietary Supplement: Magnesium Citrate']}\n- {'label': 'Magnesium Sulfate', 'type': 'EXPERIMENTAL', 'description': '450 mg of Magnesium Sulfate per day', 'interventionNames': ['Dietary Supplement: Magnesium Sulfate']}\n- {'label': 'Magnesium Oxide', 'type': 'EXPERIMENTAL', 'description': '450 mg of Magnesium Oxide per day', 'interventionNames': ['Dietary Supplement: Magnesium Oxide']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Magnesium Citrate', 'description': '450 mg of Magnesium Citrate per day (6 capsules per day) for 24 weeks', 'armGroupLabels': ['Magnesium Citrate']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Magnesium Sulfate', 'description': '450 mg of Magnesium Sulfate per day (6 capsules per day) for 24 weeks', 'armGroupLabels': ['Magnesium Sulfate']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Magnesium Oxide', 'description': '450 mg of Magnesium Oxide per day (6 capsules per day) for 24 weeks', 'armGroupLabels': ['Magnesium Oxide']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'The placebo capsules will contain starch (Amylum solani) for 24 weeks', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change in vascular stiffness', 'description': 'Measured from carotid-femoral pulse wave velocity (PWV). For this assessment, a SphygmoCor will be used (SphygmoCor v9, AtCor Medical).', 'timeFrame': 'Baseline, FU-1 (2 weeks), FU-2 (12 weeks), and FU-3 (24 weeks)'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a significance level (probability) of 0.05, a power of 0.80, and a 10% dropout rate. Additionally, it is assumed that only 50% of the subjects included in the screening will meet all inclusion criteria and be willing to participate.", "answer": 162, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The current study is powered on arterial stiffness, the primary endpoint. The required sample size for noninferiority testing is calculated based on a margin of 0.5\u00e2\u0080\u0089m/s, a probability of 0.05 and a power of 0.80. Therefore, 41 subjects per magnesium group are needed. To compare magnesium citrate with placebo, we assume that the number of subjects per group calculated for a two-arm trial (n\u00e2\u0080\u0089=\u00e2\u0080\u008924) is sufficient. Because a 10% dropout rate is expected, 162 will be recruited to start the study. By taking into account that only 50% of the subjects included in the screening will meet all inclusion criteria and are willing to participate, 324 subjects are expected to participate in the screening visits.\n This sample size calculation is based on an intra-subject variability of 0.9\u00e2\u0080\u0089m/s and a 1.0\u00e2\u0080\u0089m/s change in the PWVc\u00e2\u0080\u0093f after 24\u00e2\u0080\u0089weeks of magnesium supplementation found in our previous study [9]. The equivalence margin of 0.5\u00e2\u0080\u0089m/s is based on the observed effect [9], which is 50% of the magnesium citrate supplementation effect compared to placebo. For the calculation of the sample size, the formula of Julious [21] was used.", "id": 345, "split": "train"} +{"trial_id": "NCT03634826", "pmid": "31195991", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Study of Longitudinal Monitoring in Surgical Lung Cancer Patients by Circulating Tumor DNA and Its Methylation\n\nIncluded conditions:\n- Carcinoma\n- Lung Cancer\n- NSCLC\n- Lung Neoplasm\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': \"Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.\", 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nThe follow-up rate is assumed to be 85%. The significance level (alpha) is set at 0.05, and the power is over 90%.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to previous studies, the sensitivity of ctDNA methylation detection is above 70% in stage I lung adenocarcinoma [21]. So we assume our panel has a sensitivity of at least 70% in stage IA to III surgical patients. As our study focuses on early stage patients, we hypothesize the postoperative positive rate to be 15% during the 3-year follow-up, and assume a 85% follow-up rate. In the field of breast cancer and colon cancer, the recurrence rate within one year was over 50% in ctDNA-positive patients and less than 10% in ctDNA-negative patients [5, 7]. We assume ctDNA have similar prognostic prediction value in NSCLC patients. Given the information above, we plan to recruit 200 individuals for the final analysis. As a result, when alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, the two groups (postoperative positive vs. postoperative negative) would demonstrate statistical difference on DFS, with a power over 90%.", "id": 346, "split": "train"} +{"trial_id": "NCT03635710", "pmid": "30617104", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Measuring the Prevalence of Nocturnal Cough in Asthmatics by Means of Smartphone-enabled Acoustic Recording and Evaluating the Potential of Nocturnal Cough Rate as a Prognostic Marker for Asthma Control: An Observational Two-Stage Study\n\nIncluded conditions:\n- Asthma\n- Cough\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'The patient will undergo no intervention', 'description': 'Night coughs will be monitored using smartphone a app and interpreted using machine learning algorithm.'}\n\nPrimary Outcomes:\n- {'measure': 'Coughs per night assessed by smartphone audio recording', 'description': 'Number of coughs per night measured by means of smartphone audio recording', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level of 5%, and a dropout rate of 10%.", "answer": 94, "answer_type": "ACTUAL", "explanation": "Sample size\n The study is powered with regard to the primary endpoint of the second stage. The required sample size was calculated based on the results of Marsden et al.7 That is, a correlation of r=0.30 between nocturnal cough frequency and asthma control was set as the expected strength of correlation. In order to ensure a power (1-\u00c3\u009f) of 80% with a two-tailed type 1-error probability (\u00ce\u00b1) of 5% for rejecting a zero bivariate correlation,16 85 participants are required. In terms of parameter accuracy estimation,17 this sample size would result in a 95% CI for the above-mentioned correlation of [0.09, 0.48].\n A dropout rate of 10% is assumed, thus 94 participants will be recruited. To the best knowledge of the authors, no research that investigated the relationship of nocturnal cough, sleep quality and asthma control in a longitudinal setting is available hitherto. This prohibits a more precise evidence-based estimation of the required sample size. Consequently, the required sample size calculation does not take sleep quality and the longitudinal data structure into account. However, due to the comparable strength of association between sleep quality and asthma control (r=0.31\u00e2\u0080\u00930.36)6 and nocturnal cough and asthma control (r=0.30),7 the required sample size holds for this relationship, too.", "id": 347, "split": "train"} +{"trial_id": "NCT03636165", "pmid": "31230016", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP)\n\nIncluded conditions:\n- Pain, Postoperative\n- Post-Craniotomy Headache\n\nStudy Armgroups:\n- {'label': 'MP plus RP group', 'type': 'EXPERIMENTAL', 'description': 'Patients in RP/MP group will receive a peri-incisional scalp infiltration with 0.125% methylprednisolone and 0.2% ropivacaine and normal saline miscible liquids. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.', 'interventionNames': ['Drug: Methylprednisolone', 'Drug: Ropivacaine']}\n- {'label': 'RP group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in RP group will receive peri-incisional scalp infiltration with 0.2% ropivacaine alone. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.', 'interventionNames': ['Drug: Ropivacaine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Methylprednisolone', 'description': 'The local infiltration solution containing 1.25mg Methylprednisolone per milliliter.', 'armGroupLabels': ['MP plus RP group']}\n- {'type': 'DRUG', 'name': 'Ropivacaine', 'description': 'The local infiltration solution containing 2mg Ropivacaine per milliliter.', 'armGroupLabels': ['MP plus RP group', 'RP group']}\n\nPrimary Outcomes:\n- {'measure': 'Cumulative fentanyl consumption within 24 hours postoperatively', 'description': 'The PCIA device provides bolus (0.5\u00b5g/kg, 10min lock-out time) and the maximum dose will be limited as 2\u00b5g/kg per hour. If the patients feel inadequate analgesia after 5 times of fentanyl bolus, the bolus dose will be increased to 1 \u00b5g/kg and the maximum dose will be increased to 4 \u00b5g/kg per hour', 'timeFrame': 'Within 24 hours after the operation'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed with a 90% power and a two-sided \u03b1 level of 0.05. A dropout rate of 20% is also considered.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to Ju\u00e2\u0080\u0099s article, the total fentanyl consumption during the first 24\u00e2\u0080\u0089hours after surgery was 103.9 (11.5) \u00c2\u00b5g for children who received local infiltration with RP for tonsillectomy and adenoidectomy.37 Maxwell et al reported that paediatric craniotomy patients receive approximately 300\u00e2\u0080\u0089\u00c2\u00b5g/kg of morphine on the first postoperative day.38 This dose of morphine is converted to an equianalgesic dose of fentanyl (the conversion factor is 1\u00e2\u0080\u0089mg morphine=10\u00e2\u0080\u0089\u00c2\u00b5g fentanyl), that\u00c2\u00a0is, paediatric craniotomy patients receive approximately 3\u00e2\u0080\u0089\u00c2\u00b5g/kg of fentanyl on the first postoperative day. Combined with the previous experience of our centre, we hypothesise that the total fentanyl consumption during the first 24\u00e2\u0080\u0089hours after craniotomy will be 110\u00c2\u00b130\u00e2\u0080\u0089\u00c2\u00b5g for children who received local infiltration with RP.\n Although Ersayli\u00e2\u0080\u0099s study did not identify any extra effect of MP in patients undergoing lumbar discectomy,27 this study suggested a trend that local infiltration by MP could reduce the amount of postoperative analgesics in the 24\u00e2\u0080\u0089hours after lumbar discectomy by 20%. We hypothesise that the local application of MP will reduce the dosage of fentanyl by 20%, that is, 88\u00c2\u00b130\u00e2\u0080\u0089\u00c2\u00b5g, within 24\u00e2\u0080\u0089hours after paediatric craniotomy.\n Therefore, we estimate that the accumulated fentanyl dose after 24\u00e2\u0080\u0089hours will be approximately 110\u00c2\u00b130\u00e2\u0080\u0089\u00c2\u00b5g in the RP group and 88\u00c2\u00b130\u00e2\u0080\u0089\u00c2\u00b5g in the RP/MP group. Forty patients per group will be needed based on a 90% power with a two-sided \u00ce\u00b1 level of 0.05 to show a relative between-group difference of 20% in the composite primary outcome measure. Considering a dropout rate of 20%, a total of 50 patients per arm will be required; thus, the total sample size will be 100 patients in this RP/MP versus RP trial.", "id": 348, "split": "train"} +{"trial_id": "NCT03640377", "pmid": "34488846", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Phase II PK/PD Driven Dose Finding Trial of Praziquantel in Children Under Four\n\nIncluded conditions:\n- Schistosomiasis\n- Schistosomiasis Mansoni\n- Schistosoma Japonicum Infection\n\nStudy Armgroups:\n- {'label': 'Praziquantel 40 mg/kg dose only baseline treatment', 'type': 'ACTIVE_COMPARATOR', 'description': '150 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline', 'interventionNames': ['Drug: Praziquantel']}\n- {'label': 'Praziquantel 80 mg/kg dose only baseline treatment', 'type': 'ACTIVE_COMPARATOR', 'description': '150 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline', 'interventionNames': ['Drug: Praziquantel']}\n- {'label': 'Praziquantel 40 mg/kg dose at baseline and 6 months', 'type': 'ACTIVE_COMPARATOR', 'description': '150 children will receive 40 mg/kg Praziquantel at baseline and again six months later.', 'interventionNames': ['Drug: Praziquantel']}\n- {'label': 'Praziquantel 80 mg/kg dose at baseline and 6 months', 'type': 'ACTIVE_COMPARATOR', 'description': '150 children will receive 80 mg/kg Praziquantel at baseline and again six months later.', 'interventionNames': ['Drug: Praziquantel']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Praziquantel', 'description': 'Praziquantel given as crushed tablets (40 or 80 mg/kg)', 'armGroupLabels': ['Praziquantel 40 mg/kg dose at baseline and 6 months', 'Praziquantel 40 mg/kg dose only baseline treatment', 'Praziquantel 80 mg/kg dose at baseline and 6 months', 'Praziquantel 80 mg/kg dose only baseline treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment efficacy', 'description': 'Treatment efficacy as captured by egg reduction rate', 'timeFrame': 'Four weeks post treatment'}\n- {'measure': 'Treatment efficacy', 'description': 'Treatment efficacy as captured by cure rate', 'timeFrame': 'Four weeks post treatment'}\n\nPlease estimate the sample size based on the assumption: \nUsing a two-sided 5% significance level, 80% power requires approximately 173 children per trial arm, and 90% power requires 232 per arm. Allowing for a 7% loss to follow-up, a total of approximately 500 children will be required.", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size\n We plan to recruit 600 children into the trial, 300 in Uganda and 300 in the Philippines. The first co-primary outcome will compare cure rate at 4 weeks in the 300 children who received 80\u00e2\u0080\u0089mg/kg PZQ at enrolment compared to the 300 children who received 40\u00e2\u0080\u0089mg/kg PZQ at enrolment. Data from Uganda estimate cure rates for S. mansoni infected 3\u00e2\u0080\u00939\u00e2\u0080\u0089years olds of 70% and 82% for 40\u00e2\u0080\u0089mg/kg and 60\u00e2\u0080\u0089mg/kg PZQ, respectively [17]. Using a two-sided 5% significance level, approximately 173 children per trial arm will be required for 80% power and 232 per arm (N = 464) for 90% power to detect a difference in cure rate of 70% versus 82% at 4\u00e2\u0080\u0089weeks between the trial arms. Allowing for loss to follow-up of 7%, a total of approximately 500 children will be required. A sample size of 600 will allow us adequate power to examine sub-groups such as setting/Schistosoma species, younger (12\u00e2\u0080\u009330\u00e2\u0080\u0089months) versus older (30\u00e2\u0080\u009347\u00e2\u0080\u0089months) children, particularly given that cure rates may be lower in younger children and the effect size is likely to be larger based on a higher dose (80\u00e2\u0080\u0089mg/kg).", "id": 349, "split": "train"} +{"trial_id": "NCT03640845", "pmid": "32312242", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of a Hospital Medication Expertise on the Rate of Unplanned Hospitalizations at 3 Months of Patients Residing in Nursing Homes (EPAD)\n\nIncluded conditions:\n- Age Problem\n\nStudy Armgroups:\n- {'label': 'experimental group', 'type': 'EXPERIMENTAL', 'description': 'Patient living in nursing homes a tele-expertise will be performed', 'interventionNames': ['Other: tele-expertise']}\n- {'label': 'control group', 'type': 'NO_INTERVENTION', 'description': 'Patient living in nursing homes will performed a normal care.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'tele-expertise', 'description': 'Tele-expertise consists of the remote realization of a multi-professional medication review (clinical pharmacist and doctor / geriatrician), ie a complete and systematic analysis of sociodemographic, clinical, biological and pharmaceutical data transmitted in such a way standardized at the EHMP and aimed at optimizing the therapeutics of the resident patient of the EHPAD requesting tele-expertise.\\n\\nTele-expertise is realized in three stages, that are\\n\\n* the transmission, the collection and the organization of the data,\\n* the analysis of the data and their confrontation with the referential and recommendations\\n* the writing of a Personalized Pharmaceutical Plan', 'armGroupLabels': ['experimental group']}\n\nPrimary Outcomes:\n- {'measure': 'number of unplanned hospitalizations', 'description': 'The main endpoint is the rate of unplanned hospitalizations (all structures) of nursing home residents', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-tailed significance level of 0.05, 25% loss to follow-up.", "answer": 364, "answer_type": "ESTIMATED", "explanation": "Sample size\n On the basis of a unplanned hospital admission rate of 25% over a 3-month period [23] and taking into consideration the results of a study evaluating the impact at 8\u00e2\u0080\u0089weeks of medication review on admission to nursing home [24], we estimate a unplanned hospital admission rate of 10% in the experimental group. The initial sample size of 292 patients provided 90% power to detect this difference at a two tailed significance level of 0.05. Assuming possibly 25% of patients lost to follow-up, a total of 364 patients is required (182 per group) (Fig.\u00c2\u00a01).\nFig. 1Flow diagram of the study protocol", "id": 350, "split": "train"} +{"trial_id": "NCT03645733", "pmid": "32998761", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Effect of Cooled Haemodialysis on Cognitive Function in Patients Suffering With End-stage Kidney Disease: Feasibility Study\n\nIncluded conditions:\n- Cognitive Impairment\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'The control group will be at the standard dialysate temperature of 36.5 \u00b0C (which is the standard of care in the sites), 3 times a week for 12 months'}\n- {'label': 'Lower Temperature Group', 'type': 'EXPERIMENTAL', 'description': 'These patients will receive haemodialysis with a dialysate temperature of 35 degree centigrade. The intervention group will start off using a dialysate temperature that is 36 \u00b0C. Thereafter the dialysate temperature will be reduced every two week by 0.5 \u00b0C until 35 \u00b0C or the lowest tolerated temperature reached. Patients who would fail to tolerate the temperature of 35 \u00b0C, the lowest tolerated temperature will be carried over to the end of the study.', 'interventionNames': ['Procedure: Lower Temperature Group']}\n- {'label': 'Caregivers', 'type': 'NO_INTERVENTION', 'description': \"Patients, who consent for the study, will be asked to identify the most suitable carer to participate in the study who could be approach in person, over the phone or by post as deemed suitable by the research team and convenient by the carer. Patient's permission to contact their identified carer will be recorded. Carers of consenting patients will be approached in the same manner as above after obtaining patients consent to contact their carers. Patients will still be able to take part in the study even if their carer declines consent.\"}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Lower Temperature Group', 'description': 'Dialysate temperature of 35 degree centigrade. The intervention group will start off using a dialysate temperature that is 36 \u00b0C. Thereafter the dialysate temperature will be reduced every two week by 0.5 \u00b0C until 35 \u00b0C or the lowest tolerated temperature reached.', 'armGroupLabels': ['Lower Temperature Group']}\n\nPrimary Outcomes:\n- {'measure': 'Investigation of lower temperatures of dialysis and cognitive decline', 'description': 'To assess whether lower temperatures of dialysis fluid prevents the decline in cognitive function via utilisation of the Montreal Cognitive Assessment (MOCA) v7.2. The MOCA includes activities relating to Visuospatial / Executive (score out of 5); Naming (score out of 3); Memory (score of of 10); Attention (score out of 6); Naming (score out of 3) Abstraction (score out of 2); Delayed Recall (score out of 5) and Orientation (score out of 6). 1 point is given for each correct answer, and a higher score represents normal cognitive function, whilst lower scores represent possible cognitive decline. A total of 30 points can be achieved.', 'timeFrame': '1.5 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for a 95% confidence interval. An expected attrition rate of 20% is considered.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n The outcome data from this feasibility study will be used to inform the sample size calculation for the definitive trial, by providing estimates of the primary outcome and its variability and the expected attrition. The study aims to recruit a total of 90 patients from four sites. Lancaster and co-workers outlined the key aspects of feasibility studies and indicated at least 30 patients per each arm are required to identify the sample variability (standard deviation) in key variables to enable the calculation of power for testing hypotheses in subsequent definitive studies [46]. The primary outcome in the definitive study is likely to be a value from the MoCA. With 45 patients in each arm, and if the mean (SD) value of the MoCA is 27 (2) in the control and intervention arms at the study start, we could expect a 95% confidence interval to range from 26.4 to 27.6 in each arm. This will give adequate precision for the estimate required in the study. With 45 patients in the control arm, and assuming a mean (SD) value of MoCA of 22 (3) after 12\u00e2\u0080\u0089months, we could expect a 95% confidence interval to range from 21.1 to 22.9. In the intervention arm, assuming a mean (SD) MoCA value of 25 (3) after 12\u00e2\u0080\u0089months, we could expect a 95% confidence interval to range from 24.1 to 25.9. Furthermore, with a total sample size of 90 patients, with an expected loss of 20% of the patients, a 95% confidence interval could be produced, ranging from 70.2 to 87.7%.", "id": 351, "split": "train"} +{"trial_id": "NCT03650517", "pmid": "32660467", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis\n\nIncluded conditions:\n- Colorectal Cancer\n- Anastomotic Complication\n- Colectomy\n\nStudy Armgroups:\n- {'label': 'Robotic Right Colectomy with ICA', 'description': 'Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.\\n\\nIntracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.', 'interventionNames': ['Procedure: Intracorporeal Anastomosis', 'Procedure: Robotic Surgery']}\n- {'label': 'Robotic Right Colectomy with ECA', 'description': 'Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.\\n\\nExtracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.', 'interventionNames': ['Procedure: Extracorporeal Anastomosis', 'Procedure: Robotic Surgery']}\n- {'label': 'Laparoscopic Right Colectomy with ICA', 'description': 'Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.\\n\\nIntracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.', 'interventionNames': ['Procedure: Intracorporeal Anastomosis', 'Procedure: Laparoscopic Surgery']}\n- {'label': 'Laparoscopic Right Colectomy with ECA', 'description': 'Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.\\n\\nExtracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.', 'interventionNames': ['Procedure: Extracorporeal Anastomosis', 'Procedure: Laparoscopic Surgery']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Extracorporeal Anastomosis', 'description': 'Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.', 'armGroupLabels': ['Laparoscopic Right Colectomy with ECA', 'Robotic Right Colectomy with ECA']}\n- {'type': 'PROCEDURE', 'name': 'Intracorporeal Anastomosis', 'description': 'Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique', 'armGroupLabels': ['Laparoscopic Right Colectomy with ICA', 'Robotic Right Colectomy with ICA']}\n- {'type': 'PROCEDURE', 'name': 'Robotic Surgery', 'description': 'Procedure is performed using robotic instruments', 'armGroupLabels': ['Robotic Right Colectomy with ECA', 'Robotic Right Colectomy with ICA']}\n- {'type': 'PROCEDURE', 'name': 'Laparoscopic Surgery', 'description': 'Procedure is performed using standard laparoscopic instruments', 'armGroupLabels': ['Laparoscopic Right Colectomy with ECA', 'Laparoscopic Right Colectomy with ICA']}\n\nPrimary Outcomes:\n- {'measure': 'Surgical wound infection', 'description': '(CDC definition \\\\[Health Protection Agency. Surveillance of Surgical Site Infection in England: October 1997-September 2005. London: Health Protection Agency; 2006): Superficial incisional, affecting the skin and subcutaneous tissue. These infections may be indicated by localised (Celsian) signs such as redness, pain, heat or swelling at the site of the incision or by the drainage of pus.', 'timeFrame': '30 days'}\n- {'measure': 'Clavien Dindo Complication', 'description': 'Complications according to Clavien Dindo Classification.', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 2-sided interval, with a 10% loss to follow-up. Several interim analyses are planned to adjust the sample size if needed. Statistical inferences will be made using a propensity score to account for confounding covariates.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The assumptions for the sample size of this study have been developed based on the incidence of Surgical Wound Infection, as well as the incidence of Clavien-Dindo grade\u00e2\u0080\u0089>\u00e2\u0080\u0089III complications as seen in the Introduction. The sample size is based on attaining a success rate of 85% for the primary endpoint, with the lower 95% confidence limit being no greater than 5% from the estimated success rate. Assuming a 2-sided interval, a total of 245\u00e2\u0080\u0093317 subjects will be required within each cohort. Accounting for a 10% loss to follow up, a total of 1200 subjects will be recruited for this study. Several interim analysis are planned through the study in order to build new power analysis and adjust sample size accordingly if needed.\n The design of this study envisages four parallel cohorts for which the sample size has been developed for each cohort according to a precision around an expected success rate with enough subject and sufficient power to make multiple comparisons within the appropriate method. Any statistical inferences drawn based on pairwise comparisons will be undertaken in a posteriori statistical analysis using a propensity score to account for confounding covariates.\n The primary endpoint for success is defined as a patient meeting the following criteria:\nSurgical Wound Infection 5% lower in the ICA group.Grade IIIb-IV Clavien -Dindo complications at 30\u00e2\u0080\u0089days post op 5% lower in the ICA group.\n According to the current literature the the following numbers represent Surgical Wound Infection and Severe Complications in intermediate volume centers:\nICAECASurgical Wound Infection4\u00e2\u0080\u00935%5,8,1010\u00e2\u0080\u009314%5,8,10Morbidity Dindo 3b-41.1\u00e2\u0080\u00935%5,88\u00e2\u0080\u009311%5,8", "id": 352, "split": "train"} +{"trial_id": "NCT03651284", "pmid": "32014057", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Project LiGHT (Living Green and Healthy for Teens): A Novel Weight Management Program That Emphasizes the Benefits of a Healthy Lifestyle\n\nIncluded conditions:\n- Obesity, Pediatric\n\nStudy Armgroups:\n- {'label': 'Aim2Be Live Coach', 'type': 'EXPERIMENTAL', 'description': 'Aim2Be app with Live Coach + Fitbit + BMI tracking tools', 'interventionNames': ['Behavioral: Aim2Be app with Live Coach + Fitbit + BMI tracking tools']}\n- {'label': 'Aim2Be Waitlist', 'type': 'OTHER', 'description': 'Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools for three months, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools', 'interventionNames': ['Behavioral: Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Aim2Be app with Live Coach + Fitbit + BMI tracking tools', 'description': 'Participants will spend six months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. They will also complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Live Coach and the Virtual Coach. The Live Coach has specialized training in lifestyle and motivational interviewing and will support families in changing their health behaviours through in-app messaging and phone calls. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory.', 'armGroupLabels': ['Aim2Be Live Coach']}\n- {'type': 'BEHAVIORAL', 'name': 'Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools', 'description': 'Participants in this condition will be waitlisted for three months while they receive standard of care (Canadian Health Recommendations for physical activity, dietary habits, screen behaviours, and sleep). Participants will gain access to the Aim2Be app with Virtual Coach after the three month assessment. Participants will then spend three months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. For the whole six months, participants will complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Virtual Coach only. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory.', 'armGroupLabels': ['Aim2Be Waitlist']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Body Mass Index z-score (youth)', 'description': 'Change in BMI z-scores will be computed from measured height and weight using World Health Organization (WHO) cut-offs', 'timeFrame': 'Baseline, 3 months, 6 months'}\n- {'measure': 'Change in health behaviour knowledge (youth)', 'description': \"Survey questions (using a LiGHT-specific tool) will assess teens' knowledge of Canadian recommendations for healthy eating, physical activity, and sedentary behaviours. Knowledge will be reported as an aggregate knowledge score from 0 to 8 (a score of 0 indicates low knowledge and a score of 8 indicates high knowledge), as well as sub-score for each of the knowledge areas (nutrition, physical activity, recreational screen time, sleep).\", 'timeFrame': 'Baseline, 3 months, 6 months'}\n- {'measure': 'Change in objective dietary behaviour (youth)', 'description': 'Change in mean daily servings of fruits and vegetables and sugar-sweetened beverages consumed over three consecutive 24-hour dietary recalls.', 'timeFrame': 'Baseline, 3 months, 6 months'}\n- {'measure': 'Change in number of daily steps (youth)', 'description': 'Change in mean daily steps over a 14-day period at each assessment point, as measured using a Fitbit activity monitor.', 'timeFrame': 'Baseline, 3 months, 6 months'}\n- {'measure': 'Change in screen behaviour (youth)', 'description': \"Survey questions will assess adolescents' recreational screen time use (using the Take Action survey), and will be reported as the number of self-reported hours of recreational screen time per day.\", 'timeFrame': 'Baseline, 3 months, 6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an 80% power, an alpha of .05, a 15% attrition rate from baseline to 3 months, and an 8% rate of families not downloading the Aim2Be app.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Based on previously published data [31], the RCT will have 80% power at an alpha of .05 to detect a .5 decrease in BMI z-score when the sample size in each group is 60. The BMI z-score was used to calculate sample size because this is the most difficult variable to change and requires the largest sample size of all of the primary outcomes. Based on this and accounting for both missing data and attrition, we project needing at least 80 families in each condition. However, to be able to detect a 20% difference in adherence (e.g., secondary aims outcome) between the two intervention groups (odds ratio of 2.33) at an alpha of .05 with 80% power using a one-sided t-test, 77 families are needed in each group. As the waitlist control group will receive the intervention at 3\u00e2\u0080\u0089months, we require 100 participants enrolled in each group (this accounts for 15% attrition from baseline to 3-month and the approximately 8% of families who will not download the Aim2Be app). Power calculations were conducted in nQuery (Statsols, USA). Based on these computations, we aim to enroll 200 participants in the RCT.", "id": 353, "split": "train"} +{"trial_id": "NCT03652519", "pmid": "30849952", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Influence of Different Rehabilitative Aerobic Exercise Programs on (Anti-) Inflammatory Immune Signalling, Cognitive Performance and Processing Skills in Persons With MS - A Randomized Controlled Trial\n\nIncluded conditions:\n- Multiple Sclerosis\n\nStudy Armgroups:\n- {'label': 'High-intensity Interval Training (HIIT)', 'type': 'EXPERIMENTAL', 'description': 'Participants of the HIIT group will exercise three times per week over a period of three weeks (inpatient rehabilitation) on a cycle ergometer. Exercise intensity will be regulated and heart rate controlled based on the achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Each exercise session will last 30 minutes and will be started and finalized with three minutes at low intensity (50% HRmax, warm-up / cool-down). During each exercise session, participants of the HIIT group will perform 5x one-and-a-half Minute high-intensive exercise bouts at 95-100% of their HRmax followed by active breaks of unloaded pedalling over 2 minutes with the aim to achieve 60% HRmax.', 'interventionNames': ['Behavioral: Exercise Training']}\n- {'label': 'Moderate Continous Training (ST)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants of the ST group will exercise three times per week over a period of three weeks (inpatient rehabilitation) on a cycle ergometer. Exercise intensity will be regulated and heart rate controlled based on the achieved maximum heart rate (HRmax) assessed during the initial Cardiopulmonary Exercise Testing. Each exercise session will last 30 minutes and will be started and finalized with three minutes at low intensity (50% HRmax, warm-up / cool-down). During each exercise session, participants of the ST group will exercise 30 minutes continuously at 65% of HRmax. This moderate continous training program represents the standard care at the local rehabilitation clinic.', 'interventionNames': ['Behavioral: Exercise Training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Exercise Training', 'description': 'Treatment in both arms consists of specific of aerobic exercise training modalities. Exercise has become an efficient strategy within rehabilitative programs and is part of a goal-orientated multidisciplinary approach to improve disability and participation in persons with MS. Recently, short and exhaustive bouts of exercise have gained much attention as a promising option in supportive care in MS.', 'armGroupLabels': ['High-intensity Interval Training (HIIT)', 'Moderate Continous Training (ST)']}\n\nPrimary Outcomes:\n- {'measure': 'Tregs', 'description': 'Proportion of regulatory T-cells with higher values indicating higher levels of Inflammation.', 'timeFrame': 'Three weeks (day 0 to day 21)'}\n\nPlease estimate the sample size based on the assumption: \nalpha of 5%, power (1-\u03b2) of 80%, 10% drop-out rate, estimated association between baseline levels and at T1 of \u03c1 = .7", "answer": 72, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The required sample size to evaluate the between-group effect of the exercise-interventions (HIIT vs. ST) on the primary endpoint (proportion of Tregs in blood samples of persons with MS) in an analysis of covariance model (ANCOVA) was estimated using G*Power 3.1.9.2 [47]. The following parameters were defined for power analysis: medium effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u0089.5, alpha of 5% and power (1-\u00ce\u00b2) of 80%. As covariate in the model participants\u00e2\u0080\u0099 proportion of Tregs at baseline will be used. Sample size needed to meet the above stated suppositions can be calculated according to the formula described by Borm and colleagues [48] (1-\u00cf\u00812)*n. An estimated association between participants\u00e2\u0080\u0099 baseline levels and at T1 of \u00cf\u0081\u00e2\u0080\u0089=\u00e2\u0080\u0089.7 was used. Calculation of required sample size revealed 33 participants in each group (total N\u00c2\u00a0=\u00e2\u0080\u008966). A 10% drop-out rate was expected. This estimation was done according to the attrition rates in previous similar studies [11]. Against this background, we will recruit 72 participants in total.", "id": 354, "split": "train"} +{"trial_id": "NCT03653832", "pmid": "38072483", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Alpha 2 Agonists for Sedation to Produce Better Outcomes From Critical Illness (A2B Trial): A Randomised, Parallel-group, Allocation Concealed, Controlled, Open, Phase 3 Pragmatic Clinical and Cost- Effectiveness Trial With Internal Pilot\n\nIncluded conditions:\n- Critical Illness\n\nStudy Armgroups:\n- {'label': 'Dexmedetomidine Group', 'type': 'EXPERIMENTAL', 'description': \"For dexmedetomidine, the regimen will follow the manufacturer's guidance and regimens used in previous trials. Dexmedetomidine will be up and down titrated against sedation targets set by clinical staff and reviewed at regular intervals, and documented at least daily. No loading dose will be administered. The starting dose will be 0.7 \u00b5g.kg-1.hour-1 titrated to a maximum dose 1.4 \u00b5g.kg-1 hour-1. Lower starting doses will be used at clinical discretion for patients with cardiovascular instability.\", 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'Clonidine Group', 'type': 'EXPERIMENTAL', 'description': \"For clonidine, the regimen is designed to be equipotent with dexmedetomidine based on known pharmacokinetics and pharmacodynamics. The chosen regimen is similar to that currently used in many UK ICUs as part of routine 'off label' practice. Clonidine will be up and down titrated against sedation targets set by clinical staff and reviewed at regular intervals, and at least daily. No loading dose will be administered. The starting dose will be 1.0\u00b5g.kg-1.hour-1 titrated to a maximum dose of 2 \u00b5g.kg-1.hour-1. Lower starting doses will be used at clinical discretion for patients with cardiovascular instability.\", 'interventionNames': ['Drug: Clonidine']}\n- {'label': 'Usual Care (Propofol) Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Usual Care Group : Patients will continue to receive intravenous propofol according to usual current care . The sedation targets, weaning, and sedation discontinuation procedures will follow the same clinical targets as for the clonidine and dexmedetomidine groups.', 'interventionNames': ['Drug: Propofol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'Patients will commence intravenous infusion of open-label study drug according to a weight-based dose regimen as early as possible post-randomisation, and within a maximum of two hours.\\n\\nBedside clinical staff will transition patients to achieve sedation with the allocated \u03b12-agonist agent as quickly as clinically feasible and safe, to replicate the way these drugs would be used in routine practice. Additional opiate will be used for analgesia using clinical judgement. Once established, additional propofol will only be used when the maximum \u03b12-agonist dose is reached or because cardiovascular or other side-effects limit dose escalation.', 'armGroupLabels': ['Dexmedetomidine Group'], 'otherNames': ['Dexdor']}\n- {'type': 'DRUG', 'name': 'Clonidine', 'description': 'Patients will commence intravenous infusion of open-label study drug according to a weight-based dose regimen as early as possible post-randomisation, and within a maximum of two hours.\\n\\nBedside clinical staff will transition patients to achieve sedation with the allocated \u03b12-agonist agent as quickly as clinically feasible and safe, to replicate the way these drugs would be used in routine practice. Additional opiate will be used for analgesia using clinical judgement. Once established, additional propofol will only be used when the maximum \u03b12-agonist dose is reached or because cardiovascular or other side-effects limit dose escalation.', 'armGroupLabels': ['Clonidine Group'], 'otherNames': ['Catapres']}\n- {'type': 'DRUG', 'name': 'Propofol', 'description': 'Patients will continue to receive intravenous propofol according to current usual care.', 'armGroupLabels': ['Usual Care (Propofol) Group'], 'otherNames': ['Diprivan']}\n\nPrimary Outcomes:\n- {'measure': 'Time to first successful extubation post-randomisation (hours).', 'description': 'How many hours are participants on the study ventilated for?', 'timeFrame': 'Ventilation status will be recorded twice daily from the date of randomisation until the date of documented successful extubation, or 180 days, whichever comes first.'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical assumptions include maintaining 99% power for stage 1 comparisons and the superiority comparison in stage 2, increasing the significance level for the non-inferiority test from 2.5% to 4%, and an increase in the familywise type I error rate from 5% to 6.5%. The power for detecting the mortality effect decreased from 83% to 76%.", "answer": 1437, "answer_type": "ACTUAL", "explanation": "Modifications to sample size due to impact of COVID-19 pandemic\n The COVID-19 pandemic had a major impact on the trial progress and recruitment. In consultation with the funder, a modification to the original sample size was agreed in February 2023. The focus was on maintaining high power for the stage 1 hypothesis testing, and included modelling the impact of a reduced sample size on the stage 2 test of non-inferiority of clonidine versus dexmedetomidine, plus the power for detecting an effect on mortality. Based on these investigations, the sample size was reduced to 1437. This maintained 99% power for the stage 1 comparisons of clonidine and dexmedetomidine versus propofol (H1 and H2), and also for the superiority comparison of dexmedetomidine versus clonidine if progression to stage 2 testing occurs (H4). The main effect on power was for the non-inferiority comparison of clonidine versus dexmedetomidine (H3). For this comparison, in order to maintain 80% power when using the non-inferiority margin of 1\u00e2\u0080\u0089day, the significance level for test H3 was increased from 2.5% to 4%. This change to the hypothesis testing hierarchy meant that the upper limit on the familywise type I error rate increased from 5% to 6.5%. For the key secondary outcome of mortality, for the same 7% mortality difference, power decreased from 83% to 76%.", "id": 355, "split": "train"} +{"trial_id": "NCT03660670", "pmid": "38367968", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Medico-economic Evaluation of the ONCORAL Program of Multidisciplinary ONCOlogic Interventions Between Town and Hospital (Doctor-pharmacist-nurse) for Ambulatory Patients Under oRAL Anticancer Drugs Versus Usual Care\n\nIncluded conditions:\n- Cancer\n\nStudy Armgroups:\n- {'label': 'Interventional Arm', 'type': 'EXPERIMENTAL', 'description': 'Application of the ONCORAL program of multidisciplinary ONCOlogic interventions between town and hospital (doctor-pharmacist-nurse) for ambulatory patients under oRAL anticancer drugs', 'interventionNames': ['Behavioral: ONCORAL therapeutic education']}\n- {'label': 'Standard of care', 'type': 'SHAM_COMPARATOR', 'description': 'Patients in the control group will receive regular follow-up from their oncologist, but no more that the standard care.', 'interventionNames': ['Behavioral: Standard of care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'ONCORAL therapeutic education', 'description': 'Multidisciplinary program that includes informative cessions with a hospital pharmacist about the anticancer drug: information is given to the patients on adverse events and their managements, optimizing drug dosage plans. Moreover, information is shared with town partners: doctor, pharmacists, and nurses.', 'armGroupLabels': ['Interventional Arm']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard of care', 'description': 'In the group of standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessments.', 'armGroupLabels': ['Standard of care']}\n\nPrimary Outcomes:\n- {'measure': 'Evaluate efficiency of ONCORAL program for ambulatory patients under oral anticancer drugs versus usual care', 'description': 'Efficiency is calculated on the double dimension cost and year of life corrected by quality of life (QALY).', 'timeFrame': 'Month 12'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed with an 80% power and a 0.05 two-sided significance level. An unbalanced 2:1 ratio in favour of the ONCORAL programme is used, and early withdrawal is accounted for.", "answer": 215, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was based on RDI, as it is associated with the effectiveness of OAA. According to the information available in the literature at the time of the study design, its value was 0.70 in usual care.28 We assume that the ONCORAL programme will achieve the RDI of 0.85. For an unbalanced 2:1 ratio in favour of the ONCORAL programme, a sample of 130 patients in the ONCORAL group and 65 in the usual care group will achieve a power of 80% at a 0.05 two-sided significance to detect a difference of 0.15 with a SD of 0.35. To take into account early withdrawal from the study, a total of 215 patients will be included in the study (143 in the ONCORAL group and 72 in the usual care group).\n The number of patients treated with OAA in the study centre is approximately 350 per year, which will allow the recruitment of the expected number of subjects.", "id": 356, "split": "train"} +{"trial_id": "NCT03667651", "pmid": "30867201", "question": "Here is the design of a clinical trial:\n\nOfficial Title: THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy\n\nIncluded conditions:\n- Eczema\n- Asthma\n- Allergy;Food\n\nStudy Armgroups:\n- {'label': 'Twice daily use treatment with EpiCeram', 'type': 'ACTIVE_COMPARATOR', 'description': 'They will be instructed to apply EpiCeram\u2122 to the full skin surface of their child twice per day for 6 months. The prophylactic use of EpiCeram\u2122 is the intervention that is being tested for its effect on infant skin barrier function. We will instruct parents to apply approximately 6 grams of EpiCeram\u2122 per application at two regular times each day, including after bathing the infant, or at the time they would normally bathe their child.', 'interventionNames': ['Drug: EpiCeram']}\n- {'label': 'Standard skin care', 'type': 'NO_INTERVENTION', 'description': 'Parents are to follow standard skin care practices'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'EpiCeram', 'description': 'Parents will be instructed to apply EpiCeram\u2122 to the full skin surface of their child twice per day for six months.', 'armGroupLabels': ['Twice daily use treatment with EpiCeram']}\n\nPrimary Outcomes:\n- {'measure': 'Presence of eczema', 'description': 'as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema.', 'timeFrame': '12 months of age.'}\n- {'measure': 'Confirmed diagnosis of food allergy at 12 months (52 weeks).', 'description': \"This diagnosis is derived from a combination of allergic sensitisation, reaction history and food challenge. A skin prick test to six common allergens will be performed (egg white, cows' milk, peanut, dust mite, cat dander, and rye grass) along with a negative (saline) and a positive (histamine) control. Participants that are sensitised to certain foods (\\\\>=1mm wheal) during the skin prick testing will be given a challenge to determine if they are allergic to those foods. This will be conducted at the MCRI Allergy Clinic under the supervision of a Doctor specifically trained in oral food challenges.\", 'timeFrame': '12 months of age'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes 86% power for the AD outcome and 80% power for the food allergy outcome. Additionally, there is an expectation of up to 80% loss to follow-up for participants with FLG null mutations.", "answer": 760, "answer_type": "ESTIMATED", "explanation": "Sample size\n We require 760 participants (380 in each group). With 380 infants per group, we will have, (1)\u00c2\u00a086% power to demonstrate that the intervention causes an absolute risk reduction for AD of 12% (from 40% to 28%, RR=0.7), and (2)\u00c2\u00a080% power to detect a 7.5% reduction in food allergy at 12 months (from 15% to 7.5%, RR=0.5). As the population prevalence of FLG null mutations is approximately 10%,33 and we will only recruit children with a family history of allergic disease, we expect at least 15% of participants to have one or more FLG null mutation. This will result in 45 infants per group (allowing for up to 80% loss to follow-up) with one or more such mutations. We will have approximately 80% power to detect a relative risk of 0.40 (20% vs 50%) induced by the treatment for the outcome of AD.", "id": 357, "split": "train"} +{"trial_id": "NCT03670615", "pmid": "34863115", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Exercise Augmenting Cognition tDCS (EXACT): A Pilot Study of a Combined Exercise and Transcranial Direct Current Stimulation Intervention for Cognition\n\nIncluded conditions:\n- Mild Cognitive Impairment\n- Alzheimer Disease\n\nStudy Armgroups:\n- {'label': 'Exercise and tDCS', 'type': 'EXPERIMENTAL', 'description': 'Patients randomized to this group will attend Toronto Rehabilitation Institute - University Health Network (TRI-UHN) for an individualized exercise program and active tDCS intervention.', 'interventionNames': ['Other: tDCS', 'Other: Exercise']}\n- {'label': 'Exercise Education and tDCS', 'type': 'OTHER', 'description': 'Patients randomized to this group will undergo treatment as usual, receiving routine advice about physical activity and active tDCS intervention.', 'interventionNames': ['Other: tDCS', 'Other: Exercise Education']}\n- {'label': 'Exercise and Sham tDCS', 'type': 'OTHER', 'description': 'Patients randomized to this group will attend TRI-UHN for an individualized exercise program and sham tDCS intervention.', 'interventionNames': ['Other: Exercise', 'Other: Sham tDCS']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'tDCS', 'description': 'All study participants randomized to tDCS will receive active tDCS.', 'armGroupLabels': ['Exercise Education and tDCS', 'Exercise and tDCS']}\n- {'type': 'OTHER', 'name': 'Exercise', 'description': 'Participants will exercise at TRI according to an individualized exercise prescription.', 'armGroupLabels': ['Exercise and Sham tDCS', 'Exercise and tDCS']}\n- {'type': 'OTHER', 'name': 'Exercise Education', 'description': 'Exercise education/ treatment as usual will include routine advice about physical activity for older adults.', 'armGroupLabels': ['Exercise Education and tDCS'], 'otherNames': ['Treatment as usual']}\n- {'type': 'OTHER', 'name': 'Sham tDCS', 'description': 'The same procedure for tDCS will be used for the sham condition, except without active current.', 'armGroupLabels': ['Exercise and Sham tDCS']}\n\nPrimary Outcomes:\n- {'measure': \"Change in cognition: The Word Recognition Task from the Alzheimer's Disease Assessment Scale Cog (ADAS-Cog)\", 'description': 'Assess recognition memory. Words incorrectly recognized will be tallied. Word Recognition scores range from 0 to 12. Higher scores represent a worse outcome.', 'timeFrame': 'Change over 2 weeks (Baseline to Endpoint)'}\n\nPlease estimate the sample size based on the assumption: \n83% power, alpha of 0.05, adjusting for 4 covariates, medium effect size", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation was performed using G*Power version 3.1.9.2 (Kiel, Germany). The sample size was based on findings from a study reporting a 2-point change in MMSE score following anodal tDCS in mild to moderate AD [33]. No studies to date have assessed changes in the MoCA following anodal tDCS. However, a strong correlation between the MMSE and MoCA (r\u00e2\u0080\u0089=\u00e2\u0080\u00890.86) in mild AD [89] implies that a similar change in the MoCA could be found in this population. Based on that assumption, a sample size of 60 completers (20 per treatment group) achieves 83% power for a repeated measures analysis of covariance (ANCOVA), adjusting for 4 covariates with an alpha of 0.05 to detect a medium effect size.", "id": 358, "split": "train"} +{"trial_id": "NCT03672487", "pmid": "32831069", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age: A Non-inferiority Randomized Controlled Trial\n\nIncluded conditions:\n- Chagas Disease\n\nStudy Armgroups:\n- {'label': '60/300mg', 'type': 'ACTIVE_COMPARATOR', 'description': 'The investigators will use a preparation of benznidazole (BZN) that is commercially available in Argentina: Abarax\u00ae 100mg and 50mg tablets from ELEA laboratories (Buenos Aires, Argentina). The investigators will purchase the drug at full cost.\\n\\nInterventions: The standard 60d course will be 300 mg per day, which is similar to the dose used in the second phase of the BENEFIT trial. The drug will be administered orally in two doses per day: the standard course will be one 100mg and one 50mg tablet in the morning and in the evening for 60 days.', 'interventionNames': ['Drug: Benznidazole']}\n- {'label': '30/150mg', 'type': 'EXPERIMENTAL', 'description': 'The investigators will use a preparation of benznidazole (BZN) that is commercially available in Argentina: Abarax\u00ae 100mg and 50mg tablets from ELEA laboratories (Buenos Aires, Argentina). ELEA laboratories will prepare the placebo oral tablets, which will be identical to the drug tablets in aspect and taste. The investigators will purchase the drug and placebo at full cost.\\n\\nInterventions: The BZN short course low dose scheme will be 150 mg per day for 30 days. The drug will be administered orally in two doses per day: the short course treatment will start with the active drug and then placebo oral tablet; one 100 mg tablet and one placebo tablet in the morning and one 50 mg tablet and one placebo tablet in the evening for the first 30 days. The last 30 days will be two placebo tablets in the morning and the evening.', 'interventionNames': ['Drug: Benznidazole', 'Drug: Placebo Oral Tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Benznidazole', 'description': 'Benznidazole tablet', 'armGroupLabels': ['30/150mg', '60/300mg'], 'otherNames': ['Abarax']}\n- {'type': 'DRUG', 'name': 'Placebo Oral Tablet', 'description': 'Sugar pill manufactured to mimic Benznidazole', 'armGroupLabels': ['30/150mg'], 'otherNames': ['Placebo (for Benznidazole)']}\n\nPrimary Outcomes:\n- {'measure': 'Frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg', 'description': 'The frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg will be non-inferior (Non Inferiority \\\\[NI\\\\] margin for PCR: 10% absolute difference) to BZN 60d/300mg.', 'timeFrame': '30 days for the 30d course arm, and 60 days for the 60d course arm'}\n- {'measure': 'The frequency of positive PCR and the parasitic load measured by qPCR 10 months after BZN 30d/150mg', 'description': 'The frequency of positive PCR and the parasitic load measured by qPCR immediately after BZN 30d/150mg will be non-inferior (Non Inferiority \\\\[NI\\\\] margin for PCR: 10% absolute difference) to BZN 60d/300mg.', 'timeFrame': '10 months from the end of the 60d treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at \u03b1 = 0.025 for the non-inferiority hypothesis and \u03b1 = 0.05 for the superiority hypothesis. The power is set at 90% for detecting non-inferiority and more than 80% for detecting a reduction in serious adverse events. A 10% loss to follow-up rate is assumed.", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size\n For Specific Aim 1 and following Food Drug Administration (FDA) and CONSORT guidance, we estimated that the NI margin should preserve 75% of the effect of 60d/300\u00e2\u0080\u0089mg (considered as 100%) over placebo (considered as 0%) found in previous trials [29, 44]. The primary outcome is the frequency of positive T. cruzi PCR.\n We estimated an effect on PCR conversion to negative with BZN 60d of 80 and 30% with placebo. This is supported by: 1) the observed effects of BZN and placebo in the BENEFIT study in Argentina and Bolivia, which showed conversion rates from a positive to a negative PCR of 73.0% in the BZN 60d group and 28.6% in the placebo group at the end of treatment [17] and 2) the therapeutic response to BZN treatment is better in young and healthy subjects than in older subjects with cardiomyopathy (see 1.2.2 Drug of choice for preconceptional treatment). We will enroll mostly healthy young women (median 23\u00e2\u0080\u0089years old), compared to the older subjects (mean 55\u00e2\u0080\u0089years old) with cardiomyopathy participating in the BENEFIT study. We used the 78.4% positive PCR rate at delivery we found in our previous study in Tucum\u00c3\u00a1n, Argentina [48].\n Based on these figures, we estimated a frequency of positive PCR of 15% (0.78(1\u00e2\u0080\u00930.8)) after BZN 60d/300\u00e2\u0080\u0089mg and of 55% (0.78(1\u00e2\u0080\u00930.3)) after placebo. To preserve 75% of the BZN 60d/300\u00e2\u0080\u0089mg effect over placebo (40% absolute rate difference), the NI margin will be 10.0% absolute rate difference. For the 10-month follow-up aim (Hypothesis 1b), we expect that after almost 1 year, the PCR positive rates will be up to 20% higher, as shown in the BENEFIT study [17]. The NI margin preserving 75% of the effect will be 9% in this case. Table\u00c2\u00a03 shows that we will need to enroll nearly 540\u00e2\u0080\u0089T. cruzi seropositive women. With this sample size, we will have adequate power to detect non-inferiority with a NI margin preserving 75% of the effect of the 60d course over placebo if the PCR rates following treatment are higher than expected, or for preserving 70% if a 3% difference in PCR rates between arms is found. To protect from a potential 10% loss to follow-up at 10\u00e2\u0080\u0089months, we will enroll 600 women.\nTable 3Statistical power and sample size assessment for specific aim 1a for n\u00c2\u00a0=\u00e2\u0080\u0089268 subjects per group (N\u00c2\u00a0=\u00e2\u0080\u0089536 total subjects)60da(%)30da(%)Placeboa(%)Effect sizea(%)Proportion retainedNI margina(%)Power(%)15.015.055.040.00.7510.09018.018.055.034.00.759.38015.018.055.040.00.7012.080aCells show PCR positive rate\n For Specific Aim 2, we postulated a superiority hypothesis. The rate of serious adverse events leading to treatment interruption observed in the BENEFIT trial was 24%. As mentioned above, our population is healthier and younger; thus, we will conservatively assume a 20% rate. We will have more than 90% power to detect a reduction of serious adverse events and/or any adverse event leading to treatment interruption from 20% in the 60d course group to 10% in the short course group (Table\u00c2\u00a04) and more than 80% power if the rate is 12%. The two-sided Type I error rate was set at \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.025 and 0.05 for the NI and superiority hypotheses respectively, and calculations were carried out with the power sample size calculator for a two-sample non-inferiority study with a sampling ratio of one [49].\nTable 4Statistical power assessment for specific aim 2 (superiority hypothesis)60d(%)30d(%)Total(N)Power(%)201060095201260081", "id": 359, "split": "train"} +{"trial_id": "NCT03673397", "pmid": "31196147", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression: a Randomized Controlled Trial\n\nIncluded conditions:\n- Depression\n- Sleep\n- Sleep Disorder\n- Sleep Disturbance\n- Sleep Fragmentation\n- Sleep Initiation and Maintenance Disorders\n- Insomnia\n- Insomnia, Psychophysiological\n- Insomnia Due to Other Mental Disorder\n- Insomnia Related to Another Mental Condition\n\nStudy Armgroups:\n- {'label': 'Aerobic exercise', 'type': 'EXPERIMENTAL', 'description': 'Patients allocated to the intervention group will perform a single bout of supervised aerobic exercise. The starting time will be approximately 1630 hrs. The exercise mode will be a bicycle ergometer. After a warm-up period, during which the intensity is gradually increased, an intensity of 80% of the individual anaerobic threshold will be maintained for 30 minutes. The intensity level was chosen based on clinical experience that this corresponds to an approximate rate of perceived exertion of 13 (on a scale from 6-20) in this population.', 'interventionNames': ['Behavioral: Aerobic exercise, bicycle ergometer']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Individuals allocated to the control group will be placed in a room with analogous conditions to the exercise group concerning light, temperature and absence of music at the same time as individuals performing the exercise intervention. The control group will be asked to remain seated and read magazines.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Aerobic exercise, bicycle ergometer', 'description': 'Exercise performed below individual anaerobic threshold for 30 minutes', 'armGroupLabels': ['Aerobic exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in sleep efficiency (%) at follow-up assessed by polysomnography', 'description': 'Calculated as (total sleep time / total recording time) \\\\* 100. Higher values represent a better outcome. A one-way ANCOVA will be computed with baseline sleep efficiency (%) and minimization factors as covariates, intervention as the independent variable, and follow-up sleep efficiency (%) as the dependent variable.', 'timeFrame': 'Baseline (night 1) and follow-up (night 2)'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a power of 0.8, a two-sided alpha of 0.05, and a correlation coefficient (\u03c1) of 0.5. The dropout rate is estimated at 7%.", "answer": 92, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The theoretical rationale for the analysis of the primary outcome, using an ANCOVA model, is outlined above (see the \u00e2\u0080\u009cPolysomnography (baseline and follow-up)\u00e2\u0080\u009d section). Furthermore, minimization necessitates adjustment for minimization factors [186]. Sample size calculation was performed according to the procedure defined by Borm et al. [187]. The allocation ratio is 1:1. The expected treatment effect is based on the work of Passos et al. [63], who found a standardized mean difference in sleep efficiency of 0.53. The estimate is based on this publication because it is the only one known to the authors which (1) evaluated the acute effect of (2) a similar intervention (i.e., moderate aerobic exercise) (3) in individuals with sleep disorders. Due to the well-documented ceiling and floor effects [188], meta-analyses concerning predominantly healthy individuals (explicitly excluding individuals with mental disorders) [54] are of no use. Meta-analyses including individuals with sleep complaints are limited to the analysis of the chronic effects of exercise on sleep [55, 189]. With a power of 0.8 and a two-sided alpha of 0.05, 57 subjects would be required for each group using a t-test. According to the method of Borm et al., this sample size can be multiplied by a \u00e2\u0080\u0098design factor\u00e2\u0080\u0099 of (1 \u00e2\u0088\u0092 \u00cf\u00812), where \u00cf\u0081 is the correlation coefficient between baseline and follow-up outcome [187]. Despite contacting other researchers, the authors are not aware of any previous study which have analyzed this aspect. Hence, we need to make an estimate. Recommended values for imputation of \u00cf\u0081 vary between 0.5 (if variances are equal at pre- and post-measurements, \u00cf\u0081 is at least 0.5) and 0.7 [190, 191]. We use a conservative estimate and let \u00cf\u0081\u00e2\u0080\u0089=\u00e2\u0080\u00890.5. This leads to a design factor of 0.75 (1 \u00e2\u0088\u0092 0.52\u00c2\u00a0=\u00e2\u0080\u00890.75). Hence, the sample size needed per group is 43 (57 \u00c3\u0097 0.75\u00e2\u0080\u0089=\u00e2\u0080\u008942.75). Due to the short-term nature of this study, we expect approximately half the dropout rate of trials investigating the chronic effects of exercise in patients with depression [192]. Thus, we anticipate 7% dropouts. Therefore, the total sample size is 92 (2 \u00c3\u0097 43 \u00c3\u0097 1.07\u00e2\u0080\u0089=\u00e2\u0080\u008992).", "id": 360, "split": "train"} +{"trial_id": "NCT03673800", "pmid": "34848517", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Control Training in Online Problem Gambling: an Online Randomized Controlled Trial Among Non-treatment Seeking Problem Gamblers\n\nIncluded conditions:\n- Pathological Gambling\n\nStudy Armgroups:\n- {'label': 'Cognitive Training', 'type': 'EXPERIMENTAL', 'description': 'Online Cognitive training on the Scientific Brain Training\u00ae (SBT\u00ae) platform with optional guidance by phone', 'interventionNames': ['Other: Experimental Group']}\n- {'label': 'Online sensorial program', 'type': 'SHAM_COMPARATOR', 'description': 'Online sensorial program on the Scientific Brain Training\u00ae (SBT\u00ae) platform with optional guidance by phone', 'interventionNames': ['Other: Control Group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Experimental Group', 'description': 'Cognitive web-based training : 2 up to 30 minutes sessions a week during 6 weeks. Optional debriefing by a neuropsychologist up to 15 minutes twice a week', 'armGroupLabels': ['Cognitive Training'], 'otherNames': ['Cognitive training with optional guidance by phone']}\n- {'type': 'OTHER', 'name': 'Control Group', 'description': 'Sensorial web-based training : 2 up to 30 minutes sessions a week during 6 weeks. Optional debriefing by a neuropsychologist up to 15 minutes twice a week', 'armGroupLabels': ['Online sensorial program']}\n\nPrimary Outcomes:\n- {'measure': 'The change over 6 weeks in Problem gambling severity index (PGSI)-recent total score, collected by internet', 'description': 'PGSI-recent, a modified version of Problem Gambling Severity Index (PGSI) with a 30 days recall period in patients with problem gambling, at 6 weeks', 'timeFrame': 'Change from baseline at 6 weeks'}\n\nPlease estimate the sample size based on the assumption: \nloss to follow-up at 6 weeks: 55% maximum, power of 80%, two-sided type I error rate of 5%", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Estimating expected effect sizes and required sample size\n The sample size was based on the following assumptions on the PGSI: between group change difference: 3 points, estimated SD of the change: 5 points, loss to follow-up at 6 weeks: 55% maximum. With a power of 80%, a two-sided type I error rate of 5%, 200 patients must be included (100 in each group).", "id": 361, "split": "train"} +{"trial_id": "NCT03675360", "pmid": "33522954", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial\n\nIncluded conditions:\n- Diabetes\n- PreDiabetes\n- Metabolic Disease\n- Hyperglycemia\n- Diet Modification\n- Glucose Intolerance\n- Glucose Metabolism Disorders (Including Diabetes Mellitus)\n- Endocrine System Diseases\n\nStudy Armgroups:\n- {'label': 'Low-Carbohydrate Diet', 'type': 'EXPERIMENTAL', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\\\<40 g net carbohydrates per day for first 3 months; \\\\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\\n\\nAt baseline, participants will receive written information with standard physical activity recommendations.', 'interventionNames': ['Behavioral: Low-Carbohydrate Diet']}\n- {'label': 'Usual Diet', 'type': 'NO_INTERVENTION', 'description': 'No dietary intervention.\\n\\nAt baseline, participants will receive written information with standard dietary advice and standard physical activity recommendations.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Low-Carbohydrate Diet', 'description': 'Behavioral modification to reduce carbohydrate consumption. Target \\\\<40 g net carbohydrates per day for first 3 months; \\\\<60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.\\n\\nAt baseline, participants will receive written information with standard physical activity recommendations.', 'armGroupLabels': ['Low-Carbohydrate Diet']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Hemoglobin A1c', 'description': '6-month change in Hemoglobin A1c comparing low-carbohydrate arm with usual diet arm', 'timeFrame': 'Baseline and six months'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation of change in HbA1c of 0.35%, 95% follow-up rate, 80% power, two-sided alpha of 0.05.", "answer": 150, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The primary outcome will be the difference in the change of HbA1c between the intervention and usual diet groups. Pilot data from our group suggests that the standard deviation (SD) of 6-month change in HbA1c is 0.35%, with 6-month follow-up >\u00e2\u0080\u008995% (follow-up rate to-date is 96%). Based on an estimated standard deviation of change in HbA1c of 0.35% and 95% follow-up, we would need a total of 150 participants (142 participants with follow-up data) to have 80% power to detect a difference in the change in HbA1c from baseline to 6\u00e2\u0080\u0089months of 0.17% between the intervention and usual diet groups (unpaired t tests, two-sided alpha of 0.05).", "id": 362, "split": "train"} +{"trial_id": "NCT03677037", "pmid": "30953536", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Short-term Versus Long-term Mentalization-based Therapy for Outpatients With Subthreshold or Diagnosed Borderline Personality Disorder: a Randomized Clinical Trial\n\nIncluded conditions:\n- Borderline Personality Disorder\n\nStudy Armgroups:\n- {'label': 'Short-term MBT', 'type': 'EXPERIMENTAL', 'description': 'The experimental group is short-term mentalization-based therapy. The treatment program includes 20 weeks of mentalization-based group therapy with conjoined individual therapy every second week. The program also includes psychoeducation and individual caseformulations.', 'interventionNames': ['Other: Short-term MBT']}\n- {'label': 'Long-term MBT', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group is long-term mentalization-based therapy. The treatment program includes 14 months of weekly mentalization-based group therapy with combined individual therapy every second week. The program also includes psychoeducation and individual caseformulations.', 'interventionNames': ['Other: Long-term MBT']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Short-term MBT', 'description': 'Short-term mentalization-based therapy', 'armGroupLabels': ['Short-term MBT']}\n- {'type': 'OTHER', 'name': 'Long-term MBT', 'description': 'Long-term mentalization-based therapy', 'armGroupLabels': ['Long-term MBT']}\n\nPrimary Outcomes:\n- {'measure': 'Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview', 'description': 'ZAN-BPD is an investigator-administered interview assessing change in severity of borderline personality disorder over time. Each of the nine DSM-5 criteria for borderline personality disorder are rated on a scale from 0-4, where 4 is the most severe, yielding a total score from 0-36.', 'timeFrame': 'Assessed at baseline, and at 8, 16 and 24 months post-randomization'}\n\nPlease estimate the sample size based on the assumption: \nPower set at 80% and alpha set at 5% two-tailed.", "answer": 166, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was determined by the predicted change in the primary outcome measure, ZAN-BPD. A 3.5-point superiority margin is considered to be the minimal important difference. Consistent with previous trials that have used ZAN-BPD as an outcome measure for a patient group like ours [24, 58], we expect a standard deviation of 8. With power set at 80% and alpha set at 5% two-tailed, a sample size of 83 participants is needed in each treatment group, corresponding to a total of 166 participants.", "id": 363, "split": "train"} +{"trial_id": "NCT03677856", "pmid": "37996898", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Controlled Trial to Investigate the Effectiveness of ThOracic Epidural and Paravertebral Blockade In Reducing Chronic Post- Thoracotomy Pain: 2\n\nIncluded conditions:\n- Anesthesia\n- Thoracic Diseases\n\nStudy Armgroups:\n- {'label': 'Paravertebral Blockade', 'type': 'EXPERIMENTAL', 'description': \"Anaesthesia to single side of the patient's chest\", 'interventionNames': ['Procedure: Paravertebral blockade']}\n- {'label': 'Thoracic epidural block', 'type': 'ACTIVE_COMPARATOR', 'description': \"Anaesthesia to both sides of the patient's chest\", 'interventionNames': ['Procedure: Thoracic epidural block']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Paravertebral blockade', 'description': 'Type of anaesthesia', 'armGroupLabels': ['Paravertebral Blockade']}\n- {'type': 'PROCEDURE', 'name': 'Thoracic epidural block', 'description': 'Type of anaesthesia', 'armGroupLabels': ['Thoracic epidural block']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of chronic pain: incidence = score > 40 on visual analogue score', 'description': 'Patient reported pain lasting at least 3 months as measured by visual analogue score', 'timeFrame': '6 months post trial thoracotomy'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-sided significance level of 0.05, 10% rate of death by 6-month follow-up, 15% loss to follow-up at 6 months", "answer": 1026, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Assuming a 30% incidence of CPTP in the TEB group (similar to that seen in our previous TOPIC-pilot trial results [12] and systematic review [13], 392 patients in each group will give 90% power (two-sided, p\u00e2\u0080\u0089=\u00e2\u0080\u00890.05) to detect a 10% absolute reduction (i.e. down to 20%, a 33% relative reduction) in the PVB group. Assuming a 10% rate of death by 6-month follow-up (similar to that seen in the TOPIC pilot) and a further 15% loss to follow-up at 6\u00c2\u00a0months, we will recruit a total of 1026 participants.", "id": 364, "split": "train"} +{"trial_id": "NCT03679130", "pmid": "33741668", "question": "Here is the design of a clinical trial:\n\nOfficial Title: FitMum: Fitness for Good Health of Mother and Child\n\nIncluded conditions:\n- Pregnancy Related\n- Physical Activity\n\nStudy Armgroups:\n- {'label': 'Structured exercise training (EXE)', 'type': 'EXPERIMENTAL', 'description': 'Structured supervised exercise training (EXE) contains three weekly one-hour exercise sessions at moderate intensity, more specifically one water exercise session and two land exercise sessions. The training will be supervised, held in teams, and both water and land exercise sessions will consist of a combination of aerobic and resistance training.', 'interventionNames': ['Behavioral: Structured supervised exercise training']}\n- {'label': 'Motivational counseling (MOT)', 'type': 'EXPERIMENTAL', 'description': 'Motivational counseling supported by health technology (MOT) contains four individual and three group counseling sessions taking place from randomization until GA week 33+6 and aim to motivate the participants to increase their physical activity level at moderate intensity. During individual sessions, feedback on physical activity performance will be provided based on activity data acquired from the activity tracker and further, MOT-participants will receive weekly SMS-reminders about physical activity.', 'interventionNames': ['Behavioral: Motivational counseling supported by health technology']}\n- {'label': 'Control group (CON)', 'type': 'NO_INTERVENTION', 'description': 'Control group receiving standard treatment.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Structured supervised exercise training', 'description': 'EXE contains three weekly one-hour exercise sessions at moderate intensity, more specifically one water exercise session and two land exercise sessions. The training will be supervised, held in teams, and both water and land exercise sessions will consist of a combination of aerobic and resistance training.', 'armGroupLabels': ['Structured exercise training (EXE)'], 'otherNames': ['EXE']}\n- {'type': 'BEHAVIORAL', 'name': 'Motivational counseling supported by health technology', 'description': 'MOT contains four individual and three group counseling sessions taking place from randomization until GA week 33+6 and aim to motivate the participants to increase their physical activity level at moderate intensity. During individual sessions, feedback on physical activity performance will be provided based on activity data acquired from the activity tracker and further, MOT-participants will receive weekly SMS-reminders about physical activity.', 'armGroupLabels': ['Motivational counseling (MOT)'], 'otherNames': ['MOT']}\n\nPrimary Outcomes:\n- {'measure': \"Min/week of moderate-to-vigorous-intensity physical activity from randomization to GA week 28+0-6 determined by a Garmin Vivosport activity tracker [ Time Frame: Continuously 24/7 from inclusion (at latest GA week 15+0) to GA week 28+0-6 ]'\", 'description': 'Physical activity level from randomization to GA week 28+0-6 determined by a wrist-worn activity tracker, Garmin Vivosport, with built-in heart rate monitor and accelerometer. The activity tracker is to be worn continuously by the women from inclusion until delivery. After inclusion baseline physical activity level will be measured for one week, followed by randomization to one of the three study groups and continuous monitoring of physical activity level by the activity tracker. Preferably, the activity tracker is also worn continuously from delivery and one year ahead. The activity tracker determines the frequency, duration and intensity of activity periods on a minute-to-minute basis and data from the activity tracker is wirelessly synced to its associated smartphone application, Garmin Connect, and research platform, Fitabase.', 'timeFrame': 'Continuously 24/7 from inclusion (at latest GA week 15+0) to GA week 28+0-6'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered to achieve 80% power with a family-wise significance level of 5% and accounts for a 20% lost to follow-up rate.", "answer": 220, "answer_type": "ACTUAL", "explanation": "Sample size\n FitMum RCT has been powered to detect an overall significant difference in the primary outcome between the three groups as well as a significant difference between the two intervention groups (EXE vs MOT) with average activity levels of 210 (EXE), 150 (MOT) and 60 (CON) min/week. The SD was set at 116\u00e2\u0080\u0089min/week and based on the results from Oostdam et al.51 The required sample size is determined to obtain a power of 80% with a family-wise significance level of 5%. The sample size calculation showed that the required number of participants is 35 in CON and 70 in each of the two intervention groups due to the randomisation ratio of 1:2:2 to CON, EXE and MOT, respectively. Based on an expected lost to follow-up rate of 20%, as seen in similar exercise studies in pregnant women,28 32 33 51 we plan to include 44 participants in CON and 88 participants in each of the two intervention groups, making a total of 220 participants.", "id": 365, "split": "train"} +{"trial_id": "NCT03680963", "pmid": "34521655", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure: A Multicentre, Open-label, Pragmatic, Randomised, Non-inferiority Controlled Trial (EVERDAC Trial)\n\nIncluded conditions:\n- Acute Circulatory Failure\n\nStudy Armgroups:\n- {'label': 'Non-invasive strategy', 'type': 'EXPERIMENTAL', 'description': 'Non-invasive strategy consisting of blood pressure monitoring by non-invasive automated cuff measurements', 'interventionNames': ['Procedure: Non-invasive strategy']}\n- {'label': 'Control strategy', 'type': 'OTHER', 'description': 'Usual strategy of systematic indwelling arterial catheter insertion in the early hours of acute circulatory failure', 'interventionNames': ['Procedure: Control strategy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Non-invasive strategy', 'description': 'No indwelling arterial catheter insertion will be allowed during the first 28 days, excepted if predefined safety criteria (indicating absolute need of indwelling arterial catheter insertion) are reached.\\n\\nIn the \"non-invasive\" group, automated oscillometric monitor will be used to monitor BP (blood pressure).', 'armGroupLabels': ['Non-invasive strategy']}\n- {'type': 'PROCEDURE', 'name': 'Control strategy', 'description': 'An indwelling arterial catheter will be inserted as soon as possible (within the first four hours after randomization) and will be maintained except in case of indwelling arterial catheter futility, suspected or proven indwelling arterial catheter related infection or thrombosis (at discretion of attending physician) until day 28 or ICU (Intensive Care Unit) discharge (whichever comes first). After day 28, clinicians may choose to maintain or to remove indwelling arterial catheter.', 'armGroupLabels': ['Control strategy']}\n\nPrimary Outcomes:\n- {'measure': 'All-cause mortality by 28 days after randomisation', 'timeFrame': 'Patients will be followed from randomization to day 28'}\n\nPlease estimate the sample size based on the assumption: \nNon-inferiority margin set at 5%, power at 80%, and alpha risk at 5%.", "answer": 1010, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The hospital mortality of patients with septic shock, the most prevalent cause of shock in the ICU, is around 30%\u00e2\u0080\u009335% depending on initial lactate level.52 We speculated that the day 28 mortality would be lower, around 25% in the study cohort for several reasons: (1) Patients with shock other than septic shock can be included, and the mortality rates of haemorrhagic, hypovolaemic non-haemorrhagic and cardiogenic shock are highly variable depending on the cause; (2) The use of vasopressor is not mandatory for inclusion, so patients with short-lived hypotension (but with at least one sign of hypoperfusion) can be included; (3) Patients with very high vasopressor dosages are excluded and (4) Patients with severe traumatic brain injury are excluded, an exclusion policy which should lower the mortality rate of the haemorrhagic shocks of traumatic origin.\n We assume that the mortality rate at day 28 will be 22.5% in the \u00e2\u0080\u0098non-invasive\u00e2\u0080\u0099 group and 25% in the control (invasive, usual care) group. With the non-inferiority margin set at 5%, power at 80% and alpha risk at 5%, the inclusion of 1010 patients is needed.\n The 5% non-inferiority margin has been obtained through a consensus between the investigators and the methodologists of the study, considering that a 5% difference is the smallest value that would be clinically relevant between arms.", "id": 366, "split": "train"} +{"trial_id": "NCT03682523", "pmid": "37563553", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Breaking \"Bad Rest\" Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care\n\nIncluded conditions:\n- Sedentary Lifestyle\n\nStudy Armgroups:\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Fitted with an accelerometer to measure time spent out of bed while in hospital. Otherwise, participants in the control group will receive usual care from the hospital medical team during their hospital stay. Daily activities of participants will not be restricted if patients are assigned to the control group.'}\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Fitted with accelerometer to measure time spent out of bed while in hospital; daily goals set for time spent out of bed; mobilization feedback real-time feedback on goal attainment; hands on mobilization by physiotherapist for participants in late afternoon for participants who do not meet daily goal.', 'interventionNames': ['Behavioral: Sedentary behavior reduction intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Sedentary behavior reduction intervention', 'description': 'Participants will be provided with a device to measure physical activity and sedentary behaviours. A tablet will be in the research office and each afternoon, it will be synced to the device to assess the activity progress of the patient. The research team will deliver an upright time goal and will target a 20% increase in upright time from the previous hospital day. Physiotherapist research assistants will visit the participants every afternoon to monitor progress and safely mobilize participants to their maximum ability if they have not met their daily goal (including weekend). The maximum level of ability will be determined in consultation with the healthcare team. Participants who do not meet their goal will be mobilized in the late afternoon/ early evening.', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the Frailty Index', 'description': 'The frailty index (FI) operationalizes frailty in clinical practice and for research. FI scores are calculated as the proportion of potential deficits present in a given individual. For this study we will construct a 30-item FI using a health questionnaire administered to patients or their care partners (if patients are not able to self-report) at each study time point. The proportion of patients changing their FI scores by \\\\>=0.1 from baseline to hospital discharge is the primary outcome.\\n\\nData collection is opportunistic, based on length of stay. The discharge date is not fixed - thus day-in-study at discharge will not be the same for all participants. Depending on length of stay, participants will provide data for additional time points between baseline and discharge, including week 1, week 2, week 3, week 4 and then in 30 day intervals. However, not every participant will have the same number of time points. Note that the median hospital length of stay is 14 days.', 'timeFrame': 'Change from baseline frailty up to a median 14 day hospital length of stay'}\n\nPlease estimate the sample size based on the assumption: \n80% power.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Sample size\n We will recruit 25 participants for the usual care group and 25 participants for the treatment group. This number is based on a previous observational study in which 62% of individuals had an improvement of \u00e2\u0089\u00a5\u00e2\u0080\u00890.10 in their frailty index score during hospitalization (see below for details) [8]. Using these prior estimates, group sample sizes of 25 per group achieves 80% power to detect a relative increase of 50% (i.e., an increase from 62 to 93%) in the proportion achieving a difference of 0.10 in the frailty index. A increase of 0.10 in the frailty index score has been shown to be associated with various adverse health outcomes including extended length of hospital stay, institutionalization, in-hospital falls, delirium, pressure ulcer incidence, and mortality [18].", "id": 367, "split": "train"} +{"trial_id": "NCT03684681", "pmid": "31719087", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Navigator Trial\n\nIncluded conditions:\n- Opioid Use\n- Opioid Dependence\n- Opioid Abuse\n- Opioid-Related Disorders\n\nStudy Armgroups:\n- {'label': 'Peer Navigator', 'type': 'OTHER', 'description': 'Current standard of care', 'interventionNames': ['Behavioral: Peer Navigator Intervention']}\n- {'label': 'Social Worker', 'type': 'OTHER', 'description': 'Current standard of care', 'interventionNames': ['Behavioral: Social Work Intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Peer Navigator Intervention', 'description': 'A peer navigator delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals.', 'armGroupLabels': ['Peer Navigator']}\n- {'type': 'BEHAVIORAL', 'name': 'Social Work Intervention', 'description': 'A hospital social workers uses their own previous training to help people meet their goals.', 'armGroupLabels': ['Social Worker']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of participants who are admitted to a formal addiction treatment program within thirty days following the initial ED visit.', 'description': 'Engagement in addiction treatment will be defined as the proportion who are admitted to a formal addiction treatment program within thirty days following the initial ED visit. The research team will be using BHDDH and Prescription Drug Monitoring Program (PDMP) records. The BHDDH database contains information on all admissions to publicly funded substance abuse treatment programs in the state. The RI PDMP manages a database that contains information on all prescriptions for schedule II-IV substances filled in the state. The database is updated daily; all pharmacies are required to report prescriptions within 48-hours of the fill date. All records will be linked deterministically to participant data using identifiable information (e.g., name, social security number) within the Stronghold computing environment, a HIPAA-compliant server maintained by the team at Brown University.', 'timeFrame': '30 days'}\n- {'measure': 'The proportion of participants who are treated in any Rhode Island ED for an opioid overdose at any time during the 18-month follow-up period following the initial ED visit.', 'description': 'The proportion of participants who are treated in any Rhode Island ED for an opioid overdose at any time during the 18-month follow-up period following the initial ED visit, will be assessed by first accessing the electronic medical records (EMRs) of the 12 EDs in Rhode Island (RI) through the Rhode Island Quality Institute Statewide Health Information Exchange. This unified data system provides access to EMR data from all major health systems in RI, capturing repeat visits for an opioid overdose that occur in all 12 EDs in RI. Secondly the research team will query the RI Department of Health (RIDOH) Opioid 48-Hour Overdose Surveillance System which mandates all suspected opioid overdose cases presenting to an RI hospital be reported to the department within 48 hours. This data source will capture recurrent overdoses not identified by ICD codes in the unified EMR data system, and also contains additional fields of interest (e.g., pre-existing risk factors for overdose).', 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power to detect a twofold increase in treatment engagement; 80% power to detect a 50% relative reduction in the risk of recurrent ED visits for opioid overdose; significance level implied by 95% CI.", "answer": 650, "answer_type": "ACTUAL", "explanation": "Sample size\n Based on preliminary assessments from the study sites, we are assuming that 7% of participants assigned to receive a behavioural intervention from an LCSW will enrol in a formal SUD treatment programme within 30 days of their ED visit. Given this assumption for a sample size of 650 participants, we have at least 80% power to detect a twofold increase in treatment engagement among participants assigned to receive a behavioural intervention from a peer recovery specialist (risk difference: 0.07; 95%\u00e2\u0080\u0089CI 0.02 to 0.12). This twofold increase was identified by community stakeholders as an appropriate benchmark for this outcome. Based on a recent medical record review from one of the study sites and estimates from other studies,20 33 we are assuming that 15% of participants who receive a behavioural intervention from an LCSW will experience a subsequent repeat ED visit for opioid overdose. Given this assumption and our sample, we have at least 80% power to detect a 50% relative reduction in the risk of recurrent ED visits for opioid overdose within 18 months following the initial visit among those assigned to receive a behavioural intervention from a peer recovery specialist (risk difference: 0.075; 95%\u00e2\u0080\u0089CI 0.02 to 0.13).", "id": 368, "split": "train"} +{"trial_id": "NCT03689569", "pmid": "33243160", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Prebiotic Supplementation and Exercise on Inflammatory Markers, Vascular Function, Cognition, and Mental Well-being in Pre-Dialysis Kidney Patients\n\nIncluded conditions:\n- Chronic Kidney Diseases\n\nStudy Armgroups:\n- {'label': 'Exercise', 'type': 'EXPERIMENTAL', 'description': 'Exercise only: Patients randomized to this group will receive a placebo (corn starch) and be given 16 weeks of personal training.', 'interventionNames': ['Behavioral: Exercise']}\n- {'label': 'Resistant Starch', 'type': 'EXPERIMENTAL', 'description': 'Resistant starch only: Patients randomized to this group will receive 30 g of resistant starch daily for 16 weeks. They will not be given an exercise training', 'interventionNames': ['Dietary Supplement: Resistant starch']}\n- {'label': 'Exercise & Resistant Starch', 'type': 'EXPERIMENTAL', 'description': 'Exercise \\\\& resistant starch: Patients assigned to this group will do 16 weeks of personal training and they will be supplemented with 30 g of resistant starch daily for the 16 week period', 'interventionNames': ['Dietary Supplement: Resistant starch', 'Behavioral: Exercise']}\n- {'label': 'Starch', 'type': 'PLACEBO_COMPARATOR', 'description': 'Corn starch only: Patients assigned to this group will not be given and exercise program and they will receive the placebo for 16 weeks', 'interventionNames': ['Behavioral: Starch']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Resistant starch', 'description': 'Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion', 'armGroupLabels': ['Exercise & Resistant Starch', 'Resistant Starch']}\n- {'type': 'BEHAVIORAL', 'name': 'Exercise', 'description': 'Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity', 'armGroupLabels': ['Exercise', 'Exercise & Resistant Starch']}\n- {'type': 'BEHAVIORAL', 'name': 'Starch', 'description': 'Patients will be given 30 grams of corn starch', 'armGroupLabels': ['Starch']}\n\nPrimary Outcomes:\n- {'measure': 'Change in hs CRP', 'description': 'hsCRP', 'timeFrame': 'baseline and after 16 weeks'}\n- {'measure': 'Change in TNF alpha', 'description': 'TNFalpha', 'timeFrame': 'Baseline and at week 16'}\n- {'measure': 'Change in IL6', 'description': 'IL6', 'timeFrame': 'Baseline and at week 16'}\n- {'measure': 'Change in IL10', 'description': 'IL10', 'timeFrame': 'Baseline and at week 16'}\n- {'measure': 'Change in MCP1', 'description': 'MCP1', 'timeFrame': 'Baseline and at week 16'}\n\nPlease estimate the sample size based on the assumption: \nPower set at 0.80, alpha set at 0.05, multiple imputation for missing data, per-protocol analysis for participants completing 70% or more of their assigned tasks.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n A study investigating the effects of aerobic exercise on inflammation reduction [24] demonstrated effect sizes (Cohen\u00e2\u0080\u0099s d) varying between .40 and .77 for IL-6 and IL-10 and their ratio, which would be considered a medium to large effect. Few studies have investigated the effect of prebiotic supplements on inflammation, though similar magnitude effect sizes were reported for a prebiotic supplement intervention on changes in free circulating uremic solutes indoxyl sulfate and p-cresol sulfate, key indicators of adverse outcomes of CKD [9], though those changes were not found to be significant in that small sample study. Based on these studies, we anticipate medium effect sizes, and with power set at .80, and alpha set at .05, a sample size of 60 (15 per group) is predicted to be sufficient for detecting significant two-way interactions specified in the statistical analysis section. To account for any dropouts from the protocol, missing data will be addressed through multiple imputation, and results of all analyses averaged over multiple imputed datasets. All variables in the analysis will be examined for assumptions for all statistical tests. Data will also be examined in a per-protocol analysis, using only data from participants in all groups who completed 70% or more of their assigned exercise sessions and/or supplement use and who provided outcome data on the relevant variables.", "id": 369, "split": "train"} +{"trial_id": "NCT03691441", "pmid": "32727416", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparative Effectiveness Trial of Transoral Head and Neck Surgery Followed by Adjuvant Radio(Chemo)Therapy Versus Primary Radiochemotherapy for Oropharyngeal Cancer\n\nIncluded conditions:\n- Oropharyngeal Cancer\n\nStudy Armgroups:\n- {'label': 'Resection/adjuvant radio(-chemo)therapy', 'type': 'EXPERIMENTAL', 'description': '* Transoral surgical resection within 4 weeks after randomization\\n* Neck dissection can be performed during resection of the primary tumor or within 4 weeks after randomization\\n* 6-7 weeks standard risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy according to arm B if necessary), start within 6 weeks post-surgery', 'interventionNames': ['Procedure: Resection', 'Radiation: Radiotherapy', 'Drug: Chemotherapy']}\n- {'label': 'Adjuvant radio(-chemo)therapy/salvage neck dissection', 'type': 'ACTIVE_COMPARATOR', 'description': '* 6-7 weeks standard radiotherapy (IMRT-technique), start within 4 weeks after randomization\\n* 70-72 Gy, SIB possible\\n* Cisplatin 100 mg/m2 on days 1, 22, 43 or Cisplatin once weekly (30-40 mg/m2) on days 1, 8, 15, 22, 29, 36 or Mitomycin C 10 mg/m2 d1, 29 and 5-FU 600 mg/m2/day iv on days 1-5 or Cisplatin 20 mg/m\u00b2 + 5-FU 600 mg/m\u00b2/day iv d 1-5 and 29-33\\n* +/- Salvage neck dissection 12\u00b12 weeks after treatment', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Chemotherapy', 'Procedure: Salvage neck dissection']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Resection', 'description': 'Definitive surgery should generally be performed within 2 weeks, but not more than 4 weeks after randomization. The appropriately indicated neck dissection(s) may be performed either prior to, during the same session, or within 2 weeks after the resection of the primary tumor, but not later than 4 weeks following randomization. The primary tumor is to be resected with clear margins (R0) and en bloc in all cases. Frozen section assessment must be routinely and readily available.', 'armGroupLabels': ['Resection/adjuvant radio(-chemo)therapy'], 'otherNames': ['Transoral Surgery']}\n- {'type': 'RADIATION', 'name': 'Radiotherapy', 'description': '6-7 weeks standard risk-adapted adjuvant radiotherapy 56-66 Gy, start within 6 weeks post-surgery Arm B: 6-7 weeks standard radiotherapy (IMRT-technique), start within 4 weeks after randomization, 70-72 Gy, SIB possible', 'armGroupLabels': ['Adjuvant radio(-chemo)therapy/salvage neck dissection', 'Resection/adjuvant radio(-chemo)therapy']}\n- {'type': 'DRUG', 'name': 'Chemotherapy', 'description': 'The investigational medicinal product (IMP) are the chemotherapeutical drugs Cisplatin, Mitomycin C and 5-FU. According to local routine, chemotherapy protocols as listed in study protocol should be used.', 'armGroupLabels': ['Adjuvant radio(-chemo)therapy/salvage neck dissection', 'Resection/adjuvant radio(-chemo)therapy']}\n- {'type': 'PROCEDURE', 'name': 'Salvage neck dissection', 'description': '+/- Salvage neck dissection 12\u00b12 weeks after treatment', 'armGroupLabels': ['Adjuvant radio(-chemo)therapy/salvage neck dissection']}\n\nPrimary Outcomes:\n- {'measure': 'Time to local or locoregional failure or death from any cause', 'description': 'The primary objective of this study is to evaluate the effectiveness of primary surgical versus non-surgical treatment of patients with locally advanced, but transorally resectable oropharyngeal cancer in terms of time to local or locoregional failure or death from any cause (LRF).', 'timeFrame': 'Defined as time from randomization up to 36 month'}\n\nPlease estimate the sample size based on the assumption: \nThe trial has a planned observational period of 5 years (2 years recruitment and 3 years follow-up). A 3% lost to follow-up rate is estimated for both arms. Blinded interim analysis will be performed after recruiting 250 patients, and unblinded interim analyses will be conducted after 50% and 75% of observed events. The steering committee will decide on adaptations or early stopping based on these analyses.", "answer": 280, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n The trial is based on an event-driven design with a planned observational period of 5\u00e2\u0080\u0089years (recruitment time 2\u00e2\u0080\u0089years and follow-up time 3\u00e2\u0080\u0089years).\n The event rate in the definitive chemoradiotherapy for oropharyngeal cancer group is assumed to be 50% after 36\u00e2\u0080\u0089months. The transoral head and neck surgery followed by adjuvant (chemo) radiotherapy is assumed to reduce the event rate for the primary outcome to 35%. It is assumed that the hazard rate is constant over time. Under these assumptions, 142 events have to be observed during the planned observation period, which will result in a sample size of 280 patients.\n In both arms a 3% lost to follow-up during the study is estimated. After recruiting 250 patients a blinded interim analysis will be performed. The steering committee will decide on adaptation of the sample size/ recruiting time. Additionally, based on results of the planned unblinded interim analysis after 50 and 75% of available observed events, the steering committee will decide on adaptation of the recruiting/follow up time or to allow an early stopping of the trial for success. The recruitment will be stopped immediately if the needed number of events is reached.", "id": 370, "split": "train"} +{"trial_id": "NCT03691987", "pmid": "38858151", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Fecal Microbiota Transplantation in Chronic Fatigue Syndrome - an RCT\n\nIncluded conditions:\n- Chronic Fatigue Syndrome\n- Myalgic Encephalomyelitis\n\nStudy Armgroups:\n- {'label': 'Preprocessed thawed donor FMT', 'type': 'EXPERIMENTAL', 'description': 'The active transplants are processed in a 2-3 weeks period before treatment of the first participant. Fifty to eighty grams of freshly delivered feces from donors is mixed with 100 mL isotonic saline and 25 mL 85% glycerol, homogenized and poured through a 0.5 mm mesh steel strainer, and transferred to 60 ml luerlock syringes and stored at -40\u00b0C.\\n\\nFrozen transplants are slowly thawed 2 hours prior to administration by transferring the FMT-syringes to a waterbath (+30\u00b0C). The transplant is then mixed with 125 mL 12\u00b0C isotonic saline in an enema bag prior to installation.', 'interventionNames': ['Biological: Preprocessed thawed donor FMT']}\n- {'label': 'Preprocessed thawed autologous FMT', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo transplant from each participant is prepared during the inclusion process four to six weeks before intervention and stored at -40\u00b0C. Fifty to eighty grams of freshly delivered feces from participants is mixed with 100 mL isotonic saline and 25 mL 85% glycerol is homogenized and poured through a 0.5 mm mesh steel strainer, and transferred to 60ml Luerlock syringes.\\n\\nFrozen transplants are slowly thawed 2 hours prior to administration by transferring the Luerlock syringes to a waterbath (+30\u00b0C). The transplant is then mixed with 125 mL 12\u00b0C isotonic saline in the enema bag prior to installation.', 'interventionNames': ['Biological: Preprocessed thawed autologous FMT']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Preprocessed thawed donor FMT', 'description': 'Delivered as an enema using the same equipment and technique as X-ray of the colon', 'armGroupLabels': ['Preprocessed thawed donor FMT']}\n- {'type': 'BIOLOGICAL', 'name': 'Preprocessed thawed autologous FMT', 'description': 'Delivered as an enema using the same equipment and technique as X-ray of the colon', 'armGroupLabels': ['Preprocessed thawed autologous FMT']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion with treatment success in FSS score in donor versus placebo FMT group. Treatment success is defined as an improvement of more than 1.2 points on the Fatigue Severity Scale (FSS)', 'description': 'Fatigue Severity Scale (FSS) is a self-reported, 9-item fatigue scale. Participants rate all 9 items on a 7-point Likert scale (1-2-3-4-5-6-7) depending on how appropriate they felt the statement applied to them over the preceding week. The total score is calculated by adding up the answer from each item and divide by 9. Lower scores indicate better outcomes. Maximum score is 7.\\n\\nIn an intention to treat analysis we will categorize participants as responders/non-responders, defining responders as decrease of more than 1,2 to the total baseline score in the FSS at 3 months post FMT by Chi Square. Baseline score will be the average of the two scores from the screening period. Missing values will be regarded as non responders', 'timeFrame': 'Three months after treatment'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80% in a balanced two-group design (\u03b1=0.05; 1\u2212\u03b2 = 0.80).", "answer": 80, "answer_type": "ACTUAL", "explanation": "Determination of sample size\n The only published open labelled uncontrolled trial with transplantation of enteric bacteria for ME/CFS reported response rate of approximately 58% from one treatment. If the effect is much less, the clinical significance of FMT as treatment modality is questionable due to the nature of the procedure. There are no reviews of the expected placebo effect in this patient group, and validations of questionnaires to assess symptom severity are sparse. From other RCTs performed in this patient group, the response rates to placebo seems to lie somewhere in between 10% and 30%.62\n\n Assuming that response rate in the placebo group is either 10%, 20% or 30% and 50% in the treatment group, power analysis (independent proportions in SPSS V.28) yields 20, 39 or 93 participants respectively in each group for a statistical power of 80% in a balanced two-group design (\u00ce\u00b1=0.05; 1\u00e2\u0088\u0092\u00ce\u00b2 = 0.80). As the change from 20% to 50% response rate going from placebo to treatment would represent a clinically relevant difference, and accounting for a couple of dropouts, we, therefore, plan to include and assign the study treatment or placebo to 80 ME/CFS patients in total.", "id": 371, "split": "train"} +{"trial_id": "NCT03693781", "pmid": "31152038", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Colchicine for Amyotrophic Lateral Sclerosis: a Phase II, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial\n\nIncluded conditions:\n- Amyotrophic Lateral Sclerosis\n\nStudy Armgroups:\n- {'label': 'Colchicine 0.01mg/kg/day + Riluzole 100 mg', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral colchicine will be administered at fast, at specified dose pro kilograms for 30 weeks, while taking Riluzole 100 mg/day', 'interventionNames': ['Drug: Colchicine 1 MG Oral Tablet']}\n- {'label': 'Colchicine 0.005 mg/kg/day + Riluzole 100 mg', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral colchicine will be administered at fast, at specified dose pro kilograms for 30 weeks, while taking Riluzole 100 mg/day', 'interventionNames': ['Drug: Colchicine 1 MG Oral Tablet']}\n- {'label': 'Placebo + Riluzole 100 mg', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo pills will be administered at fast, while taking Riluzole 100 mg/day', 'interventionNames': ['Drug: Placebo Oral Tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Colchicine 1 MG Oral Tablet', 'description': 'Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (\\\\>70 kg or \\\\<71 kg) for 30 weeks of duration.', 'armGroupLabels': ['Colchicine 0.01mg/kg/day + Riluzole 100 mg']}\n- {'type': 'DRUG', 'name': 'Colchicine 1 MG Oral Tablet', 'description': 'Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (\\\\>70 kg or \\\\<71 kg) for 30 weeks of duration.', 'armGroupLabels': ['Colchicine 0.005 mg/kg/day + Riluzole 100 mg']}\n- {'type': 'DRUG', 'name': 'Placebo Oral Tablet', 'description': 'Corresponding tablets for 30 weeks', 'armGroupLabels': ['Placebo + Riluzole 100 mg']}\n\nPrimary Outcomes:\n- {'measure': 'Decrease in ALS disease progression as measured by ALS Functional rating Scale Revised (ALSFRS-R)', 'description': 'ALSFRS-R is a scale that measures disability in ALS; the scores range from 0 (maximum disability, the worst score) to 48 (no disability, the best score). We will measure total score changes from baseline to week 30 in treatment and placebo arms.', 'timeFrame': 'comparison between baseline and treatment end (week 30)'}\n\nPlease estimate the sample size based on the assumption: \nThe null hypothesis is that there is no difference in the percentage of positive response between the Colchicine and placebo groups. The alternative hypothesis is that Colchicine increases the positive response by at least 50% (60% vs 10%). The study is designed with an alpha error of 0.025 and a power of 0.80. An average dropout rate of 5% is considered.", "answer": 54, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n ALS progression will be assessed through the ALSFRS-R. It has been reported that ALS caring neurologists consider of clinical significance a difference of 4 points in the decline of ALSFRS-R, and that patients with ALS have on average an ALSFRS-R decline of 0.89 points/month (SD:0.13).36\u00e2\u0080\u009338 Therefore, we can consider a mean ALSFRS-R decline in 30 weeks of 6.23, with 90% of patients presenting a decline of the ALSFRS-R total score ranging from 4.7 to 7.7.\n As a result, for this study, during the 30 weeks of treatment, we will expect that the minority (10%) of patients with ALS will not have a decline at ALSFRS-R of at least 4 points from baseline, whereas a relevant number of those treated, that we quantify in a maximum of 60%, will not have the same decline. In other words, we expect that after 30 weeks of treatment the percentage of positive response in the control group will be equal to 10%, whereas in the experimental group it will be equal to 60%.\n The null hypothesis is that the percentage of positive response (increase of ALSFRS-R <4 points at 30 weeks) between Colchicine and placebo groups will not differ after 30 weeks of treatment.\n The alternative hypothesis is that Colchicine determines an increase of positive response compared to placebo of at least 50%, in absolute scale (60% vs 10%).\n The study has been designed to reject the null hypothesis with an alpha error of 0.025 (to take into account a multiple comparison with a control arm) and a power of 0.80. For this purpose, a sample of 51 patients randomised in 3 arms would be needed. Considering an average drop out of 5%, a recruitment of 54 patients will be necessary.", "id": 372, "split": "train"} +{"trial_id": "NCT03701581", "pmid": "38773595", "question": "Here is the design of a clinical trial:\n\nOfficial Title: 4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy\n\nIncluded conditions:\n- Nerve Injury\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Group A: Investigational Treatment', 'type': 'EXPERIMENTAL', 'description': '* FDA-approved 10mg dalfampridine (generic Ampyra)\\n* Subjects will not take more than 2 tablets in a 24-hour period\\n* Subjects will take the tablets whole. They will not break, crush, chew, or dissolve tablets before swallowing.\\n* The subjects will be told that the medication is released slowly over time and if the tablet is broken, the medicine may be released too fast which can raise the chance of having a seizure.\\n* Study drug can be taken with or without food.\\n* If a dose is missed they should not make up the missed dose. They will be told not to take two doses at the same time but to take the next dose at the regular scheduled time.\\n* Subjects will be reminded not to take study drug together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine or fampridine).', 'interventionNames': ['Drug: 4-Aminopyridine']}\n- {'label': 'Group B: Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Subjects will receive an oral dose of placebo treatment the day after surgery, continuing daily for 3 months (90 days) following the same administration instructions as the investigational treatment. The placebo tablets will be manufactured by a licensed compounding pharmacy. The Investigational Drug Service at Banner University Medical Center will manage the placebos.\\n\\nThe placebo will be tooled to look similar to the investigational treatment using Coni-Snap #00 White/White (Opaque) capsules manufactured by Medisca and CapsOral filler manufactured by Specialized Rx.', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '4-Aminopyridine', 'description': 'FDA-approved tablets.', 'armGroupLabels': ['Group A: Investigational Treatment'], 'otherNames': ['4-AP', 'Fampridine', 'Dalfampridine']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo will be tooled to look similar to the study drug.', 'armGroupLabels': ['Group B: Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Michigan Incontinence Sympton Index (M-ISI) (change over time)', 'description': 'Incontinence measurement (change over time)', 'timeFrame': 'Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).'}\n- {'measure': 'International Index of Erectile Function (IIEF) (change over time)', 'description': 'Erectile function measurement tool. (change over time)', 'timeFrame': 'Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).'}\n- {'measure': 'Placebo vs. Active Drug Questionnaire', 'description': 'Specific questions regarding patient blinding', 'timeFrame': 'through study completion, an average of 1 year'}\n\nPlease estimate the sample size based on the assumption: \nPearson's chi-square test, 90% power, significance level of 0.05, and an estimated dropout rate of 30%.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The primary outcome is return to baseline ability to achieve and maintain erection as measured by Item of the Abridged International Index of Erectile Function (IIEF-5) by 12\u00c2\u00a0weeks after surgery. Suppose at the conclusion of the follow-up period, the rates of returning to the baseline ability in the treatment and control groups are 70% and 30%, respectively. Pearson\u00e2\u0080\u0099s chi-square test indicates that a sample size of 56 (with 28 individuals in each group) achieves 90% power to detect the intended difference of 40% (at a significance level of 0.05). Accounting for an estimated dropout rate of 30%, we plan to recruit 40 subjects in each group.", "id": 373, "split": "train"} +{"trial_id": "NCT03703440", "pmid": "31719096", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of a Group Education Program to Improve the Transition From Pediatric to Adult Care for Emerging Adults With Type 1 Diabetes\n\nIncluded conditions:\n- Diabetes Mellitus, Type 1\n- Type1diabetes\n- Insulin Dependent Diabetes\n\nStudy Armgroups:\n- {'label': 'Active', 'type': 'EXPERIMENTAL', 'description': '\u22653 group education sessions (60 minutes per session) in addition to usual diabetes care, every 3 months for 12 months. Each group session (3-8 patients per group) will be facilitated by a diabetes nurse educator and/or dietitian. The group session content will be guided by the needs of the group participants. The group discussion will end with participants setting goals for their next appointment.', 'interventionNames': ['Other: Active arm']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'Usual diabetes care, every 3 months for 12 months, which consists of visits with their diabetes care physician. In addition, as per usual diabetes care, an individual education session and written information will be provided before formal transfer.', 'interventionNames': ['Other: Control arm']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Active arm', 'description': '\u22653 group education sessions in addition to usual diabetes care, every 3 months for 12 months', 'armGroupLabels': ['Active']}\n- {'type': 'OTHER', 'name': 'Control arm', 'description': 'Usual diabetes care, every 3-month for 12 months', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Hemaglobin A1c (HbA1c)', 'description': 'HbA1c will be measured using an A1c Test Kit, which is a non-fasting, finger stick, whole blood test', 'timeFrame': '0, 12, 24 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 0.05 two-sided alpha, and a loss to follow-up rate of up to 15%.", "answer": 212, "answer_type": "ACTUAL", "explanation": "Sample size\n A pilot study testing the effect of group education visits on changes in HbA1c55 demonstrated a stabilisation of HbA1c by the end of the intervention compared with deterioration in HbA1c in the 9\u00e2\u0080\u0089months leading up to the study by an absolute difference of 0.7%. To be conservative, we aim to detect a 0.5% absolute difference in HbA1c between intervention and control arms. Based on a SD of 1.2,55 we require 92 participants per arm to have 80% power with a 0.05 two-sided alpha using t-test. Allowing a loss to follow-up of up to 15%,55 we require a sample size of 212 participants.", "id": 374, "split": "train"} +{"trial_id": "NCT03703635", "pmid": "37202152", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Clinical Study to Evaluate the Safety and Efficacy of Intracranial Balloon Angioplasty Plus Aggressive Medical Management for Symptomatic Intracranial Artery Stenosis\n\nIncluded conditions:\n- Intracranial Artery Stenosis\n\nStudy Armgroups:\n- {'label': 'Intracranial balloon angioplasty and aggressive medical management', 'type': 'EXPERIMENTAL', 'description': 'All the participants in this group will be given Intracranial balloon angioplasty and aggressive medical management.', 'interventionNames': ['Device: intracranial balloon angioplasty', 'Drug: aggressive medical management']}\n- {'label': 'Aggressive Medical management', 'type': 'EXPERIMENTAL', 'description': 'All the participants in this group will be given aggressive medical management alone.', 'interventionNames': ['Drug: aggressive medical management']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'intracranial balloon angioplasty', 'description': 'A balloon (recommending the Neuro RX and Neuro LPS Intracranial Balloon Dilation Catheter \\\\[Sinomed Inc., Tianjin, China\\\\]) is navigated by the microwire to the lesion of the target artery.', 'armGroupLabels': ['Intracranial balloon angioplasty and aggressive medical management']}\n- {'type': 'DRUG', 'name': 'aggressive medical management', 'description': 'Aspirin 100mg once/day during the follow-up period, Clopidogrel 75mg once/day for at least 90 days, Atorvastatin 20-80mg once/day as the situation requires and risk factors management including blood pressure to maintain 130-140/80-90 mmHg and LDL lower than 70 mg/dl or 1.8mmol/L.', 'armGroupLabels': ['Aggressive Medical management', 'Intracranial balloon angioplasty and aggressive medical management']}\n\nPrimary Outcomes:\n- {'measure': 'Stroke or death within 30 days after enrollment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischemic stroke or revascularization from the qualifying artery beyond 30 days through 12 months after enrollment', 'description': 'This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after enrollment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after enrollment.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power, one-sided \u03b1 of 2.5%, and a 10% dropout rate.", "answer": 512, "answer_type": "ACTUAL", "explanation": "Sample size\n According to VISSIT trial and a previous randomised trial in China, the composite event rate of the primary outcome in the control group is anticipated to be 15%.4 14 As to the balloon angioplasty group, we assume a 7% of the primary outcome based on studies of angioplasty without stenting9 15 and investigators\u00e2\u0080\u0099 clinical practice experience in China. As a result, the sample size needs to detect an 8% absolute difference. A total of 512 patients (256 per group) will be enrolled considering an 80% statistical power at a one-sided \u00ce\u00b1 of 2.5% and a 10% dropout rate.", "id": 375, "split": "train"} +{"trial_id": "NCT03705845", "pmid": "32152169", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Actions of Dietary Tocotrienols on Obesity\n\nIncluded conditions:\n- Obesity\n- Postmenopausal Women\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'One 430 mg olive oil softgel daily for 24 weeks. Each placebo softgel of 430 mg olive oil will contain no tocotrienol or tocopherols at detectable levels.', 'interventionNames': ['Drug: placebo softgel']}\n- {'label': 'Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'One 430 mg tocotrienol softgel daily for 24 weeks. Each tocotrienol softgel (DeltaGold\u00ae Tocotrienol 70%) contains 430 mg tocotrienol (90% \u03b4-tocotrienol+10% \u03b3-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.', 'interventionNames': ['Drug: DeltaGold\u00ae Tocotrienol 70%']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'placebo softgel', 'description': 'Each placebo softgel of 430 mg olive oil will contain no TT or tocopherols at detectable levels.', 'armGroupLabels': ['Control'], 'otherNames': ['olive oil']}\n- {'type': 'DRUG', 'name': 'DeltaGold\u00ae Tocotrienol 70%', 'description': 'DeltaGold\u00ae Tocotrienol 70% contains 430 mg tocotrienol (90% \u03b4-tocotrienol + 10% \u03b3-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.', 'armGroupLabels': ['Intervention'], 'otherNames': ['tocotrienols']}\n\nPrimary Outcomes:\n- {'measure': 'Fat mass', 'description': 'total and regional fat mass by DXA', 'timeFrame': '24 weeks'}\n- {'measure': 'visceral adipose tissue', 'description': 'VAT by BIA', 'timeFrame': '24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes 0.20 correlations among repeated measures, 80% power, a significance level of 5%, and a high attrition rate of 20%. Missing data will be addressed via multiple imputation.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size\n Sample size is determined to provide adequate power for the study. Data from previous studies suggest that the TT intervention would yield moderate to large changes (median f=0.31) in total fat mass and body weight. The power analysis for the present study is considered to observe similar changes in other previous studies20 37\u00e2\u0080\u009339 and assumed 0.20 correlations among repeated measures. The analysis results revealed that the sample size of n=46\u00e2\u0080\u0089will produce 80% power while controlling type I error under 5%. Conservatively assuming a high attrition rate of 20%, therefore, we plan to recruit 60 participants (30 in each group) at baseline\u00e2\u0080\u0094that is, anticipated final n\u00e2\u0089\u00a546 (power \u00e2\u0089\u00a580%) at the end of the study with up to 20% attrition. Missing data, either attrition or non-response, will be fully recovered via multiple imputation as described later, which will remove or minimise (if present) confounding effects of missingness on our statistical power.", "id": 376, "split": "train"} +{"trial_id": "NCT03709511", "pmid": "38135333", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Open-label, Controlled Trial on Perioperative Rehabilitation of Cardiac Valvular Surgery\n\nIncluded conditions:\n- Heart Valve Diseases\n- Pulmonary Complication\n\nStudy Armgroups:\n- {'label': 'Conventional Treatment Group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will receive the usual care protocol. On the day of admission, a registered nurse in cardiac ward will provide operating skills of deep breathing, cough exercises, and incentive spirometry, then patients will be instructed to perform the respiratory exercise as much as they can during the hospitalization without supervision. These participants will not receive additional rehabilitation interventions, unless individual indications are present.'}\n- {'label': 'Cardiac Rehabilitation Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention group will receive the PORT protocol, contains education, IMT, ACBT, EM. Participants will be provided information about the cardiac surgery and adverse effect on postoperative recovery, and the importance of PORT program.\\n\\nAn inspiratory threshold-loading device is used for IMT. Participants will be instructed to breathe in as forcefully as possible before slowly breathing out five times and then rest for one minute, followed by another set of five breaths. Patients will complete three sessions of ACBT consisting of breathing control, thoracic expansion exercises and forced expiratory techniques. The mobilization protocol will be performed via a progressive approach, consisting of 6 steps. EM will be personalized to each patient.', 'interventionNames': ['Other: Cardiac rehabilitation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Cardiac rehabilitation', 'description': 'perioperative rehabilitation consists of education, inspiratory muscle training, active cycle of breathing techniques, and early mobilization.', 'armGroupLabels': ['Cardiac Rehabilitation Group']}\n\nPrimary Outcomes:\n- {'measure': 'composite end point of in-hospital all-cause death, pulmonary complications and the ratio of postoperative hospitalization longer than 7 days.', 'description': 'the composite of in-hospital all-cause death and pulmonary complications, such as pulmonary infection, postoperative hospitalization days.', 'timeFrame': 'Through hospitalization (up to 2 months)'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% to detect a difference in the primary outcome at a significance level of 0.05 (two sided). An 11% lost to follow-up rate is estimated.", "answer": 800, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated using inference for proportions comparing two independent samples performed by nQuery Advisor+nTerim 4.0 (Statistical Solutions, Ireland). Data from the pilot study (to be submitted) showed that the incidence in the primary endpoint was 13.56% (intervention group) vs 21.21% (control group). We calculated that enrolling 360\u00e2\u0080\u0089patients in each group would provide a power of 80% to detect a difference in the primary outcome at a significance level of 0.05 (two sided). Estimating an 11% lost to follow-up, the recruitment goal is 400\u00e2\u0080\u0089patients per group (n=800).", "id": 377, "split": "train"} +{"trial_id": "NCT03714633", "pmid": "32007087", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Stockholm Preterm Interaction-Based Intervention\n\nIncluded conditions:\n- Extreme Prematurity\n\nStudy Armgroups:\n- {'label': 'Stockholm Preterm Interaction-Based Intervention (SPIBI)', 'type': 'EXPERIMENTAL', 'description': 'Home-based post-discharge intervention for extreme premature babies and their parents. The intervention consists of one hospital visit, nine home-visits and two telephone calls during the first year corrected age, specifically from one week before discharge to 12 months corrected age. The intervention is strengths-based working with the infant-parent interaction, supporting infant development and strengthening the parent in his/her role.', 'interventionNames': ['Behavioral: Stockholm Preterm Interaction-Based Intervention (SPIBI)']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The participants of the Control Group receives treatment as usual, which consists of a regular follow-up program with neurodevelopmental assessment at term age, 3 months corrected age, 12 months corrected age, 24 months corrected age and 66 months corrected age. Compared to children not participating in the study, the control group will receive an extended follow-up program, with assessment and questionnaires at term age, 3 months corrected age, 12 months corrected age, 24 months corrected age and 36 months corrected age. Participants in the control group will be referred to specialized care when needed.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Stockholm Preterm Interaction-Based Intervention (SPIBI)', 'description': 'Post-discharge intervention to extreme premature infants and their parents', 'armGroupLabels': ['Stockholm Preterm Interaction-Based Intervention (SPIBI)']}\n\nPrimary Outcomes:\n- {'measure': 'Parent-child interaction', 'description': 'Emotional availability scales, EAS The scale has four parental dimensions; sensitivity, structure, non-intrusiveness, non-hostility and two child dimensions; child responsiveness and child involvement. Each subscale has a maximum score of 29 and a direct score of 1-7. Hypothesis of higher scores in intervention group.', 'timeFrame': '12 months corrected age.'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a power of 0.8, a significance level (alpha) of 0.05, and a normal distribution.", "answer": 130, "answer_type": "ACTUAL", "explanation": "Sample size and statistical power\n The hospitals in Stockholm treat more than 100 extremely preterm infants every year, but several of them are not residents of Stockholm County, which is a prerequisite for study inclusion. The study team is prepared to recruit 130 participants, 50% of which will be randomized to the SPIBI intervention. The sample size is based on feasibility, and the assumption is that the effect size of the intervention on the primary outcome measure Emotional Availability Scales (EAS) will be moderate, i.e., Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.5. This is largely in line with the results of Flierman et al. [50] for the sensitivity scale of the EAS in the previously mentioned Dutch trial. Hence, we aim to recruit 130 participants, which gives us a power of 0.8 given a normal distribution and an alpha value of 0.05.", "id": 378, "split": "train"} +{"trial_id": "NCT03717896", "pmid": "38423765", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Thiamine As Adjunctive Therapy for Diabetic Ketoacidosis\n\nIncluded conditions:\n- Diabetic Ketoacidosis\n\nStudy Armgroups:\n- {'label': 'Thiamine', 'type': 'EXPERIMENTAL', 'description': '200mg IV thiamine in 50mL 0.9% saline twice daily for 2 days', 'interventionNames': ['Drug: 200mg IV thiamine in 50mL 0.9% saline']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '100mL 0.9% saline twice daily for two days', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '200mg IV thiamine in 50mL 0.9% saline', 'description': 'Thiamine 200mg IV every 12 hours for 2 days', 'armGroupLabels': ['Thiamine'], 'otherNames': ['Vitamin B1']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': '50mL 0.9% saline', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'plasma bicarbonate levels', 'description': 'Our primary outcome is change in bicarbonate over the 24 hours following enrollment with measurements at 0, 6, 12, 18, 24 hours using a linear-effects model', 'timeFrame': '24 hours'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a type-I error of 0.05, a power of 99%, and a small dropout rate of less than 20%. The variance-covariance structure of the bicarbonate data follows a compound-symmetry structure with a between-subject variance of 3.8.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size\n The analysis method for the primary endpoint will be linear mixed-effects modelling (LMM). This type of modelling is used in longitudinal or repeated measures studies to take into account the correlation of within-subject measurements. In this study, each subject is expected to have five bicarbonate measurements, one at 0, 6, 12, 18 and 24 hours, which are correlated. Based on preliminary data from a pilot study, which had three consistent time points, we observed that patients with DKA had a mean of 8.9 mEq/L at time 0, 18 mEq/L at 12 hours and 20 mEq/L at 24 hours. We took a conservative position to assume that the potential effect size (the mean difference of bicarbonate between the two groups) will be 20%. That is, we assumed that the mean bicarbonate level at the three different time points was 8.9 mEq/L, 21.6 mEq/L and 22.5 mEq/L. We then simulated the longitudinal data with the assumption that the variance\u00e2\u0080\u0093covariance structure of the bicarbonate data followed a compound-symmetry structure with between-subject variance of 3.8. The linear-mixed effects model was used on the simulated data to obtain the estimated F statistic, numerator and denominator df. From these estimates, the non-centrality parameter was computed and used to obtain the power. With 80 subjects with type-I error of 0.05, we have a power of 99% to detect the stated difference over 0, 12 hours and 24 hours. The addition of two more time points with similar between-subject variance will increase our power. We plan to enrol 100 subjects (50 thiamine and 50 placebo) to allow for a small drop-out rate (less than 20%; due to reasons such as subject withdrawal, hospital discharge or death prior to outcomes of interest, potentially missing data due to patient clinical care (eg, having testing done, having access issues for blood draws, etc) and to ensure adequate power for the preplanned key analysis of thiamine-deficient patients.", "id": 379, "split": "train"} +{"trial_id": "NCT03720041", "pmid": "35654466", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Myeloma XIV: A Phase III Trial to Compare Standard and Frailty-adjusted Induction Therapy With Ixazomib, Lenalidomide and Dexamethasone (IRD) and Maintenance Lenalidomide (R) to Lenalidomide Plus Ixazomib (R+I)\n\nIncluded conditions:\n- Multiple Myeloma\n\nStudy Armgroups:\n- {'label': 'R1: IRD induction therapy (reactive)', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the reactive arm at Randomisation 1, participants will receive IRD induction therapy with standard up-front dosing, with toxicity assessed at each cycle and doses adjusted in accordance with the guidelines given in the trial protocol.', 'interventionNames': ['Drug: R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - reactive arm']}\n- {'label': 'R1: IRD induction therapy (adaptive)', 'type': 'EXPERIMENTAL', 'description': 'In the adaptive arm at Randomisation 1, participants will receive IRD induction therapy with up-front dose reductions adjusted according to their frailty score: fit, unfit, or frail.', 'interventionNames': ['Drug: R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - adaptive arm']}\n- {'label': 'R2: Lenalidomide plus placebo maintenance', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants randomised to this arm at Randomisation 2 will receive lenalidomide plus placebo maintenance.', 'interventionNames': ['Drug: R2: Lenalidomide plus placebo maintenance']}\n- {'label': 'R2: Lenalidomide + ixazomib maintenance', 'type': 'EXPERIMENTAL', 'description': 'Participants randomised to this arm at Randomisation 2 will receive lenalidomide plus ixazomib maintenance.', 'interventionNames': ['Drug: R2: Lenalidomide + ixazomib maintenance']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - reactive arm', 'description': 'In the reactive arm at Randomisation 1, participants will receive IRD induction therapy with standard up-front dosing, with toxicity assessed at each cycle and doses adjusted in accordance with the guidelines given in the trial protocol. All participants will be given the following starting doses:\\n\\nIxazomib: 4mg/day on days 1, 8 and 15, taken orally\\n\\nLenalidomide: 25mg/day on days 1-21, taken orally\\n\\nDexamethasone: 40mg on days 1, 8, 15 and 22 for participants aged \u226475 years, or 20mg on days 1, 8, 15 and 22 for participants aged \\\\> 75 years; taken orally\\n\\nParticipants will receive this dosing regimen for 12 cycles of induction treatment, in the absence of disease progression or unacceptable toxicity. Each cycle is 28 days.', 'armGroupLabels': ['R1: IRD induction therapy (reactive)'], 'otherNames': ['Ninlaro', 'Revlimid']}\n- {'type': 'DRUG', 'name': 'R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - adaptive arm', 'description': 'In the adaptive arm at Randomisation 1, participants will receive IRD induction therapy with up-front dose reductions adjusted according to their frailty score: fit, unfit, or frail. The starting doses for each frailty category are described below:\\n\\n1. Fit category:\\n\\n Ixazomib: 4mg/day on days 1, 8 and 15, taken orally Lenalidomide: 25mg on days 1-21, taken orally Dexamethasone: 40mg on days 1, 8, 15 and 22, taken orally\\n2. Unfit category:\\n\\n Ixazomib: 4mg/day on days 1, 8 and 15, taken orally Lenalidomide: 15mg on days 1-21, taken orally Dexamethasone: 20mg on days 1, 8, 15 and 22, taken orally\\n3. Frail category:\\n\\nIxazomib: 4mg/day on days 1, 8 and 15, taken orally Lenalidomide: 10mg on days 1-21, taken orally Dexamethasone: 10mg on days 1, 8, 15 and 22, taken orally\\n\\nParticipants will receive this dosing regimen for 12 cycles of induction treatment, in the absence of disease progression or unacceptable toxicity. Each cycle is 28 days.', 'armGroupLabels': ['R1: IRD induction therapy (adaptive)'], 'otherNames': ['Ninlaro', 'Revlimid']}\n- {'type': 'DRUG', 'name': 'R2: Lenalidomide plus placebo maintenance', 'description': 'Participants randomised to receive lenalidomide plus placebo maintenance at Randomisation 2 will receive the following starting doses:\\n\\nLenalidomide: 10mg\\\\*/day on days 1-21, taken orally Placebo: 4mg\\\\*/day on days 1, 8 and 15\\n\\n\\\\* or final dose administered at the end of induction treatment if lower.\\n\\nThis dosing regimen is continued for every maintenance cycle. Participants will continue maintenance treatment until disease progression or intolerance/unacceptable toxicity. Each maintenance cycle is 28 days.\\n\\nRandomisation 2 is double-blind - participants and their treating clinicians will be blinded to maintenance allocation.', 'armGroupLabels': ['R2: Lenalidomide plus placebo maintenance'], 'otherNames': ['Revlimid']}\n- {'type': 'DRUG', 'name': 'R2: Lenalidomide + ixazomib maintenance', 'description': 'Participants randomised to receive lenalidomide plus ixazomib maintenance at Randomisation 2 will receive the following starting doses:\\n\\nLenalidomide: 10mg\\\\*/day on days 1-21, taken orally Ixazomib: 4mg\\\\*/day on days 1, 8 and 15\\n\\n\\\\* or final dose administered at the end of induction treatment if lower.\\n\\nThis dosing regimen is continued for every maintenance cycle. Participants will continue maintenance treatment until disease progression or intolerance/unacceptable toxicity. Each maintenance cycle is 28 days.\\n\\nRandomisation 2 is double-blind - participants and their treating clinicians will be blinded to maintenance allocation.', 'armGroupLabels': ['R2: Lenalidomide + ixazomib maintenance'], 'otherNames': ['Revlimid', 'Ninlaro']}\n\nPrimary Outcomes:\n- {'measure': 'Randomisation 1: Number of participants with early treatment cessation', 'description': 'Early treatment cessation is defined as a binary endpoint. Participants will be defined to have experienced an event if they die, progress, or are withdrawn from treatment (by a treating clinician) or withdraw consent for trial treatment, within 60 days of Randomisation 1.', 'timeFrame': 'Within 60 days of Randomisation 1'}\n- {'measure': 'Randomisation 2: Progression-free survival (PFS-R2)', 'description': 'PFS-R2 is defined as the time from Randomisation 2 to the time of first documented evidence of disease progression or death from any cause. Individuals who are lost to follow-up or progression-free at the time of analysis will be censored at their last known date to be alive and progression-free. Disease progression is defined according to the IMWG Uniform Response Criteria for Multiple Myeloma.', 'timeFrame': 'The time from the date of Randomisation 2 to the date of first documented evidence of disease progression or death from any cause, up to 120 months'}\n\nPlease estimate the sample size based on the assumption: \nCalculations are based on a Pearson\u2019s \u03c72 test without continuity correction, assume a two-sided 5% level of significance, 80% power, and allow for a 1% dropout prior to 60 days post randomisation. For R2, calculations assume a two-sided 5% significance level, 80% power, and allow for a 3% dropout rate prior to a PFS event. 80% power is attained when 302 events have been observed. OS requires 180 events with a minimum of 2-year follow-up for all participants for 80% power.", "answer": 740, "answer_type": "ESTIMATED", "explanation": "Sample size\n In total, 740 participants will be enrolled into the trial at R1 to ensure that at least 478 participants remain on trial and are randomised to R2. It is assumed that 65% of those randomised at R1 will be progression free and, therefore, eligible for R2, hence 740 participants are required to be enrolled.\n Based on data from the Myeloma XI non-intensive pathway, we hypothesise the frail and unfit patients in R1 will be similar to the older patients in Myeloma XI (>75 years) who have an early treatment cessation rate (within 60 days of R1) of 20%. This hypothesis is based on the expectation that the frailty score is heavily driven by patient age. Younger patients (\u00e2\u0089\u00a475 years) in the Myeloma XI non-intensive pathway have an early treatment cessation rate of 9%, and it is our hypothesis that our frailty-based dosing schedule has the potential to reduce the rate among the unfit and frail patients to the proportion observed in fit patients.28 29\n To demonstrate a decrease of 11% in the proportion of early treatment cessation from 20% in the standard dosing schedule arm to 9% in the frailty score-adjusted dose arm among those patients scored at baseline to be unfit or frail would require the recruitment of 324 patients with an allocation ratio of 1:1. These calculations are based on a Pearson\u00e2\u0080\u0099s \u00cf\u00872 test without continuity correction, assume a two-sided 5% level of significance, 80% power, and allow for a 1% dropout prior to 60 days post randomisation. Given that we anticipate that 45% of patients will be scored as unfit or frail, by assuming this trial will have a similar underlying population as in Myeloma XI non-intensive pathway and the age distributions in the IMWG report proposing the frailty score,14 we would anticipate that we will require 720 patients to enter the trial at R1 to have sufficient unfit and frail patients available to answer this question.\n For R2, in the non-intensive pathway of Myeloma XI, the median PFS for patients on R following CRDa induction was approximately 33 months,19 where approximately 65% of individuals were progression-free 12 months post randomisation. As R2 is approximately 12 months following R1 in FiTNEss, we assume that the median PFS for patients receiving R maintenance therapy will be 21 months from R2. Tourmaline-MM112 demonstrated an HR for PFS of 0.74 when comparing IRD and RD in patients with relapsed and refractory multiple myeloma. Thus a similar HR would be the minimum clinically relevant difference for our comparison in patients with newly diagnosed multiple myeloma. Assuming a median PFS of 29 months for those in the R+I maintenance group in addition to the assumption of 21 months in the R group equates to an HR of 0.72.\n The above assumptions require the recruitment of 478 participants over a 30 month recruitment period with a further 24 months of follow-up. These calculations also assume a two-sided 5% significance level, 80% power and allow for a 3% dropout rate prior to a PFS event being experienced. Note that 80% power is attained when 302 events have been observed. A total of 740 participants should be allocated to R1 to ensure that 478 participants are available at the second randomisation.\n OS is considered to be a key secondary endpoint for R2, 180 events with a minimum of 2-year follow-up for all participants are required for 80% power.", "id": 380, "split": "train"} +{"trial_id": "NCT03724318", "pmid": "38741218", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Left Atrial Appendage Closure by Surgery-2\n\nIncluded conditions:\n- Stroke, Ischemic\n- Atrial Fibrillation\n\nStudy Armgroups:\n- {'label': 'Closure', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to the active Group will undergo closure of the left atrium appendage during Heart surgery by means of commercial clips', 'interventionNames': ['Procedure: closure of the left atrium appendage']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The left atrium appendage will remain open in patients randomized to the control group'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'closure of the left atrium appendage', 'description': 'closure of the left atrium appendage in addition to the planned Heart operation', 'armGroupLabels': ['Closure']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with Stroke occurrence including Transitory cerebral ischemia (TCI)', 'description': 'Stroke is an acute episode of focal dysfunction of the brain, retina, or spinal cord lasting longer than 24 h, or of any duration if imaging (CT or MRI) or autopsy show focal infarction relevant to the symptoms. Transitory cerebral ischemia (TCI) is defined as above, but with symptoms lasting less than 24 h.\\n\\nEndpoints will be assigned by two independent neurologists, who are blinded to what procedure the patient undergo. In case of discrepancy, the events will be assigned by consensus.', 'timeFrame': 'at least two years, until end of follow-up'}\n\nPlease estimate the sample size based on the assumption: \nRandomized 1:1, followed for 2 years, significance level of 0.05, 90% power, and accounting for deviations in treatment allocation and death.", "answer": 1500, "answer_type": "ACTUAL", "explanation": "Sample size\n Based on previous studies, estimated event rates are 1.2% vs. 3.0% per year for patients with and without LAA closure, respectively [8, 9, 11, 16, 18, 19]. A total of 1302 patients need to be included if they are randomized 1:1, followed for 2\u00c2\u00a0years, and a significance level of 0.05 and 90% power is to be achieved. With these numbers, 16 primary events are expected for patients with LAA closure and 39 for patients with an open LAA. The trial will enroll 1500 patients to account for deviations in treatment allocation and death. Please see the trial protocol for more details [20].", "id": 381, "split": "train"} +{"trial_id": "NCT03724903", "pmid": "33039992", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ductal Lavage Versus Corticosteroids Therapy for Idiopathic Granulomatous Mastitis: a Multicenter, Randomized, Open-labelled, Non-inferior Trial.\n\nIncluded conditions:\n- Granulomatous Mastitis\n\nStudy Armgroups:\n- {'label': 'Ductal lavage', 'type': 'EXPERIMENTAL', 'description': 'Ductal lavage and breast massage for two weeks.', 'interventionNames': ['Procedure: Ductal lavage']}\n- {'label': 'Corticosteroids therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral corticosteroids therapy for 6 months.', 'interventionNames': ['Drug: Corticosteroid therapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Ductal lavage', 'description': 'The patients received ductal lavage and breast massage every other day for two weeks. We used lidocaine (1%) for local anesthesia around the nipple. We used a lacrimal probe to identify 4-5 openings in the lactiferous ducts on the nipple and inserted the infusion cannula (21-23G). A total of 25ml of irrigation solution (5 ml of 2% lidocaine, 40 mg of triamcinolone acetonide, 20 ml of 0.9% saline and 1.0 g of ceftriaxone) was pumped into the ducts over 20-25 minutes. The patient returned to the clinic the next day for breast massage, and the cycle was repeated for two weeks.', 'armGroupLabels': ['Ductal lavage']}\n- {'type': 'DRUG', 'name': 'Corticosteroid therapy', 'description': 'Methylprednisolone(Common brand names: Medrol) or prednisone 20-40mg, qd for two weeks, then temper the dose gradually, and then 20mg qd for maintenance (The total duration of the treatment is 6 months).', 'armGroupLabels': ['Corticosteroids therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Complete Clinical Response(cCR)', 'description': 'The proportion of patients that achieve M-score \\\\<=1 at 1 year after the treatment.', 'timeFrame': '1 year since randomization'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of \u03b1=0.025 and power of \u03b2=0.80 were considered. A loss to follow-up rate of 10% was also assumed.", "answer": 140, "answer_type": "ACTUAL", "explanation": "Sample size and statistical analysis\n We will report the continuous and categorical variables as the medians (ranges) and counts (percentages), respectively, for the descriptive analysis. The Mann-Whitney U test and \u00cf\u0087\u00c2\u00b2-square test will be used to compare the clinicopathological features between the two groups. The primary and secondary endpoints will be compared by intention-to-treat analysis. We will determine whether there are missing data, and we will use multiple imputation and sensitivity analyses to explore the impact of the missing data.\n We hypothesise that the 1-year cCR rate of oral corticosteroid treatment will be 90%. This trial was designed to assess the non-inferiority of ductal lavage compared with oral corticosteroids, and the clinically acceptable non-inferiority margin for the ductal lavage group was defined as a 1-year cCR rate equal to or better than 15%. This non-inferiority margin was decided before the initiation of the study during a consensus meeting with a panel of experts. A loss to follow-up rate of 10% was considered, and it was calculated that 70 participants (total of 140 participants) were needed in each group, with a significance level of a=0.025\u00e2\u0080\u0089and power of b=0.80. If non-inferiority is confirmed and the lower border of the 95% CI is >0, the superiority effects of ductal lavage vs oral steroids can be suggested.\n An exploratory analysis will be performed to investigate the potential interaction between treatment benefits and the baseline clinicopathological factors, for example, M-score (\u00e2\u0089\u00a55\u00e2\u0080\u0089or <5). Subgroup analysis will be performed for significant interactions. Longitudinal data analysis will be performed using marginal generalised estimating equations for the cCR, as well as the random effects/mixed models for the M-scores. All of the statistical analyses will be conducted using STATA V.13 statistical software (StataCorp, College Station, Texas, USA).", "id": 382, "split": "train"} +{"trial_id": "NCT03729648", "pmid": "33407413", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Psycho-physiological & Social-spiritual Effects of Expressive Arts-based Intervention on Young and Pre-elderly Stroke Survivors: A Randomized Controlled Study\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'This arm of participants will be receiving Expressive Arts Therapy as intervention', 'interventionNames': ['Behavioral: Expressive Arts Therapy']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'This arm of participants will not receive any intervention and are allocated as a wait-list control group'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Expressive Arts Therapy', 'description': 'The intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflect and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in therapy may seek meaning, clarity, insight and healing.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Depression and Anxiety level at 2 months and 8 months', 'description': 'Administration of the Chinese translated version of Hospital Anxiety and Depression Scale\\n\\n* This scale is adopted to measure the level of Depression and Anxiety.\\n* Two scores, Depression score and Anxiety score, are generated.\\n* The minimum score is 0 and the maximum score is 21.\\n* Scores ranging from \"0-7\" represents \"Normal\", ranging from \"8-10\" represents \"Borderline abnormal\", and ranging from \"11-21\" represents \"Abnormal\".', 'timeFrame': 'Baseline, Month 2, and Month 8'}\n- {'measure': 'Change of Baseline Perceived Stress level at 2 months and 8 months', 'description': 'Administration of Chinese translated version of Perceived Stress Scale\\n\\n* This scale is adopted to measure the level of perceived stress\\n* The total score of Perceived Stress Scale is summing all the scores from each item, with Q4, Q5, Q7, and Q8 are reverse items.\\n* The minimum score is 0 and the maximum score is 40.\\n* Scores ranging from \"0-13\" represents low stress, ranging from \"14-26\" represents moderate stress, and \"27-40\" represents high perceived stress.', 'timeFrame': 'Baseline, Month 2, and Month 8'}\n- {'measure': 'Change of Baseline Perceived Social Support level at 2 months and 8 months', 'description': 'Administration of the Chinese version of the Multidimensional Scale of Perceived Social Support\\n\\n* This scale has adopted the measure the level of perceived social support from family, friends, or significant other.\\n* The mean score of perceived social support from \"family\" is calculated by summing across Q3, Q4, Q8, and Q11, then divide by 4.\\n* The mean score of perceived social support from \"friends\" is calculated by summing across Q6, Q7, Q9, and Q12, then divide by 4.\\n* The mean score of perceived social support from \"significant other\" is calculated by summing across Q1, Q2, Q5, and Q10, then divide by 4.\\n* The mean total score is calculated by summing across all 12 items, then divide by 12.\\n* The minimum mean score of each sub-score and the total score is 1 and the maximum mean score is 7.', 'timeFrame': 'Baseline, Month 2, and Month 8'}\n- {'measure': 'Change of Baseline Self-esteem at 2 months and 8 months', 'description': 'Administration of the Chinese version of the Rosenberg Self-esteem Scale\\n\\n* This scale is adopted to measure the level of self-esteem.\\n* Q2, Q5, Q6, Q8, Q9 are reversed items.\\n* Total self-esteem score is calculated by summing all items.\\n* The minimum score is 10 and the maximum score is 40.\\n* A higher score represents a higher level of self-esteem.', 'timeFrame': 'Baseline, Month 2, and Month 8'}\n- {'measure': 'Change of Baseline Hope level at 2 months and 8 months', 'description': 'Administration of the Chinese version of the Adult State Hope Scale\\n\\n* This scale is adopted to measure the level of hope.\\n* Pathways sub-scale score is calculated by summing across Q1, Q3, and Q5.\\n* Agency sub-scale score is calculated by summing across Q2, Q4, and Q6.\\n* Total hope score is calculated by summing all items.\\n* The minimum score of the sub-scales is 3 and the maximum score of the sub-scales is 24.\\n* The minimum score of the total score is 6 and the maximum score of the total score is 48.\\n* The higher scores in sub-scales represent higher levels of pathways thinking or higher agency thinking respectively. The higher total score represents higher hope levels.', 'timeFrame': 'Baseline, Month 2, and Month 8'}\n- {'measure': 'Change of Baseline Spiritual well-being level at 2 months and 8 months', 'description': 'Administration of the Chinese version of the 3-item spiritual care sub-scale of the Body-Mind-Spirit Holistic Well-being Scale\\n\\n* This sub-scale is adopted to measure the level of spiritual well-being.\\n* The sub-scale score is calculated by summing across all three items.\\n* The minimum score of this sub-scale is 3 and the maximum score of this sub-scale is 30.\\n* A higher score represents a higher level of spiritual well-being.', 'timeFrame': 'Baseline, Month 2, and Month 8'}\n- {'measure': 'Change of Baseline Stroke-specific quality of life at 2 months and 8 months', 'description': 'Administration of the Chinese version of the Stroke-specific Quality of Life Short Form\\n\\n* This scale is adopted to measure the level of stroke-specific Quality of Life.\\n* Physical components of stroke-specific Quality of Life is calculated by summing across Q1, Q2, Q4, Q7, Q10, Q11, and Q12.\\n* Psychosocial components of stroke-specific Qualify of life is calculated by summing across Q3, Q5, Q6, Q8, and Q9.\\n* The minimum score of physical and psychosocial components is 7 and 5 respectively.\\n* The maximum score of physical and psychosocial components is 35 and 25 respectively.\\n* A higher score represents a higher level of stroke-specific quality of life.', 'timeFrame': 'Baseline, Month 2, and Month 8'}\n- {'measure': 'Change of Baseline general quality of life at 2 months and 8 months', 'description': 'Administration of the Chinese version of the 12-item Short Form Health Survey\\n\\n* This scale is adopted to measure the level of health-related Quality of life.\\n* Q1, Q8, Q9, and Q10 are reversed items.\\n* Physical and Mental Health Composite Scale scores are calculated.', 'timeFrame': 'Baseline, Month 2, and Month 8'}\n- {'measure': 'Change of Baseline Physical stress level and cortisol rhythm at 2 months and 8 months', 'description': 'Collection of saliva samples for analysis', 'timeFrame': 'Baseline, Month 2, and Month 8'}\n\nPlease estimate the sample size based on the assumption: \nstatistical power of 80%, significance level of 0.05, attrition rate of 25%", "answer": 154, "answer_type": "ACTUAL", "explanation": "Sample size estimates\n To achieve a statistical power of 80% with a medium effect size (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.63) at a significance level of 0.05 in regression modelling (latent growth modelling) under the proposed two-arm, three-time point design, a sample size of 116 is needed according to Monte Carlo simulation. Assuming an attrition rate of 25% based on prior trials of arts-based therapies in stroke survivors [49], a total of 154 participants will be required (i.e. 77 per arm).", "id": 383, "split": "train"} +{"trial_id": "NCT03730623", "pmid": "31964402", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cross-sectoral Rehabilitation for Patients With Intermittent Claudication: Effects and Patient Experience - The CIPIC-Rehab Study (Cross-sectoral Intervention for Patients With Intermittent Claudication)\n\nIncluded conditions:\n- Intermittent Claudication\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Usual care. Conservative management of IC'}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Supervised exercise', 'interventionNames': ['Behavioral: Supervised exercise training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Supervised exercise training', 'description': 'Supervised exercise training as a conservative management of intermittent claudication in a community setting based on cardiac rehabilitation program', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Maximum Walking Distance on a treadmill', 'description': 'Change from Baseline Maximum Walking Distance at 12 months. Detect an improvement of 60 meters in Maximum Walking Distance in the intervention group compared to the control group, using the standardized Treadmill Walking Test.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level, 80% power, and a 25% dropout rate.", "answer": 118, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n The expected average baseline value of MWD has been set to 120\u00e2\u0080\u0089m with a detected 50% improvement (60\u00e2\u0080\u0089m). There is a wide variance in MWD in this patient group and consequently the standard deviation (SD) is set at 100\u00e2\u0080\u0089m, based on an expected improvement in walking ability of approximately 50% to 200% [18]. With a 5% significance level and 80% power, it will thus be necessary to include 88 patients to detect an improvement of 60\u00e2\u0080\u0089m in MWD in the intervention group at the 12-month follow-ups, compared with the control group. Owing to the previously mentioned risk of co-morbidities, combined with an expected drop-out, a drop-out of 25% must be expected, therefore the investigators plan to include 118 patients in total (59 in each group).", "id": 384, "split": "train"} +{"trial_id": "NCT03730701", "pmid": "31678952", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"Make my Day\"- Incorporating Healthy Activity Patterns: A Person-centered, Digital Prevention Program to Support Health Among Persons at Risk for Stroke\n\nIncluded conditions:\n- Non-Communicable Diseases\n- Stroke\n- Cardiovascular Risk Factor\n\nStudy Armgroups:\n- {'label': 'Prevention treatment group', 'type': 'EXPERIMENTAL', 'description': 'Prevention program with 10 week blended intervention utilizing both a digital health app, group-sessions with peers and a interprofessional team of health-care workers chairing 5+1 themed group-sessions as support to change lifestyle habits in to a pattern of activities (behaviors and actions) in everyday life that can promote health and wellbeing and decrease risk for stroke. Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.', 'interventionNames': ['Behavioral: Prevention program for stroke']}\n- {'label': 'Standard treatment group', 'type': 'NO_INTERVENTION', 'description': 'Usal care in Swedish primary health care. In addition a Lifestyle analysis and stroke risk screening before, at follow up and 12 months after the prevention program.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Prevention program for stroke', 'description': 'The prevention program include individual and group intervention sessions supported by a digital platform. The program will be personally tailored in relation to what the person needs and what to change and the individuals rediness for change. The digital platform will support the person during and in between sessions by prompting goals and goal-fulfilment, logging activities, step counts and provide a forum for sharing and reflection.', 'armGroupLabels': ['Prevention treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'Stroke risk score card', 'description': \"Through the stroke risk score card estimate change in risk for Stroke and how high this risk are.\\n\\nThree colums with different colours. Red, yellow and green. Red is High risk, Yellow is Caution, and Green is Low risk. In total there is 8 points per column.\\n\\nHigh risk: \\\\>3 red points: Ask about stroke prevention right away. Caution: 4-6: A good start. Work on reducing risk. Low risk: 6-8: You're doing very well at controlling stroke risk.\", 'timeFrame': 'Baseline, within a month after the intervention, 1 year follow-up after baseline.'}\n- {'measure': 'Healthy Activity patterns (PPR profile)', 'description': 'PPRP (Daily Experiences of Pleasure, Productivity, and Restoration Profile) is a activity-diary where change is meant to be measured regarding activity patterns in everyday life. Experiences are scored as 1-7 in four domains (Pleasure, Productivity, Restoration and Health promotion). For example the domain of health promotion is scored as 1 (very unhealthy) to 7 (very healthy) in regards to different engagements in everyday life. The higher the value the better.', 'timeFrame': 'Baseline, within a month after the intervention, 1 year follow-up after baseline.'}\n- {'measure': 'Questions of Lifestyle habits', 'description': 'Measuring change in lifestyle habits with a self-percieved questionnaire with open questions and estimations of different lifestyle habits in everyday life regarding dietary, smoking, alcohol, physical activity habits.\\n\\nParticipants selects an option on each question or writes an estimated number or answer on what and how they usually do regarding each lifestyle habit.\\n\\nFor example if they are or have been smoking and how much.\\n\\nExample of answers options:\\n\\n1. I have never smoked\\n2. I have smoked but I have stoped\\n3. I smoke, but not daily\\n4. I smoke daily.....X cigarettes a day. Where answer 4. is worse than answer 1.\\n\\nAnd on alcohol consumption. Question: How many standard glases do you drink a normal week? Answer with a self-percieved number, no fixed response options.', 'timeFrame': 'Baseline, within a month after the intervention, 1 year follow-up after baseline.'}\n- {'measure': 'Canadian Occupational Performance Measurement (COPM)', 'description': 'COPM is a client-centered, semi-structured interview assessment that enables the person to identify and prioritize areas of improvement in everyday life. To support goal-setting, defined areas is scored between 0-10 guiding prioritizations of areas of which is scored in regards to performance and satisfaction, also scored between 0-10. Where a higher value is better experience of performance and satisfaction of occupations. Mean change will be measured.', 'timeFrame': 'Baseline, within a month after the intervention, 1 year follow-up after baseline.'}\n\nPlease estimate the sample size based on the assumption: \nNo statistical power analyses have been calculated. A dropout rate of 20% is expected.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Sample size and power considerations\n This study is an explorative pilot and feasibility study; no statistical power analyses have been calculated. A total sample of 60 participants will be enrolled, of which 30 will be randomised to the intervention group. It is estimated that a total of four PHCs will participate and deliver the intervention (two from rural and urban Stockholm, and two from rural and urban G\u00c3\u00a4vleborg), each running an intervention group with 8\u00e2\u0080\u009310 participants. A dropout rate of 20% is expected, resulting in a total of n=26 in the intervention and control groups, respectively.", "id": 385, "split": "train"} +{"trial_id": "NCT03730974", "pmid": "32807208", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy and Appropriateness of Ball Blankets on Insomnia in Depression in Outpatient Clinics\n\nIncluded conditions:\n- Insomnia Due to Mental Disorder\n\nStudy Armgroups:\n- {'label': 'Experimental arm AB (Ball blanket + TAU)', 'type': 'EXPERIMENTAL', 'description': 'Participants will be randomized into either sequence AB or BA each lasting four weeks.\\n\\nPatients that are randomized to the AB sequence receive intervention A (Protac Ball BlanketTM 7 kg Flexible) in the first two weeks and treatment B treatment as usual (TAU) in the second period.', 'interventionNames': ['Device: Protac Ball BlanketTM (7kg Flexible)']}\n- {'label': 'Experimental arm BA (TAU + Ball blanket)', 'type': 'EXPERIMENTAL', 'description': 'Patients that are randomized to the BA sequence receive treatment B (TAU) in the first period and intervention A in the second period (Protac Ball BlanketTM 7kg Flexible).', 'interventionNames': ['Device: Protac Ball BlanketTM (7kg Flexible)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Protac Ball BlanketTM (7kg Flexible)', 'description': 'All patients will wear a MotionLogger Micro Watch from Ambulatory Monitoring Inc. NY in all four weeks during all 24hours of the day.', 'armGroupLabels': ['Experimental arm AB (Ball blanket + TAU)', 'Experimental arm BA (TAU + Ball blanket)'], 'otherNames': ['MotionLogger Micro Watch from Ambulatory Monitoring Inc. NY']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in total night time sleep (TST) measured by actigraphy (Micro MotionLogger Watch)', 'description': 'The investigators will detect the change in total night time sleep in minutes (actual sleep time, excluding sleep latency and wakes after sleep onset) by comparing the means of the difference in TST for each participant between period A and B or B and A', 'timeFrame': 'Four weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe power calculation assumes a paired t test with a significance level (alpha) of 0.05 and a power of 0.80. The differences in sleep duration are assumed to be normally distributed.", "answer": 45, "answer_type": "ESTIMATED", "explanation": "Sample size\n The power calculation is based on data from a pilot study (N\u00c2\u00a0=\u00e2\u0080\u00898) as we have not identified any studies investigating the effects of ball blankets on TST in depressed patients.\n The main outcome will be changes in total night-time sleep with and without PBB estimated by the means of the differences between the periods for each participant. The null hypothesis is that there is no change in sleep duration. In the pilot study, the mean sleep duration appeared normally distributed and the mean sleep duration without a ball blanket was 420\u00e2\u0080\u0089min. The standard deviation of the difference between the sleep duration with and without a ball blanket was 42\u00e2\u0080\u0089min. Based on the potential clinical gains, we aim to be able to detect a change in total sleep duration of 20\u00e2\u0080\u0089min. Assuming that the differences in sleep duration with and without a ball blanket is normally distributed, we performed power calculations for a paired t test, and with an alfa\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80 the minimum required sample size is N\u00c2\u00a0=\u00e2\u0080\u008937. To take into account dropout rates, we aim to include 45 patients.", "id": 386, "split": "train"} +{"trial_id": "NCT03733197", "pmid": "31345981", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Developing a Barbershop-Based Trial on Masculinity Barriers to Care and Colorectal Cancer Screening Uptake Among African-American Men Using a Mixed Methods Approach\n\nIncluded conditions:\n- Colorectal Cancer\n\nStudy Armgroups:\n- {'label': 'Culture specific', 'type': 'EXPERIMENTAL', 'description': 'The culture-specific arm \"may\" entail FIT kits plus barbers as motivational interviewers.', 'interventionNames': ['Behavioral: Culture Specific']}\n- {'label': 'Control', 'type': 'EXPERIMENTAL', 'description': 'Distribution of CRC screening brochures \\\\& FIT (Fecal Immunochemical Test) kits by barbers', 'interventionNames': ['Behavioral: Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Culture Specific', 'description': 'We anticipate the culture-specific arm developed minimally will include two core components: barbers as motivational interviewers, and (2) fecal immunochemical test (FIT) kits distributed by barbers. If we choose this route for the culture-specific arm, preliminary data from our barbers suggest I teach the barbers the MI technique using content that stems from Aim 1 findings. Additional components for this arm may be developed during the APEASE process.', 'armGroupLabels': ['Culture specific']}\n- {'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'the (control) arm will include an informational CRC screening brochure developed by the American Cancer Society plus a FIT kit distributed by the barbers.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Scale development', 'description': 'Develop, validate, and test a culture-specific measure of masculinity barriers to medical care relative to psychosocial factors and CRC screening uptake among African-American men', 'timeFrame': 'Year 1-2'}\n\nPlease estimate the sample size based on the assumption: \n80% power at the 0.05 significance level, with an average screening rate of 35%. The relationship between the masculinity barriers to care index and confounders is assumed to be moderately strong (R2=0.25). If R2=0.2, power is 82%, and if R2=0.1, power is 87%.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size and power considerations\n With a sample of 400 African-American men, we will have 80% power at the 0.05 level to detect a masculinity barriers to care effect on the odds of having had CRCS, assuming 35% of men with a masculinity barriers to care index equal to the mean have had CRCS compared with 25% of men with a masculinity barriers to care index 1 SD above the mean. We estimate that the average screening rate will be 35%, as the screening rate for African\u00c2\u00a0Americans is 53.1% in Utah and 52% in Minnesota and African-American men in both states tend to have lower CRCS rates than women.4 6 12 45 This assumes a moderately strong relationship between the masculinity barriers to care index and confounders (ie, R2=0.25 for the linear model that regresses the masculinity barriers to care index on the confounders). If the relationship between the confounders and the masculinity index is weaker, the power will be higher: 82% power with R2=0.2% and 87% power with R2=0.1. Power calculations were performed using PASS V.15.", "id": 387, "split": "train"} +{"trial_id": "NCT03733197", "pmid": "31345981", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Developing a Barbershop-Based Trial on Masculinity Barriers to Care and Colorectal Cancer Screening Uptake Among African-American Men Using a Mixed Methods Approach\n\nIncluded conditions:\n- Colorectal Cancer\n\nStudy Armgroups:\n- {'label': 'Culture specific', 'type': 'EXPERIMENTAL', 'description': 'The culture-specific arm \"may\" entail FIT kits plus barbers as motivational interviewers.', 'interventionNames': ['Behavioral: Culture Specific']}\n- {'label': 'Control', 'type': 'EXPERIMENTAL', 'description': 'Distribution of CRC screening brochures \\\\& FIT (Fecal Immunochemical Test) kits by barbers', 'interventionNames': ['Behavioral: Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Culture Specific', 'description': 'We anticipate the culture-specific arm developed minimally will include two core components: barbers as motivational interviewers, and (2) fecal immunochemical test (FIT) kits distributed by barbers. If we choose this route for the culture-specific arm, preliminary data from our barbers suggest I teach the barbers the MI technique using content that stems from Aim 1 findings. Additional components for this arm may be developed during the APEASE process.', 'armGroupLabels': ['Culture specific']}\n- {'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'the (control) arm will include an informational CRC screening brochure developed by the American Cancer Society plus a FIT kit distributed by the barbers.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Scale development', 'description': 'Develop, validate, and test a culture-specific measure of masculinity barriers to medical care relative to psychosocial factors and CRC screening uptake among African-American men', 'timeFrame': 'Year 1-2'}\n\nPlease estimate the sample size based on the assumption: \n80% power at the 0.05 significance level, with an average screening rate of 35%. The relationship between the masculinity barriers to care index and confounders is assumed to be moderately strong (R2=0.25). If R2=0.2, power is 82%, and if R2=0.1, power is 87%.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n The intraclass correlation coefficient will be estimated from our study data and inflated (due to the expected downward bias) to estimate the necessary sample size for the full trial.80", "id": 388, "split": "train"} +{"trial_id": "NCT03734367", "pmid": "31462466", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intervention in Emotional Intelligence in Adolescents With Type 1 Diabetes Mellitus\n\nIncluded conditions:\n- Type1 Diabetes Mellitus\n\nStudy Armgroups:\n- {'label': 'Emotional abilities training program', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention program on emotional abilities that will be carried out for 10 hours distributed over 5 weeks, in two and a half hour session. The work methodology will be eminently practical, working in groups including real case analysis and interactive simulation', 'interventionNames': ['Behavioral: Emotional abilities training program']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Control group that will not receive the training program on emotional abilities but usual care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Emotional abilities training program', 'description': 'A randomized controlled trial that evaluates the effectiveness of a program of emotional skills on metabolic control to be assessed through the glycosylated hemoglobin (HbA1c), healthy lifestyle habits and wellbeing in adolescents with type 1, Diabetes Mellitus', 'armGroupLabels': ['Emotional abilities training program']}\n\nPrimary Outcomes:\n- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to a greater emotional regulation', 'description': 'Participants will be asked to complete a battery of psychological questionnaires\\n\\n-Difficulties in Emotion Regulation Scale (DERS) This is a 28-item, self-report questionnaire measuring clinically relevant difficulties in emotion regulation. In the Spanish adaptation, the items are grouped into five subscales: impulse control difficulties, non-acceptance of emotional response, difficulties engaging in goal-directed behavior, lack of emotional awareness and lack of emotional clarity. Subscales are scored on a 5-point scale ranging from 1 (never) to 5 (always). Higher scores indicate greater difficulty with emotion regulation. This scale has been shown to have adequate psychometric properties.', 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}\n- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to less stress levels', 'description': \"Participants will be asked to complete a battery of psychological questionnaires\\n\\n-The Diabetes Distress Scale (DDS-17). It assesses the emotional distress associated with diabetes and it includes four dimensions: emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal distress. Higher scores indicate greater stress related to disease. This scale has been shown to have adequate internal consistency and validity. Cronbach's alpha ranged from 0.88 to 0.93\", 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}\n- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to a greater positive affect', 'description': \"Participants will be asked to complete a battery of psychological questionnaires\\n\\n-Positive and Negative Affect Schedule (PANAS). It is a self-reported adjective checklist that contains two 20-item subscales designed for the assessment of positive and negative affect. Respondents use a 5-point Likert scale to rate the extent to which they usually feel each of 20 emotion-related words. Reliability and validity reported by Watson and colleagues was moderately good. Cronbach's alpha ranged from 0.87 to 0.90.\", 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}\n- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to an increase in healthy life habits', 'description': 'Participants will be asked to complete a battery of psychological questionnaires\\n\\n-eVITAL toolkit8. Adaptation of the Macrodomain Diet and Exercise 4.1 Domain diet and nutrition and 4.2. Domain exercise eVITAL toolkit for measuring healthy habits in diabetes.', 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}\n- {'measure': 'Change in emotional skills of adolescents with type 1 diabetes related to a greater perception of quality of life', 'description': 'Participants will be asked to complete a battery of psychological questionnaires\\n\\n-The PedsQL 4.0 Generic Core Scales. The 23-item PedsQL 4.0 Generic Core Scales comprise four multi-item scales that explore dimensions of health-related quality of life: 1) physical functioning (8 items), 2) emotional functioning (5 items), 3) social functioning (5 items), and 4) school functioning (5 items). Respondents use a 5-point Likert scale. Higher scores indicate greater quality of life.', 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}\n- {'measure': 'Change in the emotional skills of adolescents with type 1 diabetes that will be related to a glycosylated index between normal values', 'description': 'Metabolic variables will be assessed using a flash glucose monitoring (FGM) device.\\n\\nGlycemic control. Participants report their HbA1c level from their last blood test. The American Diabetes Association recommends a target HbA1c of 7.5% for children and adolescents. Moreover, mean glucose, standard deviation, percentage of glucose in normoglycemia (time in range, according to individualized target), percent of time in hypoglycemia (below 70) and percent of time in hyperglycemia (according to an individualized target), and number of hypoglycemic episodes will be collected. Variables will be analyzed from the last 15 days prior to evaluation. Metabolic variables will be obtained using a flash glucose monitoring (FMG) device (Free Style Libre) as it has become the standard glucose monitoring system in the Andalusian Public Health System for the pediatric population. For non-FMG users, metabolic variables will be obtained by glucometers through their specific software.', 'timeFrame': 'Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, mean (SD) HbA1c of 8.84% (1.39) in adolescents aged 11-16 years diagnosed within the previous 12 months.", "answer": 62, "answer_type": "ESTIMATED", "explanation": "Sample size\n Thirty-one participants will be needed per group (n=62) to achieve an 80% probability of detecting a 1% (11 mmol/mol) difference in mean HbA1c between the two groups with a 5% significance in adolescents who initially have HbA1c above a high range of 8%\u00e2\u0080\u00938.5%.29 In adolescents with reduced HbA1c (less than 8%), the goal will be combined taking into account the reduction of HbA1c and the reduction of the hypoglycaemic rate.\n For the evaluation of hypoglycaemia, the aim is to reduce the number of episodes of hypoglycaemia (<70\u00e2\u0080\u0089mg/dL) by 20% and/or to obtain a number of hypoglycaemia less than four episodes per week, ensuring the evaluation of records of six capillary glycaemia a day. The estimation for the sample size is based on a mean (SD) HbA1c of 8.84% (1.39) (73.1\u00c2\u00b115.3\u00e2\u0080\u0089mmol/mol) in adolescents 11\u00e2\u0080\u009316 years of age diagnosed within the previous 12 months.", "id": 389, "split": "train"} +{"trial_id": "NCT03735381", "pmid": "32912184", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efecto de Caminar en La prevenci\u00f3n de aparici\u00f3n de Insomnio en el Tercer Trimestre de la gestaci\u00f3n. Ensayo de Campo Controlado y Aleatorizado\n\nIncluded conditions:\n- Insomnia\n\nStudy Armgroups:\n- {'label': 'Intervention 1: pedometer', 'type': 'ACTIVE_COMPARATOR', 'description': 'Minimum intervention:\\n\\n1. Use of pedometer watch from 12 to 32 GW\\n2. Recommendations of physical activity', 'interventionNames': [\"Device: Pedometer watch 'Xiomi mi band2'\"]}\n- {'label': 'Intervention 2: pedometer+goal+reminds', 'type': 'EXPERIMENTAL', 'description': 'Maximum intervention:\\n\\n1. Use of pedometer from 12 to 32 GW\\n2. Recommendations of physical activity\\n3. Information about get a goal of 11000 steps/day\\n4. Reminds the goal every two weeks.', 'interventionNames': [\"Device: Pedometer watch 'Xiomi mi band2'\"]}\n- {'label': 'Control: without pedometer', 'type': 'NO_INTERVENTION', 'description': 'Women receive some recommendations of physical activity during pregnancy. They do not use the pedometer during pregnancy'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': \"Pedometer watch 'Xiomi mi band2'\", 'description': '1. They receive information on the use of the pedometer.\\n2. Carry the pedometer (Xiaomi Mi Band 2 \u2122) from 12 to 32GW.\\n3. Prescription of benefits of walking in pregnancy:\\n\\n * Receive information about the goal of steps / day to be reached: 10,000-11,000 steps / day (Only the intervention 2 group).\\n * Receive information on the adequacy of walking with moderate intensity.\\n4. They will receive messages on the mobile phone remembering the goal to achieve and a notification that the researching staff will proceed to collect the average count of steps / day of the week prior to 20 and 32 gestation weeks (only for the intervention 2 group).', 'armGroupLabels': ['Intervention 1: pedometer', 'Intervention 2: pedometer+goal+reminds']}\n\nPrimary Outcomes:\n- {'measure': 'Prevalence of Insomnia in third trimester of pregnancy in the three arms with the Insomnia Athens Scale', 'description': 'Insomnia Athens Scale (IAS): An eight-item scale that assesses the quantity and quality of sleep (first five items) and the diurnal repercussion of insomnia (daytime sleepiness, physical and mental functioning and well-being during the day). Each of the items scores from 0 to 3 (affectation of the item from light to severe). The total score ranges from 0 to 24 points, considering insomnia from a score equal to or greater than 6 points (S = 93% and E = 85%) or equal to or greater than 7 points (S = 84% and E = 90%).', 'timeFrame': '32 Gestational Week (GW)'}\n- {'measure': 'Change in mean steps/day after intervention in the arms using pedometer', 'description': 'Pedometer register', 'timeFrame': '19 Gestational Week (GW) and 32 GW'}\n\nPlease estimate the sample size based on the assumption: \nAlpha error: 5%; Power: 80%; Estimated 20-30% dropout rate.", "answer": 265, "answer_type": "ESTIMATED", "explanation": "Sample size\n First, we have carried out the theoretical calculation of the sample size for the definitive study (n\u00e2\u0080\u0089=\u00e2\u0080\u0089265), based on the following premises: 1) Three study arms: maximum intervention group, pedometer + goal + recall (I1): minimum absolute reduction in the prevalence of low compliance with recommendations that are statistically significant to be detected, that it is 15% with respect to I1; minimum intervention group, pedometer (I2): minimum absolute reduction in the prevalence of low compliance with recommendations that are statistically significant to be detected, that is 30% with respect to C; and control group (C), with an estimated prevalence of low compliance with physical activity recommendations of 50% [12, 13]. 2) Alpha error: 5%; 3) Power of the study: 80%; 4) Comparison of I1 vs I2: from the previous premises, 120 women would be needed in each arm; Comparison of I1 vs C: from the previous premises, and taking as reference the 120 women of the I1 arm required for the previous comparison, 25 women in the C arm would be required.\n A pilot of the previous design was carried out with 72 women not included in this study: 24 women in each arm of the study, interviewed twice (12th and 20th GW), during the months of February to May 2018. The recruitment period was 3\u00c2\u00a0months. To select a total of 265 women, 1\u00c2\u00a0year and 7\u00c2\u00a0months would be required (considering holiday periods and Covid-19). We estimate 20\u00e2\u0080\u009330% of losses in second and third interviews (due to neonatal loss or abandonment of the study).", "id": 390, "split": "train"} +{"trial_id": "NCT03739359", "pmid": "31239304", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Investigating the Role of Gas Flow in Transnasal Pulmonary Aerosol Delivery Via Nasal Cannula: A Double-blinded, Randomized Controlled Trial\n\nIncluded conditions:\n- COPD Asthma\n\nStudy Armgroups:\n- {'label': 'Gas flow 50 L/min', 'type': 'ACTIVE_COMPARATOR', 'description': 'In this group, nasal cannula gas flow will be set at 50 L/min.', 'interventionNames': ['Other: nasal cannula gas flow']}\n- {'label': 'GF:IF=1', 'type': 'EXPERIMENTAL', 'description': \"In this group, nasal cannula gas flow will be set at each individual patient's own inspiratory flow (GF:IF=1)\", 'interventionNames': ['Other: nasal cannula gas flow']}\n- {'label': 'GF:IF=0.5', 'type': 'EXPERIMENTAL', 'description': \"In this group, nasal cannula gas flow will be set at 50% of each individual patient's own inspiratory flow (GF:IF=0.5)\", 'interventionNames': ['Other: nasal cannula gas flow']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'nasal cannula gas flow', 'description': 'High flow nasal cannula (HFNC) is a relatively new oxygen device, which provides warmed and humidified oxygen for patients. When patients need to inhale aerosolized medication during HFNC, the nebulizer will be placed in-line in order to provide both treatments. This study will investigate the influence of three flow settings (50 L/min, GF:IF=1, GF:IF=0.5) on the clinical effects of nebulization.', 'armGroupLabels': ['GF:IF=0.5', 'GF:IF=1', 'Gas flow 50 L/min']}\n\nPrimary Outcomes:\n- {'measure': 'The number of patients who meet the positive criteria of responding to albuterol at the dose of 0.5mg', 'description': 'The number of patients in HFNC nebulization who respond to albuterol at the dose of 0.5mg', 'timeFrame': '30 minutes'}\n- {'measure': 'The number of patients who meet the positive criteria of responding to albuterol at the dose of 1.5 mg', 'description': 'The number of patients in HFNC nebulization who respond to albuterol at the dose of 1.5mg', 'timeFrame': '60 minutes'}\n- {'measure': 'The number of patients who meet the positive criteria of responding to albuterol at the dose of 3.5 mg', 'description': 'The number of patients in HFNC nebulization who respond to albuterol at the dose of 3.5mg', 'timeFrame': '90 minutes'}\n- {'measure': 'The number of patients who meet the positive criteria of responding to albuterol at the dose of 7.5mg', 'description': 'The number of patients in HFNC nebulization who respond to albuterol at the dose of 7.5mg', 'timeFrame': '120 minutes'}\n\nPlease estimate the sample size based on the assumption: \nConfidence level (\u03b1) of 95%, power (1\u2212\u03b2) of 80%, and margin (\u0394) of 0.2.", "answer": 75, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n This study is a superiority study. Since all the recruited subjects are responders to 400 \u00ce\u00bcg of bronchodilator via MDI+VHC\u00e2\u0080\u0089and the inhaled dose of MDI+VHC is reported to be approximately 20% of emitted dose (80 \u00ce\u00bcg).21 From our in vitro study, inhaled dose of bronchodilator via nasal cannula at GF:IF=0.5 was found to be approximately 20% of dose,16 compared with 3.5% with gas flow rate at 50\u00e2\u0080\u0089L/min.14 15 We hypothesise that a 20% inhaled dose of 0.5\u00e2\u0080\u0089mg in the group of GF:IF=0.5\u00e2\u0080\u0089would be 100 \u00ce\u00bcg, which is >80 \u00ce\u00bcg administered with MDI+VHC. In contrast, at 50\u00e2\u0080\u0089L/min with 3.5% lung dose an accumulative inhaled dose of 2.5\u00e2\u0080\u0089mg would provide an inhaled dose of 87.5 \u00ce\u00bcg. We hypothesise that almost all subjects in the GF:IF=0.5\u00e2\u0080\u0089group would respond to albuterol at the accumulative inhaled dose of 1.5\u00e2\u0080\u0089mg. To calculate the sample size, with confidence level (\u00ce\u00b1) of 95%, power (1\u00e2\u0088\u0092\u00ce\u00b2) of 80% and margin (\u00ce\u0094) of 0.2, we assumed 80% of GF: IF=0.5\u00e2\u0080\u0089group will respond to cumulative dose of 1.5\u00e2\u0080\u0089mg albuterol, compared with 40% 50\u00e2\u0080\u0089L/min group. The number of subjects in each group will be 25 and the total number of subjects will be 75.", "id": 391, "split": "train"} +{"trial_id": "NCT03747471", "pmid": "31286927", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Conversation Map on Diabetes Management Self-efficacy and Diabetic Distress Among Type 2DM Patient in Pakistan: A Randomized Controlled Trial\n\nIncluded conditions:\n- Diabetes Mellitus\n- Diabetes\n- Self Efficacy\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'Experimental Arm', 'type': 'EXPERIMENTAL', 'description': 'Intervention: Diabetic Conversation Map x 4 Sessions', 'interventionNames': ['Behavioral: Diabetic Conversation Map']}\n- {'label': 'Control Arm', 'type': 'NO_INTERVENTION', 'description': 'No intervention'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Diabetic Conversation Map', 'description': 'Diabetic Conversation Map education tools are a series of tools for facilitated group education 5-8that were developed by Healthy Interactions in collaboration with the International Diabetes Federation (IDF) and are sponsored by Lilly Diabetes.\\n\\nCM-based education guides people with diabetes through a process with the aim of helping them understand and internalize information about their disease and generate insightful conclusions, which may then result in improved self-management decisions and actions.', 'armGroupLabels': ['Experimental Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline Diabetes Management Self-Efficacy (DMSE) at 3 months:', 'description': 'The change in DMSE will be measured using validated DMSE scale. The scale has 20 items comprised of 4 domains; 1) nutrition specific and weight, 2) medical treatment, 3) physical exercise, 4) blood sugar. Each item is scored on 11 point likert scale (0=completely unable to 10=completely able). Possible score ranges from 0 to 200, with higher score representing higher self-efficacy.', 'timeFrame': 'at baseline and after 3 months of enrollment'}\n- {'measure': 'Change from baseline Diabetes distress (DD) 3 months:', 'description': 'The change in DD will be screened using validated DD scale. The scale has two parts; part 1 is consisting of two items asking about feelings of overburden due to demands of living with diabetes and feelings of failure with diabetes routine; the aim of part 1 is to screen for the presence of DD. Part 1 will be administered before the enrollment of the patient to screen for the presence of DD. If DD is present, part 2 will begin consisting of 17 items to score the extent of DD. Each item is scored on a likert scale ranging from 1 (not a problem) to 6 (a very serious problem). According to the instructions of DDS scoring sheet, total DDS will be measured with mean score while dividing the sum of all items by 17.The mean score of \u22653 will be the threshold for being distressed.', 'timeFrame': 'baseline and 3 months of enrollment'}\n\nPlease estimate the sample size based on the assumption: \nConsidering 95% confidence interval, 80% power of the test, and accounting for attrition rate.", "answer": 120, "answer_type": "ACTUAL", "explanation": "Sample size\n A study from China [17] reported mean DD score of control and intervention group at baseline as 32.77\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008914.57 and 26.08\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00899.92 respectively (p value 0.073). After six months of the intervention the respective scores were 30.09\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008912.14 and 22.79\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00894.95 (p value 0.014). Aiming for a higher average difference of the differences (difference of 7.30) as compared to the study from china (0.62) between the intervention and control arm (which is also clinically significant), considering 95% confidence interval and 80% power of the test to detect the given difference, the minimum sample size to achieve the objective of this study will be 88 (44 in each group). After adding attrition rate, a total of 120 subjects i.e. 60 in RC arm and 60 in DCM arm will be enrolled in this study.", "id": 392, "split": "train"} +{"trial_id": "NCT03749070", "pmid": "36899430", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Silymarin in Patients With Non-alcoholic Fatty Liver Disease - The SILIVER Trial: Randomized Clinical Trial\n\nIncluded conditions:\n- Non-Alcoholic Fatty Liver Disease\n\nStudy Armgroups:\n- {'label': 'Silymarin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive 2 capsules containing a total of 700mg of silymarin, 8mg of vitamin E and 50mg of phosphatidylcholine, in addition to the excipient, which should be ingested daily for 12 weeks.', 'interventionNames': ['Dietary Supplement: Silymarin']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients will also receive similarly 2 capsules per day, but without the bioactive principle tested (silymarin). Therefore, the capsules in the control group will contain only 700 mg of maltodextrin, a neutral food component derived from starch, in addition to the excipient and the same amount of vitamin E and phosphatidylcholine to balance the two groups.', 'interventionNames': ['Dietary Supplement: Silymarin']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Silymarin', 'description': 'It is a randomized, double-blind, controlled clinical trial to be performed at outpatient level. The intervention will last 12 weeks and the invited participants will be patients attended at the outpatient clinic of the Edgard Santos Hospital, which will be randomized into two groups: control and intervention. Data on laboratory and clinical markers, imaging, nutritional and dietary assessment will be collected at the beginning and end of the trial for comparison purposes.', 'armGroupLabels': ['Placebo', 'Silymarin']}\n\nPrimary Outcomes:\n- {'measure': 'Absence or change in NAFLD degree', 'description': 'Absence or change in NAFLD degree, assessed by the value of the difference in the attenuation coefficient between liver and spleen obtained by computed tomography of the upper abdomen performed at the beginning and at the end of the study.', 'timeFrame': 'They will be dosed at baseline and after 12 weeks of intervention.'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 0.05 and a power of 80% were adopted.", "answer": 132, "answer_type": "ESTIMATED", "explanation": "Sample Size {14}\n The sample size was determined through an accuracy analysis of the primary outcome. A significance level of 0.05 and a power of 80% were adopted, which resulted in a minimum sample size of approximately 132 participants.", "id": 393, "split": "train"} +{"trial_id": "NCT03750448", "pmid": "34316356", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Does Rehabilitation After Total Hip and Knee Arthroplasty Work: A Pragmatic, Randomised, Controlled, Superiority Trial (The DRAW1 Trial)\n\nIncluded conditions:\n- Arthroplasty, Replacement, Knee\n- Arthroplasty, Replacement, Hip\n- Telerehabilitation\n- Rehabilitation\n\nStudy Armgroups:\n- {'label': 'Telerehabilitation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to this group will receive interactive virtual rehabilitation using a mobile app. The telerehabilitation is based on sensor technology, developed by ICURA. This technology consists of motion sensors that can measure and analyse the quantity and quality of the exercises, and a mobile application that can guide the patient with visual response. A unique feature of ICURA trainer allows the physiotherapist to remotely supervise the individual patients exercise adherence and progress. This technology has already been successfully implemented in several different rehabilitation facilities across Denmark, and, hence, reflects current clinical practice.', 'interventionNames': ['Other: Telerehabilitation']}\n- {'label': 'No intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group of randomised patients will not be given any physical rehabilitation intervention. This means no physical activity or exercise designed and prescribed for restoring normal function or reducing pain cause by disease, injury or surgery. The no intervention group will be encouraged to stay active and continue life as usual, gradually returning to their activities of daily living when they feel ready for it.', 'interventionNames': ['Other: No intervention']}\n- {'label': 'Unsupervised rehabilitation', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will be instructed in similar exercises as patients allocated to telerehabilitation. However, this group will receive a written exercise-program with instructions to perform these exercises at home. The home-based exercise program will be created using exercise templates from Exorlive. Using a link provided in the exercise-program, the patients will be able to see short instruction-videos of the individual exercises.', 'interventionNames': ['Other: Unsupervised rehabilitation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Telerehabilitation', 'description': 'The telerehabilitation intervention is based on sensor technology, developed by ICURA. The technology consists of motion sensors that can measure and analyse the quantity and quality of the exercises, and a mobile application that can guide the patients with visual response. A unique feature of ICURA trainer allows the physiotherapist to remotely supervise the individual patients exercise adherence and progress. The patients will receive a suitcase with five sensors (to be placed bilaterally on lower legs, thighs and one around the waist), a smartphone to record the exercises and a charging station free of charge during the 6-week intervention. At the end of the intervention the material will be returned at the first follow-up (t1). For more information please visit https://icura.dk.', 'armGroupLabels': ['Telerehabilitation']}\n- {'type': 'OTHER', 'name': 'No intervention', 'description': 'Patients allocated to the no intervention group will receive encouragement to stay active and be encouraged to gradually return to activities of daily living. This will be the only exercise-encouragement given to the no-intervention group.', 'armGroupLabels': ['No intervention']}\n- {'type': 'OTHER', 'name': 'Unsupervised rehabilitation', 'description': 'The unsupervised rehabilitation group will receive a written exercise program in order to perform daily exercises at home. The exercise program will be made using Exorlive (for more information about Exorlive please visit https://www.exorlive.com). In addition to the written program, patients will able to use a link provided to see small video-instructions on the internet of each exercise on the program. No feedback or supplementary instructions will be given after the initial face-to-face appointment.', 'armGroupLabels': ['Unsupervised rehabilitation']}\n\nPrimary Outcomes:\n- {'measure': \"For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: function in daily living (ADL).\", 'description': 'This subscale consists of 17 questions related to the patient\\'s function in activities of daily living such as \"descending stairs\", \"standing\" and \"getting in/out of car\". The subscale is scored by the degree of difficulty the patient experiences in the last week on a 5-point Likert scale (none, mild, moderate, severe, and extreme), and calculated to a score ranging from 0 (worst/extreme difficulties) to 100 (best/ no problems). The total questionnaire takes about 10 minutes to complete. At least 50% of the questionnaire items are required to be answered to permit calculation of a mean score.', 'timeFrame': 'Difference between groups at first follow up (6 weeks)'}\n- {'measure': \"For TKA's: Knee injury and Osteoarthritis Outcome Score (KOOS) subscale: function in daily living (ADL).\", 'description': 'This subscale consists of 17 questions related to the patient\\'s function in activities of daily living such as \"descending stairs\", \"standing\" and \"getting in/out of car\". The subscale is scored by the degree of difficulty the patient experiences in the last week on a 5-point Likert scale (none, mild, moderate, severe, and extreme), and calculated to a score ranging from 0 (worst/extreme difficulties) to 100 (best/ no problems). The total questionnaire takes about 10 minutes to complete. At least 50% of the questionnaire items are required to be answered to permit calculation of a mean score.', 'timeFrame': 'Difference between groups at first follow up (6 weeks)'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.80, a significance level of 0.05, and a 10% loss to follow-up rate. For the comparison of any physical rehabilitation to no physical rehabilitation, the expected power is 0.89.", "answer": 168, "answer_type": "ACTUAL", "explanation": "Sample size\n A clinically important difference of 10 points on the HOOS/KOOS subscale function in daily living (ADL)\n36,\n45 is used as our superiority margin, with an expected standard deviation of 20 points, a power of 0.80 and a significance level of 0.05 resulting in a sample size of 50 patients in each group. With 10% loss to follow up\n46 this results in 56 patients in each group. This calculation will be used for each comparison of individual physical rehabilitations to no physical rehabilitation; therefore, 56 patients are needed for each of the three groups resulting in 168 patients included in total (3 groups of 56 patients). Comparison of any physical rehabilitation to no physical rehabilitation is done under the same clinically important difference and expected standard deviation as the individual comparisons. With a sample size of 100 (patients receiving one of the two physical rehabilitation strategies) and 50 (patients receiving no physical rehabilitation) the expected power is 0.89.\n We expect a relatively low inclusion rate of 50%, since one of the interventions includes \u00e2\u0080\u009cno physical rehabilitation\u00e2\u0080\u009d, compared to standard rehabilitation. Furthermore, based on the expected patient flow at our trial sites and the need to conduct the trial within a realistic timeframe, we do not initially intend to stratify THA and TKA for subgroup analysis. There will not be any specific strategies for increasing participant enrolment related to this trial.", "id": 394, "split": "train"} +{"trial_id": "NCT03751306", "pmid": "31232920", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sensory-Motor and Cardiorespiratory Rehabilitation Associated With Transcranial Laser Therapy in Patients With Central Nervous System Injury\n\nIncluded conditions:\n- Post Stroke\n- Post-Traumatic Headache\n- Spinal Injuries\n- Cerebral Palsy, Spastic\n- Surgery\n- Sclerosis, Multiple\n- Spastic\n\nStudy Armgroups:\n- {'label': 'Control-Cardiorespiratory Rehabilitation', 'type': 'ACTIVE_COMPARATOR', 'description': 'These individuals will compose the control group for transcranial laser therapy, which will only receive cardiorespiratory rehabilitation.', 'interventionNames': ['Procedure: Cardiorespiratory Rehabilitation']}\n- {'label': 'Transcranial Photobiomodulation Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'In this group, the application of laser irradiation will be simulated, and the laser will be turned off. And the simulation of irradiation, the individuals will initiate cardiorespiratory rehabilitation.', 'interventionNames': ['Procedure: Transcranial Photobiomodulation (Placebo)', 'Procedure: Cardiorespiratory Rehabilitation']}\n- {'label': 'Transcranial Photobiomodulation', 'type': 'EXPERIMENTAL', 'description': 'In this group, low-intensity irradiation will be applied and after irradiation, the volunteers will begin cardiorespiratory rehabilitation.', 'interventionNames': ['Procedure: Transcranial Photobiomodulation', 'Procedure: Cardiorespiratory Rehabilitation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Transcranial Photobiomodulation', 'description': 'Photobiomodulation Rehabilitation:\\n\\nDiode laser, \u03bb infrared = 810 nm, 0.028 cm2 beam area, 100 mW power, 3.5 W / cm2 power density, 3 Joules / dot and Energy Density of 107.1 J / cm2). Each point will be radiated for 30 seconds. The regions of irradiation will be in the middle cerebral arteries (points F7 and F8 will be used as reference point according to the International System 10-20 of the electroencephalogram) and anterior cerebral artery (AFz point according to the International System 10-20 of the electroencephalogram) .', 'armGroupLabels': ['Transcranial Photobiomodulation']}\n- {'type': 'PROCEDURE', 'name': 'Transcranial Photobiomodulation (Placebo)', 'description': 'Photobiomodulation Placebo Therapy:\\n\\nThe same apparatus of the transcranial group photobiomodulation and the same irradiation points will be used. However, during the procedure, with the laser off.', 'armGroupLabels': ['Transcranial Photobiomodulation Placebo']}\n- {'type': 'PROCEDURE', 'name': 'Cardiorespiratory Rehabilitation', 'description': 'Cardiorespiratory Rehabilitation:\\n\\nAerobic training on the treadmill will be reliated for 30 minutes using the support of the Rehabilitation and Physical Activity Station BrainMov\u00ae (equipment with 4 pillars condition that favors the suspension and stabilization of people with neuromuscular dysfunctions of mild to severe impairment. For monitoring, the training heart rate equation - Karvonen equation, effort perception scale - BORG, systemic arterial pressure, peripheral oxygen saturation, and patient signs and symptoms will be used. Subsequently, respiratory exercises and muscle strengthening of lower limbs, final relaxation and general guidelines will be performed for research volunteer and his / her relatives.', 'armGroupLabels': ['Control-Cardiorespiratory Rehabilitation', 'Transcranial Photobiomodulation', 'Transcranial Photobiomodulation Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Muscular electrical activity (Surface electromyograph).', 'description': 'The surface electrodes will be positioned in the rectus femoris and femoral biceps muscles. The evaluation of the muscles will be realized during the squat movement. 10 seconds of signal collection (in triplicate).', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in analysis of bipodal balance during the squat movement.', 'description': 'The balance evaluation will be performed during the squat movement on the power platform (Stabilometric analysis in Kgf). 10 seconds of signal collection (in triplicate).', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in analysis of the heart rate variability to study the responses of the autonomic nervous system', 'description': 'Heart rate variability will be assessed during aerobic training on the treadmill for 40 minutes (5 minutes of initial rest, 30 minutes of exercise and 5 minutes of final rest).', 'timeFrame': 'Baseline (First day of rehabilitation) and after 9 weeks (Last day of rehabilitation).'}\n- {'measure': 'Change in Pulmonary function analysis (spirometry): forced vital capacity', 'description': 'Using the spirometry technique, forced vital capacity (measured in liters) will be evaluated. The volunteer will be asked to perform the maximum inspiration and exhale with maximum effort.', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in Pulmonary function analysis (spirometry): forced expiratory volume in the first second', 'description': 'Using the spirometry technique, forced expiratory volume in the first second (measured in liters) will be evaluated. The volume of exhaled air in the first second in the forced vital capacity maneuver will be evaluated.', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in Pulmonary function analysis (spirometry): Tiffeneau Index', 'description': 'Using the spirometry technique, Tiffeneau Index will be evaluated. The Tiffeneau index is the result of the division of forced expiratory volume in the first second in relation to forced vital capacity.', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in Pulmonary function analysis (spirometry): maximum voluntary ventilation', 'description': 'Using the spirometry technique, maximum voluntary ventilation will be evaluated. Maximum voluntary ventilation is the largest volume of air that the individual can mobilize in one minute with maximum voluntary effort. The test gives an overview of the ventilatory function (measured in L / min).', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in analysis of inspiratory muscle strength', 'description': 'The inspiratory muscle strength will be evaluated by means of the manovacuometer.', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Analysis of expiratory muscle strength', 'description': 'The expiratory muscle strength will be evaluated by means of the manovacuometer', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in analysis of Peak expiratory flow.', 'description': 'To analyze the velocity of the air out of the lungs.', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in analysis of the thoracic expandability (axillary level).', 'description': 'In order to analyze the chest expansion at the axillary level, a metric tape placed at the torarico-axillary level will be used, which will measure the inspiratory and expiration mobility values, and will be subtracted (Insp-Exp).', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in analysis of the thoracic expandability (xiphoid level).', 'description': 'In order to analyze the chest expansion at the xiphoid level, a metric tape will be used, placed at the thoracic-xiphoid level, which will measure the inspiratory and expiration mobility values and then be subtracted (Insp-Exp).', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in analysis of abdominal level expandability.', 'description': 'In order to analyze abdominal expansibility, a tape measure will be used, placed at the level of the umbilical scar, which will measure the inspiratory and expiration mobility values and will be subtracted (Insp-Exp).', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in analysis of change in Infrared Thermography.', 'description': 'By means of an infrared thermographic camera, the blood circulation of the lower limbs will be evaluated by the temperature difference.', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in aariation of blood lactate level.', 'description': \"The blood lactate level will be measured by a lactometer, which will be collected from the volunteer's blood sample before starting the aerobic training on the treadmill and after training.\", 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in 6-Minute Walk Test (Adapted)', 'description': 'The 6-minute-walk test will be adapted for neurological patients, which will be evaluated for exercise tolerance using a treadmill (Moviment RT200\u00ae). Volunteers will be assisted by the BrainMov\u00ae Rehabilitation and Physical Activity Station to stabilize the trunk and thus remain upright to wander on the treadmill', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in Mini-Mental State Examination (MINI MENTAL).', 'description': 'To evaluate the cognitive functions, the MINI MENTAL test will be applied.', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 weeks.'}\n- {'measure': 'Change in Short Form 36 questionnaire (SF-36)', 'description': 'To evaluate the domains of quality of life: Functional Capacity, physical aspect, pain, general health, vitality, social aspect, emotional spectrum and mental health', 'timeFrame': 'Baseline (before starting rehabilitation) and after 9 week.'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "2.4\n Groups e sample size\n The present trial will include 90 patients who will be divided randomly into 3 experimental groups:\n \n \n (1)\n Control group (CCR): (n\u00e2\u0080\u008a=\u00e2\u0080\u008a30) These individuals will receive only cardiorespiratory rehabilitation; therefore, no PBM Therapy will be applied, either real or placebo.\n \n \n (2)\n Transcranial Photobiomodulation Group (CR-PBM): (n\u00e2\u0080\u008a=\u00e2\u0080\u008a30) Individuals in this group will receive PBM Therapy followed by cardiorespiratory rehabilitation.\n \n \n (3)\n Placebo Group Photobiomodulation (CR-PlaceboPBM): (n\u00e2\u0080\u008a=\u00e2\u0080\u008a30) Individuals in this group will receive placebo PBM Therapy; the device will not deliver therapeutic light. Subsequently, they will receive cardiorespiratory rehabilitation.\n \n \n All patients, after completing the trial, may receive PBM Therapy treatment. Thus, if there is any interest of a patient who did not receive the PBM Therapy during the trial, this will be provided after trial completion", "id": 395, "split": "train"} +{"trial_id": "NCT03758105", "pmid": "31937653", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.\n\nIncluded conditions:\n- Depression\n\nStudy Armgroups:\n- {'label': 'Usual care and tDCS (Arm A)', 'type': 'EXPERIMENTAL', 'description': 'Arm A patient receives a first tDCS treatment in association with usual care (medication, psychotherapy...). If the patient is responding to tDCS, he can have other tDCS treatments in case of relapse.', 'interventionNames': ['Other: tDCS associated with usual care']}\n- {'label': 'Usual care without tDCS (Arm B)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Arm B patient receives usual care: medication management and psychotherapy.', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'tDCS associated with usual care', 'description': 'A tDCS cure will be given to the group \"tDCS\", one week after their randomization.\\n\\nThis will be done in association with usual care: medication and psychotherapy Parameters: Anodal stimulation on dorso-lateral prefrontal cortex left, 2mA current.\\n\\nTreatment will consist of 15 days with 30 minutes stimulation per day, 5 days a week for 3 weeks.', 'armGroupLabels': ['Usual care and tDCS (Arm A)']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Medication and psychotherapy as prescribed in usual care', 'armGroupLabels': ['Usual care without tDCS (Arm B)']}\n\nPrimary Outcomes:\n- {'measure': 'Cost-utility ratio, according to collective perspective of tDCS use in depression compared to usual care without active tDCS.', 'description': 'The utility will be measured by :\\n\\nQuality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.\\n\\nThe costs will be measured by the addition of the following costs:\\n\\nDrugs dispensing via Health insurance database \"National system of information of the French health insurance\" (SNIIRAM), hospitalizations, work stoppages and care consumption collected in a declarative patient questionnaire.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n5% (two-tailed) type I error, 80% power, 10% attrition rate", "answer": 214, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n To our knowledge, no published study has evaluated the quality of life, healthcare resource consumption and costs associated with tDCS treatment for depression, meaning there is no precedent for establishing the number of subjects needed for our study with the formula by Glick.46 We therefore determined this number using a clinical efficacy criterion.\n We hypothesised tDCS-TAU response rate of 60% at M\n12\n14 47 and a TAU-only response rate of 40%.5 Assuming a 5% (two-tailed) type I error, a power of 80% and an attrition rate of 10%, a total of 214 subjects are required (107 subjects per arm) according to SAS software V.9.4.", "id": 396, "split": "train"} +{"trial_id": "NCT03763448", "pmid": "33099502", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty in Patients With Knee Osteoarthritis - A Multicenter Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Knee Osteoarthritis\n- Arthropathy of Knee\n\nStudy Armgroups:\n- {'label': 'Infrapatellar Fat Pad Preservation', 'type': 'EXPERIMENTAL', 'description': 'The IPFP retention of more than 80% in actual operation shall be regarded as IPFP retention.', 'interventionNames': ['Procedure: Infrapatellar Fat Pad preservation']}\n- {'label': 'Infrapatellar Fat Pad Resection', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the clinical practice, more than 80% of IPFP volume is commonly resected by surgeons during total knee arthroplasty. The investigators hereby define resection of more than 80% IPFP volume as IPFP excision.', 'interventionNames': ['Procedure: Infrapatellar Fat Pad resection']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Infrapatellar Fat Pad preservation', 'description': 'In the IPFP preservation group, IPFP (more than 80%) will be preserved by retracting out of the operative field.', 'armGroupLabels': ['Infrapatellar Fat Pad Preservation'], 'otherNames': ['Infrapatellar fat pad retention']}\n- {'type': 'PROCEDURE', 'name': 'Infrapatellar Fat Pad resection', 'description': 'In the IPFP resection group, more than 80% IPFP will be resected during the total knee arthroplasty.', 'armGroupLabels': ['Infrapatellar Fat Pad Resection']}\n\nPrimary Outcomes:\n- {'measure': 'The total score of Knee Injury and Osteoarthritis Outcome Score(KOOS)', 'description': 'The KOOS is a knee-specific patient-reported questionnaire with 42-items in five separately analysed subscales of pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.', 'timeFrame': 'From pre-operation to 12 months after operation'}\n- {'measure': 'The functional subscale score of Knee Injury and Osteoarthritis Outcome Score(KOOS)', 'description': 'KOOS functional subscale score including function in daily living and function in sport and recreation. Scores range from 0 (worst) to 100 (best).', 'timeFrame': 'From pre-operation to 12 months after operation'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, power (\u03b2) of 0.80, and a 10% dropout rate.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size and power calculation was based on the primary endpoints of KOOS daily activity function score and total score in the mean change from baseline to 12 months. All sample size calculations assume \u00ce\u00b1=0.05 and \u00ce\u00b2=0.20\u00e2\u0080\u0089and are performed using formulae provided by Cohen.36\n Based on the data collected in previous study,37 38 a between-subject SD of 14 on KOOS daily activity function score will be used and at least 15% improvement would be detected.39 40 To obtain a power of 80% at a significant level of \u00ce\u00b1=0.05, a total of 48 participants per group are needed. Assuming a 10% drop out rate, we will need to enrol approximately 54 participants per group to complete the study.\n Sample size calculation is also performed based on another primary outcome total KOOS score with a between-subject SD of 17,41 and eight points difference between groups would be detected according to the literature.42 A total of 82 participants per group are needed to obtain 80% power to detect a significant group effect using an \u00ce\u00b1 level of 0.05. Assuming a 10% drop out rate, 90 participants are needed in each group.\n Take into consideration of these two calculations, 90 participants in each arm will be sufficient to detect the differences of primary outcomes between groups. Because stratified analyses will be performed to compare clinical outcomes after IPFP preservation versus resection in patients with normal as well as abnormal IPFP qualities, in total 360 participants are needed.", "id": 397, "split": "train"} +{"trial_id": "NCT03769922", "pmid": "32085793", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease\n\nIncluded conditions:\n- Postoperative Surgical Recurrence\n\nStudy Armgroups:\n- {'label': 'Extensive mesenteric resection', 'type': 'EXPERIMENTAL', 'description': 'Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.', 'interventionNames': ['Procedure: Extensive mesenteric resection']}\n- {'label': 'Limited mesenteric excision', 'type': 'ACTIVE_COMPARATOR', 'description': 'Mesentery is retained, i.e. \"Close shave\" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).', 'interventionNames': ['Procedure: Limited mesenteric excision']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Extensive mesenteric resection', 'description': 'The mesentery is resected avoiding the root region.', 'armGroupLabels': ['Extensive mesenteric resection']}\n- {'type': 'PROCEDURE', 'name': 'Limited mesenteric excision', 'description': 'The mesentery is retained.', 'armGroupLabels': ['Limited mesenteric excision']}\n\nPrimary Outcomes:\n- {'measure': 'Accumulated 5-year postoperative surgical recurrence', 'description': \"The requirement for repeat surgery for a Crohn's disease related indication.\", 'timeFrame': '5 years after the first surgery'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, 10% loss to follow-up, 5% anastomotic leak", "answer": 116, "answer_type": "ESTIMATED", "explanation": "Sample size\n There are no registered or published randomized controlled trials (RCTs) comparing limited with extensive mesenteric resection in patients with CD. Our sample size calculation is based on the surgical recurrence in a retrospective study reported by Coffey et al. [9]. It is estimated that 30% of subjects undergoing an ileocolonic anastomosis with conventional limited mesenteric excision would develop surgical recurrence at 60\u00e2\u0080\u0089months after surgery. To detect a 20% decrease in the surgical recurrence rate after wide mesenteric excision with 80% power and 5% significance, a total of 100 patients must be recruited. The sample size is adjusted to 116 to allow for a 10% loss to follow-up and 5% anastomotic leak.", "id": 398, "split": "train"} +{"trial_id": "NCT03770390", "pmid": "37321811", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations\n\nIncluded conditions:\n- Funnel Chest\n\nStudy Armgroups:\n- {'label': 'The study population', 'type': 'OTHER', 'description': 'Patients included in this study have pectus excavatum. The have either already undergone corrective surgery during the four years prior to the inclusion period, or are scheduled for surgery during the inclusion period.\\n\\nIntervention: Surgical correction of pectus excavatum', 'interventionNames': ['Procedure: Surgical correction of pectus excavatum']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Surgical correction of pectus excavatum', 'description': 'Surgical correction of pectus excavatum', 'armGroupLabels': ['The study population']}\n\nPrimary Outcomes:\n- {'measure': 'Change in: Oxygen pulse (mL O2 / heart beat)', 'description': 'Recorded during incremental exercise testing.', 'timeFrame': 'post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error rate set at \u03b1=0.05 and power at 90% (type 2 error: \u03b2=0.10).", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to data collected in a previous study (NCT03086499), we are expecting a presurgical O2-pulse at around 13.2\u00c2\u00b13.4\u00e2\u0080\u0089mL O2/min. In order to detect a moderate effect size associated with surgical PE correction (ie, a Cohen\u00e2\u0080\u0099s effect size of d=0.5, corresponding to a postoperative change in O2 pulse of 1.5\u00c2\u00b13\u00e2\u0080\u0089mL O2/min) with a type 1 error rate set at \u00ce\u00b1=0.05\u00e2\u0080\u0089and power at 90% (type 2 error: \u00ce\u00b2=0.10), 44 data points would be required. In order to allow for a large loss to follow-up (this rather young population can be hard to follow), we propose including 70\u00e2\u0080\u0089patients.\n \n Logistics\n The practical deployment of this study is based on the routine pathways of patients coming in for postsurgical check-ups (historical prospective cases) or for presurgical assessments (prospective cases). To this end, upcoming consultation lists within the department were systematically screened for potential candidates. All consecutive patients were targeted to avoid recruitment bias. Candidates were proposed study participation and appropriate consent procedures during their next consult. An overview of the study visits and associated assessments is presented in table 3.\n \n Table 3\n \n The visits and assessments occurring during the HeartSoar study\n \n \n \n \n Visit:\n Preoperative consult\n Surgery\n Postoperative follow-up\n \n \n \n \n Timeframe\n \u00e2\u0088\u00924 to \u00e2\u0088\u00921\u00e2\u0080\u0089months\n Day 0\n A single visit at 12, 24, 36 or 48\u00e2\u0080\u0089months (\u00c2\u00b13\u00e2\u0080\u0089months)\n \n \n Historical-prospective inclusions\n \n \n \u00e2\u0080\u0083Verification of eligibility criteria\n \n \n \u00e2\u009a\u00ab\n \n \n \u00e2\u0080\u0083Consent procedures\n \n \n \u00e2\u009a\u00ab\n \n \n Prospective inclusion with a single visit at 12\u00e2\u0080\u0089months\n \n \n \u00e2\u0080\u0083Verification of eligibility criteria\n \u00e2\u009a\u00ab\n \n \n \n \n \u00e2\u0080\u0083Consent procedures\n \u00e2\u009a\u00ab\n \n \n \n \n Intervention evaluated via the before-after design\n \n \n \u00e2\u0080\u0083Surgical correction of pectus excavatum\n \n \u00e2\u009a\u00ab*\n \n \n \n Assessments/data recording\n \n \n \u00e2\u0080\u0083Baseline data recording\n \u00e2\u009a\u00ab*\n \n \n \n \n \u00e2\u0080\u0083Incremental exercise testing\n \u00e2\u009a\u00ab*\n \n \u00e2\u009a\u00ab\n \n \n \u00e2\u0080\u0083Lung volumes and function\n \u00e2\u009a\u00ab*\n \n \u00e2\u009a\u00ab\n \n \n \u00e2\u0080\u0083BMI, body composition and weight intentions\n \u00e2\u009a\u00ab*\n \n \u00e2\u009a\u00ab\n \n \n \u00e2\u0080\u0083Questionnaires (SF-36, RSES, BES)\n \u00e2\u009a\u00ab\u00e2\u0080\u00a0\n \n \u00e2\u009a\u00ab\n \n \n \u00e2\u0080\u0083Surgical data recording\n \n \u00e2\u009a\u00ab*\n \n \n \n \u00e2\u0080\u0083Haemodynamic variation during surgery\n \n \u00e2\u009a\u00ab\u00e2\u0080\u00a0\n \n \n \n \u00e2\u0080\u0083Complications\n \n \u00e2\u009a\u00ab*\n \u00e2\u009a\u00ab\n \n \n \n \n \n *For historical-prospective inclusions, these data are recovered in as much as possible from patient files.\n \n \n \u00e2\u0080\u00a0Prospective inclusions only.\n \n \n BES, Body Esteem Scale; BMI, body\u00e2\u0080\u0089mass index; RSES, Rosenberg\u00e2\u0080\u0089Self Esteem Scale; SF-36, Short\u00e2\u0080\u0089Form 36.\n \n \n \n \n \n Historical-prospective inclusions\n Only one visit, a routine postoperative consult, is required for historical-prospective inclusions (table 3). These routine visits are performed annually at the participating hospital and may occur at approximately 12, 24, 36 or 48\u00e2\u0080\u0089months after surgery, with generous leeway (\u00c2\u00b13\u00e2\u0080\u0089months). During this visit, the study will be proposed to the patient, and consent procedures are implemented if he/she is interested in participating. In addition to the recovery of baseline data, assessments are performed in line with table 3, namely, incremental exercise testing, pulmonary volumes and function, BMI, body fat percentage and quality-of-life/self-esteem questionnaires.\n \n \n Prospective inclusions\n Patients in this group have not yet had corrective surgery and are invited to participate in the study during their presurgical work-up, which will include the assessments listed in table 3. Patients will then follow a routine pathway, with a postsurgical follow-up visit at 1\u00e2\u0080\u0089year following surgery. The data recovered enable a before\u00e2\u0080\u0093after evaluation of the effect of surgical correction of PE on variables issuing from key HeartSoar assessments, namely, incremental exercise testing, pulmonary volumes and function, BMI, body composition and quality-of-life/self-esteem questionnaires.", "id": 399, "split": "train"} +{"trial_id": "NCT03773406", "pmid": "35978374", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT): An Intervention Development Study for Aphasia\n\nIncluded conditions:\n- Aphasia\n\nStudy Armgroups:\n- {'label': 'Offline tDCS-before therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive 20 minutes of tDCS prior to the 40 minute speech-language therapy session.', 'interventionNames': ['Device: Offline tDCS-before therapy']}\n- {'label': 'Offline tDCS-after therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive 20 minutes of tDCS after the 40 minute speech-language therapy session.', 'interventionNames': ['Device: Offline tDCS-after therapy']}\n- {'label': 'Online tDCS', 'type': 'ACTIVE_COMPARATOR', 'description': 'tDCS will be applied at the beginning of the 40 minute speech-language therapy session and will last for 20 minutes.', 'interventionNames': ['Device: Online tDCS']}\n- {'label': 'Sham tDCS', 'type': 'SHAM_COMPARATOR', 'description': 'Sham tDCS will be applied at the beginning of the 40 minute speech-language therapy session.', 'interventionNames': ['Device: Sham tDCS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Offline tDCS-before therapy', 'description': 'Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.', 'armGroupLabels': ['Offline tDCS-before therapy']}\n- {'type': 'DEVICE', 'name': 'Sham tDCS', 'description': 'Stimulation will be given for a total 30 seconds (including ramp-up and ramp-down of current) and then the tDCS device will be turned off. The brief stimulation will produce tDCS-induced sensation so that participants will not be aware when the tDCS was turned off .We will use standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.', 'armGroupLabels': ['Sham tDCS']}\n- {'type': 'DEVICE', 'name': 'Offline tDCS-after therapy', 'description': 'Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.', 'armGroupLabels': ['Offline tDCS-after therapy']}\n- {'type': 'DEVICE', 'name': 'Online tDCS', 'description': 'Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.', 'armGroupLabels': ['Online tDCS']}\n\nPrimary Outcomes:\n- {'measure': 'Change in trained conversational script.', 'description': 'Changes in accuracy and rate of production on a trained conversational script from pre to post-treatment.', 'timeFrame': '3 weeks.'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed analyses with a significance level (\u00ce\u00b1) of 0.05, 80% power, and a two-sample t-test. The precision of the estimate is a half-width of a 95% confidence interval of \u00b15.2%.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n The study will enroll a total of 48 subjects (12 in each group). Power calculations were based on our previous work with similar participants, and planned two-tailed analyses (\u00ce\u00b1 = .05) for the primary outcome measure, the simulated conversation on the trained script.\n In preliminary work without tDCS, we observed improvement in trained script accuracy at the end of language treatment relative to baseline was 10.4% (SD = 8.2%). Assuming similar variability in the proposed study, n = 12 subjects per group will allow us to estimate changes in accuracy with precision (half-width of a 95% confidence interval) of \u00c2\u00b15.2% in each group. In addition, a sample size of n = 12 subjects per group will provide 80% power with two-sided \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 for a two-sample t-test to detect a 9.9% difference in accuracy improvement between treatment arms and the sham treatment (e.g., improvement in accuracy of 10.4% and 20.3% in the two arms, respectively).", "id": 400, "split": "train"} +{"trial_id": "NCT03774329", "pmid": "32430452", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of a Physical Activity Program on Bone Mineral Density (BMD) in Children / Adolescents With Chronic Inflammatory Bowel Disease (IBD): Crohn's Disease, Ulcerative Colitis, Unclassified Chronic Colitis\n\nIncluded conditions:\n- Crohn's Enteritis\n- Crohn Disease\n- Ulcerative Colitis\n- Chronic; Colitis (Noninfective)\n\nStudy Armgroups:\n- {'label': 'physical activity program', 'type': 'EXPERIMENTAL', 'description': 'Child with an adapted physical activity program', 'interventionNames': ['Other: adapted physical activity']}\n- {'label': 'Usual care', 'type': 'OTHER', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Patients included in the control group will not benefit from the intervention in adapted physical activity. However, this will not affect their support. Patients will be seen by their specialist doctor as part of the usual management of their IBD.', 'armGroupLabels': ['Usual care']}\n- {'type': 'OTHER', 'name': 'adapted physical activity', 'description': 'Patients in the experimental group will have, in addition to their usual follow-up with their specialist doctor, an intervention in adapted physical activity at home, at the rate of 3 sessions (of a duration of 10 to 20 minutes) per week during 9 consecutive months.', 'armGroupLabels': ['physical activity program']}\n\nPrimary Outcomes:\n- {'measure': 'Change in total (whole body) Bone Mineral Density', 'timeFrame': 'At 9 months'}\n\nPlease estimate the sample size based on the assumption: \nTo detect this effect size, with a two-sided test at the 0.05 level of significance, a power of 80%, an SD of 0.1 (assuming a correlation of 0.5 between baseline and 9-month follow-up values) with 36 subjects per group will be required. To account for an anticipated rate of 10% of missing data (loss to follow-up), we plan to include a total of 80 subjects (40 per arm).", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on the literature, we expect a mean whole-body BMD value at inclusion of 0.645\u00c2\u00b10.1\u00e2\u0080\u0089g/cm2 in our study population, and annual variation of 4.4% yielding to an expected mean value of 0.666\u00c2\u00b10.1\u00e2\u0080\u0089g/cm2 at the end of the 9-month study in the control group (ie, a mean change from baseline of 0.021).44 We assume that the mean whole-body BMD value after the 9-month PA training period will be higher than 10% of control group values, corresponding to a whole-body BMD value of 0.733\u00e2\u0080\u0089g/cm2 (ie, a mean change from baseline of 0.088). To detect this effect size, with a two-sided test at the 0.05 level of significance, a power of 80%, an SD of 0.1 (assuming a correlation of 0.5 between baseline and 9-month follow-up values) with 36 subjects per group will be required. To account for an anticipated rate of 10% of missing data (loss to follow-up), we plan to include a total of 80 subjects (40 per arm). As a conservative approach, the sample size calculation did not take into account the adjustment for baseline values.", "id": 401, "split": "train"} +{"trial_id": "NCT03775785", "pmid": "33225961", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Targeted vs Standard Fortification of Breast Milk on Growth and Development of Preterm Infants (\u2264 32 Weeks): a Randomised Controlled Trial\n\nIncluded conditions:\n- BPD - Bronchopulmonary Dysplasia\n- NEC - Necrotizing Enterocolitis\n- Weight Gain\n- VLBW - Very Low Birth Weight Infant\n- ROP - Retinopathy of Prematurity\n\nStudy Armgroups:\n- {'label': 'tailored enteral nutrition', 'type': 'EXPERIMENTAL', 'description': 'Tailored Human milk fortification procedure Tailored milk fortification will be done twice a day (8 am and 8 pm) for each following 12 hour nursing shift. Standard fortification will be added first. The remainder amount of protein, lipids and carbohydrates required to meet the recommended by ESPGHAN doses will be acheived by adding single ingrediant nutrients.', 'interventionNames': ['Dietary Supplement: Tailored enteral nutrition']}\n- {'label': 'standard enteral nutrition', 'type': 'NO_INTERVENTION', 'description': 'Standard fortification will be added according to the unit protocol.'}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Tailored enteral nutrition', 'description': 'The mean of three measurements per batch (3 x 2-3ml) will be used to calculate the required amount of extra fat, protein, and carbohydrate for the following 3 days of fortification using a predefined Excel spread sheet (Microsoft Inc, Redmond, Washington).\\n\\nThe intervention will consist of adding fat, protein, and/or carbohydrate to achieve target levels of macronutrients.\\n\\nThe defined macronutrient concentration in breast milk is 4.4 g/100 mL of fat, 3 g/100 mL of protein, and 8.8 g/ 100 mL of carbohydrate to meet the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) guidelines (6.6 g/kg/d of fat, 4.5 g/kg/d of protein, and 13.2 g/kg/d of carbohydrate) assuming an intake of 150 mL/kg/d.', 'armGroupLabels': ['tailored enteral nutrition']}\n\nPrimary Outcomes:\n- {'measure': 'Growth', 'description': 'weight will be assessed every day.', 'timeFrame': 'from birth at postmentrual age <32 to up to 37 weeks of post-conceptional age'}\n- {'measure': 'Velocity of weight gain in grams', 'description': 'weight will be assessed every day.', 'timeFrame': 'from birth at postmentrual age <32 to up to 37 weeks of post-conceptional age'}\n\nPlease estimate the sample size based on the assumption: \nType I error (\u03b1) is 5%, power is 80%, equal sample sizes in both groups, and the standard deviation for weight gain is increased by 50% to 3.75. For the secondary outcome, the mean cognitive score is 100 points with a standard deviation of 12. An attrition rate of 20% is assumed for weight gain, and 10% for the overall study.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size required to compare two means in two-sided equality test was estimated based on results from a prior double blind, randomized clinical trial, investigating the effect of TG vs SF of breast milk on the changes of anthropometric parameters and body composition in preterm children [23, 24]. It was determined that a mean difference of weight gain 1.9\u00e2\u0080\u0089g/kg/day between groups would be clinically important and feasible during intervention.\n The following assumptions were made for the calculation: type I error (\u00ce\u00b1) 5%, power 80%, equal sample sizes in both groups, the mean weight gain in the standard fortification group 19.3\u00e2\u0080\u0089g/kg/day, and the mean weight gain in the target fortification group 21.2\u00e2\u0080\u0089g/kg/day. To account for the higher uncertainty in measured weight gain due to differences between the studied and the quoted trial population, standard deviation value taken from the prior trial was increased by 50% to 3.75.\n An estimated minimum size of each group is 68. Accounting for a presumed 20% attrition rate, due to potential dropouts, deviations from the protocol, and loss to follow-up, a minimum sample size required was estimated at 156 infants or 78 infants per treatment arm.\n However, in order to detect a difference of 5 points in cognitive score of Bayley-III (secondary outcome) at 12\u00e2\u0080\u0089months of age (mean of 100 points, standard deviation (SD) 12) between the study groups with a power of 80% and \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, we have decided to increase the sample to 91 infants in each study group.\n In summary, allowing for 10% of loss to follow-up, the target number of 200 premature infants will be recruited.", "id": 402, "split": "train"} +{"trial_id": "NCT03779126", "pmid": "36351736", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis\n\nIncluded conditions:\n- Chronic Kidney Diseases\n\nStudy Armgroups:\n- {'label': 'Active comparator', 'type': 'EXPERIMENTAL', 'description': 'Low frequency electrical stimulation for 60 minutes, three times a week during 60 days.', 'interventionNames': ['Device: Electrical stimulation']}\n- {'label': 'Other', 'type': 'EXPERIMENTAL', 'description': 'High frequency electrical stimulation for 60 minutes, three times a week during 60 days.', 'interventionNames': ['Device: Electrical stimulation']}\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days.', 'interventionNames': ['Device: Electrical stimulation']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo electrical stimulation for 60 minutes, three times a week during 60 days. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current', 'interventionNames': ['Device: Electrical stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Electrical stimulation', 'description': '1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.', 'armGroupLabels': ['Active comparator', 'Experimental group', 'Other', 'Placebo'], 'otherNames': ['Low frequency electrical stimulation (LF)', 'High frequency (HF)', 'Low and High frequency (LHF)', 'sham stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'Assess the improvement of muscle mass', 'description': 'The muscle mass will be assessed by electric bioimpedance', 'timeFrame': 'Eight weeks'}\n- {'measure': 'Assess the improvement of muscle strength', 'description': 'The muscle strength will be assessed using isokinetic by peak torque', 'timeFrame': 'Eight weeks'}\n- {'measure': 'Assess the improvement of muscle resistance', 'description': 'The muscle resistance will be assessed using isokinetic by fatigue index', 'timeFrame': 'Eight weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5% and statistical power of 80%", "answer": 56, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was performed using a statistics programme (SigmaStat V.3.5; San Jose, California, USA), based on the results obtained by Dobsak et al,10 who found, in the group that performed NMES, a baseline value of peripheral muscle strength of 185.4\u00c2\u00b153.0\u00e2\u0080\u0089kgf and a post-treatment value of 222.4\u00c2\u00b136.6\u00e2\u0080\u0089kgf. Considering an error of 5% and statistical power of 80%, a sample size of 14 patients in each group will be necessary, totalling the inclusion of 56 patients.", "id": 403, "split": "train"} +{"trial_id": "NCT03781700", "pmid": "33947355", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial\n\nIncluded conditions:\n- Facial Palsy\n- Facial Nerve Diseases\n- Borrelia Infection of Central Nervous System\n- Bell Palsy\n\nStudy Armgroups:\n- {'label': 'Prednisolone', 'type': 'EXPERIMENTAL', 'description': 'Prednisolone', 'interventionNames': ['Drug: Prednisolone']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo oral tablet', 'interventionNames': ['Drug: Placebo Oral Tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Prednisolone', 'description': 'Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.', 'armGroupLabels': ['Prednisolone'], 'otherNames': ['Batch 18A71, Orifarm Generics A/S']}\n- {'type': 'DRUG', 'name': 'Placebo Oral Tablet', 'description': 'Placebo tablets with identical appearance to the experimental drug', 'armGroupLabels': ['Placebo'], 'otherNames': ['Batch 18A61, Orifarm Generics A/S']}\n\nPrimary Outcomes:\n- {'measure': 'House-Brackmann scale', 'description': 'Total recovery in the two treatment groups measured with the House-Brackmann scale.\\n\\nThe House-Brackmann scale (I is normal function and VI is total loss of function) is chosen as primary outcome measure since it is an objective instrument, easy to perform and the one most frequently used in previous studies. The time point 12 months for evaluation of total recovery is chosen as no further improvement of the facial nerve function is expected after 12 months.', 'timeFrame': 'At 12 months (+/- 2 weeks) after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical significance level is set at p < 0.05, with a power of 80%. A 10% dropout rate is also assumed.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Sample size estimation and recruitment\n In the FACE study, the sample size is calculated on the primary outcome (i.e. complete recovery, defined as HBGS grade I, at the 12-month follow-up visit). Previous studies have shown spontaneous complete recovery (HBGS\u00e2\u0080\u0089=\u00e2\u0080\u0089I) to occur in approximately 80% of untreated children with an acute FNP [10\u00e2\u0080\u009312], this is the estimated percentage for complete recovery in the control group. Furthermore, in accordance with previous studies in adults [18], we consider a clinically important difference between groups to be 10%, hypothesizing the intervention to cause an increase in complete recovery rate from 80 to 90% in the treatment group. To be able to show a 10% difference between groups with statistical significance (p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05) and a power of 80% [38], a total of 500 participants (250 in each group), is needed for the trial, allowing 10% of participants to be lost to follow-up.\n In order to promote progress and ensure high quality of study procedures, investigators and study nurses received education in Good Clinical Practice before the study start and attend yearly meetings available to all personnel. Investigators are thoroughly instructed in applying the HBGS and the SFGS for reliable evaluation of facial impairment, and at the 1- and 12-month follow-ups, only one or two investigators per study center will apply the HBGS and the SFGS. Recruitment rate is enhanced by continuous contact between the coordinating investigator, the principal investigators and study nurses at each study center, throughout the study period.", "id": 404, "split": "train"} +{"trial_id": "NCT03783065", "pmid": "32580978", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)\n\nIncluded conditions:\n- Portal Hypertension\n- Variceal Rebleeding\n\nStudy Armgroups:\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Procedure: Laparoscopic splenectomy and pericardial devascularization Drug: Propranolol', 'interventionNames': ['Drug: Propranolol', 'Procedure: Laparoscopic splenectomy and pericardial devascularization']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Procedure: Endoscopic therapy Drug: Propranolol', 'interventionNames': ['Drug: Propranolol', 'Procedure: Endoscopic therapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Propranolol', 'description': 'Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.', 'armGroupLabels': ['Control group', 'Experimental group']}\n- {'type': 'PROCEDURE', 'name': 'Laparoscopic splenectomy and pericardial devascularization', 'description': 'Including splenectomy and pericardial devascularizaion under laparoscopy', 'armGroupLabels': ['Experimental group']}\n- {'type': 'PROCEDURE', 'name': 'Endoscopic therapy', 'description': 'Either endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Variceal rebleeding', 'description': 'The occurrence rate of gastroesophageal varices rebleeding within 1-year follow-up', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate (\u03b1) of 5%, Type II error rate (1\u2212\u03b2) of 20%, and a dropout rate of 10%.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n No study has yet compared the outcome between cirrhotic patients with gastro-oesophageal variceal bleeding receiving either laparoscopic therapy or endoscopic therapy. Also, because of the lack of study restricting HVPG baseline level and studies about laparoscopic therapy plus propranolol oral administration, the sample size is determined based on pooled data of variceal rebleeding rate of several studies including endoscopic therapy plus propranolol oral administration or laparoscopic therapy. The variceal rebleeding rate of endoscopic therapy plus propranolol oral administration is estimated by six randomised controlled trials (table 2).22\u00e2\u0080\u009327 The variceal rebleeding rate of laparoscopic therapy is estimated by six retrospective studies (table 2).20 28\u00e2\u0080\u009332 Pooled rates of variceal rebleeding for the endoscopic group and laparoscopic group are 44% and 6%, respectively. Considering a type I error rate (\u00ce\u00b1) of 5% and a type II error rate (1\u00e2\u0088\u0092\u00ce\u00b2) of 20% and a dropout rate of 10%, the calculated sample size for this trial is 40.\n \n Table 2\n \n Variceal rebleeding rates in cirrhotic patients with portal hypertension bleeding treated by endoscopic therapy plus propranolol or laparoscopic therapy: a review of 12 studies\n \n \n \n \n Laparoscopic therapy\n Endoscopic therapy plus propranolol\n \n \n First author, year\n Patients (n)\n Rebleeding, n (%)\n First author, year\n Patients (n)\n Rebleeding, n (%)\n \n \n \n \n Zheng, 201829\n 250\n 9 (3.6)\n Lv, 201822\n 25\n 13 (52)\n \n \n Bai, 201728\n 40\n 2 (5)\n Holster, 201623\n 35\n 10 (28.6)\n \n \n Bao, 201730\n 76\n 19 (25)\n Luo, 201524\n 36\n 21 (58.3)\n \n \n Cheng, 201420\n 204\n 7 (3.4)\n Hung, 201225\n 47\n 22 (46.8)\n \n \n Jiang, 200931\n 26\n 0 (0)\n Sauer, 200226\n 40\n 12 (30)\n \n \n Wang, 200832\n 22\n 0 (0%)\n R\u00c3\u00b6ssle, 199727\n 62\n 29 (46.8)", "id": 405, "split": "train"} +{"trial_id": "NCT03784625", "pmid": "35428211", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012: Phase I Study\n\nIncluded conditions:\n- Melanoma\n\nStudy Armgroups:\n- {'label': 'therapeutic dose activity (level 1)', 'type': 'EXPERIMENTAL', 'description': '\\\\[131\\\\]ICF01012 at a therapeutic dose of 800 MBq/m\u00b2 , single dose at D11 (intravenous administration)', 'interventionNames': ['Drug: [131I]ICF01012 (therapeutic dose level 1)']}\n- {'label': 'therapeutic dose activity (level 2)', 'type': 'EXPERIMENTAL', 'description': '\\\\[131\\\\]ICF01012 at a therapeutic dose of 1600 MBq/m\u00b2 , single dose at D11 (intravenous administration)', 'interventionNames': ['Drug: [131I]ICF01012 (therapeutic dose level 2)']}\n- {'label': 'therapeutic dose activity (level 3)', 'type': 'EXPERIMENTAL', 'description': '\\\\[131\\\\]ICF01012 at a therapeutic dose of 2700 MBq/m\u00b2 , single dose at D11 (intravenous administration)', 'interventionNames': ['Drug: [131I]ICF01012 (therapeutic dose level 3)']}\n- {'label': 'therapeutic dose activity (level 4)', 'type': 'EXPERIMENTAL', 'description': '\\\\[131\\\\]ICF01012 at a therapeutic dose of 4000 MBq/m\u00b2 , single dose at D11 (intravenous administration)', 'interventionNames': ['Drug: [131I]ICF01012 (therapeutic dose level 4)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '[131I]ICF01012 (therapeutic dose level 1)', 'description': '* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs)\\n* 1 therapeutic injection (D11) at a dose of 800 MBq/m\u00b2', 'armGroupLabels': ['therapeutic dose activity (level 1)']}\n- {'type': 'DRUG', 'name': '[131I]ICF01012 (therapeutic dose level 2)', 'description': '* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs)\\n* 1 therapeutic injection (D11) at a dose of 1600 MBq/m\u00b2', 'armGroupLabels': ['therapeutic dose activity (level 2)']}\n- {'type': 'DRUG', 'name': '[131I]ICF01012 (therapeutic dose level 3)', 'description': '* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs)\\n* 1 therapeutic injection (D11) at a dose of 2700 MBq/m\u00b2', 'armGroupLabels': ['therapeutic dose activity (level 3)']}\n- {'type': 'DRUG', 'name': '[131I]ICF01012 (therapeutic dose level 4)', 'description': '* 1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs)\\n* 1 therapeutic injection (D11) at a dose of 4000 MBq/m\u00b2', 'armGroupLabels': ['therapeutic dose activity (level 4)']}\n\nPrimary Outcomes:\n- {'measure': 'Evaluation of the recommended therapeutic dose of [131I] ICF01012', 'description': 'defined as the highest dose at which the percentage of DLT (dose limiting toxicity) is less than 33%. The DLT is defined as:\\n\\n* all non hematologic toxicities NCI-CTC grade 3-4 except for alopecia, nausea, vomiting and fever that can be controlled by appropriate measures.\\n* hematologic toxicities as thrombopenia and anemia of grade 4, neutropenia of grade 4 for more than 5 days, thrombopenia of grade 3 with bleeding and all other hematologic toxicities of grade 3 clinically significant of more than 3 weeks', 'timeFrame': 'Only toxicities observed during the 6 weeks following administration of the therapeutic dose will be considered for the evaluation of DLT'}\n\nPlease estimate the sample size based on the assumption: \nUsing a CRM model with 4 dose levels, with cohorts of one patient by dose level and at least 6 patients at the recommended dose", "answer": 10, "answer_type": "ACTUAL", "explanation": "Sample size\n Using a CRM model with 4 dose levels, i.e. with cohorts of one patient by dose level and at least 6 patients at the recommended dose, a minimum of 6 patients and a maximum of 18 patients should be included in the \u00e2\u0080\u009ctherapeutic part\u00e2\u0080\u009d. Sample size calculation for the selection part is based on the hypothesis that 50% of patients will have at least an [131I]ICF01012 lesion uptake as observed with BZA2 in phase III study [8] and thus be eligible for the therapeutic part. Therefore, between 12 to 36 patients will be enrolled in the selection part in order to ensure the necessary sample size for the therapeutic part (between 6 to 18).", "id": 406, "split": "train"} +{"trial_id": "NCT03784729", "pmid": "32711555", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Acupuncture for Intermittent Claudication of Patients With Lumbar Spinal Stenosis\n\nIncluded conditions:\n- Lumbar Spinal Stenosis\n- Intermittent Claudication\n\nStudy Armgroups:\n- {'label': 'Acupuncture', 'type': 'EXPERIMENTAL', 'description': 'The acupoints of Shenshu (BL23), \"Dachangshu (BL25)\", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted.', 'interventionNames': ['Other: Acupuncture']}\n- {'label': 'Sham acupuncture', 'type': 'SHAM_COMPARATOR', 'description': 'The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm.', 'interventionNames': ['Other: Sham acupuncture']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Acupuncture', 'description': 'The acupoints of Shenshu (BL23), \"Dachangshu (BL25)\", Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted. For the bilateral\" BL25\", sterile disposable steel needles (Huatuo, Suzhou, China; 0.3 mm\u00d775 mm) will be inserted to a depth of 50-70mm until until participates feel a sensation similar to electric shock radiating downward to the knees. For the other four acupoints (BL23, BL40, BL57 and KI3), the needles (Huatuo, Suzhou, China; 0.3 mm\u00d740 mm) will be inserted to a depth of 15-25 mm, gently rotated three times and lifted to achieve de qi. It should be noted that the needle at KI3 will be inserted at an angle of 45\u00b0obliquely downward. There will be 18 treatment sessions with 3 times a week for continuous 6 weeks and a 30 min treatment per session.', 'armGroupLabels': ['Acupuncture']}\n- {'type': 'OTHER', 'name': 'Sham acupuncture', 'description': 'The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm .No manipulation of needles without deqi will be conducted. The treatment duration and frequency of sessions for participants in the SA group will be the same as in the acupuncture group.', 'armGroupLabels': ['Sham acupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'The change in Modified Roland-Morris Disability Questionnaire (RMDQ) score from baseline', 'description': 'Modified Roland-Morris Disability Questionnaire (RMDQ) is a reliable pain-specific functional status questionnaire which is easy and simple for patients to complete. The RMDQ includes 24 questions with a score range of 0-24, and there is a phrase \"caused by low back pain\" after each question which could excluded other reasons for dysfunction of the back. For this scale, higher scores indicate more severe symptoms.', 'timeFrame': 'week 6'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided alpha level of 0.05, common standard deviation of 5.52, and a dropout rate of 20%.", "answer": 196, "answer_type": "ESTIMATED", "explanation": "Sample size\n With approximately 196 patients in the trial (98 in each group), the study is predicted to have 80% power to detect a between-group difference of 2.5 for the reduction in RMDQ score from baseline using a two-sided alpha level of 0.05 and assuming a common standard deviation of 5.52 and a dropout rate of 20%. A difference of 2.5 points on the RMDQ score was selected based on a 2\u00e2\u0080\u00933-point change, which is the MCID recommended for sample size calculations for RMDQ scores [25].", "id": 407, "split": "train"} +{"trial_id": "NCT03785691", "pmid": "32209630", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Validating the Effect of Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum: A Double-Blind Randomised Placebo-Controlled Multicentre Trial\n\nIncluded conditions:\n- Hyperemesis Gravidarum\n- Nausea Gravidarum\n- Vomiting of Pregnancy\n\nStudy Armgroups:\n- {'label': 'Mirtazapine', 'type': 'EXPERIMENTAL', 'description': 'Mirtazapine 15 mg oral tablet (incapsulated in gelatine to provide blinding) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered once daily (morning).\\n\\nOn Day 7 dosage increase is optional. If desired, mirtazapine 30 mg oral tablet (incapsulated in gelatine) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered three times daily (morning, noon and late afternoon). In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.', 'interventionNames': ['Drug: Mirtazapine']}\n- {'label': 'Ondansetron', 'type': 'EXPERIMENTAL', 'description': 'Ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered twice daily (morning and bedtime) for 7 days.\\n\\nOn Day 7 dosage increase is optional. If desired, ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.', 'interventionNames': ['Drug: Ondansetron']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo oral tablet (empty gelatine capsule) will be administered twice daily (morning and bedtime) for 7 days.\\n\\nOn Day 7 dosage increase is optional. If desired, placebo oral tablet (empty gelatine capsule) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Mirtazapine', 'description': 'Mirtazapine 15 mg oral tablet (incapsulated in gelatine to provide blinding) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered once daily (morning).\\n\\nOn Day 7 dosage increase is optional. If desired, mirtazapine 30 mg oral tablet (incapsulated in gelatine) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered three times daily (morning, noon and late afternoon). In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.', 'armGroupLabels': ['Mirtazapine'], 'otherNames': ['KRKA Mirtazapine Oral Tablet']}\n- {'type': 'DRUG', 'name': 'Ondansetron', 'description': 'Ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered twice daily (morning and bedtime) for 7 days.\\n\\nOn Day 7 dosage increase is optional. If desired, ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.', 'armGroupLabels': ['Ondansetron'], 'otherNames': ['Bluefish Ondansetron Oral Tablet']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo oral tablet (empty gelatine capsule) will be administered twice daily (morning and bedtime) for 7 days.\\n\\nOn Day 7 dosage increase is optional. If desired, placebo oral tablet (empty gelatine capsule) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Placebo Oral Tablet']}\n\nPrimary Outcomes:\n- {'measure': 'Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group.', 'description': 'Change in Pregnancy Unique Quantification of Emesis 24 score (PUQE-24 score) (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group. PUQE-24 score ranges 3-15 with 3 being better and 15 being worse.', 'timeFrame': '2 days'}\n- {'measure': 'Change in nausea and vomiting from baseline to Day 2 (short term) in the ondansetron group versus the placebo group.', 'description': 'Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the ondansetron group versus the placebo group.', 'timeFrame': '2 days'}\n- {'measure': 'Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the mirtazapine group versus the placebo group.', 'description': 'Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the mirtazapine group versus the placebo group. Only tested if outcome 1 is significant.', 'timeFrame': '14 days'}\n- {'measure': 'Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the ondansetron group versus the placebo group.', 'description': 'Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the ondansetron group versus the placebo group. Only tested if outcome 2 is significant.', 'timeFrame': '14 days'}\n- {'measure': 'Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group.', 'description': 'Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group. Only tested if outcome 1 is significant.', 'timeFrame': '2 days'}\n\nPlease estimate the sample size based on the assumption: \nEach hypothesis for coprimary outcomes will be tested at a significance level of 2.5% to obtain a family-wise type I error of 5% based on a Bonferroni correction. The power calculation is based on a standard deviation of change in PUQE-24 score of 3. Expecting a dropout rate of 35%, the trial aims for a power of 80%.", "answer": 58, "answer_type": "ACTUAL", "explanation": "Sample size\n The trial is dimensioned to detect a difference of 2 or more in the coprimary outcomes; change in PUQE-24 score from baseline to day 2 in the mirtazapine versus the placebo group, or in the ondansetron versus the placebo group. Each hypothesis for coprimary outcomes will be tested at significance level 2.5% in order to obtain at family-wise type I error of 5% based on a Bonferroni correction. The power calculation is based on a standard deviation of change in PUQE-24 score of 3, which is a conservative estimate based on a placebo-controlled trial with doxylamine-pyridoxine.26 Expecting dropout of 35%, 58 participants are required in each of the three groups to obtain a power of 80%. Rounding that up to 60 participants, we aim to include 180 participants in total.", "id": 408, "split": "train"} +{"trial_id": "NCT03785743", "pmid": "35379633", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Pancreatic Carcinoma\n- Laparoscopic\n- Pancreaticoduodenectomy\n\nStudy Armgroups:\n- {'label': 'TLPD', 'type': 'EXPERIMENTAL', 'description': 'Total laparoscopic pancreaticoduodenectomy for pancreatic cancer', 'interventionNames': ['Procedure: TLPD Surgery']}\n- {'label': 'OPD', 'type': 'EXPERIMENTAL', 'description': 'Open pancreaticoduodenectomy for pancreatic cancer', 'interventionNames': ['Procedure: OPD Surgery']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'TLPD Surgery', 'description': 'TLPD', 'armGroupLabels': ['TLPD']}\n- {'type': 'PROCEDURE', 'name': 'OPD Surgery', 'description': 'OPD', 'armGroupLabels': ['OPD']}\n\nPrimary Outcomes:\n- {'measure': '5-year overall survival', 'description': '5-year overall survival', 'timeFrame': '5 year'}\n\nPlease estimate the sample size based on the assumption: \nOne-tailed significance level of 2.5%, power of 80%, and a balanced design (1:1 ratio). The maximum conversion rate from LPD to OPD is assumed to be 10%. An additional 10% of patients are considered for non-resectable patients, withdrawals, and loss to follow-up.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was performed according to the primary endpoint, the 5-year OS rate, and the non-inferiority design of this trial. Assumptions were made based on a previous study by Kuesters et al,25 which compared LPD with OPD for PDAC treatment with the 5-year OS rate being 20% in the LPD group and 14% in the OPD group. Based on the 6% decrease in 5-year OS rate in the OPD group compared with the LPD group, the sample size required for each group was estimated to be 86 patients to achieve a non-inferiority limit of 10% at a one-tailed significance level of 2.5% with a power of 80% and a balanced design (1:1 ratio). Moreover, the primary analyses will be based on the modified intention-to-treat (mITT), per-protocol (PP) and as-treated (AT) sets. We aimed to reach a statistical power of 80% when analysing the smallest population, namely the PP set.\n Patients converted from LPD to open surgery will not be included in the PP set. Patients will be randomised in a 1:1 manner to either the LPD or OPD arm, with the maximum conversion rate from LPD to OPD assumed to be 10%, resulting in a ratio of up to 9:10 in the PP set. To meet these assumptions, 83 patients in the LPD group and 91 patients in the OPD group will be needed for analysis using the one-sided t test at a one-sided significance level of 0.025. PASS V.15.0.5 will be used for the calculations. An additional 10% of patients will be needed to be randomised considering the non-resectable patients, patients withdrawing from the study, and patients lost to follow-up. Accordingly, 100 patients in the LPD arm and 91 patients in the OPD arm will be randomised. The randomisation ratio of this trial is 1:1, requiring 100 patients in each arm and 200 patients in total to be included for randomisation.", "id": 409, "split": "train"} +{"trial_id": "NCT03786549", "pmid": "32039737", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of a Pediatric-adult Care Transition Program on the Health Status of Patients With Sickle Cell Disease - A Randomized Controlled Trial\n\nIncluded conditions:\n- Sickle Cell Disease\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Patients included in this arm wil have usual follow-up.'}\n- {'label': 'Care transitional program', 'type': 'EXPERIMENTAL', 'description': 'Patients included in this arm will get a care transitional program. Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent\\n\\nThree axes are :\\n\\n* Educative, family (patient and parent), at home\\n* Psychological, with the patient individually\\n* Medico-social orientation, group of patients', 'interventionNames': ['Other: pediatric-adult care transition program']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'pediatric-adult care transition program', 'description': 'Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent\\n\\nThree axes are :\\n\\n* Educative, family (patient and parent), at home\\n* Psychological, with the patient individually\\n* Medico-social orientation, group of patients', 'armGroupLabels': ['Care transitional program']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of sickle cell related severe complications leading to hospitalization', 'description': 'Number of hospital admission or emergency visit in the index hospital', 'timeFrame': 'Within 24 months after transfer to the adult sector'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided test at a significance level of 5%, and a 10% inflation factor to account for study deviations such as missing data, withdrawal, and loss to follow-up.", "answer": 196, "answer_type": "ESTIMATED", "explanation": "Sample size and recruitment\n A total of 196 (98 in each group) is required to detect at least a 15% reduction of the hospitalisation rate for complications 2 years after the transfer in the intervention group compared to the control group. This reduction assumes a hospitalisation rate of 3.5 per patient per year [7] with 80% power and the use of a two-sided test at a significance level of 5% and a 10% inflation factor to anticipate study deviations (missing data, withdrawal, loss to follow-up).\n Participants are recruited in the hospital when they come for a medical consultation or at the end of a hospitalisation for complications. Potential participants are screened. The investigator informs the patient and caregiver about the study, following which the patient gives oral consent and the patient\u00e2\u0080\u0099s caregiver the written informed consent for patient participation. The information note and consent form is presented in Additional file 1. When the patient legally becomes an adult (i.e. at 18\u00e2\u0080\u0089years of age in France), he will give his/her own written informed consent.", "id": 410, "split": "train"} +{"trial_id": "NCT03788213", "pmid": "32998747", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HYPOfractionated Radiation Therapy Comparing a Standard Radiotherapy Schedule (Over Three Weeks) With a Novel One Week Schedule in Adjuvant Breast Cancer: An Open Label Randomised Controlled Study (HYPORT- Adjuvant)\n\nIncluded conditions:\n- Breast Cancer Female\n\nStudy Armgroups:\n- {'label': '3 week RT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Adjuvant Radiotherapy delivered over 3 weeks', 'interventionNames': ['Radiation: 3 week RT']}\n- {'label': '1 Week RT', 'type': 'EXPERIMENTAL', 'description': 'Adjuvant Radiotherapy delivered over 1 week', 'interventionNames': ['Radiation: 1 week RT']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': '3 week RT', 'description': '40 Gy in 15 fractions over 3 weeks to the whole breast or chest wall. Patients undergoing breast conservation therapy will receive additional boost radiotherapy to the tumor bed. The supraclavicular fossa will be treated in patient with node positive disease or those receiving neoadjuvant chemotherapy. IMC and Axillary radiotherapy will be given as per the institutional policy. Boost Dose schedule for BCS patients will be 8 Gy delivered in 15 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.', 'armGroupLabels': ['3 week RT']}\n- {'type': 'RADIATION', 'name': '1 week RT', 'description': '26 Gy in 5 fractions over 1 week to the whole breast or chest wall. Treatment volumes will be same as the control arm. Additional boost will be delivered to patients who have undergone breast conservation. Boost Dose schedule for BCS patients will be 6 Gy delivered in 5 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.', 'armGroupLabels': ['1 Week RT']}\n\nPrimary Outcomes:\n- {'measure': 'Locoregional Recurrence Rate (LRR)', 'description': 'Cumulative proportion of patients with locoregional recurrence', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a one-sided type I error of 0.025, a power of 80%, and a 2% annual dropout rate. Patients will be accrued over 5 years with a total trial duration of 10 years to ensure a minimum follow-up of 5 years for the last patient.", "answer": 2100, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n \n Non-inferiority margin and justification for the same\n Assuming that the locoregional recurrence rate in the control arm is 5%, a non-inferiority margin of 3% is clinically acceptable and corresponds to a hazard rate of 1.63. The choice of the non-inferiority marginis arbitrary to a significant extent and we base it on the guidance that it should not be larger than the expected benefit from adjuvant radiotherapy. A large volume of data is available regarding the benefit of adjuvant radiotherapy in breast cancer patients. In the setting of breast conservation surgery, the EBCTCG meta-analysis demonstrated that use of adjuvant radiotherapy reduced the 5-year local recurrences by 17% after breast conservation surgery [2], while in the postmastectomy setting the 5-year local recurrence was reduced by 14.7% for N+ patients [3]. The START trials were designed to show a difference of 5% as the non-inferiority margin [28]. This is approximately 33% of the benefit that can be expected from RT vs no RT. Since the START trials have demonstrated that the 40\u00e2\u0080\u0089Gy is non-inferior to 50\u00e2\u0080\u0089Gy we can thus consider a non-inferiority margin of 3% as appropriate for this study.\n \n \n Sample size\n The sample is calculated based on the assumption that the 5-year local recurrence rate in the control arm is 5% with an exponential distribution. We hypothesize that the use of 1-week course of adjuvant radiotherapy will not increase the locoregional recurrence beyond 8% (absolute difference of 3%), corresponding to a hazard ratio of 1.63. We further assume that patients will be accrued over 5\u00e2\u0080\u0089years with an initial ramp-up in the first year and that 2% of the patients will be lost to follow-up each year of the trial. The total trial duration is expected to be 10\u00e2\u0080\u0089years to ensure a minimum follow-up of 5\u00e2\u0080\u0089years for the last patient. For a fixed sample size design to achieve the required number of events to achieve a one-sided type I error of 0.025 and a power of 80% the total number of events required is 140. The total planned sample size is 2100 patients.", "id": 411, "split": "train"} +{"trial_id": "NCT03788213", "pmid": "32998747", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HYPOfractionated Radiation Therapy Comparing a Standard Radiotherapy Schedule (Over Three Weeks) With a Novel One Week Schedule in Adjuvant Breast Cancer: An Open Label Randomised Controlled Study (HYPORT- Adjuvant)\n\nIncluded conditions:\n- Breast Cancer Female\n\nStudy Armgroups:\n- {'label': '3 week RT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Adjuvant Radiotherapy delivered over 3 weeks', 'interventionNames': ['Radiation: 3 week RT']}\n- {'label': '1 Week RT', 'type': 'EXPERIMENTAL', 'description': 'Adjuvant Radiotherapy delivered over 1 week', 'interventionNames': ['Radiation: 1 week RT']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': '3 week RT', 'description': '40 Gy in 15 fractions over 3 weeks to the whole breast or chest wall. Patients undergoing breast conservation therapy will receive additional boost radiotherapy to the tumor bed. The supraclavicular fossa will be treated in patient with node positive disease or those receiving neoadjuvant chemotherapy. IMC and Axillary radiotherapy will be given as per the institutional policy. Boost Dose schedule for BCS patients will be 8 Gy delivered in 15 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.', 'armGroupLabels': ['3 week RT']}\n- {'type': 'RADIATION', 'name': '1 week RT', 'description': '26 Gy in 5 fractions over 1 week to the whole breast or chest wall. Treatment volumes will be same as the control arm. Additional boost will be delivered to patients who have undergone breast conservation. Boost Dose schedule for BCS patients will be 6 Gy delivered in 5 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.', 'armGroupLabels': ['1 Week RT']}\n\nPrimary Outcomes:\n- {'measure': 'Locoregional Recurrence Rate (LRR)', 'description': 'Cumulative proportion of patients with locoregional recurrence', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a one-sided type I error of 0.025, a power of 80%, and a 2% annual dropout rate. Patients will be accrued over 5 years with a total trial duration of 10 years to ensure a minimum follow-up of 5 years for the last patient.", "answer": 2100, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample is calculated based on the assumption that the 5-year local recurrence rate in the control arm is 5% with an exponential distribution. We hypothesize that the use of 1-week course of adjuvant radiotherapy will not increase the locoregional recurrence beyond 8% (absolute difference of 3%), corresponding to a hazard ratio of 1.63. We further assume that patients will be accrued over 5\u00e2\u0080\u0089years with an initial ramp-up in the first year and that 2% of the patients will be lost to follow-up each year of the trial. The total trial duration is expected to be 10\u00e2\u0080\u0089years to ensure a minimum follow-up of 5\u00e2\u0080\u0089years for the last patient. For a fixed sample size design to achieve the required number of events to achieve a one-sided type I error of 0.025 and a power of 80% the total number of events required is 140. The total planned sample size is 2100 patients.", "id": 412, "split": "train"} +{"trial_id": "NCT03797716", "pmid": "40010809", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-site Randomised Controlled Trial Assessing the Effectiveness of the Little Journey App at Reducing Peri-operative Anxiety Compared to Standard Care.\n\nIncluded conditions:\n- Anxiety Acute\n- Anxiety Fear\n- Peri-operative\n- Psychological Distress\n- Surgery\n- Children, Only\n\nStudy Armgroups:\n- {'label': 'Standard Care arm', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive standard of care from the pre-assessment clinic until discharge.\\n\\nA typical preparatory National Health Service pathway would include: meeting a specialist nurse in the preoperative assessment clinic; a preoperative anaesthetic and surgical consultation; interaction with health play specialists on the day of surgery; and distraction interventions such as hand-held tablets during induction of anaesthesia. Participants may have inhalation or intravenous induction depending on the primary management plan of the anaesthetist in charge.\\n\\nParticipants in the standard care arm will also receive a virtual reality cardboard headset, which can be taken home, personalised and decorated before use with virtual reality apps available to download from the app stores.'}\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': \"Participants allocated to the intervention arm will receive the same peri-operative management as the standard care arm and will also receive an access code enabling them to use the Little Journey app in the weeks leading up to their operation. We suggest the Little Journey app is used in the days to weeks leading up to the child's operation depending on their age. On downloading the app, if parents/carers insert the age of the child and date of surgery into the Little Journey app they will be sent a push notifications reminding them when to use it according to their child's age. However, it can be used as frequently as the child and/or their parents or carers wish before the operation.\", 'interventionNames': ['Device: Little Journey app']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Little Journey app', 'description': 'The Little Journey app allows children to explore 360-degree hospital environments familiarising and desensitising them to areas and staff they\\'ll see on the day of surgery. Children can \"visit\" the day case ward, anaesthetic and recovery rooms where their operation will occur -all while feeling safe in their own home. As the child explores the three areas, they are introduced to animated characters of staff who explain what will happen, the equipment that will be used and how they might feel. Using head tracking technology, the child triggers the animated characters by looking at them; meaning they control the pace of learning and speed at which they progress. The preparatory tool follows a pre-set story-line reflecting what happens from admission to discharge on the day of surgery.', 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'Modified Yale Pre Operative Anxiety scale - short form(m-YPAS-SF)', 'description': 'An independent and blinded observer completed observational scoring tool. Children are scored in four categories: Activity, vocalisations, emotional expressivity and state of apparent arousal, according to pre-determined Likert scale observations. Each category score is divided by its highest possible score, before being added together; these scores are then divided by four and multiplied by 100, giving a value between 22.92 to 100. Higher values indicate greater anxiety levels, with scores greater than 30 typically representing clinically significant anxiety.', 'timeFrame': 'Day of surgery (Day 1): Measured during the induction of anaesthesia in the anaesthetic room'}\n\nPlease estimate the sample size based on the assumption: \nThe interim analysis used a nominal 5% significance level with an O'Brien-Fleming adjustment within a Lan-de Mets framework. The primary outcome was analyzed with a statistical stopping rule for safety only.", "answer": 596, "answer_type": "ACTUAL", "explanation": "Interim analysis and revision of sample size estimation and trial protocol\n We planned to perform an interim analysis following the recruitment of 100 participants to the trial, to check that the baseline rates and variability in m-YPAS-SF which have guided our sample size calculations hold true in our expanded study population. Due to the pandemic, this was performed early with 119 participants recruited and 67 participants having completed their primary outcome data collection. The primary outcome was analysed with a statistical stopping rule for safety only. This analysis was carried out using a nominal 5% significance level with an O\u00e2\u0080\u0099Brien-Fleming adjustment (within a Lan-de Mets framework). This identified no evidence of harm or need to stop the trial.\n However, this analysis revealed a poor correlation between the baseline and preanaesthesia m-YPAS scores. Consequently, the sample size was recalculated without the baseline adjustment, resulting in a revised sample size of 596 patients. The baseline, prerandomisation mY-PAS-SF score was also dropped from data collection.", "id": 413, "split": "train"} +{"trial_id": "NCT03803683", "pmid": "34715833", "question": "Here is the design of a clinical trial:\n\nOfficial Title: mLab App for Improving Uptake of Rapid HIV Self-testing and Linking Youth to Care\n\nIncluded conditions:\n- HIV Infections\n\nStudy Armgroups:\n- {'label': 'mLab App Intervention', 'type': 'EXPERIMENTAL', 'description': \"Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.\", 'interventionNames': ['Device: mLab App', 'Behavioral: HIV Prevention Information', 'Device: HIV Home Tests']}\n- {'label': 'Standard of Care HIV Information Control Arm', 'type': 'ACTIVE_COMPARATOR', 'description': \"Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.\", 'interventionNames': ['Behavioral: HIV Prevention Information']}\n- {'label': 'HIV Home Tests', 'type': 'ACTIVE_COMPARATOR', 'description': \"Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.\", 'interventionNames': ['Behavioral: HIV Prevention Information', 'Device: HIV Home Tests']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'mLab App', 'description': 'The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick\u00ae In-Home HIV Test.', 'armGroupLabels': ['mLab App Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'HIV Prevention Information', 'description': 'Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.', 'armGroupLabels': ['HIV Home Tests', 'Standard of Care HIV Information Control Arm', 'mLab App Intervention']}\n- {'type': 'DEVICE', 'name': 'HIV Home Tests', 'description': 'Youth randomized into this arm will receive OraQuick\u00ae In-Home HIV Test.', 'armGroupLabels': ['HIV Home Tests', 'mLab App Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Total Number of Youth Tested for HIV', 'description': 'Total number of youth tested for HIV at 6 months', 'timeFrame': '6 months'}\n- {'measure': 'Total Number of Youth Tested for HIV', 'description': 'Total number of youth tested for HIV at 12 months', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe power calculations are based on a significance level (alpha) of 0.05, two-sided tests, and an attrition rate of 20% at 6 and 12 months.", "answer": 525, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The targeted enrollment is 525 participants (210, 210, and 105 in arms 1, 2, and 3, respectively). The power and sample size calculations are based on a primary comparison between HIV testing rates in the mLab App arm (Arm 1) and the standard of care arm (Arm 2). The effect size is based on findings from the FORTH trial [38] in which promotion of home-testing resulted in a two times increase in frequency of HIV testing in high-risk MSM and a nearly four times increase in non-recent testers compared with standard care, without reducing the frequency of facility-based HIV testing. We estimate a 40% HIV testing rate over 6\u00e2\u0080\u0089months for the control group and approximately 60% HIV testing rate for the intervention group. We are using a more conservative effect size by assuming 60% testing rate for the intervention as compared to 85% found in the FORTH RCT study [38]. This 20% difference is equivalent to a medium effect size. All power calculations are based on alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and two-sided tests of the primary comparison and an attrition rate of 20% at 6 and 12\u00e2\u0080\u0089months.", "id": 414, "split": "train"} +{"trial_id": "NCT03809884", "pmid": "35164833", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Diet or Additional Supplement to Increase Potassium Intake: An Adaptive Clinical Trial\n\nIncluded conditions:\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Dietary Counselling', 'type': 'EXPERIMENTAL', 'description': 'All enrolled patients will undergo a 1:1 counselling with a registered dietitian (with possible inclusion of family members, as appropriate). The dietitian will undertake an assessment of the comorbidities (e.g. diabetes), dietary intake, dietary habits (e.g. eating out, food preparation, socio-cultural aspects) and provide an individually tailored strategy to increase potassium in the diet. Secondly, on a weekly basis, the dietitian will contact the patient by telephone, or electronically (as preferred by the patient) to reinforce the advice and provide support/advice as necessary.', 'interventionNames': ['Behavioral: Dietary Counselling']}\n- {'label': 'Potassium Citrate Supplement', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients who are not able to successfully increase their potassium intake at 4 weeks with dietary counselling will receive potassium citrate supplements. They will receive oral potassium supplementation in the form of 50 to 100 mmol of potassium citrate (as 25 to 50 ml of the liquid solution).', 'interventionNames': ['Behavioral: Dietary Counselling', 'Drug: Potassium Citrate']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Dietary Counselling', 'description': 'Individually tailored strategy to increase potassium in the diet.', 'armGroupLabels': ['Dietary Counselling', 'Potassium Citrate Supplement']}\n- {'type': 'DRUG', 'name': 'Potassium Citrate', 'description': 'Dosing of 50 to 100 mmol of potassium citrate per day (as 25 to 50 ml of the liquid solution).', 'armGroupLabels': ['Potassium Citrate Supplement'], 'otherNames': ['K-Citra']}\n\nPrimary Outcomes:\n- {'measure': 'Successful increase in potassium intake', 'description': 'As estimated by 24 hour urine results at 4 weeks, achieving a urinary sodium \\\\> 90 mmol/day.', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: p < 0.05 for paired comparisons of continuous outcomes. Power: Not explicitly stated. Missing/dropout rate: Estimated at 20%. No interim analysis planned. Multiple imputation for missing data.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size and analytical plan\n The study goal is to estimate the success rate of the dietary intervention, as well as the success rate of the two-stage approach. Dietary counselling alone will not exceed this degree of increase which was seen with supervised intake and meal provision, but there are no robust data to support an estimate of its effect. However, potassium supplementation at the dose proposed would very likely result in achieved potassium intake of >\u00e2\u0080\u008990\u00e2\u0080\u0089mmol/day in all participants. A sample size of 100 participants will allow us to able to estimate both success rates to within a margin of error of at most 5%. At 4\u00e2\u0080\u0089weeks, there should be little loss to follow-up; however, we estimate this to be about 20% to be conservative. Thus, this trial will enrol 120 participants. Furthermore, there are no plans for additional analyses including subgroup. Multiple imputation will be done for any missing data.\n The primary outcome is a simple proportion of the participants who are able to achieve an increase in potassium intake. Secondary outcomes of the proportion of participants with persistent adequate potassium intake at 52\u00e2\u0080\u0089weeks, and safety outcomes, will also be reported as proportions. For the secondary outcomes of change in sodium, potassium, and blood pressure, the mean differences will be calculated and reported, and a paired t-test will be used to compare for statistical significance. There will be no interim analysis.\n The proportions will be summarized as absolute numbers and percentages. Continuous outcomes will be reported as mean (and 95% confidence intervals). A p value of <\u00e2\u0080\u00890.05 will be used for the paired comparisons of the continuous outcomes (i.e. secondary outcomes of change in sodium, potassium and blood pressure).", "id": 415, "split": "train"} +{"trial_id": "NCT03810755", "pmid": "33158422", "question": "Here is the design of a clinical trial:\n\nOfficial Title: EfiKroniK Research Program: Effectiveness of Physical Exercise for People With Chronic Pathologies. Hybrid, Clinical and Implementation Randomized Trial\n\nIncluded conditions:\n- Neoplasms\n- Schizophrenia\n- COPD\n- Physical Activity\n- Quality of Life\n- Primary Care\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'OTHER', 'description': 'Personalized program (PVS), of proven effectiveness for the promotion of physical activity, diet and smoking cessation.', 'interventionNames': ['Other: Personalized Supervised physical activity']}\n- {'label': 'Supervision group', 'type': 'OTHER', 'description': 'Personalized Supervised physical activity: personalized exercise program for patients, supervised during 3 months by nursing in primary and autonomous care afterwards, with support from community resources', 'interventionNames': ['Other: Personalized Supervised physical activity']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Personalized Supervised physical activity', 'description': 'personalized exercise program for patients, supervised during 3 months by nursing in primary and autonomous care afterwards, with support from community resources', 'armGroupLabels': ['Control group', 'Supervision group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Functional capacity (6 minute walking test)', 'description': 'The Test of the 6-minute applies to assess functional capacity, as well as a predictor of morbidity and mortality in people with different pathologies. Most of the daily activities that the patients with these pathologies are performed at submaximal exercise intensity, similar to this test is performed. In addition, as a method of controlling the intensity. Measurements: baseline, at the end of the exercise program, at 6 and 12 months', 'timeFrame': 'One year follow up'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) = 0.05, power = 90% for most outcomes, 80% power for physical and emotional roles in SF-36 questionnaire, standard deviation of 40s, intra-patient correlation of 0.6, and a 30% loss to follow-up rate.", "answer": 370, "answer_type": "ACTUAL", "explanation": "Sample size\n We expect to recruit a total of 370 patients over 2\u00e2\u0080\u0089years; with a loss to follow-up (including deaths) of 30%, this would provide the study with a power of over 90% to detect differences between the two comparison groups in the primary outcome variable (400-m walk completion time) of at least 6\u00e2\u0080\u0089s after 3\u00e2\u0080\u0089months, 12\u00e2\u0080\u0089s after 6\u00e2\u0080\u0089months and 24\u00e2\u0080\u0089s after 12\u00e2\u0080\u0089months of follow-up as significant (alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), assuming a linear increase in the impact of the exercise over time, a standard deviation of 40\u00e2\u0080\u0089s and intra-patient correlation of 0.6. These differences are less than those found in previous studies.\n Regarding the quality of life outcome variable, we would have a power of 90% to detect differences between the two groups of 2.5 points at 3\u00e2\u0080\u0089months, 5 points at 6\u00e2\u0080\u0089months and 10 points at 12\u00e2\u0080\u0089months as significant (alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), for all the dimensions of the SF-36 questionnaire, except for physical and emotional roles (80% power) [40].", "id": 416, "split": "train"} +{"trial_id": "NCT03815253", "pmid": "34217283", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial\n\nIncluded conditions:\n- Central Obesity\n\nStudy Armgroups:\n- {'label': 'Acupuncture group', 'type': 'EXPERIMENTAL', 'description': 'Body electro-acupuncture will be conducted for 2 sessions per week over 8 consecutive weeks.\\n\\nBody electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.\\n\\nWe will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.', 'interventionNames': ['Other: acupuncture']}\n- {'label': 'sham-acupuncture group', 'type': 'PLACEBO_COMPARATOR', 'description': 'As to the participants allocated to control group, Streitberger\\'s non-invasive acupuncture needles (Gauge 8 x 1.2\" / 0.30 x 30 mm) will be applied to act as sham control at the same acupoints with same stimulation modality. However, the needles will be only adhered to the skin instead of insertion. The validity and credibility of this model has been well demonstrated.', 'interventionNames': ['Other: acupuncture']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'acupuncture', 'description': 'Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.\\n\\nWe will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.', 'armGroupLabels': ['Acupuncture group', 'sham-acupuncture group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in waist circumference', 'description': 'Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).', 'timeFrame': '0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% efficacy, 5% alpha (two tails), 20% dropout rate", "answer": 168, "answer_type": "ACTUAL", "explanation": "Sample size\n The calculation of the sample size is based on the measurement of the main results.\n Our preliminary clinical study of 72 participants\u00e2\u0080\u0099 results [28] showed that electroacupuncture combined with auricular acupressure decreased from baseline to week 8 by 1.57% (sd\u00e2\u0080\u0089=\u00e2\u0080\u00890.025) in WC, compared with 0.14% (sd. = 0.041) in the sham group). Considering 80% efficacy and 5% alpha (two tails), at least 70 subjects in each group were required to test its importance. Considering a 20% dropout rate, we plan to recruit 84 subjects per group, for a total of 168 subjects. Calculations were performed using PASS 11 software in Caseville, Utah, USA.", "id": 417, "split": "train"} +{"trial_id": "NCT03821883", "pmid": "33722871", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Aspirin Discontinuation After Left Atrial Appendage Occlusion in Atrial Fibrillation\n\nIncluded conditions:\n- Atrial Fibrillation\n- Stroke\n- Bleeding\n\nStudy Armgroups:\n- {'label': 'Aspirin group', 'type': 'EXPERIMENTAL', 'description': 'Study patients assigned to Aspirin group will receive enteric coated aspirin (100 mg/day).', 'interventionNames': ['Drug: Aspirin Tablet']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Study patients assigned to control group will receive placebo.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Aspirin Tablet', 'description': 'Aspirin 100mg qd', 'armGroupLabels': ['Aspirin group']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo qd', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Participants with stroke', 'description': 'A stroke is a medical condition in which poor blood flow to the brain results in cell death. There are two main types of stroke: ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding. They result in part of the brain not functioning properly. Signs and symptoms of a stroke may include an inability to move or feel on one side of the body, problems understanding or speaking, dizziness, or loss of vision to one side. If symptoms last less than one or two hours it is known as a transient ischemic attack (TIA) or mini-stroke. A hemorrhagic stroke may also be associated with a severe headache. The symptoms of a stroke can be permanent. Brain computed tomography or MRI may help diagnose stroke.', 'timeFrame': '24 months after the date of randomization.'}\n- {'measure': 'Number of participants with systemic embolism', 'description': 'An embolism is the lodging of an embolus, a blockage-causing piece of material, inside a blood vessel. The embolus is usually a blood clot (thrombus). An embolism can cause partial or total blockage of blood flow in the affected vessel.\\n\\nAn embolism in which the embolus is a piece of thrombus is called a thromboembolism.\\n\\nAn embolism is usually a pathological event, i.e., accompanying illness or injury. Sometimes it is created intentionally for a therapeutic reason, such as to stop bleeding or to kill a cancerous tumor by stopping its blood supply.\\n\\nEmbolism can be classified as to where it enters the circulation either in arteries or in veins. Arterial embolism are those that follow and, if not dissolved on the way, lodge in a more distal part of the systemic circulation.', 'timeFrame': '24 months after the date of randomization.'}\n- {'measure': 'Number of participants with cardiovascular/unexplained death', 'description': 'Cardiovascular deaths refer to deaths due to heart dysfunction, injury of cardiac structure, coronary artery diseases and lethal arrhythmias or sudden death that cannot be explain. Cardiovascular deaths can be diagnosed with clinical symptoms or from the results of diagnostic examinations.', 'timeFrame': '24 months after the date of randomization.'}\n- {'measure': 'Number of participants with major bleedings', 'description': 'Major bleedings refer to the heavy bleedings of the mains organs of the body, usually include intracranial bleeding and gastrointestinal bleeding et al.. Brain computed tomography and gastrointestinal endoscope are the common approaches for diagnosing major bleedings.', 'timeFrame': '24 months after the date of randomization.'}\n- {'measure': 'Number of participants with acute coronary syndrome', 'description': 'Acute coronary syndrome is a syndrome (set of signs and symptoms) due to decreased blood flow in the coronary arteries such that part of the heart muscle is unable to function properly or dies. The most common symptom is chest pain, often radiating to the left shoulder or angle of the jaw, crushing, central and associated with nausea and sweating. Many people with acute coronary syndromes present with symptoms other than chest pain, particularly, women, older patients, and patients with diabetes mellitus.\\n\\nAcute coronary syndrome is commonly associated with three clinical manifestations, named according to the appearance of the electrocardiogram (ECG): ST elevation myocardial infarction (STEMI, 30%), non-ST elevation myocardial infarction (NSTEMI, 25%), or unstable angina (38%). There can be some variation as to which forms of myocardial infarction (MI) are classified under acute coronary syndrome.', 'timeFrame': '24 months after the date of randomization.'}\n- {'measure': 'Number of participants with coronary or periphery artery disease requiring revascularization', 'description': 'Conronary or periphery artery diseases, regardless stable or not, need revascularization by stent which require long-term aspirin therapy', 'timeFrame': '24 months after the date of randomization.'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a power of 0.8, a one-sided alpha of 0.025, and a 10% attrition rate.", "answer": 1120, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n The statistical objective is to determine if the control group is non-inferior to the aspirin group with respect to the event rate for the composite endpoints. The reasons for the non-inferiority design are as follows. First, aspirin, as one of the most widely used drugs, serves as a standard treatment. Second, if placebo is non-inferior to aspirin, discontinuation of aspirin post LAAO will be of high cost effectiveness and may improve quality of life if not on medication. Also, testing the non-inferiority hypothesis requires smaller sample size.\n Event rate is defined as the expected number of events per 100 patient years of follow-up. The study event rate is the combination of event rates from both the aspirin and placebo arms. The estimated event rates for this trial were established based on the rates seen in the LAAO arm of previous Watchman studies and the aspirin arm of previous aspirin trials.13 14 16\u00e2\u0080\u009318 20 30\u00e2\u0080\u009333 In the EWOLUTION study, the rates of stroke, major bleeding and cardiovascular death were 1.3%, 2.7% and 2.25%, respectively.17 In the ASCEND (A Study of Cardiovascular Events iN Diabetes) trial, the rates of myocardial infarction and vascular diseases requiring revascularisation were approximately 0.9%.32 Therefore, we conservatively estimate a combined rate for the primary endpoint of 7 events per 100 patient-years. A risk ratio criterion (control group over aspirin group) of 1.5 will be used to establish non-inferiority with a power of 0.8. Therefore, 191 events are required to be observed based on one-sided alpha of 0.025. The subject recruitment is assumed to be over a 2-year period and all subjects will be followed up until 2 years after the last recruitment. Given these assumptions, the sample size of the ASPIRIN LAAO trial is calculated as 1120 subjects, considering a 10% attrition rate. The attrition rate is estimated according to our follow-up data of a previous registry regarding Watchman device implantation (ClinicalTrials.gov: NCT03788941). Achieving adequate participant enrollment to reach target sample size should be feasible within the 2-year recruitment period due to the large operation volume of the participating centres. To further facilitate the recruitment of patients, advertisement of this study will be exhibited by posters in the wards and outpatient clinics.", "id": 418, "split": "train"} +{"trial_id": "NCT03825198", "pmid": "31315670", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Randomized Double Blind Trial of the Efficacy of a Bilateral Lumbar Erector Spinae Block on the 24h Morphine Consumption After Posterior Lumbar Interbody Fusion Surgery.\n\nIncluded conditions:\n- Pain, Postoperative\n- Anaesthesia\n- Surgery\n- Nerve Block\n- Anesthesia, Local\n- Back Pain\n- Spinal Fusion\n\nStudy Armgroups:\n- {'label': 'ESB group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Erector Spinae plane block with 20 ml levobupivacaine 0,25% on each side. General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane.\\n\\nPostoperative analgesia with Ketorolac (0,5 mg/kg), paracetamol 1000 mg (4 times/ day) and Morphine PCA. Dexamethasone is administered for the prevention of nausea.', 'interventionNames': ['Procedure: Erector spinae plane block', 'Drug: Levobupivacaine 0,25%', 'Procedure: spine fusion', 'Drug: Sufentanil', 'Drug: propofol', 'Drug: Rocuronium Bromide', 'Drug: sevoflurane', 'Drug: paracetamol', 'Drug: Ketorolac', 'Drug: morphine pca', 'Drug: Dexamethasone', 'Drug: Morphine']}\n- {'label': 'SHAM group', 'type': 'SHAM_COMPARATOR', 'description': 'Erector Spinae plane block with 20 ml NaCl 0,9% on each side General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane.Postoperative analgesia with Ketorolac (0,5 mg/kg, paracetamol 1000 mg 4times/ day and Morphne PCA .Dexamethasone is administered for the prevention of nausea.', 'interventionNames': ['Procedure: Erector spinae plane block', 'Procedure: spine fusion', 'Drug: NaCL 0,9%', 'Drug: Sufentanil', 'Drug: propofol', 'Drug: Rocuronium Bromide', 'Drug: sevoflurane', 'Drug: paracetamol', 'Drug: Ketorolac', 'Drug: morphine pca', 'Drug: Dexamethasone', 'Drug: Morphine']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Erector spinae plane block', 'description': 'Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle', 'armGroupLabels': ['ESB group', 'SHAM group'], 'otherNames': ['Locoregional anaesthesia']}\n- {'type': 'DRUG', 'name': 'Levobupivacaine 0,25%', 'description': '20 ml levobupivacaine 0,25% used for the infiltration between the transverse process and the erector spinal muscle', 'armGroupLabels': ['ESB group'], 'otherNames': ['chirocaine']}\n- {'type': 'PROCEDURE', 'name': 'spine fusion', 'description': 'fusion of lumbar vertebral body on 1 or two levels', 'armGroupLabels': ['ESB group', 'SHAM group']}\n- {'type': 'DRUG', 'name': 'NaCL 0,9%', 'description': '20 ml solution used for the infiltration between the transverse process and th erector spinal muscle', 'armGroupLabels': ['SHAM group']}\n- {'type': 'DRUG', 'name': 'Sufentanil', 'description': 'opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)', 'armGroupLabels': ['ESB group', 'SHAM group'], 'otherNames': ['sufenta']}\n- {'type': 'DRUG', 'name': 'propofol', 'description': 'induction agent for general anaesthesia ( 2-3 mg/kg)', 'armGroupLabels': ['ESB group', 'SHAM group']}\n- {'type': 'DRUG', 'name': 'Rocuronium Bromide', 'description': 'muscle relaxant used during general anaesthesia ( 0,5 mg/kg)', 'armGroupLabels': ['ESB group', 'SHAM group'], 'otherNames': ['sermon']}\n- {'type': 'DRUG', 'name': 'sevoflurane', 'description': 'inhalation aesthetic used for the maintenance of general anaesthesia', 'armGroupLabels': ['ESB group', 'SHAM group']}\n- {'type': 'DRUG', 'name': 'paracetamol', 'description': 'postoperative drug for analgesia ( 1 gram 4/day)', 'armGroupLabels': ['ESB group', 'SHAM group']}\n- {'type': 'DRUG', 'name': 'Ketorolac', 'description': 'non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg)', 'armGroupLabels': ['ESB group', 'SHAM group']}\n- {'type': 'DRUG', 'name': 'morphine pca', 'description': 'postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml', 'armGroupLabels': ['ESB group', 'SHAM group'], 'otherNames': ['patient controlled analgesia']}\n- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'drug given during general anaesthesia to prevent postoperative nausea', 'armGroupLabels': ['ESB group', 'SHAM group'], 'otherNames': ['aacidexam']}\n- {'type': 'DRUG', 'name': 'Morphine', 'description': 'loading dose morhine 0,1 mg/kg at the end of surgery', 'armGroupLabels': ['ESB group', 'SHAM group']}\n\nPrimary Outcomes:\n- {'measure': '24 hour morphine consumption', 'description': 'total milligrams (0-150) of morphine used in the first 24 hours after surgery, extracted out of the pca pump data.', 'timeFrame': '24 hours'}\n\nPlease estimate the sample size based on the assumption: \nMean morphine consumption of 51 mg with a standard deviation of 19 mg, type 1 failure risk (significance level) of 5%, type 2 failure risk (power) of 20%, and the use of an independent samples t test.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our sample size calculation is based on data from a randomized controlled trial comparing the effect of systemic infused lidocaine with placebo on the 24-h morphine requirement in posterior lumbar arthrodesis [11]. We considered a 25% reduction in PCA morphine consumption to be clinically relevant. To calculate the sample size, we assumed a mean of 51-mg morphine with standard deviation of 19\u00e2\u0080\u0089mg (mean morphine consumption for the placebo group of the above-mentioned trial), a type 1 failure risk of 5%, and a type 2 failure risk of 20%. Thirty-five patients are required in each group to detect a 25% reduction in morphine equivalent over 24\u00e2\u0080\u0089h. The sample size calculation was based on an independent samples t test. We plan to include 80 patients in total to compensate for potential dropouts and uncertainty in predicting the actual standard deviation.", "id": 419, "split": "train"} +{"trial_id": "NCT03825835", "pmid": "38576007", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants - The HiLo-Trial\n\nIncluded conditions:\n- Premature Infant\n- Respiratory Distress Syndrome in Premature Infant\n- Neurodevelopmental Outcome\n\nStudy Armgroups:\n- {'label': '30% group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Infants in the 30% oxygen group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \\\\<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.\\n\\nIntervention: Infants randomized to the 30% oxygen group will receive 30% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.', 'interventionNames': ['Drug: 30% oxygen group']}\n- {'label': '60% group', 'type': 'EXPERIMENTAL', 'description': 'Infants in the 60% oxygen group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \\\\<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.\\n\\nIntervention: Infants randomized to the 60% oxygen group will receive 60% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.', 'interventionNames': ['Drug: 60% oxygen group']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '30% oxygen group', 'description': 'Infants in the 30% oxygen group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \\\\<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.\\n\\nIntervention: Infants randomized to the 30% oxygen group will receive 30% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.', 'armGroupLabels': ['30% group']}\n- {'type': 'DRUG', 'name': '60% oxygen group', 'description': 'Infants in the 60% oxygen group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is \\\\<85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.\\n\\nIntervention: Infants randomized to the 60% oxygen group will receive 60% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed.', 'armGroupLabels': ['60% group']}\n\nPrimary Outcomes:\n- {'measure': 'Neurodevelopmental outcome at 24+/- 6 months', 'description': 'At 24+/- 6 months corrected age, the infants will be assessed using the Bayley Scales of Infant Development-3rd edition (Bayley-III). A score 85-114 will be classified as normal, and scores \\\\<70 (2 SD below the mean of 100) will define severe cognitive delay.', 'timeFrame': '24+/- 6 months of age'}\n- {'measure': 'Hearing loss', 'description': 'Audiometry will be performed to assess the presence or absence of severe hearing loss.', 'timeFrame': '24+/- 6 months of age'}\n- {'measure': 'Blindness', 'description': 'Blindness will be defined as a corrected visual acuity of \\\\<20/200.', 'timeFrame': '24+/- 6 months of age'}\n- {'measure': 'Mortality', 'description': 'All cause mortality from birth until follow-up at 24+/- 6 months of age', 'timeFrame': 'From birth up to 24+/- 6 months of age'}\n\nPlease estimate the sample size based on the assumption: \ntype I error of 5%, power of 80%, within-cluster within-period ICC of 0.034, within-cluster between-period ICC of 0.029, cluster size in each arm of 10-80 (unequal cluster period but equal cluster size), loss to follow-up rate of ~10%", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A sample size of 1200 (600 per group, adjusted for 10% loss of follow-up) infants has been determined based on: baseline outcome rate of 35% (18% mortality and 17% abnormal neurodevelopmental outcomes) [48], RRR of 25%, type I error of 5%, power of 80%, within-cluster within-period ICC of 0.034, within-cluster between-period ICC of 0.029, cluster size in each arm of 10\u00e2\u0080\u009380 (unequal cluster period but equal cluster size), and loss to follow-up rate of\u00e2\u0080\u0089~\u00e2\u0080\u008910%. ICCs were derived from existing data from the Canadian Neonatal Network sites [48]. With these assumptions, we will need up to 20 centers (clusters) to recruit 20\u00e2\u0080\u009380 patients per arm (20\u00e2\u0080\u0093160/center) for a total of 1200 neonates at all sites.", "id": 420, "split": "train"} +{"trial_id": "NCT03831178", "pmid": "31530611", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Docosahexaenoic Acid (DHA) for Women With Breast Cancer in the Neoadjuvant Setting\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'DHA', 'type': 'EXPERIMENTAL', 'description': 'Participants will take 11 capsules per day containing DHA-enriched triglyceride oil (1 g capsules containing at least 400 mg DHA) for a total of 5 g DHA/day divided into three times daily with meals or as tolerated.', 'interventionNames': ['Dietary Supplement: Docosahexaenoic acid (DHA)']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will take 11 capsules per day containing corn/soy oil blend capsules divided into three times daily with meals or as tolerated.', 'interventionNames': ['Drug: Placebo oral capsule']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Docosahexaenoic acid (DHA)', 'description': 'Participants will take 11 capsules of DHA oil for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.', 'armGroupLabels': ['DHA']}\n- {'type': 'DRUG', 'name': 'Placebo oral capsule', 'description': 'Participants will take 11 capsules of placebo (corn/soy oil blend) for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Percent change in Ki67 index from baseline to surgical excision.', 'description': 'Ki67 will be measured by image analysis at baseline biopsy and at experimental end (surgical excision).', 'timeFrame': 'Pre-intervention (on the baseline biopsy) and post- intervention (at the time of surgical excision).'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a two-sided t-test with a significance level of 0.05 (achieved 0.0497) and 81% power. The dropout rate is estimated at approximately 10%.", "answer": 52, "answer_type": "ESTIMATED", "explanation": "Sample size\n Fifty-two women prescribed neoadjuvant breast cancer chemotherapy will be enrolled in a two-arm trial with 26 participants per arm. The sample size calculation is based on the primary objective, which is to determine the efficacy of supplemental DHA provided with standard neoadjuvant as measured by change in the Ki67 index from biopsy to surgical excision. Group sample sizes of 23 patients in each group are required to achieve 81% power to detect a difference between the group proportions of 0.4. The proportion in group 1 is assumed to be 0.3 under the null hypothesis and 0.7 under the alternate hypothesis. The proportion in group 2, which is the control group, is 0.3. The test statistic used is the two-sided t-test. The significance level of the test was targeted at 0.05, and the significance level actually achieved by this design is about 0.0497. Assuming a dropout rate estimated at approximately 10% for this patient population, which is approximately 5 patients, a total of 52 patients (26 patients in the DHA supplementation group and 26 in the placebo group) are required for the study.", "id": 421, "split": "train"} +{"trial_id": "NCT03831243", "pmid": "31484505", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase III Randomized-controlled, Single-blind Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases\n\nIncluded conditions:\n- Metastasis to Bone\n- Radiotherapy\n- Neoplasm Metastasis\n\nStudy Armgroups:\n- {'label': 'Single fraction of 8 Gy', 'type': 'ACTIVE_COMPARATOR', 'description': 'The current standard treatment will be prescribed, i.e. a 3D-conformal radiotherapy of a single fraction dose of 8.0 Gy to the metastasis with a planning target volume (PTV) margin for set-up and positioning uncertainties of 1 cm. This can be performed at any linear accelerator.', 'interventionNames': ['Radiation: 3D-conformal radiotherapy']}\n- {'label': 'Single fraction of 20 Gy', 'type': 'EXPERIMENTAL', 'description': 'Within the framework of stereotactic body radiotherapy, a single fraction dose of 20.0 Gy will be delivered to the metastasis using a PTV margin of 3-5 mm based on high-precision image-guided radiotherapy (IGRT). Therefore, only linear accelerators with the European Organization for Radiotherapy \\\\& Oncology advisory committee on radiation oncology practice (ESTRO-ACROP) specifications for SBRT can be accepted. A risk-adapted approach will be applied, aiming for the highest possible dose no less than 16 Gy, while respecting the tolerances of critical organs at risk (e.g. spinal cord, cauda equina, brainstem etc.).', 'interventionNames': ['Radiation: Stereotactic body radiotherapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Stereotactic body radiotherapy', 'description': 'Treatment will be prescribed to the periphery of the target, i.e. 80% of the dose should cover 95% of the PTV. The organ at risk (OAR) dose constraints will be in accordance with the recommendations from the report of the American Association of Physicists in Medicine (AAPM) task group 101. Image-guidance will consist of cone-beam CT in combination with 6 degrees of freedom corrections using robotic couch.', 'armGroupLabels': ['Single fraction of 20 Gy']}\n- {'type': 'RADIATION', 'name': '3D-conformal radiotherapy', 'description': 'In the standard setting, 95% of the PTV should receive 95% of the prescribed dose while near maximum dose (Dnear-max) in the PTV should not exceed 107%. Image-guidance will consist of portal images showing the relevant bony anatomy.', 'armGroupLabels': ['Single fraction of 8 Gy']}\n\nPrimary Outcomes:\n- {'measure': 'Pain response', 'description': 'Pain response at the treated index site at 1 month after radiotherapy (RT), as defined by the consensus statement.', 'timeFrame': '4 weeks after RT visit'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 0.05, power of 0.8, and a drop-out rate of 10%.", "answer": 126, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Currently, a complete pain response rate of maximum 25% after a single fraction of 8.0\u00e2\u0080\u0089Gy can be assumed [1\u00e2\u0080\u00933]. With 116 patients, we can show a statistically significant increase to 50% in complete pain response (with Type I error of 0.05 and power of 0.8). Assuming a drop-out rate of 10%, we need to include 126 patients.", "id": 422, "split": "train"} +{"trial_id": "NCT03840005", "pmid": "32759251", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial To Assess The Safety And Tolerability Of 30mg/kg Daily Ursodeoxycholic Acid (UDCA) In Patients With Parkinson's Disease (PD)\n\nIncluded conditions:\n- Parkinson's Disease\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '2:1 in favour of UDCA', 'interventionNames': ['Drug: Ursonorm']}\n- {'label': 'Ursonorm (Ursodeoxycholic acid)', 'type': 'EXPERIMENTAL', 'description': 'UDCA 30 mg/kg daily, tablet form taking orally , administered 3 monthly for 12 months, dose titration during the 1st month will occur.', 'interventionNames': ['Drug: Ursonorm']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ursonorm', 'description': 'Ursodeoxycholic acid', 'armGroupLabels': ['Placebo', 'Ursonorm (Ursodeoxycholic acid)'], 'otherNames': ['UDCA']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Participants with Incidence of Treatment-Emergent Adverse Events', 'description': 'Safety of a 56-week UDCA Intervention will be assessed by measuring the number of participants with adverse events that are related to treatment.', 'timeFrame': 'Timepoint: start of treatment to 56 weeks (visit 6)'}\n- {'measure': 'Number of Participants with Incidence of Serious Adverse Events', 'description': 'Safety of a 56-week UDCA Intervention will be assessed by measuring the number of participants with serious adverse events.', 'timeFrame': 'Timepoint: start of treatment to 56 weeks (visit 6)'}\n- {'measure': 'Number of Participants that complete the study', 'description': 'Safety of a 56-week UDCA Intervention will be assessed by measuring the number of participants that complete the study.', 'timeFrame': 'Timepoint: start of treatment to 56 weeks (visit 6)'}\n\nPlease estimate the sample size based on the assumption: \nThe study is a pilot and is not powered to statistically compare the SAE rate between the groups. The sample size has not been adjusted for lost to follow-up, but participants withdrawing or lost to follow-up will be replaced. The study is not formally powered for secondary or exploratory outcomes, and interpretation will focus on observed trends and confidence intervals.", "answer": 31, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary outcome of interest for this study is the safety and tolerability of UDCA which will be assessed by comparing the rate of SAEs in the UDCA and placebo groups, alongside review of adverse treatment reactions and study completion. As the study is a pilot, it is not powered to compare the SAE rate between the groups statistically, but any SAEs in either group will be presented descriptively, the placebo group providing a baseline against which to view any SAEs in the UDCA group. Should this study result in no SAEs then it would be of interest to determine how likely it is that a larger study would find an intolerable rate of SAEs. For this purpose, we will consider the rate of SAEs reported in the exenatide PD trial to be tolerable and acceptable (ie, 20%).15 In this study, should no SAEs be found in the group receiving UDCA (n=20) then the likelihood that the true SAE rate is less than 20% is 0.990778.\n The sample size has not been prospectively adjusted to account for any lost to follow-up. Instead, as the trial is of a relatively short duration we have instead allowed for any participants withdrawing from the study or lost to follow-up before the completion of 12 weeks of treatment to be replaced with a new participant.\n The study has not been powered formally for the secondary or exploratory outcome measures, therefore, interpretation will concentrate on observed trends and confidence intervals for estimated differences. The data collected for the secondary and exploratory outcomes will allow the estimation of the effect size and variance in each outcome to facilitate formal power calculations for future phase III studies. Of note, there is currently no longitudinal clinical trial data using either 31P-MRS or our sensor-based approached quantification of motor impairment. The collection of such data is critical to allow high-quality future trial design using these novel outcome measures.", "id": 423, "split": "train"} +{"trial_id": "NCT03841305", "pmid": "32560632", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Simultaneous Portal and Hepatic Vein Embolization Versus Portal Vein Embolization for Hypertrophy of the Future Liver Remnant Before Major Hepatectomy of Non-cirrhotic Liver : a Multicentric Comparative Randomized Phase II Trial\n\nIncluded conditions:\n- Liver Metastasis Colon Cancer\n\nStudy Armgroups:\n- {'label': 'portal vein embolization', 'type': 'ACTIVE_COMPARATOR', 'description': 'Liver preparation before major hepatectomy : portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.', 'interventionNames': ['Procedure: Liver preparation before major hepatectomy']}\n- {'label': 'liver venous deprivation', 'type': 'EXPERIMENTAL', 'description': 'Liver preparation before major hepatectomy : Patients with the liver venous deprivation (LVD) technique that combines both PVE and hepatic vein embolization (HVE) during the same procedure.', 'interventionNames': ['Procedure: Liver preparation before major hepatectomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Liver preparation before major hepatectomy', 'description': 'Simultaneous portal and hepatic vein embolization versus Portal vein embolization, also called venous deprivation OR portal vein embolization.', 'armGroupLabels': ['liver venous deprivation', 'portal vein embolization']}\n\nPrimary Outcomes:\n- {'measure': 'increase in volume of the future remnant liver (FRL)', 'description': 'The primary outcomes is to compare the increase in volume of the future remnant liver (FRL)', 'timeFrame': 'at 3 weeks after liver venous deprivation (LVD) or portal vein embolization (PVE) using MRI or CT-scan'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation of 14% in each arm, two-sided \u03b1 = 5%, power of 90%, and a 5% dropout rate.", "answer": 64, "answer_type": "ACTUAL", "explanation": "Sample size and follow-up period\n Our hypotheses for sample size calculation are based on a systematic review on PVE before liver resection, involving 1791 patients [9]: the mean increase of the FLR volume was 37.9% at 26\u00e2\u0080\u0089days. In our preliminary study [5] and in a more recent paper by Le Roy et al. [10], a mean increase of 53% of the FLR volume was observed after 3\u00e2\u0080\u0089weeks. Therefore, it is realistic to expect a difference of 12% (or more) between the 2 procedures at 21\u00e2\u0080\u0089days. With a standard deviation of 14% in each arm, a two-sided \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00895% and a power of 90%, according to a Student Test, 30 patients have to be randomized by arm. Taking into account that 5% of the patients could not be evaluable, 32 patients have to be randomized per arm. Finally, planned enrollment will be 64 subjects. The expected duration of the recruitment of all patients is 24\u00e2\u0080\u0089months with a minimal duration of the subject participation of 5\u00e2\u0080\u0089months.", "id": 424, "split": "train"} +{"trial_id": "NCT03842319", "pmid": "34772433", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of MEditerranean Diet, Inflammation and Microbiome on Plaque Vulnerability and Microvascular Dysfunction After an Acute Coronary Syndrome. A Randomized, Controlled, Mechanistic Clinical Trial.\n\nIncluded conditions:\n- Acute Coronary Syndrome\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'EXPERIMENTAL', 'description': 'In patients allocated to the control group, the currently used Spanish Mediterranean diet will be recommended as part of a standard high-quality secondary prevention program, where the patient is invited to participate in a single 45 minute nutritional educational group session. Interventions: Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation', 'interventionNames': ['Other: Microbiota analysis', 'Other: Immunological analysis', 'Other: Proteome analysis', 'Other: Metabolome analysis', 'Other: Clinical evaluation', 'Other: Diet evaluation']}\n- {'label': 'High-intensity MedDiet', 'type': 'EXPERIMENTAL', 'description': \"Patients allocated to the interventional group will be individually evaluated by a dietitian and will participate in dedicated individual and group sessions at baseline, and at 3, 6, 9 and 12 months. In the interventional group, a personalized MedDiet will assess chemical and nutritional composition and total energy intake will be adapted to participant's weight, age, and requirements, and the dietitian's tailored advice to his/her individual needs. A 14-item dietary screen for adherence to the Mediterranean diet will be used to personalize the intervention and negotiate dietary changes. Furthermore, free virgin olive oil, recipes, shopping list and designed weekly menus will be provided to maximize the differences between groups. Interventions: MedDiet, Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation, Diet evaluation\", 'interventionNames': ['Other: Microbiota analysis', 'Other: Immunological analysis', 'Other: Proteome analysis', 'Other: Metabolome analysis', 'Other: Clinical evaluation', 'Other: Diet evaluation', 'Other: MedDiet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Microbiota analysis', 'description': 'From the feces and oral cavity samples, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons.', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}\n- {'type': 'OTHER', 'name': 'Immunological analysis', 'description': 'A study of immunological cell populations, inmunogenetics and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}\n- {'type': 'OTHER', 'name': 'Proteome analysis', 'description': 'A study of host and microbiota proteome will be carried out from samples using mass spectrometry', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}\n- {'type': 'OTHER', 'name': 'Metabolome analysis', 'description': 'A study of host and microbiota metabolome will be carried out from samples using MS-based as well as NMR-based methods', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}\n- {'type': 'OTHER', 'name': 'Clinical evaluation', 'description': 'Clinical evaluation including hemostasis and biochemical studies', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}\n- {'type': 'OTHER', 'name': 'Diet evaluation', 'description': 'Biochemical analysis and questionaries for diet adherence and exercise registration', 'armGroupLabels': ['Control', 'High-intensity MedDiet']}\n- {'type': 'OTHER', 'name': 'MedDiet', 'description': 'The high-intensity Mediterranean diet will include the promotion of the following: a) abundant use of olive oil (\\\\>40 g/d) for cooking and dressing dishes; b) consumption of \\\\>2 daily servings of vegetables; c) \\\\>2-3 daily serving of fresh fruits; d) \\\\>3 weekly servings of legumes; e) \\\\>3 weekly servings of fish or seafood; f) \\\\>1 weekly serving of nuts or seeds; g) select white meats instead of red meats or processed meats; and h) cook regularly with tomato, garlic and onion adding or no other aromatic herbs, and dress vegetables, pasta, rice and other dishes with tomato, garlic and onion adding or no other aromatic herbs. Two main meals per day should be eaten (seated at a table, lasting more than 20 minutes). A recommendation to drink a glass of wine per day during meals is given. Limited consumption is advised for cured ham, red meat, chocolate, cured or fatty cheeses', 'armGroupLabels': ['High-intensity MedDiet']}\n\nPrimary Outcomes:\n- {'measure': 'Fibrous cap thickness change', 'description': 'Change in the thickness of the fibrous layer of the atheroma plaque in the non-culprit vessel measured by optical coherence tomography at 12 months.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sample bilateral alpha error of 0.05, power of 0.80, and an attrition rate of 10%.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size of the MEDIMACS clinical trial has been calculated on the assumption of an expected difference of 40% on the relative change in the fibrous cap thickness of the atherosclerotic plaque from baseline to 12\u00e2\u0080\u0089months between patients undergoing a high-intensity MedDiet intervention in comparison with the standard of care. This magnitude is a 10% lower than the difference previously reported using a similar design in a clinical trial comparing the effect on the fibrous cap of lipid-lowering therapy with 5\u00e2\u0080\u0089mg/day versus 20\u00e2\u0080\u0089mg/day atorvastatin, with an estimated standard deviation of 58% [37]. Based on a two-sample bilateral alpha error of 0.05 and a power of 0.80, the required number of patients is 35 per group. Assuming an attrition rate of 10%, 100 patients are needed to be randomized following a 1:1 allocation ratio. With this sample size, different scenarios could be contemplated under potential deviations from the expected effect size (Table 2).\nTable 2Alternative scenarios for statistical power with n = 100 sample size, assuming 10% attrition ratesEffect sizePowerComment50%100%Effect addressed in EASY-FIT Study40%99.60%Baseline assumptions30%93.45%Effect 25% relatively lower than expected\n Regarding the suitability of this sample size to evaluate the secondary endpoints, micro- and macrovascular endothelial functions are proven to be highly sensitive to detect meaningful effects using small sample populations (50\u00e2\u0080\u0093100 patients) [38, 39]. Microbiota, immunological and metabolic changes in response to diet interventions have been widely reported using small sample populations (20\u00e2\u0080\u009350 patients), particularly under pathological conditions [40, 41].", "id": 425, "split": "train"} +{"trial_id": "NCT03842579", "pmid": "32653012", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of High-protein Diet Combined With Exercise to Counteract Frailty in Pre-frail and Frail Community-dwelling Older Adults: a Three-arm Randomized Controlled Trial\n\nIncluded conditions:\n- Physical Frailty\n\nStudy Armgroups:\n- {'label': 'Exercise and Protein (EXEPROT)', 'type': 'EXPERIMENTAL', 'description': 'Participants in EXEPROT receive: a high-protein diet combined with Resistance training. The high-protein diet is based on milk-based protein-rich products to supplement the habitual diet (corresponding to a protein intake of 1.5 g/kg/day). 4-day food records are used to estimate the needed protein. Of the shelf-products (e.g. milk, cheese) are used considering the individually preferences. Products are delivered once a week. The training intervention includes progressive explosive type heavy-resistance training two times per week. The intervention runs for 16 weeks. Adherence to the training protocol is monitored at each session. Adherence with the nutrition protocol is monitored daily plus at phone follow-ups where participants are asked about e.g. appetite, weight, habitual intake.', 'interventionNames': ['Other: Resistance training', 'Other: High-protein diet']}\n- {'label': 'Protein-only (PROT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in PROT-group receive the nutritional intervention: The high-protein diet.\\n\\nThe diet is based on daily milk-based protein-rich products to supplement the habitual diet (corresponding to a total protein intake of 1.5 g/kg/day). The needed amount of protein supplementation is estimated from 4-day food records. Of the shelf-products (e.g. milk, skyr, cheeses) are used considering the individually preferences. Products will be delivered once a week at the home of the participant. The intervention runs for 16 weeks.\\n\\nAdherence with the nutrition protocol is monitored daily (registration of compliance with the dietary plan) as well as at phone follow-ups where participants are asked about e.g. changes in appetite, weight, and habitual intake.', 'interventionNames': ['Other: High-protein diet']}\n- {'label': 'Recommendations (REC)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the REC-Group receive the comparative intervention: Recommendations.\\n\\nThe official national dietary recommendations for adults \\\\>65 years, developed by the Ministry of Environment and Food of Denmark, and related materials is given to the participants and they are encouraged to follow the guidelines (recommending a protein intake of 1.0-1.3 g/kg/day). The intervention runs for 16 weeks.\\n\\nDuring the intervention all groups will receive two seminars on specific topics related to healthy ageing (e.g. talks on physical activity, sedentary behaviour, and nutrition).', 'interventionNames': ['Other: Recommendations']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Resistance training', 'description': 'Supervised progressive explosive type heavy-resistance training two times per week', 'armGroupLabels': ['Exercise and Protein (EXEPROT)']}\n- {'type': 'OTHER', 'name': 'High-protein diet', 'description': 'Daily supplementation with milk-based protein-rich products', 'armGroupLabels': ['Exercise and Protein (EXEPROT)', 'Protein-only (PROT)']}\n- {'type': 'OTHER', 'name': 'Recommendations', 'description': 'Provided with the official national recommendations on nutrition', 'armGroupLabels': ['Recommendations (REC)']}\n\nPrimary Outcomes:\n- {'measure': 'Changes from baseline lower leg muscle power at 4 months', 'description': 'Lower leg muscle power will be assessed unilaterally using the Nottingham Leg Rig', 'timeFrame': 'Baseline and 4-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level of 0.05, a power of 0.8, and a dropout rate of 25%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n Muscle power is the primary outcome of this study. Due to lack of studies comparable to this study design (e.g., age and frailty status of the participants, type of exercise and level of protein supplementation), we have calculated sample size using a combination of studies and methods. Based on findings by Bechsh\u00c3\u00b8ft et al. [36], the effect of 12\u00c2\u00a0weeks of protein supplementation (two daily supplements of 20\u00e2\u0080\u0089g milk protein) in combination with resistance training in +\u00e2\u0080\u008980-year-old healthy adults increased muscle power by 15% (SEM \u00c2\u00b1\u00e2\u0080\u00895%) in comparison with \u00e2\u0088\u0092\u00e2\u0080\u00897% (SEM\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00896%) in the control group (receiving protein supplementation only). In the study by Park et al. [37], 12\u00e2\u0080\u0089weeks of protein supplementation (0.8\u00e2\u0080\u0089g/kg/day, 1.2\u00e2\u0080\u0089g/kg/day, or 1.5\u00e2\u0080\u0089g/kg/day) to pre-frail or frail older adults above 70\u00e2\u0080\u0089years resulted in an increase in muscle mass (estimated by DXA) of approximately 4% in the group receiving 1.5\u00e2\u0080\u0089g/kg/day. Unpublished data from our own group shows that change in muscle mass (estimated by DXA) accounted for 1.95% of the change in muscle power (power-rig) in older adults following 12\u00e2\u0080\u0089weeks of explosive resistance training. Hence, the estimated effect of an increase in muscle mass of 4% on muscle power is 7.8%. Adding this to the results from Bechsh\u00c3\u00b8ft et al. [36] gives us an estimated change on 0.8% in the PROT group. Assuming that the change in muscle mass are comparable in the three groups, we therefore expect a change in muscle power of 15%, 0.8%, and \u00e2\u0088\u0092\u00e2\u0080\u00897% with a SD of 30 in the EXEPROT, PROT, and REC groups, respectively.\n Setting a power of 0.8 a sample size with 37 participants in each arm should be enough to detect a significant difference in muscle power (significance level at 0.05). Adding 25% to account for dropouts a total of 150 participants is needed.\n Strength calculation was made in PASS 14.", "id": 426, "split": "train"} +{"trial_id": "NCT03843385", "pmid": "35193638", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis\n\nIncluded conditions:\n- Ulcerative Colitis\n- Inflammatory Bowel Diseases\n\nStudy Armgroups:\n- {'label': 'faecal microbiota filtrate', 'type': 'EXPERIMENTAL', 'description': 'Encapsulated faecal microbiota filtrate . 2\u00d75 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or cool drink.', 'interventionNames': ['Drug: encapsulated faecal microbiota filtrate']}\n- {'label': 'faecal microbiota', 'type': 'ACTIVE_COMPARATOR', 'description': 'Encapsulated faecal microbiota. 2\u00d75 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or cool drink.', 'interventionNames': ['Drug: encapsulated faecal microbiota']}\n- {'label': 'Placebo', 'type': 'SHAM_COMPARATOR', 'description': 'Placebo: Encapsulated sterile saline. 2\u00d75 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or cool drink.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'encapsulated faecal microbiota filtrate', 'description': 'Multidonor stool mixed with sterile normal saline, homogenized, filtered, centrifuged, air pressure filtered, encapsulated in hypromellose capsules and frozen.', 'armGroupLabels': ['faecal microbiota filtrate'], 'otherNames': ['FMFT']}\n- {'type': 'DRUG', 'name': 'encapsulated faecal microbiota', 'description': 'Multidonor stool mixed with sterile normal saline, homogenized, filtered, encapsulated in hypromellose capsules and frozen.', 'armGroupLabels': ['faecal microbiota'], 'otherNames': ['FMT']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Sterile saline encapsulated in hypromellose capsules and frozen.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Encapsulated sterile saline']}\n\nPrimary Outcomes:\n- {'measure': 'clinical remission', 'description': 'The primary outcome will be clinical remission at week 12 post first transfer of FMFT or FMT, defined by Mayo score \u2264 2, all subscores \u2264 1; additionally patients unavailable at the week 12 follow-up will be included as non-responders (i.e. counted no remission).', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe overall power is set at 0.8 (80%) with a global significance level of 0.05 (two-sided). A potential dropout rate of 30% is considered.", "answer": 174, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculations were performed for the primary outcome remission rates 12 weeks post first FMT/FMFT/placebo. The sample size calculation is based on a 2\u00c3\u00973 table \u00cf\u00872 test as implemented in nQuery Advisor 7.0 (\u00cf\u00872 test of equal proportions in G groups (equal n\u00e2\u0080\u0099s)) even though a more complicated model will be used for the confirmatory analysis. Based on this, we estimate the remission rates 12 weeks post first FMT/FMFT to be \u00cf\u0080FMT \u00e2\u0089\u008830% or \u00cf\u0080FMFT \u00e2\u0089\u008830% while \u00cf\u0080Placebo\u00e2\u0089\u00885% are expected under placebo. To detect such a clinically relevant benefit at an overall power of 1 \u00e2\u0080\u0093 \u00ce\u00b2 = 0.8 for a global significance level of \u00ce\u00b1 = 0.05 (two-sided), a sample size of n = 3 \u00c3\u0097 40 = 120 is required for the confirmatory analysis. To account for a potential dropout rate of 30% overall and/or lower power of the more advanced analysis model, the total sample size is n = 3 \u00c3\u0097 58 = 174 patients.\n Table 1 shows the impact of slightly altered planning assumptions regarding the true rates on the global power. Moreover, the table also depicts power estimates for the joint test of FMT/FMFT against placebo and the two-group tests of FMT vs. placebo, FMFT vs. placebo (two group continuity corrected \u00cf\u00872 test of equal proportions; unequal and equal n). As similar rates are expected for FMT and FMFT, no power estimates are provided for this comparison.\nTable 1Statistical power analysisTrue rates [%]Sample size per group (including dropouts)aPower for the respective test setting [%]\u00cf\u0080FMT\u00cf\u0080FMFT\u00cf\u0080PlaceboGlobal testbFMT and FMFT vs. placeboFMT or FMFT vs. placebo303055893989230401058929569 rsp 9540401058969995aResulting in a total sample size would be 3 \u00c3\u0097 58 = 174, 3 \u00c3\u0097 93 = 279, and 3 \u00c3\u0097 50 = 150 patients to be randomizedbThe increased power (i.e., a power larger than 80%) results from the inclusion of dropouts in the analysis", "id": 427, "split": "train"} +{"trial_id": "NCT03843463", "pmid": "34941929", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Escitalopram and Language Intervention for Subacute Aphasia (ELISA)\n\nIncluded conditions:\n- Aphasia\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Naming Treatment + Escitalopram', 'type': 'EXPERIMENTAL', 'description': '10 mg escitalopram daily for three months (escalating from 5 mg per day for the first week and tapering to 5 mg per day for the last two weeks)', 'interventionNames': ['Drug: Escitalopram 10mg', 'Behavioral: Computer-delivered naming treatment']}\n- {'label': 'Naming Treatment + Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '10 mg placebo daily for three months', 'interventionNames': ['Drug: Placebo', 'Behavioral: Computer-delivered naming treatment']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Escitalopram 10mg', 'description': 'Escitalopram tablet', 'armGroupLabels': ['Naming Treatment + Escitalopram'], 'otherNames': ['Lexapro']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Sugar pill manufactured to mimic escitalopram 10 mg tablet', 'armGroupLabels': ['Naming Treatment + Placebo'], 'otherNames': ['Placebo (for Escitalopram)']}\n- {'type': 'BEHAVIORAL', 'name': 'Computer-delivered naming treatment', 'description': '15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke', 'armGroupLabels': ['Naming Treatment + Escitalopram', 'Naming Treatment + Placebo'], 'otherNames': ['Computer-delivered naming treatment (CoDeNT)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Philadelphia Naming Test short-form accuracy score', 'description': 'Number of correctly named items of 30 total items on the computerized picture naming assessment. Scores ranges from 0 to 30 with higher scores meaning better naming ability.', 'timeFrame': 'Baseline, 1 week after computer-delivered naming treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed with a significance level (\u00ce\u00b1) of 0.05, one-tailed, and 90% power. An attrition or non-compliance rate of up to 20% is anticipated, leading to an inflation factor of R = 1/(1-0.20)^2.", "answer": 88, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n Eighty-eight participants are expected to enroll in this study. We expect at least 56 will complete the study on the study drug. However, all participants randomized will be included in the intent-to-treat analysis. A final sample size of 28 per group has 90% power to detect an effect size of d = 0.8 using a t-test with \u00ce\u00b1 = 0.05, one-tailed. The planned sample size was inflated from N = 56 to N = 88 to account for up to 20% attrition or non-compliance, using an inflation factor of R = 1/(1\u00e2\u0080\u00930.20)2. Effect sizes >1 in naming improvements amongst post-stroke patients who took SSRIs for three months SSRIs have been reported [7]; however, we have conservatively powered this study for a smaller effect.\n We predict no difficulty recruiting at least 22 people with aphasia due to acute stroke each year. The PI has recruited an average of 13 people with aphasia due to acute left hemisphere ischemic stroke each year in her ongoing treatment study with tDCS at Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center, with similar inclusion and exclusion criteria. We anticipate having more difficulty enrolling in this trial, because of the exclusion criteria of moderately-severe depression or use of SSRIs at the time of stroke. We also plan for a relatively high dropout rate/crossovers, because of the risk of developing moderate-severe depression or other events for which stroke patients are at risk (e.g. recurrent stroke) and a small risk of developing prolonged QTc interval on electrocardiogram on escitalopram.", "id": 428, "split": "train"} +{"trial_id": "NCT03843905", "pmid": "31915159", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Predictive Value of Innovative Prognostic Markers (Gut Microbiota, Sarcopenia, Metabolic Syndrome and Obesity) on Surgical and Oncologic Results in the Management of Sporadic Colorectal Adenocarcinoma.\n\nIncluded conditions:\n- Colorectal Neoplasms\n- Microbiota\n- Prognosis\n- Metabolic Syndrome\n- Sarcopenia\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': 'no intervention', 'description': 'The aim of this translational research project is to study the impact of these new prognostic tools on surgical and oncologic results in a prospective cohort of patients who underwent CRC surgery at the Digestive Surgery Department of the University Hospital of Clermont-Ferrand (France)'}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival (OS)', 'description': 'defined by the time between surgery and last follow-up. The 5 years overall survival will be recorded.', 'timeFrame': 'at 5 years'}\n\nPlease estimate the sample size based on the assumption: \ntwo-sided type I error at 5%, statistical power greater than 90%", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Estimation of sample size\n Sample size estimation is based on literature about statistical power and number of prognostic factors. According to recommendations reported by Harrell, Green and Hsieh et al.,44\u00e2\u0080\u009346 we plan to include 300 patients in order to identify prognostic factors for 5-year survival for a two-sided type I error at 5%, a statistical power greater than 90% and 5-year survival equals 55% for rectal cancer patients and 60% for colon cancer patients.\n A sequential analysis will be carried out every 100 inclusions in order to estimate the statistical power calculated from the work of Hsieh et al\n45 and Demidenko47 after estimating the number of factors actually tested and on the basis of preselected factors, determined according to univariate analysis and clinical relevance.", "id": 429, "split": "train"} +{"trial_id": "NCT03844919", "pmid": "34952879", "question": "Here is the design of a clinical trial:\n\nOfficial Title: TICS: Transcranial Magnetic Stimulation for Intervening in Children With Tourette's Syndrome\n\nIncluded conditions:\n- Tic Disorders\n\nStudy Armgroups:\n- {'label': 'rTMS + CBIT', 'type': 'EXPERIMENTAL', 'description': 'Repetitive transcranial magnetic stimulation (rTMS) and Comprehensive Behavioural Intervention for Tics (CBIT)', 'interventionNames': ['Device: rTMS + CBIT', 'Behavioral: Sham rTMS + CBIT']}\n- {'label': 'Sham rTMS + CBIT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Sham repetitive transcranial magnetic stimulation (rTMS) and Comprehensive Behavioural Intervention for Tics (CBIT)', 'interventionNames': ['Behavioral: Sham rTMS + CBIT']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'rTMS + CBIT', 'description': 'Repetitive Transcranial Magnetic Stimulation (rTMS) parameters are: intensity 100% resting motor threshold (RMT), frequency 1Hz, duration = 30 minutes (1800 stimulations; 900 per side), target - the supplementary motor area (SMA). Treatments occur on weekdays (T - F) for four weeks (20 total).\\n\\nThe Comprehensive Behavioral Intervention for Tics (CBIT) will be completed over eight sessions that will average 60 minutes in duration. First, participants will undergo awareness training. Participants will then be introduced to competing response training, which involves performing a voluntary behaviour designed to disrupt the execution of the tic. The eight sessions will occur on Mondays, once a week for six weeks and then on weeks 8 and 10.', 'armGroupLabels': ['rTMS + CBIT']}\n- {'type': 'BEHAVIORAL', 'name': 'Sham rTMS + CBIT', 'description': 'Sham rTMS (sham coil) will be paired with CBIT. Sham rTMS will be delivered over the same time-frame as above. CBIT will be identical to the above.', 'armGroupLabels': ['Sham rTMS + CBIT', 'rTMS + CBIT']}\n\nPrimary Outcomes:\n- {'measure': 'Yale Global Tic Severity Scale Total Tic score (YGTSS)', 'description': '30% reduction in Yale Global Tic Severity Scale Total Tic score (YGTSS) (\\\\~9 point reduction).\\n\\nA higher score on all scales suggests a more severe tics.\\n\\nThe YGTSS provides two tic severity scores:\\n\\n1. Total Motor (0 to 25)\\n2. Total Phonic (0 to 25)\\n\\nThese are summed to form the Total Tic Severity Score (0 to 50). This is the measure for the primary outcome variable.\\n\\nThere is also the separate Impairment Dimension Score (0 to 50).\\n\\nThe total score is hence 0 to 100 (sum of Total Tic Severity Score and Impairment Dimension Score).', 'timeFrame': 'Baseline to week 7'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level adjusted using Benjamini-Hochberg approach with a false discovery rate of 5%, minimum power of 80%, and a potential data loss of 20%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was estimated with G*Power (V.3.1.9.4).55 Prior pilot rTMS data (n=10) and a previous randomised controlled CBIT study (n=126) informed the estimates of effect size. Piacentini et al37 reported a mean difference of 4.1 (95% CI, 2.0 to 6.2) and a standardised mean difference of 0.7 in total YGTSS scores between a CBIT and control group.37 We expect the added effect of rTMS to be of the same magnitude, and thus we expect to see a difference in change of at least 4.1 between rTMS plus CBIT compared with CBIT alone. We estimate the SD of change to be 5.85 based on the reported Cohen\u00e2\u0080\u0099s d of 0.7. We will use the Benjamini-Hochberg approach to adjust alpha, with a false discovery rate of 5% and a minimum power of 80%. We assume a potential data loss of 20% due to withdrawal, loss of follow-up, data acquisition failures/errors and so on. With this difference of 4.1 and SD of 5.85 our ideal sample size calculation is 31 per group (62 total), 80% power. However, the funding received for this study allows for n=25 per group (50 total): with 25 per group, as long as the SD of pre to post change is not bigger than 5.31 (alpha (\u00ce\u00b1)=0.033 as per Benjamini-Hochberg), we will still be powered to detect a desired 4.1 change. In addition, 20 participants per group (due to potential data loss/drop out) is still powered to detect a 4.1 difference as long as the SD of the pre to post change is not bigger than 4.73 (\u00ce\u00b1=0.033).\n Participants will be recruited through the Calgary Tourette\u00e2\u0080\u0099s Syndrome Clinic (ACH, Calgary, Alberta\u00e2\u0080\u0094led by TP), a network of paediatricians, TS families and advertisements.", "id": 430, "split": "train"} +{"trial_id": "NCT03845101", "pmid": "35110313", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SoREAL- a Randomized Clinical Trial\n\nIncluded conditions:\n- Social Anxiety Disorder\n- Agoraphobia\n\nStudy Armgroups:\n- {'label': 'CBT in virtuo', 'type': 'EXPERIMENTAL', 'description': 'Receives CBT in group format with Virtual Reality Exposure Therapy', 'interventionNames': ['Behavioral: CBT with virtual reality exposure therapy']}\n- {'label': 'CBT in vivo', 'type': 'ACTIVE_COMPARATOR', 'description': 'Active comparator, receives CBT in group format. Treatment as usual.', 'interventionNames': ['Behavioral: CBT in vivo']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'CBT with virtual reality exposure therapy', 'description': 'The patients receiving the in virtuo exposure will be immersed using an Oculus Go head-mounted display, enabling viewing of 360\u00b0 spherically camera recorded VR environments. The VR scenarios will thus be high-resolution 360\u00b0 stereoscopic films, that are played around the viewer. For ease of use, the individual videos will be administered from an app that has been designed to be as intuitive to operate as possible. The patient will only have to put on the headset, adjust the focus and choose the desired environment by looking at it in the app. 360\u00b0 video was chosen because it gives the most photorealistic visuals, while also being the cheapest to produce. The downside is that it does not allow direct user-interaction (e.g. the viewer cannot affect the environment in any way). To circumvent this, there are multiple junctions throughout the films where the actors will talk directly and unsolicited to the viewer while also allowing time for the viewer to respond.', 'armGroupLabels': ['CBT in virtuo']}\n- {'type': 'BEHAVIORAL', 'name': 'CBT in vivo', 'description': 'The therapeutic intervention is manual-based cognitive-behavioral CBT group therapy adapted from the approach of Turk, Heimberg \\\\& Magee and Graske \\\\& Barlow with worksheets from Arendt \\\\& Rosenberg and inspiration from Bouchard et al. The treatment will consist of 14 weekly two-hour group sessions following the manual to ensure equal and uniform treatment for every patient throughout the study. Concurrent psychopharmacological treatment is allowed in both intervention arms.', 'armGroupLabels': ['CBT in vivo']}\n\nPrimary Outcomes:\n- {'measure': 'Change in symptom severity of primary diagnosis', 'description': \"Total scores on the Liebowitz Social Anxiety Scale (LSAS) for patients with social anxiety disorder and the Mobility Inventory for Agoraphobia (MIA) for patients with Agoraphobia measured pre-treatment, post-treatment and at one-year follow-up converted to the 'Percentage of Maximum Possible Score' (POMP) and averaged within treatment arms. POMP calculations can bring differently measured items to the same metric and do not change the multivariate distribution and covariance matrix of the transformed variables.\\n\\nRanges from 0 to 100. Higher is worse.\", 'timeFrame': 'Between 30 to 1 day(s) before treatment, between 0 and 14 days after treatment ends and between 365 to 395 days after first assesment.'}\n\nPlease estimate the sample size based on the assumption: \nAlpha=0.05, 80% power, and an expected standard deviation (SD) of 21.", "answer": 302, "answer_type": "ESTIMATED", "explanation": "Outcomes and sample size calculation\n We originally designed the trial around inclusion of only patients with social anxiety disorder, basing the sample size calculation on the following parameters on the LSAS: with alpha=0.05, 80% power, and an expected SD of 21, 302 patients would be required to detect the minimal relevant difference of 6.8 on the LSAS total score between the groups.\n On deciding to expand the diagnostic criteria for inclusion to also include patients with agoraphobia, it was necessary to change our primary outcome measure. For patients with agoraphobia, we primarily rate symptoms using MIA. To include both patients with social anxiety disorder and patients with agoraphobia, we thus decided to recalculate scores on these two scales to POMP as described below. Since the sample size calculation for LSAS was based on a Cohen\u00e2\u0080\u0099s d=0.33, we also set the minimum clinically relevant difference on MIA, and by extension on the POMP, to d=0.33. Consequently, the required sample size remained unaffected by this change of primary outcome measures and is thus still 302 patients. See figure 3 for power calculations on secondary outcomes.\n \n Figure 3\n \n Power calculation for secondary outcomes in the SoREAL trial. LSAS, Liebowitz Social Anxiety Scale; MIA, Mobility Inventory for Agoraphobia; VR, virtual reality.", "id": 431, "split": "train"} +{"trial_id": "NCT03853122", "pmid": "34404699", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of a Common Exercise Programme With an Individualized Progression Criterion Based on the Measurement of Neuromuscular Capacity Versus Eccentric Training for Lower Limb Tendinopathies (MaLaGa Trial): Randomised Clinical Trial\n\nIncluded conditions:\n- Tendinopathy\n\nStudy Armgroups:\n- {'label': 'Best current practice exercise programme', 'type': 'ACTIVE_COMPARATOR', 'description': 'Therapeutic physical exercise, best current practice:\\n\\nAchilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: two exercises performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group).\\n\\nPatellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: one exercise performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group).\\n\\nGluteal Tendinopathy: EXERCISE LEAP PROTOCOL, from daily to twice weekly, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group).', 'interventionNames': ['Other: Best current practice exercise programme']}\n- {'label': 'Experimental exercise programme', 'type': 'EXPERIMENTAL', 'description': 'Therapeutic physical exercise common for the three locations (Achilles, patellar and gluteal tendinopathy), based on an individual dosage and neuromuscular adaptations (five stages):\\n\\nStrength training four exercises, once daily, three times/week, 14 weeks Aerobic training: Once daily, twice weekly', 'interventionNames': ['Other: Experimental exercise programme']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Best current practice exercise programme', 'description': 'Therapeutic Physical Exercise programme based on the protocol of Afredson (for Achilles and patellar tendinopathies) and LEAP (for gluteal tendinopathy).\\n\\nAchilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetitions of two eccentric exercises\\n\\nPatellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetions of one eccentric exercise\\n\\nGluteal Tendinopathy: EXERCISE LEAP PROTOCOL: an exercise programme divided into stages with progression in different exercises, volumes and loads', 'armGroupLabels': ['Best current practice exercise programme'], 'otherNames': ['Alfredson protocol', 'LEAP protocol']}\n- {'type': 'OTHER', 'name': 'Experimental exercise programme', 'description': 'Therapeutic Physical Exercise programme structured in five stages oriented to specific neuromuscular adaptations based on the characteristics of the neuromuscular system, once daily, three times/week, sets, repetitions and load based on individually performed tests.', 'armGroupLabels': ['Experimental exercise programme'], 'otherNames': ['MaLaGa protocol']}\n\nPrimary Outcomes:\n- {'measure': 'Victorian Institute of Sport Assessment (VISA) questionnaire POST', 'description': 'Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).', 'timeFrame': 'Post, 14 weeks after start of the intervention (when intervention is finished)'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, power of 0.8, and a 15% dropout rate", "answer": 104, "answer_type": "ESTIMATED", "explanation": "Sample size\n The treatment effect will be evaluated by comparing success rates on the VISA measurements at follow-up between groups. With an a priori calculation based on the effect size of the LEAP study for gluteal tendinopathy (d=0.59),17 and using an \u00ce\u00b1 value of 0.05 and a power of 0.8, the sample size is estimated at 44 participants per arm. Assuming losses of 15% of the sample in the follow-up measurement, the necessary sample size will be of 52 participants per group for a total sample of 104 participants.", "id": 432, "split": "train"} +{"trial_id": "NCT03854682", "pmid": "36195936", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Surgical or Non-surgical Treatment of Plantar Fasciitis - A Randomized Clinical Trial\n\nIncluded conditions:\n- Fasciitis, Plantar, Chronic\n\nStudy Armgroups:\n- {'label': 'Surgical', 'type': 'EXPERIMENTAL', 'description': 'Radiofrequency microtenotomy (RF): A longitudinal incision of about 3 cm will be made over the most tender part of the foot taking care to avoid the weight bearing part of the sole, and the tissues dissected down to the affected plantar fascia. After initiating sterile isotonic saline flow of 1 drop every 1-2 s from a line connected to the RF system, the TOPAZ tip will be placed onto the fascia and the micro debridements carried out in a grid like pattern on and throughout the symptomatic fascia area. After debridement, the wound will be irrigated with copious amounts of normal saline solution and closed in layers. A local anaesthetic will be injected into the skin and subcutaneous tissues around the wound and standard wound dressings will be applied', 'interventionNames': ['Procedure: Radiofrequency microtenotomy']}\n- {'label': 'Non-surgical', 'type': 'ACTIVE_COMPARATOR', 'description': 'Strength training: Consists of one-legged heel lift to primarily activate the windlass effect and increase the mechanical stress on the tendon. The exercise is performed on a step, a thick book or the like, so the heel movement finishes below the horizontal level. The exercise is performed every other day with as many sets as possible and as heavy as possible, but not heavier than eight repetitions can be performed per. set. The load progressed from two to one leg +/- backpack. The exercise is performed as 3 s/2 s / 3 s concentric, isometric and eccentric respectively followed by 2 min rest. Patients continue to exercise 4 weeks after patient acceptable symptom state (PASS) has been achieved', 'interventionNames': ['Behavioral: Strength training']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Radiofrequency microtenotomy', 'description': 'A longitudinal incision of about 3 cm will be made over the most tender part of the foot taking care to avoid the weight bearing part of the sole, and the tissues dissected down to the affected plantar fascia. After initiating sterile isotonic saline flow of 1 drop every 1-2 s from a line connected to the RF system, the TOPAZ tip will be placed onto the fascia and the micro debridements carried out in a grid like pattern on and throughout the symptomatic fascia area. After debridement, the wound will be irrigated with copious amounts of normal saline solution and closed in layers. A local anaesthetic will be injected into the skin and subcutaneous tissues around the wound and standard wound dressings will be applied', 'armGroupLabels': ['Surgical']}\n- {'type': 'BEHAVIORAL', 'name': 'Strength training', 'description': 'Non-surgical treatment consists of one-legged heel lift to primarily activate the windlass effect and increase the mechanical stress on the tendon. The exercise is performed on a step, a thick book or the like, so the heel movement finishes below the horizontal level. The exercise is performed every other day with as many sets as possible and as heavy as possible, but not heavier than eight repetitions can be performed per. set. The load progressed from two to one leg +/- backpack. The exercise is performed as 3 s/2 s / 3 s concentric, isometric and eccentric respectively followed by 2 min rest. Patients continue to exercise 4 weeks after patient acceptable symptom state (PASS) has been achieved', 'armGroupLabels': ['Non-surgical'], 'otherNames': ['Resistance training']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the Foot Health Status Questionnaire (FHSQ)', 'description': 'Subdomain foot pain score range 0-100, low values represent worse conditions', 'timeFrame': 'Change from baseline at 6 months'}\n\nPlease estimate the sample size based on the assumption: \nstandard deviation of 19.7 points, two-sided significance level of 0.05, power of 80%, and accounting for possible drop-outs", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on a standard deviation of 19.7 points, a two-sided significance level of 0.05, and a power of 80%, it will require 32 participants in each group to be able to detect a difference in the clinically relevant 14.1 points in the pain domain of FHSQ-DK [34]. To account for possible drop-outs, we will include a total of 70 participants.", "id": 433, "split": "train"} +{"trial_id": "NCT03858179", "pmid": "31662370", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Photobiomodulation Therapy in Strength Training and Detraining in Humans\n\nIncluded conditions:\n- Muscle Strength\n\nStudy Armgroups:\n- {'label': 'PBMT + training/ PBMT + detraining', 'type': 'EXPERIMENTAL', 'description': 'PBMT applied before the strength training sessions (12 weeks, 2 times a week) and PBMT applied during the detraining period (4 weeks, 2 times a week).', 'interventionNames': ['Device: PBMT']}\n- {'label': 'PBMT + training/ placebo + detraining', 'type': 'EXPERIMENTAL', 'description': 'PBMT applied before the strength training sessions (12 weeks, 2 times a week) and placebo applied during the detraining period (4 weeks, 2 times a week).', 'interventionNames': ['Device: PBMT', 'Device: Placebo']}\n- {'label': 'Placebo + training/ PBMT + detraining', 'type': 'EXPERIMENTAL', 'description': 'Placebo applied before the strength training sessions (12 weeks, 2 times a week) and PBMT applied during the detraining period (4 weeks, 2 times a week).', 'interventionNames': ['Device: PBMT', 'Device: Placebo']}\n- {'label': 'Placebo + training/ placebo + detraining', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo applied before the strength training sessions (12 weeks, 2 times a week) and placebo applied during the detraining period (4 weeks, 2 times a week).', 'interventionNames': ['Device: Placebo']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'PBMT', 'description': 'PBMT will be applied bilaterally using the direct contact method with light pressure on the skin to 6 sites of the anterior thigh (2 medial, 2 lateral, and 2 central). A 12-diode cluster, with 4 905-nm laser diodes (12.5W peak power for each diode), 4 875-nm LED diodes (17.5 mW mean power for each diode), and 4 640-nm LED diodes (15 mW mean power for each diode), manufactured by Multi Radiance Medical\u00ae (Solon, OH, USA), will be used to apply the PBMT. The dose used for applications during the training and/or detraining periods will be 30 Joules (J) per site (180 J per thigh). PBMT will be applied before each workout and during the detraining period, depending on the group to which the volunteers are allocated.', 'armGroupLabels': ['PBMT + training/ PBMT + detraining', 'PBMT + training/ placebo + detraining', 'Placebo + training/ PBMT + detraining']}\n- {'type': 'DEVICE', 'name': 'Placebo', 'description': 'Placebo PBMT will be applied bilaterally using the direct contact method with light pressure on the skin to 6 sites of the anterior thigh (2 medial, 2 lateral, and 2 central). The placebo PBMT will per performed using the dose of 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). Placebo PBMT will be applied before each workout and during the detraining period, depending on the group to which the volunteers are allocated.', 'armGroupLabels': ['PBMT + training/ placebo + detraining', 'Placebo + training/ PBMT + detraining', 'Placebo + training/ placebo + detraining']}\n\nPrimary Outcomes:\n- {'measure': 'Peak Torque', 'description': 'The peak torque will be measured by Maximum Voluntary Contraction (MVC) test.', 'timeFrame': '16 weeks - 4 weeks after completing the training (detraining period).'}\n\nPlease estimate the sample size based on the assumption: \nA \u03b2 value of 20% and an \u03b1 of 5% were used to calculate the sample size. Predicting a 20% sample loss.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Subjects and sample size\n As far as we know there are no published studies assessing the effects of PBMT/sMF during the detraining period after a strength-training programme. Therefore, the number of participants per group in the present study was calculated based on a pilot study that was recently conducted by our research group that had five volunteers per group. A \u00ce\u00b2 value of 20% and an \u00ce\u00b1 of 5% were used to calculate the sample size.\n The pilot study showed that applying PBMT/sMF during the detraining period resulted in a peak torque (the primary outcome of this study) of 257.25\u00e2\u0080\u0089Nm (SD: 33.73) during the maximum voluntary contraction (MVC) test, whereas applying the placebo during the detraining period resulted in a peak torque of 222.05\u00e2\u0080\u0089Nm (SD: 29.87). We used the Researcher\u00e2\u0080\u0099s Toolkit to calculate the sample size (https://www.dssresearch.com/KnowledgeCenter/toolkitcalculators/samplesizecalculators.aspx).\n Based on the aforementioned parameters used to calculate the sample, we found an n of 10 volunteers per group, for a total of 40 volunteers, was required. Therefore, predicting a 20% sample loss, 48 healthy, male volunteers aged from 18 to 35 years will be recruited for the study (12 volunteers per group). The choice to recruit only male volunteers is to allow direct comparison with a previous study carried out by our research group.24 As previously demonstrated by Joensen et al\n32 some PBMT devices can significantly increase skin temperature, promote discomfort and even lead to interruption of treatment/irradiation in patients with darker skin. However, since the PBMT/sMF device used in the study does not cause any significant increase in skin temperature nor harmful thermal effects in light, medium or dark human skin,33 volunteers of different skin colours will be recruited. Volunteers will be informed about all study procedures and asked to sign the informed consent form prior to their enrolment in the study.", "id": 434, "split": "train"} +{"trial_id": "NCT03858790", "pmid": "33028415", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Spinal Cord Stimulation System in the Treatment of Chronic Pain\n\nIncluded conditions:\n- Pain\n- Chronic Pain\n- Back Pain\n- Spinal Cord Stimulation\n- Nervous System Diseases\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': \"Subjects' PINS spinal cord stimulator randomized to this arm is on always\", 'interventionNames': ['Device: PINS Spinal Cord Stimulator']}\n- {'label': 'Control', 'type': 'SHAM_COMPARATOR', 'description': \"Subjects' PINS spinal cord stimulator randomized to this arm is off for a week\", 'interventionNames': ['Device: PINS Spinal Cord Stimulator']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'PINS Spinal Cord Stimulator', 'description': 'Subjects will be implanted with PINS spinal cord stimulator', 'armGroupLabels': ['Control', 'Experimental']}\n\nPrimary Outcomes:\n- {'measure': 'The difference of Visual-analogue scale (VAS) between the experimental group and the control group', 'description': 'Pain will be evaluated in the different groups according to the Visual-analogue scale (VAS) varying from 0 to 10 with a higher score indicating a higher level of pain.', 'timeFrame': '13 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power to detect the significant difference using a two-sided, two-sample t test at a significance level (alpha) of 0.025. The first class error level (alpha) is 0.025 for unilateral test and 0.05 for bilateral test. The second class error level (beta) is 0.2. The maximum possible loss rate is 10%.", "answer": 54, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculations\n The primary comparison is the difference between EG and CG in terms of VAS score in the withdrawal period. According to the results of the study [25], the clinically important outcome of VAS score is 20\u00e2\u0080\u0089mm at most, which does not vary with gender, age, cause, or severity of pain [26, 27]. A sample size of 48 (24 per arm) achieves 80% power to detect the significant difference using a two-sided, two-sample t test at a significance level (alpha) of 0.025. We assumed the true difference between the means to be 0 and a standard deviation of the outcome of 2.6. Thus, the sample size calculation formula was:\n \n2\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ n=\\frac{2{\\left({Z}_{1-\\alpha /2}+{Z}_{1-\\beta}\\right)}^2{\\delta}^2}{{\\left(\\left|D\\right|-\\Delta \\right)}^2} $$\\end{document}n=2Z1\u00e2\u0088\u0092\u00ce\u00b1/2+Z1\u00e2\u0088\u0092\u00ce\u00b22\u00ce\u00b42D\u00e2\u0088\u0092\u00e2\u0088\u00862\n where |D| is the expected mean difference of the two groups, \u00e2\u0088\u0086 is the superiority threshold value (0, here),\u00c2\u00a0Z is the quantile of the standard normal distribution, \u00ce\u00b1 is the first class error level for the statistical test (0.025, here for unilateral test; 0.05 for bilateral test if need), and \u00ce\u00b2 is the second class error level for the statistical test (0.2, here). The calculated sample size per group through this calculation is 21. Considering that the maximum possible loss rate is 10%, the total sample size is 24 pairs (N\u00c2\u00a0=\u00e2\u0080\u008948) [24].\n These 48 cases will use the G122R rechargeable IPG combined with percutaneous leads (PINS, Inc., Beijing, BJ, China). For the non-rechargeable model G122 and paddle lead, other 6 participants will be recruited for each condition (3 cases for each). No statistical requirements are needed for these 6 cases. In summary, the final sample size is 54 (24 pairs plus extra 6).\n To implement within-group comparisons, data will be analyzed with t tests and \u00cf\u00872 tests for continuous variables and categorical variables, respectively. The Kolmogorov-Smirnov test or parametric tests will be performed with the data of normal distributions. Rank-sum test will be used for the non-parametric data. The factors that affect curative effects will be analyzed with a multinomial logistic regression method. A p value <\u00e2\u0080\u00890.05 will be considered as statistically significant. A validated statistical software package will be used for the analyses of the study results (for example, SAS).", "id": 435, "split": "train"} +{"trial_id": "NCT03859973", "pmid": "32036587", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia\n\nIncluded conditions:\n- Schizophrenia\n\nStudy Armgroups:\n- {'label': 'BI 425809 10 mg + Computerized Cognitive Training', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: BI 425809']}\n- {'label': 'Placebo + Computerized Cognitive Training', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'BI 425809', 'description': 'Tablet', 'armGroupLabels': ['BI 425809 10 mg + Computerized Cognitive Training'], 'otherNames': ['iclepertin']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Tablet', 'armGroupLabels': ['Placebo + Computerized Cognitive Training']}\n\nPrimary Outcomes:\n- {'measure': 'Change From Baseline in Neurocognitive Function as Measured by the Neurocognitive Composite Score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment', 'description': 'MCCB neurocognitive composite T-score assesses 6 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving. MCCB neurocognitive T-scores in the general population have a mean of 50 and standard deviation of 10. A higher T-score indicates better cognition. Change from baseline in MCCB neurocognitive composite T-score at Week 12 was modelled based on a restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value. The Least Squares Mean (95 % Confidence Interval) at Week 12 is reported.', 'timeFrame': 'At screening (28 days prior to first drug drug administration), at baseline and at Weeks 6 and 12 after first drug administration.'}\n\nPlease estimate the sample size based on the assumption: \nA 10% dropout rate is assumed. The simulations were performed using R version 3.3.2.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample Size Calculation\n Monte Carlo simulations (10,000 simulations) were made to assess the probabilities of observing different effect sizes of BI 425809 over placebo, given the true effect sizes. Based on the simulation results, a sample size of 200 patients is sufficient to achieve the aims of this exploratory trial. Predicting a 10% dropout rate, this will result in a total of 180 evaluable patients, or 90 evaluable patients per treatment arm. If the true effect size (mean treatment difference/SD) is 0.45, there is a 64% probability that a mean difference between the treatment and placebo groups greater than 0.4 will be observed, and an 84% probability that a mean difference of at least 0.3 will be seen. On the other hand, assuming the true effect size is only 0.2, there is a 75% probability of observing a mean difference less than 0.3, and a 91% probability of observing a mean difference of at most 0.4. The simulations were performed using R version 3.3.2.", "id": 436, "split": "train"} +{"trial_id": "NCT03863015", "pmid": "33081828", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Interleukin-6 Receptor Antibodies for Modulating the Systemic Inflammatory Response After Out-of-Hospital Cardiac Arrest - a Randomized Clinical Trial\n\nIncluded conditions:\n- Heart Arrest\n- Out-Of-Hospital Cardiac Arrest\n- Systemic Inflammatory Response Syndrome\n\nStudy Armgroups:\n- {'label': 'Tocilizumab', 'type': 'ACTIVE_COMPARATOR', 'description': 'A one hour infusion of a single 8mg/kg dose (max. 800mg) of tocilizumab to attenuate systemic inflammation after out-of-hospital cardiac arrest, given as early as possible after hospital admission.', 'interventionNames': ['Drug: Tocilizumab 20 Mg/mL Intravenous Solution']}\n- {'label': 'Isotonic saline', 'type': 'PLACEBO_COMPARATOR', 'description': 'A one hour infusion of isotonic saline', 'interventionNames': ['Drug: isotonic saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tocilizumab 20 Mg/mL Intravenous Solution', 'description': 'Tocilizumab is suspended in isotonic saline to a total volume of 100mL prior to infusion', 'armGroupLabels': ['Tocilizumab'], 'otherNames': ['RoActemra']}\n- {'type': 'DRUG', 'name': 'isotonic saline', 'description': 'A one hour infusion of 100mL isotonic saline', 'armGroupLabels': ['Isotonic saline'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Concentration of hsCRP', 'description': 'high sensitivity C-reactive protein', 'timeFrame': 'Daily measurements from admission to 72 hours after admission.'}\n\nPlease estimate the sample size based on the assumption: \nThe trial assumes a significance level (\u03b1) of 0.05, a power of 0.81, and accounts for an 8% mortality rate within the first 3 days and potential missing blood samples.", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The trial is powered at the primary endpoint. A previous trial has shown an effect of tocilizumab on hsCRP in NSTEMI patients [21]. That trial demonstrated a median area under the hsCRP curve of 2.0\u00e2\u0080\u0089mg/L/h in patients receiving tocilizumab compared to 4.2\u00e2\u0080\u0089mg/L/h in patients receiving placebo, i.e., a reduction of 52%. However, the systemic inflammatory response in a NSTEMI population will be limited compared to an OHCA population. For example, hsCRP levels in NSTEMI patients have been reported at approximately 2\u00e2\u0080\u00936\u00e2\u0080\u0089mg/L [21], whereas CRP levels in OHCA patients have been reported at approximately 100\u00e2\u0080\u0093250\u00e2\u0080\u0089mg/L after 48\u00e2\u0080\u009372\u00e2\u0080\u0089h [25].\n As no previous data exists regarding the effect of tocilizumab on hsCRP over time, we chose to power the present trial towards a single hsCRP measurement drawn 48\u00e2\u0080\u0089h after admission. In 140 resuscitated OHCA patients from our institution, the mean hsCRP level after 48\u00e2\u0080\u0089h was 179\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008975\u00e2\u0080\u0089mg/L (unpublished data). We assumed that tocilicumab treatment would reduce the hsCRP level by 30%. Assuming an \u00ce\u00b1-level of 0.05, the trial would achieve a power of 0.81, if 64 patients were included. However, taking mortality within the first 3\u00e2\u0080\u0089days (estimated at 8% [26]) as well as blood samples missing for other reasons into account, we aimed to include 80 patients.", "id": 437, "split": "train"} +{"trial_id": "NCT03864991", "pmid": "32312302", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Lifestyle Changes and Glycemic Control in Type 1 Diabetes Mellitus: A Factorial Design Approach\n\nIncluded conditions:\n- Type1 Diabetes Mellitus\n- Life Style\n- Behavioral Changes\n- Self-Management\n\nStudy Armgroups:\n- {'label': 'Routine Care', 'type': 'NO_INTERVENTION', 'description': 'This group will be followed up for routine care, maintaining a standard log book for documenting blood sugar and insulin dosages per advice and explanation by doctors, nurses and nutritionists.'}\n- {'label': 'e-device for step count (fit-bit)', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will receive e-device for step count (fit-bit) in addition to routine care.', 'interventionNames': ['Device: e-device for step count (fit-bit)']}\n- {'label': 'e-messages for log book', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will receive daily e-messages for maintaining log book in addition to routine care.', 'interventionNames': ['Behavioral: e-messages for log book']}\n- {'label': 'e-messages for log book & fit-bit', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will receive e-device for step count (fit-bit), daily e-messages for maintaining log book for blood sugar, insulin dosages and step count in addition to routine care.', 'interventionNames': ['Device: e-device for step count (fit-bit)', 'Behavioral: e-messages for log book & fit-bit']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'e-device for step count (fit-bit)', 'description': 'Patients in this group will receive fitbit device to count their daily steps and record it into their log books.', 'armGroupLabels': ['e-device for step count (fit-bit)', 'e-messages for log book & fit-bit']}\n- {'type': 'BEHAVIORAL', 'name': 'e-messages for log book', 'description': 'Patients in this group will receive e-messages to maintain their log books as per instruction for blood sugar levels and send back weekly through snap shot.', 'armGroupLabels': ['e-messages for log book']}\n- {'type': 'BEHAVIORAL', 'name': 'e-messages for log book & fit-bit', 'description': 'Patient in this group will receive e-messages to maintain their log books for blood sugar levels as well as use fitbit device and maintain their log book for daily step count and send back weekly through snap shot.', 'armGroupLabels': ['e-messages for log book & fit-bit']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in HbA1c', 'description': 'Blood HbA1c levels will be measured at baseline, three and six months. It will be taken on ratio scale measured in mmol/mol', 'timeFrame': 'Each participant will be in the study for the period of six months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided significance level of 5%, standard deviation of change in HbA1C between 1.1% and 2.3%.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size and sampling technique\n Overall, 120 patients with T1D will be randomized into four equal groups for evaluating changes in HbA1C using multiple measurements at multiple time points. Thirty patients in each group will be required in order to achieve 80% power for a two-sided level of significance of 5%, using a standard deviation of change in HbA1c between 1.1% and 2.3% and absolute difference of at least 2% expected over a period of 6 months within a group from baseline as well as when compared across the four groups [29]. A consecutive sampling technique will be used to enroll participants visiting AKU pediatric and endocrinology clinics and fulfilling the eligibility criteria.", "id": 438, "split": "train"} +{"trial_id": "NCT03871803", "pmid": "32073676", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Betablockers Withdrawal in Patients With Heart Failure With Preserved Ejection Fraction and Chronotropic Incompetence: Effect on Functional Capacity Rationale and Study Design of a Prospective, Randomized, Controlled Trial\n\nIncluded conditions:\n- Heart Failure With Normal Ejection Fraction\n- Chronotropic Incompetence\n\nStudy Armgroups:\n- {'label': 'Arm A', 'type': 'ACTIVE_COMPARATOR', 'description': 'Controlled Withdrawal of Beta-blockers and Cardiopulmonary Exercise Testing (CPET) Patient will be assessed for chronotr0pic incompetence by CPET. If the patient exhibits chronotropic incompetence, we will reduce half dose of previous beta-blocker.\\n\\nA cardiologist will evaluate clinically the the patient and the heart rate in 3 days. If clinical and heart rate stability (below 90 bpm), the patients will withdraw the beta-blocker and will be assessed by CPET at 15-day.\\n\\nAfter second CPET, the patient will introduce the half-dose of beta-blocker and will be evaluated in 3 days. If clinical stability, the patient will introduce the previous dose of beta-blocker A third CPET will be performed at 15-day', 'interventionNames': ['Drug: Controlled withdrawal of beta-blockers', 'Diagnostic Test: Cardiopulmonary Exercise Testing']}\n- {'label': 'Arm B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Cardiopulmonary Exercise Testing (CPET) and Controlled Withdrawal of Beta-blockers Patient will be assessed for chronotropic incompetence by CPET.If the patient exhibits chronotropic incompetence, a cardiologist will evaluate clinically the patient and the heart rate in 3 days and will be assessed by CPET at 15-day.\\n\\nAfter second CPET, the patient will reduce half dose of previous beta-blocker. A cardiologist will evaluate clinically the the patient and the heart rate in 3 days. If clinical and heart rate stability (below 90 bpm), the patients will withdraw the beta-blocker and will be assessed by CPET at 15-day.', 'interventionNames': ['Drug: Controlled withdrawal of beta-blockers', 'Diagnostic Test: Cardiopulmonary Exercise Testing']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Controlled withdrawal of beta-blockers', 'description': 'Controlled withdrawal of previos doses of beta-blockers after diagnosis of chronotropic incompetence', 'armGroupLabels': ['Arm A', 'Arm B']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Cardiopulmonary Exercise Testing', 'description': 'Cardiopulmonary Exercise Testing to evaluate the chronotropic incompetence and the primary endpoint (functional capacity)', 'armGroupLabels': ['Arm A', 'Arm B']}\n\nPrimary Outcomes:\n- {'measure': 'Maximal functional capacity', 'description': 'Maximal functional capacity measured by peak oxygen consumption in the cardiopulmonary exercise testing (CPET). The peak oxygen consumption is expressed in mL/kg/min.The investigators will measure the change of peak oxygen consumption .', 'timeFrame': 'The change in peak oxygen consumption will be measured at baseline, at 15-day and at 30-day'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a two-sided test at a 0.05 significance alpha level, with 90% power and an assumption of 20% withdrawals or losses to follow-up.", "answer": 52, "answer_type": "ACTUAL", "explanation": "2.5\n Sample size calculation\n The null hypothesis of the study is that the mean peakVO2 absolute differences from baseline to 15\u00e2\u0080\u0089days after the withdrawal of beta\u00e2\u0080\u0090blockers will be similar. The sample size determination for this study assumes two\u00e2\u0080\u0090sided testing at the 0.05 significance alpha level. Because this is a randomized clinical trial, we assume no differences in peakVO2 at baseline among the two arms. Based on a prior study of our group in HFpEF, we assume eligible patients will have a mean (SD) peakVO2 of 10\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00892.8 mL/kg/min.8 Along the same line, and based on prior studies about the deleterious effects of heart rate slowing in HFpEF patients, we speculate a blocker withdrawal will increase peak VO2 about 10%. With this data in mind, we assume a mean change of 1.2 mL/kg/min and a common SD of 2.0,8, 25, 26 a clinical meaningful change according a recent HFA position paper that consider significant clinical changes of peakVO2 those greater than 6% when baseline peakVO2 is lower than 14\u00e2\u0080\u0089mL/min/1.73\u00e2\u0080\u0089m2.27\n\n Assuming an allocation ratio of 1:1, a total of 42 patients (21 patients per group) would provide 90% of power at a significance alpha level\u00e2\u0080\u0089<\u00e2\u0080\u00890.05. Assuming 20% of withdrawals or losses to follow\u00e2\u0080\u0090up, a total of 26 patients per arm (52 patients) will be enrolled. The software used for sample size calculation was \u00e2\u0080\u009cxsampsi\u00e2\u0080\u009d from Stata 14.1.", "id": 439, "split": "train"} +{"trial_id": "NCT03875573", "pmid": "34362344", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer: a Phase ll Randomised Trial\n\nIncluded conditions:\n- Luminal B\n\nStudy Armgroups:\n- {'label': 'Chemotherapy and radiotherapy', 'type': 'EXPERIMENTAL', 'description': 'The combination of weekly paclitaxel 80 mg/m\u00b2 IV followed by q2w dose-dense doxorubicin-cyclophosphamide (ddAC) (60 mg/m\u00b2 doxorubicin IV and 600 mg/m\u00b2 cyclophosphamide IV) and pre-operative radiation therapy on the primary tumour (3x8 Gy).', 'interventionNames': ['Radiation: Stereotactic Body Radiotherapy']}\n- {'label': 'Chemotherapy and pre-operative radiotherapy plus durvalumab', 'type': 'EXPERIMENTAL', 'description': 'The combination of weekly paclitaxel 80 mg/m\u00b2 IV followed by q2w dose-dense doxorubicin-cyclophosphamide (ddAC) (60 mg/m\u00b2 doxorubicin IV and 600 mg/m\u00b2 cyclophosphamide IV) and pre-operative radiation therapy on the primary tumour (3x8 Gy) with the addition of the anti-PD-L1 antibody durvalumab IV 1500 mg q4w.', 'interventionNames': ['Drug: Durvalumab', 'Radiation: Stereotactic Body Radiotherapy']}\n- {'label': 'Chemotherapy & pre-op radiotherapy + durvalumab + oleclumab', 'type': 'EXPERIMENTAL', 'description': 'The combination of weekly paclitaxel 80 mg/m\u00b2 IV followed by q2w dose-dense doxorubicin-cyclophosphamide (ddAC) (60 mg/m\u00b2 doxorubicin IV and 600 mg/m\u00b2 cyclophosphamide IV) and pre-operative radiation therapy on the primary tumour (3x8 Gy) with the addition of the anti-PD-L1 antibody durvalumab IV 1500 mg q4w and the addition of the anti-CD73 antibody oleclumab IV 3000 mg q2w for 4 administrations, followed by q4w for 3 administrations.', 'interventionNames': ['Drug: Durvalumab', 'Radiation: Stereotactic Body Radiotherapy', 'Drug: Oleclumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Durvalumab', 'description': 'an anti PD-L1 intravenous administration at 1500 mg every 4 weeks for 19 weeks.', 'armGroupLabels': ['Chemotherapy & pre-op radiotherapy + durvalumab + oleclumab', 'Chemotherapy and pre-operative radiotherapy plus durvalumab'], 'otherNames': ['MEDI4736']}\n- {'type': 'RADIATION', 'name': 'Stereotactic Body Radiotherapy', 'description': 'Pre-operative radiation therapy (boost dose) 3x8 Gy on the primary tumour at week 5 given in 3 fractions. The 3 fractions will be spread at the minimum over 3 days and at the maximum over 6 days.', 'armGroupLabels': ['Chemotherapy & pre-op radiotherapy + durvalumab + oleclumab', 'Chemotherapy and pre-operative radiotherapy plus durvalumab', 'Chemotherapy and radiotherapy'], 'otherNames': ['SBRT']}\n- {'type': 'DRUG', 'name': 'Oleclumab', 'description': 'an anti-CD73 intravenous administration at 3000 mg every 2 weeks for the first 4 administrations then every 4 weeks for the last 3 administrations.', 'armGroupLabels': ['Chemotherapy & pre-op radiotherapy + durvalumab + oleclumab'], 'otherNames': ['MEDI9447']}\n\nPrimary Outcomes:\n- {'measure': 'Safety Run-in: Evaluation of the immune related or radiation therapy related toxicity of special interest', 'description': 'Immune related or radiation therapy related toxicity of special interest are identifitied as:\\n\\n* Any Grade 4 immune-related AE\\n* Any \u2265 Grade 3 colitis\\n* Any \u2265 Grade 3 renal failure/nephritis\\n* Any \u2265 Grade 3 non-infectious pneumonitis irrespective of duration\\n* Any Grade 3 immune-related AE, excluding colitis, renal failure/nephritis and pneumonitis, that does not downgrade to \u2264 Grade 2 within 3 days after onset of the event despite maximal medical supportive care including systemic corticosteroids or does not downgrade to \u2264 Grade 1 or baseline within 14 days\\n* Liver transaminase elevation \u2265 5 ULN or total bilirubin \\\\> 3 \u00d7 ULN will be considered a DLT regardless of duration or reversibility\\n* Any increase in AST or ALT \\\\> 3 \u00d7 ULN and concurrent increase in total bilirubin \\\\> 2 \u00d7 ULN', 'timeFrame': '7 months'}\n- {'measure': 'Safety Run-in: Evaluation of the feasibility of the primary surgery', 'description': 'Feasibility of performing surgery within 6 weeks after the last neo-adjuvant treatment. This would indicate that there were no significant delays or toxicities that would results in surgery being delayed.', 'timeFrame': '7 months'}\n- {'measure': 'Phase II: Demonstration of the tumour response in arms 2 or 3 versus arm 1', 'description': 'To demonstrate improved tumour response of the primary tumour and nodal metastases in arms 2 or 3 versus arm 1 using residual cancer burden (RCB 0-1 vs. RCB 2-3) at time of surgery.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided alpha level of 2.5% and a power of 80% have been targeted. No continuity correction was used, and a pooled estimate of variance was chosen. A 5% non-evaluability rate, a 5% non-eligibility rate, and a 20% screening failure rate were considered.", "answer": 147, "answer_type": "ACTUAL", "explanation": "Sample size\n Six patients will be included in the safety run-in. In the phase II part, patients will be randomized in a 1:1:1 ratio between 3 arms and the primary endpoint that will be measured on those patients is the binary achievement of RCB 0\u00e2\u0080\u00931 versus RCB 2\u00e2\u0080\u00933. The trial is designed to compare arm 2 to arm 1 as well as arm 3 to arm 1. The trial is not powered to compare arms 2 and 3 and no specific hypothesis is formulated for that comparison. It is expected that arm 1 will achieve an RCB 0\u00e2\u0080\u00931 rate of 15% and the experimental treatment arms will be considered of interest for further investigation if this rate can be increased to 45%. This estimation for arms 2 and 3 are based on the first results of the I-SPY 2 trial (2017): the addition of immune checkpoint blockade (ICB) to standard NACT increased pCR from 13.6 to 34.2% [16]. Taking into account the addition of radiation therapy and the use of RCB 0\u00e2\u0080\u00931 as endpoint, we hypothesize an increase in RCB 0\u00e2\u0080\u00931 rates from 15 to 45% in either arm 2 or 3. There will be then two hypotheses testing, both aiming to reject the null hypothesis of equality of the RCB 0\u00e2\u0080\u00931 rates between the control and in the experimental arms. A two-sided alpha level of 2.5% will be used and a power of 80% has been targeted in case the true RCB rate in either arm 2 or arm 3 is at least 45%. The alpha level of 2.5% was chosen to adjust for multiplicity. No continuity correction was used, and a pooled estimate of variance was chosen to estimate requested sample size. Sample size calculations are summarized in Table\u00c2\u00a02. With those assumptions, 44 evaluable patients per arm are needed, i.e. a total of 132 patients. In order to take into account a 5% non-evaluability rate and a 5% non-eligibility rate, this sample size will be increased to 147 patients to be randomized. Assuming 20% screening failures (taking into account MammaPrint patients that are screened as MammaPrint genomic low risk), 184 patients will have to be screened.\nTable 2Statistical sample size calculationSafety run-inNumbers of subjects needed6 subjectsPhase II trial\u00e2\u0080\u0083Primary endpoint achievement RCB 0/1 vs. RCB 2/3Standard arm: 15%Experimental arms: 45%Hypothesis: increase in RCB 0/1 rates from 15 to 45% in either arm 2 or 3.\u00e2\u0080\u0083Alpha level (two-sided)2.5%\u00e2\u0080\u0083Power80%Number of subjects needed\u00e2\u0080\u00831:1:1 randomization44 subjects per arm, total of 132 subjectsIncrease for:\u00e2\u0080\u00a2 5% ineligible after randomisationAdd 15 subjects\u00e2\u0080\u00a2 5% unevaluable subjects147 randomised subjectsIncrease for 20% ineligible after screening (MammaPrint genomic low risk).Add 37 subjects.Total for phase 2 trial184 subjects screenedTotal evaluable subjects (safety run-in\u00e2\u0080\u0089+\u00e2\u0080\u0089phase II)136 subjects", "id": 440, "split": "train"} +{"trial_id": "NCT03875976", "pmid": "34001185", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on Functional Outcomes and Hospital Stay Of Total Hip Arthroplasty\n\nIncluded conditions:\n- Hip Osteoarthritis\n- Arthropathy of Hip\n\nStudy Armgroups:\n- {'label': 'Fast Track Protocol', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients treated using Fast Track Care Protocol', 'interventionNames': ['Procedure: Fast Track Protocol']}\n- {'label': 'Standard Protocol', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients treated using Standard Care Protocol', 'interventionNames': ['Procedure: Standard Care Protocol']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Fast Track Protocol', 'description': 'Fast Track Care consists in educational preoperative preparation for patients, particular strategies for controlling pain and intensive early rehabilitation protocol', 'armGroupLabels': ['Fast Track Protocol']}\n- {'type': 'PROCEDURE', 'name': 'Standard Care Protocol', 'description': 'Standard Care Protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol', 'armGroupLabels': ['Standard Protocol']}\n\nPrimary Outcomes:\n- {'measure': 'Early functional outcomes', 'description': 'Early functional outcomes are collecting using Lowa Level of Assistance(ILOA) during the third post-operative day.\\n\\nThis scale is able to provide data on the autonomy reached by the patient in the first postoperative period going to investigate five main motor activities (get up from supine to seated, from sitting to standing position, walk around, take three steps, the speed of walking). The total score can vary from 0 to 56, where 56 indicates worst functional results.', 'timeFrame': 'Third post operative day'}\n\nPlease estimate the sample size based on the assumption: \nA power of 90%, a significance level of 0.05, and a 10% drop-out rate are assumed.", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size calculation, randomization, and statistical analysis\n The sample size was calculated based on the primary outcome\u00e2\u0080\u0094i.e., score changes in the ILOA scale collected at the third postoperative day. Specifically, considering a standard deviation of the ILOA scale of \u00c2\u00b1 6.9, a difference of seven points deemed clinically significant [20, 29], and a power of 90% with a significance level of 0.05, the minimum number of patients to be enrolled is estimated at 40 per arm (1:1 ratio) [43]. Presuming a 10% drop-out rate, following potential rare severe complications during surgery, it is necessary to enroll 90 patients, 45 per arm.\n The subjects are randomized to either the SC group or the FT group by the ER software [44] using the permuted blocks method [45] to randomly allocate the participants to each group in order to avoid imbalance in the number of participant assignment. Randomization, 1:1 ratio for each treatment arm, is performed centrally at the IRCCS Istituto Ortopedico Rizzoli by a colleague who is not involved in subject enrolment and is blinded to the participants, investigators/health care providers, or persons assessing outcomes. The randomization list is inserted in envelopes sequentially numbered and sealed; the investigator opens the envelopes in sequence on the day of enrolment.\n A modified intention-to-treat (mITT) analysis is used to handle data of patients. Specifically, every subject who is randomized to each treatment group, excepted for patients with severe intraoperative complications, ignoring withdrawal, and anything that happens after surgery, is accounted for in the interpretation of results.\n Patients are monitored at third postoperative day, at discharge, and during follow-up fixed at 6 weeks and 3, 6, and 12 months (according to standard clinical practice).\n ILOA, NRS, WOMAC and HHS scores, LOS, the number of postoperative blood transfusions, the need for rescue doses during analgesic therapy and AEs are assessed to compare the two treatment arms. Outcome assessors and analysts are blinded.\n Analyses are performed using GraphPad Prism ver. 6. For the values for which the mean and standard deviation is determined, a 95% confidence coefficient (CI 95%) is also determined, indicating a range of values with a 95% confidence level of a similar group mean. The ILOA difference between groups is calculated using the chi-square criterion method or Fisher\u00e2\u0080\u0099s direct test. A significant difference between groups is considered for P < 0.05. In addition, for the evaluation of secondary outcomes (i.e., scores for the NRS, WOMAC, HHS, LOS, the number of blood transfusion and rescue doses, AEs), a comparison between groups will be performed using the Student t-test if the data will be normally distributed. If not, the Mann-Whitney U test will be used to compare groups at each measurement time. Differences between groups are considered significant for P < 0.05. In case of data collected by primary and secondary outcome measurements will be affected by covariates (e.g., age, gender, BMI, ASA, short/standard stem, or the number of blood transfusions), a post hoc regression analysis will be performed to reduce any bias in the estimation of treatment effect which may occur by a potential random imbalance between groups [46].", "id": 441, "split": "train"} +{"trial_id": "NCT03875989", "pmid": "32641096", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vaginal Native Tissues Repair for Pelvic Organ Prolapse\n\nIncluded conditions:\n- Prolapse, Vaginal\n\nStudy Armgroups:\n- {'label': 'Arm A', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: Anterior colporraphy']}\n- {'label': 'Arm B', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: vaginal patch plastron']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Anterior colporraphy', 'description': 'It will be delimitate a rectangular vaginal strip which will be isolated from the anterior colpocele. The superior edge of the strip is placed 2 cm from the urethral orifice. After lateral vesico-vaginal dissection, the paravesical fossae will be wide opened to repair the tendinous arches. The vaginal plastron will be fixed to the tendinous arch of the pelvic fascia by 3 lateral stitches (anterior/ lateral/ posterior) on each side of the plastron. After, the plastron will be tensioning and the cystocele will be suspended. The closure of the vaginal wall will end the procedure.', 'armGroupLabels': ['Arm A']}\n- {'type': 'PROCEDURE', 'name': 'vaginal patch plastron', 'description': 'It will be make a midline incision of the anterior vaginal wall from the urethrovesical junction to the vaginal apex or anterior fornix. The vaginal epithelium will be separated from the underlying fibromuscular layer (Halban Fascia) after the midline incision. Midline plication of the fibromuscular layer will be obtained by interrupted horizontal stiches. The closure of the vaginal wall will end the procedure.', 'armGroupLabels': ['Arm B']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of the prolapse surgery', 'description': 'The success rate of the prolapse surgery defined by a composite of objective and subjective measures:\\n\\n* Anatomic success defined by Aa and Ba values \\\\<0 in Pelvic Organ Prolapse Quantification System (POP-Q) AND\\n* Subjective success through reliable condition-specific quality-of-life questionnaires:\\n\\n * A negative response to the question \"Do you usually have a bulge or something falling out that you can see or feel in your vaginal area?\" (question 3 of the Pelvic Floor Distress Inventory (PFDI-20)) AND\\n * Range score of Patient Global Impression of Improvement (PGI-I) 1 or 2 AND\\n* No need for other treatment for prolapse (surgical nor medical)', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nCalculations are based on a significance level (alpha) of 5% and a power (beta) of 80%. A 10% rate of lost-to-follow-ups at 1 year is assumed.", "answer": 214, "answer_type": "ESTIMATED", "explanation": "Sample size\n The estimated number of required participants is based on the primary outcome. We estimate that the rate of success defined by combined objective and subjective measures of the anterior colporraphy is about 45% at 1\u00c2\u00a0year, with anatomical success defined with Aa and Ba point of 0 [6, 12].\n Vaginal patch plastron technique has never been studied with a combined definition of success (anatomical and functional). Its reported anatomical success rate ranges from 93 to 98% while its functional success rate ranges from 74 to 92% [16]. This procedure combines the advantages of techniques used for the management of median and lateral cystoceles. Therefore, we hypothesize that vaginal patch plastron will be more effective than anterior colporraphy regarding the primary outcome. Sample size calculation is based on an expected difference of 20% in the rate of success as defined by the primary outcome. Calculations with alpha\u00e2\u0080\u0089=\u00e2\u0080\u00895% and beta\u00e2\u0080\u0089=\u00e2\u0080\u008920% yielded 96 patients per group. Assuming a 10% rate of lost-to-follow-ups at 1\u00c2\u00a0year, we have planned to include a total of 214 women (107 patients per treatment arm).\n To date, 8 centers are participating in the study. We expect to enroll 90 patients per year. With an inclusion period of 30\u00e2\u0080\u0089months, we are hoping for a total of 225 inclusions.", "id": 442, "split": "train"} +{"trial_id": "NCT03880032", "pmid": "32300002", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan\n\nIncluded conditions:\n- Postpartum Depression\n- Small for Gestational Age at Delivery\n- Preterm Birth\n- Anxiety\n- Birth Weight\n\nStudy Armgroups:\n- {'label': 'Cognitive Behavioral Therapy Intervention for Anxiety', 'type': 'EXPERIMENTAL', 'description': \"Pregnant women experiencing anxiety randomized to the Happy Mother Healthy Baby (HMHB) intervention receive a CBT-based psychosocial intervention (with six core and up to six booster sessions). HMHB is a facility-based intervention delivered by non-specialist providers. It is aimed to raise psychosocial awareness and facilitate positive change inter personal wellbeing, social support, and bonding with their baby during pregnancy. It addresses with relapse prevention, planning for the baby's arrival, and in management of emotional challenges in the early postnatal period. Family member/s will be invited to attend 3 core sessions.\", 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy Intervention for Anxiety']}\n- {'label': 'Enhanced Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Women randomized to the control group will receive enhanced usual care (EUC). The World Health Organization (WHO) recommends 8 antenatal visits for a positive pregnancy experience, the number of visits our EUC control group participants will receive (depending on their gestational week). Usual care will also be enhanced by hospital staff receiving additional training in mental health treatment and counseling. Reminder calls were given, provider visits were facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the intervention group).'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive Behavioral Therapy Intervention for Anxiety', 'description': 'Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.', 'armGroupLabels': ['Cognitive Behavioral Therapy Intervention for Anxiety']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression).', 'description': 'Data reported is the number of participants with Common Mental Disorders (CMDs), which is defined as a woman having either high anxiety or clinical depression at the time of follow-up. Both CMDs, anxiety was indicated by moderate to severe symptoms on the anxiety portion of the Hospital and Anxiety Scale (HADS). A cutoff of \\\\>10 was used as the threshold for moderate to severe levels of anxiety. A Major Depressive Episode (MDE) was measured with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID), which is a semi-structured interview used to make major Axis I Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses. Its scoring will be based on case or non-case basis.', 'timeFrame': '6 weeks postpartum'}\n\nPlease estimate the sample size based on the assumption: \nWe assumed a significance level of 0.05 and aimed for 85% power to detect the reduction in CMDs. We also considered a 30% attrition rate post-enrollment. For SGA, we aimed for 90% and 80% power to detect specific reductions.", "answer": 1200, "answer_type": "ACTUAL", "explanation": "Sample size determination\n In our study, the unit of randomisation is an individual woman, with an equal number of women randomised to the intervention and control groups. We assumed a significance level of 0.05. Sample size calculations were based on \u00cf\u00872 tests comparing outcome rates in the intervention and control groups. We assumed an outcome prevalence of CMDs (MDE and GAD) at 30%, which we considered conservative given that most estimates of prenatal depression in Pakistan are higher than this.3 4 39 44 Assuming this prevalence and considering a 30% reduction in CMDs as meaningful,1 45 46 we will need to measure this outcome in 840 pregnant women (420 in each arm) to achieve 85% power. Based on our prior research experience in Pakistan, we will overenrol to compensate for 30% attrition post enrolment; this attrition rate will require us to enrol 600 women per group in this study, for a total of 1200 women.\n This sample size of 420 outcomes per group provides ample power to detect important reductions in SGA, which we currently estimate to occur in approximately 47% of births. For example, we will have 90% and 80% power to detect reductions in SGA incidence of 23.7% and 20.2%, respectively. With the sample size of 420 per group, we will have about 85% power to detect a 21.6% relative reduction in SGA, if SGA in the population is 47%.", "id": 443, "split": "train"} +{"trial_id": "NCT03880877", "pmid": "31856912", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Regorafenib Plus FOLFIRI With Irinotecan Dose Escalated According to UGT1A1 Genotyping Versus Regorafenib Monotherapy in Patients With Previously Treated Metastatic Colorectal Cancer: A Prospective, Randomized, Controlled Study\n\nIncluded conditions:\n- Metastatic Colorectal Cancer\n\nStudy Armgroups:\n- {'label': 'Regorafenib plus FOLFIRI', 'type': 'EXPERIMENTAL', 'description': 'Regimen for treatment consists of irinotecan (180 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7); 120 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA7/TA7)), followed by Leucovorin (400 mg/m2 IV infusion over 2 hours), and fluorouracil (5-FU) (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks.\\n\\nAfter every 2 cycles of each different dose of irinotecan, if adverse events (AEs) are under the grade 2, we will escalate the dose of 30 mg/m2. The estimated maximal dose of irinotecan is 260 mg/m2 for UGT1A1 genotyping (TA6/TA6); 240 mg/m2 for UGT1A1 genotyping (TA6/TA7); 180 mg/m2 for UGT1A1 genotyping (TA7/TA7).\\n\\nRegorafenib is administered at adjusted dosage of 120 mg daily for 3 weeks in a 4-week cycle.', 'interventionNames': ['Drug: Regorafenib', 'Genetic: UGT1A1 genotyping (TA6/TA6)', 'Genetic: UGT1A1 genotyping (TA6/TA7)', 'Genetic: UGT1A1 genotyping (TA7/TA7)', 'Drug: Leucovorin and 5-FU']}\n- {'label': 'Regorafenib', 'type': 'ACTIVE_COMPARATOR', 'description': 'Regorafenib is administered at adjusted dosage of 120 mg daily for 3 weeks in a 4-week cycle.', 'interventionNames': ['Drug: Regorafenib']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Regorafenib', 'description': 'Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle', 'armGroupLabels': ['Regorafenib', 'Regorafenib plus FOLFIRI'], 'otherNames': ['stivarga']}\n- {'type': 'GENETIC', 'name': 'UGT1A1 genotyping (TA6/TA6)', 'description': 'The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2', 'armGroupLabels': ['Regorafenib plus FOLFIRI']}\n- {'type': 'GENETIC', 'name': 'UGT1A1 genotyping (TA6/TA7)', 'description': 'The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2', 'armGroupLabels': ['Regorafenib plus FOLFIRI']}\n- {'type': 'GENETIC', 'name': 'UGT1A1 genotyping (TA7/TA7)', 'description': 'The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2', 'armGroupLabels': ['Regorafenib plus FOLFIRI']}\n- {'type': 'DRUG', 'name': 'Leucovorin and 5-FU', 'description': 'Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period)', 'armGroupLabels': ['Regorafenib plus FOLFIRI']}\n\nPrimary Outcomes:\n- {'measure': 'Progression-free survival', 'description': 'Time from treatment to disease progresses and lives', 'timeFrame': 'From date of initiation of treatment until the date of first documented progression, assessed up to 23 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided \u03b1 of 0.025, 90% power, overall probability of events is 0.77, and a 20% drop-rate.", "answer": 153, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Using a per-protocol two-sided \u00ce\u00b1 of 0.025, a 2:1 randomization between regorafenib plus FOLFIRI dose escalation and regorafenib, and a median PFS of 3.2\u00e2\u0080\u0089months in the regorafenib group [9], the study would have 90% power to detect assumed median PFS of 7.0\u00e2\u0080\u0089months with regorafenib plus FOLFIRI [3]. The assumption of overall probability of events is 0.77 (10 progressions at the end of the study out of 13 in total) [9]. The calculated sample size is 121 patients. Considering a 20% drop-rate, a total of 153 patients should be enrolled into the study, with 102 assigned to the study group (FOLFIRI plus regorafenib group) and 51 to the control group (regorafenib monotherapy group).", "id": 444, "split": "train"} +{"trial_id": "NCT03884049", "pmid": "34998425", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Novel Transcatheter Arterial Embolization for Treatment of Knee Osteoarthritis: a Randomized Sham-controlled Clinical Trial\n\nIncluded conditions:\n- Osteoarthritis, Knee\n\nStudy Armgroups:\n- {'label': 'Embolization group', 'type': 'EXPERIMENTAL', 'description': 'Group undergoes transcatheter arterial embolization of neovessels around the knee.', 'interventionNames': ['Procedure: Embolization']}\n- {'label': 'Sham Embolization Group', 'type': 'SHAM_COMPARATOR', 'description': 'Group undergoes sham embolization', 'interventionNames': ['Procedure: Sham embolization']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Embolization', 'description': 'transcatheter arterial embolization of neovessels around the knee', 'armGroupLabels': ['Embolization group']}\n- {'type': 'PROCEDURE', 'name': 'Sham embolization', 'description': 'Sham transcatheter arterial embolization of neovessels in the knee', 'armGroupLabels': ['Sham Embolization Group']}\n\nPrimary Outcomes:\n- {'measure': 'KOOS pain sub score', 'description': 'KOOS pain sub score after 4 months', 'timeFrame': '4 months'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation of 16 for the KOOS pain score, significance level (alpha) of 0.05, power (beta) of 0.80, and an estimated 20% dropout rate.", "answer": 58, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Calculations are partly based on the previous observational studies by Okuno et al. [6, 7]. Despite a possible placebo effect, which account for effect sizes up to 0.5 [21], they found effect sizes of >\u00e2\u0080\u00895. For our study, we assumed we would require to demonstrate a large effect size of >\u00e2\u0080\u00890.8 (strong effect) compared to sham embolization since GAE still is (minimally) invasive. Assuming this projected effect size of 0.8, and a standard deviation of 16 for the KOOS (100-0) pain score (estimated from multiple OA studies at Erasmus MC), beta of 0.80, and alpha of 0.05, 48 patients (n = 24 per study arm) are required to detect an increase (higher scores indicate less pain) in primary outcome measure of 8 points in the control group (placebo effect) compared to 21 points in the intervention group. The targeted sample size will be 58 to account for approximately 20% of patients lost to follow-up. We also expect a more homogeneous study population since all included subjects have an NRS pain score \u00e2\u0089\u00a5 4 and \u00e2\u0089\u00a4 8. With this sample size, and in case of lower variation in pain scores than SD of 16, we expect we could also detect smaller effect sizes between 0.5 (moderate effect) and 0.8.", "id": 445, "split": "train"} +{"trial_id": "NCT03886675", "pmid": "37105705", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Carbon-Dioxide Flushing Versus Saline Flushing in Thoracic Endovascular Aortic Repair to Reduce Neurological Injury: A Pilot Randomised Controlled Trial\n\nIncluded conditions:\n- Stroke\n- Silent Cerebral Infarction\n- Neurocognitive Dysfunction\n- Vascular Brain Injury\n\nStudy Armgroups:\n- {'label': 'carbon-dioxide', 'type': 'EXPERIMENTAL', 'description': 'Flushing of stent-grafts in TEVAR with carbon-dioxide', 'interventionNames': ['Other: CO2 flushing']}\n- {'label': 'Saline', 'type': 'ACTIVE_COMPARATOR', 'description': 'Flushing of stent-grafts with saline', 'interventionNames': ['Other: Saline flushing']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'CO2 flushing', 'description': 'As above', 'armGroupLabels': ['carbon-dioxide']}\n- {'type': 'OTHER', 'name': 'Saline flushing', 'description': 'As above', 'armGroupLabels': ['Saline']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment', 'description': 'The number of patients recruited into the trial will be collected', 'timeFrame': '36 months'}\n- {'measure': 'Retention', 'description': 'The proportion of patients undergoing follow-up assessments will be collected', 'timeFrame': '36 months'}\n- {'measure': 'Study design for full randomised controlled trial', 'description': 'The proportion of patients who are eligible for the trial will be collected', 'timeFrame': '36 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level and power are not explicitly mentioned. Assumes a 20% MRI dropout rate.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n Observational data indicate that the incidence of SCI from TEVAR is 81%.6 Based on our CO2-pilot study that reduced SCI to 25%, a 50% reduction in SCI is possible. Taking a pragmatic and realistic approach to recruitment, we aim for an effect size of 40% reduction in incidence of SCI. Considering a 10% MRI dropout rate from our observational study, a total of 76 (38 per group) would be sufficient to detect an effect size. However, given that randomisation will be by zone of TEVAR, of which there are 5, and we expect a 20% MRI drop-out rate, we are aiming to recruit 120 cases (60 in each arm). This number has been chosen to ensure 10\u00e2\u0080\u009312 patients in each of five arch landing zones in each of the two intervention groups, to allow us to quantify brain injury by zone between the two interventions in addition to establishing an overall measure of effect between the two interventions.", "id": 446, "split": "train"} +{"trial_id": "NCT03886909", "pmid": "36657760", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of a Prehabilitation Exercise Program in Adults Receiving a Hematopoietic Stem Cell Transplant\n\nIncluded conditions:\n- Hematopoietic Stem Cell Transplant\n- Hematologic Diseases\n- Physical Activity\n- Prehabilitation\n\nStudy Armgroups:\n- {'label': 'Home-Based Prehabilitation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Will be offered an individual one-on-one appointment for an exercise introduction session with an exercise and cancer specialist and periodical phone calls to support and adapt the exercise program. The exercises should be done home-based for 5 times a week until the time of transplant.', 'interventionNames': ['Behavioral: Exercise']}\n- {'label': 'Prehabilitation Education', 'type': 'ACTIVE_COMPARATOR', 'description': 'Will be offered a prehabilitation and stem cell education class at the Penn State Hershey Cancer Institute.', 'interventionNames': ['Behavioral: Prehabilitation Education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Exercise', 'description': 'The exercise intervention is at least 2 weeks lasting (till the day transplant is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).', 'armGroupLabels': ['Home-Based Prehabilitation']}\n- {'type': 'BEHAVIORAL', 'name': 'Prehabilitation Education', 'description': 'Participant will receive a prehabilitation and stem cell education class which will be held at the Penn State Cancer Institute.', 'armGroupLabels': ['Prehabilitation Education']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of the exercise intervention: 50% of included patients actually complete at least one third of the exercise sessions', 'description': 'The exercise intervention will be considered feasible if 50% of included patients actually complete at least one third of the exercise sessions prescribed for 2 weeks or more.', 'timeFrame': 'Through study completion, an average of 18 months'}\n- {'measure': 'Acceptability of the exercise intervention: more than 50% of the patients approached', 'description': 'The exercise intervention will be considered acceptable if more than 50% of the patients approached agree to receive at least the first exercise session.', 'timeFrame': 'During recruitment'}\n- {'measure': 'Safety of the exercise intervention: questionnaire', 'description': 'Within the questionnaire we will assess whether musculoskeletal occur (yes/no; ongoing; location; severity (mild-life threatening); daily activities affected). The intervention will be considered as safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).', 'timeFrame': 'Through the study completion, an average of 18 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided significance level of 0.05 will be used for all statistical tests. The study will include various clinical covariates to address heterogeneity and will evaluate missing data at the time of analysis.", "answer": 84, "answer_type": "ACTUAL", "explanation": "Statistical analysis and sample size calculations\n Our primary outcomes are descriptive. Acceptability will be defined by the proportion of approached patients who agree to participate and complete at least the prehab counselling session. Our a priori threshold is 50%. We will consider the intervention feasible if 50% of included patients complete at least one third of the prescribed exercise sessions for 2 weeks or more. Safety will be reported by the number of exercise-associated events. Exercise adherence during the prehabilitation period will be calculated as the proportion of completed exercise sessions over the number of prescribed exercise sessions. Summary statistics including mean and SD for continuous variables and frequency with percentage for categorical variables will be reported. We will examine differences within-group and between-group using linear mixed-effects models for physical performance measures, patient-reported outcomes and body composition. A two-sided significance level of 0.05 will be used for all statistical tests. Various clinical covariates including transplant type, prehabilitation duration and baseline differences will be included as statistical covariates to address heterogeneity. Evaluation of missing data will occur at the time of analysis in order to select the best method to evaluate and analyse missing data. This study will provide estimates of mean and SD to support a sample size calculation for a larger, fully powered trial. The anticipated sample size for this pilot trial is 84 participants\u00e2\u0080\u009442 in each intervention arm\u00e2\u0080\u0094based on the PSCI HSCT programme annual enrolment and projected withdrawal rate from similar previous trials within our working group. All data will be entered and stored on secure servers at PSCI. Regular data range checks will be performed to promote data quality.", "id": 447, "split": "train"} +{"trial_id": "NCT03891030", "pmid": "32033576", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Checklist Based Box System Interventions (CBBSI) on Improving Utilization of Maternal Health Service in North West, Ethiopia: a Cluster Randomized Controlled Trial\n\nIncluded conditions:\n- Maternal Health Service\n\nStudy Armgroups:\n- {'label': 'Checklist Based Box system', 'type': 'EXPERIMENTAL', 'description': 'Pregnant mothers will receive scheduled person-centered health educations starting from: they are identified as suspected pregnant mother up to attending their third PNC visit. In between the first ANC and the third PNC drop out tracing mechanisms will be applied, for mothers who fail to utilize the recommended maternal health services.', 'interventionNames': ['Other: Checklist Based Box system intervention']}\n- {'label': 'Routine maternal health care', 'type': 'NO_INTERVENTION', 'description': 'Pregnant mothers in this arm will receive the usual routine maternal health care.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Checklist Based Box system intervention', 'description': 'The intervention has both behavioural change and service utilization drop out tracing mechanism. Special type of boxes designed to schedule health educations and continued service utilization monitoring boxes will be placed at health posts and health centers respectively. Community level survey will be conducted to identify suspected pregnant mothers using stanback et al, 1999 checklist, and mothers are linked to health centers. Then, they will be followed for their subsequent attendance of consecutive maternal health services (ANC 2nd-third PNC). Mothers who fail to utilize the service will be traced; will get person-centered health education to continue the service.', 'armGroupLabels': ['Checklist Based Box system']}\n\nPrimary Outcomes:\n- {'measure': 'Continued maternal health service utilization (ANC 1-4), Institutional Delivery, PNC (1-3)', 'description': 'Proportion of mothers receiving continued maternal health service (four ANC, skilled birth attendance and PNC three) in the intervention and control clusters, assessed using standard questionnaire', 'timeFrame': '42 days after delivery'}\n\nPlease estimate the sample size based on the assumption: \nNumber of clusters is 30 (15 per arm), 95% confidence interval, 80% power, and an intracluster correlation coefficient of 0.04849.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n The sample size was calculated based on the recommendations of sample size calculations for cluster randomized controlled trials with fixed number of clusters [19] by using the following assumptions: utilization of the third PNC in the control group is 16% based on a previous study [20], the number of clusters available is 30 (15 clusters per arm), with 95% confidence interval and 80% power, and an intracluster correlation coefficient of 0.04849 [21]. The sample size was calculated to determine the number of observations required per cluster for a two-sample comparison of proportions (using normal approximation) using STATA software. Assuming individual randomization, the sample size per arm is 194; allowing for cluster randomization, the average cluster size required is 40. A total of 1200 pregnant mothers (600 in the intervention and 600 in the control groups) will be recruited to detect a 12% increase in the utilization of ANC visit four, skilled birth attendance and PNC. The outcome is treated as a binary measure.", "id": 448, "split": "train"} +{"trial_id": "NCT03891277", "pmid": "38789134", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA,FAVORITE\n\nIncluded conditions:\n- Vascular Cognitive Impairment\n- Dementia, Vascular\n- Iron-deficiency\n- Cerebral Infarction\n- TIA\n\nStudy Armgroups:\n- {'label': 'Ferrous succinate', 'type': 'ACTIVE_COMPARATOR', 'description': 'Ferrous succinate sustained-release tablets\uff08Ferrous succinate 0.2g\uff091 tablet, Qd, po during or after breakfast, Lasting for 12 weeks.', 'interventionNames': ['Drug: Ferrous succinate']}\n- {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'placebo with almost the same size, color and smell as Ferrous iron will be used with 1 tablet, Qd, po during or after breakfast, Lasting for 12 weeks.', 'interventionNames': ['Drug: Ferrous succinate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ferrous succinate', 'description': 'Ferrous succinate sustained-release tablets\uff08Ferrous succinate 0.2g\uff091 tablet, Qd,po during or after breakfast, Lasting for 12 weeks.\\n\\nplacebo with almost the same size, color and smell as Ferrous iron will be used with 1 tablet, Qd, po during or after breakfast, Lasting for 12 weeks.', 'armGroupLabels': ['Ferrous succinate', 'placebo'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'prevalence of vascular cognitive impairment in patients given Ferrous succinate versus placebo', 'description': 'Vascular cognitive impairment will be diagnosed with Montreal Cognitive Assessment(MoCA, range 0-30 scores) \\\\<26 scores', 'timeFrame': '1 year after randomization'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 0.05 for a two-sided test, statistical power of 90%, and an estimated 20% of patients with mild anaemia or low haemoglobin.", "answer": 1006, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on the risk of primary outcome (3-month risk of VCI). We applied the following assumptions: a significance level of 0.05 for a two-sided test; statistical power of 90%; according to the previous studies, the risk of VCI within 3 months after ischaemic cerebrovascular disease is 21%\u00e2\u0080\u009370%, it is conservatively estimated that the risk of VCI within 3 months in patients with ischaemic cerebrovascular disease combined with iron deficiency or haemoglobin deficiency is 45% in the control group.1 2 According to the previous studies, the relative improvement rate of iron treatment for cognitive impairment in patients with iron deficiency is about 25%,911 and it is conservatively estimated that the 3-month risk of VCI in patients with ischaemic cerebrovascular disease combined with iron deficiency or haemoglobin deficiency treated by iron supplementation is 35%. Proportional risk reduction of 25% (rate ratio=0.75). We estimated that 1006 eligible patients (503 for each arm) are required. As 20% of patients are mild anaemia or low haemoglobin,4 5 we will screen about 5030 patients in total.", "id": 449, "split": "train"} +{"trial_id": "NCT03892603", "pmid": "33154058", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rotator Cuff Related Shoulder Pain: Does The Type of Exercise Influence Outcome? - A Randomized Controlled Trial\n\nIncluded conditions:\n- Shoulder Pain\n- Rotator Cuff Injury\n- Rotator Cuff Tendinitis\n- Rotator Cuff Impingement Syndrome\n\nStudy Armgroups:\n- {'label': 'Strengthening exercises program', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Strengthening exercises program']}\n- {'label': 'Motor control exercises program', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Motor control exercises program']}\n- {'label': 'Education and advice', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Education and advice']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Strengthening exercises program', 'description': 'Participants from this group will be given a progressive shoulder strengthening exercises program based on 1 RM that will involve isometric, concentric and eccentric contractions. The exercises will target shoulder internal/external rotators and abductors and the scapular muscles. They will have to exercise every other day for 12 weeks. At each session with the therapist (6 over a 12 week period), strength will be reassessed and the program will be progressed accordingly. Any questions or concerns will also be addressed and participants will be requested to complete a paper based or digital record of their exercise participation.', 'armGroupLabels': ['Strengthening exercises program']}\n- {'type': 'OTHER', 'name': 'Motor control exercises program', 'description': \"Each session will start with a series of clinical tests that will look at the influence of different corrections to alleviate symptoms during upper limb movements.The tests will be performed in a sequential format through four key areas: thoracic repositioning, scapula facilitation, humeral head procedures and neuromodulatory techniques. If a correction reduces pain, that technique will then be performed as exercises and incorporated into the participant's functional movement. In addition, motor control exercises during arm elevation, progressed through a standardized 6-phase retraining sequence, will be executed. Retraining phases will be graded according to: 1) resistance applied on the shoulder; and 2) use or non-use of feedback. Once participants reach pain free execution, the program will be progressed into re-education exercises according to the participants' work, sport and activities of daily living and will incorporate activities involving the upper and lower limbs.\", 'armGroupLabels': ['Motor control exercises program']}\n- {'type': 'OTHER', 'name': 'Education and advice', 'description': \"Each participant will be given written information about the shoulder (anatomy and function), basic pain science and will be directed to the Internet to watch a series of carefully selected educational videos. Comprehensive written advice will include: Information about the shoulder and the condition; Pain neuroscience; Activity modification (when to increase and decrease); Pain management (night and day); A series of educational videos to watch with 2 questions to answer per video: a) what was the most important message? and b) was there anything you didn't understand in the video?\", 'armGroupLabels': ['Education and advice']}\n\nPrimary Outcomes:\n- {'measure': 'Change in symptoms and functional limitations from baseline to 3 weeks: QuickDASH', 'description': 'The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).', 'timeFrame': '0 and 3 weeks'}\n- {'measure': 'Change in symptoms and functional limitations from baseline to 6 weeks: QuickDASH', 'description': 'The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).', 'timeFrame': '0 and 6 weeks'}\n- {'measure': 'Change in symptoms and functional limitations from baseline to 12 weeks: QuickDASH', 'description': 'The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).', 'timeFrame': '0 and 12 weeks'}\n- {'measure': 'Change in symptoms and functional limitations from baseline to 24 weeks: QuickDASH', 'description': 'The QuickDASH is a self-reported questionnaire that includes 11 items measuring physical disability and symptoms. This tool uses a 5-point (1-5) Likert scale. The total out of 55 is then reported to a score from 0 to 100. Score ranges from 0 (no disability) to 100 (most severe disability).', 'timeFrame': '0 and 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1=0.05, power=0.95, SD=13 DASH points, expected lost at follow-up=15%", "answer": 123, "answer_type": "ACTUAL", "explanation": "Participants and sample size\n Adults presenting with RCRSP will be recruited using the following inclusion criteria: (1) 18\u00e2\u0080\u009375 years of age, (2) symptoms lasting longer than 3 months, (3) presence of a painful arc in flexion or abduction, (4) presence of a positive Neer sign or Hawkins-Kennedy Test, (5) presence of pain when resisting humeral external rotation or abduction, or positive Jobe Test, and (6) ability to speak English or French. A positive cluster of criteria 3, 4 and 5 represents an adequate diagnostic tool for RCRSP (sensitivity: 0.75, specificity: 0.74).25 Participants will be excluded if they present any of the following criteria: (1) clinical signs of massive rotator cuff tears as defined by presence of gross weakness in the absence of limited pain, (2) other shoulder disorders, for example, adhesive capsulitis (restriction of passive glenohumeral movement of at least 30% for two or more directions), severe osteoarthritis, fracture, dislocation, severe acromioclavicular joint pathology, (3) previous shoulder surgery, (4) presence of significant comorbidity, for example, neurological disorders, rheumatoid arthritis, (5) current or past carcinoma, (6) unlikely to be able to perform required clinical assessment tasks or attend the required evaluation and intervention sessions, (7) symptomatic cervical spine pathology, defined as reproduction of symptoms with active physiological cervical spine movements, and (8) corticosteroid injection in the last 6 weeks. All recruited participants will be evaluated by a physiotherapist (PT) in order to confirm their eligibility.\n Based on our sample size calculation, calculated for our primary outcome (abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)), 41 participants are required per group (G*Power V.3.1.9; effect size: 0.80, \u00ce\u00b1=0.05, power=0.95, SD=13\u00e2\u0080\u0089DASH points, clinically important difference (CID)=11\u00e2\u0080\u0089DASH points, expected lost at follow-up=15%). Therefore, 123 participants with RCRSP will be recruited. This sample size should be sufficient to detect a CID between groups.\n Potential participants will be recruited in outpatient physiotherapy clinics of hospitals and in private physiotherapy clinics in the Quebec City region, and through electronic mailing lists of employees and students at Universit\u00c3\u00a9 Laval (>52\u00e2\u0080\u0089000 individuals). Since our research team has performed studies evaluating the same population in the same metropolitan area, we are confident to recruit the targeted population.26\u00e2\u0080\u009328 With an average rate of seven new participants per month, we estimate that 18 months will be ample time to reach our goal of 123 participants.", "id": 450, "split": "train"} +{"trial_id": "NCT03892941", "pmid": "32576247", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Electric Pace-pitched Hearing Achieves Natural Tonotopy\n\nIncluded conditions:\n- Deafness\n\nStudy Armgroups:\n- {'label': 'Imaged based fitting', 'type': 'EXPERIMENTAL', 'description': 'Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.', 'interventionNames': ['Device: Imaged based fitting']}\n- {'label': 'Clinical routine', 'type': 'NO_INTERVENTION', 'description': 'Mapping of the electrical input of the cochlear implant will be based on a one-size-fits-all, as is part of clinical routine.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Imaged based fitting', 'description': 'Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.', 'armGroupLabels': ['Imaged based fitting']}\n\nPrimary Outcomes:\n- {'measure': 'Speech understanding in quiet with cochlear implant', 'description': 'Speech understanding with CI in quiet measured with the Dutch Consonant Nucleus Consonant (CNC) test.', 'timeFrame': 'During the first 12 months of CI rehabilitation'}\n- {'measure': 'Speech understanding in quiet with cochlear implant', 'description': 'Speech understanding with CI in quiet will be measured with the Dutch Matrix sentence test.', 'timeFrame': 'During the first 12 months of CI rehabilitation'}\n- {'measure': 'Speech understanding in noise with cochlear implant', 'description': 'Speech understanding with CI in noise will be measured with the Dutch Matrix sentence test.', 'timeFrame': 'During the first 12 months of CI rehabilitation'}\n- {'measure': 'Patient preference', 'description': 'At every fitting session, patients will be asked to rate their satisfaction with either the control or experimental program on a 10-point Visual Analog Sscale (1 dissatisfied - 10 very satisfied).', 'timeFrame': 'During the first 12 months of CI rehabilitation'}\n\nPlease estimate the sample size based on the assumption: \nAlpha range is 0.01-0.08, power is 0.08, and type 1 error is 0.05.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n Complementary to the new study design for clinical trials presented in this paper, thought has also been given to a different method for a priori calculation of sample size and power. Instead of calculating the estimated number of participants needed for a given research study, one could also work the other way around. After all, many clinical trials depend on the supply of patients within a selective pool and do not have any additional recruiting possibilities. This study, which is no exception to that point, will aim to include a minimum sample of 20 participants during an inclusion period of 18\u00e2\u0080\u009324\u00e2\u0080\u0089months. A maximum of 30 participants will be included if recruitment is prosperous.\n Sample size calculation is usually based on the primary study outcome, which in this study is the difference in CNC word recognition (test-retest at 65\u00e2\u0080\u0089dB SPL) between the experimental and standard CI setting after 6\u00e2\u0080\u0089months of rehabilitation. Using the concept of effect size as interpreted by Cohen\u00e2\u0080\u0099s d [64, 65], the following formula could be used to calculate sample size for a paired t test:\n \\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ \\mathrm{N}=2+\\left({\\left({\\mathrm{Z}}_{1-\\upalpha /2}+{\\mathrm{Z}}_{1-\\upbeta}\\right)}^2/{\\mathrm{d}}^2\\right) $$\\end{document}N=2+Z1\u00e2\u0088\u0092\u00ce\u00b1/2+Z1\u00e2\u0088\u0092\u00ce\u00b22/d2where N\u00e2\u0080\u0089=\u00e2\u0080\u0089sample size, \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u0089type 1 error, \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u0089type 2 error, d\u00e2\u0080\u0089=\u00e2\u0080\u0089effect size.\n Given the idea of a restricted sample size, it can be argued that it is more valuable to rearrange this formula as to calculate effect size.\n\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ \\mathrm{d}=\\surd \\left(2+\\left({\\left({\\mathrm{Z}}_{1-\\upalpha /2}+{\\mathrm{Z}}_{1-\\upbeta}\\right)}^2\\right)/\\mathrm{N}\\right) $$\\end{document}d=\u00e2\u0088\u009a2+Z1\u00e2\u0088\u0092\u00ce\u00b1/2+Z1\u00e2\u0088\u0092\u00ce\u00b22/N\n As a result, different outcomes in effect size can be calculated with a sample size range of 20\u00e2\u0080\u009330 participants, an alpha range of 0.01\u00e2\u0080\u00930.08 and a given power of 0.08. When considering a type 1 error of 0.05 and a sample size of 20, an effect size of 0.66 or larger can be detected. If 30 study participants are recruited and the alpha level is kept similar, the resulting detectable effect size is at least 0.53.", "id": 451, "split": "train"} +{"trial_id": "NCT03893474", "pmid": "33980536", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Quality-Assured Follow-up of Quiescent Neovascular Age -Related maculaR dEgeneration by Non-medical Practitioners: a Randomised Controlled Trial\n\nIncluded conditions:\n- AMD\n\nStudy Armgroups:\n- {'label': 'Control Arm', 'type': 'OTHER', 'description': 'All investigations are the same in both arms, but patients within this arm will be seen in the hospital as per standard practice.', 'interventionNames': ['Diagnostic Test: OCT', 'Diagnostic Test: Visual Acuity']}\n- {'label': 'Study Arm', 'type': 'OTHER', 'description': 'All investigations are the same in both arms, but patients within this arm will be seen in a community optometrist practice.', 'interventionNames': ['Diagnostic Test: OCT', 'Diagnostic Test: Visual Acuity']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'OCT', 'description': 'Optical Coherence Tomography of study eye.', 'armGroupLabels': ['Control Arm', 'Study Arm']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Visual Acuity', 'description': 'Visual acuity measured by ETDRS', 'armGroupLabels': ['Control Arm', 'Study Arm']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).', 'description': 'The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).', 'timeFrame': '12 months'}\n- {'measure': 'Primary economic outcome: Incremental cost per quality adjusted life year (QALY) gained over the estimated patient lifetime estimated from an economic model informed by trial data.', 'description': 'Primary economic outcome: Incremental cost per quality adjusted life year (QALY) gained over the estimated patient lifetime estimated from an economic model informed by trial data.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe test of non-inferiority will be one-sided at the 2.5% significance level with 90% power. A conservative estimate of 10% loss to follow-up is assumed.", "answer": 742, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The ECHOES study has shown that the rate of false negatives per lesion assessment when conducted by an ophthalmologist was 62/994, that is, 6.2% (95% CI of 4.8% to 7.9%).6 Over the course of 1\u00e2\u0080\u0089year, a patient will typically have lesions assessed on 12 occasions. The overall chance of being a false negative at any point during the 12 months of follow-up is estimated at 20% (determined by the summation of the probability of reactivating and the probability of being a false negative and deducting the chance of being a false negative on repeat occasions, with figures estimated from Madhusudhana et al).\n8 This estimate requires adjustment for the fact that ECHOES figures were based on scenarios and vignettes and did not factor in additional patient information that may be available to the clinician, thus the false negative rate is expected to be lower than 20% in reality. The test of non-inferiority will be one sided at the 2.5% level. This approach is the conservative approach which is the standard for regulatory approval of new pharmaceuticals and many devices.9 While approval has been made on the basis of a non-inferiority design with a one-sided alpha of 5%, this is generally frowned on and thus we have adopted the more conservative approach. One of the major challenges in the design of a non-inferiority trial is the determination of the non-inferiority margin. This margin is the smallest difference between patient management approaches which, if true, would mean that management by non-medical professionals is declared inferior. We adopted a non-inferiority margin of 10%, the same as margin adopted by the ECHOES study and appraised by five peer reviewers, none of whom suggested it was too large. It has subsequently been published within the BMJ Open paper6 and attracted no criticism or referee comment about it being too high.\n With an overall sample size in each group of 337, a two-group large-sample normal approximation test of proportions with a one-sided 0.025 significance level will have 90% power to reject the null hypothesis that the test and the standard are not equivalent (the difference in proportions, \u00cf\u0080\u00e2\u0082\u0081 \u00e2\u0088\u0092 \u00cf\u0080\u00e2\u0082\u0080, is 0.1 or farther from zero in the same direction) in favour of the alternative hypothesis that the proportions in the two groups are equivalent, assuming that the expected difference in proportions is 0 and the proportion in the standard group is 0.2.\n Thus, data of the primary outcome would be required from 674 participants in total. Seven per cent loss to follow-up was observed in the first year of the IVAN study10 on a patient population with nAMD. We adopted a more conservative estimate of 10% loss to follow-up, leading to an overall sample size of 742 participants. Of these, 72 participants are expected to be recruited in the pilot trial, with the remainder recruited from the full trial. Sample size calculation was conducted using nQuery Advanced software V.8.1.2.0.", "id": 452, "split": "train"} +{"trial_id": "NCT03894241", "pmid": "31349791", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rationale, Design and Methods of a Study on Physical Activity, Sedentarism, Physical Fitness, and Brain , Cognitive Performance and Academic Achievement in School Children. The Cogni-Action Project\n\nIncluded conditions:\n- Cognitive Function 1, Social\n\nStudy Armgroups:\n- {'label': 'Sedentary condition', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: physical activity']}\n- {'label': 'Moderate-intensity continuous training', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: physical activity']}\n- {'label': 'Cooperative-high-intensity interval training', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: physical activity']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'physical activity', 'description': 'Participants will assist to the three different sessions at the same weekday (e.g., Monday) and at the same daytime to avoid differences in preceding school activities or circadian rhythms. Participants will undergo a \"Sedentary condition\" (SC), sitting and watching a documentary on TV as has been used previously, and two different PA protocols consisting in \"Moderate-Intensity Continuous Training\" (MICT), i.e., continuous outdoor walking, and \"Cooperative High-Intensity Interval Training\" (C-HIIT), composed of a circuit training with a partner (physical education teacher)', 'armGroupLabels': ['Cooperative-high-intensity interval training', 'Moderate-intensity continuous training', 'Sedentary condition']}\n\nPrimary Outcomes:\n- {'measure': 'Cognitive performance', 'description': 'The Neurocognitive Performance test (NCPT, Lumos Labs, Inc.) is used to assess cognitive performance. It is a brief, repeatable, web-based platform of cognitive tasks intended to measure functioning across several cognitive domains including: working memory, visuospatial memory, psychomotor speed, fluid and logical reasoning, response inhibition, numerical calculation, and selective and divided attention. The NCPT has demonstrated adequate reliability and validity as a measure of cognitive performance, and in good concordance with pencil-paper assessments. Moreover, verb generation and working memory n-back tasks will be measured during the analysis with magnetic resonance in resting state. Also, reading and working memory n-back tasks will be measured during neuroelectric and eye-tracker measurements', 'timeFrame': 'up to eight months'}\n- {'measure': 'Brain structure and function', 'description': 'Brain structural and functional information will be acquired using neuroimaging techniques. All images will be obtained with a 1.5 Tesla MRI scanner (AVANTO, Siemens Medical Systems, Erlangen, Germany).', 'timeFrame': 'up to eight months'}\n- {'measure': 'Neuroelectric measurement', 'description': 'Electroencephalogram (EEG) measurement: A B-Alert X24 device for EEG (Advanced Brain Monitoring, California, United States) will be used, which consists of 24 active electrodes that minimize the noise of electrical devices outside the biological processes of interest, ensuring good signal quality.', 'timeFrame': 'up to eight months'}\n- {'measure': 'Eye-tracker measurement', 'description': 'Eye-tracker: A Tobii Pro TX300 (Tobii, Stockholm, Sweden) will be used to track eye movements directly through a light sensitive camera near the infrared spectrum.', 'timeFrame': 'up to eight months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) < 0.05, power > 80%, and a loss rate of 20%.", "answer": 32, "answer_type": "ACTUAL", "explanation": "Total sample size and power\n For feasibility reasons, the school chosen for the development of exercise sessions is close to our laboratory. Sample size is estimated according to the mean difference of two independent samples from a randomized controlled trial were a working memory task (2-back) was tested [56]. Children control group achieved a positive variation (\u00e2\u0088\u0086\u00e2\u0080\u0089=\u00e2\u0080\u00892.05\u00e2\u0080\u0089ms; SD\u00e2\u0080\u0089=\u00e2\u0080\u008993.1) while exercise group a negative variation (\u00e2\u0088\u0086\u00e2\u0080\u0089=\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u008969.45\u00e2\u0080\u0089ms; SD\u00e2\u0080\u0089=\u00e2\u0080\u008991.6) [56]. A loss rate of 20% was considered. Statistical power analysis indicated that at least 32 participants would yield adequate power (i.e., >\u00e2\u0080\u008980%) and \u00ce\u00b1 (i.e.,\u00e2\u0080\u0089<\u00e2\u0080\u00890.05), with a detectable variation of 71.50\u00e2\u0080\u0089ms (\u00e2\u0088\u0086 between experimental conditions \u00e2\u0080\u0093 control condition).", "id": 453, "split": "train"} +{"trial_id": "NCT03894462", "pmid": "36868590", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Targeted Brief Intervention for Recent Suicide Attempt Survivors\n\nIncluded conditions:\n- Suicide, Attempted\n\nStudy Armgroups:\n- {'label': 'Zero Suicide Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'In Onondaga County, New York State (NYS) aims to implement a countywide \"Zero Suicide Safety Net\" of providers who share enhanced protocols for clinical care, staff training, and data collection (improved coding of suicidal behavior). Participating behavioral health systems have agreed to common protocols for clinical care, training, and data collection. Participating providers receive robust training in suicide prevention best practices. Because of the wide participation of mental health facilities in the NYS Office of Mental Health (OMH) Zero Suicide project, most subjects who engage in outpatient treatment will receive that treatment in facilities that are adopting NYS Zero Suicide protocols. Those who do not engage in care will nonetheless experience enhanced transition and follow-up contact from the services from which they are discharged.', 'interventionNames': ['Behavioral: Zero Suicide Usual Care']}\n- {'label': 'Zero Suicide Usual Care + ASSIP', 'type': 'EXPERIMENTAL', 'description': 'Patients in this treatment arm will receive ASSIP brief therapy in addition to being able to access any usual care as recommended by their provider.\\n\\nASSIP is a manualized, three-session intervention, delivered either in-person or via telehealth: In Session 1, the therapist guides the patient in telling the story of their attempt. The session is video recorded. In Session 2, the therapist and patient sit side-by-side to view selections of the video, working together to understand the feelings and events that preceded the attempt. The patient is assigned a homework task. In Session 3, the therapist and patient create a summary of the suicide attempt and what led up to it, along with creating a personal safety plan.', 'interventionNames': ['Behavioral: Attempted Suicide Short Intervention Program']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Attempted Suicide Short Intervention Program', 'description': 'ASSIP is a manualized, three-session intervention, delivered either in-person or via telehealth: In Session 1, the therapist guides the patient in telling the story of their attempt. The session is video recorded. In Session 2, the therapist and patient sit side-by-side to view selections of the video, working together to understand the feelings and events that preceded the attempt. The patient is assigned a homework task. In Session 3, the therapist and patient create a summary of the suicide attempt and what led up to it, along with creating a personal safety plan.', 'armGroupLabels': ['Zero Suicide Usual Care + ASSIP']}\n- {'type': 'BEHAVIORAL', 'name': 'Zero Suicide Usual Care', 'description': 'Participants will have access to outpatient treatment in facilities that are adopting NYS Zero Suicide protocols. Those who do not engage in care will nonetheless experience enhanced transition and follow-up contact from the services from which they are discharged.', 'armGroupLabels': ['Zero Suicide Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Time to Suicide Attempt', 'description': 'Time from randomization to first suicide re-attempt', 'timeFrame': 'Up to 18 months'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a significance level of 5% (two-tailed), power of 80%-90%, and assumed rates of participant withdrawal.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n The primary outcome variable is time from randomisation to first suicide reattempt. Under the assumption of proportional hazards, the sample size for a time-to-event outcome depends on the anticipated incidence of the event in the control group, the treatment effect to be detected (or the anticipated incidence in the ASSIP group), assumed rates of participant withdrawal, and the specified significance level and power. Assuming a sample size of 400, table 2 identifies treatment effects that can be detected with 80%\u00e2\u0080\u009390%\u00e2\u0080\u0089power using a log-rank test and a two-tailed 5% significance level for varying 18-month incidence of suicide reattempt. The detectable treatment effects on suicide attempts thus span those observed in the two most relevant trials: Brown and colleagues'9 study of cognitive\u00e2\u0080\u0093behavioural therapy for suicide prevention (42% vs 24%) and Gysin-Maillart and colleagues'13 study of ASSIP (27% vs 8%).\n \n Table 2\n \n Power analysis for aim 1\n \n \n \n \n Power\n Control group incidence\n ASSIP group incidence\n HR\n \n \n \n \n 80%\n 20.0%\n 9.3%\n 0.44\n \n \n 25.0%\n 13.2%\n 0.49\n \n \n 30.0%\n 17.2%\n 0.53\n \n \n 35.0%\n 21.5%\n 0.56\n \n \n 40.0%\n 25.9%\n 0.59\n \n \n 90%\n 20.0%\n 7.9%\n 0.37\n \n \n 25.0%\n 11.5%\n 0.42\n \n \n 30.0%\n 15.4%\n 0.47\n \n \n 35.0%\n 19.5%\n 0.50\n \n \n 40.0%\n 23.8%\n 0.53\n \n \n \n \n \n Treatment effects detectable with 80%\u00e2\u0080\u009390%\u00e2\u0080\u0089power assuming different 18-month suicide attempt incidence rates in control group (N=400 participants).", "id": 454, "split": "train"} +{"trial_id": "NCT03895086", "pmid": "32943085", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Fibromyalgia and Specific Physical Activity\n\nIncluded conditions:\n- Fibromyalgia\n\nStudy Armgroups:\n- {'label': 'Specific Physical Activity', 'type': 'EXPERIMENTAL', 'description': 'Specific patient care in telephone coaching of fibromyalgia patients.', 'interventionNames': ['Other: Specific Physical Activity']}\n- {'label': 'Classic Physical Activity', 'type': 'OTHER', 'description': 'Classic patient care in common group of multipathological patients.', 'interventionNames': ['Behavioral: Classic Physical Activity']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Specific Physical Activity', 'description': 'An individual one hour face-to-face session conducted by adaptated physical activities teachers followed by eight telephone sessions by physical therapists and adaptated physical activities teachers (4 sessions each)', 'armGroupLabels': ['Specific Physical Activity']}\n- {'type': 'BEHAVIORAL', 'name': 'Classic Physical Activity', 'description': 'One session per week in groups conducted by adaptated physical activities teachers of \"Siel Bleu\" association', 'armGroupLabels': ['Classic Physical Activity']}\n\nPrimary Outcomes:\n- {'measure': \"Compare the Interest of a Specific Physical Activity Program on Patients' Quality of Life\", 'description': 'Evolution of the Fibromyalgia Impact Questionnaire (FIQ) score (questionnaire of specific quality of life in the management of fibromyalgia patients) between the beginning of care (J0) and six months (M6).\\n\\nThe scale score ranges from 0 to 100. The higher the score, the greater the difficulty in functioning and the severity of symptoms.', 'timeFrame': '6 months after randomization'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80, alpha risk of 0.05, and a 10% increase to account for potential dropouts.", "answer": 1, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The study by Hackshaw et al. [14] used inclusion criteria that were similar to those of the present study; the mean FIQR at baseline for the 10 patients included was 49.4\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008913.8 (mean\u00e2\u0080\u0089+\u00e2\u0080\u0089SD). We consider that a 7-point difference between the two treatment arms at 6\u00e2\u0080\u0089months would be clinically significant. The sample size required to show a between-group difference of 7 points in the FIQR with a power of 0.80 and an alpha risk of 0.05 is 114 patients. In order to ensure this power is achieved, 10% more patients will be included, thus a total of 126 patients.", "id": 455, "split": "train"} +{"trial_id": "NCT03896399", "pmid": "35123419", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Laparoscopic Ischemic Conditioning Prior to Esophagectomy in Patients With Esophageal Cancer and Arterial Calcifications\n\nIncluded conditions:\n- Esophageal Cancer\n\nStudy Armgroups:\n- {'label': 'Laparoscopic ischemic conditioning followed by esophagectomy', 'type': 'EXPERIMENTAL', 'description': 'All included patients will receive a laparoscopic ischemic conditioning followed by an esophagectomy after an interval of 12-18 days.', 'interventionNames': ['Procedure: Laparoscopic ischemic conditioning followed by esophagectomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Laparoscopic ischemic conditioning followed by esophagectomy', 'description': 'All included patients will receive a laparoscopic ischemic conditioning followed by an esophagectomy after an interval of 12-18 days.', 'armGroupLabels': ['Laparoscopic ischemic conditioning followed by esophagectomy']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with a grade 2 or higher complication after laparoscopic ischemic conditioning', 'description': 'Complications grade 2 and higher (Clavien-Dindo classification)', 'timeFrame': 'Occuring after operation 1(laparosocpic ISCON), but before operation 2 (esophagectomy). This time-frame is usually 13-15 days.'}\n\nPlease estimate the sample size based on the assumption: \nNo formal sample size calculations are performed.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size\n This is a prospective single arm safety and feasibility trial, classified as a \u00e2\u0080\u009cstage 2a Development\u00e2\u0080\u009d study according to the IDEAL recommendations for surgical innovation [19]. Based upon these recommendations, a total of 20 subjects will be included and no formal sample size calculations are performed (10 patients per centre).", "id": 456, "split": "train"} +{"trial_id": "NCT03899103", "pmid": "33256621", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Clinical Trial to Compare Efficacy and Safety of Repeated Courses of Rituximab to That of Maintenance Mycophenolate Mofetil Following Single Course of Rituximab in Maintaining Remission Over 24 Months Among Children With Steroid Dependent Nephrotic Syndrome\n\nIncluded conditions:\n- Steroid-Dependent Nephrotic Syndrome\n\nStudy Armgroups:\n- {'label': 'Repeated Courses of Rituximab Only', 'type': 'EXPERIMENTAL', 'description': 'First course Course Rituximab at Randomization. Prophylactic 2nd and 3rd course rituximab re-administration will be done at 8 months and 16 months of follow-up if B cell count normalize.', 'interventionNames': ['Drug: Rituximab']}\n- {'label': 'Rituximab and Mycophenolate Mofetil', 'type': 'ACTIVE_COMPARATOR', 'description': 'First course Course Rituximab at Randomization. Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards.', 'interventionNames': ['Drug: Rituximab', 'Drug: Mycophenolate Mofetil']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rituximab', 'description': 'First course Course Rituximab at Randomization.', 'armGroupLabels': ['Repeated Courses of Rituximab Only', 'Rituximab and Mycophenolate Mofetil']}\n- {'type': 'DRUG', 'name': 'Mycophenolate Mofetil', 'description': 'Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards', 'armGroupLabels': ['Rituximab and Mycophenolate Mofetil']}\n\nPrimary Outcomes:\n- {'measure': 'The primary endpoint is the time to first relapse or death (whichever occurs first) till end of study (follow-up phase of 24 months)', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, two-sided alpha level of 5%, and a drop-out rate of 10%.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size/ power calculation\n The sample size calculation is based on the primary endpoint, time to first relapse or death (whichever occurs first), using log-rank test to compare the event times of arm A and B. An event rate of 25% after 24\u00e2\u0080\u0089months in arm A and 5% in arm B was assumed (hazard ratio\u00e2\u0080\u0089=\u00e2\u0080\u00890.178) [12\u00e2\u0080\u009314, 17\u00e2\u0080\u009322]. Assuming an individual follow-up time of 24\u00e2\u0080\u0089months, in total 95 patients (15 events) are required to prove efficacy with a power of 90% and a two-sided alpha level of 5% for the log-rank test. To account for major protocol violations and drop-outs an assumed drop-out rate of 10% yields a total of 100 patients to be randomized [23, 24].", "id": 457, "split": "train"} +{"trial_id": "NCT03899610", "pmid": "31576697", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Study of Neoadjuvant Chemotherapy Plus Durvalumab (MEDI4736) and Tremelimumab in Advanced-stage Ovarian Cancer (TRU-D)\n\nIncluded conditions:\n- Ovarian Cancer Stage IIIC\n- Ovarian Cancer Stage IV\n\nStudy Armgroups:\n- {'label': 'Neoadjuvant chemotherapy+Durvalumab+Tremelimumab', 'type': 'EXPERIMENTAL', 'description': '1. Neoadjuvant treatment:\\n\\n Standard chemotherapy + Durvalumab + Tremelimumab Durvalumab : 1500mg q3 weeks (total 3 dosing) Tremelimumab : 75mg q 3 weeks (total 3 dosing) Chemotherapy regimen: Paclitaxel 175 mg/m2 , Carboplatin AUC 5-6 q3 weeks (total 3 dosing)\\n2. Interval debulking surgery\\n3. Adjuvant treatment:\\n\\nStandard chemotherapy + Durvalumab Durvalumab; 1120mg q3 weeks (total 12 dosing) Chemotherapy regimen: Paclitaxel 175mg/m2, carboplatin AUC 5-6 q 3weeks (total3 dosing)', 'interventionNames': ['Drug: Neoadjuvant chemotherapy+Durvalumab+Tremelimumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Neoadjuvant chemotherapy+Durvalumab+Tremelimumab', 'description': '1. Neoadjuvant treatment:\\n\\n Standard chemotherapy + Durvalumab + Tremelimumab Durvalumab : 1500mg q3 weeks (total 3 dosing) Tremelimumab : 75mg q 3 weeks (total 3 dosing) Chemotherapy regimen: Paclitaxel 175 mg/m2 , Carboplatin AUC 5-6 q3 weeks (total 3 dosing)\\n2. Interval debulking surgery\\n3. Adjuvant treatment:\\n\\nStandard chemotherapy + Durvalumab Durvalumab; 1120mg q3 weeks (total 12 dosing) Chemotherapy regimen: Paclitaxel 175mg/m2, carboplatin AUC 5-6 q 3weeks (total3 dosing)', 'armGroupLabels': ['Neoadjuvant chemotherapy+Durvalumab+Tremelimumab']}\n\nPrimary Outcomes:\n- {'measure': 'Progression-free survival(PFS)', 'description': '12-months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% statistical power, 5% of 1-sided type I errors, 10% drop-out rate.", "answer": 24, "answer_type": "ESTIMATED", "explanation": "SAMPLE SIZE JUSTIFICATION\n The sample size was calculated based on the 1-sample log-rank test.\n Median PFS is 12 months in advanced-stage ovarian cancer from European Organisation for Research and Treatment of Cancer 55971 and Chemotherapy or Upfront Surgery. The rate of patients with disease-free status at 12 months is expected to be 50% with conventional chemotherapy (SOC). The rate of patients with disease-free status at 12 months is expected to be 70% with the addition of immunotherapy (combination of durvalumab+tremelimumab+SOC followed by durvalumab+SOC) (hazard ratio=0.515). With 80% statistical power and 5% of 1-sided type I errors, 21 patients are needed when patients are accrued for 12 months and followed for 30 months after the last patients is enrolled. The number of expected events would be 14. In anticipation of a 10% drop-out rate, 24 patients will be enrolled in this study.", "id": 458, "split": "train"} +{"trial_id": "NCT03899961", "pmid": "34745566", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Clinical Carbetocin Myocardium Trial Part 2\n\nIncluded conditions:\n- Pregnancy Complications\n\nStudy Armgroups:\n- {'label': 'Oxytocin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oxytocin 2.5 U i.v.', 'interventionNames': ['Drug: Oxytocin']}\n- {'label': 'Carbetocin', 'type': 'EXPERIMENTAL', 'description': 'Carbetocin 100 \u00b5g i.v.', 'interventionNames': ['Drug: Carbetocin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oxytocin', 'description': 'Oxytocin 2.5 U i.v.', 'armGroupLabels': ['Oxytocin']}\n- {'type': 'DRUG', 'name': 'Carbetocin', 'description': 'Carbetocin 100 \u00b5g i.v.', 'armGroupLabels': ['Carbetocin']}\n\nPrimary Outcomes:\n- {'measure': 'Plasma Concentration Troponin I', 'description': 'Group difference in Troponin I', 'timeFrame': '8 hours'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level of 5%, adjustments for unequal variances, and a low expected dropout rate.", "answer": 240, "answer_type": "ACTUAL", "explanation": "Power and sample size considerations\n The sample size required for our current study was calculated using data from a pilot study of 40 patients, in which the largest difference in plasma troponin I concentration was found at 10 hours, with a mean \u00c2\u00b1 standard deviation change from baseline of 0.41 \u00c2\u00b1 0.79 ng/L in the carbetocin group versus 1.78 \u00c2\u00b1 4.48 in the oxytocin group. The sample size calculation was thus based on 80% power to detect a between-group difference in change from baseline to 10 hours of 1.37, to be analysed using a two-sample T-test with adjustments for unequal variances. With a significance level of 5%, our study will need to include 178 patients (89 in each treatment group) in this confirmatory trial. To adjust for loss of information from missing values and patient dropouts, 240 women will be enrolled. The drop-out rate after enrolment is expected to be low as the duration of the study is short.", "id": 459, "split": "train"} +{"trial_id": "NCT03900806", "pmid": "32690067", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Internet-based WOrk-related Cognitive Rehabilitation for Cancer Survivors: a Randomized Controlled Trial\n\nIncluded conditions:\n- Cognitive Problems\n\nStudy Armgroups:\n- {'label': 'Basic Cognitive Rehabilitation', 'type': 'EXPERIMENTAL', 'description': 'The basic arm will consist of a brief cognitive training programme without individual guidance throughout the intervention, involving three to five sessions (each approximately 60 minutes in duration), which have to be completed in a period of 12 weeks.', 'interventionNames': ['Behavioral: online cognitive rehabilitation']}\n- {'label': 'Extensive Cognitive Rehabilitation', 'type': 'EXPERIMENTAL', 'description': \"The extensive arm will consist of a comprehensive training program, involving five to eight sessions (each approximately 60 minutes in duration), which have to be completed in a period of 12 weeks. After the first session, each further session in the extensive group involves tailored therapy guidance . Cognitive strategy modules will be assigned by the therapist depending on the participants' cognitive profile and personal treatment goals.\", 'interventionNames': ['Behavioral: online cognitive rehabilitation']}\n- {'label': 'Waitlist control group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the waiting list control group will be offered the opportunity to follow the basic cognitive rehabilitation program after completion of the 26-week follow-up measurement.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'online cognitive rehabilitation', 'description': 'The cognitive rehabilitation program will be based on the protocol of a frequently used meta-cognitive strategy approach applied in many rehabilitation centers in the Netherlands. The program consists of several modules that can be used in a flexible way, depending on the specific individual problems and goals. Therapists have undergone additional training in issues related to cancer-related cognitive impairment and problems occupationally active cancer survivors might experience at work. In both intervention arms, participants will receive access to a secured personal webpage, where all content relevant to the treatment sessions can be obtained.', 'armGroupLabels': ['Basic Cognitive Rehabilitation', 'Extensive Cognitive Rehabilitation']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline Goal Attainment Scaling (GAS) at 3 and 6 months follow-up.', 'description': \"Individually defined work-related treatment goals will be measured using the 6-point Goal Attainment Scale (GAS) on personal outcome (-3, achievement of the goal after training is worse; -2, achievement of the goal is the same; 1, partial achievement of the goal; 0, achievement of the goal; 1, exceeding the goal, and 2, greatly exceeding the goal). Patients will formulate three treatment goals at baseline, in collaboration with their cognitive therapist. Attainment of the goals is measured in a standardized way, i.e., an overall GAS T-score will be computed for each participant on basis of aggregated GAS scores involving attainment of multiple personal treatment goals, according a summary scoring algorithm that calculates the extent to which patients' goals are met.\", 'timeFrame': 'T0 (baseline), T1 (12 weeks), T2 (26 weeks)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha = 0.05, 80% power, and an attrition rate of approximately 20%.", "answer": 261, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This longitudinal study design will allow for testing of the main effect of the intervention over time, with the GAS score as the primary outcome measure. With a sample size of 65, and an alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, the study will allow for an attrition rate of approximately 20% and have 80% power to detect an effect size of f\u00c2\u00a0=\u00e2\u0080\u00890.2 (equivalent to Cohens d\u00c2\u00a0=\u00e2\u0080\u00890.4) for the main effect of the intervention between both the basic and extended cognitive rehabilitation treatment group versus the waitlist control group (first hypothesis). To perform subgroup analysis, used to test our second hypothesis, sample size should be inflated fourfold [50]. Therefore, we strive for a sample size of 261, with 87 patients in each group.", "id": 460, "split": "train"} +{"trial_id": "NCT03901326", "pmid": "32819429", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of On-site CT-derived Fractional Flow Reserve on the Management Making for the Patients With Stable Chest Pain (TARGET Trial)\n\nIncluded conditions:\n- Coronary Artery Disease\n\nStudy Armgroups:\n- {'label': 'CTA/CT-FFR care group', 'type': 'EXPERIMENTAL', 'description': 'If the subjects are randomly allocated to CT-FFR arm, they will be examined by on-site DeepFFR for three major epicardial coronary arteries. If the result of CT-FFR calculation is less than or equal to 0.8 in one or more major coronary arteries, the patient will be referred to ICA directly; if the result of CT-FFR value is more than 0.8, optimal medical therapy will be recommended. The decision on the mode of revascularization is left to the treating cardiologists and depends on local practice standard.', 'interventionNames': ['Diagnostic Test: CT-FFR assessment']}\n- {'label': 'Routine clinically-indicated diagnostic care group', 'type': 'NO_INTERVENTION', 'description': 'If the subjects are randomized to usual care arm, attending physicians will decide the next step of diagnosis and treatment, such as exercise ECG, stress cardiac echo, cardiac MR, and SPECT. According to the results of examination combined with risk factors assessment and clinical manifestations, physicians should provide recommendation whether the subjects would undergo ICA or not.'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'CT-FFR assessment', 'description': 'When subjects are randomized to the CTA/CT-FFR arm, FFR based on the coronary CTA imaging will be measured. DEEPVESSEL FFR workstation is very dedicated software utilizing the original CTA imaging to meter simulated FFR values based on a machine learning algorithm. The first step is to extract a 3D coronary artery model and generate coronary centerlines which are similar to the routine reconstruction of coronary CTA. The centerlines are extracted using a minimal path extraction filter. Then a novel path-based deep learning model, referred to DEEPVESSEL FFR, is used to predict the simulated FFR values on the vascular centerlines. Deep learning algorithm is used to establish characteristic sample database of coronary hemodynamics characteristic parameters. When deep training model is proved to be valid, it is applied to a new lesion-specific measurement. Lesion-specific CT-FFR is defined as simulated FFR value at distance of 20mm away from the lesion of interest.', 'armGroupLabels': ['CTA/CT-FFR care group']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Participants With ICA Without Obstructive CAD or Intervention', 'description': 'Number of those patients with planned ICA in whom no significant obstructive CAD (no stenosis\u226570% by core lab quantitative analysis or invasive FFR\u22640.8) is found or interventions (including stent implantation, balloon dilation and bypass graft) are performed during ICA within 90 days.', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level is not explicitly mentioned, but the power is assumed to be \u2265 90%. A dropout rate of up to 10% is considered.", "answer": 1216, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size is defined based on the rate of planned ICA without significant obstructive CAD within 90\u00e2\u0080\u0089days. Based on previous data and assuming the prevalence of non-obstructive CAD during ICA in usual care group is about 30% [7]. The frequency of reduction in the primary endpoint is expected to be 30% for a \u00e2\u0089\u00a5\u00e2\u0080\u008990% power. Considering a drop-off up to 10%, the final overall population should be of 1216 patients.", "id": 461, "split": "train"} +{"trial_id": "NCT03903068", "pmid": "32311940", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Efficacy of Transcranial Alternating Current Stimulation for Treating Post-stroke Depression: a Randomized Controlled Trial\n\nIncluded conditions:\n- Post-stroke Depression\n\nStudy Armgroups:\n- {'label': 'NEXALIN Stimulator Group', 'type': 'EXPERIMENTAL', 'description': 'In this study, the group is the treatment group. Patients are randomly assigned to participate, and patients will be given current parameters for setting time and flow.', 'interventionNames': ['Device: NEXALIN ADI AC stimulator']}\n- {'label': 'Pseudo-Stimulator Group', 'type': 'SHAM_COMPARATOR', 'description': 'In this study, the group is the control group. Patients are randomly assigned to participate, and patients will be given simulated electrical stimulation.', 'interventionNames': ['Device: Pseudo-stimulator']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'NEXALIN ADI AC stimulator', 'description': \"When the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. The three electrodes are placed in this way to enhance the performance of the Nexalin ADI device. When the device is activated, there will be a weak current passing through the forehead electrode and each mastoid electrode. The current intensity of Nexalin ADI treatment defaults to 15.00 mA and the duration defaults to 40 minutes. Both are preset to default parameters and cannot be changed.\", 'armGroupLabels': ['NEXALIN Stimulator Group']}\n- {'type': 'DEVICE', 'name': 'Pseudo-stimulator', 'description': \"When the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. When the device is started, no current flows through the electrodes, but the instrument's operating procedures, parameter displays, and prompts are the same as for a real instrument.\", 'armGroupLabels': ['Pseudo-Stimulator Group']}\n\nPrimary Outcomes:\n- {'measure': 'the proportion of participants having an improvement at week 8', 'description': 'the proportion of participants having an improvement at week 8, which includes response per the Hamilton Depression Rating Scale 17-Item (HAMD-17) defined as a \u2265 50% reduction from the baseline or clinical recovery (score \u2264 7).', 'timeFrame': 'week 8'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 2-tailed \u03b1 level of 5%, 20% attrition rate", "answer": 70, "answer_type": "ESTIMATED", "explanation": "2.13\n Sample size calculation\n The sample size is estimated by assuming a 50% improvement rate at the end of 8 weeks in the active group and a 15% in the sham group, which were based on our pilot trial of the effect of tACS in adults with major depression disorder.[38] Thus, each group will be recommended to have a minimum sample size of 26 with a power to 80% and a 2-tailed \u00ce\u00b1 level of 5%.[53] Considering the 20% attrition rate, 32 evaluable participants will be required for each group. And the total sample size will be 70.", "id": 462, "split": "train"} +{"trial_id": "NCT03904771", "pmid": "34001230", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Food for Mind - Group-based Behavioral Nutrition Intervention in the Treatment of Depression\n\nIncluded conditions:\n- Depression\n\nStudy Armgroups:\n- {'label': 'Food for Mind -intervention group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Nutrition counselling + peer support', 'interventionNames': ['Behavioral: Nutrition counselling + peer support']}\n- {'label': 'Befriending group -control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Social activation + peer support', 'interventionNames': ['Behavioral: Social activation + peer support']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Nutrition counselling + peer support', 'description': 'Behavioral nutrition counselling and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by a nutrition therapist.', 'armGroupLabels': ['Food for Mind -intervention group']}\n- {'type': 'BEHAVIORAL', 'name': 'Social activation + peer support', 'description': 'Social activation and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by group leader.', 'armGroupLabels': ['Befriending group -control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline Depressive Symptomatology at eight weeks, 6 months and 12 months.', 'description': 'Depressive symptomatology measured with the Center for Epidemiologic Studies (CES-D) scale at eight weeks, 6 months and 12 months after patient recruitment compared to the social support befriending group.\\n\\nThe scale has 20 items and measures symptoms of depression. Each item is scored from 0 (zero) to 3 points. The total score ranges from 0 (zero) to 60 points.Higher values of the total score represent a worse outcome.Four of the items (#4, #8, #12, #16) are reversed before calculating the total score. The total score is calculated as follows: the answers to the items are summed, the sum is divided by the number of scored items, and this value is multiplied by 20. If the answers are missing to more than five items, the total score will not be calculated.', 'timeFrame': '12 months: assessed at baseline, at eight weeks, at 6 months and at 12 months.'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1=0.05, power=0.8, estimated loss of participants is 15%", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The total sample size of n=144 is based on the power calculation, when \u00ce\u00b1=0.05, power=0.8, and effect size=0.5, and the estimated loss of participants is 15%. The calculation is based on the decline of 7 points assessed with the Center for Epidemiologic Studies Depression (CES-D) Scale.", "id": 463, "split": "train"} +{"trial_id": "NCT03908593", "pmid": "35840999", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Efficacy of Different Duration of a Proton Pump Inhibitor in the Prevention of Upper Gastrointestinal Mucosal Injury in Patients Taking 12-month Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting\n\nIncluded conditions:\n- Gastrointestinal Ulcer (Peptic) or Erosion\n- Anti-Platelet Therapy\n- Coronary Artery Bypass\n\nStudy Armgroups:\n- {'label': 'One month of therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Pantoprazole, 40mg, tablet, oral, once daily for 1 month', 'interventionNames': ['Drug: Pantoprazole']}\n- {'label': 'Twelve months of therapy', 'type': 'EXPERIMENTAL', 'description': 'Pantoprazole, 40mg, tablet, oral, once daily for 12 months', 'interventionNames': ['Drug: Pantoprazole']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Pantoprazole', 'description': 'Pantoprazole (40mg qd) will be concomitant used with DAPT', 'armGroupLabels': ['One month of therapy', 'Twelve months of therapy'], 'otherNames': ['PANTOLOC, Tablet from Takeda Pharmaceutical Company Limited']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of patients with gastroduodenal erosions and ulcers evaluated by EGD.', 'description': 'Gastroduodenal erosions and ulcers will be assessed according to the Lanza Endoscopic Scoring System. Lanza score is a categorical score (0-4) and defined as follows: 0, normal; 1, mucosal hemorrhages only; 2, 1-2 erosions; 3, 3-10 erosions; 4, \\\\>10 erosions or an ulcer \u22653 mm. In addition, \u22651 ulcer with a diameter no less than 5mm will be grouped separately.', 'timeFrame': 'within 12 months after randomization'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided \u03b1 of 0.05, a randomization ratio of 1:1, and a power of 80% are assumed. A 20% drop-out rate is also considered.", "answer": 232, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to the results of the preliminary study, the cumulative incidence of severe gastric and duodenal bulb erosion and ulcers of the 1-month PPI treatment group is assumed to be 36%, and that of the 12-month PPI treatment group was assumed to be 18%. Based on a two-sided \u00ce\u00b1 of 0.05 and a randomization ratio of 1:1, a total of 186 subjects are required to provide a power of 80%. Considering a 20% drop-out rate, the sample size of 232 subjects was determined.", "id": 464, "split": "train"} +{"trial_id": "NCT03909672", "pmid": "31871257", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cupping Therapy in the Treatment of Individuals With Nonspecific Chronic Low Back Pain\n\nIncluded conditions:\n- Low Back Pain\n\nStudy Armgroups:\n- {'label': 'Cupping therapy with 2 suctions', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention group will receive the application of cupping therapy with two acrylic type 1 cups with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally. This group will consist of the application of windsheets with 2 suctions for 10 minutes, once a week, for 10 weeks. The cups shall be secured by means of elastic bands.', 'interventionNames': ['Other: Cupping Therapy']}\n- {'label': 'Cupping Therapy sham', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo group will receive the application of cupping therapy with 2 cups of acrylic type size 1 with a distance of 3 cm each cup, parallel to the vertebrae L1 to L5, bilaterally . This group will consist of applying the sham winds for 10 minutes, once a week for 10 weeks.\\n\\nHowever, the cups will be made with small holes \\\\<2 mm in diameter to release the negative pressure in seconds. The cups will also be fixed by means of elastic bands.', 'interventionNames': ['Other: Cupping Therapy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Cupping Therapy', 'description': 'application of cupping therapy with two acrylic type 1 cups (4.5 cm internal diameter, Dong Yang \u00ae brand) with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally', 'armGroupLabels': ['Cupping Therapy sham', 'Cupping therapy with 2 suctions']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Numeric Rating Scale (NRS) of Pain', 'description': \"The patients are asked to circle the number between 0 and 10. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'\", 'timeFrame': 'T0 -baseline, T4 (four week) and T8 (eight week)'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 90%, alpha of 5%, and a loss rate of 10%.", "answer": 90, "answer_type": "ACTUAL", "explanation": "\u00e2\u0080\u008bSample size calculation\n Based on study values using similar methods,65 a total sample of 90 participants (45 in IG and 45 in PG) will be sufficient to detect a clinically important difference between the two-point groups on the NPRS scale. A statistical power of 90% and an alpha of 5% and a loss rate of 10% were considered for the sample calculation. Gpower 3 software was used for the calculation.", "id": 465, "split": "train"} +{"trial_id": "NCT03910374", "pmid": "37525278", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction\n\nIncluded conditions:\n- Cranial Sutures; Closure\n\nStudy Armgroups:\n- {'label': 'Classical Treatment', 'type': 'PLACEBO_COMPARATOR', 'description': 'In this arm, dural closure will be performed with the classical fibrine sealants.', 'interventionNames': ['Procedure: Dural closure']}\n- {'label': 'L-PRF', 'type': 'ACTIVE_COMPARATOR', 'description': 'In this arm, dural closure will be performed with the autologous L-PRF', 'interventionNames': ['Procedure: Dural closure']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Dural closure', 'description': 'Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair', 'armGroupLabels': ['Classical Treatment', 'L-PRF']}\n\nPrimary Outcomes:\n- {'measure': 'To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority', 'description': 'The primary aim of this study is identifying the role of L-PRF in the endoscopic endonasal closure of skull base defects. More specific, we want to demonstrate in a prospective, randomized trial that the use of L-PRF is non-inferior to classical closure techniques regarding prevalence of CSF-leaks The number of patients with a CSF-leak will be compared between both treatment groups.', 'timeFrame': '4 years'}\n- {'measure': 'Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).', 'description': 'Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants.', 'timeFrame': '4 years'}\n\nPlease estimate the sample size based on the assumption: \nThis is a non-inferiority trial with a binary outcome using a one-sided alpha of 0.05 and 80% power. The expected dropout rate is less than 2%.", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size calculation was performed according to the primary outcome, using an online power calculator for binary outcome non-inferiority trials (Sealed Envelope Ltd. Available from: https://www.sealedenvelope.com). This is a non-inferiority trial with a binary outcome using a one-sided alpha 0.05 and 80% power. The assumed success rate is 94.3% in the control arm, based on center-specific experience as well as the literature [14]. Data on the use of L-PRF for this indication is limited, but we assume a 95% success rate based on prior feasibility studies [8\u00e2\u0080\u009310].\n The statistical hypothesis for testing the treatment difference is presented as follows; H0: \u00ce\u0094\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u0089\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.07 tested against the alternative hypothesis HA: \u00ce\u0094\u00e2\u0080\u0089>\u00e2\u0080\u0089\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.07, where \u00ce\u0094 is the difference between the success rates of experimental and control condition and\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00890.07 is the non-inferiority difference. The non-inferiority limit was set at 0.07 considering (a) reported CSF leakage rates without commercially available fibrin sealant averaging 17.2% [15] and (b) important additional benefits of L-PRF compared to commercially available fibrin sealants including the completely autologous nature (eliminating immune reactions), presence of immunologic cells and reduced costs.\n Based on this power calculation, 212 patients need to be included, 106 in each group. In order to account for potential missing follow-up information, failure of L-PRF preparation, or non-adherence to the allocation (expected drop-out rate less than 2%), 220 subjects will be enrolled, 110 in each group.", "id": 466, "split": "train"} +{"trial_id": "NCT03910738", "pmid": "32600454", "question": "Here is the design of a clinical trial:\n\nOfficial Title: TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis\n\nIncluded conditions:\n- Multiple Sclerosis, Relapsing-Remitting\n\nStudy Armgroups:\n- {'label': 'Testosterone treatment (Nebido\u00ae)', 'type': 'EXPERIMENTAL', 'description': '\"Treatment/Nebido\u00ae\" arm: in this experimental arm, each patient will be injected intramuscularly with 1000 mg / 4 ml of testosterone undecanoate (Nebido\u00ae).\\n\\nTreatment will be injected at baseline, week 6, 18, 30, 42 and 54', 'interventionNames': ['Drug: Nebido\u00ae Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection', 'Procedure: MRI', 'Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities', 'Behavioral: Assessment of disability']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '\"Placebo\" arm: In this arm, each patient will be injected intramuscularly with 4 ml of placebo solution.\\n\\nPlacebo will be injected at baseline, week 6, 18, 30, 42 and 54', 'interventionNames': ['Drug: Placebo 4 mL Solution for Injection', 'Procedure: MRI', 'Behavioral: Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities', 'Behavioral: Assessment of disability']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Nebido\u00ae Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection', 'description': 'Active treatment (Nebido\u00ae Testosterone Undecanoate ) will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)', 'armGroupLabels': ['Testosterone treatment (Nebido\u00ae)']}\n- {'type': 'DRUG', 'name': 'Placebo 4 mL Solution for Injection', 'description': 'Placebo will be injected at Baseline, at week 6 and then every 12 weeks (Week 18, 30, 42 and 54)', 'armGroupLabels': ['Placebo']}\n- {'type': 'PROCEDURE', 'name': 'MRI', 'description': 'Conventional MS sequences (OFSEP recommendations) and unconventional MRI sequences (Baseline, week 30 and 66)', 'armGroupLabels': ['Placebo', 'Testosterone treatment (Nebido\u00ae)']}\n- {'type': 'BEHAVIORAL', 'name': 'Assessment of impact of MS on cognition; quality of life; fatigue; anxiety/depression and work and activities', 'description': 'BICAMS; SF-36 and EQ-5D-3L; MFIS; HADS; WPAI:MS (at baseline, week 30 and 66)', 'armGroupLabels': ['Placebo', 'Testosterone treatment (Nebido\u00ae)']}\n- {'type': 'BEHAVIORAL', 'name': 'Assessment of disability', 'description': 'EDSS (Baseline, week 30 and 66)', 'armGroupLabels': ['Placebo', 'Testosterone treatment (Nebido\u00ae)']}\n\nPrimary Outcomes:\n- {'measure': 'Change on MRI binary criterion combining thalamic atrophy and modification in transverse diffusivity of lesions', 'description': 'The primary endpoint is a binary criterion comparing the success rate in each treatment group, defined by thalamic atrophy lower than 0.5% and modification in transverse diffusivity of lesions lower than 0.5% per year compared between baseline and week 66 in each group.', 'timeFrame': 'At baseline, week 30 and week 66 (end of study)'}\n\nPlease estimate the sample size based on the assumption: \nThe success proportions of each group are compared using the posterior distribution of the difference in proportions, with Nebido\u00ae declared superior if the posterior probability that the difference between the two proportions is positive exceeds 0.95. The empirical type I error risk is 2%. The power of the test is 80%.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is calculated using Bayesian methods. Subjects have about 30 to 35% chances of benefiting from an effect of the testosterone treatment with a halt in the development of their pathology. Placebo patients should not benefit from this effect. The sample size calculation is based on the following parameters:\nIn the experimental group (Nebido\u00c2\u00ae/testosterone), the expected proportion of subjects is modeled with a beta distribution (35, 65), indicating an expected proportion of success of 35%, with a standard deviation of 0.047 (or 4.7%).In the placebo group, the expected proportion of subjects is modeled with a beta distribution (5.95) indicating an expected proportion of success in the order of 5%, with a standard deviation of 0.022 (or 2.2%).\n The success proportions of each group are then compared on the basis of the posterior distribution of the difference in proportions, using McMC methods, and the Nebido\u00c2\u00ae is declared superior if the posterior probability that the difference between the two proportions is positive exceeds 0.95: Pr (pT \u00e2\u0088\u0092 pP\u00e2\u0080\u0089>\u00e2\u0080\u00890) >\u00e2\u0080\u00890.95.\n The empirical type I error risk is 2%. With N\u00e2\u0080\u0089=\u00e2\u0080\u008920 subjects per group, over all simulations, the power of the test is of 80%. Thus, 40 subjects meeting eligibility criteria will be randomized, for a total of 80 subjects to be included in the study. The simulations were carried out with R 3.3.1.", "id": 467, "split": "train"} +{"trial_id": "NCT03914820", "pmid": "35914916", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prophylactic Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC CO2) Versus Standard Surgery in Colorectal Carcinoma at High Risk Peritoneal Carcinomatosis. Short and Long-term Outcomes. CHECK STUDY\n\nIncluded conditions:\n- Colorectal Neoplasms\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': 'ARM A: Prophylactic surgery plus HIPEC CO2 performed with mitomycin', 'interventionNames': ['Procedure: HIPEC CO2 surgery', 'Drug: Mitomycin']}\n- {'label': 'Comparator', 'type': 'ACTIVE_COMPARATOR', 'description': 'ARM B: Standard surgey without HIPEC CO2 The arm B is with standard surgery without HIPEC CO2', 'interventionNames': ['Procedure: Standard surgery']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'HIPEC CO2 surgery', 'description': 'Prophylactic surgery plus HIPEC CO2 performed with mitomycin', 'armGroupLabels': ['Experimental']}\n- {'type': 'PROCEDURE', 'name': 'Standard surgery', 'description': 'Standard surgery without HIPEC CO2', 'armGroupLabels': ['Comparator']}\n- {'type': 'DRUG', 'name': 'Mitomycin', 'description': 'Prophylactic surgery plus HIPEC CO2 performed with mitomycin', 'armGroupLabels': ['Experimental'], 'otherNames': ['HIPEC CO2 surgery with mitomycin']}\n\nPrimary Outcomes:\n- {'measure': 'Local recurrence free survival (LRFS)', 'description': 'The primary efficacy endpoint is LRFS defined as the time from randomization to the date of first local relapse, peritoneal carcinomatosis or death for any cause, whichever comes first.', 'timeFrame': 'This outcome measure will be assess approximately 3 years after the last patient enrolled'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided type I error of 4.9%, power of 80%, 15% of randomised patients not eligible, 5% level of significance for secondary endpoint, 80% power to detect a relative reduction in the risk of recurrence/death of at least 33%.", "answer": 330, "answer_type": "ESTIMATED", "explanation": "Sample size\n Setting a two-sided type I error of 4.9% and a power of 80%, to detect a relative reduction of 50% in the incidence of LRFS events in the experimental group compared with the control group, 72 events are required. Assuming 36 months of accrual and 36 months of follow-up, it will be necessary to include approximately 330 patients (165 per arm). Assuming a 15% of randomised patients not eligible because of the presence of PC undetected by CT scan and discovered only during the surgical procedure, it will be necessary to randomise a total of 388 patients (194 per arm) in order to reach approximately 330 patients evaluable for the analysis of the primary endpoint.\n In this setting considering all types of recurrences (local and distant), we expect a incidence of local recurrence as primary site in 30%\u00e2\u0080\u009340% of patients.\n Reaching the target number of events of local recurrences (72 events), about 200 recurrences of any type (local or distant) will be observed. Therefore, the trial will have adequate power to analyse the secondary endpoint DFS: 80% power to detect a relative reduction in the risk of recurrence/death of at least 33%, with a 5% level of significance at two sides.", "id": 468, "split": "train"} +{"trial_id": "NCT03915691", "pmid": "37594646", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Isthmus Guided vs Anatomical Linear Ablation in the Treatment of Scar Related Atrial Tachycardia\n\nIncluded conditions:\n- Atrial Tachycardia\n\nStudy Armgroups:\n- {'label': 'Isthmus targeted approach using Ripple Mapping', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention: Isthmus targeted approach using Ripple Mapping catheter ablation of atrial tachycardia.', 'interventionNames': ['Procedure: Catheter ablation of atrial tachycardia: Ripple Mapping guided.']}\n- {'label': 'Conventional Mapping', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention: conventional catheter ablation of atrial tachycardia.', 'interventionNames': ['Procedure: Catheter ablation of atrial tachycardia: Conventional mapping guided.']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Catheter ablation of atrial tachycardia: Ripple Mapping guided.', 'description': 'Ripple Mapping is used to map the atrial tachycardia mechanism. Using the scar thresholding technique the Ripple Map is interpreted and catheter ablation directed to the site of the heart identified as putative to the arrhythmia mechanism. All ablation lesions are confirmed to have conduction block across them using Ripple Mapping. This can include lesions created at previous ablation procedures.', 'armGroupLabels': ['Isthmus targeted approach using Ripple Mapping']}\n- {'type': 'PROCEDURE', 'name': 'Catheter ablation of atrial tachycardia: Conventional mapping guided.', 'description': 'Conventional activation mapping is used to map the atrial tachycardia mechanism. The resultant (activation) map is interpreted and ablation directed to the site of the heart identified as putative to the arrhythmia mechanism. All ablation lesions are confirmed to have conduction block across them using conventional mapping. This can include lesions created at previous ablation procedures.', 'armGroupLabels': ['Conventional Mapping']}\n\nPrimary Outcomes:\n- {'measure': 'Atrial arrhythmia recurrence', 'description': 'Any confirmed episode of atrial arrhythmia (\\\\>30 seconds on Holter or 12 lead ECG) occurring in the 12 months after catheter ablation.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, alpha value of 0.05, 10% non-completion rate, 10% loss to follow-up rate.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size for this study is based on previous evidence published by our group. In a non-randomised, prospective study comparing ripple mapping\u00e2\u0080\u0093guided ablation to conventional mapping\u00e2\u0080\u0093guided ablation, the diagnostic accuracy was 90% and 65% respectively [10]. A similar effect size was also seen in a randomised prospective study (Ripple-AT Study), showing acute success was 90.5% and 70.7% respectively. In order to detect a difference between arms with 90% power and an alpha value of 0.05, at least 80 patients would be needed to be randomised to each treatment arm. Accounting for potential non-completion of protocol (10%) and loss to follow-up (10%), a minimum of 200 patients will need to be enrolled. Power calculations were performed using the G*Power software (University of Dusseldorf).", "id": 469, "split": "train"} +{"trial_id": "NCT03918057", "pmid": "34384459", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy\n\nIncluded conditions:\n- Insomnia\n- Sleep Disturbance\n\nStudy Armgroups:\n- {'label': 'Cognitive-Behavioural Therapy Group', 'type': 'EXPERIMENTAL', 'description': 'Participants receive 5 in-person weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.', 'interventionNames': ['Behavioral: Cognitive Behavioural Therapy for Insomnia']}\n- {'label': 'Treatment as Usual Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants receive usual obstetric care and are placed on a wait-list until six months postpartum. All activities or efforts participants make to treat or improve their sleep on their own is recorded and coded. After the final assessment six months postpartum, participants have the option of receiving 1.5-hour sessions (for a total of 5 session) of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.', 'interventionNames': ['Other: Active Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive Behavioural Therapy for Insomnia', 'description': 'Cognitive behavioural therapy for insomnia (CBT-I) is an evidence-based psychotherapeutic intervention that combines cognitive and behavioural principles. Specifically, this therapy provides psychoeducation about thoughts contributing to the maintenance of sleep problems, and instruction in behavioural techniques to help decrease sleep onset latency and promote effective sleep maintenance.', 'armGroupLabels': ['Cognitive-Behavioural Therapy Group']}\n- {'type': 'OTHER', 'name': 'Active Control', 'description': 'Participants will receive regular obstetric care and will be placed on a wait-list for CBT-I treatment after their final assessment. All activities women try for improving their own sleep problems between assessments will be recorded and coded for.', 'armGroupLabels': ['Treatment as Usual Group']}\n\nPrimary Outcomes:\n- {'measure': 'Insomnia Severity Index', 'description': 'The ISI is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes. The ISI assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems. It was found to be a clinically useful tool in assessing changes in insomnia symptoms in insomnia treatment research.', 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up.'}\n- {'measure': 'Pittsburgh Sleep Quality Index', 'description': \"The PSQI instrument is used in assessing one's sleep quality during the previous month. It consists of 19 self-rated items and 5 questions rated by the roommate or bed partner. There are seven components of the PSQI and these are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction.\", 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up.'}\n- {'measure': 'Actigraphy (Actiwatch II, Phillips, USA) - Circadian rhythm amplitude, acrophase, mesor', 'description': 'Actigraphy monitoring provides objective sleep data. The values for circadian rhythm amplitude, acrophase, and mesor will be combined for each participant to describe their full Circadian rhythm.', 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up'}\n- {'measure': 'Actigraphy (Actiwatch II, Phillips, USA) - Sleep efficiency', 'description': 'Actigraphy monitoring provides objective sleep data. A sleep efficiency value is recorded by the actigrapher and will be reported.', 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up'}\n- {'measure': 'Actigraphy (Actiwatch II, Phillips, USA) - Sleep latency', 'description': 'Actigraphy monitoring provides objective sleep data. A sleep latency value is recorded by the actigrapher and will be reported.', 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up'}\n- {'measure': 'Actigraphy (Actiwatch II, Phillips, USA) - Total sleep time', 'description': 'Actigraphy monitoring provides objective sleep data. A total sleep time value is recorded by the actigrapher and will be reported.', 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up'}\n- {'measure': 'Actigraphy (Actiwatch II, Phillips, USA) - Number and frequency of awakenings', 'description': 'Actigraphy monitoring provides objective sleep data. The number of times participants wake up during nighttime sleep is recorded by the actigrapher and will be reported.', 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up'}\n- {'measure': 'Sleep Logs - Latency', 'description': 'Sleep logs provide self-reported subjective sleep. One of the variables participants will report is the amount of time they think it takes them to fall asleep.', 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up'}\n- {'measure': 'Sleep Logs - Total sleep time', 'description': 'Sleep logs provide self-reported subjective sleep. Participants will be asked to report on their estimated total sleep time.', 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up'}\n- {'measure': 'Sleep Logs - Number and frequency of awakenings', 'description': 'Sleep logs provide self-reported subjective sleep. Participants will be asked to report on the number of times they woke up during nighttime sleep.', 'timeFrame': 'Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe study aimed for over 90% power to detect a clinically significant change, accounted for a 20% attrition rate, and adjusted for pandemic-related dropouts.", "answer": 62, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n We used pre-post data available from our Phase IIb pilot trial, comparing in-person CBT-I to waitlist control (\u00ce\u00b72 = .41, f = 0.84), to conduct a power analysis. The effect size was large, and the power analysis indicated that we would need 18 participants to provide power over 90% to detect a clinically significant change of 8 points on the ISI [83]. Although longitudinal analyses of CBT-I show that gains are maintained up to two years posttreatment, we wanted to account for the possibility that the effects of treatment may decrease by 6 months postpartum. We therefore powered the RCT to detect a medium effect size (\u00ef\u00bb\u00bff = 0.25), resulting in a total sample size of 44 participants (22 per group) over three assessment time points. Although retention in our studies has been excellent, we accounted for a potential attrition rate of 20% based on previous research in this area with longer follow-up periods [89], resulting in an initial total of 54 participants. When the protocol was amended due to the COVID-19 pandemic, 2 participants had to drop out of the intervention due to pandemic related schedule adjustments and we were unable to send actiwatches to 3 participants due to the temporary university closure. Therefore, the recruitment of 5 additional participants was needed to make up for the incomplete data and/or participation. To ensure there was a 1:1 ratio of participants per group, a final total of 62 participants will be recruited.", "id": 470, "split": "train"} +{"trial_id": "NCT03920033", "pmid": "34674739", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study\n\nIncluded conditions:\n- Prostate Cancer\n- Biochemical Recurrence\n- Radiation\n- Hypofractionation\n- Dose Escalation\n- Survival\n- Radiation Toxicity\n- Quality of Life\n\nStudy Armgroups:\n- {'label': 'Hypofractionated', 'type': 'EXPERIMENTAL', 'description': '65 Gy/ 26 fractions (fraction size 2.5 Gy)', 'interventionNames': ['Radiation: Salvage radiation therapy']}\n- {'label': 'Standard', 'type': 'ACTIVE_COMPARATOR', 'description': '66 Gy/ 33 fractions (fraction size 2 Gy)', 'interventionNames': ['Radiation: Salvage radiation therapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Salvage radiation therapy', 'description': 'Salvage radiation therapy for biochemical recurrence', 'armGroupLabels': ['Hypofractionated', 'Standard']}\n\nPrimary Outcomes:\n- {'measure': 'Biochemical recurrence-free survival', 'description': 'PSA \\\\>0.2 ng/mLfollowed by a repeat measurement \\\\>0.2 ng/mL', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \nThe trial assumes a minimum 5-year follow-up period, a 5% loss rate, 80% power, and a two-sided significance level (\u03b1) of 0.05.", "answer": 288, "answer_type": "ESTIMATED", "explanation": "Sample size considerations and statistical analysis\n The trial is powered to assess the superiority of HRT when compared with CRT. Power calculations are based on an absolute increase in bPFS of 15% (from 50 to 65%) at 5\u00e2\u0080\u0089years following HRT compared with CRT according to the dose-response relationship described by King [9]. By postulating a minimum 5-year follow-up period and allowing 5% for loss, at least 144 patients per treatment arm (288 patients in total) are required, which achieves 80% power, with a two-sided \u00ce\u00b1 of 0.05. Subgroup analyses will be performed based on the risk group (intermediate vs. high-risk group), RT field size (prostate bed only vs. elective pelvic nodal irradiation), and use of ADT.\n Statistical analysis will be conducted according to the intention-to-treat approach. Survival data, PSA value, toxicity, and QoL information will be collected even though participants discontinue the planned treatment. Multiple imputation method will be used for handling missing data. The chi-square test and Student\u00e2\u0080\u0099s t test will be used for categorical and continuous variables of patient characteristics, respectively. Time to biochemical progression will be calculated from the end of RT. The Kaplan\u00e2\u0080\u0093Meier method will be applied to estimate bPFS curves, and the log-rank test will be used to compare the curves between the two study arms. The Kaplan-Meier method and log-rank test will be used to investigate DMFS and CSS. Acute toxicity outcomes and QoL will be estimated using the chi-square test, and late toxicity outcomes will be determined using the Kaplan-Meier method.", "id": 471, "split": "train"} +{"trial_id": "NCT03924518", "pmid": "31574878", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adjunctive Granisetron Therapy in Patients With Sepsis or Septic Shock\uff1aA Single-center, Randomized, Controlled, Single-blind Clinical Trial\n\nIncluded conditions:\n- Sepsis\n\nStudy Armgroups:\n- {'label': 'granisetron group', 'type': 'EXPERIMENTAL', 'description': '3ml granisetron\uff083mg\uff09 will be diluted in 22 mL of 0.9% normal saline,and the granisetron diluted will be intravenously injected for at 10 minutes\uff0c every 8 hours for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first.', 'interventionNames': ['Drug: Granisetron Hydrochloride']}\n- {'label': 'placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Normal saline 25ml every 8h for 4 days or until leaving the ICU(death or transfer from ICU to general ward or discharge), whichever come first.', 'interventionNames': ['Drug: Placebo\uff08Normal saline\uff09']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Granisetron Hydrochloride', 'description': 'Granisetron will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.', 'armGroupLabels': ['granisetron group'], 'otherNames': ['Selective 5-hydroxytryptamine 3 receptor inhibitor']}\n- {'type': 'DRUG', 'name': 'Placebo\uff08Normal saline\uff09', 'description': 'therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.', 'armGroupLabels': ['placebo group'], 'otherNames': ['0.9% saline']}\n\nPrimary Outcomes:\n- {'measure': 'all-cause mortality rate', 'description': 'All-cause mortality rate from the enrollment to the 28th days', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 0.05, power at 80% (\u03b2 = 0.2), and an additional 15% is added to account for shedding and loss of follow-up.", "answer": 154, "answer_type": "ACTUAL", "explanation": "2.11\n Sample size\n According to previous clinical experience, the mortality rate of sepsis in this study center is about 33%. Our sample size was calculated to detect a 20% difference in mortality on day 28 between the 2 groups with a 2-tailed test, a = 0.05, \u00ce\u00b2\u00e2\u0080\u008a=\u00e2\u0080\u008a0.2 (power = 80%). Considering some factors such as shedding and loss of follow-up, an additional 15% of the sample size was added, resulting in a total of 154 patients, 77 in the control group, and 77 in the treatment group.", "id": 472, "split": "train"} +{"trial_id": "NCT03924791", "pmid": "31481010", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transforaminal Epidural Injection in Acute Sciatica\n\nIncluded conditions:\n- Sciatica\n- Sciatica Due to Intervertebral Disc Disorder\n- Sciatic Radiculopathy\n\nStudy Armgroups:\n- {'label': 'Transforaminal Epidural Injection', 'type': 'EXPERIMENTAL', 'description': 'Transforaminal Epidural Injection containing 1,5 mL lidocaine 2% and 40mg methylprednisolone acetate for injections L3 or below Transforaminal Epidural Injection containing 1,5 mL lidocaine 1% and 10mg dexamethasone for injections above L3', 'interventionNames': ['Drug: Lidocaine', 'Drug: Methylprednisolone Acetate', 'Drug: Dexamethasone']}\n- {'label': 'Oral pain medication', 'type': 'NO_INTERVENTION', 'description': 'Patients will receive oral pain medication according to general practitioner guidelines.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lidocaine', 'description': 'In combination with dexamethasone or methylprednisolone acetate', 'armGroupLabels': ['Transforaminal Epidural Injection']}\n- {'type': 'DRUG', 'name': 'Methylprednisolone Acetate', 'description': 'In combination with lidocaine', 'armGroupLabels': ['Transforaminal Epidural Injection'], 'otherNames': ['Depo-Medrol']}\n- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'In combination with lidocaine', 'armGroupLabels': ['Transforaminal Epidural Injection']}\n\nPrimary Outcomes:\n- {'measure': 'Numerical Rating Scale (NRS) for leg pain', 'description': 'Pain intensity in the leg using the NRS. 0 is the minimal score indicating no pain, 10 is the maximum indicating the worst imaginable pain. Scale increases with increments of 1.', 'timeFrame': '2 weeks after randomization'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90% (\u03b2 = 0.10) and a significance level of 5% (\u03b1 = 0.05). Estimated loss to follow-up of 10%.", "answer": 142, "answer_type": "ESTIMATED", "explanation": "Sample size\n It is hypothesized that patients in the intervention group will have a mean NRS for leg pain of 4.0 on a 11-point scale at two weeks after treatment with TEI and patients in the control group will have a mean NRS for leg pain of 5.5 two weeks after randomization. Based on literature review, a difference of 1.5 points on the NRS scale will be considered clinically relevant and a standard deviation of 2.6 is considered [12, 16]. Together with a power of 90% (\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.10) and a level of significance of 5% (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), 64 patients per group are needed. With two study groups and an estimated loss to follow-up of 10% a total of 142 patients needs to be recruited.", "id": 473, "split": "train"} +{"trial_id": "NCT03925480", "pmid": "36456016", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL): a Blinded, Randomised, Placebo-controlled Trial\n\nIncluded conditions:\n- Bacterial Infections\n\nStudy Armgroups:\n- {'label': 'Azithromycin', 'type': 'EXPERIMENTAL', 'description': 'A single 2g dose of Azithromycin', 'interventionNames': ['Drug: Azithromycin 500 mg Oral Tablet x 4']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Matching Placebo', 'interventionNames': ['Drug: Matching Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Azithromycin 500 mg Oral Tablet x 4', 'description': 'A single prophylactic dose of antibiotic given during labour', 'armGroupLabels': ['Azithromycin']}\n- {'type': 'DRUG', 'name': 'Matching Placebo', 'description': 'Matching Placebo', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Cumulative incidence of skin and soft tissue infection by 3 months of age in infants', 'description': 'Born to mothers receiving a single dose of 2g Azithromycin during labour. Assessed by history and physical examination at 7 days, 6 weeks and 3 months.', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-sided alpha of 0.05, 5% dropout rate for SSTIs; 95% power, two-sided alpha of 0.05, no loss to follow-up for infant GBS carriage.", "answer": 2110, "answer_type": "ACTUAL", "explanation": "Sample size\n To detect a 50% decrease in SSTIs, from 6% in the controls to 3% in the intervention arm, with 90% power and a two-sided alpha of 0.05, a sample size of 1002 participants per arm is required. These assumptions were based on rates of impetigo in infants in Fiji and declines in skin infection in the Gambia following 2\u00e2\u0080\u0089g of oral azithromycin.19 22 This sample size was inflated to 1055 participants per arm (total n=2110) to allow for 5% dropout.39 44\n For the secondary outcome of bacterial infant carriage at 7\u00e2\u0080\u0089days of age, 940 mother/infant pairs (470 per arm) will provide 95% power at a two-sided 0.05 alpha level to detect an 80% reduction in infant GBS carriage with the intervention, assuming 5% placebo group infant GBS carriage and no loss to follow-up. These assumptions were based on maternal carriage rates in Suva,45 an assumed 50% likelihood of GBS transfer to neonates from colonised mothers46 and carriage reduction levels found in the Gambian trial.20 This sample size will also detect reductions in the infant carriage rate for all relevant bacteria.", "id": 474, "split": "train"} +{"trial_id": "NCT03926767", "pmid": "34488856", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Additional Effect of Pain Neuroscience Education to Orofacial Manual Therapy and Orofacial and Neck Motor Control Exercises for Pain Intensity and Disability in Temporomandibular Disorders: a Randomized Clinical Trial\n\nIncluded conditions:\n- Temporomandibular Disorders\n\nStudy Armgroups:\n- {'label': 'Pain Neuroscience Education + orofacial and neck exercises', 'type': 'EXPERIMENTAL', 'description': 'All participants in this arm will initially receive two additional sessions in which a workshop on PNE will be administered and discussed. A power-point presentation with metaphors and animated videos will be employed. The PNE program will be held in 2 sessions of 30 minutes each. A protocol of Orofacial Exercises and Manual Therapy will be adopted in the present study. A protocol of neck motor control protocol will be adopted in our study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will be comprised of orofacial strategies and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.', 'interventionNames': ['Other: Pain Neuroscience Education (PNE)', 'Other: Orofacial Manual Therapy', 'Other: Orofacial Exercises', 'Other: Neck Motor Control Exercises']}\n- {'label': 'Orofacial and neck exercises', 'type': 'ACTIVE_COMPARATOR', 'description': 'A protocol of neck motor control protocol will be adopted in our study. The exercises will be administered during six weeks, twice a week. One session will run in the outpatient clinic and the other will be home based. Half of the sessions will be comprised of orofacial strategies and the other half neck motor control exercises. Each exercise and technique will be administered 10 times for 10 seconds.', 'interventionNames': ['Other: Orofacial Manual Therapy', 'Other: Orofacial Exercises', 'Other: Neck Motor Control Exercises']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Pain Neuroscience Education (PNE)', 'description': 'A power-point presentation with metaphors and animated videos will be employed. The PNE program will be held in 2 sessions of 30 minutes each. The intervention program will be divided into 17 thematic topics according to Explain Pain.', 'armGroupLabels': ['Pain Neuroscience Education + orofacial and neck exercises']}\n- {'type': 'OTHER', 'name': 'Orofacial Manual Therapy', 'description': 'A protocol of Orofacial Exercises and Manual Therapy will be adopted in the present study. The manual therapy techniques will be: Intraoral temporalis release, Intraoral medial and lateral pterygoid (origin) technique and Intraoral sphenopalatine ganglion technique.', 'armGroupLabels': ['Orofacial and neck exercises', 'Pain Neuroscience Education + orofacial and neck exercises']}\n- {'type': 'OTHER', 'name': 'Orofacial Exercises', 'description': 'Two mandibular exercises: Mandibular body-condylar cross-pressure chewing technique and Post-isometric relaxation stretches-laterotrusion and opening. Each exercise will be executed 10 times per session for 10 seconds.', 'armGroupLabels': ['Orofacial and neck exercises', 'Pain Neuroscience Education + orofacial and neck exercises']}\n- {'type': 'OTHER', 'name': 'Neck Motor Control Exercises', 'description': 'A protocol of neck motor control protocol will be adopted in our study. The exercises included bracing exercises (six hierarchical levels) in neurodevelopment stages for the cervical spine. Extremity range of motion exercises will be conducted while maintaining a stable spine at the specific positions. Also, cervical isometric exercises (five hierarchical levels) will be carried out directly forward, obliquely, toward right and left, and directly backward by maintaining a stable spine with elastic resistive bands. Finally, exercises also included functional training with elastic resistance and exercise balls on unstable surfaces (eight hierarchical levels). The criteria to progress in each exercise domain (bracing, isometric exercises or functional training) will be sustain the contraction for 10 seconds, 10 times.', 'armGroupLabels': ['Orofacial and neck exercises', 'Pain Neuroscience Education + orofacial and neck exercises']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Pain intensity', 'description': 'The Numerical Pain Rating Scale will be used to assess pain intensity in this trial and consists in a sequence of numbers from 0 to 10, in which 0 represents \"no pain\" and 10 represents \"worst pain imaginable\".', 'timeFrame': 'Immediately after, one- and three-month follow-up'}\n- {'measure': 'Change in Orofacial Pain related Disability', 'description': 'The Craniofacial Pain and Disability Inventory (CF-PDI) is a self-administered questionnaire that measures the outcomes of pain and disability related to craniofacial pain and demonstrated a good structure, internal consistency, reproducibility, and construct validity. Also, the Brazilian Portuguese version showed acceptable psychometric measurements. It consists of 21 items, with a score ranging from 0 to 63 points. Each question is scored on 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher disability levels.', 'timeFrame': 'Immediately after, one- and three-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a power of 80%, an alpha of 5%, and f tests of 0.33 for pain intensity and 0.25 for disability. A follow-up loss of up to 15% is also considered.", "answer": 148, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The study was designed to detect a between-group difference of 2 points in pain intensity (30%) measured by the NPRS, with an estimated standard deviation of 3 points. A previous study [42] recommended a minimum sample size of n=61 per group.\n For disability, a between-group difference of 5.08 points for disability measured by the CF-PDI, considering the Smallest Detectable Change of CF-PDI Brazilian version [26], with an estimated standard deviation of 10 points resulted in a sample size of 64 participants per group. The other specifications were power of 80%, an alpha of 5%, f test of 0.33 (pain intensity) and 0.25 (disability). Therefore, a total of 128 participants was obtained, however considering a follow-up loss up to 15%, we will recruit 148 participants. G*Power was used to run the sample size calculation (GPower 3.0.10, da University of Kiel, Germany).", "id": 475, "split": "train"} +{"trial_id": "NCT03927534", "pmid": "31753880", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of a Mindful Eating Program to Reduce Emotional Eating in Patients Suffering From Overweight or Obesity in Primary Care Settings: a Cluster Randomized Controlled Clinical Trial Protocol\n\nIncluded conditions:\n- Overweight and Obesity\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': 'Mindful Eating program is apply face to face 7 sessions of 120 minutes/session. ME is apply in groups of 10-12 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.', 'interventionNames': ['Behavioral: Mindful Eating']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Treatment As Usual (TAU) in Primary Care (PC) is any kind of treatment administered by the GP to the patient with overweight and obesity. According to nutritional status, overweight or obesity, as well as the presence of co-morbidity, different actions can comprise the treatment offered at a PC level. For individuals presenting with overweight (BMI 25-29.9 kg/m2) but with no co-morbidities, PC teams organise care plans to enable them to achieve a normal BMI range (BMI 18.5-24.9 kg/m2). In case of suicide risk, severe social dysfunction or worsening of symptoms, it is recommended that patients are referred to mental health facilities.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindful Eating', 'description': 'The ME group will be composed by 7 weekly group sessions with a minimum duration of two hours, mixing theoretical contents with practices. Sessions will always be the same day of the week, except for bank holidays or eventualities, and will be conducted by a psychologist specially trained and certified in ME with experience in leading mindfulness groups. Group sizes will range between 10 and 12 participants. At the end of each session, participants will receive theoretical contents and homework activities to be practiced along the week.', 'armGroupLabels': ['Experimental']}\n\nPrimary Outcomes:\n- {'measure': 'The Dutch Eating Behavior Questionnaire', 'description': 'It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., \"Desire to eat when irritated\"), and 10 items referring to the external (e.g., \"Eating when you feel lonely\") and restrictive (e.g., \"Difficult to resist delicious food\") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating \"never\" and 5 indicating \"very often\".', 'timeFrame': 'Baseline in experimental and control groups.'}\n- {'measure': 'The Dutch Eating Behavior Questionnaire', 'description': 'It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., \"Desire to eat when irritated\"), and 10 items referring to the external (e.g., \"Eating when you feel lonely\") and restrictive (e.g., \"Difficult to resist delicious food\") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating \"never\" and 5 indicating \"very often\".', 'timeFrame': 'Post-treatment 8 weeks from baseline in experimental and control groups'}\n- {'measure': 'The Dutch Eating Behavior Questionnaire', 'description': 'It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., \"Desire to eat when irritated\"), and 10 items referring to the external (e.g., \"Eating when you feel lonely\") and restrictive (e.g., \"Difficult to resist delicious food\") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating \"never\" and 5 indicating \"very often\".', 'timeFrame': 'twelve-months follow-up in experimental and control groups'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a 5% significance level, 80% power, and a 20% dropout rate at 1-year follow-up. The intracluster correlation coefficient (ICC) is assumed to be 0.03.", "answer": 76, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size estimation has been based on the main comparison, which contemplates the possible differences between the \u00e2\u0080\u0098ME +TAU\u00e2\u0080\u0099 and \u00e2\u0080\u0098TAU alone\u00e2\u0080\u0099 groups of patients. Based on previous research,72 we assume that \u00e2\u0080\u0098ME +TAU\u00e2\u0080\u0099 would be able to present high effects compared with \u00e2\u0080\u0098TAU alone\u00e2\u0080\u0099 on EE at post test. To operationalise this, we consider a standardised difference between arms on the referred main outcome of 0.80.72 To detect this difference between the groups, assuming a common SD, a 5% significance level and a statistical power of 80% using a 1:1 ratio, we need 25 subjects in each group. However, these numbers correspond to the sample size needed under individual randomisation, which is the absolute upper bound for cluster size\u00e2\u0080\u0094clusters are randomised and thus we need to allow for the correlation between the EE outcomes of participants from the same cluster.73 To determine the minimum number of clusters needed, we used the formula \u00e2\u0080\u0098n * ICC\u00e2\u0080\u0099, where n is the sample size for each arm under individual randomisation and ICC is the intracluster correlation coefficient that quantifies the amount of within-cluster correlation for the outcome of interest, assuming a typical fairly value in CRTs of ICC=0.03,74 with a result of approximately one cluster in each arm. Because the number of clusters in the trial is limited by the number of PC settings available to implement the ME programme, we increased the number of clusters to one more than the minimum, supposing that the cluster size would be at most \u00e2\u0080\u0098n/1\u00e2\u0080\u0099. Thus, we fixed the number of clusters per arm to 2 in order to determine the required cluster size.75 In order to maintain the same absolute difference and significance level described above to achieve 80% power with 2 clusters in each arm, we needed a cluster size of 16 participants. In addition, by fixing the cluster size at 16 participants in the same conditions, we obtained the need of 2 clusters per arm, equating to a total sample size of 64 subjects under the condition of equal cluster sizes. Finally, we inflated the numbers to reach a total sample size of 76 patients (38 per arm), considering a drop-out rate of approximately 20% at 1-year follow-up.76 This can be considered an efficient design based on the rule that cluster size should not exceed the number estimated in each arm under individual randomisation.73 This number also enlarges the sample size under individual randomisation in a measure that includes the design effect \u00e2\u0080\u0098DEFF=1 + (m \u00e2\u0080\u0093 1) * ICC\u00e2\u0080\u0099\u00e2\u0080\u0094where m is the average number of patients per cluster\u00e2\u0080\u0094with a value of DEFF=1.45, and thus demanding an increase with regard to individual randomisation of around 45%.57", "id": 476, "split": "train"} +{"trial_id": "NCT03928925", "pmid": "34035106", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Bougie or Stylet In Patients Undergoing Intubation Emergently (BOUGIE): a Randomized, Multi-center Trial\n\nIncluded conditions:\n- Acute Respiratory Failure\n\nStudy Armgroups:\n- {'label': 'BOUGIE', 'type': 'ACTIVE_COMPARATOR', 'description': 'For patients randomized to use of a bougie, the operator will use a bougie on the first attempt at intubation. If successful, an assistant will load an endotracheal tube over the bougie, and the operator (without removing the laryngoscope from the mouth) will guide the tube through the vocal cords to the desired depth in the trachea.\\n\\nIf the bougie is not successfully placed in the trachea or the endotracheal tube cannot be successfully advanced over the bougie on the first attempt at intubation, the operator may use any approach during subsequent attempts at tracheal intubation.', 'interventionNames': ['Other: Bougie']}\n- {'label': 'Endotracheal Tube with Stylet', 'type': 'ACTIVE_COMPARATOR', 'description': 'For patients randomized to use of an endotracheal tube with stylet, the operator will use an endotracheal tube containing a removeable, malleable stylet, on the first attempt at intubation.\\n\\nManipulation of the shape/curve of the endotracheal tube with stylet is at the discretion of the operator, however a \"straight-to-cuff\" shape and a bend angle of 25\u00b0 to 35\u00b0 is encouraged. The stylet will be left in place until the tube is advanced to the trachea.\\n\\nIf the endotracheal tube with stylet is not successfully placed in the trachea on the first attempt at intubation, the operator may use any approach during subsequent attempts at tracheal intubation.', 'interventionNames': ['Other: Endotracheal Tube with Stylet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Bougie', 'description': 'disposable tracheal tube introducer of approximately 70 cm in length', 'armGroupLabels': ['BOUGIE']}\n- {'type': 'OTHER', 'name': 'Endotracheal Tube with Stylet', 'description': 'endotracheal tube preloaded with a removable, malleable stylet', 'armGroupLabels': ['Endotracheal Tube with Stylet']}\n\nPrimary Outcomes:\n- {'measure': 'Number of intubations with successful intubation on the first attempt', 'description': 'The primary outcome is successful intubation on the first attempt. Successful intubation on the first attempt is defined as placement of an endotracheal tube in the trachea (confirmed by standard means including capnography) following: (1) a single insertion of a laryngoscope blade into the mouth and (2) EITHER a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth OR a single insertion of an endotracheal tube with stylet into the mouth.', 'timeFrame': 'from induction to 2 minutes following tracheal intubation'}\n\nPlease estimate the sample size based on the assumption: \nAssuming 84% of patients in the endotracheal tube with stylet group experience successful intubation on the first attempt, the trial aims for 80% power at a two-sided alpha level of 0.05, with an anticipated missing data rate of 5% or less.", "answer": 1106, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n There is no established minimum clinically important difference in successful intubation on the first attempt. A prior single-centre randomised trial reported an absolute difference of 11% in successful intubation on the first attempt between the bougie and endotracheal tube with stylet groups. Because this trial was performed in an ED where the majority of first intubation attempts used a bougie, we anticipated a potentially smaller difference between groups in this multicenter trial conducted in a broader range of clinical settings with a broader range of operators. Therefore, the current trial was designed to detect a 6% absolute difference between groups in the proportion of patients who experience successful intubation on the first attempt. For two inexpensive interventions already routinely available and used in practice, the minimally clinically significant difference that would be expected to change practice is unknown. However, an absolute difference of 6% in successful intubation on the first attempt is similar to or smaller than the difference considered to be clinically meaningful in the design of prior airway management trials.7 10 14 Assuming 84% of patients in the endotracheal tube with stylet group experience successful intubation on the first laryngoscopy attempt, detecting a 6% absolute increase in successful intubation on the first attempt with 80% power at a two-sided alpha level of 0.05 would require enrolment of 1050 patients (525 per group). Anticipating missing data for 5% of patients or less, we will plan to enrol a total of 1106 patients (553 per group).", "id": 477, "split": "train"} +{"trial_id": "NCT03931083", "pmid": "33371015", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Screening Test Accuracy of a Gynocular\u2122, HR-HPV Testing, and VIA for Detection of Cervical Intraepithelial Neoplasia, Grade Two and Above, in Women Living With HIV in Lusaka, Zambia\n\nIncluded conditions:\n- Uterine Cervical Neoplasms\n- HIV/AIDS\n\nStudy Armgroups:\n- {'label': 'Portable magnification device (Gynocular\u2122)', 'description': \"The Gynocular\u2122 examination will be performed following the steps involved in colposcopy as described in the IARC colposcopy manual. These steps include: visualization of the vagina, vulva and cervix following insertion of a speculum, magnified assessment after application of normal saline, examination of cervical vessel patterns using the red-free mode (or green filter), application of 5% acetic acid for 1 minute and finally assessment following application with Lugol's iodine. The findings of the live examination will be documented using the parameters of the Swede score. Each parameter is scored between zero and two. Treatment will be based on the results found at histopathology, unless the woman is also VIA positive in which case, after biopsy she will undergo routine treatment as per local guidelines. The results will be used to determine the optimal threshold for treatment in WLHIV.\", 'interventionNames': ['Diagnostic Test: Screening for CIN2+/HSIL']}\n- {'label': 'Testing for high risk HPV (HRHPV)', 'description': \"To reduce the number of examinations undergone by the study participant during the same day, HRHPV testing will be carried out at the time of the first gynecological examination by the VIA nurse (see next arm). Using specific single-use cervical cytobrush provided by GeneXpert, a specimen will be collected immediately prior to VIA examination. Cervical cytobrush specimens will be placed into ThinPrep PreservCyt (Cepheid, Sunnyvale, CA) immediately after collection. The HR-HPV testing of cervical specimens will be conducted by a GeneXpert\u2122 machine (Cepheid, Sunnyvale, CA), which will be placed at the health facility and will be operated by a trained nurse in accordance with the manufacturer's instructions. Additionally, as part of the baseline clinical characteristics of the study participant, the study participant will undergo an STI test at the same time. The sample will be collected and tested using the same GeneXpertTM platform.\", 'interventionNames': ['Diagnostic Test: Screening for CIN2+/HSIL']}\n- {'label': 'Visual inspection with acetic acid (VIA)', 'description': 'VIA, which is standard of care for cervical cancer screening in Zambia, will be carried out using the methodology described by IARC. This is summarized as follows: visualization of the vagina, vulva and cervix following insertion of a speculum; assessment with the naked eye after application of normal saline; and further assessment after application of 5% acetic acid for 1 minute. This will be recorded as normal or abnormal by the assessor.', 'interventionNames': ['Diagnostic Test: Screening for CIN2+/HSIL']}\n- {'label': 'Histopathological examination of tissue biopsies', 'description': 'All acetowhite lesions will be biopsied. When no lesion is seen, one biopsy is taken from each quadrant at the squamocolumnar junction. Biopsies will be sent and examined in a South African based lab. All histological slides will also be verified independently by an IARC trained pathologist at the end of the study. Histological endpoints are defined by the CIN classification system: CIN 1 affects only the lower third of the epithelium (mild dysplasia), CIN 2 involves two thirds of the epithelium and CIN 3 involves the full thickness (severe dysplasia and carcinoma in situ). These findings can be dichotomized by the Lower Anogenital Squamous Terminology into low-grade squamous intraepithelial lesions (LSIL) and high-grade squamous intraepithelial lesions (HSIL). All patients with CIN grade 2 that stained diffusely positive for p16 are considered as HSIL, all patients with CIN 3 are considered as HSIL. Expression of p16 will be visually assessed by immunohistochemistry.', 'interventionNames': ['Diagnostic Test: Screening for CIN2+/HSIL']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Screening for CIN2+/HSIL', 'description': 'The investigators will compare three different screening methods: visual assessment with portable magnification device , visual inspection after application of acetic acid, screening for high risk variants of HPV. All patients will receive cervical biopsies and histopathological examination.', 'armGroupLabels': ['Histopathological examination of tissue biopsies', 'Portable magnification device (Gynocular\u2122)', 'Testing for high risk HPV (HRHPV)', 'Visual inspection with acetic acid (VIA)']}\n\nPrimary Outcomes:\n- {'measure': 'Test accuracy (sensitivity, specificity) of the Gynocular\u2122 when used as stand-alone tests to detect CIN2+', 'description': 'To estimate the sensitivity and specificity of the Gynocular when used as a standalone tests to detect CIN2+ among WLHIV.', 'timeFrame': '6 months'}\n- {'measure': 'Test accuracy (sensitivity, specificity) of HR-HPV when used as stand-alone tests to detect CIN2+', 'description': 'To estimate the sensitivity and specificity of HR-HPV when used as a standalone tests to detect CIN2+ among WLHIV.', 'timeFrame': '6 months'}\n- {'measure': 'Test accuracy (sensitivity, specificity) of VIA when used as stand-alone tests to detect CIN2+', 'description': 'To estimate the sensitivity and specificity of VIA when used as a standalone tests to detect CIN2+ among WLHIV.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nScreening accuracy measures will be estimated with 95% Wilson confidence intervals. There is an expected 10% loss to follow-up and up to 10% of tests that are not analysable or interpretable.", "answer": 450, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and analysis\n This screening test accuracy study requires 350 participants to estimate the sensitivity and specificity of Gynocular, HR-HPV and VIA for CIN2+ lesions with the precision detailed in table 1. Screening accuracy measures will be estimated with 95% Wilson confidence intervals with no formal hypothesis testing between modalities.\n \n Table 1\n \n Sensitivity and specificity table, n = 350. The expected 95% Wilson confidence interval for sensitivity and specificity with varying prevalence\n \n \n \n \n \n Expected 95% CIs for sensitivity (%)Expected 95% CIs for specificity (%)\n \n \n 50\n 55\n 60\n 65\n 70\n 75\n 80\n 85\n 90\n 95\n \n \n \n \n Expected prevalence (%)\n 14\n 37.5 to 64.4\n 41.3 to 68.1\n 45.2 to 71.8\n 51.3 to 77.1\n 55.5 to 80.5\n 61.9 to 85.4\n 66.4 to 88.5\n 73.3 to 92.9\n 78.2 to 95.6\n 86.3 to 98.9\n \n \n \n 44.6 to 55.8\n \n \n 49.5 to 60.7\n \n \n 54.5 to 65.5\n \n \n 59.6 to 70.3\n \n \n 64.7 to 75.0\n \n \n 69.9 to 79.6\n \n \n 75.2 to 84.2\n \n \n 80.6 to 88.6\n \n \n 86.1 to 92.9\n \n \n 91.9 to 97.0\n \n \n \n 16\n 37.3 to 62.7\n 42.4 to 67.6\n 47.6 to 72.4\n 51.2 to 75.5\n 56.7 to 80.1\n 62.3 to 84.5\n 68.2 to 88.7\n 74.3 to 92.6\n 78.5 to 95.0\n 85.4 to 98.2\n \n \n \n 44.3 to 55.7\n \n \n 49.4 to 60.7\n \n \n 54.2 to 65.3\n \n \n 59.4 to 70.2\n \n \n 64.6 to 75.0\n \n \n 69.9 to 79.8\n \n \n 75.0 to 84.1\n \n \n 80.5 to 88.7\n \n \n 86.2 to 93.0\n \n \n 91.8 to 96.9\n \n \n \n 18\n 38.8 to 62.7\n 43.3 to 67.2\n 48.0 to 71.5\n 52.8 to 75.7\n 57.6 to 79.8\n 62.7 to 83.7\n 67.8 to 87.5\n 75.0 to 92.3\n 80.7 to 95.6\n 86.9 to 98.4\n \n \n \n 44.4 to 55.9\n \n \n 49.3 to 60.7\n \n \n 54.2 to 65.4\n \n \n 59.5 to 70.4\n \n \n 64.5 to 75.0\n \n \n 69.6 to 79.6\n \n \n 75.1 to 84.3\n \n \n 80.4 to 88.7\n \n \n 85.9 to 92.9\n \n \n 92.0 to 97.1\n \n \n \n 20\n 38.6 to 61.4\n 44.1 to 66.8\n 48.3 to 70.7\n 54.0 to 75.8\n 58.5 to 79.5\n 64.5 to 84.2\n 69.2 to 87.7\n 75.7 to 92.1\n 80.8 to 95.1\n 88.1 to 98.5\n \n \n \n 44.2 to 55.8\n \n \n 49.1 to 60.7\n \n \n 54.2 to 65.6\n \n \n 59.2 to 70.3\n \n \n 64.4 to 75.1\n \n \n 69.6 to 79.7\n \n \n 74.9 to 84.3\n \n \n 80.3 to 88.7\n \n \n 85.9 to 93.0\n \n \n 91.8 to 97.0\n \n \n \n 22\n 39.7 to 61.5\n 43.5 to 65.2\n 48.6 to 70.0\n 53.8 to 74.7\n 59.2 to 79.2\n 64.6 to 83.6\n 70.3 to 87.8\n 74.7 to 90.9\n 80.8 to 94.6\n 87.4 to 98.0\n \n \n \n 44.3 to 56.1\n \n \n 49.0 to 60.7\n \n \n 54.2 to 65.7\n \n \n 59.0 to 70.3\n \n \n 64.3 to 75.1\n \n \n 69.6 to 79.8\n \n \n 74.7 to 84.2\n \n \n 80.3 to 88.7\n \n \n 86.0 to 93.1\n \n \n 91.6 to 96.9\n \n \n \n \n \n \n %, percentage; CI, Confidence interval; n, number of women.\n \n \n \n We will enrol 450 women to obtain data from at least 350 patients for statistical analyses. We expect the prevalence of CIN2+ in WLHIV in Zambia to be 16%\u00e2\u0080\u009320%.8 27 28 We expect disease prevalence to be lower than in previous years. Increases in the number of women receiving ART, and commencing treatment at higher CD4 cell counts,29 may lead to a decline in HPV prevalence.30 Higher rates of voluntary male circumcision in male partners may also contribute to lower levels of HPV infection.30 We also estimate that there might be up to 10% loss to follow-up and up to 10% of tests that are not analysable or interpretable. We have implemented rigorous data collection methods to avoid missing data, such as patient demographics, clinical history and test results.\n A complete list of outcomes can be found in our clinical trials registration and in the online supplemental material 1.\n \n 10.1136/bmjopen-2020-037955.supp1\n Supplementary data\n \n \n \n \n Primary outcomes are:\n \n \n The sensitivity and specificity of the Gynocular, HR-HPV and VIA when used as stand-alone tests to detect CIN2+ among WLHIV.\n \n \n Secondary outcomes are:\n \n \n Other test accuracy measures of the Gynocular, HR-HPV testing and VIA which include positive and negative predictive values, positive and negative likelihood ratios, false-positive rate, false-negative rate, number needed to screen, and area under the receiver operating characteristic (ROC) curve and the diagnostic ORs.\n \n \n Estimates of accuracy for tests when they are done in sequence. For example, HR-HPV positive test followed by Gynocular, and HR-HPV positive test followed by VIA.\n \n \n Estimates of test accuracy in subgroups defined by age, menopausal status, parity, education, ART status, CD4 cell count, HIV RNA viral load, coinfection with T. vaginalis, methods of contraception, and earlier treatment for precancer and potential effect modification. The specific categorisation of the variables in the subgroup analysis is defined in the online supplemental material 2.\n \n \n Area under the ROC curve for the Swede score determined by Gynocular.\n \n \n \n 10.1136/bmjopen-2020-037955.supp2\n Supplementary data\n \n \n \n \n A detailed statistical analysis plan has been drafted as a separate document, to describe planned analyses for the predefined outcomes and planned subgroup analyses. This can be found as an attachment to our clinical trials registration. In summary, two-by-two tables will be created to calculate sensitivity and specificity, positive and negative predictive values, positive and negative likelihood ratios, false-positive rate, false-negative rate, diagnostic odds ratio, and number needed to screen. Test accuracies will be calculated for each test in a stand-alone and add-on capacity, with corresponding confidence intervals using the Wilson score method.31 Area under the ROC curve for the Swede score as determined by the Gynocular will also be calculated. We will also evaluate test accuracy in subgroups defined by age, menopausal status, parity, education, ART status, CD4 cell count, HIV RNA viral load, coinfection with T. vaginalis, methods of contraception and earlier treatment for precancer. We will use logistic regression models to assess whether these patient characteristics have an influence on the association between each diagnostic test and disease status.\n Indeterminate results from the index test or reference standard will be reported, and sensitivity analysis will be performed to quantify the possible range of accuracy if participants with an indeterminate test or reference standard data are classified as positive or negative. The distribution of baseline characteristics between the participants with missing data and those without will be compared and managed similarly, with a sensitivity analysis to quantify the possible range of accuracy if participants with missing data are classified as diseased or non-diseased. If the missing data can be categorised as missing at random, such as lost samples, technical failures or accidental deviations from the protocol, multiple imputation may be used to reconstruct the data.", "id": 478, "split": "train"} +{"trial_id": "NCT03931564", "pmid": "36721130", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SIGHT Study: Cost-effectiveness of InnFocus Microshunt (IMS) Implantation Versus Standard Trabeculectomy (TE)\n\nIncluded conditions:\n- Primary Open-angle Glaucoma\n\nStudy Armgroups:\n- {'label': 'PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS))', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention group will undergo PRESERFLO (formerly InnFocus) Microshunt implantation (IMS).', 'interventionNames': ['Procedure: PRESERFLO Microshunt implantation']}\n- {'label': 'Trabeculectomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'The usual care/control group will undergo a standard trabeculectomy.', 'interventionNames': ['Procedure: Trabeculectomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'PRESERFLO Microshunt implantation', 'description': 'The intervention consists of the microshunt implantation augmented with mitomycin C application.', 'armGroupLabels': ['PRESERFLO Microshunt (formerly InnFocus Microshunt (IMS))'], 'otherNames': ['InnFocus Microshunt implantation']}\n- {'type': 'PROCEDURE', 'name': 'Trabeculectomy', 'description': 'The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.', 'armGroupLabels': ['Trabeculectomy']}\n\nPrimary Outcomes:\n- {'measure': 'Intraocular pressure', 'description': 'The intraocular pressure is measured using a Goldmann applanation tonometer', 'timeFrame': '12 months postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nWithin-group standard deviation of 4.4, 90% power, one-sided significance level alpha of 0.025, and 20% loss-to-follow-up. For secondary outcomes, 90% power, two-sided alpha of 0.05, and within-group SD of 0.2.", "answer": 124, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size is based on the primary outcome, IOP, a numerical response variable, to detect non-inferiority of an experimental group compared to a control group at 12\u00e2\u0080\u0089months of follow-up. A couple of studies have been published on the efficacy of the experimental group. Based on observed means of postoperative IOP from these studies [11, 26, 27], a mean IOP for the experimental group of 12\u00e2\u0080\u0089mmHg was chosen. The non-inferiority margin (control minus intervention) of \u00e2\u0088\u0092\u00e2\u0080\u00892.5\u00e2\u0080\u0089mmHg is chosen based on previous trials investigating glaucoma surgery [26, 28, 29]. Assuming this non-inferiority margin of \u00e2\u0088\u0092\u00e2\u0080\u00892.5\u00e2\u0080\u0089mmHg, a within-group standard deviation (SD) of 4.4, and an expected effect (control minus intervention) of 0.4 [5], 49 patients per group will be required to show non-inferiority with 90% power and a one-sided significance level alpha of 0.025. Accounting for 20% loss-to-follow up, we will need to include 62 patients per group, i.e., 124 patients in total.\n As for secondary outcome parameters, this number of patients should be sufficient to detect relevant differences in CDVA and postoperative intervention and complication rates. A 0.13 logMAR difference between the two groups (within group SD\u00e2\u0080\u0089=\u00e2\u0080\u00890.2) can be detected with 90% power and a two-sided alpha of 0.05. In the primary tube versus trabeculectomy study [5], the postoperative intervention and complication rate in the control group was 63 and 41%, respectively. With the planned sample size for our study (124 patients in total with 20% dropout), we can detect a difference of 32% (63% in the control group versus up to 31% in the intervention group) for postoperative interventions and 28% (41% in the control group versus 13% in the intervention group) for postoperative complications, with 90% power and a one-sided significance level alpha of 0.025.", "id": 479, "split": "train"} +{"trial_id": "NCT03931577", "pmid": "31847912", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Cost-effectiveness of Improving Clinicians' Diagnostic and Communication Skills on Antibiotic Prescribing Appropriateness in Patients With Acute Cough in Primary Care in Catalonia.\n\nIncluded conditions:\n- Respiratory Tract Infections\n- Cough\n\nStudy Armgroups:\n- {'label': 'C-reactive protein rapid testing', 'type': 'EXPERIMENTAL', 'description': 'Continuous (workshop and monthly web-based training) disease-focused intervention with the use of C-reactive protein rapid testing.', 'interventionNames': ['Diagnostic Test: C-reactive protein rapid testing']}\n- {'label': 'Enhancement of communication skills', 'type': 'EXPERIMENTAL', 'description': 'Continuous (on-site and monthly online training) illness-focused intervention with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets.', 'interventionNames': ['Procedure: Communication skill enhancement']}\n- {'label': 'C-reactive protein + communication skills', 'type': 'EXPERIMENTAL', 'description': 'Continuous (workshop and monthly web-based training) disease-focused intervention with C-reactive protein rapid testing and on-site and continuous (monthly online training illness-focused intervention) with enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets.', 'interventionNames': ['Diagnostic Test: C-reactive protein rapid testing', 'Procedure: Communication skill enhancement']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Usual care.'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'C-reactive protein rapid testing', 'description': 'Continuous (workshop and monthly web-based training) disease-focused intervention with the provision of CRP rapid testing in the primary care practices.', 'armGroupLabels': ['C-reactive protein + communication skills', 'C-reactive protein rapid testing'], 'otherNames': ['CRP']}\n- {'type': 'PROCEDURE', 'name': 'Communication skill enhancement', 'description': 'Continuous (on-site and monthly online training) illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) in the primary care practices.', 'armGroupLabels': ['C-reactive protein + communication skills', 'Enhancement of communication skills'], 'otherNames': ['Leaflet provision']}\n\nPrimary Outcomes:\n- {'measure': 'Antibiotic use', 'description': 'Number of antibiotics consumed (as documented in the CRFs and double-checked by the Pharmacy Unit of Institut Catal\u00e0 de Salut that can track if the antibiotic has been dispensed at any of the Catalan pharmacies)', 'timeFrame': 'Day 42'}\n- {'measure': 'Health status', 'description': 'Quality of life score obtained using the EuroQol questionnaire', 'timeFrame': 'Difference between baseline visit and day 42'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 5%, power of 80%, drop-out rate of 12%, intra-cluster correlation coefficient of up to 0.07.", "answer": 2940, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n To calculate the sample size, we will use a type I error of 5% and a power of 80%, and we will assume that antibiotic prescribing will decrease by at least 15%, from 60% to 45%, in any one of the three intervention groups. We will also assume a drop-out rate of 12% and an intra-cluster correlation coefficient for antibiotic prescribing within practices of up to 0.07, based on two recent studies [14, 16]. We estimate that a sample of 788 (197\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00894) patients will be needed. Allowance for an inflation factor of 3.73 due to clustering and rounding of numbers for the four subgroups give an overall sample size of 2940 [17]. As a consequence, at least 147 patients will be recruited per centre.", "id": 480, "split": "train"} +{"trial_id": "NCT03932214", "pmid": "39915026", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Infrared Illumination for Difficult Peripheral Venous Catheterization in Adult Critically-ill Patients\n\nIncluded conditions:\n- Peripheral Venous Catheterization\n\nStudy Armgroups:\n- {'label': 'Infrared illumination group', 'type': 'EXPERIMENTAL', 'description': 'The nurse uses the Accuvein\u00ae device to identify the veins before puncture.', 'interventionNames': ['Device: ACCUVEIN']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'The nurse proceeds as usual (visual identification in the light of the room and palpation)'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'ACCUVEIN', 'description': 'The nurse uses the Accuvein\u00ae device to identify the veins before puncture and then proceeds as usual, under illumination of the device.', 'armGroupLabels': ['Infrared illumination group']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of primary success of peripheral venous catheterization in the upper limbs.', 'description': 'success defined as the need of a single puncture for the effective catheterization.\\n\\nThe effective catheterization is confirmed by obtaining venous reflux by declivity of the infusion bag.', 'timeFrame': 'Day 1'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a two-sided alpha risk of 5% and aims for a power of 90%.", "answer": 460, "answer_type": "ESTIMATED", "explanation": "Sample size and its justification\n The sample size calculation is based on the results of a previous randomised trial in paediatrics with a similar device, which demonstrated an increase of more than 30% in the primary success rate in the subgroup at risk of difficult catheterisation.10 Given the limited sample size of the previous study (n=44 at risk of difficult catheterisation), the present project will use a more conservative difference to be detected of 15% between the two groups. This equates to an expected success rate of 47% (control)3 versus 62% (intervention). Based on these assumptions and a two-sided alpha risk of 5%, the inclusion of 230 patients per group (total 460) is required to detect a significant difference with a power of 90%.\n \n Recruitment\n Patients will be enrolled for 54 months starting in December 2019. The study timeline is as follows: (1) January 2021: winning grant award; (2) June 2019: approval by an independent ethics committee; (3) December 2019\u00e2\u0080\u00932024: inclusion of patients; (5) 2024\u00e2\u0080\u00932025: the investigators will review the data and check for protocol violations; (6) 2024\u00e2\u0080\u00932025: the investigators will analyse the data, write the manuscript and submit it for publication.\n \n \n Allocation of intervention and data collection\n Centralised block randomisation using a 1:1 ratio will be prepared by the Clinical Research Unit before the start of the trial. Randomisation will be carried out using permuted blocks of varying size and stratified according to the centre and the experience of the operator in the ICU (\u00e2\u0089\u00a52\u00e2\u0080\u0089vs < 2 years) because of the likely impact of experience on the success of catheterisation. There is no need to stratify by patient characteristics, as patients are already selected based on a risk score for difficult catheterisation. Patients will be randomised electronically via a website. A computer-generated randomization list will be prepared prior to enrolment of the first patient into the trial. No patient can be enrolled twice. Investigators or research assistants at each centre will enter data into the e-CRF (CleanWeb) via a web browser. The centres can access the e-CRF forms via a web-based data collection system.", "id": 481, "split": "train"} +{"trial_id": "NCT03932461", "pmid": "35619144", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis: A Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Fecal Peritonitis\n- Secondary Peritonitis\n- Diffuse; Peritonitis\n\nStudy Armgroups:\n- {'label': 'Vacuum assisted closure', 'type': 'ACTIVE_COMPARATOR', 'description': 'The VAC\u00ae Abdominal Dressing System (KCI Vacuum Assisted Closure, San Antonio, TX, USA) will be used. Intestines, including lateral aspects, are covered by the visceral protective layer. The first layer of foam is placed in the laparostoma on the visceral protective layer and must extend below the fascia at a distance of 5 cm from the facial opening. Above this, a minimum of one piece of foam is folded and placed in the laparostoma. Finally, the laparostoma will be covered by the occlusive drape. A circular opening of approximately 5 cm in diameter will be created in the drape where the connection tubes to the vacuum pump will be placed. Simultaneously while applying the negative pressure of 125 mmHg, the wound edges are approximated manually towards the midline. Each dressing change must be performed in the operation theatre with the patient in general anesthesia and muscle relaxation.', 'interventionNames': ['Procedure: Vacuum assisted closure']}\n- {'label': 'Relaparotomy \"on-demand\"', 'type': 'ACTIVE_COMPARATOR', 'description': \"The Isreaelsson principle includes a running suture of the fascia with a distance of 5 mm between the stitches of 5 mm and the distance to the facial edge of 5-10 mm. Monofilament PDS 2-0 or equivalent is used. The suturing is started cranially and caudally, and the sutures are tied with self-locking knots. Four times as much suture material as the length of the wound must be used. The peritoneal fluid must be cultured at closure.\\n\\nThe treating surgeon decides to perform a ROD and should be guided by the patient's general condition, gastrointestinal function, renal function, and inflammatory parameters at daily rounds.\", 'interventionNames': ['Procedure: Relaparotomy \"on demand\"']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Vacuum assisted closure', 'description': 'The Vacuum assisted closure system consists of an abdominal dressing covering the intra abdominal viscera over the dressing there will be placed a blue sponge which will be covered by drape and connected to a vacuum pump.', 'armGroupLabels': ['Vacuum assisted closure'], 'otherNames': ['VAC\u00ae Abdominal Dressing System, KCI, (San Antonio, TX)']}\n- {'type': 'PROCEDURE', 'name': 'Relaparotomy \"on demand\"', 'description': 'Abdomen is closed at the index operation after source of peritonitis is treated. Every 48-hours the patients are evaluated for the need of relaparotomy based on clinical and paraclinical parameters.', 'armGroupLabels': ['Relaparotomy \"on-demand\"']}\n\nPrimary Outcomes:\n- {'measure': 'Primary endpoint is to compare peritonitis related complications and Comprehensive Complication Index (CCI) between NPWT treatment (VAC) and conventional treatment (ROD) at 30, 90 days and 1 year.', 'description': 'Disease-Related Major Morbidity Needing Readmission and Conservative Treatment but Not Surgery\\n\\n* Fistula\\n* Wound dehiscence/incisional hernia with obstruction\\n* Abscess needing percutaneous drainage\\n* Renal failure\\n* Myocardial infarction\\n* Gastric or duodenal bleeding\\n* Respiratory failure\\n* Urosepsis\\n\\nDisease-Related Major Morbidity Needing Surgical Intervention During First Admission or Readmission\\n\\n* Incisional hernia\\n* Bowel obstruction or herniation due to intra-abdominal adhesions\\n* Burst abdomen\\n* Abdominal compartment syndrome\\n* Fistula\\n* Intra-abdominal bleeding\\n* Intra-abdominal hematoma needing surgical evacuation\\n* Perforation of visceral organ confirmed at surgery\\n* Anastomotic leakage\\n* Ischemia or necrosis of a visceral organ\\n* Enterostomy dysfunction due to prolapse, stenosis, or retraction\\n* Gastric or duodenal ulcer bleeding needing intervention of any type', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nDesired power of 80%, significance level of 0.05, and an expected drop-out rate of 5%.", "answer": 340, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n With an expected peritonitis-related complications rate of 40% in the ROD group [20] and 25% in the VAC group [42, 44], the desired power of 80%, a significance level of 0.05, and an expected drop-out of 5%, a total of 340 patients should be included.\n As the CCI distribution in this group of patients is unknown, we could not perform an explicit sample size calculation for this secondary outcome. A 0.32 standard deviation difference in mean CCI between the two groups could be detected with 80% power with this sample size.\n To ensure sufficient recruitment, the study will be multicentre and European. Eight active centres have been included, and two are in process. Randomisation tools along with eligibility criteria are accessible through our website. The workflow and relevant contact details appear on posters at the participating departments. Study progress will be available on the website.", "id": 482, "split": "train"} +{"trial_id": "NCT03934931", "pmid": "32787925", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention: the 3HP Options Implementation Trial\n\nIncluded conditions:\n- Tuberculosis\n- Latent Tuberculosis\n- HIV/AIDS\n\nStudy Armgroups:\n- {'label': 'Facilitated Directly Observed Therapy (DOT)', 'type': 'EXPERIMENTAL', 'description': 'Facilitated DOT arm participants will attend the Mulago Immune Suppression Syndrome (ISS) clinic on a weekly basis to ingest 3HP medication under direct observation. DOT will be defined as a designated clinic staff member observing ingestion of each dose of 3HP. Additionally, participants randomized to facilitated DOT will receive: 1) DOT cards with instructions to present directly to the pharmacy for a pharmacy-only visit, without the need to wait in the general queue; 2) Automated short message service (SMS) or phone call reminders at no cost to participants the day before each appointment, 3) A fixed level of reimbursement (\\\\~$5/visit) for each weekly visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment.', 'interventionNames': ['Other: Streamlined weekly DOT visits', 'Other: Weekly DOT visit reminders', 'Other: Cost reimbursement DOT']}\n- {'label': 'Facilitated Self-Administered Therapy (SAT)', 'type': 'EXPERIMENTAL', 'description': 'Facilitated SAT participants will take their 1st dose of medication under direct observation and be given a 4-week 3HP supply to take weekly via self-administration. Participants will return to the Mulago ISS clinic after completing their 5th dose to review adherence data with the clinic pharmacy technician and receive 5 additional 3HP doses (doses 7-11). At the scheduled refill visit (dose 6) and end-of-treatment visit (dose 12) participants will ingest 3HP via direct observation. Participants will also receive: 1) Free automated SMS reminders or phone call reminders before each scheduled dose; 2) Weekly check-ins inquiring about side effects via two-way SMS with a follow-up phone call depending on participant response, 3) Fixed level of reimbursement (\\\\~$5/visit) for the refill/end-of-treatment visit, conditional on either directly observed therapy or evidence of an adverse event that would preclude further treatment.', 'interventionNames': ['Other: 99DOTS', 'Other: Weekly SAT dosing reminders/check-ins', 'Other: Cost reimbursement SAT']}\n- {'label': 'Patient Choice between facilitated DOT and facilitated SAT', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to the Patient Choice between facilitated DOT and facilitated SAT arm will be offered a choice between arms 1 and 2. A research nurse will review each section of the decision aid with participants, discuss values and preferences, and, after addressing any questions, ask participants to select facilitated DOT or facilitated SAT. Participants will have the option to switch between DOT and SAT at any time. The reason for switching and time spent under each strategy will be recorded.', 'interventionNames': ['Other: Streamlined weekly DOT visits', 'Other: Weekly DOT visit reminders', 'Other: Cost reimbursement DOT', 'Other: 99DOTS', 'Other: Weekly SAT dosing reminders/check-ins', 'Other: Cost reimbursement SAT']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Streamlined weekly DOT visits', 'description': 'Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects', 'armGroupLabels': ['Facilitated Directly Observed Therapy (DOT)', 'Patient Choice between facilitated DOT and facilitated SAT']}\n- {'type': 'OTHER', 'name': 'Weekly DOT visit reminders', 'description': 'Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits', 'armGroupLabels': ['Facilitated Directly Observed Therapy (DOT)', 'Patient Choice between facilitated DOT and facilitated SAT']}\n- {'type': 'OTHER', 'name': 'Cost reimbursement DOT', 'description': 'Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12)', 'armGroupLabels': ['Facilitated Directly Observed Therapy (DOT)', 'Patient Choice between facilitated DOT and facilitated SAT']}\n- {'type': 'OTHER', 'name': '99DOTS', 'description': '99DOTS-based digital adherence technology to monitor and promote adherence', 'armGroupLabels': ['Facilitated Self-Administered Therapy (SAT)', 'Patient Choice between facilitated DOT and facilitated SAT']}\n- {'type': 'OTHER', 'name': 'Weekly SAT dosing reminders/check-ins', 'description': 'Weekly SMS or IVR phone call dosing reminder/check-in for side effects', 'armGroupLabels': ['Facilitated Self-Administered Therapy (SAT)', 'Patient Choice between facilitated DOT and facilitated SAT']}\n- {'type': 'OTHER', 'name': 'Cost reimbursement SAT', 'description': 'Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12)', 'armGroupLabels': ['Facilitated Self-Administered Therapy (SAT)', 'Patient Choice between facilitated DOT and facilitated SAT']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of Participants Who Accepted and Completed 3HP', 'description': 'The count of eligible participants who accept treatment and take at least 11 of 12 once weekly doses of rifapentine (RPT)/isoniazid (INH) within 16 weeks of treatment initiation divided by the count of those randomized.', 'timeFrame': 'Within 16 weeks of treatment initiation'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha of 0.025, 5% loss between consent and allocation, power of 0.90 to detect the difference, and Bonferroni correction applied for two independent comparisons.", "answer": 1656, "answer_type": "ACTUAL", "explanation": "Sample size and power\n We estimated our sample size based on a minimum clinically important difference of 10% in 3HP completion, comparing patient choice vs. DOT arms. Of note, a similar study of 3HP delivery strategies chose a 15% non-inferiority margin between DOT and SAT based on cost-effectiveness modeling in the USA [15]. We chose 10% to be more conservative because similar modeling studies have not been done in low-income settings and because ours is not a non-inferiority design. To be maximally conservative, we applied a Bonferroni correction based on two independent comparisons (choice vs. DOT and choice vs. SAT). Assuming a two-sided alpha of 0.025 and 5% loss between consent and allocation, a sample size of 552 participants per arm (1656 total) is required to provide power of 0.90 to detect this difference. This sample size will also give us power of 0.85 to detect a point estimate of at least 80% effectiveness in the patient choice arm, assuming a true effectiveness of 85%. If the true effectiveness rises to 86%, our power to show effectiveness > 80% increases to 0.96.", "id": 483, "split": "train"} +{"trial_id": "NCT03935776", "pmid": "33581715", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Lifestyle and Risk Factor Modification on Occlusive Peripheral Arterial Disease Outcomes: Standard Healthcare vs Structured Programme\n\nIncluded conditions:\n- Peripheral Arterial Occlusive Disease\n\nStudy Armgroups:\n- {'label': 'Risk Factors Modification Programme', 'type': 'EXPERIMENTAL', 'description': '* Patients in the intervention arm will attend a 12-week intensive lifestyle programme.\\n* The intervention includes weekly exercise class and educational workshops, serial blood pressure, body mass index, glucose and lipid measurements.\\n\\n * Weekly multidisciplinary team meetings and targeted and protocol pharmacotherapy to support lifestyle changes.', 'interventionNames': ['Behavioral: Risk Factors Modification Programme']}\n- {'label': 'Standard Healthcare', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will receive information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan.', 'interventionNames': ['Behavioral: Standard Healthcare']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Risk Factors Modification Programme', 'description': '12- week supervised risk factor modification programme derived from the Euroaction study standards', 'armGroupLabels': ['Risk Factors Modification Programme']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard Healthcare', 'description': 'Patients are advised to adjust lifestyle without the support of the structured supervised programme', 'armGroupLabels': ['Standard Healthcare']}\n\nPrimary Outcomes:\n- {'measure': 'Lifestyle and medical risk factor modification', 'description': 'Achieving target Improvement in lifestyle risk factors. Target improvement will be considered if the patient achieves any one or more of the following:\\n\\n1. Smoking cessation\\n2. Body mass index 20-25 (kg/m\\\\^2). BMI is calculated by dividing body weight in kilograms by the square of height in meters\\n3. Glycosylated haemoglobin (HbA1c) less than 7%\\n4. Total Cholesterol less than 5.0 mmol/L', 'timeFrame': 'at 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nEighty percent statistical power and an alpha level of 5%", "answer": 208, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n For sample size calculation, the EUROACTION study [30] was used to estimate the coefficient of variation for sample proportions.\n Data from the EUROACTION [30] study suggest that 12-week intervention response rates for the primary endpoint of 54.8% (intervention programme) and 35.6% (usual care). Eighty percent statistical power and an alpha level of 5% were chosen. A two-sample comparison of proportions sample size calculation was implemented.\n With these parameters, the G*Power [31] software yields a trial with a maximum sample size of 208 patients completing the intervention (104 per intervention group).", "id": 484, "split": "train"} +{"trial_id": "NCT03937115", "pmid": "32493462", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effets de la tDCS Sur la Performance Sportive de 2 Profils d'athl\u00e8tes : Explosifs (Sauteurs de Haut Niveau et Amateur) et Endurants (Cyclistes de Haut Niveau et Amateur)\n\nIncluded conditions:\n- Healthy Volunteers\n- High-level Sportsman\n\nStudy Armgroups:\n- {'label': 'Group S1', 'type': 'EXPERIMENTAL', 'description': 'High level jump practice : more 4000 hours of practice during the last five years', 'interventionNames': ['Device: Active tDCS', 'Device: Sham tDCS']}\n- {'label': 'Group S2', 'type': 'EXPERIMENTAL', 'description': 'Amateur jump practice : less 4000 hours of practice during the last five years', 'interventionNames': ['Device: Active tDCS', 'Device: Sham tDCS']}\n- {'label': 'Group C1', 'type': 'EXPERIMENTAL', 'description': 'High level cycling practice: more 4000 hours of practice during the last five years', 'interventionNames': ['Device: Active tDCS', 'Device: Sham tDCS']}\n- {'label': 'Group C2', 'type': 'EXPERIMENTAL', 'description': 'Amateur cycling practice: less 4000 hours of practice during the last five years', 'interventionNames': ['Device: Active tDCS', 'Device: Sham tDCS']}\n- {'label': 'Group T', 'type': 'EXPERIMENTAL', 'description': 'Sedentary : less two hours of recreationally practice of sport by week', 'interventionNames': ['Device: Active tDCS', 'Device: Sham tDCS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Active tDCS', 'description': '2 active tDCS sessions (20 min each, 2 mA) applied to the dlPFC and right motor cortex', 'armGroupLabels': ['Group S1', 'Group S2'], 'otherNames': ['Starstim\u00ae (Neuroelectrics, Spain)']}\n- {'type': 'DEVICE', 'name': 'Sham tDCS', 'description': '1 sham tDCS session (20 min, 0 mA) applied to the dlPFC', 'armGroupLabels': ['Group S1', 'Group S2'], 'otherNames': ['Starstim\u00ae (Neuroelectrics, Spain)']}\n- {'type': 'DEVICE', 'name': 'Active tDCS', 'description': '10 tDCS sessions (2 sessions/day for 5 days, 20 mA, 20 min each) applied to the dlPFC', 'armGroupLabels': ['Group C1', 'Group C2', 'Group T'], 'otherNames': ['Starstim\u00ae (Neuroelectrics, Spain)']}\n- {'type': 'DEVICE', 'name': 'Sham tDCS', 'description': '10 tDCS sessions (2 sessions/day for 5 days, 0 mA, 20 min each) applied to the dlPFC', 'armGroupLabels': ['Group C1', 'Group C2', 'Group T'], 'otherNames': ['Starstim\u00ae (Neuroelectrics, Spain)']}\n\nPrimary Outcomes:\n- {'measure': 'Performance (in meters) measured during jumps', 'description': 'Performance measurement (in meters) during the three types of jumps (long jump, squat jump and countermovement jump) before and after tDCS session', 'timeFrame': 'Day 5'}\n\nPlease estimate the sample size based on the assumption: \nConsidering a significance level of 5%, a power of 90%, and a standard deviation for paired differences of 6.5.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our sample size calculation is based on the primary efficacy outcome that relates to changes in motor performance before and after a tDCS session during an explosive task (jumps). In a previous study, Lattari et al. [22] showed an 11.2% improvement in the height of the CMJ following a tDCS session, corresponding to a difference of 3.9\u00e2\u0080\u0089cm (Table 1 of Lattari\u00e2\u0080\u0099s et al.). We expect a 15% improvement in our study corresponding to a difference of 5.1\u00e2\u0080\u0089cm. No difference is expected in the sham tDCS group. Considering a significance level of 5%, a power of 90%, and a standard deviation for paired differences of 6.5 (calculated from standard deviations, page 21, Table 1 with an hypothesis of a covariance of measures of 50%), 20 jumpers are included to meet the objectives of the study. Sample size calculation was performed on PASS 13 Power Analysis and Sample Size Software (2014) [39, 40] .", "id": 485, "split": "train"} +{"trial_id": "NCT03938233", "pmid": "33020090", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Scalable Solution for Delivery of Diabetes Self-Management Education in Thailand\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'DSME program delivered by community health volunteers', 'type': 'ACTIVE_COMPARATOR', 'description': 'Randomisation will happen in 21 primary care units to offer DSME delivered by lay health workers to those newly diagnosed with diabetes and those having difficulties with self-managing their diabetes.', 'interventionNames': ['Behavioral: A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system']}\n- {'label': 'DSME program delivered by nurses', 'type': 'ACTIVE_COMPARATOR', 'description': 'Randomisation will happen in 21 primary care units to offer DSME delivered by nurses (for comparative effectiveness) to those newly diagnosed with diabetes and those having difficulties with self-managing their diabetes.', 'interventionNames': ['Behavioral: A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system']}\n- {'label': 'Usual care(no DSME program)', 'type': 'NO_INTERVENTION', 'description': 'Randomisation will happen in 21 primary care units where no DSME will be offered to those newly diagnosed with diabetes and/or those having difficulties with self-managing their diabetes.These patients will continue with usual care and will be assessed as the control group.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system', 'description': 'The intervention will be based on behaviour-change and social support theories, delivered in monthly group meetings by lay health workers or nurses, and aided by a suite of short films to introduce key topics and stimulate discussion.', 'armGroupLabels': ['DSME program delivered by community health volunteers', 'DSME program delivered by nurses']}\n\nPrimary Outcomes:\n- {'measure': 'Hemoglobin A1c levels (HbA1c)', 'description': 'HbA1c will measures the average blood glucose (sugar) levels months', 'timeFrame': '12 months'}\n- {'measure': 'Total cardiovascular risk', 'description': 'The cardiovascular risk will be estimated by Systemic Coronary Risk Evaluation. (SCORE) model. This is a range from 120 to 180 measuring systolic blood pressure (mmHq).', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nAn intraclass correlation coefficient of 0.02, a loss-to-follow-up rate of 20%, 80% power, and a 2.5% significance level.", "answer": 693, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The trial is powered to detect a difference in HbA1c of 0.6% (SD 1.5%) between control and intervention arms, based on the effect size of 0.6% noted in a previous diabetes management study in Thailand,21 and the fact that an increase in HbA1c of ~0.5% was associated with increased mortality among people with diabetes.22 An intraclass correlation coefficient between primary care units of 0.02 was assumed based on a similar study which found that the intraclass correlation for HbA1c at 3\u00e2\u0080\u0089years was 0.02 (95% CI 0.00 to 0.08).23 Allowing for a loss-to-follow up rate of 20%, 693 participants are needed from 21 primary care units (7 in each trial arm arm) to achieve 80% power at 2.5% significance level.", "id": 486, "split": "train"} +{"trial_id": "NCT03941613", "pmid": "34187524", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Stereotactic-EEG Guided Radio-frequency Thermocoagulation Versus Anterior Temporal Lobectomy for Mesial Temporal Lobe Epilepsy With Hippocampus Sclerosis\n\nIncluded conditions:\n- Epilepsy, Temporal Lobe\n\nStudy Armgroups:\n- {'label': 'Anterior temporal lobectomy', 'type': 'EXPERIMENTAL', 'description': 'surgical treatment for mTLE', 'interventionNames': ['Procedure: Anterior temporal lobectomy']}\n- {'label': 'SEEG guided RF-TC', 'type': 'ACTIVE_COMPARATOR', 'description': 'SEEG recording and minimal invasive treatment for mTLE', 'interventionNames': ['Procedure: SEEG guided RF-TC']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'SEEG guided RF-TC', 'description': 'SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.', 'armGroupLabels': ['SEEG guided RF-TC']}\n- {'type': 'PROCEDURE', 'name': 'Anterior temporal lobectomy', 'description': 'classical surgical treatment for mesial temporal lobe epilepsy, including the resection of neocortex for 5.5cm in non dominant hemisphere or 4.5cm in dominant hemisphere', 'armGroupLabels': ['Anterior temporal lobectomy']}\n\nPrimary Outcomes:\n- {'measure': 'Cognitive function', 'description': 'Full scaled Wechsler Adult Intelligence Quality IV Chinese edition (WAIS-IV-C), or Wechsler Children Intelligence Quality IV Chinese edition (WCIS-IV-C) Higher values represent a better outcome.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided 95% confidence interval, non-inferiority limit of 10%, expected withdraw rate of 20%.", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was calculated based on our previous experience (cognitive performance decrease of 25% after ATL), similar to findings reported in earlier studies [18]. Approximately 5% of patients exhibited decreased cognitive performance after SEEG-guided RF-TC in our previous series, while most previous studies have reported improvements or a lack of impairment [20\u00e2\u0080\u009322]. We expect to enrol 20 patients in each arm using a one-sided 95% confidence interval, a non-inferiority limit of 10%, and an expected withdraw rate of 20%. Thus, we aim to include a total of 40 patients in this trial. Patients will be recruited from outpatient and MDT with strict inclusion criteria.\n Participants will be replaced if they withdraw at any time prior to the final follow-up supervised by Dr Yong-Zhi Shan and Guo-Guang Zhao. Those who withdraw from the study during treatment because of specific medical or technical events will also be monitored and replaced. The trial conduct will be audited by the investigators with the whole MDT monthly.", "id": 487, "split": "train"} +{"trial_id": "NCT03946722", "pmid": "34716161", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer.\n\nIncluded conditions:\n- Adenomyosis\n\nStudy Armgroups:\n- {'label': 'Standard downregulation with GnRH analogue', 'type': 'OTHER', 'description': \"Participants in this arm will be assigned to the routine IVF protocol currently being used in the investigators' IVF unit, as outlined below, with one week of downregulation. Downregulation is the suppression of the ovaries during an IVF cycle in order to perform controlled ovarian stimulation and prevent premature ovulation.\\n\\nStart progesterone (Norethisterone 5mg twice daily orally) on day 14 of downregulation cycle and continue for 11 days. Start GnRH analogue (Buserelin 0.5ml subcutaneously once daily) on day 21 of downregulation cycle and reduce to 0.2ml on day 1 of bleed. Baseline scan on day 1 - 5 of bleed and start oestrogen (Progynova 2mg three times daily orally). Serial scanning from day 10 until endometrial thickness more than 8mm. Once endometrial thickness more than 8mm start progesterone (Cyclogest 400mg twice daily vaginally/rectally and Lubion 25mg twice daily subcutaneously) and proceed to embryo transfer on appropriate day for embryo age.\", 'interventionNames': ['Drug: GnRH analogue downregulation', 'Other: Participant questionnaire']}\n- {'label': 'Prolonged downregulation with GnRH analogue', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will be exposed to an additional five weeks of downregulation using a GnRH analogue. Downregulation is the suppression of the ovaries during an IVF cycle in order to perform controlled ovarian stimulation and prevent premature ovulation.\\n\\nBaseline scan on day 1-5 of bleed and administer GnRH analogue (Leuprorelin acetate 3.75 mg subcutaneously single injection). 28 days later administer second dose of GnRH analogue (Leuprorelin acetate 1.875 mg subcutaneously), and 21 days later start oestrogen (Progynova 2 mg three times daily orally). Serial scanning from day 10 of oestrogen until endometrial thickness more than 8mm. Once endometrial thickness more than 8mm start progesterone (Cyclogest 400mg twice daily vaginally/rectally and Lubion 25mg twice daily subcutaneously) and proceed to embryo transfer on appropriate day for embryo age.', 'interventionNames': ['Drug: GnRH analogue downregulation', 'Other: Participant questionnaire']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'GnRH analogue downregulation', 'description': 'Downregulation is the suppression of the ovaries during an IVF cycle in order to perform controlled ovarian stimulation and prevent premature ovulation.\\n\\nParticipants will be exposed to one week of downregulation using a GnRH analogue in the standard downregulation arm and 6 weeks of downregulation using a GnRH analogue in the modified downregulation arm.', 'armGroupLabels': ['Prolonged downregulation with GnRH analogue', 'Standard downregulation with GnRH analogue']}\n- {'type': 'OTHER', 'name': 'Participant questionnaire', 'description': 'Participant will be offered the opportunity to complete an adenomyosis symptom assessment questionnaire at the start of their treatment, and again two months after completion of treatment.', 'armGroupLabels': ['Prolonged downregulation with GnRH analogue', 'Standard downregulation with GnRH analogue']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical pregnancy rate', 'description': 'Clinical pregnancy is defined as an intrauterine pregnancy with a visible heart beat older than 6 weeks gestation.', 'timeFrame': '6 weeks after embryo transfer'}\n\nPlease estimate the sample size based on the assumption: \n80% power for detecting a 20% difference in the primary outcome at 5% significance level. Estimated prevalence of adenomyosis is 20.9% in benign gynaecology patients, with a higher prevalence among women seeking assisted conception with a history of subfertility.", "answer": 162, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our previous observational studies suggest a clinical pregnancy rate of 42.7% in women with mild adenomyosis compared with 22.9% with moderate/severe adenomyosis.7 We theorise that the modified protocol will improve the chance of clinical pregnancy to similar levels in those with mild disease. We need to randomise 162 patients over 3 years to achieve 80% power for detecting a 20% difference in the primary outcome across those groups at 5% significance.\n Adenomyosis has an estimated prevalence of 20.9% in benign gynaecology patients,2 we estimate higher prevalence among women seeking assisted conception with a history of subfertility. Given our yearly 750 cycles of IVF/ICSI, we estimate a recruitment period of 3 years to achieve our target sample size.", "id": 488, "split": "train"} +{"trial_id": "NCT03949088", "pmid": "32641335", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Integrated Strategies to Prevent Intradialytic Hypotension: a Prospective Randomized Cross-over Trial in Hypotension-prone Hemodialysis Patients (The DialHypot Study)\n\nIncluded conditions:\n- Hypotension During Dialysis\n- Dialysis Hypotension\n\nStudy Armgroups:\n- {'label': 'Linear descending UF profile', 'type': 'EXPERIMENTAL', 'description': '2-step descending Na profile, linear descending UF profile 3 weeks (9 sessions)', 'interventionNames': ['Other: UF and Na profiling']}\n- {'label': 'Run-in & washout phases', 'type': 'EXPERIMENTAL', 'description': 'constant Na concentration, constant UF rate 3 weeks (6+3 sessions)', 'interventionNames': ['Other: UF and Na profiling']}\n- {'label': 'Ascending/descending UF profile', 'type': 'EXPERIMENTAL', 'description': '2-step descending Na profile, ascending/descending UF profile 3 weeks (9 sessions)', 'interventionNames': ['Other: UF and Na profiling']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'UF and Na profiling', 'description': 'Modulation of UF and dialysate sodium', 'armGroupLabels': ['Ascending/descending UF profile', 'Linear descending UF profile', 'Run-in & washout phases']}\n\nPrimary Outcomes:\n- {'measure': 'Occurrence of intradialytic hypotensive episodes (number of episodes within every HD session and time interval from HD start)', 'description': 'Hypotensive events and symptoms (headache, cramps, nausea and vomiting) will be recorded and analyzed as both number of occurrences and time of occurrence from the beginning of the HD session.\\n\\nIDH will be defined as follows:\\n\\n* \"symptomatic IDH\": decrease in SBP \u2265 20 mmHg or in MAP \u2265 10 mmHg associated with symptoms (KDIGO definition)\\n* \"asymptomatic IDH\": drop in BP (SBP \u2265 20 mmHg or MAP \u2265 10 mmHg) within a 20 minutes interval, regardless of symptoms\\n* for patients whose SBP is \\\\< 100 mmHg at the beginning of treatment, the investigators will consider as IDH any decrease of SBP \u2265 10%', 'timeFrame': 'Within each dialysis session from the time of enrolment to the end of each study phase (9-11 weeks)'}\n\nPlease estimate the sample size based on the assumption: \n85% power, alpha level of 0.05, two-tailed test, correlation between paired observations ranges between 0.1 and 0.5, dropout rate of 20%.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size and assumptions\n Based on our preliminary data, assuming an incidence of hypotensive events of 4/9 of HD sessions with a classic (linear) UF profile, and a reduction in the incidence of IDH by 2/9 sessions with new (ascending/descending) UF profile, we estimated that at least 50 patients in a three-period three-treatment crossover trial would be needed to achieve 85% power to detect such difference between individualised ascending/descending UF profile and linear UF profile, with an alpha level of 0.05, using a two-tailed test if the correlation between paired observations ranges between 0.1 and 0.5. Therefore, we established a target sample of 60 patients, accounting for an approximate dropout rate of 20%.", "id": 489, "split": "train"} +{"trial_id": "NCT03949725", "pmid": "37875962", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Hans Kai Program for Canadian Adults Via an 18-month Mixed Methods Randomized Controlled Trial\n\nIncluded conditions:\n- Mental Health\n- Social Isolation\n- Loneliness\n- Health-Related Behavior\n\nStudy Armgroups:\n- {'label': 'Hans Kai program', 'type': 'EXPERIMENTAL', 'description': 'The Hans Kai program is a peer-led, preventative, self-sustaining, community-based health promotion program for adults of all ages, genders, and socioeconomic circumstances who wish to maintain or improve their health. Hans Kai empowers individuals to take control of their own health and provides a unique opportunity for participants to have an active role in improving or maintaining their health and wellbeing.', 'interventionNames': ['Behavioral: Hans Kai Program']}\n- {'label': 'Wait list control', 'type': 'NO_INTERVENTION', 'description': \"Participants in the waitlist control group will remain as close to a 'typical' community member as possible as they will be able to receive any health programming normally available to them in Winnipeg, except the Hans Kai program. Standard of care is made available to all members of the control group as related to the healthcare rights of Canadians and Manitobans holding a Manitoba health card. NorWest staff will provide support to the community members without a Manitoba health card in obtaining one. The only deviation from standard care in the waitlist control group will be the pre- and post-intervention visits during which the control participants will fill out self-report questionnaires and undergo physical assessments.\"}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Hans Kai Program', 'description': 'In Hans Kai, first, participants attend a 2-month Health School to develop the skills necessary to improve their health and wellbeing. The Health School includes sessions on health indicators; nutrition, grocery shopping and meal planning; physical activity; stress, coping, and health (sleep); and primary care through the years. After participants complete the Health School, they form Hans Kai groups (of 3 or more adults) and begin to meet regularly (at least once a month) independently of facilitators, in a self-sustaining model.', 'armGroupLabels': ['Hans Kai program']}\n\nPrimary Outcomes:\n- {'measure': 'Mental Health', 'description': 'Mental health will be measured using the Mental Health Continuum Short Form (MHC-SF). The MHC-SF is a standardized self-report questionnaire that measures emotional, social, and psychological well-being by assessing the regularity with which respondents experience symptoms of positive mental health. The questionnaire includes 14 items asking respondents to indicate on a 6-point Likert scale (ranging from 0 = never to 5 = everyday) how often in the previous month they experienced symptoms of emotional, social, and psychological wellbeing. Item responses are summed, yielding a total score ranging from 0 to 70, with higher scores indicating more positive wellbeing.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a standard deviation of 5 for normally distributed changes in MHC-SF scores, a significance level that provides 80% power, and a 15% dropout rate.", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary analysis will be performed based on the pre- to post-intervention changes in the primary outcome, the Mental Health Continuum Short Form (MHC-SF) [23], comparing the mean change scores between the intervention and control participants, with a nested design to account for participant group membership in Hans Kai [24]. Based on data from previous studies [4, 24] and the RCT study design, we expect the changes from baseline MHC-SF scores within each subject group to be approximately normally distributed with a standard deviation of 5. The average within-group pre-post changes in MHC-SF scores in the Hans Kai prospective cohort study were\u00e2\u0080\u0089+\u00e2\u0080\u00896.5 in 34 participants at 6\u00c2\u00a0months [18]. With a planned sample size that accounts for dropouts of 90 adults, with 60 intervention participants and 30 control participants, we would have a power of 80% to detect a true difference in the mean response of intervention and control participants of\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00893.1 or 3.1 at the end of the 6-month RCT component [25]. This scenario assumes that the outcomes of each participant will be independent of the Hans Kai peer group they join. However, since part of the Hans Kai program includes forming groups, a very conservative power calculation considers the \u00e2\u0080\u009ceffective\u00e2\u0080\u009d sample size for the Hans Kai program to be equal to the number of groups rather than the number of participants. We anticipate that 60 intervention participants will form 10 independent groups of six participants per group. In this very conservative scenario, with 10 groups in the intervention arm and 30 control participants, we would be able to detect a true difference in the mean scores of intervention and control participants of\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00895.2 or 5.2 with 80% power. We believe that the actual study power will fall somewhere between the two scenarios presented here. With a starting sample size of 105 adults and an estimated 15% dropout rate during the study period [18], we expect to generate a minimum sample of approximately 90 participants at the 18-month follow-up.", "id": 490, "split": "train"} +{"trial_id": "NCT03951311", "pmid": "35501092", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Estimation of Metabolic Abnormalities,Lifestyle Behaviors and Diet Pattern in Adults With Heart Failure\n\nIncluded conditions:\n- Heart Failure\n- Metabolic Disease\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'a composite of cardiovascular mortality or hospitalization due to subjectively and objectively worsening HF', 'description': \"An independent committee of experts including three physicians reviews all the death certificates and medical records for adjudicating the death cases and all suspected CVD cases biennially from the index episode, via telephone contacting patients' family members or reviewing medical records and the Hospital Discharge Register data.\", 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \n5% loss to follow-up, two-sided alpha level of 0.05, >80% power, two-sided Z test", "answer": 1500, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n We use data of previous cohort studies of lifestyle behaviours in patients with chronic HF to determine the sample size. The sample size is calculated with the estimate of an 25.9% mortality in patients with HF without alcohol consumption,28 the estimate of an 37% mortality in patients with HF without exercise prescription.29 Assuming a 5% loss to follow-up,30 a two-sided alpha level of 0.05, we calculate that the study will have >80% power to detect a 20% reduction in mortality with a total number of 1500 patients, using the two-sided Z test. If the sample size cannot be fulfilled during the study time frame, the recruitment period will be extended. Sample size calculations are performed using PASS 15 (NCSS, Kaysville, Utah, USA).", "id": 491, "split": "train"} +{"trial_id": "NCT03951350", "pmid": "33372070", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Cost-effectiveness of a Lifestyle Modification Program in the Prevention and Treatment of Subclinical, Mild and Moderate Depression in Primary Care: A Randomized Clinical Trial Protocol\n\nIncluded conditions:\n- Depression\n\nStudy Armgroups:\n- {'label': 'Control (TAU)', 'type': 'NO_INTERVENTION', 'description': 'Patients will follow the usual treatment provided by their GP (treatment-as-usual, TAU).'}\n- {'label': 'Lifestyle Modification Program (LMP)', 'type': 'EXPERIMENTAL', 'description': 'It will consist of 6 weekly group sessions (lasting 90 minutes each).', 'interventionNames': ['Behavioral: Lifestyle Modification Program (LMP)', 'Behavioral: Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)']}\n- {'label': 'Lifestyle Modification Program (LMP) + ICTs', 'type': 'EXPERIMENTAL', 'description': 'It will consist of 6 weekly group sessions (lasting 90 minutes each).', 'interventionNames': ['Behavioral: Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Lifestyle Modification Program (LMP)', 'description': 'Patients will follow TAU and LMP. This program will consist of 6 weekly group sessions (lasting 90 minutes each) led by an experienced psychologist and complemented by PowerPoint presentations. The content is the following:\\n\\n1. Presentation of the project and psychoeducation on depression.\\n2. Behavior activation.\\n3. Sleep hygiene habits and careful exposure to sunlight.\\n4. Physical activity.\\n5. Adherence to the Mediterranean diet.\\n6. Summary of previous sessions with practical final suggestions.', 'armGroupLabels': ['Lifestyle Modification Program (LMP)']}\n- {'type': 'BEHAVIORAL', 'name': 'Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)', 'description': 'Patients will follow TAU and LMP and will be monitored using a wearable smart wristwatch that will track their daily sleep patterns and physical activity (LMP+ICTs).', 'armGroupLabels': ['Lifestyle Modification Program (LMP)', 'Lifestyle Modification Program (LMP) + ICTs']}\n\nPrimary Outcomes:\n- {'measure': 'Beck II Self-Applied Depression Inventory (BDI-II)', 'description': 'The primary outcome will be measured using the BDI-II (Beck et al., 1996). This is a self-report inventory for measuring the severity of depression, consisting of 21 multiple-choice questions with each answer being scored on a scale ranged from 0 to 3. It was translated and validated into Spanish with a reliability of .89 (Sanz et al., 2005). The standardized cutoffs are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.', 'timeFrame': 'Change from baseline, immediately after the intervention and at six and 12-month follow-up.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, power (\u03b2) of 0.20, and an estimated withdrawal rate of 20%.", "answer": 159, "answer_type": "ACTUAL", "explanation": "Sample size\n Scientific evidence suggests that a 17% reduction in the BDI-II34 is considered clinically relevant.36 In a previous study conducted by our team with psychiatric outpatients, we found that the average BDI score at the beginning of the study was 24.5 points (SD 9.8),22 so we consider that a reduction of at least 4.8 points would have clinical significance and would benefit the patient. Accepting an \u00ce\u00b1 risk of 0.05 and a \u00ce\u00b2 risk of 0.20 in a bilateral contrast, 44 subjects will be required for each group. With an estimated withdrawal rate of 20%, the sample size will require approximately 53 patients in each group. The total sample required is 159 subjects. A formula based on the Snedecor\u00e2\u0080\u0099s F distribution37 has been used (see online supplemental file 2). It is estimated that approximately 50% of these patients will present some physical or mental comorbidity.12\n \n 10.1136/bmjopen-2020-038457.supp2\n Supplementary data", "id": 492, "split": "train"} +{"trial_id": "NCT03952676", "pmid": "32102679", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Evaluation of Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial\n\nIncluded conditions:\n- Plaque Psoriasis\n\nStudy Armgroups:\n- {'label': 'Moving cupping intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will received moving cupping therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment.', 'interventionNames': ['Device: Moving cupping']}\n- {'label': 'Moving cupping placebo control', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will received moving cupping placebo therapy once a week for 4 weeks.In addition, participants will receive basic treatment, including the use of moisturizing lotion, avoid induction and aggravating factors, proper bathing to clean the skin, reasonable lifestyle and treatment.', 'interventionNames': ['Device: Moving cupping placebo']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Moving cupping', 'description': \"1. We use a black opaque eye mask to shield the patient's eyes and choose different sizes of cup according to the location of the treatment (There are three sizes of cups)\\n2. (1) First apply Vaseline to the skin lesions area; (2) Then hold the 95% ethanol cotton ball with tweezers, and hold the cup with the facing down, after the cotton ball is ignited, immediately sway down in the cup and then exit, and quickly buckle the cup to the skin lesions area. (3) After using the cup to absorb the skin lesions area, hold the cup body in one hand and push and pull the cup along the certain route with a little strength, so that the skin purple color of the treatment area is suitable. (4) Apply even force when pushing the cup to prevent the cup from falling off due to air leakage. (5) Acting on the skin lesions area 30 times, change cup 5 times per push and pull, the interval is not more than 10 seconds.\", 'armGroupLabels': ['Moving cupping intervention']}\n- {'type': 'DEVICE', 'name': 'Moving cupping placebo', 'description': 'Using of special perforated cups, the manipulation method is the same as the intervention group.', 'armGroupLabels': ['Moving cupping placebo control']}\n\nPrimary Outcomes:\n- {'measure': 'Psoriasis area and severity index (PASI)', 'description': 'Psoriasis Area and Severity Index (PASI) involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - \\\\<10%, 2 - 10-\\\\<30%, 3 - 30-\\\\<50%, 4 - 50-\\\\<70%, 5 - 70-\\\\<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.', 'timeFrame': 'Up to 56 days after treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) was 0.05 and the power was 0.8 (\u03b2 = 0.2). A 20% loss to follow-up was assumed.", "answer": 122, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size of the current trial was calculated based on the following formula [33]:\n\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ {\\mathrm{n}}_1={\\mathrm{n}}_2=\\frac{p_1\\times \\left(1-{p}_1\\right)+{p}_2\\times \\left(1-{p}_2\\right)}{{\\left({p}_2-{p}_1\\right)}^2}\\times {\\left({\\mu}_{\\alpha /2}+{\\mu}_{\\beta}\\right)}^2 $$\\end{document}n1=n2=p1\u00c3\u00971\u00e2\u0088\u0092p1+p2\u00c3\u00971\u00e2\u0088\u0092p2p2\u00e2\u0088\u0092p12\u00c3\u0097\u00ce\u00bc\u00ce\u00b1/2+\u00ce\u00bc\u00ce\u00b22\n According to recently published clinical trial results [27], the PASI-50 reached 62.1% (P1) in the study group and 35.3% in the control group (P2). Therefore, we assumed that the inspection level (\u00ce\u00b1) was 0.05 and the power was 0.8 (\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00891-power\u00e2\u0080\u0089=\u00e2\u0080\u00890.2). For the two-sided tests, 51 participants will be required for each group. Given a 20% loss to follow-up, we expect to require 61 participants for each group. Therefore, this trial will require at least 122 participants.", "id": 493, "split": "train"} +{"trial_id": "NCT03960255", "pmid": "31848165", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective Exploration of the Effect of Adiposity and Associated Microbial Factors on the Healing and Progression of Diabetic Foot Ulcers in Tanzania\n\nIncluded conditions:\n- Diabetic Foot Ulcer\n\nStudy Armgroups:\n- {'label': 'Normal adiposity group', 'description': 'Body fat \\\\< 25% and \\\\<32% in men and women respectively, will be categorized as high adiposity. This is according to the The American Council on Exercise criteria.', 'interventionNames': ['Other: Normal standard care']}\n- {'label': 'High adiposity group', 'description': 'Body fat \u2265 25% and \u226532% in men and women respectively, will be categorized as high adiposity. This is according to the The American Council on Exercise criteria.', 'interventionNames': ['Other: Normal standard care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Normal standard care', 'description': 'Both groups will receive standardized treatment and care for diabetic foot ulcers', 'armGroupLabels': ['High adiposity group', 'Normal adiposity group']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion (%) of patients with complete wound healing at 24 weeks', 'description': 'Complete healing will be defined based on the criteria of the wound healing society, as 100% re-epithelialization of the wound surface (complete wound closure) with a complete absence of drainage.', 'timeFrame': '24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 80% with a 95% confidence interval. A maximum of 20% loss to follow-up is assumed, considering competing risks such as lower limb amputation and death.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size calculations and analysis plan\n \n \n \nSample size calculation: We estimated the required sample size based on power calculations. A 20% difference in DFU healing at 24 weeks, between the high and normal adiposity groups will be considered as a clinically meaningful difference. To attain a power of 80% at 95% CI and aiming to recruit equal numbers of patients with DFU in the two groups (normal and high adiposity), a total sample size of 188 subjects is required. This calculation is based on the assumptions that the proportions (cumulative incidences) of complete wound healing at 24 weeks in normal and high adiposity groups are 55% and 35%, respectively. This assumption was based on clinical records of patients with complete wound healing at 24 weeks, who were attending DFU clinics in Dar es Salaam (unpublished data). These patients were predominantly overweight and obese hence the proportion (35%) has been used for the high adiposity group. Assuming a maximum of 20% loss to follow-up and considering the presence of competing risks (lower limb amputation and death) we plan to recruit a total of 300 patients with DFU (150 in each group) to maintain the power that might be weakened by a decrease in sample size due to loss to follow-up, and also to maintain the effect size that might be affected by competing risks (lower limb amputation and death).\n \n \n \nPrimary outcome analysis: The cumulative incidence competing risk method will be used. This method takes into account all the different events/outcomes that may affect the outcome of interest,66 in this case, amputation and death.\n At 24 weeks, we will summarise the outcome of categorised study participants (normal and raised adiposity groups) by using the proportions of complete wound healing in the two groups. These proportions will be estimated from the cumulative incidence (rate) of healing at 24 weeks (with death and amputation as competing risks) and compare the incidences (proportions) between normal and raised adiposity groups (using \u00cf\u00872 or Grey\u00e2\u0080\u0099s test).67 In this regard healing estimates and cumulative incidence curves of the time to healing, in the presence of competing risks will be provided with 95% CIs. Participants who will not experience any adverse event (amputation or death) before and at the end of initial follow-up (24 weeks) will be censored.\n To find out whether there is any significant difference in healing between patients with normal and those with high adiposity, we will use the subdistribution proportional hazards mode in a multivariate survival analysis to compare the two groups by examining the difference in the hazards of healing between normal and high adiposity groups (adjusting for known covariates including baseline ulcer characteristics that describe severity including ulcer surface area, stage, presence of infection and others). Similar analysis will be done to compare the outcome of grouped study participants based on ulcer-related events that are our secondary end points (outcome measures).\n \n \n \nDescriptive analysis: Exploratory analysis beyond the primary study design will be done among the incident cases at baseline and different follow-up points.\n Descriptive and inferential statistics will be used to determine the characteristics of DFUs in patients with T2DM. Measured variables will include type and load/density of microorganisms and their characteristics (dominance, diversity and antimicrobial sensitivity pattern). Related factors are systemic factors such as adiposity, circulatory insufficiency, impaired LBM, poor glycaemic control and behavioural characteristics like cigarette smoking, dietary habits and physical activity type/levels. Local factors including ulcer types/grades/classes will also be considered. Univariate analysis that includes measures of distribution, central tendency and dispersion will be used. Frequency of occurrences of different types and characteristics of microorganisms will be measured using proportions/means/median and compared using appropriate statistical tests, depending on the nature of the analysed data (t-test, analysis of variance and \u00cf\u00872).\n Linear and logistic regression models will also be used to determine systemic factors that predict or explain local DFU characteristics for continuous and categorical data, respectively.\n \n \n \nPredictive validity testing: Given its longitudinal nature, this study will offer an opportunity to evaluate the utility/ability of various assessment methods (physical examination, ABI, TBI, PVR and combined ABI and PVR) in predicting wound healing in an African population. We will calculate sensitivity and specificity of different methods (feeling peripheral pulses and ABI with PVWs) against ulcer outcomes (healed or not healed) at different follow-up points. Both independent and combined validity of ABI and PVW will be evaluated against ulcer outcomes. The receiver operating characteristics curve will be used to compare the diagnostic performance of the different assessment methods in predicting wound healing and also to set up reasonable cut-off points for the different tests.\n Sensitivity, specificity, positive and negative predictive values, as well as accuracy will be calculated.", "id": 494, "split": "train"} +{"trial_id": "NCT03960801", "pmid": "33785069", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessment of Remifentanil for Rapid Sequence Induction and Intubation in Full Stomach Patient Compared to Muscle Relaxant. A Non-inferiority Simple Blind Randomized Controlled Trial\n\nIncluded conditions:\n- Intra-tracheal Intubation\n\nStudy Armgroups:\n- {'label': 'Remifentanil group', 'type': 'EXPERIMENTAL', 'description': 'bolus intravenous injection of 3 to 4\u00b5g/kg of remifentanil after hypnotic administration for a crush anesthetic induction', 'interventionNames': ['Drug: Remifentanil group']}\n- {'label': 'Neuromuscular blockade group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction', 'interventionNames': ['Drug: neuromuscular blockade group']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Remifentanil group', 'description': 'bolus intravenous injection of 3 to 4\u00b5g/kg of remifentanil after hypnotic administration for a crush anesthetic induction', 'armGroupLabels': ['Remifentanil group']}\n- {'type': 'DRUG', 'name': 'neuromuscular blockade group', 'description': 'Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction', 'armGroupLabels': ['Neuromuscular blockade group']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of tracheal intubation without major complication', 'description': 'Primary endpoint is the rate of tracheal intubation without major complications as defined by\\n\\n1. tracheal intubation with less than 2 laryngoscopies\\n2. no aspiration during the 10 minutes after induction\\n3. no desaturation under 95% during the 10 minutes after induction\\n4. no hypo or hypertension as defined by a MAP\\\\<50mmHg or \\\\>110mmHg\\n5. no ventricular arrhythmia involving an emergency treatment or cardiac arrest during the 10 minutes after induction\\n6. no grade III or IV anaphylactic reaction during the 10 minutes after induction', 'timeFrame': 'Day 7 from randomization'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, alpha risk of 2.5%.", "answer": 1150, "answer_type": "ACTUAL", "explanation": "Sample size\n The proportion of successful tracheal intubation without any major complications is the primary outcome. In previous studies, the proportion of rapid sequence induction of general anesthesia with a rapid-onset paralytic agent without major complications ranged between 70 and 92%, depending on the studies and definitions [19\u00e2\u0080\u009321]. It is also recommended to set non-inferiority margins lower than a 10% relative difference between the intervention and control groups [22]. Assuming an 80% rate of tracheal intubation without major complication in the rapid-onset paralytic agent group, and given the potential benefit of avoiding the use of rapid paralytic agents, we deemed it medically acceptable to set the non-inferiority margin to an absolute difference of 7% (8.75% relative difference). We thus calculated that a total of 1150 patients (575 patients per group) was needed to demonstrate the non-inferiority of the intervention with a statistical power of 80% an alpha risk of 2.5.", "id": 495, "split": "train"} +{"trial_id": "NCT03962231", "pmid": "33310803", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rotator Cuff Unloading Versus Loading Exercise Program in Patients With Shoulder Pain and Rotator Cuff Tear: a Randomized Clinical Trial\n\nIncluded conditions:\n- Shoulder Pain\n- Rotator Cuff Injuries\n- Rehabilitation\n\nStudy Armgroups:\n- {'label': 'Rotator Cuff Unloading Exercise Program', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in this group will perform semi-closed kinetic chain elevation exercises, deltoid re-education exercises, assisted arm elevation and scapula control exercises.', 'interventionNames': ['Other: Rotator Cuff Unloading Exercise Program']}\n- {'label': 'Rotator Cuff Loading Exercise Program', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in this group will perform conventional exercises with focus on lateral rotation, medial rotation and arm elevation.', 'interventionNames': ['Other: Rotator Cuff Loading Exercise Program']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Rotator Cuff Unloading Exercise Program', 'description': 'Patients in this group will perform semi-closed kinetic chain elevation exercises, deltoid reeducation exercises, assisted arm elevation and scapular control exercises.', 'armGroupLabels': ['Rotator Cuff Unloading Exercise Program']}\n- {'type': 'OTHER', 'name': 'Rotator Cuff Loading Exercise Program', 'description': 'Patients in this group will perform conventional exercises focusing on lateral rotation, medial rotation and arm elevation.', 'armGroupLabels': ['Rotator Cuff Loading Exercise Program']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Quality of Life at 12 weeks and 1 month (follow-up) - The Western Ontario Rotator Cuff Index (WORC)', 'description': 'The Western Ontario Rotator Cuff Index (WORC) contains 21 questions distributed in five domains, each question can be scored between 0 and 100 on the Analogic visual scale. The final result of WORC varies from 0 to 2100, higher value indicates worse the quality of life of the individual.', 'timeFrame': 'Pre (baseline) treatment, post treatment (12 weeks) and after 1 month (follow-up)'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level of 5%, and a 15% drop-out rate", "answer": 78, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was based on the smallest significant difference of 282.6 points from the WORC40 with an standard deviation of 400 points, a power of 80%, and a significance level of 5%. WORC was selected because it evaluates the quality of life of individuals with rotator cuff disease. Accounting for a 15% drop-out, 78 subjects will be included in the study, randomly allocated to two treatment groups: Rotator Cuff Unloading Exercise Programme (n=39) and Rotator Cuff Loading Exercise Programme (n=39).", "id": 496, "split": "train"} +{"trial_id": "NCT03962335", "pmid": "32517729", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ModulAtion of Gut Microbiota Through Nutritional Interventions in Behcet's Syndrome pAtients: the MAMBA Study\n\nIncluded conditions:\n- Behcet Syndrome\n\nStudy Armgroups:\n- {'label': 'VD group', 'type': 'EXPERIMENTAL', 'description': 'Group that starts with Vegetarian diet (VD)', 'interventionNames': ['Behavioral: Vegetarian diet', 'Behavioral: Mediterranean diet with butyrate', 'Behavioral: Mediterranean diet']}\n- {'label': 'MD+Bt group', 'type': 'EXPERIMENTAL', 'description': 'Group that starts with Mediterranean diet with oral supplementation with butyrate (MD+Bt)', 'interventionNames': ['Behavioral: Vegetarian diet', 'Behavioral: Mediterranean diet with butyrate', 'Behavioral: Mediterranean diet']}\n- {'label': 'MD group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Group that starts with Mediterranean diet (MD)', 'interventionNames': ['Behavioral: Vegetarian diet', 'Behavioral: Mediterranean diet with butyrate', 'Behavioral: Mediterranean diet']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Vegetarian diet', 'description': '7-days dietary profile with a Vegetarian diet (VD), containing inulin and resistant starch-rich foods and including no meat and fish, but containing eggs and dairy, for 3 months', 'armGroupLabels': ['MD group', 'MD+Bt group', 'VD group'], 'otherNames': ['VD']}\n- {'type': 'BEHAVIORAL', 'name': 'Mediterranean diet with butyrate', 'description': '7-days dietary profile with Mediterranean diet with oral supplementation with butyrate (MD+Bt), 2 g/day, for 3 months', 'armGroupLabels': ['MD group', 'MD+Bt group', 'VD group'], 'otherNames': ['MD+Bt']}\n- {'type': 'BEHAVIORAL', 'name': 'Mediterranean diet', 'description': '7-days dietary profile with Mediterranean diet (MD), including 2 portions per week of fish and 3 portions per week of fresh and processed meat (2 of which fresh or processed red meat), for 3 months', 'armGroupLabels': ['MD group', 'MD+Bt group', 'VD group'], 'otherNames': ['MD']}\n\nPrimary Outcomes:\n- {'measure': 'Disease severity of Behcet syndrome assessed by Behc\u0327et Disease Current Activity Form', 'description': 'The disease activity will be assessed by the use of the validated Behc\u0327et Disease Current Activity Form (BCDAF), at the baseline and after the dietary intervention. The BCDAF will assess the presence of oral and genital ulceration, skin, joint and gastrointestinal involvement, presence of fatigue and headache with a 5-point scale according to the duration of symptoms, with 0 meaning no symptoms and 4 meaning symptoms for 4 weeks. The presence of eyes, large vessels or central nervous system (CNS) involvement are document with \"yes/no\" answers. In addition, patients will be asked to rate on a 7-point scale how active they felt. Similarly, the clinicians will complete a 7-rating scale to assess their opinion of overall activity of the disease, with lower scores representing better outcomes.', 'timeFrame': '1 year'}\n- {'measure': \"Behcet disease's improvement of symptoms assessed by the Global Assessment of Improvement Scale (GAI) modified form\", 'description': 'The Global Assessment of Improvement Scale (GAI) modified form will assess Behcet disease\\'s improvement of symptoms using a 7-point scale, with higher scores meaning an improvement of the symptoms. The severity of abdominal pain, severity of abdominal distention, satisfaction with bowel habits, severity of headache, severity of exhaustion, severity of nausea, attention disorder, muscle/joint pain, and quality of life will be investigated in response to the following question: \"Compared to the way you felt before you entered the study, have your symptoms over the past 7 days been: 1) \"Substantially Worse\", 2) \"Moderately Worse, 3) \"Slightly Worse\", 4) \"No Change\", 5) \"Slightly Improved\", 6) \"Moderately Improved\" or 7) \"Substantially Improved\".', 'timeFrame': '1 year'}\n- {'measure': \"Behcet disease's severity of gastrointestinal symptoms assessed by the Symptom Severity Scale (SSS) modified form\", 'description': \"The Symptom Severity Scale (SSS) modified form is a multidimensional rating scale assessing overall symptoms' severity on a Visual Analogue Scale (VAS). An overall score will be calculated from six items: pain severity, pain frequency, abdominal bloating, bowel habit dissatisfaction, abdominal heaviness, and life interference. The modified SSS ranges from 0 to 600, with higher scores meaning more severe symptoms.\", 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \npower of 80% (beta), significance level (alpha) of 0.05, and allowance for non-compliance and loss to follow-up", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Due to the lack of dietary intervention trials on BS and to the fact that gastrointestinal symptoms are quite similar in BS and inflammatory bowel disease, based on a previously published trial [24], a sample size of 80 individuals with BS is required to achieve power of 80% (beta) with alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, to detect a 50-point difference in the mean of SSS (the primary outcome), between VD and MD interventions. We will recruit an extra 10 volunteers (for a total of 90), as we assume that not all individuals would be compliant with the treatments and in case of loss to follow up. Losses will be included in the intention-to-treat but not in the per-protocol analyses.", "id": 497, "split": "train"} +{"trial_id": "NCT03965299", "pmid": "32792454", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transcutaneous Tibial Nerve Stimulation in Patients with Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity: a Nationwide Randomised, Sham-controlled, Double-blind Clinical Trial\n\nIncluded conditions:\n- Spinal Cord Injury, Acute\n\nStudy Armgroups:\n- {'label': 'VERUM transcutaneous tibial nerve stimulation (TTNS)', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: VERUM TTNS']}\n- {'label': 'SHAM transcutaneous tibial nerve stimulation (TTNS)', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Device: SHAM TTNS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'VERUM TTNS', 'description': '* Daily 30-minute TTNS intervention is performed 5 days a week during a treatment period of 6-9 weeks, until 3-month post assessments\\n* During a preparation phase of several minutes, sensory and motor thresholds are assessed and stimulation intensities are adjusted for the following 30-minute treatment phase', 'armGroupLabels': ['VERUM transcutaneous tibial nerve stimulation (TTNS)']}\n- {'type': 'DEVICE', 'name': 'SHAM TTNS', 'description': '* Daily 30-minute SHAM intervention is performed 5 days a week during a treatment period of 6-9 weeks, until 3-month post assessments\\n* During a preparation phase of several minutes, sensory and motor thresholds are assessed and stimulation intensities are adjusted for the following 30-minute treatment phase', 'armGroupLabels': ['SHAM transcutaneous tibial nerve stimulation (TTNS)']}\n\nPrimary Outcomes:\n- {'measure': 'The occurrence of neurogenic DO jeopardizing the upper urinary tract', 'description': 'Defined as composite measure: Urodynamic assessment establishing DO amplitude \u226540 cmH2O; or else initiation of DO treatment (with antimuscarinics and/or intradetrusor onabotulinumtoxinA injections)', 'timeFrame': 'up to 12 months after SCI'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, type I error probability of 0.05, and a continuity correction for binary outcome variable to avoid type I error inflation.", "answer": 114, "answer_type": "ESTIMATED", "explanation": "Sample size\n Presuming a proportion of spontaneous success among the sham group of 0.15,23 114 participants (57 verum, 57 sham) need to be included to detect a difference of 0.25 in the proportion of participants who develop NDO, and thereby to correctly reject the null hypothesis with a probability (power) of 0.8. The type I error probability associated with the test of this null hypothesis is 0.05. Since the primary outcome variable is binary, this sample size analysis included a continuity correction to avoid type I error inflation.\n Using prospective data collected by the SwiSCI inception cohort for the years 2014\u00e2\u0080\u00932016 and applying a modified version of the TASCI inclusion/exclusion criteria, a total of 193 eligible patients are predicted during the 3-year recruitment period of TASCI. Anticipating a recruitment rate of 66%, this implies that the requisite 114 participants can be included within 3 years. Expected participant numbers per centre during the study period are 20 for Basel, 42 for Nottwil, 13 for Sion and 39 for Z\u00c3\u00bcrich. Moreover, these data imply that participants who withdraw or drop out can be replaced.", "id": 498, "split": "train"} +{"trial_id": "NCT03966781", "pmid": "32299454", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Single-blinded, Single-center, Parallel-group, Sham-controlled, Prospective Trial of Combined Extracorporeal Shock Wave Lithotripsy and Endotherapy for Pain in Chronic Pancreatitis\n\nIncluded conditions:\n- Chronic Pancreatitis\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'ESWL followed by ERCP', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients enrolled in the active treatment group will be subjected to ESWL followed by ERCP and pancreatic duct stenting.', 'interventionNames': ['Procedure: ESWL', 'Procedure: ERCP']}\n- {'label': 'Sham ESWL followed by sham ERCP', 'type': 'SHAM_COMPARATOR', 'description': 'Patients enrolled in the sham treatment group will be subjected to sham ESWL followed by sham ERCP with no pancreatic duct intervention.', 'interventionNames': ['Procedure: Sham ESWL', 'Procedure: Sham ERCP']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'ESWL', 'description': \"ESWL will be conducted under epidural anesthesia. For epidural anesthesia, bupivacaine will be used to block the T6-T12 spinal segments. The patient's eyes will be lightly covered all along the procedure. Once epidural anesthesia is achieved, the patient will be given a light sedation and ESWL will be performed using a Dornier dual focus lithotripsy system providing a maximum of 5000 at the rate of 90 shocks per minute in over 1-2 days.\", 'armGroupLabels': ['ESWL followed by ERCP']}\n- {'type': 'PROCEDURE', 'name': 'ERCP', 'description': 'Once ESWL is over, an endoscopic pancreatic sphincterotomy will be performed and complete stone removal will be attempted with subsequent stenting of the pancreatic duct in the presence of a pancreatic stricture (not detected on MRCP prior to enrolment) or in case of incomplete stone removal', 'armGroupLabels': ['ESWL followed by ERCP']}\n- {'type': 'PROCEDURE', 'name': 'Sham ESWL', 'description': 'In the sham/control group, patients will be given a transient superficial pin-prick sensation to give the feel of epidural anesthesia. After that the lithotripsy machine the will be switched on, without establishing any form of contact with the patients body.', 'armGroupLabels': ['Sham ESWL followed by sham ERCP']}\n- {'type': 'PROCEDURE', 'name': 'Sham ERCP', 'description': 'Following sham ESWL patientswill be subjected to sham ERCP to examine the papillary area, but no pancreatic ductal intervention will be performed.', 'armGroupLabels': ['Sham ESWL followed by sham ERCP']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline pain score at 3 months', 'description': 'The primary clinical endpoint is pain relief. Average and maximal daily clinical pain intensity scores will be recorded in a patient pain diary based on a 0-10 visual analogy scale (VAS), with registration of the baseline pain intensity scores the week prior to intervention and weekly recordings continued for a 3 months period after intervention. Mean values of pain scores will be calculated over 1 week to adjust for day-to-day variability in pain intensity. The difference in pain scores between patients receiving active treatment (ESWL and ERCP) and sham treatment are compared, with the primary comparison of average pain scores 3 months after intervention. Weekly telephone interviews from a study co-ordinator will be undertaken to facilitate accurate registration and compliance pain score).', 'timeFrame': '3 months after intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for a power of 90% with a two-sided significance level of 0.05 and accounts for a 10% dropout rate.", "answer": 106, "answer_type": "ACTUAL", "explanation": "Sample size determination\n The study is powered to detect a minimal difference between groups of 30% in the average clinical pain score 3\u00e2\u0080\u0089months after intervention [34]. On the basis of an assumed SD of 45%, we determine that a study with 48 patients per group is needed to provide power of 90% (to allow secondary endpoints) with the use of a two-sided significance level of 0.05 [35]. To allow a 10% dropout rate, the sample size is set at 106 patients.", "id": 499, "split": "train"} +{"trial_id": "NCT03968224", "pmid": "32059692", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of the Treatment With Dapagliflozin and Metformin Compared to Metformin Monotherapy for Weight Loss on Diabetic and Prediabetic Patients With Obesity Class III\n\nIncluded conditions:\n- PreDiabetes\n- Obesity, Morbid\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'Metformin/Dapagliflozin', 'type': 'EXPERIMENTAL', 'description': 'Metformin 1,700 mg/day and Dapagliflozin 10 mg/day for a year.', 'interventionNames': ['Drug: Dapagliflozin/Metformin']}\n- {'label': 'Metformin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Metformin 1,700 mg/day', 'interventionNames': ['Drug: Metformin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dapagliflozin/Metformin', 'description': 'Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.', 'armGroupLabels': ['Metformin/Dapagliflozin'], 'otherNames': ['Group 1']}\n- {'type': 'DRUG', 'name': 'Metformin', 'description': 'Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.', 'armGroupLabels': ['Metformin'], 'otherNames': ['Group 2']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Weight', 'description': 'Change of 10 percent of initial weight', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% and an alpha level of 0.05 were used in a two-sided T-test. A 20% dropout rate was also considered.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n Weight loss after dapagliflozin treatment has not been previously used as primary outcome in randomized controlled trials (RCT) of patients with prediabetes or diabetes and grade III obesity. Zhang et al. performed a meta-analysis that included seven RCTs evaluating the effect of metformin combined with SGLT2-inhibitors (dapagliflozin 10\u00e2\u0080\u0089mg/day, canagliflozin 300\u00e2\u0080\u0089mg/day, empagliflozin 25\u00e2\u0080\u0089mg/day, or ipragliflozin 300\u00e2\u0080\u0089mg/day) vs. metformin (at doses of 1.5 to 3\u00e2\u0080\u0089g/day) with placebo on HbA1c; fasting plasma glucose; and body weight over 24\u00e2\u0080\u0089weeks, 1\u00e2\u0080\u0089year, and 2\u00e2\u0080\u0089years. The total sample was 2847 patients with a mean BMI of 31.7\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00894.9\u00e2\u0080\u0089kg/m2. After a year of treatment, the placebo\u00e2\u0080\u0093metformin control group showed a reduction in body weight of 1.1\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00893.39\u00e2\u0080\u0089kg, whereas the SGLT-2 inhibitor\u00e2\u0080\u0093metformin group showed a 3.6\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00894.22\u00e2\u0080\u0089kg reduction with a mean difference of \u00e2\u0088\u0092\u00e2\u0080\u00892.6\u00e2\u0080\u0089kg (\u00e2\u0088\u0092\u00e2\u0080\u00893.17 to \u00e2\u0088\u0092\u00e2\u0080\u00892.03\u00e2\u0080\u0089kg), p\u00e2\u0080\u0089<\u00e2\u0080\u00890.00001 [16]. Using these data, we calculated a sample size using a mean difference formula. With a power of 80% (alpha level of 0.05) in a two-sided T-test, the sample size required is 90 patients: 45 patients in the M group and 45 patients in the D/M group. The final sample size required is 108 patients: 54 patients in metformin and 54 patients in the dapagliflozin group, allowing for a 20% dropout rate.", "id": 500, "split": "train"} +{"trial_id": "NCT03969628", "pmid": "34922527", "question": "Here is the design of a clinical trial:\n\nOfficial Title: CARies DEtection in Children-Pelotas (CARDEC-PEL): Comparison of Two Methods of Caries Risk Assessment in Children\n\nIncluded conditions:\n- Caries,Dental\n\nStudy Armgroups:\n- {'label': 'Multivariate risk assessment group (ICCMS\u00ae)', 'type': 'EXPERIMENTAL', 'description': 'Multivariate risk assessment group (ICCMS\u00ae): multivariate caries risk assessment based on International Caries Classification and Management System (ICCMS\u2122) guide', 'interventionNames': ['Diagnostic Test: ICCMS']}\n- {'label': 'Simplified risk assessment group (dental caries experience)', 'type': 'EXPERIMENTAL', 'description': 'Simplified risk assessment group (dental caries experience): simplified caries risk assessment based on dental caries experience (WHO criteria)', 'interventionNames': ['Diagnostic Test: ICCMS']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'ICCMS', 'description': 'Risk caries assessment will consider ICCMS criteria', 'armGroupLabels': ['Multivariate risk assessment group (ICCMS\u00ae)', 'Simplified risk assessment group (dental caries experience)']}\n\nPrimary Outcomes:\n- {'measure': 'New caries lesions', 'description': 'Incremental number of dental surfaces with operative treatment needs. This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the treatment plan.', 'timeFrame': 'from baseline (first measurement) to 24months'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 0.05 and a power of 0.80 were used, with a two-tailed test. A sample loss of 20% was also considered.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample estimation was based on the primary outcome, which is the number of tooth surfaces in need of surgery during follow-up. Therefore, the following possibilities were considered to compose this outcome:New caries lesions;Restorations in need of replacement;Dental extractions (5 surfaces per tooth);Resolution of pain episodes and/or need for endodontic treatment (5 surfaces per tooth).\n To perform the sample calculation, incidence data were collected for all possibilities in the literature, reaching an average occurrence of 17.6 new decayed surfaces in 2\u00c2\u00a0years [22], 10% failure of occlusal-proximal and composite resin and glass ionomer occlusal restorations, which gives an average of 0.1 surface with the need to change for occlusal restorations and 0.2 surfaces in 2\u00c2\u00a0years [23], 0.08 tooth extractions for caries in two years, totaling 0.2 surfaces [24] and 0.2 pain episodes in 2\u00c2\u00a0years on average, leading to an average of 1 surface treated in 2\u00c2\u00a0years. Thus, the estimate of surfaces in need of surgical treatment in 2\u00c2\u00a0years is an average of 19. It was considered that the reduction of 5 surfaces in need of treatment would be a significant number. The expected mean for the test group would be 14. The expected standard deviation values for the control and test groups are 15 and 10, respectively [22\u00e2\u0080\u009324]. Considering a significance level of 0.05 and a power of 0.80, using a two-tailed test, the minimum number of children per group calculated was 103. Considering a sample loss of 20%, the final rounded number required of 250 children was reached.", "id": 501, "split": "train"} +{"trial_id": "NCT03972592", "pmid": "31847908", "question": "Here is the design of a clinical trial:\n\nOfficial Title: 0.1% Topical Sirolimus in the Treatment of Cutaneous Microcystic Lymphatic Malformations in Children and Adults: Phase II, Split-body Randomized, Double-blind, Vehicle-controlled Clinical Trial\n\nIncluded conditions:\n- Vascular Malformations\n- Lymphatic Malformation\n\nStudy Armgroups:\n- {'label': 'Topical sirolimus', 'type': 'EXPERIMENTAL', 'description': 'The experimental group will consist in one area of the CMLM (almost half of it) that will receive 0.1% sirolimus preparation. This product will be applied 1/day on the randomly allocated area, by a nurse at home, during 12 weeks.', 'interventionNames': ['Drug: Topical 0.1% Sirolimus']}\n- {'label': 'Vehicle', 'type': 'PLACEBO_COMPARATOR', 'description': 'The control group will consist in the other half area of the CMLM, that will receive the same vehicle than the one used in the topical 0.1% sirolimus preparation. It will be applied 1/day in the corresponding area by a nurse, at home, during 12 weeks.', 'interventionNames': ['Drug: Topical Vehicle']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Topical 0.1% Sirolimus', 'description': 'The formulation is 0.03 g rapamycin, 1.5 g Transcutol, Quantum Satis (QS) 30g Excipial\u00ae hydrocream, corresponding to a concentration at 0.1%. The cream will be packaged in 30 ml aluminium tubes.', 'armGroupLabels': ['Topical sirolimus'], 'otherNames': ['Verum']}\n- {'type': 'DRUG', 'name': 'Topical Vehicle', 'description': 'The same vehicle than the one used in the topical 0.1% sirolimus preparation will be used for the other half area of CMLM, i.e. Excipial\u00ae hydrocream. It will be packaged to maintain the double blind way of this trial and will be undistinguishable from the sirolimus cream.', 'armGroupLabels': ['Vehicle'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Efficacy of a 12-week application period of 0.1% topical sirolimus in cutaneous microcystic lymphatic malformation versus topical vehicle', 'description': 'PGA (Physician Global Assessment) score assessed by the investigator physician (blinded from the treatment). PGA score ranges from 0 (clear) to 5 (severe lesions), and is commonly used in several dermatologic conditions. For each patient, PGA of the area treated with the intervention (0.1% topical sirolimus) will be compared to PGA of the area treated with topical vehicle (inactive comparator)', 'timeFrame': 'Week 12'}\n\nPlease estimate the sample size based on the assumption: \nAssuming a power of 80%, a two-sided type I error rate of 5%.", "answer": 55, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study is planned as a within-person design, which means that data from the two areas on a patient will be matched. In addition, the PGA score is an ordered score ranging from 0 (clear) to 5 (severe). Therefore, to estimate the sample size,\u00c2\u00a0we used an approach based on continuous data and a paired sample t test, assuming that the PGA\u00c2\u00a0score difference (between the two areas) follows a normal distribution. Hypothesizing a 1-point difference and a 2.5-point standard deviation would lead to a 0.4 effect size. Assuming a power of 80%, a two-sided type I error rate of 5%, we will need to recruit 52 patients. We plan to recruit 55 patients.", "id": 502, "split": "train"} +{"trial_id": "NCT03974477", "pmid": "32423935", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trial With SALT CONTROL H - Impact on Individual Sodium and Sodium to Potassium Ratio Excretion\n\nIncluded conditions:\n- Salt; Excess\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention will last for 8 weeks, an individual session of presentation of SALT CONTROL H will be carried out, with explanation of how the equipment works in the culinary preparation with an adequate salt content (will be used an illustrative video and recipes with an adequate salt content); use of SALT CONTROL H at home by the participant to control the use of salt during the cooking process; supervision and enhancement of the use of equipment; daily occurrence log; and the application of a satisfaction questionnaire on the use of SALT CONTROL H. A leaflet will also be delivered about \"The new Food Wheel, a guide to the daily food choice!\".', 'interventionNames': ['Device: SALT CONTROL H equipment to control and monitor salt during cooking process']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'No intervention will be carried out except the provision of a leaflet on \"The new Food Wheel, a guide to the daily food choice!\" to the participants.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'SALT CONTROL H equipment to control and monitor salt during cooking process', 'description': 'Participants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline 24h urinary sodium excretion at during and after intervention', 'description': 'Sodium excretion as a proxy of dietary salt intake', 'timeFrame': 'Baseline, at the 4th and 8th intervention weeks, and 6 months after intervention'}\n\nPlease estimate the sample size based on the assumption: \nMore than 80% statistical power at a significance level of 0.05 bicaudal, with a 20% participant dropout rate.", "answer": 260, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated to provide more than 80% statistical power at a significance level of 0.05 bicaudal, assuming a difference in the mean 24-hour urinary sodium excretion equal to or greater than 27\u00e2\u0080\u0089mmol/day between IG and CG, with an SD of 70\u00e2\u0080\u0089mmol/day.29 In addition, this calculation was adjusted considering a 20% participant dropout, resulting in a sample size of 260 participants. A subsample of participants (n=20) will be used for intestinal microbiota analysis.", "id": 503, "split": "train"} +{"trial_id": "NCT03975894", "pmid": "32312326", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Feasibility Trial of Serial Prophylactic Exchange Blood Transfusion in Pregnant Women With Sickle Cell Disease Aiming to Improve Maternal and Infant Outcomes\n\nIncluded conditions:\n- Sickle Cell Disease\n- Pregnancy, High Risk\n- Blood Transfusion Complication\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Regular prophylactic blood transfusion given every 6-10 weeks during pregnancy to maintain a HbS% of \\\\<30%.', 'interventionNames': ['Biological: Serial prophylactic exchange blood transfusion (SPEBT).']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Symptom directed blood transfusion during pregnancy.'}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Serial prophylactic exchange blood transfusion (SPEBT).', 'description': 'Serial prophylactic exchange blood transfusion (SPEBT) will be given via automated apheresis technology. SPEBT will be carried out on the haematology day unit or on the antenatal day unit/ward in accordance with local policies in participating units. The procedure will be carried out using standard operating procedures, by the clinical or research nurse/midwife, haematology day unit staff or specialist sickle nursing staff. Venous access will be via peripheral access if possible or by femoral line access if not.\\n\\nSPEBT will be commenced between 6 and 18+0 weeks gestation. It will be repeated at 6-10 weekly intervals aiming to maintain HbS% \\\\<30%. It will continue throughout pregnancy and be stopped at the end of pregnancy.\\n\\nNumber of red cell units used per transfusion will depend on patient weight and pre-transfusion HbS%, but will usually be between 6 and 8 units of red cells on each occasion of exchange transfusion.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Recruitment rate', 'description': 'ratio of women eligible:women randomised', 'timeFrame': 'Baseline'}\n\nPlease estimate the sample size based on the assumption: \nAssumptions include a recruitment rate of 50-60%, a 20% loss to follow-up, and an 18-month recruitment period.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Power and sample size\n The study is designed to establish the rates at which women with SCD can be recruited and retained in a future definitive RCT. A sample of 40 women (20 in each arm) will allow us to estimate the overall recruitment rate per woman with SCD to within 10% of the true value. This approach will accurately predict the recruitment rate in the main study and determine the required length of the recruitment period.\n Over an 18-month recruitment period, we estimate that a total of approximately 100 women with SCD will be seen in participating maternity units. Assuming a 50\u00e2\u0080\u009360% recruitment rate (allowing for ineligible women and those who do not wish to take part), we plan to recruit 50 participants during the study period (25 in each arm). Allowing for a 20% loss to follow-up, we estimate that 40 women should complete postpartum follow-up, consistent with our required sample size.", "id": 504, "split": "train"} +{"trial_id": "NCT03976063", "pmid": "34496799", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial\n\nIncluded conditions:\n- Preterm Premature Rupture of Membrane\n\nStudy Armgroups:\n- {'label': 'Nifedipine', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Nifedipine']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo of Nifedipine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Nifedipine', 'description': 'Loading dose: Oral Nifedipine 20 mg prolonged-release at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose: Oral Nifedipine 20 mg prolonged-release at T3, then 1 pill every 8 hr for 48 hr (i.e. T11, T19, T27, T35 and T43, total=6x20 mg)', 'armGroupLabels': ['Nifedipine']}\n- {'type': 'DRUG', 'name': 'Placebo of Nifedipine', 'description': 'Oral Placebo of Nifedipine 20 mg, at T0, T0.5, T3, T11, T19, T27, T35 and T43', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Perinatal morti-morbidity', 'description': 'Composite outcome including fetal death, neonatal death and/or neonatal severe morbidity (mechanical ventilation \u2265 48 hrs, severe bronchopulmonary dysplasia, severe intraventricular hemorrhage, cystic periventricular leucomalacia, neonatal early-onset sepsis, necrotizing enterocolitis, retinopathy of prematurity).', 'timeFrame': 'Up to discharge from hospital, with a maximum of 24 weeks after birth.'}\n\nPlease estimate the sample size based on the assumption: \nWe assume an alpha-risk of 0.05 and a beta-risk of 0.20 (i.e., statistical power of 80%).", "answer": 850, "answer_type": "ESTIMATED", "explanation": "Sample size\n Within the prospective, national, population-based EPIPAGE-2 cohort study of preterm births, we selected a sample of 888 women according to the TOCOPROM eligibility criteria and estimated the frequency of infants diagnosed with any criterion of the composite primary outcome to be 35.5%. This is an average estimate taking into account the expected variation of gestational age at birth in our study population from 22 to 37+ weeks. This estimate is consistent with findings in recent studies [15, 52, 66].\n We hypothesized that the beneficial effect of tocolysis would be mediated by both higher gestational age at birth and the administration of a complete course of antenatal corticosteroids. The EPIPAGE-2 study showed that among women with PPROM, each one-day increase in gestational age at birth is significantly associated with a reduced relative risk (RR) of fetal or neonatal death or severe morbidity (RR 0.95, 95% CI 0.91\u00e2\u0080\u00930.99) [10]. With pregnancy prolonged by 48\u00e2\u0080\u0089h by effective tocolysis, we expect to reduce the rate of fetal or neonatal death or severe morbidity by 10%. Each additional day after the initial 48-h period will also contribute to reducing adverse outcomes. Moreover, this initial prolongation will allow a complete course of antenatal corticosteroids, with additional beneficial effects, as shown by Roberts et al. [28, 67]. In meta-analyses of women with PPROM, antenatal steroids have been associated with reduced perinatal (RR 0.59, 95%CI 0.39\u00e2\u0080\u00930.90) and neonatal mortality (RR 0.61, 0.46-0.83), respiratory distress syndrome (RR 0.70, 0.55-0.90), chronic lung disease (RR 0.50, 0.33\u00e2\u0080\u00930.76), necrotizing enterocolitis (RR 0.39, 0.18\u00e2\u0080\u00930.86), and IVH (RR 0.47, 0.28-0.79). Retinopathy of prematurity, early-onset sepsis, and periventricular leukomalacia were not analyzed separately by membrane status in these meta-analyses.\n When we assume an alpha-risk of 0.05 and a beta-risk of 0.20 (i.e., statistical power of 80%), 702 women (351 per arm) are required to show a reduction of the primary endpoint from 35% (placebo group) to 25% (nifedipine group). We plan to increase the required number of subjects by 20%, to replace patients who leave the study early. The total number of subjects required is thus 850.", "id": 505, "split": "train"} +{"trial_id": "NCT03977181", "pmid": "34311754", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Leveraging Community-based Platforms to Improve Access and Adherence to PrEP for Young Women in South Africa\n\nIncluded conditions:\n- PrEP\n- HIV Prevention\n- Adolescence\n- Cost-effectiveness\n\nStudy Armgroups:\n- {'label': 'Health Club', 'type': 'EXPERIMENTAL', 'description': 'A group-based community health club akin to an ART adherence club', 'interventionNames': ['Behavioral: Group-based Community Health Club']}\n- {'label': 'One-on-one', 'type': 'EXPERIMENTAL', 'description': 'One-on-one adherence counselling and support', 'interventionNames': ['Behavioral: Individual-based Adherence Support']}\n- {'label': 'Medication pick-up', 'type': 'NO_INTERVENTION', 'description': 'Community-based medication dispensary'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Group-based Community Health Club', 'description': 'GBHCs will be facilitated by trained Lay Health Counsellors (LHC). GBHCs will consist of a maximum 20 participants. GBHC sessions will held multiple times a month in each study area, allowing for flexibility for study participants. Sessions will be held at a safe and secure, centrally located area within the study community, and will be regularly monitored and assessed by the study coordinator. Participants will be invited to join a club-specific WhatsApp group to facilitate group communication and adherence support throughout the month. They will also be invited to partner up with another participant to provide mutual peer support. Permission will be sought from group-based adherence support participants before they are added to WhatsApp groups. Group adherence counsellors assigned will be members of WhatsApp groups, and will monitor all shared content to ensure that no inappropriate content or private information is shared in the group.', 'armGroupLabels': ['Health Club']}\n- {'type': 'BEHAVIORAL', 'name': 'Individual-based Adherence Support', 'description': 'IAS participants will be matched to a LHC and will schedule IAS sessions once-a-month for the duration of the study. These sessions will be held at a centralized location within the study community. The sessions will be semi-structured to allow for participant-driven discussion of any adherence challenges and key-messages. The adherence curriculum will also explore motivations for PrEP and adherence and focus on practical adherence tips, environmental cues, integration of PrEP within daily routines, short-term goal-setting, problem-solving, safe PrEP disclosure and social support, risk reduction counselling, partner communication, and HIV risk perception. A subset of IAS sessions will be audio-recorded for quality assurance by investigators and the study coordinator. These recordings are for training purposes only and will not form part of the dataset. Consent for recording IAS sessions will be sought from participants during the pre-enrolment consent process.', 'armGroupLabels': ['One-on-one']}\n\nPrimary Outcomes:\n- {'measure': 'The cost per adolescent girl and young women on pre-exposure prophylaxis', 'description': 'Itemized cost menus', 'timeFrame': '10 months'}\n- {'measure': 'The incremental cost-effectiveness ratio per incidence HIV case averted', 'description': 'Dynamic infectious disease model of HIV', 'timeFrame': '10 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha of 0.05, chi-square test for independence with two degrees of freedom, and an attrition rate of 10%.", "answer": 480, "answer_type": "ACTUAL", "explanation": "Sample size and power calculations\n A sample size was calculated to have 80% power to detect differences in the proportion of participants adhering to PrEP among the three study arms (Aim 2) using the chi-square test for independence with two degrees of freedom, with an alpha of 0.05, and assuming an attrition rate of 10% for those who (1) withdraw voluntarily from the study, (2) initiate on PrEP but withdraw due to adverse events (e.g. hepatic or renal abnormalities), or (3) become ineligible for PrEP (e.g. seroconvert). The effect size estimate was informed by prior experience from the field, where an effect size of 0.30 has been found between ART clients receiving some adherence support and those receiving none. However, we use a more conservative effect size of 0.15, to account for the fact that adherence support may not lead to the same gains in adherence among HIV-negative PrEP clients as it does with HIV-positive ART clients. The sample size was calculated to be 160 per arm (480 total).", "id": 506, "split": "train"} +{"trial_id": "NCT03977259", "pmid": "33836708", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development\n\nIncluded conditions:\n- Preterm Birth\n- Breast Milk Expression\n- Nutrition Disorder, Infant\n- Brain Development Abnormality\n- Neurodevelopmental Disorders\n\nStudy Armgroups:\n- {'label': 'Standard fortification', 'type': 'NO_INTERVENTION', 'description': 'Standard of care fortification with multicomponent human milk fortifier (24 kcal/oz) and liquid protein (0.27 g/dL); additional protein and/or calories added only for growth faltering.'}\n- {'label': 'Individually targeted fortification', 'type': 'EXPERIMENTAL', 'description': 'Standard of care fortification plus extra protein and/or calories to ensure that \"base\" milk has protein 1 g/dL and calories 67/dL.', 'interventionNames': ['Other: Individually targeted fortification']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Individually targeted fortification', 'description': 'Abbott liquid protein and/or medium chain triglyceride are added routinely to ensure that the \"base\" milk has protein 1 g/dL and calories 67/dL.', 'armGroupLabels': ['Individually targeted fortification']}\n\nPrimary Outcomes:\n- {'measure': 'Weight', 'description': 'Weight z-score', 'timeFrame': \"at study endpoint (36 weeks' postmenstrual age or discharge)\"}\n- {'measure': 'Length', 'description': 'Length z-score', 'timeFrame': \"at study endpoint (36 weeks' postmenstrual age or discharge)\"}\n- {'measure': 'Fat free mass', 'description': 'Fat free mass estimated with air displacement plethysmography (z-score)', 'timeFrame': \"at study endpoint (36 weeks' postmenstrual age or discharge)\"}\n- {'measure': 'Total brain volume', 'description': 'Total brain volume by MRI', 'timeFrame': \"at term equivalent age (38 to 41 weeks' postmenstrual age)\"}\n- {'measure': 'Cerebellar volume', 'description': 'Cerebellar volume by MRI', 'timeFrame': \"at term equivalent age (38 to 41 weeks' postmenstrual age)\"}\n- {'measure': 'Bayley-III cognitive score', 'description': 'Scaled composite score (continuous), higher score indicates better performance, range of possible scores 55-145', 'timeFrame': \"at 2 years' corrected age\"}\n- {'measure': 'Bayley-III motor score', 'description': 'Scaled composite score (continuous), higher score indicates better performance, range of possible scores 46-154', 'timeFrame': \"at 2 years' corrected age\"}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power = 0.8, 5% attrition by NICU discharge, 5% loss due to uncorrectable motion artifact for MRI outcomes, 10% further attrition to 2 years' corrected age.", "answer": 130, "answer_type": "ESTIMATED", "explanation": "Sample size\n The planned sample size is 130 infants (65 per study group). Accounting for expected attrition (5% by NICU discharge due to death or unexpected transfer) and an additional 5% loss due to uncorrectable motion artifact for MRI outcomes, we expect to be able to detect a moderate effect of the intervention on primary outcomes (0.49 z-scores in weight, 0.24 z-scores in fat free mass, 24\u00e2\u0080\u0089cc total brain volume) at \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and power 0.8. Accounting for 10% further attrition to 2\u00e2\u0080\u0089years\u00e2\u0080\u0099 corrected age, we have adequate power to detect an 8.1-point difference between groups on the Bayley cognitive scale.", "id": 507, "split": "train"} +{"trial_id": "NCT03978793", "pmid": "36627157", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users\n\nIncluded conditions:\n- HIV-positive Individuals\n\nStudy Armgroups:\n- {'label': 'MyTPill', 'description': 'Participants receive digital pills for three months, have a 2-week washout, then switch to Wisepill.', 'interventionNames': ['Device: MyTPill, a digital pill']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'MyTPill, a digital pill', 'description': 'MyTPill is a digital pill containing an approved medication', 'armGroupLabels': ['MyTPill'], 'otherNames': ['Wisepill, a digital pillbox']}\n\nPrimary Outcomes:\n- {'measure': 'Dried blood spots', 'description': 'Measurement of dried blood spots for TDF/FTC concentrations', 'timeFrame': 'six months'}\n- {'measure': 'Adherence per two different electronic adherence measures', 'description': 'Secondary outcomes are the identification of multi-level factors that are prevalent in the target population most closely linked to ART non-adherence and EAM non-adherence.', 'timeFrame': 'Six months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level that allows for 90% power to detect the absolute difference. An estimated 20% attrition rate is considered, and the comparison is based on two-sample binomial proportion using Fisher's exact test.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our sample size of 80 participants (40 per study arm \u00c3\u0097 2 study arms; estimated 20% attrition) is based on satisfying the primary aim of the study: the comparison of ART adherence efficacy of the MyTPill versus the Wisepill system. The benefit of the cross-over design permits comparison of participants across study arms (MyTPill first 3 months vs Wisepill first 3 months and MyTPill second 3 months vs Wisepill second 3 months) and within study arms (MyTPill vs Wisepill for the same participant). Comparisons within study arms permit a reduction in variance and enables detection of statistical difference with smaller effect sizes, as compared with the across study arms comparisons.\n The accuracy of the MyTPill and Wisepill measurements will be determined by examining the concordance between these measurements and the \u00e2\u0080\u0098gold standard\u00e2\u0080\u0099 DBS. As such, concordance can be considered a continuous value with a range from 0 to 100. Recent adherence is assessed by the presence of FTC-TP in DBS samples in a binomial fashion: adherent or non-adherent within the prior 48 hours. In an analogous fashion, MyTPill and Wisepill indicate whether or not ARTs were ingested (MyTPill) or the pill bottle opened (Wisepill) at least once in the prior 48 hours. Two DBS will be obtained per participant per month (12 total; 6 DBSs during Wisepill and 6 DBSs during MyTPill) for a total of 960 DBSs. If 20% are not collected or are not readable for any reason, there would be 768 samples. For this investigation, which is the first of its kind, there is no clinical standard to base the effect size, and no prior pilot studies to base the estimate. An effect size of 10%\u00e2\u0080\u009315% seems to be a reasonable gestalt estimate in comparing two behavioural interventions for adherence. Using an estimate absolute difference of 10% reflects a hypothesis that one intervention has 10% greater absolute adherence than the other intervention. The sample size is based on the number of blood samples that are concordant and as such a sample size of 80 participants providing at least 768 dried blood samples permits approximately 90% power in detecting that absolute difference. The study would have greater power for a larger effect size of 15%, if detected. In this case, the comparison is two-sample binomial proportion. Using Fisher\u00e2\u0080\u0099s exact test to examine differences in measures of concordance between the MyTPill and Wisepill, we can detect with high power (>0.9) an effect size of an absolute difference of at least 10%\u00e2\u0080\u009315% of greater concordance with the DBS gold standard.", "id": 508, "split": "train"} +{"trial_id": "NCT03978949", "pmid": "34530750", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study\n\nIncluded conditions:\n- Radiotherapy\n- Toxicity\n- Diarrhea\n- Probiotics\n\nStudy Armgroups:\n- {'label': 'Probiotics', 'type': 'EXPERIMENTAL', 'description': 'Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.', 'interventionNames': ['Drug: Bacillus Licheniformis']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Bacillus Licheniformis', 'description': 'Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.', 'armGroupLabels': ['Probiotics'], 'otherNames': ['Biscanen cap.']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Placebo oral tablet']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with grade 2 or more acute intestinal toxicities', 'description': 'Evaluation using CTCAE version 4.0', 'timeFrame': 'Adverse effect evaluated at 3 months after radiation therapy'}\n\nPlease estimate the sample size based on the assumption: \nAlpha value of 0.05, beta of 0.2, and a 5% dropout rate.", "answer": 248, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n Two proportion test in Power Analysis and Sample Size Software 2018 (NCSS, LLC. Kaysville, Utah, USA) was utilized to estimate the sample size. Based on the assumption that 30% of the patients in the placebo group and 15% of the patients in the probiotics group will experience grade\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00892 acute toxicities, 118 patients per group will be required to show a significant effect based on an alpha value of 0.05 and a beta of 0.2. Assuming a 5% dropout rate, 124 patients per group will be required (total, 248 patients).\n Acute toxicities will be analyzed in the intention to treat population, with categorical variables in the two groups compared by the Chi-Square or Fisher\u00e2\u0080\u0099s exact test. To find the other confounding factors for RIE, univariate and multivariate logistic regression for acute toxicity will be performed. The times from the start of radiotherapy to acute grade\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00892 toxicities and to any chronic toxicities will be calculated using the Kaplan-Meier method and compared in the two groups using the log-rank test to compare survival curves between two groups. In the whole population, multivariate analysis, Cox proportional hazard model will be utilized to find the significant factor for the incidence of RIE in addition to the use of probiotics. Factors with p\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00890.2 in log-rank test will be entered in multivariate analysis. Descriptive statistics of all analyzed parameters will be provided, whenever appropriate.", "id": 509, "split": "train"} +{"trial_id": "NCT03979443", "pmid": "31772100", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Finnish Trial on Practices of Anterior Cervical Decompression and Fusion (FACADE): A Protocol for a Prospective Randomized Non-inferiority Trial Comparing Outpatient vs. Inpatient Care\n\nIncluded conditions:\n- Cervical Radiculopathy\n\nStudy Armgroups:\n- {'label': 'Inpatient', 'type': 'NO_INTERVENTION', 'description': 'patients staying in the hospital for 1-3 nights after surgery'}\n- {'label': 'Outpatient', 'type': 'ACTIVE_COMPARATOR', 'description': 'discharge on the day of the surgery, usually within 6-8 hours after procedure', 'interventionNames': ['Procedure: Discharge on the day of surgery']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Discharge on the day of surgery', 'description': 'Patient discharge on the day of the surgery, usually within 6-8 hours after procedure', 'armGroupLabels': ['Outpatient']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline Neck Disability Index at 6 months after operation', 'description': 'Neck disability Index scale score ranges from 0 to 100%. Score 0 indicates no disability as score 100% indicates worst possible disability.', 'timeFrame': 'Before and up to 6 months after operation'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include no difference between treatment arms (\u03b5=0 in NDI score improvements), equal sample sizes, a standard deviation of 23%, a one-sided 2.5% significance level (z\u03b1 = 1.96), 90% statistical power (z\u03b2 = 1.28), and a 15% dropout rate.", "answer": 104, "answer_type": "ACTUAL", "explanation": "Sample size\n The trial is primarily designed to ascertain whether outpatient care is non-inferior to inpatient care, at 6 months after surgery, with NDI as the primary outcome. Only one primary analysis will be used to assess non-inferiority. The trial is powered to detect an MID in the NDI score between the two study groups. We set the MID for NDI (17.3%) as our margin of non-inferiority \u00ce\u0094 based on the results by Parker et al.14 At the 6-month time point, non-inferiority can be claimed if the lower limit of the CI (based on difference in means in the NDI) is greater than the MID in the primary comparison. According to the CONSORT (Consolidated Standards of Reporting Trials) statement for non-inferiority and equivalence trials,10 secondary outcomes can be managed using either a superiority or equivalence framework. In our trial, all secondary outcomes will be assessed with an equivalence hypothesis, but since our trial is not necessarily powered for these comparisons, and to avoid issues with multiplicity, we consider them exploratory or hypothesis-generating.\n The sample size calculation is based on the primary outcome measure, NDI at 6 months after the surgery. The sample size is approximated using the equation (Equation 3.12 in Chow: Sample Size Calculations in Clinical Research, Third Edition CRC Press 2018) for non-inferiority test:\n \nn1=\u00cf\u00b0n2andn2=(z\u00ce\u00b1+z\u00ce\u00b2)2\u00cf\u00832(1+1\u00cf\u00b0)(\u00ce\u00b5\u00e2\u0088\u0092M)2\n\n Assuming no difference between treatment arms (\u00ce\u00b5=0 in NDI score improvements), equal sample sizes (x=1, the SD 23%), a margin of non-inferiority \u00ce\u0094 of 17.3%, one-sided 2.5% statistical significance criteria (z\u00ce\u00b1 = 1.96) and 90% statistical power (z\u00ce\u00b2 =1,28), we will need 44 patients per study group. Assuming a dropout rate of 15%, the group size increases to 52 patients. Accordingly, we set the recruitment target at 104 patients.", "id": 510, "split": "train"} +{"trial_id": "NCT03982901", "pmid": "33293388", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Mental Stress on Myocardial Perfusion and Myocardial Blood Flow in Women With Chest Pain and Coronary Artery Stenosis Less Than 50%\n\nIncluded conditions:\n- Non-Obstructive Coronary Atherosclerosis\n\nStudy Armgroups:\n- {'label': 'women with chest pain', 'type': 'EXPERIMENTAL', 'description': 'women with chest pain and coronary artery stenosis less than 50%', 'interventionNames': ['Diagnostic Test: Mental Stress Test']}\n- {'label': 'healthy women', 'type': 'SHAM_COMPARATOR', 'description': 'women without chest pain and coronary artery stenosis less than 50%', 'interventionNames': ['Diagnostic Test: Mental Stress Test']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Mental Stress Test', 'description': 'In this study, we compare MSIMI prevalence in the two groups (chest pain group and no chest pain group). Each subject in both groups receive the same mental stress test process, and the mental stress test process have 3 consecutive stress tests, which including: Stroop Color-Word test; Public speaking with anger recall test and Mental arithmetic test.', 'armGroupLabels': ['healthy women', 'women with chest pain']}\n\nPrimary Outcomes:\n- {'measure': 'MSIMI (Measures as perfusion deficit with mental stress test via PET-CT) prevalence in chest pain women with coronary artery stenosis less than 50%, as compared to age matched healthy women.', 'description': 'Percentage of participants wih an presence of mental stress-induced myocardial ischemia (MSIMI) during the 3 mental stressors.\\n\\nMSIMI is defined by the following: compared to rest, 1) Each myocardial segment was scored from 0 to 4, with 0 being normal, 1 possibly normal, 2 definitely abnormal, 3 severely abnormal, and 4 no perfusion. The investigators calculated summed scores in a conventional fashion, including a summed stress score, a summed rest score, and a summed difference score. A summed difference score \u22653 is typically used as evidence of MSIMI.', 'timeFrame': 'half an hour'}\n- {'measure': 'The MBF change during mental stress test', 'description': 'The MBF change during mental stress test', 'timeFrame': 'half an hour'}\n\nPlease estimate the sample size based on the assumption: \n2:1 ratio of women with ANOCA to healthy controls, 0.80 power, p=0.05, precision of 5%, using \u03c72 test and analysis of variance.", "answer": 126, "answer_type": "ACTUAL", "explanation": "Sample size considerations\n Using pilot data, we estimate the incidence of MSIMI in women with ANOCA to be ~25%. With a 2:1 ratio of women with ANOCA and healthy controls, and assuming MSIMI incidence at 25% and a precision of 5%, a total of 126 patients (84 with ANOCA and 42 controls) will be required to achieve 0.80 power at p=0.05 using the\u00cf\u00872 test. To maximise the power to detect group differences, we will also use analysis of variance to compare continuous perfusion scores or MBF changes between the two groups of patients.", "id": 511, "split": "train"} +{"trial_id": "NCT03986177", "pmid": "32366314", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementation of a Community Intervention to Improve Asthma Self-Management Practices in Peru\n\nIncluded conditions:\n- Asthma\n- Asthma in Children\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention arm will receive a multi-faceted self-management intervention package.', 'interventionNames': ['Behavioral: Self-management Intervention Package']}\n- {'label': 'Enhanced care', 'type': 'NO_INTERVENTION', 'description': 'The control arm will receive usual care plus basic asthma education from a trained nurse educator.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Self-management Intervention Package', 'description': 'Children will receive basic asthma education, based on the National Heart, Lung, and Blood Institute \"A Breath of Life\" asthma education program. Children/caregivers in the intervention arm will also be assigned a designated nurse case manager who will provide home visits and be available via text message and phone-based support throughout follow-up. Intervention components:\\n\\n* Interactive education and support on use of an asthma action plan\\n* Locally adapted patient-provider communication tool\\n* Child-oriented educational materials in comic book format\\n* Modeling and hands-on practice of inhaler technique (written instructions, in person, video)\\n* Education regarding environmental trigger abatement\\n* Patient navigation, home visits, and goal setting support from nurse manager', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Asthma Control as assessed by Childhood Asthma Control Test (cACT) Score', 'description': 'cACT (5-11 years of age) will be administered at baseline and monthly during the follow-up period. The cACT is scored by summing the scores for all items. Overall scores ranges from 0 to 27. Lower scores indicate poorer asthma control and higher scores indicate better asthma control. Scores 19 and below suggest impaired asthma control.', 'timeFrame': 'Baseline, then monthly up to 6 months'}\n- {'measure': 'Change in Asthma Control as assessed by Asthma Control Test (ACT) Score', 'description': 'ACT (12-17 years of age) will be administered at baseline and monthly during the follow-up period. The ACT is scored by summing the scores for all items. Overall score ranges from 5 to 25. Lower scores indicate poorer asthma control and higher scores indicate better asthma control. Scores 19 and below suggest impaired asthma control.', 'timeFrame': 'Baseline, then monthly up to 6 months'}\n- {'measure': 'Number of participants with at least one asthma-related ED or urgent care visit during the six-month follow-up period', 'description': 'Number with asthma-related emergency department (ED) or urgent care visits will be used to assess healthcare utilization.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation of 3.6, type II error of 5%, 80% power, 9% attrition", "answer": 110, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary objective of this pilot trial is to assess the feasibility, acceptability, and preliminary effectiveness of the intervention package in the Peruvian context. With a sample size of 100 participants, assuming a standard deviation of 3.6 and a type II error of 5%, we will be able to detect a difference of 2 in ACT score with 80% power. These calculations were based on preliminary data from a prior epidemiological study of children with asthma in this setting, in which the standard deviation of the ACT score was 3.6 [17]. In order to account for approximately 9% attrition, we arrived at a final sample size of 110 individuals.", "id": 512, "split": "train"} +{"trial_id": "NCT03986528", "pmid": "33731199", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)\n\nIncluded conditions:\n- NSCLC\n\nStudy Armgroups:\n- {'label': 'Kanglaite Injection + Chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'Participants receive Kanglaite Injection PLUS first-line chemotherapy.', 'interventionNames': ['Drug: Kanglaite Injection+Chemotherapy']}\n- {'label': 'Chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'first-line chemotherapy.', 'interventionNames': ['Drug: Chemotherapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Kanglaite Injection+Chemotherapy', 'description': \"Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy. The patients will also receive Kanglaite injection 200ml by IV infusion per day continuously for 14 days, commencing on the first day of chemotherapy.\", 'armGroupLabels': ['Kanglaite Injection + Chemotherapy']}\n- {'type': 'DRUG', 'name': 'Chemotherapy', 'description': \"Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy.\", 'armGroupLabels': ['Chemotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Progression Free Survival(PFS)', 'description': 'Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence level, 80% power, and 20% drop-out rate.", "answer": 334, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated based on the primary study outcome. The previously reported PFS of maintenance pemetrexed plus best supportive care for NSCLC was 4.3\u00e2\u0080\u0089months (95% confidence interval [CI]: 4.1\u00e2\u0080\u00934.7), whereas the PFS for placebo plus best supportive care was 2.6\u00e2\u0080\u0089months (95% CI: 1.7\u00e2\u0080\u00932.8) [42]. Some studies showed that KLTi in combination with chemotherapy improved clinical efficacy compared with chemotherapy alone in patients with NSCLC [30\u00e2\u0080\u009333]. Therefore, we predict that the PFS in the treated group will be 2.1\u00e2\u0080\u0089months longer than that in the control group. A sample size calculation using PASS software (Version 11.0, NCSS, LLC. Kaysville, UT, USA) estimates that 167 participants would be required in the treatment and control groups (i.e., total of N\u00e2\u0080\u0089=\u00e2\u0080\u0089334), with 95% confidence level, 80% power, and 20% drop-out rate.", "id": 513, "split": "train"} +{"trial_id": "NCT03988673", "pmid": "32349746", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Explicit Values Clarification Method (VCM), Implicit VCM and no VCM Decision Aids for Men Considering Prostate Cancer Screening: Protocol of a Randomized Trial\n\nIncluded conditions:\n- Healthy Volunteers\n\nStudy Armgroups:\n- {'label': 'decision aid with information only (control)', 'type': 'NO_INTERVENTION', 'description': 'decision aid with information only, without values clarification method (VCM)'}\n- {'label': 'decision aid with implicit VCM', 'type': 'ACTIVE_COMPARATOR', 'description': 'decision aid with information plus an implicit VCM', 'interventionNames': ['Other: Decision aid with implicit values clarification method (booklet or website)']}\n- {'label': 'decision aid with explicit VCM', 'type': 'ACTIVE_COMPARATOR', 'description': 'decision aid with information plus an explicit VCM', 'interventionNames': ['Other: Decision aid with explicit values clarification method (booklet or website)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Decision aid with implicit values clarification method (booklet or website)', 'description': 'The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a grid where statements about the subject will be presented (decision aid with implicit VCM).', 'armGroupLabels': ['decision aid with implicit VCM']}\n- {'type': 'OTHER', 'name': 'Decision aid with explicit values clarification method (booklet or website)', 'description': 'The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a a grid where statements about the subject will be presented and men should indicate what statements they identify with (decision aid with explicit VCM).', 'armGroupLabels': ['decision aid with explicit VCM']}\n\nPrimary Outcomes:\n- {'measure': 'Perceived clarity of personal values', 'description': '3-item subscale of the Decisional Conflict Scale. Items are given a score of 0 (\"strongly agree\") to 4 (\"strongly disagree\"). Items are: a) summed; b) divided 3; and c) multiplied by 25. Scores range from 0 \\\\[feels extremely clear about personal values\\\\] to 100 \\\\[feels extremely unclear about personal values\\\\].', 'timeFrame': 'immediately after the intervention'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level of 0.05, 80% power, 10% dropout rate", "answer": 276, "answer_type": "ESTIMATED", "explanation": "Sample size\n We estimated a total sample size of 276 participants, 92 in each group, using the ANOVA test for three groups and considering an average effect size of 0.2 with a significance level of 0.05 and 80% power, attending to the psychometric properties of the DCS and also accounting for 10% of participants leaving the study before conclusion.", "id": 514, "split": "train"} +{"trial_id": "NCT03990857", "pmid": "32580980", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care: Quasi-experimental Study.\n\nIncluded conditions:\n- Type 2 Diabetes\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Group of participants with a recent DM2 debut (less than 5 months) treated according to the comprehensive care protocol in DM2 with comorbidities attended in Primary care nurse office', 'interventionNames': ['Other: Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care']}\n- {'label': 'comparison group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the study that do not receive the intervention. usual care.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care', 'description': 'This comprehensive intervention is developed in a structured way in the Primary care nurse office. 5 individual intensive visits will be carried out with a weekly or bi-weekly frequency (according to the learning process) to work for an integral care and to transmit the knowledge and skills required. The maximum time expected to receive this 5 visits is 3 months. At least one of the visits, preferably the one that deals with dietary aspects, the patient is asked to be visited with the partner, child or cohabiting person. The research team elaborated the support material with the minimum contents that every patient that begins with T2DM and other chronic pathologies should know. It allows incorporating cultural and emotional aspects. It was agreed with hospital diabetes educators and family doctors. A graphic designer gave an enticing design. A group of patients verified their utility and intelligibility. It is delivered to the person and discussed during the intensification.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change is being assessed in Health Related Quality of Life will be measured through the EuroQoL (EQ-5D)', 'description': 'The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.', 'timeFrame': 'The outcome measure will be measured before, up to 3,6 and 12 months to assess its change'}\n- {'measure': 'HbA1c', 'description': 'Glycosylated hemoglobin for having a clinical response.', 'timeFrame': 'up to 12 months.'}\n- {'measure': 'Change is being assessed in Weigh', 'description': 'Weigh for having a clinical response.', 'timeFrame': 'The outcome measure will be measured before, up to 3,6 and 12 months to assess its change'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) of 0.05, power (beta) of 0.2, design effect of 1.2, and an estimated 10% participant loss.", "answer": 123, "answer_type": "ESTIMATED", "explanation": "Sample size\n The change in HRQoL score at 6\u00e2\u0080\u0089months from enrolment is the primary effectiveness endpoint. We will recruit and follow 123 participants per group for 2\u00e2\u0080\u0089years to detect a difference of 20% in HRQoL, accepting an alfa risk of 0.05 and a beta risk of 0.2, and assuming a design effect of 1.2. Additionally, we took into account an estimated 10% participant loss and differences between the groups. The sample size was calculated based on the expected improvement of the HRQoL of the participants. It was assumed that 70% of participants who receive the intervention will improve his/her HRQoL and that only 50% of participants who receive standard care will improve. According to the diabetes incidence of 5.3/1000 patients/year reported in primary healthcare centres in Barcelona city in 2018, a sufficiently large number of patients with a new diagnosis of T2DM will be available to fulfil the sample size.25", "id": 515, "split": "train"} +{"trial_id": "NCT03991910", "pmid": "34518254", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomised Controlled Trial Into the Role of Ramipril in Fibrosis Reduction in Rheumatic Heart Disease: The RamiRHeD Trial Protocol\n\nIncluded conditions:\n- Rheumatic Heart Disease\n- Mitral Stenosis\n- Rheumatic Mitral Stenosis\n- Fibrosis; Heart\n- ACE Inhibitor\n\nStudy Armgroups:\n- {'label': 'control', 'type': 'PLACEBO_COMPARATOR', 'description': 'control patients will be given a placebo', 'interventionNames': ['Drug: Placebos']}\n- {'label': 'treatment', 'type': 'EXPERIMENTAL', 'description': 'Ramipril 5 mg treatment group', 'interventionNames': ['Drug: Ramipril 5Mg Oral Capsule']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Placebos', 'description': \"the control group will be given placebo inside a capsule, so study participant won't be able to know the drug and doses inside the capsule (for masking). Placebo will be given until 5 days prior to Mitral valve replacement surgery.\", 'armGroupLabels': ['control'], 'otherNames': ['control group']}\n- {'type': 'DRUG', 'name': 'Ramipril 5Mg Oral Capsule', 'description': \"the treatment group will be given each Ramipril 2,5 mg inside a capsule as an initial dose, for 2 weeks. If there is no serious adverse effect in the observation period of 2 weeks, Ramipril 5 mg inside a capsule will be given for the next weeks until 5 days before the mitral valve surgery date. Study participant won't be able to know the drug and doses inside the capsule (for masking)\", 'armGroupLabels': ['treatment'], 'otherNames': ['treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'ST2 expression in mitral valve tissue and papillary muscle', 'description': 'expression of ST2 in mitral valve tissue, using immunohistochemistry method', 'timeFrame': 'a year'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical assumptions include a significance level (Z0.95) of 1.96, a standard normal distribution (\u03b4 N(0,1)=1), and a margin of error (E) of 0.05 for a 95% confidence interval. Additionally, a 10% dropout rate is considered.", "answer": 66, "answer_type": "ESTIMATED", "explanation": "Sample size and randomisation\n This is a pioneering study analysing the effects of 5\u00e2\u0080\u0089mg ramipril on ST2 expression in mitral valve tissue in humans. A previous study that used ST2 human tissue was conducted by Marzullo et al in 2016.12 The used carotid tissue from carotid endarterectomy, with a sample size of 41 consecutive patients. Because our study will use human tissue samples, we approached the sample size calculation using the multistage non-finite population method, using this specified precision estimation formula13: N=(Z\u00ce\u00b4)/E, with N=sample\u00e2\u0080\u0089size; Z0.95= 1.96; \u00ce\u00b4 N(0,1)=1; and E=0.05 for a 0.95 CI. Therefore, we calculated a required sample of 1.65(1)/0.05=33 samples.\n According to the sample size of the previous study that analysed ST in human tissue and a sample size formula that is commonly used in in vivo studies, we decided to use a sample size of 30 for each arm, and with the addition of a drop out rate of 10%, this became total of 66 for the two arms.\n The number includes a 10% dropout and withdrawal from each group. Randomisation will be done with an equal ratio of ramipril to placebo. A computerised sequence generator is used for randomisation. It will be linked with codes for placebo and treatment tablets provided by the manufacturer that was contracted to produce the trial medication. Researchers and participants will be blinded. After randomisation, the treatment pack and capsule will be identical between the two groups and will contain either active tablets or placebo. The principal investigator will have no access to the randomisation list.", "id": 516, "split": "train"} +{"trial_id": "NCT03992599", "pmid": "32664881", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]: Multicenter, Single-Arm Study\n\nIncluded conditions:\n- Adenocarcinoma of the Colon\n\nStudy Armgroups:\n- {'label': 'Laparoscopic modified central mesocolic excision', 'description': 'Patients receiving laparoscopic colectomy with the concept of modified complete mesocolic excision for right-sided colon cancer', 'interventionNames': ['Procedure: Laparoscopic modified complete mesocolic excision']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Laparoscopic modified complete mesocolic excision', 'description': \"First, complete kocherization may be required to clear possible tumor spread if the tumor is infiltrating or adhering to the duodenum or perinephric fat tissue. Second, if the tumor is locally advanced, the entire prerenal soft tissue behind Gerota's fascia may need to be cleared, especially for tumors growing toward the posterior. The third difference of mCME with the conventional CME involves the tailored resection of the mesocolon and ileal mesentery according to tumor location. After identifying the root of the middle colic artery, the site of the vascular ligation depends on the location of the tumor. When the tumor is located in the cecum and ascending colon, only the right branch of the middle colic artery is ligated. If the tumor was present in these latter sites, the root of the middle colic artery is ligated.\", 'armGroupLabels': ['Laparoscopic modified central mesocolic excision'], 'otherNames': ['Laparoscopic right hemicolectomy']}\n\nPrimary Outcomes:\n- {'measure': '3 year disease-free survival (DFS)', 'description': 'The 3 year disease-free survival is defined as the time from surgery until documented recurrence or death from any cause.', 'timeFrame': 'DFS will be measured up to three years after surgery, and the last visit is 14th visit after index surgery.'}\n\nPlease estimate the sample size based on the assumption: \nAn exact p-value of 0.025 and a power of 0.90 based on the Clopper-Pearson method. A maximum dropout rate of about 10% is considered.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n On the basis of previous data, the median 3-year disease-free survival (DFS) rate after CME for right-sided colon cancer is estimated to be approximately 80%, and the null hypothesis is a 3-years DFS rate after laparoscopic mCME for right-sided colon cancer of at least 88% [12, 13]. This will be assessed using an exact p-value of 0.025 and a power of 0.90 based on the Clopper-Pearson method. Thus, the sample size is 225. The total sample size is set to 250, considering a maximum dropout rate of about 10% for this clinical study.", "id": 517, "split": "train"} +{"trial_id": "NCT03992742", "pmid": "35982468", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Building Capacity and Promoting Smoking Cessation in the Community Via \"Quit to Win\" Contest 2019: Personalized Cocktail Interventions to Increase Abstinence: a Sequential, Multiple Assignment, Randomized Trial (SMART)\n\nIncluded conditions:\n- Smoking Cessation\n\nStudy Armgroups:\n- {'label': 'Intervention Group (subgroup A+B+C)', 'type': 'EXPERIMENTAL', 'description': 'Personalized instant messaging (PIM) + optional cocktail interventions (OCI) + AWARD advice + referral card + warning leaflet+ COSH booklet', 'interventionNames': ['Behavioral: Initial phase: personalized instant messaging (PIM)', 'Behavioral: Second phase: optional cocktail interventions (OCI)', 'Behavioral: AWARD advice', 'Behavioral: Warning leaflet', 'Behavioral: Referral card', 'Behavioral: COSH booklet']}\n- {'label': 'Control Group (subgroup D+E+F)', 'type': 'EXPERIMENTAL', 'description': 'Regular instant messaging (RIM) + personalized instant messaging (PIM) + AWARD advice + referral card + warning leaflet+ COSH booklet', 'interventionNames': ['Behavioral: Initial phase: regular instant messaging (RIM)', 'Behavioral: Second phase: personalized instant messaging (PIM)', 'Behavioral: AWARD advice', 'Behavioral: Warning leaflet', 'Behavioral: Referral card', 'Behavioral: COSH booklet']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Initial phase: personalized instant messaging (PIM)', 'description': 'intervention Group participants will receive three months of personalized interaction through IM Apps (e.g. WhatsApp, WeChat). Our counsellors will trigger the conversation and encourage the participants to set a quit day. A total of pre-set 26 messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. These messages covered generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and encouragement to quit and use SC services.\\n\\nAt the end of the initial phase (1-month), complete responders (quitters) will continue to receive PIM (subgroup C). Incomplete responders (smokers) will be randomized to continue PIM (subgroup B) or receive OCI (subgroup A).', 'armGroupLabels': ['Intervention Group (subgroup A+B+C)']}\n- {'type': 'BEHAVIORAL', 'name': 'Second phase: optional cocktail interventions (OCI)', 'description': 'For incomplete respondents (subgroup A) randomized to OCI, the available intervention options include multi-media messages, active referral plus financial incentive, phone counseling, family/peer support and medications (NRT). Participants will be guided by cessation counsellors at 1-month follow-up telephone survey to choose any combination of OCI based on their preference. If OCI participants cannot be followed up at 1-month, they will receive multi-media messages by default.', 'armGroupLabels': ['Intervention Group (subgroup A+B+C)']}\n- {'type': 'BEHAVIORAL', 'name': 'Initial phase: regular instant messaging (RIM)', 'description': 'Participants enrolled in the Control Group will receive regular messages via IM services (e.g. WhatsApp, WeChat) since initial contact and until 3-month after baseline with a tapering schedule: 1) Baseline to 4-week (1-month): 2 times/ week (8 in total); 2) 4-week to 12-week (2- \\\\& 3-month): 1 time/week (8 in total).\\n\\nSC messages will generally include benefits of SC, encouragement on abstinence and use of SC services, tips on avoiding/ handling craving and reminder of participating in telephone follow-up. A reminder to participate in the telephone follow-up will also be sent at 1-, 2-, 3- and 6-month, making up a total of 20 messages.\\n\\nAt the end of the initial phase (1-month), complete responders (quitters) will continue to receive RIM (subgroup F). Incomplete responders (smokers) will be second randomized to continue RIM (subgroup E) or receive PIM (subgroup D). Those who are unable to follow up at 1-month will be considered as nonresponsive to the intervention.', 'armGroupLabels': ['Control Group (subgroup D+E+F)']}\n- {'type': 'BEHAVIORAL', 'name': 'Second phase: personalized instant messaging (PIM)', 'description': 'For incomplete responders allocated to PIM (subgroup D), participants will receive the same intervention as the Group A delivered at the initial stage. Participants will receive two months of personalized interaction through IM application. Please refer to Intervention Group \"Initial phase: personalized instant messaging (PIM)\" for details.', 'armGroupLabels': ['Control Group (subgroup D+E+F)']}\n- {'type': 'BEHAVIORAL', 'name': 'AWARD advice', 'description': 'Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).', 'armGroupLabels': ['Control Group (subgroup D+E+F)', 'Intervention Group (subgroup A+B+C)'], 'otherNames': ['Ask, Warn, Advise, Refer, Do-it-again']}\n- {'type': 'BEHAVIORAL', 'name': 'Warning leaflet', 'description': 'The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation', 'armGroupLabels': ['Control Group (subgroup D+E+F)', 'Intervention Group (subgroup A+B+C)'], 'otherNames': ['Brief leaflet on health warning and smoking cessation']}\n- {'type': 'BEHAVIORAL', 'name': 'Referral card', 'description': 'The 3-folded \"Smoking Cessation Services\" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans', 'armGroupLabels': ['Control Group (subgroup D+E+F)', 'Intervention Group (subgroup A+B+C)'], 'otherNames': ['Smoking Cessation Service Card']}\n- {'type': 'BEHAVIORAL', 'name': 'COSH booklet', 'description': 'A general smoking cessation self-help booklet', 'armGroupLabels': ['Control Group (subgroup D+E+F)', 'Intervention Group (subgroup A+B+C)'], 'otherNames': ['COSH self-help smoking cessation booklet']}\n\nPrimary Outcomes:\n- {'measure': 'Validated abstinence of PIM + OCI vs. RIM + PIM', 'description': 'PIM + OCI (subgroup A+B+C) vs. RIM + PIM (subgroup D+E+F) on validated abstinence (exhaled CO \\\\< 4 ppm and salivary cotinine \\\\< 10 ng/ml)', 'timeFrame': '6-month follow-up'}\n- {'measure': 'Validated abstinence of OCI vs. RIM in incomplete responders', 'description': 'OCI (subgroup A) vs. RIM (subgroup E) in incomplete responders (those who are still smoking at 1-month) on validated abstinence (exhaled CO \\\\< 4 ppm and salivary cotinine \\\\< 10 ng/ml)', 'timeFrame': '6-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \n80% power with a 5% false-positive error rate with an allocation ratio of 1:1. For the second randomisation, using an allocation ratio of 3:1 with a 5% false-positive error rate, a power of 0.81.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n G*Power is used to calculate the sample size [39]. The required sample size is based on the primary comparison of validated quit rate at 6 months (Fig. 1, Subgroup A+B+C versus Subgroup D+E+F). A meta-analysis showed the risk ratio of mHealth intervention on smoking cessation for biochemically validated abstinence at 6 months was 1.83 [40]. Assuming a 6-month biochemically validated quit rate of 5.0% in the in the D+E+F subgroups, 1200 participants will be needed (600 in each group) to achieve 80% power with a 5% false-positive error rate with an allocation ratio of 1:1.\n In our previous mHealth trial, self-reported 7-day PPA at 1 month of the intervention and control group was 10.7% and 7.7%, respectively [6]. We estimate there will be 64 (= 600\u00c3\u009710.7%) and 46 (= 600\u00c3\u00977.7%) quitters for PIM and RIM groups at 1-month follow-up. Non-responders in the PIM (536, =600\u00e2\u0088\u009264) and RIM groups (554, =600\u00e2\u0088\u009246) will be reallocated by the second randomisation. Using an allocation ratio of 3:1 with a 5% false-positive error rate, a sample size of 402 (=536\u00c3\u00973/4) in subgroup A and 416 (=554\u00c3\u00973/4) in subgroup E has a power of 0.81 to test the co-primary outcome of validated quit rate at 6 months (Subgroup A versus Subgroup E).", "id": 518, "split": "train"} +{"trial_id": "NCT03994536", "pmid": "32295780", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project\n\nIncluded conditions:\n- Type 1 Diabetes\n\nStudy Armgroups:\n- {'label': 'Intervention group: transition program', 'type': 'EXPERIMENTAL', 'description': 'Participants come from two clinics and will be randomly allocated to this group. Participants will go through a transition program which will last for 2 years. The intervention will be performed by specialist nurses (transition coordinators) who meet the participants at three occasions during the study period and participants will be offered to meet peers with type 1 diabetes during an adolescent day.', 'interventionNames': ['Behavioral: A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project']}\n- {'label': 'Comparison group: Standard care', 'type': 'EXPERIMENTAL', 'description': 'Participants allocated to this group will receive usual care, which includes regular follow-up visits in pediatric diabetes outpatient clinics. Usual care can vary across the two clinics, however, they all include meetings with a nurse and a physician.', 'interventionNames': ['Other: Standard care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project', 'description': 'Behavioral: Transition program Participants will be part of a transition program that aim to prepare them for adult life and adult care wich includes eight key components: 1. A transition coordinator; 2. Education on diabetes, treatments, health behavior, dealing with school, friends; 3. Telephone availability; 4. Information about the adult diabetes service: 5. Guidance of parents; 6. Meeting with peers: 7. A person-centered transition plan; and 8. Preparation and transfer to adult diabetes service.', 'armGroupLabels': ['Intervention group: transition program']}\n- {'type': 'OTHER', 'name': 'Standard care', 'description': 'Participants allocated to this group will receive usual care, which includes regular follow-up visits in pediatric diabetes outpatient clinics. Usual care can vary across the two clinics, however, they all include meetings with a nurse and a physician.', 'armGroupLabels': ['Comparison group: Standard care']}\n\nPrimary Outcomes:\n- {'measure': 'Level of empowerment', 'description': 'Gothenburg Young Persons Empowerment Scale (GYPES) will be used to assess the level of empowerment. This scale was developed by the researchers involved in this study and has been tested in a previous cross sectional study in order to determine its psychometric properties in adolescents with congenital heart disease and type 1 diabetes.The five subscales measure: (a) self-perceived level of understanding of their disease (knowledge and understanding); (b) the capacity patients have to handle their disease (personal control); (c) the effect their illness has on their lives and sense of self (identity); (d) the capacity to make decisions along with the healthcare professional (shared decision-making); and (e) the ability to share their experiences and help others who are going through a similar situation (enabling others). The total score ranges from 15 to 75 points, with a higher score reflecting a higher level of empowerment.', 'timeFrame': 'Endpoint after 2.5 years from baseline'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided tests with alpha=0.05, power=80%, and a 10% dropout rate", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Proposed sample size\n Based on the primary outcome, we target an improved patient empowerment score of 5.25 points on a scale from 15 to 75 (ie, 0.5 SD).29 For two-sided tests with alpha=0.05 and power=80%, 63 patients are needed in each arm of the RCT. In order to compensate for a potential 10% dropout rate, 70 patients will be included in each arm. Given that the two paediatric diabetes outpatient clinics together have about 100 patients in each age cohort of adolescents, and considering a 70% participation rate, a 24-month recruitment period is needed to enrol 140 patients in study arm 1 and 2.", "id": 519, "split": "train"} +{"trial_id": "NCT03997682", "pmid": "34330854", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hands-Up Program: Protocol for a Feasibility Study of a Combined Exercise and Education Randomized Controlled Trial of a 6-week Intervention in People With a Distal Radius Fracture\n\nIncluded conditions:\n- Distal Radius Fracture\n- Osteoporosis\n\nStudy Armgroups:\n- {'label': 'Hands-Up Program', 'type': 'EXPERIMENTAL', 'description': 'Participants will be guided through a 45 minutes exercise program, set up as a group exercise class, with program modifications being made for each individual participant. In order to meet the requisite number of participants there will be approximately 4 cohorts of 10 participants. Immediately after the exercise class participants will attend a 30-minute educational session. The educational sessions will cover bone health principles, nutrition for bone health, osteoporosis practice guidelines, ways to self-monitor balance and lower extremity strength, impacts of physical activity, home hazard detection, hazards at work and in the community, postural effects on bone loading and fracture risk, and integrating physical activity in daily life. Nutritional education will emphasize the importance of calcium and vitamin D, sources of both diary and dairy free calcium, vitamin D supplements, the importance of protein, and meat and meat-free sources of protein.', 'interventionNames': ['Other: Hands-Up Program']}\n- {'label': 'Standard Care', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive usual care after a distal radius fracture. The standard care for a distal radius fracture will receive an assessment related to whether casting or surgery is necessary. The participant may be in a cast for 6 weeks with routine check up and x-rays to monitor the healing, at 3 months, 6 months and 12 months. The participant should receive some physical therapy related to restoring function of the hand and wrist.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Hands-Up Program', 'description': \"In addition to the usual care, being allocated to the intervention group would require the participant to attend an exercise and education program once their cast has been removed and they've restored some strength and function in their hand and wrist. The exercise portion of the intervention will focus on strength and balance training, with aspects of managing our distal radius fracture healing as well. The education will focus on learning about risk factors for a distal radius fracture, osteoporosis, exercise for adults, nutrition for adults and falls prevention strategies.\", 'armGroupLabels': ['Hands-Up Program']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of recruitment', 'description': 'Number of participants recruited in one year. Recruitment will be feasible if 74 participants are recruited within 12 months', 'timeFrame': '12 months'}\n- {'measure': 'Feasibility of Retention', 'description': 'number of participants that attend the final study visit. Feasibility will be met if 75% of participants attend the final study visit.', 'timeFrame': '12 months'}\n- {'measure': 'Feasibility of Adherence', 'description': 'Number of participants attending each exercise class. Feasibility will be met if the participant attends greater than 60% of the exercise classes', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated, but designed to provide sufficient data for pilot study and SGBA plan.", "answer": 74, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n A total of 74 participants, 32 in the Hands-Up group and 32 in the control group, is the sample size goal. The sample size was designed based on multiple papers and criteria for pilot studies,14 15 and to provide sufficient data to pilot our disaggregated SGBA plan.16 Given the predominance of women in this population we will specifically recruit men to aim for 40% of men participants, t supporting SGBA recommendations.", "id": 520, "split": "train"} +{"trial_id": "NCT03997708", "pmid": "38892525", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mediterranean Diet Adjusted to Low FODMAP Diet (MED-LFD) vs NICE Guidelines for Improving IBS Symptoms: a New Approach for Managing IBS\n\nIncluded conditions:\n- Irritable Bowel Syndrome With Diarrhea\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'ACTIVE_COMPARATOR', 'description': 'MED-LFD Diet (diet A) for 2 - 6 weeks. After this period there will be a reintroduction phase protocol that will last 6 - 8 weeks.', 'interventionNames': ['Other: Med-LFD']}\n- {'label': 'Group B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Diet according to guidelines from the National Institute for Health and Care Excellent (NICE) Managing IBS (diet B) for 4 weeks.', 'interventionNames': ['Other: Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Med-LFD', 'description': 'All participants of this group at phase 1 (elimination phase), will initially follow the Med- LFD (2-6 weeks). At phase 2 (reintroduction phase), patients will gradually reintroduce foods rich in FODMAPs (6-8 weeks) and test their tolerance. At phase 3 (maintenance phase), following the reintroduction of foods rich in FODMAPs, patients will follow an individualized diet based on their personal tolerance (a combination of high and low FODMAPs).', 'armGroupLabels': ['Group A']}\n- {'type': 'OTHER', 'name': 'Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS', 'description': 'All participants of this group will be informed to follow a diet based on the nutritional guidelines of the British National Institute for Health and Care Excellence (NICE) for Managing IBS for 4 weeks.', 'armGroupLabels': ['Group B']}\n\nPrimary Outcomes:\n- {'measure': 'Change of symptoms severity pre and post intervention using a specialized questionnaire.', 'description': 'IBS- SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS) with total scores ranging from 0 to 500, with higher scores indicating more severe symptoms. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (\\\\>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.', 'timeFrame': 'Baseline, 4 - 8 weeks and 6 months post intervention'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, significance level \u03b1 = 0.05, and 10% adjustment for non-adherence.", "answer": 108, "answer_type": "ACTUAL", "explanation": "2.11.1. Sample Size Calculation\n The sample size was calculated at 108 participants (54 per group) with expected values taken from the meta-analysis of Varju et al. [38] and a pre-specified statistical power of 80%, significance level \u00ce\u00b1 = 0.05, and 10% adjustment for non-adherence to detect a significant improvement in the primary outcome measure 100 vs. 59 points (estimated standard deviation = 60) in the MED-LFD and NICE groups, respectively.", "id": 521, "split": "train"} +{"trial_id": "NCT03998579", "pmid": "32842975", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Physical Rehabilitation Among Patients Undergoing Radical Cystectomy Due to Urinary Bladder Cancer - the CanMoRe Study\n\nIncluded conditions:\n- Urinary Bladder Cancer\n\nStudy Armgroups:\n- {'label': 'Individualized exercise', 'type': 'EXPERIMENTAL', 'description': 'The intervention group get a referral to physiotherapist in Primary Health Care in Stockholm County Council, close to where they live. Within the third week after discharge, the patients begin twelve weeks of biweekly exercise. The physical exercise is individually targeted aerobic and strength exercises, based on international recommendations for persons with cancer disease. The program is approved by resposible surgeons.', 'interventionNames': ['Other: The CanMoRe programme']}\n- {'label': 'Active control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral and written information of a home-based exercise programme and information of supportive techniques to improve physical activity', 'interventionNames': ['Other: Home exercise']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'The CanMoRe programme', 'description': 'An exercise intervention in Primary Health Care', 'armGroupLabels': ['Individualized exercise']}\n- {'type': 'OTHER', 'name': 'Home exercise', 'description': 'An active control group', 'armGroupLabels': ['Active control group']}\n\nPrimary Outcomes:\n- {'measure': 'Six-minute walk test', 'description': 'The test reproduces activity of daily living at a sub maximal level. Output: meters Score: 0-900.', 'timeFrame': 'Change from baseline to after 12 weeks intervention'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, type 1 error set at 0.05, and adjustments for stratification and dropout.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary outcome is physical function, evaluated with the validated 6MWT. Based on data from our pilot study [28], we calculate an increase in 100\u00e2\u0080\u0089m in the intervention group, 70\u00e2\u0080\u0089m in the control group and a standard deviation of 30\u00e2\u0080\u0089m. To obtain a statistical power of 80% with a type 1 error set at 0.05 32 patients are needed (16 in each group). However, as the test is highly correlated with sex and age [37] we will stratify the analysis and increase the sample size.\n For the secondary outcome readmissions due to complications, we will estimate 20% readmissions in the intervention group compared with the proportion of patients being readmitted today, which is 45% in the control group. To obtain a statistical power of 80% with a type 1 error of 0.05, 112 patients are needed (56 in each group). Taken all this into account and guard against dropout, 120 patients (60 in each group) will be included in the study.", "id": 522, "split": "train"} +{"trial_id": "NCT04003077", "pmid": "31574863", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adjuvant Laser Meridian Massage in Heroin Addicts With Methadone Treatment: an Observational Case-controlled Study\n\nIncluded conditions:\n- Heroin Dependence\n\nStudy Armgroups:\n- {'label': 'Laser meridian massage', 'type': 'EXPERIMENTAL', 'description': 'They are treated with laser meridian massage on the back including Bladder meridian and Governor vessel three times a week for 4 weeks.', 'interventionNames': ['Device: laser meridian massage']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'A control group of participants without laser meridian massage treatment are matched by age.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'laser meridian massage', 'description': 'The participants will undergo 12 sessions of laser meridian massage, thrice a week, for 4 weeks, using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810nm; area of probe, 0.5cm\\\\^2; power density, 300mW/cm\\\\^2; pulsed wave; RJ-Laser, Reimers \\\\& Janssen GmbH, Waldkirch, Germany). The laser treatment will be applied to the back including Bladder meridian (BL11-25) and Governor vessel (GV3-14) for 15 minutes, to deliver a total treatment dose of 67.5J/cm\\\\^2.', 'armGroupLabels': ['Laser meridian massage']}\n\nPrimary Outcomes:\n- {'measure': 'Heroin use', 'description': 'Times or days of heroin use during last week', 'timeFrame': '2 weeks of treatment'}\n- {'measure': 'Heroin use', 'description': 'Times or days of heroin use during last week', 'timeFrame': '4 weeks of treatment'}\n- {'measure': 'Urine morphine', 'description': 'Obtainurinary morphine concentration', 'timeFrame': '2 weeks of treatment'}\n- {'measure': 'Urine morphine', 'description': 'Obtain urinary morphine concentration', 'timeFrame': '4 weeks of treatment'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level (\u03b1) of 0.05, desired power (1\u2212\u03b2) of 0.80, 7% dropout rate", "answer": 30, "answer_type": "ESTIMATED", "explanation": "2.4\n Sample size\n A sample size of 28 was calculated to be needed based on 2-way repeated-measures analysis of variance with a medium effect size of 0.25, a significance level (\u00ce\u00b1) of 0.05, and a desired power (1\u00e2\u0088\u0092\u00ce\u00b2) of 0.80.[13] Anticipating a 7% dropout rate, a total of 30 study participants will need to be recruited.", "id": 523, "split": "train"} +{"trial_id": "NCT04007952", "pmid": "35907909", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair\n\nIncluded conditions:\n- Paraesophageal Hernia\n- Hiatal Hernia Large\n\nStudy Armgroups:\n- {'label': 'Intervention 1 (Control)', 'type': 'NO_INTERVENTION', 'description': 'No anterior gastropexy will be performed.'}\n- {'label': 'Intervention 2 (Treatment)', 'type': 'EXPERIMENTAL', 'description': 'Anterior gastropexy will be performed.', 'interventionNames': ['Procedure: Anterior Gastropexy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Anterior Gastropexy', 'description': 'Two permanent sutures will be introduced into the abdomen and placed along the lesser curvature of the stomach. A suture passer will be used to grasp the ends of the sutures to externalize them at separate fascial punctures. At time of abdominal desufflation, the sutures will be tied and the incision closed per individual surgeon practice.', 'armGroupLabels': ['Intervention 2 (Treatment)']}\n\nPrimary Outcomes:\n- {'measure': 'Paraesophageal Hernia Recurrence', 'description': 'Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \n20% rate of loss to follow-up, 80% power, two-sided chi-square test, alpha level of 5%, proportion of recurrences in the control group estimated to be 0.24.", "answer": 240, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Assuming a 20% rate of loss to follow-up, enrollment of 240 participants with 120 participants in each arm will provide at least 80% power for showing superiority of anterior gastropexy to no anterior gastropexy for the primary endpoint of decreased recurrence rates by 15% at the 1-year postoperative visit using a two-sided chi-square test and an alpha level of 5%. For the purpose of calculating the power of this study, the proportion of recurrences in the control group (no anterior gastropexy) is estimated to be 0.24. This is based on the reported recurrence rates for paraesophageal hernia repair without gastropexy, ranging from 7 to 66% [3, 16, 21\u00e2\u0080\u009324], with the majority falling between 13 and 42% [3, 16, 23, 24] at various time points after surgery.", "id": 524, "split": "train"} +{"trial_id": "NCT04009811", "pmid": "35303932", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A New Membrane Obturator Prothesis Concept for Soft Palate Defects\n\nIncluded conditions:\n- Mouth Neoplasms\n- Velopharyngeal Insufficiency\n- Speech Disorders\n- Deglutition Disorders\n\nStudy Armgroups:\n- {'label': 'Suersen obturator then membraneous obturator', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Suersen and membraneous obturators evaluation']}\n- {'label': 'Membraneous obturator then Suersen obturator', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Suersen and membraneous obturators evaluation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Suersen and membraneous obturators evaluation', 'description': 'The patient will wear one month each obturator prothesis (Suersen and membraneous obturators). The order of evaluation will be randomized in two arms.\\n\\nHalf of patient will first wear one month the membranous obturator then one month the Suersen, the other half of patient will first wear one month the Suersen obturator and one month the membranous obturator.', 'armGroupLabels': ['Membraneous obturator then Suersen obturator', 'Suersen obturator then membraneous obturator']}\n\nPrimary Outcomes:\n- {'measure': 'Voice Handicap Index (VHI) overall score', 'description': 'Min : 0 = Non handicap to Max : 120 = voice handicap maximum', 'timeFrame': 'Visit M2 : one month after first obturator supply i.e. two months after inclusion'}\n- {'measure': 'Voice Handicap Index (VHI) overall score', 'description': 'Min : 0 = Non handicap to Max : 120 = voice handicap maximum', 'timeFrame': 'Visit M3 : one month after second obturator supply i.e. three months after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, alpha risk of 5%, no drop-out included due to the small duration of the study follow-up (3 months).", "answer": 4, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Sample size calculation is based on the average comparison of crossover tests: the t-test for difference of means in 2 \u00c3\u0097 2 crossover design (N-Query software). We assume that the use of the rigid obturator will be associated with a mean VHI score of 34 and a standard deviation of 15 [14, 15]. To ensure a power of 90%, an alpha risk of 5%, and an expected difference of 15 points between the reference and new obturator, 7 patients per treatment sequence are required, thus 14 in all. No drop-out was included in the sample size calculation due to the small duration of the study follow-up (3 months).", "id": 525, "split": "train"} +{"trial_id": "NCT04010149", "pmid": "33243286", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Impact of Concurrent Brain Stimulation and Working Memory Training on Cognitive Performance in Acquired Brain Injury\n\nIncluded conditions:\n- Acquired Brain Injury\n\nStudy Armgroups:\n- {'label': 'Active tDCS', 'type': 'EXPERIMENTAL', 'description': 'During cognitive training in the first 2 weeks, participants will also received brain stimulation. The investigators will use a total current intensity of 2mA for 20 minutes, preceded by 30 seconds ramping up and followed by 30 seconds ramping down (total stimulation time = 21s).', 'interventionNames': ['Device: Active tDCS']}\n- {'label': 'SHAM tDCS', 'type': 'SHAM_COMPARATOR', 'description': 'During sham stimulation, concurrent with the cognitive training, The investigators will use the same setup as in the active condition but after ramping up, the current will be brought back to zero and the process repeated 30 seconds before the end of the 21 minutes time interval (total sham stimulation time = 21s).', 'interventionNames': ['Device: SHAM tDCS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Active tDCS', 'description': 'For the first two weeks of the study, participants will receive 20 min of brain stimulation, concurrent with cognitive training. Electrodes will be placed over the dorsolateral prefrontal cortex (active electrode), and the contralateral supraorbital site (return electrode).', 'armGroupLabels': ['Active tDCS']}\n- {'type': 'DEVICE', 'name': 'SHAM tDCS', 'description': 'For the first two weeks of the study, participants will receive 20 min of SHAM brain stimulation, concurrent with cognitive training. Electrodes will be placed over the dorsolateral prefrontal cortex (active electrode), and the contralateral supraorbital site (return electrode).', 'armGroupLabels': ['SHAM tDCS']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in memory capacity, as measured by number of items that are memorised successfully, in the cognitive task used as the training regime\u037e', 'description': 'The difficulty of the training regime is manipulated by increasing N, i.e. the number of items the participant is requested to memorise. As such, N is used to measure individual memory capacity. Changes in memory capacity, as the training regime progresses is the primary outcome measure of this study.', 'timeFrame': 'On day1, at end of week 2, at end of week 5 and at end of week 9'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (alpha) is set at 0.05, and the power is set at 0.80. A post hoc power analysis will be conducted to assess the appropriateness of the sample size for detecting differences in a clinical population.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The chosen sample size is based partly on the available literature that examines the effects of cognitive training on healthy young and older volunteers and additional pilot data collected in our laboratory from healthy young and elderly adults. Specifically, a statistical power analysis was performed for sample size estimation, based on data from Au et al. [39], comparing the ACTIVE (right-tDCS, 20 subjects) to the CONTROL (SHAM, 22 subjects) group. The effect size (ES) in this study was 0.73, considered to be medium to large using Cohen\u00e2\u0080\u0099s criteria [55]. With an alpha\u00e2\u0080\u0089=\u00e2\u0080\u0089.05 and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80, the projected sample size needed with this effect size (GPower 3.1) is approximately N\u00e2\u0080\u0089=\u00e2\u0080\u008948 for this simplest between group comparison.\n Evidence has shown that individuals with low initial performance respond better to brain stimulation [56]. As we expect ABI patients in our sample to have low baseline performance, due to our selection criteria, we may also expect them to respond better to the intervention, therefore showing larger effects. Assuming, as explained above, that larger effects could reasonably be expected in a clinical population, our proposed sample size of 40 will be adequate for the main objective of this study. A post hoc power analysis will be conducted to assess if the sample size is appropriate to detect differences in a clinical population such as ABI.", "id": 526, "split": "train"} +{"trial_id": "NCT04010630", "pmid": "37591655", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sodium Bicarbonate for the Treatment of Severe Metabolic Acidosis With Moderate or Severe Acute Kidney Injury in the Critically Ill: a Randomized Clinical Trial\n\nIncluded conditions:\n- Metabolic Acidosis\n- Acute Kidney Injury\n\nStudy Armgroups:\n- {'label': 'control group', 'type': 'NO_INTERVENTION', 'description': 'The physicians will resuscitate the patients according to the current critical care medicine guidelines.'}\n- {'label': 'Sodium bicarbonate group', 'type': 'EXPERIMENTAL', 'description': \"Patients randomly assigned to bicarbonate group will receive intravenous 4.2% sodium bicarbonate titrated from 125ml to 250ml in 30min at physician's discretion to target a pH equal or above 7.30. Bicarbonate infusion will be repeated up to 1000ml per 24h. Arterial blood gases will be repeated from 3 to 6 times during the first 24h at physician's discretion\", 'interventionNames': ['Drug: Sodium bicarbonate infusion']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sodium bicarbonate infusion', 'description': \"Patients randomly assigned to bicarbonate group will receive intravenous 4.2% sodium bicarbonate titrated from 125ml to 250ml in 30min at physician's discretion to target a pH equal or above 7.30. Bicarbonate infusion will be repeated up to 1000ml per 24h. Arterial blood gases will be repeated from 3 to 6 times during the first 24h at physician's discretion.\\n\\nBicarbonate infusion recommendations will be as follow: a central line is recommended, infusion will be slow (125-250ml in 30 min, no intravenous push), careful surveillance of metabolic alkalosis, cardiogenic pulmonary edema, kalemia, natremia and calcemia. Repeated arterial blood gases will be suggested to monitor these critically ill patients and physicians will be reinformed of the potential side effects of sodium bicarbonate infusion.\", 'armGroupLabels': ['Sodium bicarbonate group']}\n\nPrimary Outcomes:\n- {'measure': 'Day 90 all-cause mortality', 'description': 'Day 90 all cause mortality', 'timeFrame': 'Day 90'}\n\nPlease estimate the sample size based on the assumption: \nThe trial is designed for 80% power with a two-sided alpha level of 0.05. It assumes less than 8% non-analyzable patients and includes two interim analyses with a p value threshold of 0.001 for interim analyses and 0.05 for the final analysis (Haybittle-Peto boundary).", "answer": 640, "answer_type": "ACTUAL", "explanation": "Sample size\n Based on the BICARICU-1 trial where day 90 mortality was 81% in the control group and 64% in the bicarbonate group (post hoc analysis of BICARICU-1 trial,17) in the population of interest for the BICARICU-2 trial (severe metabolic acidosis and severe acute kidney injury in the critically ill patients), we calculated that a total of 588 patients would be needed for 80% power to show an absolute between-groups difference of 10% in the primary outcome (day 90 all-cause mortality) at a two-sided alpha level of 0.05 (overall p value for the trial), assuming that the administration of bicarbonate would be associated with a day 90 mortality of 70% vs 80% in the control group. Assuming less than 8% non-analyzable patients (lost to follow-up or consent withdrawal; the same rate as in the BICARICU-1 trial), we plan to enrol 640 patients. Two interim analyses are planned. Assuming the overall p value for the trial is 0.05, p value threshold is 0.001 for the two interim analyses and 0.05 for the final analysis (Haybittle-Peto boundary).", "id": 527, "split": "train"} +{"trial_id": "NCT04010851", "pmid": "33268416", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of a Peer Co-led Educational Programme for Parents of Children With ADHD: A Feasibility Randomized Controlled Trial\n\nIncluded conditions:\n- Attention Deficit Disorder With Hyperactivity\n\nStudy Armgroups:\n- {'label': 'Peer co-led educational group', 'type': 'EXPERIMENTAL', 'description': \"The intervention delivered in a group format is added to treatment as usual. After the parents participate in the one day-intervention, they can continue in self-help groups, which meet once a week for a 2-hour evening session. User representatives lead these weekly self-help groups, which do not require user-fees and aim to offer practical tools, support and information to increase the parent's skills, knowledge and confidence.\", 'interventionNames': ['Behavioral: Peer co-led educational group']}\n- {'label': 'Control group', 'type': 'OTHER', 'description': 'The control goup will receive treatment as usual.', 'interventionNames': ['Behavioral: Comparator treatment as usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Peer co-led educational group', 'description': \"The intervention is delivered in a group format, which takes the form of a full day's training, focusing on ADHD diagnosis, its treatment, how to cope with the challenges related to living with ADHD, as well as coping with challenges of parenting a child with chronic health conditions. After this one day-intervention, the participants can continue in self-help groups, which meet once a week for a 2-hour evening session. User representatives lead these weekly self-help groups, which do not require user-fees and aim to offer practical tools, support and information to increase the parent's skills, knowledge and confidence. Participants are encouraged to adopt an active role in order to achieve a positive parent/provider partnership.\", 'armGroupLabels': ['Peer co-led educational group']}\n- {'type': 'BEHAVIORAL', 'name': 'Comparator treatment as usual', 'description': 'Control group will receive treatment as usual, including different treatment options that can help alleviate the symptoms of ADHD and arm families with the tools needed to better handle problem behaviors when they arise. These interventions include: medication, psychotherapy, or a combination of these two approaches.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of recruitment', 'description': 'Feasibility of recruitment will be assessed by determining the recruitment rate, by monitoring patient screening and subsequent agreement to participate.', 'timeFrame': 'Over a two year study period'}\n- {'measure': 'Satisfaction with the intervention', 'description': 'Parent satisfaction will be measured by means of the client satisfaction Questionnaire, CSQ-3 as it applies to the group-based educational programme. The scale comprises three items measured on a scale from 1 (not satisfied) to 4 (very satisfied).', 'timeFrame': 'From baseline to 12- and 52-weeks follow-up'}\n- {'measure': 'Parental activation', 'description': \"Parental activation will be measure with the P-PAM-13. The 13-items P-PAM has four possible response options ranging from (1) strongly disagree, to (4) strongly agree, and an additional 'not applicable' option.\", 'timeFrame': 'From baseline to 12- and 52-weeks follow-up'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size and statistical power calculation\n The sample size in this study is related to the number of patients required for enrolment, opinions about the questionnaires and satisfaction with the intervention. Consequently, the anticipated sample will be 50 parents, that is, 25 parents in each arm.", "id": 528, "split": "train"} +{"trial_id": "NCT04010890", "pmid": "34488853", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Development and Evaluation of Culturally Adapted CBT to Improve Community Mental Health Services for Canadians of South Asian Origin\n\nIncluded conditions:\n- Depression\n- Anxiety\n\nStudy Armgroups:\n- {'label': 'Culturally adapted CBT', 'type': 'EXPERIMENTAL', 'description': 'Ca_CBT will be delivered to the experimental group using the newly developed manual . The intervention will be delivered over 8-12 sessions. The Control group will receive standard CBT', 'interventionNames': ['Behavioral: Culturally adapted CBT']}\n- {'label': 'Standard CBT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in this group will receive standard CBT', 'interventionNames': ['Behavioral: Culturally adapted CBT']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Culturally adapted CBT', 'description': 'Culturally adapted CBT for South Asian Canadians', 'armGroupLabels': ['Culturally adapted CBT', 'Standard CBT'], 'otherNames': ['CaCBT']}\n\nPrimary Outcomes:\n- {'measure': 'Hospital Anxiety and Depression Scale', 'description': 'HADS is a 14-item, self-assessment scale designed to measure anxiety and depression. The maximum score is 21 for depression and 21 for anxiety. A score of 8 - 10 suggests the presence of the borderline cases, while a score of 11 - 21 indicates abnormal cases.', 'timeFrame': '36 weeks'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level, 90% power, and up to 30% attrition rate.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated using a comparison between group change in the HADS Depression subscale scores. With a 5% significance level and 90% power, we determined that 48 subjects per group will be required for the trial, in order to detect a standardized effect size Cohen\u00e2\u0080\u0099s d = 0.68, which is equivalent to a difference in HADS score at the end of the trial of around 2.4 points, assuming a standard deviation of 3.5 found in previous studies from our lab that used the same outcome. To account for up to 30% attrition, we plan to recruit a total of 140 participants into the study.", "id": 529, "split": "train"} +{"trial_id": "NCT04011267", "pmid": "31931855", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-I) Randomized Controlled Trial\n\nIncluded conditions:\n- Diabetic Neuropathies\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Patients in the intervention group will perform foot-related exercises described in the SOPeD software three times/week at home via web-software. In the follow-up period, patients will follow the same schedule set by the project till the end of the study.', 'interventionNames': ['Other: Physical therapy by foot-ankle segmental and functional exercises']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Physical therapy by foot-ankle segmental and functional exercises', 'description': 'The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Diabetic neuropathy symptoms at 12-weeks', 'description': 'Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the diabetic neuropathy).', 'timeFrame': '12-weeks, 24-weeks (follow-up)'}\n- {'measure': 'Change from Baseline of the Fuzzy classification of the diabetic neuropathy severity at 12-weeks', 'description': 'The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture, available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.', 'timeFrame': '12-weeks, 24-weeks (follow-up)'}\n\nPlease estimate the sample size based on the assumption: \nA statistical power of 0.80, an alpha of 0.05, and an effect size of 0.20 were used. The statistical design included F-test repeated measures and interaction between and within factors with two repeated measures and two study groups. A drop-out rate of 20% was estimated.", "answer": 62, "answer_type": "ACTUAL", "explanation": "Sample size and statistical analyses\n The sample calculation was performed using the GPower v.3.1 program [60]. Two outcomes of extreme functional importance for patients with DPN were used to calculate the sample size. Considering the primary outcome (DPN symptoms), a medium effect size (0.52) was adopted and, for the secondary outcome (peak pressure at forefoot), a small effect size (0.20) was adopted. Both effect sizes were taken from the study by Sartor et al. [30] which evaluated the effect of a 12-week supervised physical therapy exercise in patients with DPN. In order to obtain the largest sample size, the smallest effect size (0.20) was used. A statistical design of F-test repeated measures and interaction between and within factors with two repeated measures and two study groups, a statistical power of 0.80, an alpha of 0.05, and an effect size of 0.20 were used for the sample size calculation. The resulting sample size was 52 individuals. A final sample size of 62 patients was then chosen after estimating a drop-out rate of 20%.\n The inferential statistical analysis will be based on an intention-to-treat analysis and per-protocol analysis. Mixed general linear models of analysis of variance for repeated measure will be used to detect treatment\u00e2\u0080\u0093time interactions (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00895%), and the Newman\u00e2\u0080\u0093Keuls post hoc test will be used to obtain group effect (intervention group and control group), time effect (between T0 and T12), and group\u00e2\u0080\u0093time interaction. Effect sizes (Cohen\u00e2\u0080\u0099s d coefficient) will also be provided between T0 and T12 and between T12 and T24 to determine if the intervention shows any treatment effect. The difference between the means with their respective 95% confidence intervals will also be calculated. Imputation of any missing data for the analyzed variables will be conducted depending on the nature of the losses: missing completely at random, missing at random, or missing not at random. The per-protocol analysis will include only those patients who completed follow-up in the allocated intervention group. If there is evidence that the difference in the treatment depends on certain patient characteristics identified in the baseline assessment, a subgroup analysis will be performed.", "id": 530, "split": "train"} +{"trial_id": "NCT04011579", "pmid": "39899835", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multiple Sclerosis Fitness Intervention Training With Pilates Exercises\n\nIncluded conditions:\n- Multiple Sclerosis\n- Physical Activity\n\nStudy Armgroups:\n- {'label': 'MSFIT', 'type': 'EXPERIMENTAL', 'description': 'The MSFIT group will self-manage Pilates exercises at-home through a tool based on XBox Kinect for 12 weeks, performing at least 3 sessions/week for a total of 30 minutes of exercises for each session(also distributed during the day with a minimum slot of 10 minutes). No rehabilitative interventions except sphincter and speech rehabilitation and psychological support, are admitted for the 12 weeks of participation to the project and the following 6 weeks before Follow-up evaluations (a total of 18 weeks). The execution of unspecific physical activities, if not already practiced, will be suggested to the participants.', 'interventionNames': ['Other: MSFIT']}\n- {'label': 'CTRL', 'type': 'NO_INTERVENTION', 'description': 'No rehabilitative interventions except sphincter and speech rehabilitation and psychological support, are admitted for the 12 weeks of participation to the project and the following 6 weeks before Follow-up evaluations (a total of 18 weeks). The execution of unspecific physical activities, if not already practiced, will be suggested to the participants.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'MSFIT', 'description': 'MSFIT, by using the Microsoft Kinect Motion Controller Xbox to deliver adapted physical activity, offers the possibility to transform the Pilates exercises into a virtual reality game. Each exercise is implemented with different levels of difficulty in order to allow the adaptation to the capacities of the user.', 'armGroupLabels': ['MSFIT']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Timed Up & Go (TUG)', 'description': 'The Timed \"Up and Go\" Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down.', 'timeFrame': 'T0: before intervention; T1: after 12 weeks of intervention; T2: 6 weeks after T1'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a significance level (2-sided) of 5%, and a potential loss of 15% of patients at follow-up.", "answer": 126, "answer_type": "ACTUAL", "explanation": "Sample Size\n The sample size was calculated by referring to the TUG change after a Pilates intervention found by Kalron et al [30] in a group of people with MS. The authors found no difference between the group receiving the Pilates intervention and the control group receiving an intervention of physical therapy. The Pilates group improved the TUG performance by about 1.8 seconds, which is clinically relevant for people with MS. Considering a variability of about 3.4 seconds, a power of 80%, a significance level (2-sided) of 5%, and a potential loss of 15% of patients at follow-up, the estimation of the necessary sample size consists of approximately 63 participants for the experimental group (a total of 126).", "id": 531, "split": "train"} +{"trial_id": "NCT04012177", "pmid": "34980232", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women to Improve Birth Outcomes in the Peri-urban Slums of Karachi, Pakistan -a Randomized Controlled Trial\n\nIncluded conditions:\n- Undernutrition\n\nStudy Armgroups:\n- {'label': 'Control Arm', 'type': 'NO_INTERVENTION', 'description': 'Arm-A: Standard antenatal care (ANC) counseling, service provision and nutrition counseling (World Health Organization (WHO) standard)'}\n- {'label': 'Nutrition only Arm', 'type': 'EXPERIMENTAL', 'description': 'Arm-B:Balanced-energy protein (BEP), ready-to-use utrition supplement for at least 6 months + Standard ANC counseling, service provision and nutrition counseling (WHO standard)', 'interventionNames': ['Dietary Supplement: Balanced-energy protein (BEP)']}\n- {'label': 'Nutrition plus Azithromycin Arm', 'type': 'EXPERIMENTAL', 'description': 'Arm-C:Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + 2000 mg of Azithromycin at week 20 and 28 of pregnancy + Standard ANC counseling, service provision and nutrition counseling (WHO standard).', 'interventionNames': ['Dietary Supplement: Balanced-energy protein (BEP)', 'Drug: Azithromycin Tablets']}\n- {'label': 'Nutrition plus Choline and Nicotinamide Arm', 'type': 'EXPERIMENTAL', 'description': 'Arm-D: Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + Choline 450 and Nicotinamide 100 mg (1 each once daily orally starting from week 20 until birth outcome) + Standard ANC counseling, service provision and nutrition counseling (WHO standard).', 'interventionNames': ['Dietary Supplement: Balanced-energy protein (BEP)', 'Drug: Azithromycin Tablets', 'Drug: Choline Bitartrate', 'Drug: Nicotinamide']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Balanced-energy protein (BEP)', 'description': 'Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.', 'armGroupLabels': ['Nutrition only Arm', 'Nutrition plus Azithromycin Arm', 'Nutrition plus Choline and Nicotinamide Arm'], 'otherNames': ['Ready-to-use-supplementary food (RUSF)']}\n- {'type': 'DRUG', 'name': 'Azithromycin Tablets', 'description': 'Pregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy.', 'armGroupLabels': ['Nutrition plus Azithromycin Arm', 'Nutrition plus Choline and Nicotinamide Arm'], 'otherNames': ['Zetro']}\n- {'type': 'DRUG', 'name': 'Choline Bitartrate', 'description': 'Pregnant women randomized in Arm D will received 450 mg of Choline orally once daily, starting from week 20 weeks of pregnancy until birth outcome', 'armGroupLabels': ['Nutrition plus Choline and Nicotinamide Arm'], 'otherNames': ['Choline']}\n- {'type': 'DRUG', 'name': 'Nicotinamide', 'description': 'Pregnant women randomized in Arm D will received 100 mg of Nicotinamide orally once daily, starting from week 20 weeks of pregnancy until birth outcome', 'armGroupLabels': ['Nutrition plus Choline and Nicotinamide Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Birth weight of newborn', 'description': 'Weight of the newborn assess in gram to assess the difference among four arms', 'timeFrame': 'To be assessed within 72 hours of birth'}\n\nPlease estimate the sample size based on the assumption: \n1-tailed hypothesis testing, significance level of 2.5%, 21% dropout rate, 80% power, family-wise error rate of 0.05, Bonferroni method for three comparisons, alpha of 0.017.", "answer": 1884, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size is calculated via permutation and subsequent adjustment for three comparisons between arms, i.e., intervention arms with control. Improved perinatal outcomes are hypothesized with the supplement of BEP alone or co-administration of BEP supplement with azithromycin as well as with nicotinamide and choline. Thus, the sample size estimated per arm is based on 1-tailed hypothesis testing of birth weight as the primary outcome, a significance level of 2.5% to account for multiple comparisons, and initial assumption of dropout proportion of 21% of study participants assumed in the trial. For birth weight (the primary outcome), it is assumed that the mean difference will be at least 100 g [30]. In order to achieve a test power of 80% and maintain family-wise error rate (FWER) of 0.05; Bonferroni method for three comparisons, alpha of 0.017, and an estimated sample size of 370 pregnant women per arm was attained. A 21% dropout rate was thereafter considered on account of miscarriages, stillbirths, early neonatal deaths, losses to follow-ups, and missed birth assessments due to varying on-field challenges owing to the pandemic. Hence, the sample size was thereafter adjusted to 471 pregnant women in each arm making up a total of 1884 pregnant women for this trial.", "id": 532, "split": "train"} +{"trial_id": "NCT04014452", "pmid": "32792427", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Severe Complicated Monochorionic Pregnancies in the Peking University Third Hospital : A Pilot Randomised Controlled Trial\n\nIncluded conditions:\n- Twin; Complicating Pregnancy\n- Microwave Ablation\n\nStudy Armgroups:\n- {'label': 'Microwave ablation group', 'type': 'EXPERIMENTAL', 'description': 'Microwave ablation is used for the treatment of Complicated Monochorionic Pregnancies', 'interventionNames': ['Procedure: Microwave ablation']}\n- {'label': 'Radiofrequency ablation group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Radiofrequency ablation is used for the treatment of Complicated Monochorionic Pregnancies', 'interventionNames': ['Procedure: Radiofrequency ablation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Microwave ablation', 'description': 'Use of microwave energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.', 'armGroupLabels': ['Microwave ablation group']}\n- {'type': 'PROCEDURE', 'name': 'Radiofrequency ablation', 'description': 'Use of radiofrequency energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.', 'armGroupLabels': ['Radiofrequency ablation group']}\n\nPrimary Outcomes:\n- {'measure': 'Neonatal survival rate', 'description': 'The proportion of live births at 28 days postpartum', 'timeFrame': 'a month after delivery'}\n\nPlease estimate the sample size based on the assumption: \n5% (two-sided) type I error, 80% power, 10% non-inferiority margin.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n The purpose of this pilot RCT is to explore the feasibility and evaluate the efficacy and safety of MWA reduction for severe complicated monochorionic pregnancies. According to previous studies, the rate of neonatal survival at 28 days of RFA ranged from 63.6% to 88.6% (average 76.0%). Based on the preliminary date of our department, the rate of neonatal survival at 28 days was nearly 73.3% in patients treated with MWA. Thus, a sample size of 878 patients (439 in each group) would be required with a 5% (two-sided) type I error and a power of 80% using a 10% non-inferiority margin. However, based on the feasibility and the intent to provide pilot dates to full sample sizes and statistical plans, 30 participants in each group and a total of 60 participants will be recruited for this trial.", "id": 533, "split": "train"} +{"trial_id": "NCT04015999", "pmid": "32066412", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Microbiota-directed Complementary Food (MDCF) Trial\n\nIncluded conditions:\n- Microbiota\n- Complementary Food\n- Nutrition\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'MDCF2 with four complementary food ingredients (rationale: lead with evidence from Pre-POC clinical trials to optimize lead microbiota-directed complementary food prototypes for their ability to repair microbiota immaturity and positive effects on growth)', 'interventionNames': ['Dietary Supplement: Microbiota Directed Complementary Food (MDCF)']}\n- {'label': 'Control arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Rice-lentil based RUSF (rationale: reference standard of care for MAM; based on knowledge of its effects on the gut microbiota or microbiota immaturity)', 'interventionNames': ['Dietary Supplement: Ready to Use Supplementary Food (RUSF)']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Microbiota Directed Complementary Food (MDCF)', 'description': 'MDCF2 with four complementary food ingredients (rationale: lead with evidence from Pre-POC clinical trials to optimize lead microbiota-directed complementary food prototypes for their ability to repair microbiota immaturity and positive effects on growth)', 'armGroupLabels': ['Intervention arm']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Ready to Use Supplementary Food (RUSF)', 'description': 'Rice-lentil based RUSF (rationale: reference standard of care for MAM; based on knowledge of its effects on the gut microbiota or microbiota immaturity)', 'armGroupLabels': ['Control arm']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Ponderal growth', 'description': 'Rate of weight gain of the enrolled participants', 'timeFrame': 'At the enrollment (day1), every 15 days during the 3 months of intervention phase and at the end of 1 month of follow up phase by anthropometry'}\n- {'measure': 'Change in Linear growth (LAZ),', 'description': 'Rate of skeletal human growth', 'timeFrame': 'At the enrollment (day1), every 15 days during the 3 months of intervention phase and at the end of q month of follow up phase by anthropometry'}\n- {'measure': 'Change in Proteomic profile', 'description': 'Information about all proteins that are made in blood, other body fluids, or tissues, at certain times. It will be assayed by Somalogic scan.', 'timeFrame': 'A total of 3 Plasma samples will be collected, just before the start of intervention phase, at the end of first month of intervention phase and just after the completion of 3rd month.'}\n- {'measure': 'Change in Morbidity', 'description': 'Refers to having a disease or a symptom of disease. It will be assessed by taking morbidity data.', 'timeFrame': 'Data will be collected every day during the 3 months of intervention phase and once at the end of 1 month of follow up phase.'}\n- {'measure': 'Change in microbiota-for-age Z score', 'description': \"Bacterial species whose proportional representation define a healthy gut microbiota as it assembles during the first two postnatal years of life.'Microbiota-for-age-Z-score' compares development of a child's fecal microbiota relative to healthy children of similar chronologic age.\", 'timeFrame': 'At the enrollment, at the beginning of the intervention phase, weekly during the 1st month of intervention, at the end of 2nd and 3rd months of intervention and at the end of 1 month of follow up phase.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, and 20% attrition rate.", "answer": 124, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Primary outcome measures will include rate of weight gain, change in weight and length; change in WLZ, change in MUAC, change in LAZ, morbidity, extent of repair of gut microbial community immaturity, and changes in the levels of key plasma biomarkers of host physiological state. We plan to include 124 participants (n\u00c2\u00a0=\u00e2\u0080\u008962/treatment arm) for the primary MAM trial and for the post-SAM MAM trial. Recruitment of 124 participants will give 80% power at 5% significance level based on the change in WLZ scores of children from the recently completed pre-POC trial of different MDCFs. In the pre-POC trial of different MDCFs, the baseline WLZ score of children who received MDCF 2 was \u00e2\u0088\u0092\u00e2\u0080\u00892.2 and after 1 month of supplementation was \u00e2\u0088\u0092\u00e2\u0080\u00891.7. If we consider the WLZ \u00e2\u0088\u0092\u00e2\u0080\u00892 at baseline and\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00891.7 at end line, pooled standard deviation as 0.53, then the sample size would be 49 in each arm at 80% power and 5% level of significance. With 20% attrition, 62 enrolled children will be needed for each arm in each of the two trials.", "id": 534, "split": "train"} +{"trial_id": "NCT04017598", "pmid": "32801202", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Is Iron Supplementation Harmful in Populations Where Iron Deficiency is Not the Cause of Anemia? A 12 Week Randomized Controlled Trial in Cambodia\n\nIncluded conditions:\n- Anemia, Iron Deficiency\n- Anemia\n- Intestinal Inflammation\n- Inflammation\n- Intestine; Complaints\n\nStudy Armgroups:\n- {'label': 'Ferrous Sulfate', 'type': 'ACTIVE_COMPARATOR', 'description': 'Iron will be given orally in the form of tablets. A supplement of 60 mg will be taken daily for 12 weeks. World Health Organization standard dose and commonly used form of iron.', 'interventionNames': ['Dietary Supplement: Ferrous sulfate']}\n- {'label': 'Ferrous Bisglycinate', 'type': 'EXPERIMENTAL', 'description': 'Iron will be given orally in the form of tablets. A supplement of 18 mg will be taken daily for 12 weeks. Ferrous bisglycinate has a bioavailability 2-4x greater than ferrous sulfate.', 'interventionNames': ['Dietary Supplement: Ferrous Bisglycinate']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo will be given orally in the form of tablets as a control made of microcrystalline cellulose.', 'interventionNames': ['Dietary Supplement: Placebo of microcrystalline cellulose']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Ferrous sulfate', 'description': '60 mg elemental iron as ferrous sulfate', 'armGroupLabels': ['Ferrous Sulfate'], 'otherNames': ['iron sulfate', 'ferrous sulphate', 'iron sulphate', 'Iron(II) sulfate']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Ferrous Bisglycinate', 'description': '18 mg elemental iron as ferrous bisglycinate', 'armGroupLabels': ['Ferrous Bisglycinate'], 'otherNames': ['iron amino acid chelate', 'Iron glycinate', 'Bisglycine iron(II) salt', 'Iron(II) bisglycinate', 'Ferrous Bis-glycinate']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo of microcrystalline cellulose', 'description': 'placebo', 'armGroupLabels': ['Placebo'], 'otherNames': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Serum Ferritin', 'description': 'Serum ferritin concentration (\u00b5g/l) at 12 weeks', 'timeFrame': '12 weeks'}\n- {'measure': 'Fecal calprotectin', 'description': 'Fecal calprotectin concentration (mg/kg stool) at 12 weeks as a measure of gut inflammation.', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, \u03b1=0.05, SD of ferritin 50 \u00b5g/L, 15% loss to follow-up.", "answer": 480, "answer_type": "ACTUAL", "explanation": "Sample size\n We based our calculation on a non-inferiority comparison between the two iron groups. To detect a non-inferiority margin of 20\u00e2\u0080\u0089\u00c2\u00b5g/L for ferritin, with 80% power and \u00ce\u00b1=0.05, we would require n=140 in each group. WHO has reported a clinically important change in ferritin in response to an iron intervention to be \u00c2\u00b10.2\u00e2\u0080\u0089SD units.56 Data from our 2015 trial indicated the SD of ferritin to be 50\u00e2\u0080\u0089\u00c2\u00b5g/L after 12 weeks of 60\u00e2\u0080\u0089mg iron;34 therefore, a margin of 20\u00e2\u0080\u0089\u00c2\u00b5g/L was chosen. Thus, we require n=140 in each of the three groups. Accounting for 15% loss to follow-up (a conservative estimate based on our previous trial),34 we require n=160 women in each of the three groups and a total of n=480 women in the study (figure 2).\n \n Figure 2\n \n Participation flowchart.", "id": 535, "split": "train"} +{"trial_id": "NCT04019821", "pmid": "35351180", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index Meal in Children With Type 1 Diabetes Mellitus- Randomized Study\n\nIncluded conditions:\n- Diabetes Mellitus, Type 1\n\nStudy Armgroups:\n- {'label': 'Normal Bolus', 'type': 'ACTIVE_COMPARATOR', 'description': 'Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR).', 'interventionNames': ['Drug: Insulin Glulisine', 'Drug: Insulin Aspart', 'Drug: Insulin Lispro']}\n- {'label': 'Super Bolus', 'type': 'EXPERIMENTAL', 'description': 'Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time.', 'interventionNames': ['Drug: Insulin Glulisine', 'Drug: Insulin Aspart', 'Drug: Insulin Lispro']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Insulin Glulisine', 'description': 'A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.', 'armGroupLabels': ['Normal Bolus', 'Super Bolus'], 'otherNames': ['Apidra']}\n- {'type': 'DRUG', 'name': 'Insulin Aspart', 'description': 'A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.', 'armGroupLabels': ['Normal Bolus', 'Super Bolus'], 'otherNames': ['NovoRapid']}\n- {'type': 'DRUG', 'name': 'Insulin Lispro', 'description': 'A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.', 'armGroupLabels': ['Normal Bolus', 'Super Bolus'], 'otherNames': ['Humalog, Liprolog']}\n\nPrimary Outcomes:\n- {'measure': 'Postprandial Glycemia', 'description': 'Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)', 'timeFrame': '90 minutes after the prandial bolus'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power = 80%, withdrawal rate = 20%, correlation = 0.", "answer": 72, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was estimated based on the calculations performed using the StatsDirect statistical software (V.3.1.4, StatsDirect, Chesire, UK). A total of 72 participants will be required to show a difference of 30 mg/dl (1.7 mmol//l) and an SD of 41 (which corresponds to the standard deviation of the paired differences being 82) and standard deviations for observations within treatment being 58 at the 90th minute of the study (the primary endpoint), with \u00ce\u00b1 = 0.05 and 80% power\u00e2\u0080\u0094assuming a 20% withdrawal rate. The correlation was set to 0 (conservative approach). We assume that glycemia differences between the study groups mentioned above are significant for metabolic control.", "id": 536, "split": "train"} +{"trial_id": "NCT04020497", "pmid": "32737097", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ensemble Programme an Early Intervention for Informal Caregivers of Psychiatric Patients: a Randomized Controlled Trial\n\nIncluded conditions:\n- Psychological Distress\n\nStudy Armgroups:\n- {'label': 'Ensemble + SAU (Support as usual)', 'type': 'EXPERIMENTAL', 'description': 'The five-session Ensemble program provided to informal caregivers targeted support + SAU', 'interventionNames': ['Behavioral: Ensemble programme', 'Other: SAU']}\n- {'label': 'SAU (Support as usual)', 'type': 'ACTIVE_COMPARATOR', 'description': 'SAU alone which was chosen as a control condition.', 'interventionNames': ['Other: SAU']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Ensemble programme', 'description': \"Ensemble is a individualized programme to address informal caregiver's specific unmet needs, emotions and social resources, in order to offer a targeted support in five sessions.\", 'armGroupLabels': ['Ensemble + SAU (Support as usual)'], 'otherNames': ['Ensemble']}\n- {'type': 'OTHER', 'name': 'SAU', 'description': 'Informal caregivers have often to manage the situation in usual different ways. Support as usual (SAU) alone consists of an informal support by patient\\'s clinical team. Specific psychoeducational programs depending on patient\\'s illnes (like \"Profamille\" for schizophrenia) or peer-support depending to the voluntary work of families\\' associations. Some general professional services focused on informal caregivers or relatives in order to inform and orient them if they are avaible in the study area. No attempts have been made to standardize this treatement as SAU depend to informal caregiver\\'s need and knowledge of the health system, also her/his capacity or possibility to be in contact with patient\\'s clinical team.', 'armGroupLabels': ['Ensemble + SAU (Support as usual)', 'SAU (Support as usual)'], 'otherNames': ['Support as usual']}\n\nPrimary Outcomes:\n- {'measure': 'Psychological state change on the Global Severity Index (GSI)', 'description': 'Assessment of psychological symptoms and psychological distress (BSI scale). The Brief Symptom Inventory (BSI) includes 53 items organized into 9 primary and clinically relevant symptom dimensions: 1) somatization, 2) obsessive-compulsive, 3) interpersonal sensitivity, 4) depression, 5) anxiety, 6) hostility, 7) phobic anxiety, 8) paranoid ideation and 9) psychoticism. This scale has also three global distress indices: The Global Severity Index (GSI), the Positive Symptom Distress Index (PSDI) and the Positive Symptom Total (PST).', 'timeFrame': 'Change from Baseline composite on the GSI score at post-test, and at 2 months follow'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1 was set at 0.05 with a power of \u00ce\u00b2=0.80. A dropout rate of 10% will be considered.", "answer": 70, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was estimated using the results of the pilot study regarding the main outcome of the expected BSI Global Index. For the sample size calculation, \u00ce\u00b1 was set at 0.05 with a power of \u00ce\u00b2=0.80. The effect size of the expected difference between the two groups was equal to Cohen\u00e2\u0080\u0099s d=0.470. Using an a priori computation for analysis of covariance (ANCOVA), the proposed trial required a total sample size of 144 participants for the two arms, 72 in each arm. In the pilot study, 1 of 22 participants dropped out, resulting in a dropout rate of approximately 5%; to increase security in the proposed study, a drop-up rate of 10% will be considered, corresponding to a dropout number of 22 participants, so the present study will recruit 160 participants. Between-group differences in pretest and post-test values will be examined using ANCOVA.", "id": 537, "split": "train"} +{"trial_id": "NCT04020744", "pmid": "33563242", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Targeting Hippocampal Hyperactivity With Real-time Functional MRI Based Neurofeedback in Elderly Individuals With and Without Memory Problems\n\nIncluded conditions:\n- Mild Cognitive Impairment\n\nStudy Armgroups:\n- {'label': 'healthy elderly participants receiving feedback from the hippocampus', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will consist of healthy elderly volunteers, who will receive feedback from their hippocampal activity.', 'interventionNames': ['Other: real-time fMRI based neurofeedback from the hippocampus']}\n- {'label': 'healthy elderly participants receiving feedback from another area', 'type': 'SHAM_COMPARATOR', 'description': 'This group will consist of healthy elderly volunteers, who will receive feedback from another brain area.', 'interventionNames': ['Other: real-time fMRI based neurofeedback from another brain area']}\n- {'label': 'patients with MCI receiving feedback from the hippocampus', 'type': 'EXPERIMENTAL', 'description': 'This group will consist of patients with mild cognitive impairment, who will receive feedback from their hippocampal activity.', 'interventionNames': ['Other: real-time fMRI based neurofeedback from the hippocampus']}\n- {'label': 'patients with MCI receiving feedback from another brain area', 'type': 'SHAM_COMPARATOR', 'description': 'This group will consist of patients with mild cognitive impairment, who will receive feedback from another brain area.', 'interventionNames': ['Other: real-time fMRI based neurofeedback from another brain area']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'real-time fMRI based neurofeedback from the hippocampus', 'description': \"During real-time fMRI neurofeedback, participants are trained to 'control' hippocampal activity. The training is accomplished by continuously measuring brain activity, analysing it in real-time, and then providing feedback about the current (and the targeted) brain activity to the participant.\", 'armGroupLabels': ['healthy elderly participants receiving feedback from the hippocampus', 'patients with MCI receiving feedback from the hippocampus']}\n- {'type': 'OTHER', 'name': 'real-time fMRI based neurofeedback from another brain area', 'description': \"During real-time fMRI neurofeedback, participants are trained to 'control' hippocampal activity. The training is accomplished by continuously measuring brain activity, analysing it in real-time, and then providing feedback about the current (and the targeted) brain activity to the participant.\", 'armGroupLabels': ['healthy elderly participants receiving feedback from another area', 'patients with MCI receiving feedback from another brain area']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of change in hippocampal activity during a memory task', 'description': 'Measured by fMRI (rate of change in activity from baseline to after the intervention)', 'timeFrame': 'Directly after the intervention'}\n\nPlease estimate the sample size based on the assumption: \nANOVA with repeated measurements and between-within interactions, significance level (\u03b1) = 0.01, power (1-\u03b2) = 0.99, number of groups = 4, number of measurements = 4", "answer": 84, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n For the determination of sample size, we used G*power [32]. Since no study so far tried to downregulate hippocampal activity, we opted for the detection of at least a small effect (i.e., cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25). This would require an inclusion of n\u00e2\u0080\u0089=\u00e2\u0080\u008984 in total (that is, n\u00e2\u0080\u0089=\u00e2\u0080\u008921 in each group) for a repeated measures design with 4 groups and 4 measurements (i.e., baseline, post-intervention, follow-up 1, follow-up 2). We used the following criteria to calculate sample size: ANOVA with repeated measurements and between-within interactions, \u00ce\u00b1 err\u00e2\u0080\u0089=\u00e2\u0080\u00890.01, 1-\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.99, number of groups\u00e2\u0080\u0089=\u00e2\u0080\u00894, number of measurements\u00e2\u0080\u0089=\u00e2\u0080\u00894.", "id": 538, "split": "train"} +{"trial_id": "NCT04020861", "pmid": "32080103", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Photobiomodulation Therapy and Transcutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients\n\nIncluded conditions:\n- Chronic Neck Pain\n\nStudy Armgroups:\n- {'label': 'PBM + TENS', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients will be submitted to the active PBM and active TENS', 'interventionNames': ['Device: Active PBM', 'Device: Active TENS']}\n- {'label': 'PBM', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients will be submitted to the active PBMT and placebo TENS', 'interventionNames': ['Device: Active PBM', 'Device: Placebo TENS']}\n- {'label': 'TENS', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients will be submitted to the placebo PBMT and active TENS', 'interventionNames': ['Device: Active TENS', 'Device: Placebo PBM']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'The patients will be submitted to the placebo PBMT and placebo TENS.', 'interventionNames': ['Device: Placebo PBM', 'Device: Placebo TENS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Active PBM', 'description': 'To active photobiomodulation therapy (PBMT) the patient will be oriented to lie preferably in prone. The treatment area will be defined according to painful area. In the active group will be used the followings parameters: low-level laser therapy, 808 nm, 4 infrared diodes, 180 mW, 9 J. In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.', 'armGroupLabels': ['PBM', 'PBM + TENS']}\n- {'type': 'DEVICE', 'name': 'Active TENS', 'description': 'To active transcutaneous electrical nerve stimulation (TENS) the patient will be oriented to lie preferably in prone. Two or four electrodes standard square self-adhesive electrodes (5 \u00d7 5 cm2) will be positioned according to the painful area related by patient. It will be used the following parameters: frequency of 100 Hz, pulse duration of 125 \u00b5s (positive phase), 30 minutes of current stimulation and the pulse amplitude will be increased until the patient reports a strong but comfortable paresthesia (including motor level stimulation but no painful TENS). The amplitude will be adjusted (if necessary) each 5 minutes to keep a strong but comfortable paresthesia.', 'armGroupLabels': ['PBM + TENS', 'TENS']}\n- {'type': 'DEVICE', 'name': 'Placebo PBM', 'description': 'In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.', 'armGroupLabels': ['Placebo', 'TENS']}\n- {'type': 'DEVICE', 'name': 'Placebo TENS', 'description': 'To placebo transcutaneous electrical nerve stimulation (TENS) Two or four electrodes standard square self-adhesive electrodes (5 \u00d7 5 cm2) will be positioned according to the painful area related by patient. This device was customized to deliver a current for 30 seconds (both channels) and then ramp off over the next 15 seconds so that it will be active for a total of 45 seconds. This will permit the patient to fell the TENS sensation while applying the settings.', 'armGroupLabels': ['PBM', 'Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Pain intensity: Numerical Rating Scale (Pain NRS)', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numerical Rating Scale (Pain NRS), which is a simple and easy-to-use measuring scale that consists of a sequence of numbers from zero to 10, in which zero represents \"no pain\" and 10 represents \"the worst pain imaginable\". The pain evaluation will be carried out verbally with the patient reporting the pain intensity.', 'timeFrame': '2 weeks after randomization'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, significance level (alpha) of 5%, and a possible sample loss of up to 15%.", "answer": 144, "answer_type": "ACTUAL", "explanation": "2.22\n Sample size\n The sample size of the study was performed based on the pain intensity outcome (as measured by the pain numerical rating scale) with mean difference of 2.3 points and an estimated standard deviation of 2.76 points.[13] Statistical power of 80% was considered with an alpha of 5% and possible sample loss of up to 15%. Accordingly, a total of 144 patients will be required for the study. The sample calculation was performed using the Minitab software, version 17, (Minitab, Inc., PA).", "id": 539, "split": "train"} +{"trial_id": "NCT04021784", "pmid": "36627616", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Limited-efficacy Testing of Spring Distraction System (SDS) and a Bilateral One Way Rod (NEMOST) for Early Onset Neuromuscular Scoliosis (BiPOWR)\n\nIncluded conditions:\n- Neuromuscular Scoliosis\n- Distraction System\n- Growth Friendly System\n\nStudy Armgroups:\n- {'label': 'Spring Distraction System (SDS)', 'type': 'EXPERIMENTAL', 'description': 'The SDS will be placed and fits around a standard rod of 5.5mm.', 'interventionNames': ['Device: SDS']}\n- {'label': 'Necker Enfants Malade OSTeosynthesis (NEMOST)', 'type': 'EXPERIMENTAL', 'description': 'The NEMOST is a one-way-rod that uses a ratchet type of locking mechanism. Both NEMOST devices should be placed in parallel, on the two fixator rods that are connected with a cross connector', 'interventionNames': ['Device: NEMOST']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'SDS', 'description': 'The patient is implanted with SDS.', 'armGroupLabels': ['Spring Distraction System (SDS)']}\n- {'type': 'DEVICE', 'name': 'NEMOST', 'description': 'The patient is implanted with NEMOST.', 'armGroupLabels': ['Necker Enfants Malade OSTeosynthesis (NEMOST)']}\n\nPrimary Outcomes:\n- {'measure': 'Limited-efficacy of SDS and NEMOST in terms of curve correction maintenance', 'description': 'Changes in cobb angle on radiographs post-op and at 4 weeks, 3 months, 6 months and 12 months follow-up (FU). A maximum of 5 degrees increase will be the threshold to define maintenance.', 'timeFrame': 'Until 1 year post-operatively'}\n- {'measure': 'Incidence of possible Treatment-Emergent Serious Adverse Events of SDS and NEMOST', 'description': 'Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months, 6 months and 12 months FU.', 'timeFrame': 'Until 1 year post-operatively'}\n\nPlease estimate the sample size based on the assumption: \nPower (1-\u03b2) of 0.8, \u03b1 = 0.05, SD = 5.1\u00b0. Statistical significance set at p < 0.05. Repeated measures ANOVA will be used, with age and sex as covariates. If assumptions for ANOVA are not met, repeated measurement multilevel modelling will be used. Kaplan\u2013Meier survival analysis and Log-Rank test will be used for survival curves. Multiple imputation for missing EOSQ-24 item scores.", "answer": 28, "answer_type": "ACTUAL", "explanation": "Sample size calculation and statistical methods\n The sample size calculation is based on potential differences between groups in maintenance of the coronal curve between the post-operative situation and 1-year follow-up. A difference in Cobb angle\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00895\u00cb\u009a is considered clinically relevant and can be reliably measured [27]. In our previous MCGR cohort studies, we found a change in Cobb angle between post-operatively and 1\u00c2\u00a0year follow-up of 1\u00cb\u009a (SD 5.1\u00cb\u009a) [28]. To determine differences in curve maintenance between groups\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00895\u00cb\u009a with a power (1-\u00ce\u00b2) of 0.8, \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, and SD\u00e2\u0080\u0089=\u00e2\u0080\u00895.1\u00cb\u009a, we calculated a sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008928, with a repeated measures ANOVA between factors design (comparing 2 timepoints). With an allocation ratio of 1:1, this means that 14 patients have to be included in each experimental group.\n If all assumptions for performing repeated measures ANOVA are met, both systems will be compared with respect to coronal curve maintenance; age and sex will be included as covariates. For the other continuous variables, repeated measures ANOVA will be used, with the same covariates, but including all evaluated time points. If the assumptions for performing repeated measures ANOVA are not met (e.g. due to missing data), repeated measurement multilevel modelling will instead be performed, with patient, age, sex and treatment group as level 2 variables, and follow-up time as a\u00c2\u00a0level 1 variable.\n A Kaplan\u00e2\u0080\u0093Meier survival analysis will be performed comparing both groups. The survival curves showing SAE-free survival of both groups will be statistically compared with the Log-Rank test. Analysis of EOSQ-24 scores will be performed using repeated measures ANOVA. In case there are missing EOSQ-24 item scores or questionnaires, multiple imputation with parcel summary scores will be performed using a previously published statistical method [29]. For all statistical tests, statistical significance will be set at p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05. All statistical analyses will be performed in IBM SPSS statistics v.26.0.0.1 (Chicago, USA).", "id": 540, "split": "train"} +{"trial_id": "NCT04024267", "pmid": "32631427", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients\n\nIncluded conditions:\n- Fatigue\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Eurythmy therapy (ERYT)', 'type': 'EXPERIMENTAL', 'description': 'Eurythmy therapy (ERYT) is a standardized movement therapy and for each medical condition standardized ERYT exercise (series) exist. In such, in the present study, the cancer series \"O-E-M-L-I-B-D\" that is specific and standardized for breast cancer patients will be applied. Patients can perform and maintain the postures without stress and tension. Patients are instructed by ERYT therapists in sessions with 1 to 4 patients.', 'interventionNames': ['Other: Eurythmy therapy']}\n- {'label': 'CoordiFit', 'type': 'ACTIVE_COMPARATOR', 'description': 'The CoordiFit program consists of standardized exercises that address physical coordination, stability, balance and dexterity. These exercises serve as a control intervention and are non-specific with respect of cancer-related fatigue and breast cancer. They mimic those of ERYT but have no mindfulness features. Patients are instructed by physical therapists in session with 1 to 4 patients.', 'interventionNames': ['Other: CoordiFit']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Eurythmy therapy', 'description': 'Mind-body therapy', 'armGroupLabels': ['Eurythmy therapy (ERYT)']}\n- {'type': 'OTHER', 'name': 'CoordiFit', 'description': 'Fitness training', 'armGroupLabels': ['CoordiFit']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in fatigue over the whole intervention', 'description': 'Fatigue is measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). FACIT-F consists of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the fatigue subscale comprising 13 fatigue-related items, with a total of 41 items. The fatigue subscale score is ranging from 8 to 44. A score \\\\< 34 is considered as cut-off for a diagnosis of relevant fatigue.', 'timeFrame': 'End of the intervention (week 20)'}\n\nPlease estimate the sample size based on the assumption: \nThe mean FACIT-F subscale score at baseline for the two groups is assumed to be 30 points with a standard deviation of 10 points. The study aims for a power of \u2265 80% to reject the null hypothesis at the \u03b1 = 0.05 level. The standard deviation of the FACIT-F subscale score should be \u2264 12 points, and the within-patient variation between two measurements should be \u2264 8 points. A dropout rate of 20% is accounted for.", "answer": 196, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and statistical analysis\n \n Sample size\n Eurythmy therapy is expected to have a greater effect on CRF than the control intervention. A validated Minimal Clinically Important Difference (MCID) for FACIT-F subscale is defined as a change in score of 3\u00e2\u0080\u00934 points [62]. We assume a non-parallel course over time of the FACIT-F subscale score between the ERYT group and the control group and a difference \u00e2\u0089\u00a5\u00e2\u0080\u00894 in the FACIT-F subscale score between the two groups at the end of the intervention (week 20).\n The mean FACIT-F subscale score at baseline for the two groups was assumed to be 30 points with a standard deviation of 10 points [60]. Simulations confirmed that the sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089156 patients (excluding drop-outs) will provide enough power (\u00e2\u0089\u00a5\u00e2\u0080\u008980%) to reject the null-hypothesis of no interaction between the group and time at the \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 level, if the effect of the ERYT intervention on the FACIT-F subscale score at the end of therapy is 4 points, if the standard deviation of the FACIT-F subscale score is \u00e2\u0089\u00a4\u00e2\u0080\u008912 points, and if the within-patient variation between two measurements is \u00e2\u0089\u00a4\u00e2\u0080\u00898 points. The simulations also confirmed that the power of 80% is reached in case of slight deviations from the assumptions if the difference between groups \u00e2\u0089\u00a5\u00e2\u0080\u00894 points at the end of the intervention. To account for a dropout rate of 20%, the total sample size will be N\u00e2\u0080\u0089=\u00e2\u0080\u0089196 patients (98 per group).\n In order to ensure the study population can comply with the intervention as excepted, we will check feasibility issues, i.e., the number of sessions completed and compliance with home training, after the inclusion of 50 patients.\n \n \n Statistical analysis\n A nonparametric ANOVA model for longitudinal data, the F1-LD-F1 model of Brunner, Domhof, and Langer, will be applied to model the course of the FACIT-F subscale scores from baseline over the whole intervention [77]. The first F1 means that there is one group factor, the second that there is one-time or repeated measures factor. The main hypotheses are the following:\n H0: there is no interaction of the treatment arm with the time;\n H1: there is an interaction of the treatment arm with the time (favoring ERYT).\n Least-square means of the original data (original scales) and 95% confidence intervals will be calculated and displayed in figures over time.\n Differences from baseline to end of intervention will be analyzed by stratified Wilcoxon rank-sum tests (via ordinal logistic regression, i.e., proportional odds model with baseline measurements as co-variable, treatment arm as binary predictor and differences as outcome variable). Least-squares means of the original differences and 95% confidence intervals will be calculated.\n Exploratory endpoints will be analyzed descriptively using mean and standard deviation or median and interquartile, as appropriate.\n Statistical analysis will be conducted applying an intention-to-treat approach, and therefore including all randomized patients. In case of protocol non-adherence, a per-protocol analysis will be conducted to estimate the robustness of the primary estimates. All tests will be two-sided with a significance level of 0.05. Statistical analysis will be performed using R [78].", "id": 541, "split": "train"} +{"trial_id": "NCT04024267", "pmid": "32631427", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients\n\nIncluded conditions:\n- Fatigue\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Eurythmy therapy (ERYT)', 'type': 'EXPERIMENTAL', 'description': 'Eurythmy therapy (ERYT) is a standardized movement therapy and for each medical condition standardized ERYT exercise (series) exist. In such, in the present study, the cancer series \"O-E-M-L-I-B-D\" that is specific and standardized for breast cancer patients will be applied. Patients can perform and maintain the postures without stress and tension. Patients are instructed by ERYT therapists in sessions with 1 to 4 patients.', 'interventionNames': ['Other: Eurythmy therapy']}\n- {'label': 'CoordiFit', 'type': 'ACTIVE_COMPARATOR', 'description': 'The CoordiFit program consists of standardized exercises that address physical coordination, stability, balance and dexterity. These exercises serve as a control intervention and are non-specific with respect of cancer-related fatigue and breast cancer. They mimic those of ERYT but have no mindfulness features. Patients are instructed by physical therapists in session with 1 to 4 patients.', 'interventionNames': ['Other: CoordiFit']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Eurythmy therapy', 'description': 'Mind-body therapy', 'armGroupLabels': ['Eurythmy therapy (ERYT)']}\n- {'type': 'OTHER', 'name': 'CoordiFit', 'description': 'Fitness training', 'armGroupLabels': ['CoordiFit']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in fatigue over the whole intervention', 'description': 'Fatigue is measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). FACIT-F consists of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the fatigue subscale comprising 13 fatigue-related items, with a total of 41 items. The fatigue subscale score is ranging from 8 to 44. A score \\\\< 34 is considered as cut-off for a diagnosis of relevant fatigue.', 'timeFrame': 'End of the intervention (week 20)'}\n\nPlease estimate the sample size based on the assumption: \nThe mean FACIT-F subscale score at baseline for the two groups is assumed to be 30 points with a standard deviation of 10 points. The study aims for a power of \u2265 80% to reject the null hypothesis at the \u03b1 = 0.05 level. The standard deviation of the FACIT-F subscale score should be \u2264 12 points, and the within-patient variation between two measurements should be \u2264 8 points. A dropout rate of 20% is accounted for.", "answer": 196, "answer_type": "ESTIMATED", "explanation": "Sample size\n Eurythmy therapy is expected to have a greater effect on CRF than the control intervention. A validated Minimal Clinically Important Difference (MCID) for FACIT-F subscale is defined as a change in score of 3\u00e2\u0080\u00934 points [62]. We assume a non-parallel course over time of the FACIT-F subscale score between the ERYT group and the control group and a difference \u00e2\u0089\u00a5\u00e2\u0080\u00894 in the FACIT-F subscale score between the two groups at the end of the intervention (week 20).\n The mean FACIT-F subscale score at baseline for the two groups was assumed to be 30 points with a standard deviation of 10 points [60]. Simulations confirmed that the sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089156 patients (excluding drop-outs) will provide enough power (\u00e2\u0089\u00a5\u00e2\u0080\u008980%) to reject the null-hypothesis of no interaction between the group and time at the \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 level, if the effect of the ERYT intervention on the FACIT-F subscale score at the end of therapy is 4 points, if the standard deviation of the FACIT-F subscale score is \u00e2\u0089\u00a4\u00e2\u0080\u008912 points, and if the within-patient variation between two measurements is \u00e2\u0089\u00a4\u00e2\u0080\u00898 points. The simulations also confirmed that the power of 80% is reached in case of slight deviations from the assumptions if the difference between groups \u00e2\u0089\u00a5\u00e2\u0080\u00894 points at the end of the intervention. To account for a dropout rate of 20%, the total sample size will be N\u00e2\u0080\u0089=\u00e2\u0080\u0089196 patients (98 per group).\n In order to ensure the study population can comply with the intervention as excepted, we will check feasibility issues, i.e., the number of sessions completed and compliance with home training, after the inclusion of 50 patients.", "id": 542, "split": "train"} +{"trial_id": "NCT04025749", "pmid": "31910803", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Executive Training in Cerebral Palsy: Participation, Quality of Life and Brain Connectivity\n\nIncluded conditions:\n- Cerebral Palsy\n\nStudy Armgroups:\n- {'label': 'Immediate intervention group', 'type': 'EXPERIMENTAL', 'description': 'Thirty children with CP aged 8 to 12 years (or fifteen with neuroimage data) will participate in a computerized executive training program from home (12 weeks, 5 days a week, 30 min a day).', 'interventionNames': ['Behavioral: Computerized Executive Functions training']}\n- {'label': 'Wait-list delayed intervention', 'type': 'OTHER', 'description': 'Thirty children with CP (or fifteen with neuroimage data) matched by age, sex, motor and cognitive impairment severity.', 'interventionNames': ['Other: Care as usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Computerized Executive Functions training', 'description': 'Home-based executive function training with adaptive difficulty, through NeuronUp (https://www.neuronup.com) over 12 weeks (30 min/day, 5 days per week, 30h in total).', 'armGroupLabels': ['Immediate intervention group']}\n- {'type': 'OTHER', 'name': 'Care as usual', 'description': 'Care as usual', 'armGroupLabels': ['Wait-list delayed intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline Executive Function', 'description': 'Spatial Span, Wechsler Nonverbal Scale of Ability (WNV)', 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n- {'measure': 'Change from baseline Executive Function', 'description': 'Digit Span, Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)', 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n- {'measure': 'Change from baseline Executive Function', 'description': 'Five Digit Test (FDT)', 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n- {'measure': 'Change from baseline Executive Function', 'description': 'Auditory attention and Response Set, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)', 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n- {'measure': 'Change from baseline Executive Function', 'description': 'Word Generation, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)', 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n- {'measure': 'Change from baseline Executive Function', 'description': 'Tower Test, Delis-Kaplan Executive Function System (D-KEFS)', 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n- {'measure': 'Change from baseline Executive Function', 'description': \"Conners' Continuous Performance Test-II (CPT-II)\", 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n- {'measure': 'Change from baseline Executive Function', 'description': 'Theory of Mind, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)', 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n- {'measure': 'Change from baseline Executive Function', 'description': 'Affect Recognition, A Developmental NEuroPSYchological Assesment-II (NEPSY-II)', 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n- {'measure': 'Change from baseline Executive Function', 'description': 'Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)', 'timeFrame': 'T0: 1 week before beginning; T1: 1 week immediately after training; T2: follow up (nine month after finished training)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level (\u03b1) of 0.05, and 15% attrition rate.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size determination\n The required sample size was calculated by taking into account the differences in the continuous primary outcomes after 12\u00e2\u0080\u0089weeks of following the computerized training programme. Simulations under two different scenarios were carried out. Specifically, calculations for separate tests and multiple-end-points were performed. By comparing the two scenarios, conservative figures regarding sample size were estimated. As a result, to detect a large standardized difference (i.e. a difference of at least 0.8 SD) between the immediate intervention and waitlist groups, with 80% power and \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, 26 children would be necessary in each group. Assuming 15% attrition, the required sample size was calculated as 60 participants.", "id": 543, "split": "train"} +{"trial_id": "NCT04026230", "pmid": "35487730", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Atorvastatin on Prostate Cancer Progression After Initiation of Androgen Deprivation Therapy - Lipid Metabolism as a Novel Biomarker to Predict Prostate Cancer Progression\n\nIncluded conditions:\n- Metastatic Prostate Cancer\n- Recurrent Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Atorvastatin', 'type': 'EXPERIMENTAL', 'description': 'Capsules of atorvastatin. Daily dose of 80 mg for max. 10 years or until development of castration resistance.', 'interventionNames': ['Drug: Atorvastatin 80mg']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Identical capsules as in the atorvastatin arm, but including no active ingredient. Used daily for max. 10 years or until development of castration resistance', 'interventionNames': ['Drug: Placebo oral capsule']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Atorvastatin 80mg', 'description': 'Capsules including 80 mg of atorvastatin', 'armGroupLabels': ['Atorvastatin'], 'otherNames': ['Lipitor']}\n- {'type': 'DRUG', 'name': 'Placebo oral capsule', 'description': 'Similar capsules as in the atorvastatin arm, but without the active ingredient', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Castration resistance', 'description': 'Castration resistance is defined as PSA progression (three consecutive PSA rises measured at least 1 week apart with two \\\\> 50% increases over the nadir and PSA \\\\> 2 ng/ml) or radiological disease progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) with serum testosterone at castrate level (\\\\< 1.73 nmol/l; 50 ng/dl) during ADT.', 'timeFrame': 'From date of randomization until the date of first occurrence of castration resistance, assessed up to 60 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha 0.05, beta 0.20 (power 0.80), 10% dropout rate, interim analysis after 100 participants, post hoc follow-up, maximum intervention duration of 10 years.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In a cohort study by Harshman et al,23 among men starting ADT, 58% of the statin users and 75% of non-users of statins progress to castration resistance during median 5.8 years. We used these crude percentages for sample size calculations.\n With alpha and beta values of 0.05 and 0.20 (power=0.80), sample size of 400 men will be enough to detect a risk difference with HR 0.65 (figure 2). We assume 10% drop-out rate in each study arm. The programme \u00e2\u0080\u0098PS\u00e2\u0080\u0094Power and sample size, V.3.1.2\u00e2\u0080\u0099 was used for the calculation.\n \n Figure 2\n \n Sample size estimation with power 0.8 as a function of HR. Calculation was made based on study by Harshman et al.23\n \n \n \n The median time to disease progression is assumed to be 12\u00e2\u0080\u009315 months for patients with de novo metastatic disease and 33 months for patients recurring after primary therapy.3\u00e2\u0080\u00937 Therefore, the intervention will continue until castration resistance, death, or for maximum of 10 years. Post hoc follow-up will continue after the intervention. A 3 months\u00e2\u0080\u0099 difference in time to castration resistance between the study arms will be considered clinically significant.\n It has to be noted that the number of studies published on this topic is low and, in the absence of randomised evidence on this topic, the power calculation is based on results of epidemiological study prone to residual bias. Therefore, an interim analysis will be performed after the first 100 participants have met the primary endpoint, that is, progressed into castration resistance. Without lifting the blinding, the power calculations are repeated to verify whether the chosen sample size has adequate statistical power to detect statistically significant difference of the effect size observed between the randomisation groups at that time. If the calculations suggest that a larger sample size is needed for the trial, the study protocol will be amended with updated recruitment target.", "id": 544, "split": "train"} +{"trial_id": "NCT04026594", "pmid": "32160891", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study\n\nIncluded conditions:\n- Burnout\n- Emotional Disturbances\n- Depression\n\nStudy Armgroups:\n- {'label': 'Mindfulness Based Stress Reduction (MBSR)', 'type': 'EXPERIMENTAL', 'description': '306 participants will be randomized in the MBSR program, consisting of 8 weekly sessions lasting 2 and half hours each. In addition to this, they will be asked to complete 30 minutes of home practice each day. In order to avoid forgetting techniques and to reinforce motivation, a MBSR recall session will be offered six month after intervention.\\n\\nAll the sessions may be carried out remotely, by videoconference. In this case, both programs should be conducted in this way in order to ensure comparability..', 'interventionNames': ['Other: Mindfulness Based Stress Reduction']}\n- {'label': 'Progressive Muscle Relaxation Training (PMRT)', 'type': 'ACTIVE_COMPARATOR', 'description': '306 participants will be randomized in a relaxation program, consisting of 8 weekly sessions lasting 2 and half hours each. In addition to this, they will be asked to complete 30 minutes of home practice each day. In order to avoid forgetting techniques and to reinforce motivation, a relaxation recall session will be offered six month after intervention.\\n\\nAll the sessions may be carried out remotely, by videoconference. In this case, both programs should be conducted in this way in order to ensure comparability', 'interventionNames': ['Other: Relaxation group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Mindfulness Based Stress Reduction', 'description': \"MBSR teaches mindfulness meditation and mindful yoga exercises to develop non-judgmental awareness of moment-to-moment experience. The intervention duration is 8 weeks, with weekly two and half hours sessions. It will be delivered according to the fundamental concepts and specific techniques provided in the MBSR manualized protocol by Kabat-Zinn. The program also includes 30-min daily homework exercises.\\n\\nMBSR teaches four main mindfulness practices: (1) body scan, a process of moving attention through the body; (2) mindful movement, consisting of gentle yoga stretches to develop awareness of body in movement; (3) sitting meditation; and (4) walking meditation. Inquiry and didactic teaching is also a part of MBSR and allows for some detailed exploration of participants' experiences.\", 'armGroupLabels': ['Mindfulness Based Stress Reduction (MBSR)']}\n- {'type': 'OTHER', 'name': 'Relaxation group', 'description': 'control group', 'armGroupLabels': ['Progressive Muscle Relaxation Training (PMRT)']}\n\nPrimary Outcomes:\n- {'measure': 'Emotional exhaustion assessed with the Maslach Burnout Inventory (MBI)', 'description': 'Evaluation of the emotional exhaustion based on the MBI score. The MBI contains three subscales, one of which assesses emotional exhaustion through 9 items. A score below 17 indicates a low degree of emotional exhaustion, a score between 18 and 29 indicates a moderate degree of emotional exhaustion and a score above 30 indicates a high degree of emotional exhaustion. Higher scores reflect greater experienced burnout.', 'timeFrame': 'at 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical power is 80% with a 2-sided \u03b1 level of 0.05. The percentage of participants lost to follow-up is estimated at 10%.", "answer": 612, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was based on the results of the work by Verweij et al. [24]. In this randomized controlled trial, the mean baseline score of the emotional exhaustion subscale of the Maslach Burnout Inventory (MBIn) [25]. of 148 residents working in one of the medical, surgical or primary care disciplines was 15.6 (SD\u00e2\u0080\u0089=\u00e2\u0080\u00897.5). Assuming that the baseline score distribution will remain unchanged at the end of the trial in the MBI group, 274 students per group are required to show a significant mean between-group difference of 1.8 points for the emotional exhaustion subscale score at the end of the trial (15.6 for the MBI group and 17.4 for the RI group) with a statistic power of 80% and a 2-sided \u00ce\u00b1 level of 0.05. The percentage of participants lost to follow-up is estimated at 10%. Therefore, in total 612 students need to be recruited in the nine universities participating in the trial.", "id": 545, "split": "train"} +{"trial_id": "NCT04026932", "pmid": "37268971", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Clinical Effects of Modified Tinnitus Relieving Sound Treatment\n\nIncluded conditions:\n- Tinnitus, Subjective\n\nStudy Armgroups:\n- {'label': 'Unmodified music group', 'type': 'PLACEBO_COMPARATOR', 'description': '34 participants in Group 1 will listen to the music without any modification for at least two hours a day in total.', 'interventionNames': ['Other: Listening to unmodified music']}\n- {'label': 'Modified tinnitus relieving sound group', 'type': 'EXPERIMENTAL', 'description': '34 participants in Group 2 will listen to the music modified according to the matched dominant tinnitus pitch for at least two hours a day in total.', 'interventionNames': ['Other: Listening to modified tinnitus relieving sound']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Listening to unmodified music', 'description': 'Listening to unmodified music for at least 2 hours a day', 'armGroupLabels': ['Unmodified music group']}\n- {'type': 'OTHER', 'name': 'Listening to modified tinnitus relieving sound', 'description': 'Listening to modified tinnitus relieving sound for at least 2 hours a day', 'armGroupLabels': ['Modified tinnitus relieving sound group']}\n\nPrimary Outcomes:\n- {'measure': 'Tinnitus Handicapped Inventory (THI)', 'description': 'THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.', 'timeFrame': '1 months from baseline'}\n- {'measure': 'Tinnitus Handicapped Inventory (THI)', 'description': 'THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.', 'timeFrame': '3 months from baseline'}\n- {'measure': 'Tinnitus Handicapped Inventory (THI)', 'description': 'THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.', 'timeFrame': '9 months from baseline'}\n- {'measure': 'Tinnitus Handicapped Inventory (THI)', 'description': 'THI is a self-assessment inventory including 25 items with grades four categories of tinnitus severity: slight corresponding to a score 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus.', 'timeFrame': '12 months from baseline'}\n- {'measure': 'Hospital Anxiety and Distress Scale (HADS)', 'description': 'HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).', 'timeFrame': '1 months from baseline'}\n- {'measure': 'Hospital Anxiety and Distress Scale (HADS)', 'description': 'HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).', 'timeFrame': '3 months from baseline'}\n- {'measure': 'Hospital Anxiety and Distress Scale (HADS)', 'description': 'HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).', 'timeFrame': '9 months from baseline'}\n- {'measure': 'Hospital Anxiety and Distress Scale (HADS)', 'description': 'HADS includes two subscales for anxiety and depression, each with respective 7 items, and the grades are valued by scoring: negative (0-7), positive (8-21).', 'timeFrame': '12 months from baseline'}\n- {'measure': 'Visual Analogue Scale (VAS) for tinnitus', 'description': 'Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.', 'timeFrame': '1 months from baseline'}\n- {'measure': 'Visual Analogue Scale (VAS) for tinnitus', 'description': 'Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.', 'timeFrame': '3 months from baseline'}\n- {'measure': 'Visual Analogue Scale (VAS) for tinnitus', 'description': 'Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.', 'timeFrame': '9 months from baseline'}\n- {'measure': 'Visual Analogue Scale (VAS) for tinnitus', 'description': 'Visual Analogue Scale (VAS) for tinnitus is a universal psychometric scale evaluating subjective tinnintus. A total score is 10, from 0 to 10. The higher the score, the more severe the symptom.', 'timeFrame': '12 months from baseline'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level, 80% power, 30% dropout rate, 1:1 grouping", "answer": 68, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The study sample size was based on the THI scale (the primary outcome), which is used to assess the severity and treatment effect of tinnitus. Considering an 80% effective rate, 5% significance level, 80% power, 30% dropout, and 1:1 grouping, a total sample of 68 (34 per group) will be required.", "id": 546, "split": "train"} +{"trial_id": "NCT04032431", "pmid": "32787896", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of a Telerehabilitation Virtual Reality Intervention on Functional Upper Limb Activities in People With Multiple Sclerosis\n\nIncluded conditions:\n- Multiple Sclerosis\n\nStudy Armgroups:\n- {'label': 'Telerehab VR intervention', 'type': 'EXPERIMENTAL', 'description': 'The telerehab VR intervention consists of a custom-made software running on a computer connected with a commercial VR device (i.e. Oculus Rift). PwMS will be requested to reproduce several ADLs from the three main areas of self-care, dressing and meal preparation. The user can physically see his/her hands within the virtual scenario and, during the exercise, the hand coordinates are continuously recorded. Thus, data on 3D trajectory, speed, accuracy on target placement and movement smoothness, will be accessible. They will be stored in the PC and also be remotely sent to the clinical center for further analysis/processing. Both target position and task complexity will define the exercise difficulty, which can be modified automatically, on the basis of the previous performance or manually modified by the user', 'interventionNames': ['Behavioral: Telerehab VR intervention']}\n- {'label': 'Conventional therapy', 'type': 'ACTIVE_COMPARATOR', 'description': \"Conventional therapy will focus on task-related upper-limb treatments while in a sitting or prone position, representing the standard care in MS. Several manual techniques, therapy tools and objects of ADL will be allowed during treatment. No restrictions will be placed on the material used (ie, ADL, reaching and grasping material). Use of additional electrical or mechanical therapy devices (ie, support arm systems, splints) will be avoided. The interventions will be conducted on a one-on-one basis in the physiotherapy or occupational therapy department of each participating center. Training and therapy content will be tailored to each participant's preferences, the agreed movement aims and the motor function level of each MS patient.\", 'interventionNames': ['Behavioral: Telerehab VR intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Telerehab VR intervention', 'description': 'Training with VR system using software specifically designed to reproduce activities of daily living', 'armGroupLabels': ['Conventional therapy', 'Telerehab VR intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Nine Hole Peg Test (9HPT)', 'description': 'The NHPT was selected based on the widespread adoption and extensive data available. Furthermore, the NHPT is recommended as a gold standard for measuring manual dexterity in pwMS.31 The NHPT has excellent psychometric properties regarding reliability, discriminant, concurrent and ecological validity, can detect progression over time, is sensitive to treatment and as such, is recommended for inclusion in clinical trials. Briefly explained, the NHPT requires participants to repeatedly place nine pegs into nine holes, one at a time, as quickly as possible and then remove them from the holes. The total time needed to complete the task is then recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand.', 'timeFrame': 'Pre-intervention (T0, baseline), post-intervention (T1, +8 weeks from baseline)'}\n\nPlease estimate the sample size based on the assumption: \nPower is set at 80% and alpha at 5%. Moderate correlations among covariates are assumed with r-squared = 0.50.", "answer": 24, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is based on Julious\u00e2\u0080\u0099s [31] recommendation that the rule of thumb for a pilot study is a sample size of 12 subjects per group. The justifications for this sample size are based on rationale relating to feasibility, mean and variance precision, regulatory considerations, and the expected change in the study\u00e2\u0080\u0099s primary outcome measure (NHPT). According to the literature, a 20% change in the NHPT demonstrates a clinically meaningful worsening in PwMS [32]. In our study, power will be set at 80% and alpha at 5%. Therefore, 24 subjects (12 in each group) will be required in order to detect differences between the two treatment groups (assuming non-inferiority with moderate correlations among covariates, r-squared\u00e2\u0080\u0089=\u00e2\u0080\u00890.50).", "id": 547, "split": "train"} +{"trial_id": "NCT04035590", "pmid": "32767988", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Seroma Reduction and Drain Free Mastectomy\n\nIncluded conditions:\n- Breast Cancer\n- Seroma\n- Wound Complication\n\nStudy Armgroups:\n- {'label': 'With drain', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients undergo mastectomy with flap fixation and low vacuum drainage.', 'interventionNames': ['Procedure: With drain']}\n- {'label': 'No drain', 'type': 'EXPERIMENTAL', 'description': 'Patients undergo mastectomy with flap fixation and low vacuum drainage is omitted.', 'interventionNames': ['Procedure: No drain']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'No drain', 'description': 'Mastectomy with flap fixation without low vacuum drainage', 'armGroupLabels': ['No drain']}\n- {'type': 'PROCEDURE', 'name': 'With drain', 'description': 'Mastectomy with flap fixation with low vacuum drainage', 'armGroupLabels': ['With drain']}\n\nPrimary Outcomes:\n- {'measure': 'Seroma aspiration of clinically significant seroma', 'description': 'Proportion of patients undergoing seroma aspiration of clinically significant seroma\\n\\nClinically significant seroma defined as:\\n\\n1. Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis)\\n2. There is discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin.\\n3. There is contaminated/ infected seroma and aspiration is necessary to treat infection. All patients that undergo seroma aspiration due to infection will also be treated with a one week course of Augmentin 625 mg 3 times daily.', 'timeFrame': 'During first six months post-operative'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level is not explicitly stated, power is 80%, and the dropout rate is 10%.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on previous studies conducted with a follow-up period of 1 year we estimate that about 10% of women in each group require seroma aspirations. If the rate of women requiring aspirations in the drain free group would be 10% larger than the overall aspiration rate of 10%, we would conclude that drain free mastectomy is inferior to standard mastectomy (i.e., the non-inferiority limit is 10%). To be able to have 80% power to reject the null-hypothesis that drain free mastectomy is inferior if in reality it is not, we need to include at least 112 patients per group. To account for a potential drop-out rate of 10% we will include 125 patients per group, or 250 in total. We expect that enrolment of these patients for the study will take 18\u00e2\u0080\u0089months.", "id": 548, "split": "train"} +{"trial_id": "NCT04036812", "pmid": "32029493", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ultrasound Guided Superficial Cervical Plexus Block for Analgesia After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial\n\nIncluded conditions:\n- Plexus Block;Analgesia;Neurosurgery\n\nStudy Armgroups:\n- {'label': 'Superficial cervical plexus block group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Superficial cervical plexus block']}\n- {'label': 'Control group', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Other: Control group']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Superficial cervical plexus block', 'description': 'superficial cervical plexus nerve block will be performed under the guidance of ultrasound', 'armGroupLabels': ['Superficial cervical plexus block group']}\n- {'type': 'OTHER', 'name': 'Control group', 'description': 'ultrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml normal saline.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'the cumulative consumption of sufentanil by the PCA', 'description': 'the cumulative consumption of sufentanil by the PCA 24 hours after surgery', 'timeFrame': '24 hours after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a two-tailed significance level of 0.05, a power of 90%, and a dropout rate of 10%.", "answer": 106, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n We estimate the sample size according to the primary outcome of postoperative-24-hour PCIA sufentanil consumption by using PASS 2011 software (NCSS LLC). Based on the previous literature,21 Akcil et al demonstrated the mean (95% CI) postoperative cumulative morphine consumption was 30 mg (25 to 35) in the scalp block group and 50 mg (40 to 60) in the control group. Considering that 1 mg morphine is equivalent to 1 \u00c2\u00b5g sufentanil, we estimated the scalp block in their study reduced PCIA sufentanil consumption by 20 \u00c2\u00b5g within postoperative 24 hours. In the routine practice without SCPB, we also apply PCIA for the patients undergoing craniotomy via suboccipital retrosigmoid approach with the dosage of sufentanil as 50 \u00c2\u00b5g during the first 24 hours after surgery. So, we estimated the effect size of mean as 20 \u00c2\u00b5g with the SD of 30 \u00c2\u00b5g for the SCPB group comparing with the control group. The sample size of 106 patients will be sufficient to detect the difference at a two-tailed significant level of 0.05 and a power of 90% using Student\u00e2\u0080\u0099s t-test, with a drop-out rate of 10%.", "id": 549, "split": "train"} +{"trial_id": "NCT04037709", "pmid": "32243363", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Photodynamic Therapy and Scraping in Patients With Gingivitis Predisposed by Fixed Orthodontic Appliances: Randomized, Controlled, Double-blind, Split-mouth Study\n\nIncluded conditions:\n- Gingivitis\n- Orthodontic Appliance Complication\n- Photodynamic Therapy\n\nStudy Armgroups:\n- {'label': 'scaling and root planing (SRP) + PDT placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '17 patients will receive periodontal treatment (scaling and root planing - SRP) with the ultrasound. The SRP will be done in one session. SRP will be performed by only one experienced researcher. Periodontal reassessment will be performed after 30 days.\\n\\nThe PDT placebo wil be done using an agent with the same vehicle as that of the methylene blue to mimic irrigation with the photosensitizer; the laser will be switched off at the time of application.', 'interventionNames': ['Procedure: scaling and root planing (SRP) + PDT placebo']}\n- {'label': 'scaling and root planing (SRP) + PDT', 'type': 'EXPERIMENTAL', 'description': '17 patients will receive the same scaling and root planing treatment that placebo group.\\n\\nHowever the PDT will be done only on one side of the mouth using methylene blue 0.005% - Chimiolux 5, DMC - purified water and methylene blue.The red laser diode (\u03bb = 660 nm) will be applied with an output power of 100mW . The laser head will be positioned in direct contact with the pseudo periodontal pocket.', 'interventionNames': ['Procedure: scaling and root planing (SRP) + PDT']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'scaling and root planing (SRP) + PDT placebo', 'description': 'Patientes will receive periodontal treatment (scaling and root planing - SRP) with the ultrasound. The SRP will be done in one session. The PDT placebo wil be done using an agent with the same vehicle as that of the methylene blue to mimic irrigation with the photosensitizer; the laser will be switched off at the time of application.', 'armGroupLabels': ['scaling and root planing (SRP) + PDT placebo']}\n- {'type': 'PROCEDURE', 'name': 'scaling and root planing (SRP) + PDT', 'description': 'patients will receive the same scaling and root planing treatment that placebo group.However the PDT will be done only on one side of mouth using methylene blue 0.005% .The red laser diode (\u03bb = 660 nm) will be applied with an output power of 100mW . The laser head will be positioned in direct contact with the pseudo periodontal pockets.', 'armGroupLabels': ['scaling and root planing (SRP) + PDT']}\n\nPrimary Outcomes:\n- {'measure': 'Gingival bleeding index', 'description': 'The periodontal probe will be inserted at all predetermined sites at the gingival margin of all teeth, 30 seconds will be waited and, at the smallest sign of bleeding, the presence or absence of bleeding will be noted. Gingival bleeding will be evaluated at 4 sites (mesiobuccal, distobuccal, mesiolingual, distolingual.The gingival Index will be presented in a percentage (%). The result will be based on the ratio of total sites to sites affected. Results will be considered indicative of gingivitis with \u2265 10% bleeding . It will be assessed at baseline and 30 days after treatment.', 'timeFrame': 'through study completion on average of one year'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error of 0.2, 95% confidence level, and a 20% drop-out rate.", "answer": 20, "answer_type": "ACTUAL", "explanation": "2.1\n Calculation of sample size\n To achieve an effect size =\u00e2\u0080\u008a0.40 between two groups (conventional treatment and PDT), for the difference in the amount of bacteria present in the crevicular fluid of participantstreated with scaling and those treated with PDT, assuming a type 1 error of 0.2[1] and 95% confidence level, the total sample size will be 34 participantsdistributed into 2 groups. The sample calculation was performed in Excel, based on the calculation formula described by Kadam and Bhalerao. Considering a 20% drop-out, 3 extra participantswill be inserted into each group, if there is said drop-out this will provide a final sample of participants per group.[32]\n To ensure participants\u00e2\u0080\u0099 adherence to the research, the steps will preferably coincide with the participants's return visits to their routine orthodontic appliance maintenance. Participants uptake will occur during routine consultations with the orthodontist.", "id": 550, "split": "train"} +{"trial_id": "NCT04037943", "pmid": "33407490", "question": "Here is the design of a clinical trial:\n\nOfficial Title: NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)\n\nIncluded conditions:\n- Cardiovascular Diseases\n- Dyslipidemias\n\nStudy Armgroups:\n- {'label': 'Low-dose group', 'type': 'EXPERIMENTAL', 'description': 'Low-dose group will received 30 grams of walnuts everyday during the study period of 6 months.', 'interventionNames': ['Dietary Supplement: Walnuts 30 grams']}\n- {'label': 'High-dose group', 'type': 'EXPERIMENTAL', 'description': 'High-dose group will received 60 grams of walnuts everyday during the study period of 6 months.', 'interventionNames': ['Dietary Supplement: Walnuts 60 grams']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Control group will received non-edible gifts during the study period of 6 months.'}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Walnuts 30 grams', 'description': 'Roasted walnuts without salt or sugar.', 'armGroupLabels': ['Low-dose group']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Walnuts 60 grams', 'description': 'Roasted walnuts without salt or sugar.', 'armGroupLabels': ['High-dose group']}\n\nPrimary Outcomes:\n- {'measure': 'Post-intervention differences in blood plasma alpha linolenic acid between groups', 'description': 'Blood plasma alpha linolenic acid will be measured at baseline and 6 months (end of trial).', 'timeFrame': 'From baseline to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha of 0.05, 90% power, standard deviation of 0.18, 10% drop-out rate", "answer": 210, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size of 210 individuals (70 in each arm) provided more than 90% power with two-sided alpha of 0.05 to detect a mean difference of 0.12% (as percent of total fatty acid) in plasma ALA between the 30\u00e2\u0080\u0089g walnut supplementation and control arms [10]. The power estimation assumed a standard deviation (SD) of 0.18 and allowed for a drop-out rate of 10%. The study had similar power to detect a mean difference of 0.12% in plasma ALA comparing the 60\u00e2\u0080\u0089g/day and 30\u00e2\u0080\u0089g/day walnut supplementation groups. The power estimations were conservative since the assumptions were based on the PREDIMED trial that provided lower doses of walnuts (15\u00e2\u0080\u0089g/day) than the doses employed in this trial [10].", "id": 551, "split": "train"} +{"trial_id": "NCT04038060", "pmid": "35417485", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design\n\nIncluded conditions:\n- HIV/AIDS\n\nStudy Armgroups:\n- {'label': 'WhatsApp Group', 'type': 'EXPERIMENTAL', 'description': 'Participants will be assigned to participate in a WhatsApp Group', 'interventionNames': ['Behavioral: WhatsApp Group']}\n- {'label': '2-way SMS', 'type': 'EXPERIMENTAL', 'description': 'Participants will be assigned to receive weekly 2-way SMS initiated by the study team', 'interventionNames': ['Behavioral: 2-way SMS']}\n- {'label': '2-way SMS and monthly counseling sessions', 'type': 'EXPERIMENTAL', 'description': 'Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions', 'interventionNames': ['Behavioral: 2-way SMS', 'Behavioral: Monthly counseling sessions']}\n- {'label': '2-way SMS and drug level feedback', 'type': 'EXPERIMENTAL', 'description': 'Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback', 'interventionNames': ['Behavioral: 2-way SMS', 'Behavioral: Drug level feedback']}\n- {'label': 'WhatsApp Group and monthly counseling sessions', 'type': 'EXPERIMENTAL', 'description': 'Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions', 'interventionNames': ['Behavioral: WhatsApp Group', 'Behavioral: Monthly counseling sessions']}\n- {'label': 'WhatsApp Group and drug level feedback', 'type': 'EXPERIMENTAL', 'description': 'Participants will be assigned to participate in a WhatsApp Group and drug level feedback', 'interventionNames': ['Behavioral: WhatsApp Group', 'Behavioral: Drug level feedback']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'WhatsApp Group', 'description': 'Participants will receive peer adherence support through WhatsApp groups', 'armGroupLabels': ['WhatsApp Group', 'WhatsApp Group and drug level feedback', 'WhatsApp Group and monthly counseling sessions']}\n- {'type': 'BEHAVIORAL', 'name': '2-way SMS', 'description': 'Participants will receive healthcare worker adherence support through 2-way SMS', 'armGroupLabels': ['2-way SMS', '2-way SMS and drug level feedback', '2-way SMS and monthly counseling sessions']}\n- {'type': 'BEHAVIORAL', 'name': 'Drug level feedback', 'description': 'Participants will receive adherence counseling based on tenofovir drug levels', 'armGroupLabels': ['2-way SMS and drug level feedback', 'WhatsApp Group and drug level feedback']}\n- {'type': 'BEHAVIORAL', 'name': 'Monthly counseling sessions', 'description': 'Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence', 'armGroupLabels': ['2-way SMS and monthly counseling sessions', 'WhatsApp Group and monthly counseling sessions']}\n\nPrimary Outcomes:\n- {'measure': 'PrEP Adherence', 'description': 'Evaluation of the proportion of young women who adhere well to PrEP in each of the intervention arms.', 'timeFrame': '9 months'}\n\nPlease estimate the sample size based on the assumption: \n96% power for 20% difference; 84% power for 15% difference; 79-96% power for 30% difference.", "answer": 350, "answer_type": "ACTUAL", "explanation": "Sample size and statistical power\n We estimate that enrolling up to 500 participants (with approximately 350 retained through their Month 9 study visit) will provide 96% power to detect an approximately 20% difference in the proportion of participants with TFV-DP levels \u00e2\u0089\u00a5700 fmol/punch between the two-way SMS and WhatsApp group arms at the Month 9 study visit. With 350 participants at the Month 9 study visit, we would have 84% power to detect a 15% difference in TFV-DP levels between the two mHealth interventions. Assuming that between 70\u00e2\u0080\u0093105 participants in each primary intervention arm are re-randomized at the Month 3 visit, we will have 79\u00e2\u0080\u009396% power in each primary intervention arm to detect a 30% difference in TFV-DP levels at the Month 9 visit in the monthly counseling arm compared with the drug-level feedback counseling arm.", "id": 552, "split": "train"} +{"trial_id": "NCT04038294", "pmid": "33514571", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PROTein to Enhance outComes of (Pre)Frail paTients Undergoing Cardiac Surgery - The PROTECT-CS Study\n\nIncluded conditions:\n- Frail Older Adult Syndrome\n- Nutrition Poor\n- Cardiovascular Morbidity\n\nStudy Armgroups:\n- {'label': 'Protein Supplementation', 'type': 'EXPERIMENTAL', 'description': 'The intended intervention consists of a leucine-rich protein-caloric supplement provided by the Enhanced Medical Nutrition\u00ae. The product contains 25 g protein and 3 g Leucine per serving (total caloric value: 160 Kcal.) to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home (Appendix A).', 'interventionNames': ['Dietary Supplement: ISOlution protein supplement']}\n- {'label': 'Placebo Supplementation', 'type': 'PLACEBO_COMPARATOR', 'description': 'Enrolled patients allocated to the control group will receive the same supplementation schedule as well as compliance verification; however, they will receive a placebo product with no supplemented protein (no nutritional benefit).', 'interventionNames': ['Dietary Supplement: Placebo Supplement']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'ISOlution protein supplement', 'description': 'EXPERIMENTAL ARM: Protein supplement to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home.', 'armGroupLabels': ['Protein Supplementation']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo Supplement', 'description': 'PLACEBO COMPARATOR ARM: Placebo supplement to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home', 'armGroupLabels': ['Placebo Supplementation']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Short-Form 36 physical Function (PF) score', 'description': 'The SF-36 PF assessment captures the physical functioning of participants. It has been moderately correlated with the SPPB and can be used interchangeably if the SPPB is not able to be completed by a patient', 'timeFrame': 'Assessed at: baseline, Day of Discharge from Hospital after cardiac surgery, 2 months post surgery and 6 months post surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a two-tailed alpha of 0.05, a power of 80%, and an overall drop-out rate of 15%.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on a previously observed distribution of SPPB scores in our elective cardiac surgery population, we expect this effect size will be approximately equivalent to either a 1-point change in the SPPB score or a 10-point change in SF-36-PF score. This magnitude of change in SPPB score is associated with a\u00e2\u0080\u0099substantial\u00e2\u0080\u0099 improvement in mobility and quality of life,27 and survival.62 Furthermore, the scale of change for the SF-36-PF is sensitive to detect even a small and clinically meaningful change in physical functioning.63 Due to the global pandemic (COVID-19), research initiatives that collected data through in-person meetings were suspended on two occasions (March 2020\u00e2\u0080\u0093August 2020, and November 2020\u00e2\u0080\u0094TBD). As a result, we developed an alternative primary outcome (ie, SF-36-PF) to implement for the trial in order to accommodate the institutional directive to transition research to use remote/virtual data collection strategies. The SF-36-PF is an optimal outcome measure appropriate for our study cohort, as it is correlated with the SPPB (r=0.5\u00e2\u0080\u00930.6) and is a surrogate measure of physical function.51 A sample size of 150 patients (75 in each group) will allow for an overall drop-out rate of 15% (n=22) while maintaining a moderate Cohen\u00e2\u0080\u0099s effect size (0.5) to detect the difference in change experienced between the two experimental groups at each follow-up time point with a two-tailed alpha of 0.05 and a power of 80% for the continuous primary outcomes. G*Power V.3.1 was used to calculate sample size for this study.", "id": 553, "split": "train"} +{"trial_id": "NCT04040296", "pmid": "37068906", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Personalized Recommendations for Acute Kidney Injury (AKI) Care Using a Kidney Action Team: A Randomized Trial\n\nIncluded conditions:\n- Acute Kidney Injury\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Kidney Action Team Recommendations will not be delivered to the primary care teams of randomized patients.'}\n- {'label': 'Kidney Action Team Recommendations', 'type': 'EXPERIMENTAL', 'description': \"Recommendations made by the Kidney Action Team will be delivered to the patient's primary care team within 30 minutes of AKI development.\", 'interventionNames': ['Other: Kidney Action Team Recommendations']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Kidney Action Team Recommendations', 'description': \"Upon review of the patient's medical information, the Kidney Action Team will create personalized recommendations that will be delivered to the patient's primary care team via a specialized note in the electronic medical record system within 30 minutes of AKI development. The attending of record will be identified as a cosigner to ensure that a member of the care team is made aware of the note's presence.\", 'armGroupLabels': ['Kidney Action Team Recommendations']}\n\nPrimary Outcomes:\n- {'measure': 'Composite outcome showing the percentage of participants with any one of the following: progression of AKI, inpatient dialysis, or inpatient death', 'description': 'Progression of AKI is defined by an increase in KDIGO creatinine stage from that present at the time of randomization.\\n\\nDialysis is defined by the receipt of hemodialysis, continuous renal replacement therapy or peritoneal dialysis. Isolated ultrafiltration treatments (for the purpose of volume removal) will not be included.\\n\\nMortality will be determined from hospital administrative records.\\n\\nThe rates of the primary outcome will be compared between the study arms using the Cochrane-Mantel-Haenszel chi-square test, accounting for stratification by hospital.', 'timeFrame': '14 days post randomization or at hospital discharge'}\n\nPlease estimate the sample size based on the assumption: \nTo achieve 90% power at an alpha of 0.05, with an additional 10% increase to account for contamination.", "answer": 4000, "answer_type": "ACTUAL", "explanation": "Power and sample size\n The overall sample size of the study is based on the composite outcome of AKI progression, dialysis and death. The baseline rate for this outcome is 21% based on preliminary data, and a 20% improvement rate would be considered clinically meaningful. To achieve 90% power, at an alpha of 0.05, we would need to enrol 1824 patients in each randomisation arm of the study for an overall total of 3624. However, given concerns about contamination, we have increased this overall number by almost 10% for a final total of 4000 patients. Enrolment of 4000 individuals allows us to maintain detection of a difference in the rate of adherence of 10% of 1 SD at an alpha of 0.05.", "id": 554, "split": "train"} +{"trial_id": "NCT04050007", "pmid": "34400454", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of a Systematic Preventive Versus Curative Strategy of Fluid Removal on the Weaning of Mechanical Ventilation\n\nIncluded conditions:\n- Respiratory Insufficiency\n\nStudy Armgroups:\n- {'label': '1', 'type': 'EXPERIMENTAL', 'description': 'Preventive initiation of fluid removal', 'interventionNames': ['Other: Preventive initiation of fluid removal']}\n- {'label': '2', 'type': 'OTHER', 'description': 'Curative initiation of fluid removal', 'interventionNames': ['Other: Curative initiation of fluid removal']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Preventive initiation of fluid removal', 'description': 'Preventive initiation of fluid removal will be started right after the randomization with intravenous diuretics according to a predefined algorithm based on the urine output every three hours.\\n\\nThe weaning process and post extubation preventive strategy will be protocolized based on the last international guidelines', 'armGroupLabels': ['1']}\n- {'type': 'OTHER', 'name': 'Curative initiation of fluid removal', 'description': 'The initiation of fluid removal will be considered by the attending physician only in case of failure to the spontaneous breathing trial with a clinical suspicion of weaning induced pulmonary edema.\\n\\nThe weaning process and post extubation preventive strategy will be protocolized based on the last international guidelines', 'armGroupLabels': ['2']}\n\nPrimary Outcomes:\n- {'measure': 'Duration of weaning from mechanical ventilation', 'description': 'Time elapsed between the day of randomization and the day of successful extubation (patient alive without reintubation 7 days after extubation)', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, two-sided alpha level of 0.05, using a likelihood ratio test in a Fine & Gray model with a time interaction term.", "answer": 410, "answer_type": "ESTIMATED", "explanation": "Sample size and its statistical justification\n A statistician calculated the sample size by estimating by simulation (2000 data sets) under a Weibull distribution using the following hypotheses derived from the BMW trial11: a cumulative incidence of successful extubation of 60% by day 7 and 80% by day 28 taking into account a competitive risk of death of 13% by day 7 and 16% by day 28. We determined that the enrolment of 410 patients (205 patients per group) would provide a power of 90% to show an absolute reduction of weaning duration of 1.6\u00e2\u0080\u0089days (4.9\u00e2\u0080\u0089days for the curative strategy versus 3.3\u00e2\u0080\u0089days for the preventive strategy) with a two-sided alpha level of 0.05 using a likelihood ratio test in a Fine & Gray model with a time interaction term.", "id": 555, "split": "train"} +{"trial_id": "NCT04053595", "pmid": "32305061", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Estimated Oxygen Extraction Versus Dynamic Parameters for Perioperative Hemodynamic Optimization of Patients Undergoing Non-cardiac Surgery: a Non-inferiority Randomized Controlled Trial\n\nIncluded conditions:\n- Perioperative/Postoperative Complications\n- Morality\n\nStudy Armgroups:\n- {'label': 'Estimated Oxygen Extraction', 'type': 'EXPERIMENTAL', 'interventionNames': ['Diagnostic Test: Estimated oxygen extraction protocol']}\n- {'label': 'Dynamic Parameters', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Diagnostic Test: Dynamic parameters of fluid responsiveness protocol']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Dynamic parameters of fluid responsiveness protocol', 'description': 'Dynamic parameter of fluid responsiveness (pulse pressure variation/stroke volume variation) are used to optimize hemodynamics intraoperatively and during the first 6 hours postoperatively when appropriate. A cutoff of 12% is used to predict an increase of stroke volume \\\\>10% after fluid administration.', 'armGroupLabels': ['Dynamic Parameters']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Estimated oxygen extraction protocol', 'description': 'Oxygen extraction is estimated by the difference of arterial oxygen saturation and central venous oxygen saturation divided by arterial oxygen saturation. A cutoff of 27% is used as a marker of inadequate tissue perfusion requiring hemodynamic optimization.', 'armGroupLabels': ['Estimated Oxygen Extraction']}\n\nPrimary Outcomes:\n- {'measure': 'Complications rate', 'description': 'Evaluate the difference of postoperative complications rate between the two groups', 'timeFrame': 'From date of randomization until the date of hospital discharge assessed up to 90 days'}\n\nPlease estimate the sample size based on the assumption: \nPower: 80%, significance level (alpha): 0.05, dropout rate: 10%", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n From literature analysis, we estimate a complication rate for control and experimental group of 28 and 35% respectively [2, 15]. With a non-inferiority margin of 10%, 184 patients (92 for each group) are needed to have a power of 80% and an alfa error of 0.05 [16]. Considering a 10% losing in follow-up, we enroll 200 patients (100 for each group).", "id": 556, "split": "train"} +{"trial_id": "NCT04053816", "pmid": "38478488", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The TIGHT-K STUDY. Prevention of Dysrhythmias on the Cardiac Intensive Care Unit - Does Maintenance of High-normal Serum Potassium Levels Matter\n\nIncluded conditions:\n- Arrhythmias, Cardiac\n\nStudy Armgroups:\n- {'label': 'Relaxed control', 'type': 'EXPERIMENTAL', 'description': \"Those randomised to the 'Relaxed' Group will receive potassium supplementation only if their serum potassium drops below 3.6 mEq/L.\", 'interventionNames': ['Drug: Potassium']}\n- {'label': 'Tight control', 'type': 'ACTIVE_COMPARATOR', 'description': \"Patients randomised to the 'Tight' group will receive potassium supplementation if their serum potassium falls below 4.5 mEq/L (current practice).\", 'interventionNames': ['Drug: Potassium']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Potassium', 'description': 'The trial treatment will start when patients are admitted to the intensive care unit after their surgery. The patient will undergo regular blood investigations, as per current practice. The frequency of K+ monitoring while on ICU will be according to clinician / nursing staff preference.\\n\\nPotassium supplementation will be according to local hospital protocols. This can be either via an intravenous infusion or as a tablet. Patients will otherwise be treated as per current hospital protocol.', 'armGroupLabels': ['Relaxed control', 'Tight control']}\n\nPrimary Outcomes:\n- {'measure': 'The presence of new onset AFACS until until hour 120 after initial admission to ICU/post-operative care facility, or discharge from hospital, whichever occurs first.', 'description': 'Episode of AFACS lasting \u226530 seconds that is both clinically detected and electrocardiographically confirmed (on either a 12-lead electrocardiogram (ECG), telemetry or Holter monitoring', 'timeFrame': 'Maximum of 5 days'}\n\nPlease estimate the sample size based on the assumption: \nAssuming a 35% and 37% AFACS incidence in the tight and relaxed groups respectively, the study aims to be 90% certain that the upper limit of a one-sided 97.5% CI (or equivalently a 95% two-sided CI) will exclude a difference in favour of tight potassium control of more than 10%. A 10% loss to follow-up is also considered.", "answer": 1684, "answer_type": "ACTUAL", "explanation": "Power calculations and sample size determination\n The sample size calculation is based on a 35% incidence of new onset AFACS, a figure derived from previous large studies and is at the lower end of the published data [1,8,23]. In the pilot study for this trial, which used a similar protocol, new onset AFACS incidence was 36.9% (95% confidence interval 29.1\u00e2\u0080\u009344.9).\n The co-applicants (from diverse backgrounds in cardiac peri-operative medicine, intensive care medicine, cardiovascular nursing, cardiac surgery, cardiology, statistics, clinical trial management with patient and public involvement) reached consensus that a clinically relevant non-inferiority margin is 10%. Assuming a 35% and 37% AFACS incidence in the tight and relaxed groups respectively, 1514 participants are required to be 90% certain that the upper limit of a one-sided 97.5% CI (or equivalently a 95% two-sided CI) will exclude a difference in favour of tight potassium control of more than 10%. Allowing for a 10% loss to follow-up means that 1684 participants should be recruited.\n The SPIRIT schedule of trial enrolment, interventions and assessments is shown in Fig 1.\n \n 10.1371/journal.pone.0296525.g001\n Fig 1\n \n SPIRIT schedule of trial enrolment, interventions and assessments [24].\n * Data recorded, but collected as part of standard care.", "id": 557, "split": "train"} +{"trial_id": "NCT04053829", "pmid": "33579762", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 2 Study to Investigate the Feasibility and Acceptability of the HOLOBalance System Compared to Standard Care in Older Adults at Risk for Falls: a Multi-site Study\n\nIncluded conditions:\n- Accidental Falls\n- Aging\n- Vestibular Disorder\n\nStudy Armgroups:\n- {'label': 'HOLOBalance', 'type': 'EXPERIMENTAL', 'description': 'The experimental arm will use the HOLOBalance tele-rehabilitation system to provide the intervention. Participants will be required to use the HOLOBalance system on a daily basis for the duration of the 8 week study. Although participants will have daily interaction with the HOLOBalance system, they will be free to choose when to complete their exercises.', 'interventionNames': ['Device: HOLOBalance']}\n- {'label': 'OTAGO Home Exercise Programme', 'type': 'ACTIVE_COMPARATOR', 'description': 'The comparator for this study is the OTAGO home exercise programme. The OTAGO is a systematic, progressive strength and balance training programme and is supported by a comprehensive workbook that provides written and pictorial instructions for each exercise. The OTAGO is well-established and is widely used in clinical practice in the UK for the management of older adults who fall or have increased risk for falling. It has been shown to be well tolerated in older adults in community settings with good adherence rates, and reduces falls rate in older adults by 35%, with greatest effects observed in frailer older women', 'interventionNames': ['Other: OTAGO Home Exercise Programme']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'HOLOBalance', 'description': \"The HOLOBalance tele-rehabilitation system will be used to deliver an evidence based, multi-sensory balance rehabilitation programme to participants, and will deliver a series of exercises prescribed by an expert balance physiotherapist following an initial balance assessment.\\n\\nThe HOLOBalance system will use a head mounted augmented reality display to deliver exercises and games to participants and will record task performance via a combination of body worn sensors and a depth camera. The HOLOBalance tele-rehabilitation system will provide feedback to the supervising clinical team regarding task performance, participant usage and user feedback. The system will have daily presence in the users' home with users expected to complete their prescribed rehabilitation on a daily basis, which mirrors the prescribed exercise routines often provided by balance physiotherapists.\", 'armGroupLabels': ['HOLOBalance']}\n- {'type': 'OTHER', 'name': 'OTAGO Home Exercise Programme', 'description': 'The OTAGO is a systematic, progressive strength and balance training programme and is supported by a comprehensive workbook that provides written and pictorial instructions for each exercise. It is well-established and widely used in clinical practice in the UK, and has been shown to reduce falls rate in older adults by 35-40%. It is well tolerated in older adults in community settings with good adherence rates.The OTAGO has also been used as the standard intervention in previous investigations of MSR interventions in older adults. To match intervention and control interventions, participants in the OTAGO group will be asked to complete the OTAGO programme every day for the duration of the 8 week programme.', 'armGroupLabels': ['OTAGO Home Exercise Programme']}\n\nPrimary Outcomes:\n- {'measure': 'Acceptability Assessment 1: Recruitment Rate', 'description': 'Assessment of recruitment rate of study (% of eligible participants enrolled)', 'timeFrame': 'Through study completion (12 months)'}\n- {'measure': 'Acceptability Assessment 2: Programme Compliance', 'description': 'Comparison of compliance with exercise programmes (% of sessions completed) within the intervention group and a control group undertaking standard practice, home based balance rehabilitation (the OTAGO Home Exercise Programme).', 'timeFrame': 'Through study completion (12 months)'}\n- {'measure': 'Acceptability Assessment 3: Drop out rate', 'description': 'Comparison of drop-out rates (%) between the intervention group and a control group undertaking standard practice, home based balance rehabilitation (the OTAGO Home Exercise Programme).', 'timeFrame': 'Through study completion (12 months)'}\n- {'measure': 'Acceptability 4: Qualitative interview', 'description': 'Acceptability of HOLOBalance to older adults will be investigated via exit interviews performed within the tele-rehabilitation intervention arm.', 'timeFrame': 'Collected at end of each participants participation in the study (After 8 weeks)'}\n- {'measure': 'Feasibility of providing HOLOBalance 1: Monitoring of Adverse and Serious Adverse Events', 'description': \"Feasibility will be assessed by documenting adverse events (and SAE's) and adverse device effects (and SADE's).\", 'timeFrame': 'Through study completion (12 months)'}\n- {'measure': 'Feasibility of providing HOLOBalance 2: Monitoring for deviations from study protocol', 'description': 'Assessment of any deviations from protocol reported logged in the site files using the deviation from protocol form.', 'timeFrame': 'Through study completion (12 months)'}\n\nPlease estimate the sample size based on the assumption: \nThe study does not specify assumptions on general statistical parameters such as significance level, power, or missing/dropout rate.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n This proof-of-concept study will recruit 60 participants per group (ie, total sample size of 120). This will allow the researchers to gain preliminary data on the primary outcomes of safety, feasibility and acceptability of the HOLOBalance intervention. This will also provide sufficient data to explore trends for effectiveness and to allow for sample size estimates to be drawn up for a future trial.", "id": 558, "split": "train"} +{"trial_id": "NCT04056884", "pmid": "33054825", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Group Intervention Trial for Siblings and Parents of Children With Chronic Illness (SIBS-RCT)\n\nIncluded conditions:\n- Siblings of Children With Chronic Illness\n\nStudy Armgroups:\n- {'label': 'SIBS intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'SIBS intervention is a 5-session group intervention for siblings and parents of children with chronic illness. Sessions 1-3 are delivered in one day, and sessions 4-5 are delivered in one day one week later.', 'interventionNames': ['Behavioral: SIBS intervention']}\n- {'label': 'Waitlist', 'type': 'NO_INTERVENTION', 'description': 'Waitlist is 12 week of no intervention/usual care'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'SIBS intervention', 'description': 'SIBS is a manual-based group intervention for siblings and parents of children with chronic illness', 'armGroupLabels': ['SIBS intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Strengths and difficulties questionnaire (SDQ)', 'description': 'Sibling mental health, reported by siblings, parents, and main teacher', 'timeFrame': 'Pre to 12-months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 0.8, significance level of 0.05, intra-cluster correlation coefficient (ICC) of 0.11, inflation factor (IF) of 1.55, and a dropout/concomitant care rate of 27%", "answer": 288, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The planned sample is 288 siblings, 288 mothers, and 288 fathers. Based on a power analysis of change in the main outcome variable (SDQ) from our open trial, with a minimal relevant standardized effect size of 0.4, a statistical power of .8, and a significance level of .05 [24], we need a sample of 136 families. The intra-cluster correlation coefficient (ICC) in our open trial was 0.11. We have taken this lack of independence between observations into account in sample size estimates. The planned group size is 6, which results in an inflation factor (IF) of 1.55 (IF\u00e2\u0080\u0089=\u00e2\u0080\u00891\u00e2\u0080\u0089+\u00e2\u0080\u0089(m\u00e2\u0080\u0089\u00e2\u0088\u0092\u00e2\u0080\u00891)\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089ICC) [25]. Adjusting with this IF resulted in a sample size of 211 (IF\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u0089136). We further increased the sample to 288 to compensate for dropouts and concomitant care (estimated to 27% based on our open trial). An estimated 5000 children with ND aged 0\u00e2\u0080\u009318\u00e2\u0080\u0089years receive health services in the catchment area, of whom an estimated 1000 (20%) have at least one sibling aged 8\u00e2\u0080\u009316\u00e2\u0080\u0089years. Thus, a 29% response rate is required to reach our sample size. We believe this is a realistic goal given the response rate in our open trial was 58%, and whereas one site recruited 107 participants in our open trial, we now have eight sites.", "id": 559, "split": "train"} +{"trial_id": "NCT04059562", "pmid": "37217885", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma\n\nIncluded conditions:\n- Cholangiocarcinoma\n\nStudy Armgroups:\n- {'label': 'Treatment', 'type': 'EXPERIMENTAL', 'description': 'Combination of Lonsurf\u00ae and Irinotecan', 'interventionNames': ['Combination Product: Combination of Lonsurf\u00ae and Irinotecan']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Combination of Lonsurf\u00ae and Irinotecan', 'description': 'Trifluridine/Tipiracil (Lonsurf\u00ae) and Irinotecan\\n\\n* Trifluridine/Tipiracil will be administered at a dose of 25 mg/m2 / dose twice daily on days 1-5 followed by a 9-days recovery period from day 6 trough day 14 of each 14-days treatment cycle.\\n* Irinotecan will be administered at the same time as Trifluridine/Tipiracil (Lonsurf\u00ae) on day 1 of each cycle at a dose of 180 mg/m2 / dose.', 'armGroupLabels': ['Treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Median progression free survival (PFS)', 'description': 'Median progression free survival (PFS)', 'timeFrame': 'through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up)'}\n\nPlease estimate the sample size based on the assumption: \nExponential failure time, censoring rate of 0.04 per month, and inclusion of 3 dropouts/invalid cases", "answer": 28, "answer_type": "ACTUAL", "explanation": "Sample size determination\n Sample size consideration for this study is based on the precision of the survival estimate for the outcome progression-free survival. Based on previous results with the combination of Irinotecan and 5-FU therapy in patients with biliary tract cancers we assume a median survival time of 3\u00c2\u00a0months. Assuming an exponential failure time with a median survival of 3\u00c2\u00a0months (hazard rate: 0.23 per month) and a censoring rate of 0.04 per month, a total sample size of 28 patients (including 3 calculated drop outs and invalid cases) results in an expected standard error of 0.09 for the 3\u00c2\u00a0months survival.", "id": 560, "split": "train"} +{"trial_id": "NCT04059562", "pmid": "37217885", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma\n\nIncluded conditions:\n- Cholangiocarcinoma\n\nStudy Armgroups:\n- {'label': 'Treatment', 'type': 'EXPERIMENTAL', 'description': 'Combination of Lonsurf\u00ae and Irinotecan', 'interventionNames': ['Combination Product: Combination of Lonsurf\u00ae and Irinotecan']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Combination of Lonsurf\u00ae and Irinotecan', 'description': 'Trifluridine/Tipiracil (Lonsurf\u00ae) and Irinotecan\\n\\n* Trifluridine/Tipiracil will be administered at a dose of 25 mg/m2 / dose twice daily on days 1-5 followed by a 9-days recovery period from day 6 trough day 14 of each 14-days treatment cycle.\\n* Irinotecan will be administered at the same time as Trifluridine/Tipiracil (Lonsurf\u00ae) on day 1 of each cycle at a dose of 180 mg/m2 / dose.', 'armGroupLabels': ['Treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Median progression free survival (PFS)', 'description': 'Median progression free survival (PFS)', 'timeFrame': 'through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up)'}\n\nPlease estimate the sample size based on the assumption: \nExponential failure time, censoring rate of 0.04 per month, and inclusion of 3 dropouts/invalid cases", "answer": 28, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Sample size consideration for this study is based on the precision of the survival estimate for In total 28 patients (including 3 calculated drop outs and invalid cases) with advanced biliary tract cancers after failure of a gemcitabine based first-line therapy will be enrolled the outcome progression-free survival. The primary endpoint, time till progression-free survival will be analyzed using a non-parametric survival estimate. To this end the method of Turnbull [22] will be used to compute the survival curve. The variance of the survival will be estimated using the Greenwood formula. The log transformation will be used for the calculation of confidence intervals. An exploratory analysis of secondary outcomes will be performed. Overall survival will be analyzed using the Kaplan\u00e2\u0080\u0093Meier estimate of survival. For the secondary outcomes, objective response and occurrence of adverse events the proportion of patients with the outcome and confidence intervals using the Wilson method will be calculated [23].", "id": 561, "split": "train"} +{"trial_id": "NCT04060368", "pmid": "34717726", "question": "Here is the design of a clinical trial:\n\nOfficial Title: STudy to Evaluate the Efficacy and Safety of Endoscopic Sleeve Gastroplasty (ESG) Versus LAparoscopic Sleeve Gastrectomy (LSG) in Obese Subjects With Non-Alcoholic SteatoHepatitis (NASH)\n\nIncluded conditions:\n- Non-alcoholic Steatohepatitis (NASH)\n\nStudy Armgroups:\n- {'label': 'ESG Stitch\u00ae system + Lifestyle modifications', 'type': 'EXPERIMENTAL', 'description': 'Endoscopic technique defined as a gastric restriction by means of continuous sutures of the entire gastric wall of the antrum and body, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan).', 'interventionNames': ['Procedure: Endoscopic Sleeve Gastroplasty (ESG) with OverStitch\u00ae system + Lifestyle modifications']}\n- {'label': 'LSG + Lifestyle modifications', 'type': 'ACTIVE_COMPARATOR', 'description': 'Minimally invasive surgical technique defined as a gastric restriction by means of an excision approximately 80% of the stomach along the greater curvature.', 'interventionNames': ['Procedure: Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modifications']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Endoscopic Sleeve Gastroplasty (ESG) with OverStitch\u00ae system + Lifestyle modifications', 'description': 'Endoscopic technique defined as a gastric restriction by means of continuous sutures of the entire gastric wall of the antrum and body, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan).', 'armGroupLabels': ['ESG Stitch\u00ae system + Lifestyle modifications']}\n- {'type': 'PROCEDURE', 'name': 'Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modifications', 'description': 'Minimally invasive surgical technique defined as a gastric restriction by means of an excision approximately 80% of the stomach along the greater curvature.', 'armGroupLabels': ['LSG + Lifestyle modifications']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of subjects undergoing ESG relative to LSG achieving resolution of NASH without worsening of fibrosis', 'description': 'To evaluate the effect of ESG compared to LSG on liver histology in obese subjects with NASH with or without fibrosis by assessing the following endpoint: The proportion of subjects undergoing ESG relative to LSG achieving NASH resolution without worsening of fibrosis. NASH resolution is defined as the disappearance of ballooning and the disappearance or persistence of minimal lobular inflammation (grade 0 or 1) The worsening of fibrosis is defined as the progression of at least one stage.', 'timeFrame': 'Measurement at 96 weeks'}\n- {'measure': 'Proportion of subjects undergoing ESG relative to LSG with cardiovascular and liver-related death events', 'description': 'To evaluate the effect of ESG compared to LSG on liver histology in obese subjects with NASH with fibrosis by assessing the following endpoint: The proportion of subjects undergoing ESG relative to LSG achieving improvement of liver fibrosis of at least one stage.', 'timeFrame': 'Measurement at 96 weeks'}\n\nPlease estimate the sample size based on the assumption: \nConfidence level of 99%, statistical power of 90%, and an assumption of 7% loss.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Previous studies have shown a resolution of NASH in the 85% of patients undergoing a bariatric surgery (69.6% in gastric tubing surgery) and a resolution of 25% in patients with a lifestyle intervention. A bilateral ratio comparison test was used for sample size calculation with a confidence level of 99%, a statistical power of 90%, and an assumption of 7% loss. Obtained sample to observe differences is n=30 (15 per treatment arm).", "id": 562, "split": "train"} +{"trial_id": "NCT04062058", "pmid": "35902798", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer\n\nIncluded conditions:\n- Gastric Cancer\n- Neoadjuvant Therapy\n\nStudy Armgroups:\n- {'label': 'Total Neoadjuvant Chemoradiotherapy', 'type': 'EXPERIMENTAL', 'description': 'Total neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery', 'interventionNames': ['Radiation: SIB-IMRT', 'Drug: S-1', 'Drug: SOX', 'Procedure: Surgery']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'SIB-IMRT', 'description': '45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target', 'armGroupLabels': ['Total Neoadjuvant Chemoradiotherapy']}\n- {'type': 'DRUG', 'name': 'S-1', 'description': \"40-60mg/m2(according to patient's body surface area), orally twice daily every weekday concurrently with radiotherapy treatment\", 'armGroupLabels': ['Total Neoadjuvant Chemoradiotherapy']}\n- {'type': 'DRUG', 'name': 'SOX', 'description': 'SOX (S-1: 40\\\\~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)', 'armGroupLabels': ['Total Neoadjuvant Chemoradiotherapy']}\n- {'type': 'PROCEDURE', 'name': 'Surgery', 'description': 'Surgery, preferred D2 lymphadenectomy', 'armGroupLabels': ['Total Neoadjuvant Chemoradiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'PCR rate', 'description': 'Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under telemicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).', 'timeFrame': '6-8 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u00ce\u00b1) is 0.05, power is 80%, and an interim analysis will be conducted after 33 patients are enrolled.", "answer": 82, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary objective is to determine the pCR rate in this trial. According to the results of the prospective phase II trial previously conducted at our center [20], the pCR rate of patients who received NCT was 14% (P0). We assume that after NCRT and six cycles of NCCT, the pCR rate will reach 28% in this study. Taking into consideration the loss of patients and the optimal two-stage design of phase II clinical trials, the test level \u00ce\u00b1 is 0.05 with a power of 80%. The required sample size of the study will be 82 patients. After 33 patients are enrolled, a planning interim analysis will be conducted. If the number of patients who received pCR is less than five, the study will be closed.", "id": 563, "split": "train"} +{"trial_id": "NCT04062695", "pmid": "34785545", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Tofacitinib in Reduction of Inflammation Detected on MRI in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement - a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial\n\nIncluded conditions:\n- Psoriatic Arthritis\n- Spondylitis\n- Sacroilitis\n\nStudy Armgroups:\n- {'label': 'Tofacitinib', 'type': 'ACTIVE_COMPARATOR', 'description': '5 mg oral BID', 'interventionNames': ['Drug: Tofacitinib 5 MG Oral Tablet [Xeljanz]']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'matching Placebo BID', 'interventionNames': ['Drug: Placebo oral tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tofacitinib 5 MG Oral Tablet [Xeljanz]', 'description': 'verum tablets', 'armGroupLabels': ['Tofacitinib'], 'otherNames': ['Xeljanz']}\n- {'type': 'DRUG', 'name': 'Placebo oral tablet', 'description': 'tablets containing placebo', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'MRI Berlin Score', 'description': 'Improvement of the Berlin MRI score for sacroiliac joints and spine. Scoring includes spinal inflammation (Lucas C et al, J Rheumatol 2007): 23 vertebral units with semiquantitative range of inflammation between 0 to 3 (min. score = 0, max. score = 69, the higher the worse). Additionally, inflammation of the sacroiliac joints is scored (Hermann KG, Rheumatologe 2004; scoring each quadrant between 0 and 4, max. score 16, the higher, the worse).', 'timeFrame': 'Week 12 vs Baseline'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level (alpha) of 0.05, and an anticipated standard deviation (SD) of 3.0. Consideration of dropout and protocol violations.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size is calculated based on results from phase II study with tofacitinib in patients with radiographic axial SpA.27 Treatment with tofacitinib 5\u00e2\u0080\u0089mg two times per day was associated with a mean (SD) absolute reduction of the Berlin MRI osteitis score for the spine (range 0\u00e2\u0080\u009369) of 2.2 (0.4) points as compared with a reduction of 0.4 in the placebo group after 12 weeks. We assume that in patients axial PsA who treated with tofacitinib, a mean reduction of at least 2.5 points of the total MRI osteitis score including spine and SIJs (range 0\u00e2\u0080\u009393) at week 12 as compared with baseline will be achieved, while a mean 0.5 points reduction is anticipated in placebo-treated patients. In order to demonstrate a significant difference between tofacitinib and placebo groups using the two-sample t test for the mean difference with the power of 80% and alpha=0.05 (anticipated SD=3.0), at least 74 patients (37 per arm) should be included in the analysis set. Considering some uncertainty in the effect estimation in the given patient population, and some expected dropout and protocol violations, we planned to include a total of 80 patients (n=40 per group) to demonstrate the expected treatment effect.", "id": 564, "split": "train"} +{"trial_id": "NCT04065685", "pmid": "32958487", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Nurse-led Patient-centred Intervention to Increase Written Advance Directives for Outpatients With Progressive Chronic Illnesses: a Randomized Controlled Trial With an Embedded Explanatory Qualitative Study\n\nIncluded conditions:\n- Advance Care Planning\n- Outpatients\n- Palliative Care\n\nStudy Armgroups:\n- {'label': 'CG', 'type': 'ACTIVE_COMPARATOR', 'description': 'control group receiving the usual care, the standardized information on anticipated directives', 'interventionNames': ['Other: usual care']}\n- {'label': 'IG p+r', 'type': 'ACTIVE_COMPARATOR', 'description': 'intervention group with patients and her/his relative', 'interventionNames': ['Other: serious game named Go Wish']}\n- {'label': 'IG p', 'type': 'ACTIVE_COMPARATOR', 'description': 'intervention group with patients without relative', 'interventionNames': ['Other: serious game named Go Wish']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'serious game named Go Wish', 'description': \"The nurse led intervention Go Wish is composed of 36 cards presenting statements of personal needs, values, and beliefs about end-of-life care. The aim is to decide about what to put into the patient's file as care options and the subsequent appointments to name a potential surrogate or to elaborate ADs.\\n\\nPatient and relative (if participating) will meet their nurse twice:\\n\\nSession 1: patient the cards in three piles and to rank the ten most important. Session 2 without relative: the nurse reiterates the wishes of care and treatments previously expressed and links them to the state of health and symptoms of the patient and the current treatments and their possible evolution.\\n\\nSession 2 with a relative: the relative sort the cards based on his/her beliefs about the patient's expectation.\\n\\nSession 3 with a relative: the nurse bring together the patient and his/her relative to discuss the priorities selected independently, identify, and explore the similarities and differences.\", 'armGroupLabels': ['IG p', 'IG p+r']}\n- {'type': 'OTHER', 'name': 'usual care', 'description': 'Standardized information on anticipated directives (ADs): the imad nurse are trained to promote AD to clients to help nurses to describe and explain ADs, to identify and to mobilize the required interview condition to promote ADs to clients to facilitate and initiate discussion on ADs', 'armGroupLabels': ['CG']}\n\nPrimary Outcomes:\n- {'measure': 'Number of completed anticipated directives', 'description': 'Completion of anticipated directives will be coded \"yes\" when anticipated directives are written and signed, otherwise it will be coded \"no\"', 'timeFrame': '6 months after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nWith a significance level of 0.05, a power of 0.8, and an attrition rate of 20%.", "answer": 135, "answer_type": "ESTIMATED", "explanation": "Sample size\n The percentage of the population with completed ADs in Switzerland has been estimated at around 2%.8 9 We anticipate that 5\u00e2\u0080\u0089months after inclusion in the study, around 5% of the patients of Group B will have ADs and around 25% of the patients of group A will have ADs. With a significance level of 0.05, a power of 0.8, and an attrition rate of 20%, we need to include 45 patients in each group to show the superiority of intervention A on the proportion of patients with completed ADs, as compared with intervention B.\n Go Wish was first developed for patients only28 and later for dyads (patients and relatives),27 to increase its beneficial effects. For ethical reasons, and to not stigmatise patients without relatives, the recruitment for the intervention group will be doubled to 45 patients with relatives and 45 patients without relatives. We will test the intervention\u00e2\u0080\u0099s efficacy for those with (hypothesis 1a) and without relatives (hypothesis 1b). Group B will include 45 patients (with or without relatives, with around 20 relatives). We will recruit a total of 135 patients receiving imad services and around 65 relatives. Twenty nurses are needed to recruit 135 patients (with an average of 25 patients referred to each nurse during the 15 months of the study; 60% in early-stage palliative care and a 50% response rate)\u00e2\u0080\u0099.\n For the second study, we will randomly select 5\u00e2\u0080\u009310 patients, relatives and nurses in each group until data saturation.", "id": 565, "split": "train"} +{"trial_id": "NCT04066764", "pmid": "34697109", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Efficacy and Safety Study of New Oral Anticoagulants and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters: A Prospective Randomized Controlled Trial\n\nIncluded conditions:\n- Venous Thromboembolism\n\nStudy Armgroups:\n- {'label': 'Rivaroxaban', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive rivaroxaban 15mg oral twice daily for 3 weeks after operation, later rivaroxaban 20mg oral once daily until 3 months after the filter is retrieved.', 'interventionNames': ['Drug: Rivaroxaban']}\n- {'label': 'Warfarin/ Nadroparin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive Nadroparin 1mg/kg twice daily (subcutaneous), plus warfarin 3mg oral once daily for 5 days after the operation, later warfarin(oral) at individually titrated doses(0.75mg to 18mg) to achieve a target international normalized ratio (INR) of 2.0 to 3.0, once daily until 3 months after the filter is retrieved.', 'interventionNames': ['Drug: Warfarin', 'Drug: Nadroparin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rivaroxaban', 'description': '15mg twice daily for 3 weeks after operation, later 20mg once daily until 3 months after the filter is removed. Application: oral', 'armGroupLabels': ['Rivaroxaban'], 'otherNames': ['Xarelto']}\n- {'type': 'DRUG', 'name': 'Warfarin', 'description': '3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until until 3 months after the filter is removed. Frequency: once daily Application: oral', 'armGroupLabels': ['Warfarin/ Nadroparin'], 'otherNames': ['coumadin']}\n- {'type': 'DRUG', 'name': 'Nadroparin', 'description': 'Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous', 'armGroupLabels': ['Warfarin/ Nadroparin'], 'otherNames': ['Fraxiparin']}\n\nPrimary Outcomes:\n- {'measure': 'All cause mortality', 'description': 'Percentage of participants with all deaths', 'timeFrame': '4 months after the filter is retrieved'}\n- {'measure': 'Pulmonary embolism related mortality', 'timeFrame': '4 months after the filter is retrieved'}\n- {'measure': 'Percentage of Participants with bleeding', 'description': 'Clinically relevant bleeding is defined as a composite of major or clinically relevant nonmajor bleeding', 'timeFrame': '4 months after the filter is retrieved'}\n- {'measure': 'Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism', 'description': 'the Composite of Recurrent Deep Vein Thrombosis \\\\[DVT\\\\] or Fatal or Non-fatal Pulmonary Embolism \\\\[PE\\\\]', 'timeFrame': '4 months after the filter is retrieved'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, dropout rate of 10%", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Adverse clinical outcomes of IVC filters are defined as a composite of recurrent VTE, IVC thrombosis or death. Weinberg et al32 reported that the adverse clinical outcomes rate for patients with IVC filters and without anticoagulants was 67.9%. However, the rate was only 30.5% and 29.1% for patients receiving prophylactic or therapeutic anticoagulation, respectively. For the group design non-inferiority test, 180 cases are sufficient under a power of 0.8, and the non-inferiority margin was \u00e2\u0080\u00930.12. Thus, we will recruit 200 patients, considering a dropout rate of 10%, 100 patients per group.", "id": 566, "split": "train"} +{"trial_id": "NCT04069884", "pmid": "39079921", "question": "Here is the design of a clinical trial:\n\nOfficial Title: RecurIndex Guided Avoidance of Regional Nodal Irradiation for Node Positive Breast Cancer\n\nIncluded conditions:\n- Breast Cancer\n- Radiation\n\nStudy Armgroups:\n- {'label': 'Arm I (Clinical low-risk, RecurIndex high-risk)', 'type': 'EXPERIMENTAL', 'description': 'Regional nodal irradiation (RNI) was given along with whole breast irradiation (WBI) or Chest wall irradiation (CWI) for breast-conserving patients and total mastectomy patients, respectively.', 'interventionNames': ['Radiation: regional nodal irradiation', 'Radiation: WBI', 'Radiation: chestwall XRT']}\n- {'label': 'Arm II (Clinical low-risk, RecurIndex high-risk)', 'type': 'ACTIVE_COMPARATOR', 'description': 'No Regional nodal irradiation (RNI) , whole breast irradiation (WBI) for breast-conserving patients and No Chest wall irradiation (CWI) for total mastectomy patients.', 'interventionNames': ['Radiation: WBI']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'regional nodal irradiation', 'description': 'external-beam radiotherapy (XRT)', 'armGroupLabels': ['Arm I (Clinical low-risk, RecurIndex high-risk)']}\n- {'type': 'RADIATION', 'name': 'WBI', 'description': 'Whole Breast Irradiation', 'armGroupLabels': ['Arm I (Clinical low-risk, RecurIndex high-risk)', 'Arm II (Clinical low-risk, RecurIndex high-risk)']}\n- {'type': 'RADIATION', 'name': 'chestwall XRT', 'description': 'chestwall irradiation', 'armGroupLabels': ['Arm I (Clinical low-risk, RecurIndex high-risk)']}\n\nPrimary Outcomes:\n- {'measure': 'Invasive disease-free survival (IDFS)', 'description': 'defined as the time between randomization and either local recur, distant metastases or death occurred', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided significance level (\u03b1) of 0.025, power (1-\u03b2) of 0.8, and a potential 20% dropout rate.", "answer": 540, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n This study is designed for superiority, referring to authoritative postoperative radiotherapy studies MA2010 and EORTC 2292211 for N1 patients, in which the 5-year IDFS in the radiotherapy group and the control group was 90.7% vs 81.9% and 87.7% vs 77.1%, respectively. In the domestic RecurIndex external validation retrospective study21 for patients with N1 breast cancer, the 5-year IDFS in the high RecurIndex-LRR risk group was 81.1% vs 69.7% in the postoperative radiotherapy group and the control group, respectively. It is expected that the 5-year IDFS for the clinically low LRR risk and high RecurIndex-LRR risk population in the experimental group and control group in this study will be 89% and 82%, respectively. The superiority margin is set to improve the primary endpoint IDFS by \u00e2\u0089\u00a57% (HR=0.587) in the postoperative radiotherapy research group compared with the control group. With a one-sided significance level (\u00ce\u00b1) of 0.025 and a power (1\u00e2\u0080\u0093\u00ce\u00b2) of 0.8, assuming the experimental group performs better than the control group, the required sample size for each group was calculated as 216 cases per group using PASS V.15.0 software. The allocation ratio between the experimental and control groups was set at 1:1. Considering a 5-year enrolment period, 5-year follow-up period and potential 20% dropout rate (mainly considering the need for further 10-year and 15-year long-term efficacy follow-up after reaching the 5-year endpoint), each group will need 270 cases, totalling 540 cases.", "id": 567, "split": "train"} +{"trial_id": "NCT04071613", "pmid": "35487712", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance\n\nIncluded conditions:\n- Stroke, Acute, Stroke Ischemic\n\nStudy Armgroups:\n- {'label': 'Intravenous tenecteplase (TNK)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over \\\\~10 seconds).', 'interventionNames': ['Drug: Tenecteplase']}\n- {'label': 'Intravenous tissue plasminogen activator (tPA)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive intravenous t-PA at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.', 'interventionNames': ['Drug: Intravenous tissue plasminogen activator (tPA)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tenecteplase', 'description': 'Route: IV bolus injection Frequency: once only, within 4.5 hours of stroke onset', 'armGroupLabels': ['Intravenous tenecteplase (TNK)'], 'otherNames': ['TNK']}\n- {'type': 'DRUG', 'name': 'Intravenous tissue plasminogen activator (tPA)', 'description': 'Route: Intravenous (IV) infusion (10% as bolus and the remainder over 60 minutes) Frequency: once only, within 4.5 hours of stroke onset', 'armGroupLabels': ['Intravenous tissue plasminogen activator (tPA)'], 'otherNames': ['TPA, Alteplase']}\n\nPrimary Outcomes:\n- {'measure': 'Perfusion lesion on CTP', 'description': 'The volume of the perfusion lesion on CTP performed on arrival at the receiving hospital, adjusted for pre-treatment NIHSS and time from initiation of treatment to CTP.', 'timeFrame': 'Within 2hrs of treatment'}\n\nPlease estimate the sample size based on the assumption: \n90% power, significance level of p=0.05, and a conservative 20% difference in post-treatment perfusion lesion.", "answer": 104, "answer_type": "ACTUAL", "explanation": "Sample size estimates\n Based on the data from the phase II and III Australian tenecteplase trials and experiences with the MSU, an estimated total sample size of 104 patients (with 52 patients in each treatment and control arms) yields 90% power to detect a hypothesised mean difference of 13\u00e2\u0080\u0089mL (SD 20\u00e2\u0080\u0089mL) in the perfusion lesion volume between treatment groups measured at the receiving hospital at a statistical significance threshold of p=0.05. The ongoing TASTE trial has a mean pre-treatment perfusion lesion volume of 65\u00e2\u0080\u0089mL (SD 20\u00e2\u0080\u0089mL). In phase II Australian tenecteplase trial, the post-treatment (24 hours) perfusion lesion was 50% smaller in the tenecteplase arm. Given post-treatment CTP will be performed considerably earlier in TASTE-A, we have assumed a more conservative 20% difference in post-treatment perfusion lesion.10\n Adaptive increase in sample size is planned based on the result of interim analysis using data from the first 80 patients, as per Mehta and Pocock.29 The maximum sample size is capped at 200 patients, with a minimum of 104.\n A blinded review of the perfusion lesion volume was conducted based on the first 80 participants. It revealed that the more appropriate model was a zero-inflated negative binomial (ZINB) regression model with the perfusion volume expressed as a count of millilitres of perfusion lesion. The ZINB model accounts for the potential overdispersion in the perfusion lesion volume distribution and the potential presence of stroke mimics among the RCT participants.\n We performed the sample size re-estimation using the ZINB regression and found no need for an adaptive increase in the sample size. Therefore, the final sample size was 104.", "id": 568, "split": "train"} +{"trial_id": "NCT04075474", "pmid": "32019596", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventing Early Childhood Caries With Silver Diamine Fluoride - a Randomised Clinical Trial\n\nIncluded conditions:\n- Dental Caries\n\nStudy Armgroups:\n- {'label': 'silver diamine fluoride', 'type': 'EXPERIMENTAL', 'description': '38% silver diamine fluoride', 'interventionNames': ['Device: silver diamine fluoride']}\n- {'label': 'sodium fluoride', 'type': 'ACTIVE_COMPARATOR', 'description': '5% sodium fluoride', 'interventionNames': ['Device: sodium fluoride']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'silver diamine fluoride', 'description': '38% SDF on primary upper anterior teeth', 'armGroupLabels': ['silver diamine fluoride']}\n- {'type': 'DEVICE', 'name': 'sodium fluoride', 'description': '5% NaF on primary upper anterior teeth', 'armGroupLabels': ['sodium fluoride']}\n\nPrimary Outcomes:\n- {'measure': 'caries prevention', 'description': 'the number of sound tooth surfaces that become cavitated caries per child', 'timeFrame': 'at 30-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power set at 0.9, type I error rate of 5% for a two-sided test, and a dropout rate of 20%.", "answer": 730, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The mean number of cavitated teeth of a 3-year-old child was five in our previous study [16]. The mean number of new cavitated caries surfaces found in the 62 children in the SDF group was 0.47 (standard deviation (SD) 0.87), and the mean new cavitated caries surfaces in the 61 children in the NaF group was 0.70 (SD 0.84) at the 30-month review. This difference corresponded to a prevented fraction of 33% more in the SDF group when compared to the NaF group, which is considered clinically significant. With the statistical power set at 0.9 and type I error rate of 5% for a two-sided test, the required sample size would be 292 for each group. Considering a dropout rate of 20%, the total number of children to be recruited at baseline should be 365 in each group. Therefore, a total of 730 children need to be recruited at baseline examination for this trial.", "id": 569, "split": "train"} +{"trial_id": "NCT04079387", "pmid": "33033014", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone on Successful First-Pass Orotracheal Intubation Among Critically Ill Patients: the Randomised STYLETO Study Protocol\"\n\nIncluded conditions:\n- Intubation Complication\n- Critically Ill\n\nStudy Armgroups:\n- {'label': 'ENDOTRACHEAL TUBE + STYLET', 'type': 'EXPERIMENTAL', 'description': 'The experimental group consists in intubating the trachea with an endotracheal tube + stylet with a \"straight-to-cuff\" shape and a bend angle of 25\u00b0 to 35\u00b0.', 'interventionNames': ['Device: ENDOTRACHEAL TUBE + STYLET']}\n- {'label': 'ENDOTRACHEAL TUBE ALONE', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group consists in intubating the trachea with an endotracheal tube alone (i.e, without stylet).', 'interventionNames': ['Device: ENDOTRACHEAL TUBE ALONE']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'ENDOTRACHEAL TUBE + STYLET', 'description': 'The experimental group consists in intubating the trachea with an endotracheal tube + stylet with a \"straight-to-cuff\" shape and a bend angle of 25\u00b0 to 35\u00b0', 'armGroupLabels': ['ENDOTRACHEAL TUBE + STYLET']}\n- {'type': 'DEVICE', 'name': 'ENDOTRACHEAL TUBE ALONE', 'description': 'intubating the trachea with an endotracheal tube alone', 'armGroupLabels': ['ENDOTRACHEAL TUBE ALONE']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients with successful first-pass orotracheal intubation', 'description': 'the proportion of patients with successful first-pass orotracheal intubation', 'timeFrame': 'At intubation'}\n\nPlease estimate the sample size based on the assumption: \ntwo-sided \u03b1 level of 0.05, statistical power of 95%, and considerations for withdrawn consent, inclusions not meeting criteria, or improvement/death before intubation", "answer": 1040, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary outcome is the first-attempt success during intubation procedure. For this study, 2\u00c3\u0097485 patients are needed to detect a 10% difference in the first-attempt success rate during intubation procedure (from 70% without stylet to 80% with stylet, difference judged clinically important,2 10 at a two-sided \u00ce\u00b1 level of 0.05 and a statistical power of 95%).4 27 28 To take into account withdrawn consent after randomisation, inclusions not meeting the inclusion criteria or improvement or death before intubation, 1040 patients will be included: 520 patients in each group.", "id": 570, "split": "train"} +{"trial_id": "NCT04082234", "pmid": "38909215", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Reducing Disparities in Behavioral Health Treatment for Children in Primary Care\n\nIncluded conditions:\n- ADHD\n\nStudy Armgroups:\n- {'label': 'Integrated Individualized Behavioral Parent Training', 'type': 'EXPERIMENTAL', 'description': 'Partnering to Achieve School Success (PASS) is a personalized, enhanced behavioral intervention for ADHD that includes evidence-based behavior therapy strategies and enhancements to promote family engagement in treatment, team-based care, and high quality therapy. Caregivers engage in up to 12 sessions with a behavioral health provider over the course of 16 weeks that are specifically tailored to caregiver goals and values.', 'interventionNames': ['Behavioral: Partnering to Achieve School Success (PASS)']}\n- {'label': 'Treatment as Usual', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control condition will be TAU informed by AAP guidelines for managing ADHD and facilitated by electronic practice supports, which have been successfully incorporated into the electronic health record (EHR) to guide primary care providers (PCPs) in implementing ADHD guidelines. At CHOP, PCPs across the primary care network were invited to participate in a distance learning, quality improvement initiative to promote implementation of AAP guidelines, including strategies to educate families about ADHD and evidence-based treatments, engage families in shared decision making, titrate medication, and monitor treatment effects. The six practices participating in this study participated in that project.', 'interventionNames': ['Other: Treatment as Usual (TAU)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Partnering to Achieve School Success (PASS)', 'description': \"Individualized parent training program delivered at child's primary care provider office. Providers use engagement and motivation strategies during each session to reinforce help-seeking behavior and family empowerment, and encourage family adherence to recommended strategies. Also includes regular communication between pass provider and PCP and development of a problem-solving partnership between parents and teachers to address school problems. Families are supported in between sessions by a Community Health Partner who contacts families to promote attendance and implementation of strategies and assist in resolving barriers to treatment. The intervention is up to 12 sessions over the course of 16 weeks depending on caregiver goals.\", 'armGroupLabels': ['Integrated Individualized Behavioral Parent Training']}\n- {'type': 'OTHER', 'name': 'Treatment as Usual (TAU)', 'description': \"Caregivers will work with their primary care physician to address their child's ADHD. Primary care physicians have been trained in and informed of American Academy of Pediatrics guidelines for treating ADHD. Treatment may include strategies to educate families about ADHD and evidence-based treatments, refer families to community mental health agencies that deliver evidence-based behavioral programming (other than PASS), engage families in shared decision making, titrate medication, and monitor treatment effects. In addition, families will have access to integrated behavioral health services that are typically offered at their child's primary care office.\", 'armGroupLabels': ['Treatment as Usual']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in Homework Performance', 'description': 'The Inattention/Task Avoidance factor of the Homework Problem Checklist (HPC) will be used as a parent-report measure of academic performance. This 12-item scale has strong psychometric properties and is responsive to family-school intervention programs.', 'timeFrame': 'Baseline, 8-weeks (mid-treatment), 16-weeks (post-treatment), 32-weeks (follow-up)'}\n- {'measure': 'Changes in Behavior Compliance', 'description': 'Behavior compliance will be determined by assessing the severity of disruptive behavior using the eight items pertaining to oppositional-defiant disorder from the Vanderbilt parent scale and four items pertaining to oppositional-defiant disorder (ODD) from the Vanderbilt teacher scale. Both parents (primary outcome) and teachers (secondary outcome) will complete this measure. The psychometric properties of parent and teacher reports on this measure have been shown to be adequate.', 'timeFrame': 'Baseline, 8-weeks (mid-treatment; parent only), 16-weeks (post-treatment), 32-weeks (follow-up)'}\n- {'measure': 'Changes in Symptoms of ADHD and Emotional and Behavioral Problems', 'description': 'Severity of ADHD symptoms will be assessed using the Vanderbilt Scales. This measure will be completed by parents and teachers. Parent and teacher ratings of ADHD symptoms have been demonstrated to have excellent psychometric properties and to be sensitive to change in response to treatment. A total symptom score will be used in this study. A child self-report measure of ADHD symptoms will not be included because children with ADHD have been shown to substantially overestimate their competence with regard to paying attention and regulating their behavior. All 18 ADHD symptom items will be completed at Baseline and all 9 ADHD Inattention items and 3 ADHD Hyperactivity/Impulsivity items will be administered at post-treatment and follow-up.', 'timeFrame': 'Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)'}\n- {'measure': 'Changes in Peer Relationships', 'description': \"The Patient Reported Outcomes Measurement Information System (PROMIS) peer relationships scales will be used to assess child relationships with their peers. The child-report version consists of 8 items and the parent-report measure has 7 items. These measures assess the quality of children's relationships with peers including the degree of peer acceptance. The scales have been shown to produce scores that are both reliable and valid based on analyses using item response theory.\", 'timeFrame': 'Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)'}\n- {'measure': 'Changes in Life Satisfaction', 'description': \"The PROMIS life satisfaction scale consists of a 4-item child-report measure and a 4-item parent-report measure. It assesses children's and parents' evaluations of the quality of the child's life. Using analyses based in item response theory, these scales have been shown to be reliable with a wide range of life satisfaction levels \\\\[from 2.5 standard deviations (SDs) below the mean to 1 SD above the mean\\\\].\", 'timeFrame': 'Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)'}\n- {'measure': 'Changes in Service Use', 'description': \"Service use for emotional and behavioral problems will be measured via a service use measure adapted for this study designed to gather information on the child's use of services to treat ADHD. In this study, we will collect data on service utilization in outpatient mental health settings and school settings, and treatment with medication.\", 'timeFrame': 'Baseline, 16-weeks (post-treatment), 32-weeks (follow-up)'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation for a single observation is assumed to be 0.50, autocorrelation is 0.3, significance level is not explicitly stated, power is 85%, and the expected attrition rate is 20%.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on prior research [26, 28, 35], the magnitude of the effect size reflecting the degree of change in response to PASS vs TAU for service use and child outcomes (Objective 1) and care processes (Objective 2) is expected to be the 0.35 to 0.60 SD range. Based on prior research using a similar behavioral intervention [41], we assumed a standard deviation for a single observation\u00e2\u0080\u0089=\u00e2\u0080\u00890.50 and an autocorrelation\u00e2\u0080\u0089=\u00e2\u0080\u00890.3. Projecting an enrollment of 300 participants (150 per condition), and given an expected 20% attrition rate, we expect 240 participants will provide parent-report and child self-report data at baseline and at least one other data collection point. Using statistical methods described below, analytic models will achieve 85% power to detect an effect size as small as 0.30 SD. Given the challenges of collecting data from teachers related to the COVID-19 pandemic, the number of evaluable cases will be well below 240 (estimated to be 100). As such, analyses of teacher-report data will be exploratory. In addition, analyses of mediation (Objective 3) and subgroup effects (Objective 4) will be exploratory.", "id": 571, "split": "train"} +{"trial_id": "NCT04084795", "pmid": "39741323", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Augmentation of EMDR With Transcranial Direct Current Stimulation in the Treatment of Fibromyalgia: a Randomized Controlled Trial\n\nIncluded conditions:\n- Fibromyalgia\n- Psychological Trauma\n- Depressive Symptoms\n- Anxiety\n\nStudy Armgroups:\n- {'label': 'EMDR plus MtCS', 'type': 'ACTIVE_COMPARATOR', 'description': 'MtCS stimulation will consist of 1mA MtDCS for 20 minutes applied immediately before EMDR sessions.', 'interventionNames': ['Behavioral: Eye Movement Desensitization and Reprocessing therapy', 'Other: Multifocal transcranial Current Stimulation']}\n- {'label': 'EMDR plus sham-MtCS', 'type': 'PLACEBO_COMPARATOR', 'description': 'Sham stimulation will consist of inactive MtDCS for 20 minutes applied immediately before EMDR sessions', 'interventionNames': ['Behavioral: Eye Movement Desensitization and Reprocessing therapy']}\n- {'label': 'Treatment as Usual', 'type': 'NO_INTERVENTION', 'description': 'Patients in this condition will not receive EMDR nor MtCS sessions, and will continue to attend their regular visits with rheumatology and psychiatry. The patients from the TAU group will have the choice to attend 10 sessions of EMDR group therapy when the research project finishes.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Eye Movement Desensitization and Reprocessing therapy', 'description': 'EMDR is a psychotherapeutic approach using a standardized 8-phase protocol to alleviate the distress associated with traumatic memories, facilitating the access to and processing of traumatic memories. Patients will receive 20 individual EMDR sessions of 60 minutes each using the standard protocol, as well as a specific pain protocol and the fibromyalgia protocol. EMDR is an integrative psychotherapy that uses standardized protocols and elements of cognitive-behavioral, interpersonal, and body-centered therapies, as well as dual stimulation (e.g., side-to-side eye movements).\\n\\nThe current standard protocol includes eight phases:\\n\\nPatient history. Patient preparation. Patient assessment. Memory desensitization. Installing the positive cognition. Body scan. Closure. Reevaluation.', 'armGroupLabels': ['EMDR plus MtCS', 'EMDR plus sham-MtCS'], 'otherNames': ['EMDR']}\n- {'type': 'OTHER', 'name': 'Multifocal transcranial Current Stimulation', 'description': 'MtCS represents a promising intervention option, given its capacity to modulate cerebral excitability in a simple, safe manner. F3 anodal; AF3, FC1, FC3, FC5, F5, return montage will be used with the anode over the left DLPFC. Half of the patients will receive active stimulation and the other half sham stimulation. Active stimulation will consist of 1mA MtDCS for 20 minutes applied immediately before EMDR sessions. The same protocol and montage will be used for sham stimulation.', 'armGroupLabels': ['EMDR plus MtCS'], 'otherNames': ['MtCS']}\n\nPrimary Outcomes:\n- {'measure': 'Change in pain assessed with the Visual Analogic Scale Questionnaire.', 'description': 'Severity and changes in pain intensity will be assessed with the Visual Analogic Scale (rated in a continuum from 0 to 10).', 'timeFrame': 'Change from baseline to visits at 6 and 12 months'}\n- {'measure': 'Change in pain assessed with the Pain Dissability Index.', 'description': 'Severity and changes in pain intensity will be assessed with the Pain Disability Index (7 items rated from 0 to 10, making a total score from 0 to 70).', 'timeFrame': 'Change from baseline to visits at 6 and 12 months'}\n- {'measure': 'Change in pain assessed with the Fibromyalgia Impact Questionnaire.', 'description': 'Severity and changes in pain intensity will be assessed with the Fibromyalgia Impact Questionnaire (the first items is rated from 0 to 4, the second from 0 to 7 and the third from 0 to 5; whereas the other 7 items are rated from 0 to 10, with a cut-off score of 50).', 'timeFrame': 'Change from baseline to visits at 6 and 12 months'}\n- {'measure': 'Change in depressive symptoms assessed by with the Hospital Anxiety and Depression Scale', 'description': 'Severity and changes in depressive symptoms will be evaluated with the Hospital Anxiety and Depression Scale. Items are rated on a 4-point Likert scale from 0 and 3, yielding a total score ranging from 0 to 21 and a cut-off score of 8 indicating probable clinical symptoms.', 'timeFrame': 'Change from baseline to visits at 6 and 12 months'}\n- {'measure': 'Change in anxious symptoms evaluated with the Hospital Anxiety and Depression Scale.', 'description': 'Severity and changes in anxious symptoms will be evaluated with the Hospital Anxiety and Depression Scale. Items are rated on a 4-point Likert scale from 0 and 3, yielding a total score ranging from 0 to 21 and a cut-off score of 8 indicating probable clinical symptoms.', 'timeFrame': 'Change from baseline to visits at 6 and 12 months'}\n- {'measure': 'Change in trauma associated symptoms assessed with the Impact of Events Scale-Revised.', 'description': \"Psychological trauma will be evaluated using the Impact of Events Scale-Revised. This scale consists in 22-item to determine frequency and impact of posttraumatic symptoms experienced, with subscales of intrusion, avoidance and hyperarousal, each scored on a 5-point Likert scale, yielding a score for each subscale and a total score. This scale has a scoring range of 0 to 88. On this test, scores that exceed 24 can be quite meaningful. High scores have the following associations: 24 or more PTSD is a clinical concern. Those with scores this high who do not have full PTSD will have partial PTSD or at least some of the symptoms; 33 and above represents the best cutoff for a probable diagnosis of PTSD; 37 or more this is high enough to suppress your immune system's functioning (even 10 years after an impact event).\", 'timeFrame': 'Change from baseline to visits at 6 and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level of 0.05, statistical power of 80%, 15% dropout rate", "answer": 96, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The main tests of the study will consist of assessing whether patients assigned to EMDR show different levels in the pain intensity variable using a standard formula for two-tailed t-tests. The total sample size required to detect large to very large effect size differences (Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00891) between three groups with a significance level of 0.05 and statistical power of 80% is 28. Assuming 15% dropouts, we will aim to randomize 96 patients, meaning 32 per group.", "id": 572, "split": "train"} +{"trial_id": "NCT04084990", "pmid": "34187829", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sleep Apnea and Fetal Growth Restriction\n\nIncluded conditions:\n- Obstructive Sleep Apnea\n- Fetal Growth Restriction\n- Pregnancy Related\n\nStudy Armgroups:\n- {'label': 'aPAP', 'type': 'EXPERIMENTAL', 'description': 'Nightly use of aPAP when sleeping through the date of delivery', 'interventionNames': ['Device: S9 VPAP Adapt']}\n- {'label': 'No aPAP', 'type': 'NO_INTERVENTION', 'description': 'No use of aPAP (standard of care)'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'S9 VPAP Adapt', 'description': 'Auto-titrated positive airway pressure', 'armGroupLabels': ['aPAP']}\n\nPrimary Outcomes:\n- {'measure': 'Birth Weight', 'description': 'Weight of child at time of birth', 'timeFrame': '1 day'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a baseline birth weight of 2535\u00b1234 g, a significance level (alpha) of 0.05, 90% power, a 5% loss to follow-up, and the use of a two-tailed t-test.", "answer": 3, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The baseline birth weight of infants with FGR in the population from our primary study centre (Barnes-Jewish Hospital, St Louis, Missouri) is 2535\u00c2\u00b1234\u00e2\u0080\u0089g (unpublished data). Based on these data, we calculated that 104 evaluable participants with OSA will need to be randomised to either PAP or control (stage 3) in order to have 90% power to detect a 150 g difference in birth weight in the PAP group compared with control. This is based on an alpha of 0.05, anticipated 5% loss to follow-up and a two-tailed t-test.\n The risk of OSA in high-risk obstetric populations (such as FGR) is as high as 35%.49 As we are screening participants for OSA risk by a brief telephone or in-person questionnaire (stage 1) prior to HSAT testing (stage 2), we estimate that there will be an OSA-positive HSAT in 30%\u00e2\u0080\u009350% of these screened participants. Consequently, we estimate that we will need to assess HSAT in 200\u00e2\u0080\u0093350 participants in stage 2 in order to achieve our sample size of 104 evaluable participants for stage 3. We estimate needing to screen some 500\u00e2\u0080\u00931000 participants in stage 1 in order to identify these 200\u00e2\u0080\u0093350 participants for stage 2. Based on an estimated combined total of 20\u00e2\u0080\u0089000 births annually with an estimated incidence of 15% of FGR at the above centres, we estimate 3000 pregnancies complicated by FGR each year. Accounting for participants who will not meet study inclusion criteria, or will decline to participate, the recruitment process is expected to last approximately 2 years.", "id": 573, "split": "train"} +{"trial_id": "NCT04086550", "pmid": "35858894", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery\n\nIncluded conditions:\n- Cerebrospinal Fluid Leak\n\nStudy Armgroups:\n- {'label': 'Investigational arm', 'type': 'EXPERIMENTAL', 'description': 'Application of LIQOSEAL after closure of dura mater', 'interventionNames': ['Device: LIQOSEAL']}\n- {'label': 'Control arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Application of Adherus or DurSeal after closure of dura mater', 'interventionNames': ['Device: DuraSeal, Adherus']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'LIQOSEAL', 'description': 'Adjunctive bioresorbable patch', 'armGroupLabels': ['Investigational arm']}\n- {'type': 'DEVICE', 'name': 'DuraSeal, Adherus', 'description': 'synthetic absorbable sealants', 'armGroupLabels': ['Control arm']}\n\nPrimary Outcomes:\n- {'measure': 'Composite endpoint defined as successful dural repair without any of the following compared to the control group: intra-operative CSF leakage percutaneous CSF leak significant pseudomeningocele wound infection', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe power of the study is 80%, with a one-sided significance level of 5%. The expected rate of attrition is 10%.", "answer": 228, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n \u00e2\u0080\u009cSuccess\u00e2\u0080\u009d was defined as absence of the composite endpoint. The success rate of the investigational product was set similar to that of the control devices combined. The combined success rate of the control devices was determined at 91%, based upon a comparative study of the two devices [6]. The non-inferiority margin was set at 10%, this was accordance with the design used by the control devices [6] and believed to be clinically acceptable. The power of the study is 80%, with a one-sided significance level of 5%. The expected rate of attrition is 10%. Under these assumptions, a total of 228 patients are required, 114 per arm.", "id": 574, "split": "train"} +{"trial_id": "NCT04087005", "pmid": "32539850", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of JHG002(Hominis Placenta, \u7d2b\u6cb3\uf902) Therapy for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial)\n\nIncluded conditions:\n- Temporomandibular Disorder\n\nStudy Armgroups:\n- {'label': 'Hominis placental pharmacopuncture', 'type': 'EXPERIMENTAL', 'description': 'The Hominis placental pharmacopuncture group will receive 10 sessions of Hominis placental pharmacopuncture at 2 sessions/week for 5 weeks. A trained doctor of Korean medicine with at least 2 years clinical experience will administer JHG002 pharmacopuncture with a disposable syringe (0.5ml) directly into the designated sites, using a standardized method.', 'interventionNames': ['Other: hominis placental pharmacopuncture']}\n- {'label': 'Transcutaneous electrical nerve stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will receive 2 sessions/week of TENS for 5 weeks. A high-frequency, low-intensity stimulus of 50-100Hz and up to 15mA will be used, such that the patients feel a current but do not feel pain. At each treatment visit, a physiotherapist will administer the treatment to the bilateral temporomandibular joint for 15 minutes. Both centres will use the same TENS device-a BioTron-DX (D.M.C, Osan, South Korea).', 'interventionNames': ['Other: hominis placental pharmacopuncture']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'hominis placental pharmacopuncture', 'description': \"Hominis placental pharmacopuncture is human placental extract, which has been used in traditional Korean medicine to treat chronic diseases, including frailty, cough, anorexia, and fatigue, by enhancing the body's resistance.\", 'armGroupLabels': ['Hominis placental pharmacopuncture', 'Transcutaneous electrical nerve stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'The difference in visual analogue scale (VAS) of temporomandibular pain', 'description': \"The primary outcome is the difference in VAS for TMJ pain between baseline and the primary end point (Week 6). VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end.\", 'timeFrame': 'Week 6'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05 (two-tailed), type 2 error (\u03b2) = 0.2, power = 80%, and a dropout rate of 20%. The correlation between baseline and primary endpoint was assumed to be 0.4 for ANCOVA.", "answer": 82, "answer_type": "ACTUAL", "explanation": "Sample size\n This is an investigator-initiated clinical trial, and we have calculated the required sample size with reference to similar studies and our clinical experience. First, we set a significance level of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (two-tailed tests), a type 2 error (\u00ce\u00b2) of 0.2, and a test power of 80%. Because there are no previous studies comparing pharmacopuncture with PT for the TMJ, we selected a moderate-to-high effect size for the comparison of mean VAS between the two groups based on our clinical experience, and used Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.65 [36]. Using these parameters, we calculated the sample size using G*Power 3.1.7. Based on an effect size\u00e2\u0080\u0089=\u00e2\u0080\u00890.65, the required sample size was estimated to be 39 persons/group (total 78 persons). However, as we plan to use an analysis of covariance (ANCOVA) correcting for the outcome at baseline for our main analysis, we calculated the sample size assuming the correlation between baseline and primary endpoint to be 0.4 [(1\u00e2\u0080\u00930.4*0.4)*78], and found that the minimum required number of participants was a total of 65 persons [37]. Thus, to account for a dropout rate of 20%, we calculated that the number of participants we need to recruit is a total of 82 persons (41 persons/group).", "id": 575, "split": "train"} +{"trial_id": "NCT04087031", "pmid": "32404132", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Parkinson's Disease Through Technological Innovation\n\nIncluded conditions:\n- Parkinson Disease\n- Frail Elderly\n- Robotic Devices in Rehabilitation\n\nStudy Armgroups:\n- {'label': 'control arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Ten traditional treatment sessions divided into 2 training sessions per week for 5 weeks', 'interventionNames': ['Other: control arm']}\n- {'label': 'virtual reality games arm', 'type': 'EXPERIMENTAL', 'description': 'Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks', 'interventionNames': ['Other: virtual reality games']}\n- {'label': 'robotic treadmill arm', 'type': 'EXPERIMENTAL', 'description': 'Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks', 'interventionNames': ['Other: robotic treadmill']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'control arm', 'description': 'Each session will include 50 minutes of traditional physical rehabilitation therapy', 'armGroupLabels': ['control arm']}\n- {'type': 'OTHER', 'name': 'virtual reality games', 'description': 'Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Tymo system (Tyromotion, Austria), a wireless static and dynamic platform, for evaluating and rehabilitating posture.', 'armGroupLabels': ['virtual reality games arm']}\n- {'type': 'OTHER', 'name': 'robotic treadmill', 'description': 'Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Walker View (TecnoBody, Italy) a treadmill equipped with a sensorized belt with eight load cells and a 3D camera', 'armGroupLabels': ['robotic treadmill arm']}\n\nPrimary Outcomes:\n- {'measure': 'difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm', 'description': 'falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). POMA test has two subscales, Balance and Gait sections. Total score is obtained by adding the scores of the two subscales (balance + gait) . Total score \\\\< 19 high fall risk, total score 19-24 medium fall risk, total score 25-28 low fall risk.', 'timeFrame': 'before treatment, at the end of treatment and 6, 12 and 24 months after the end of treatment'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, significance level of 0.05, three groups, 5 repeated assessments (baseline and 4 follow-ups), and a 25% dropout rate.", "answer": 195, "answer_type": "ESTIMATED", "explanation": "Sample size\n The Performance-Oriented Mobility Assessment (POMA) [27], a test widely used to assess walking ability and associated with equilibrium, is used to calculate the sample size [28]. Assuming a small effect size of 10% [29], it is estimated that the overall sample size needed to capture this effect size is of 153 subjects, assuming a statistical power of 80%, a significance level of 0.05, three groups and 5 repeated assessments (a baseline and 4 follow-ups) in an ANOVA model within-between interactions. Even assuming a 25% drop out rate, the total number required would be 195 subjects (65 for each arm).\n It is hypothesized that this sample dimension is more than sufficient to grasp a variation also for secondary outcomes for which a treatment effect size is assumed of a similar or higher entity than that identified for the primary outcome [30, 31].", "id": 576, "split": "train"} +{"trial_id": "NCT04088292", "pmid": "39732696", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Low Dose Thrombolysis, Ultrasound Assisted Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism\n\nIncluded conditions:\n- Pulmonary Embolism\n\nStudy Armgroups:\n- {'label': 'USAT + low dose thrombolysis', 'type': 'ACTIVE_COMPARATOR', 'description': 'UltraSound Assisted Thrombolysis (USAT) with low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus unfractionated heparin (UFH) or low molecular weight heparin (LMWH) within 12 hours of randomization', 'interventionNames': ['Drug: Alteplase 20 Mg Powder for Solution for Injection Vial', 'Device: Ultrasound assisted Thrombolysis']}\n- {'label': 'Low dose thrombolysis', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intravenous low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus UFH or low molecular weight heparin (LMWH).', 'interventionNames': ['Drug: Alteplase 20 Mg Powder for Solution for Injection Vial']}\n- {'label': 'Heparin alone', 'type': 'NO_INTERVENTION', 'description': 'UFH or low molecular weight heparin (LMWH) only (with option for conventional thrombolysis according to local protocols for hemodynamic deterioration)'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Alteplase 20 Mg Powder for Solution for Injection Vial', 'description': 'Low dose alteplase delivered IV or bu Ultrasound Assisted Thrombolysis device', 'armGroupLabels': ['Low dose thrombolysis', 'USAT + low dose thrombolysis']}\n- {'type': 'DEVICE', 'name': 'Ultrasound assisted Thrombolysis', 'description': 'Ultrasound assisted thrombolysis (USAT)', 'armGroupLabels': ['USAT + low dose thrombolysis']}\n\nPrimary Outcomes:\n- {'measure': 'Reduction in Miller score comparing low dose thrombolysis and heparin alone groups', 'description': 'Reduction in Miller Score and on follow-up (48-96 h) CT pulmonary Angiography comparing low-dose rtPA (\u00b1USAT) to UFH/LMWH group (p\\\\<0.01, N=210)', 'timeFrame': 'at 48 to 96 hours post randomization'}\n- {'measure': 'Reduction i Miller score comparing low dose thrombolysis by iv and by USATgroups', 'description': 'reduction in Miller Score and on follow-up (48-96 h) CT pulmonary Angiography comparing low-dose rtPA by USAT to iv, p\\\\<0.04, N=140)', 'timeFrame': 'at 48 to 96 hours post randomization'}\n\nPlease estimate the sample size based on the assumption: \nThe trial has two co-primary endpoints sharing a combined \u03b1-level of 0.05. For the first co-primary endpoint, a power of 0.8 is achieved with 165 patients and a power of 0.90 with 210 patients, with an \u03b1 of 0.01. For the second co-primary endpoint, a power of 0.9 is achieved with 140 patients and an \u03b1-level of 0.04, assuming a 22% or greater reduction in RMS in the USAT group compared to the IV group.", "answer": 210, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The power of the trial is calculated as two co-primary endpoints, sharing a combined \u00ce\u00b1-level of 0.05.\n A mean RMS of 18\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00897 is expected at baseline [14]. A variance component model (proc mixed, SAS enterprise ver. 8,4, Cary, NC) was applied.\n The treatment effect is expected to be a reduction in RMS of 2 points (11%) in the UFH/LMWH group after 48\u00e2\u0080\u009396\u00c2\u00a0h (extrapolation from [13]), whereas the reduction in RMS in both thrombolysis groups is expected to be 6 points (33%) [13]. The net effect of thrombolysis by USAT is expected to be similarly efficacious.\n The first co-primary endpoint evaluates the effect of the intervention of thrombolysis comparing RMS in the UFH/LMWH group to RMS in the combined groups of low-dose thrombolysis with or without USAT (1:2).\n Planning inclusion of 165 (3*55) patients will give a power of 0.8 whereas 210 (3*70) patients will give a power of 0.90, with an \u00ce\u00b1 of 0.01 for the primary endpoint.\n The second co-primary endpoint evaluates the effect of low-dose thrombolysis administered by USAT or IV will yield a power of 0.9 by the inclusion of 140 patients (1:1) with an \u00ce\u00b1-level of 0.04, assuming a 22% reduction or greater reduction in RMS in the USAT group compared the IV group.\n The trial is planning to include 210 patients, with 70 patients assigned to UFH/LMWH, 70 to low-dose thrombolysis without USAT, and 70 assigned to low-dose thrombolysis with USAT initiated within a mean of 12\u00c2\u00a0h from randomization.", "id": 577, "split": "train"} +{"trial_id": "NCT04088409", "pmid": "34627340", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis\n\nIncluded conditions:\n- Uveitis\n\nStudy Armgroups:\n- {'label': 'Baricitinib', 'type': 'EXPERIMENTAL', 'description': 'Participants \u22659 to \\\\<18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants \\\\<9 years of age were administered 2 mg baricitinib QD.\\n\\nParticipants \\\\<6 years of age received an oral suspension. Participants \u22656 to \\\\<12 years of age had the option of receiving an oral suspension. Participants \\\\>12 years of age were supplied tablets.', 'interventionNames': ['Drug: Baricitinib']}\n- {'label': 'Adalimumab', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing \\\\<30 kilograms (kg), or 40 mg every 2 weeks for participants weighing \u226530 kg.', 'interventionNames': ['Drug: Adalimumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Baricitinib', 'description': 'Administered orally', 'armGroupLabels': ['Baricitinib'], 'otherNames': ['LY3009104']}\n- {'type': 'DRUG', 'name': 'Adalimumab', 'description': 'Administered SC', 'armGroupLabels': ['Adalimumab']}\n\nPrimary Outcomes:\n- {'measure': 'Part A: Percentage of Responders for Baricitinib at Week 24', 'description': 'Response was defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.', 'timeFrame': 'Week 24'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to detect a true baricitinib treatment response rate of >57% with >80% probability.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The study will enroll at least 20 and up to 40 patients who have had an inadequate response or intolerance to MTX (MTX-IR) and/or bDMARDs (bDMARD-IR) as follows: approximately 30 patients in total will be treated with baricitinib, and at least 10 patients will be treated with adalimumab. At least 20 patients who are MTX-IR (but not bDMARD-IR) will be randomized in a 1:1 ratio to either open-label baricitinib or adalimumab; at least 10 patients will be randomized to baricitinib, and at least 10 patients will be randomized to adalimumab (Fig. 1). Approximately 20 additional patients who are MTX-IR or bDMARD-IR will be treated with baricitinib. Patients who are bDMARD-IR will only receive open-label baricitinib to avoid retreatment with a bDMARD. With a total sample size of 30 in the baricitinib arm, and assuming an observed response rate of 66.7%, the study will be able to detect a true baricitinib treatment response rate of >57% with >80% probability. The observed response rate of 66.7% is based on the assumption that 20 out of 30 patients in the baricitinib arm will achieve the primary endpoint. The response rate threshold of 57% was chosen to match the response rate observed for patients with JIA-uveitis treated with adalimumab in the SYCAMORE study [6].", "id": 578, "split": "train"} +{"trial_id": "NCT04088708", "pmid": "38702085", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME Study)\n\nIncluded conditions:\n- Breast Cancer\n- Gut Microbiome\n- Exercise\n- Fatigue\n\nStudy Armgroups:\n- {'label': 'Aerobic Exercise Training', 'type': 'EXPERIMENTAL', 'description': 'Progressive aerobic exercise training sessions supervised by exercise specialists who have experience training cancer survivors.', 'interventionNames': ['Other: Aerobic Exercise Training']}\n- {'label': 'Attention Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'The non-aerobic exercise attention control condition will control for the effects of attention with flexibility/toning activities.', 'interventionNames': ['Other: Attention Control']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Aerobic Exercise Training', 'description': 'Each session will last 20 to 60 minutes depending on the stage of progression (shorter duration in the first few weeks). Sessions will occur on nonconsecutive days of the week. Moderate-intensity, continuous aerobic exercise will be used to target large muscle groups (e.g., legs) with the principal goal of increasing cardiorespiratory fitness. Exercise intensity will be gradually increased. To mitigate stagnation and support continued improvement of cardiorespiratory fitness, high-intensity interval exercise will be added in later weeks of the intervention.', 'armGroupLabels': ['Aerobic Exercise Training']}\n- {'type': 'OTHER', 'name': 'Attention Control', 'description': 'The flexibility/toning control condition will be delivered using the same frequency as the aerobic condition (i.e., 3 times per week) and use light resistance bands of least difficulty. The flexibility/toning sessions will last about 40 minutes, be led by trained exercise specialists. Flexibility/toning activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, and ankle/foot. The progression of activities over the 10-week period will involve performing additional exercises and sets along with using progressively thicker elastic resistance bands (i.e., Thera-bands) that provide minimal resistance.', 'armGroupLabels': ['Attention Control']}\n\nPrimary Outcomes:\n- {'measure': 'Composition of gut microbiota as measured by fecal samples', 'description': 'Using standard diversity and taxa comparison metrics', 'timeFrame': 'Baseline'}\n- {'measure': 'Composition of gut microbiota as measured by fecal samples', 'description': 'Using standard diversity and taxa comparison metrics', 'timeFrame': '5 weeks after baseline'}\n- {'measure': 'Composition of gut microbiota as measured by fecal samples', 'description': 'Using standard diversity and taxa comparison metrics', 'timeFrame': '10 weeks after baseline'}\n- {'measure': 'Composition of gut microbiota as measured by fecal samples', 'description': 'Using standard diversity and taxa comparison metrics', 'timeFrame': '15 weeks after baseline'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed test, power of 0.8, significance level (alpha) of 0.05, and consideration of dropout rates.", "answer": 126, "answer_type": "ESTIMATED", "explanation": "Sample size and power considerations\n Sample size is based on detecting alpha diversity and beta diversity taxa comparisons. The power calculation is based on two-tailed test at power of 0.8 using software G*Power V.3.1.9.2.109 110 Our pre-COVID-19 pandemic sample size was estimated at 126 (63 in each group) with 100 (50 per study group) remaining after dropouts. This sample size would have allowed us to detect a medium effect size (d=0.57; power of 0.8, p<0.05) in alpha diversity which is sufficient for detecting effects related to associations with fatigue and intervention effects falling midway between that found in our two pilot studies. Relevant to taxa comparisons, we have >0.8 power to detect the effect of any of the taxa after multiple testing correction (q value <0.05).111\u00e2\u0080\u0093113 Due to the detrimental impact of the COVID-19 pandemic on recruitment into on-site, supervised exercise trials, we provide revised contingency power calculations in figure 4, where we can see that with sample size decreasing, the effect size we can detect changes from moderate to large. For example, for enrolling at 100%, 75% (74 samples with 37 per group) and 50%, the effect size that can be detected changes from 0.57, to 0.67, and to 0.81 (with power of 0.8 and alpha of 0.05). Of note, larger effect sizes are possible in this study (compared with our pilot studies) because the study will provide controlled feeding (reducing variability), select low fit individuals (greater chance of improvement) and manipulate the exercise exposure (standardise the exercise exposure). Also relevant, the sample sizes in our pilot studies (N=12\u00e2\u0080\u0089and 37) were smaller than our proposed study even with dropped enrolment yet yielded statistically significant results (eg, a significant association between alpha diversity and cardiorespiratory fitness in 37 breast cancer survivors).7 13\n\n \n Figure 4\n \n Revised contingency power curve.", "id": 579, "split": "train"} +{"trial_id": "NCT04088968", "pmid": "35449008", "question": "Here is the design of a clinical trial:\n\nOfficial Title: STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation Including Smoking, Nutrition, Alcohol and Physical Activity for Risk Reduction in Cancer Surgery\n\nIncluded conditions:\n- Risk Reduction\n- Urological Cancer\n- Surgery\n- Life Style\n\nStudy Armgroups:\n- {'label': 'Prehabilitation', 'type': 'EXPERIMENTAL', 'description': \"Intervention: Patients allocated to the intervention group receive weekly counselling sessions in 6 weeks as an integrated prehabilitation program tailored to meet the individual patient's need for risk reduction at surgery. It is introduced via the surgical 'Engage in the process of change'. The smoking and alcohol cessation intervention follows the Gold Standard Programme and patients in the intervention group are introduced to a standardized exercise training programme taking individualized needs into account. Nutritional support is also individualized.\", 'interventionNames': ['Behavioral: Prehabilitation']}\n- {'label': 'Treatment as usual', 'type': 'NO_INTERVENTION', 'description': 'Treatment as ususal covers shorter interventions, e.g. advice, brief counselling, and handing out the national folders on smoking and alcohol and surgery. Patients are ensured that they are free to access support to lifestyle changes in the community.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Prehabilitation', 'description': 'Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.', 'armGroupLabels': ['Prehabilitation'], 'otherNames': ['smoking cessation, alcohol cessation, physical activity, nutritional support for malnutrition and obesity']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients with risk reduction at surgery', 'description': 'Corresponding at least 1 step for 1 or more risky lifestyles (but only smoking in study III) on the ASA-score (American Society of Anaesthesiologists physical status classification from 1-5, lower is better)', 'timeFrame': 'End of intervention/ at surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 80% with a significance level of 2 \u00d7 alpha = 0.05. The sample size also accounts for a lower effect of the intervention and allows for dropouts.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Overall, we will include 42 patients. The power calculation regarding the main outcome is based on meta-analyses of quit rates after about 6\u00e2\u0080\u0089weeks at 70% (ranging 50\u00e2\u0080\u009390%) [29, 30] after the intensive interventions like GSP for smoking and alcohol cessation intervention in the perioperative period as well as on studies reporting completion of physical exercise programmes at 66%, while the effect in the control groups were 15% (5\u00e2\u0080\u009325%) [33, 57]. The corresponding lifestyle-related risk reduction will go from 100 to 30% in the intervention group and from 100 to 85% in the control group. Using an 80% power and 2 \u00c3\u0097 alpha = 0.05, this would result in enrolment of 2 \u00c3\u0097 11 patients. However, the effect of obesity intervention is not known in patients with cancer undergoing major bladder surgery, but the number of patients with obesity seems low based on clinical experience; thus, a conservatively estimated sample size based on a lower effect of the intervention and allowing for dropouts would be 2 \u00c3\u0097 21 patients.\n The number of participants in the interviews is determined by the concept of information power which will guide the adequate sample size. This entails an ongoing reflection during the study considering issues such as the aim of the study, sample specificity, use of a theoretical background and the chosen analytical strategy [58]. In this study, we propose to include about 8 patients from the RCT study and their relatives and clinical staff.", "id": 580, "split": "train"} +{"trial_id": "NCT04090463", "pmid": "33593311", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Study of Primary Chemotherapy, Stereotactic Body Radiation Therapy, and Intraoperative Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma\n\nIncluded conditions:\n- Borderline Resectable Pancreatic Cancer\n\nStudy Armgroups:\n- {'label': 'IORT group', 'type': 'EXPERIMENTAL', 'description': 'Intraoperative administration of 10 to 20 Gy after surgery or as an \"in situ\" treatment in case resection will not be performed', 'interventionNames': ['Radiation: Intraoperative radiotherapy']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Intraoperative radiotherapy', 'description': 'IORT will be delivered as follows:\\n\\n1. Radical resection --\\\\> delivery of 10-15 Gy to the tumor bed\\n2. Non radical resection --\\\\> delivery of 15-20 Gy to the tumor \"in situ\"', 'armGroupLabels': ['IORT group']}\n\nPrimary Outcomes:\n- {'measure': 'Disease-specific survival', 'timeFrame': '36 months'}\n\nPlease estimate the sample size based on the assumption: \nAccrual time: 36 months, Follow-up time: 36 months, Power: 0.90, Significance level (alpha): 0.5, Non-parametric estimate of survival distribution.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The estimate of accrual was calculated hypothesizing that total neoadjuvant therapy with FOLFIRINOX + SBRT + IORT will improve the 3-year survival rate up to 37% in comparison with cohort-level institutional data (patients <\u00e2\u0080\u008975\u00e2\u0080\u0089years with BRPC undergoing neoadjuvant FOLFIRINOX, 3-year survival of 23.7%) Accrual time was set at 36\u00e2\u0080\u0089months and follow-up at 36\u00e2\u0080\u0089months. At a power of 0.90, and alpha of 0.5 a sample size of 100 patients was calculated assuming a non-parametric estimate of survival distribution. The SWOG Cancer Research and Biostatistics one-arm trial with time-to-event data sample size calculator was employed [26].", "id": 581, "split": "train"} +{"trial_id": "NCT04092153", "pmid": "32070406", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Randomised Control Trial Comparing Mako Robotic-arm Assisted Functionally Aligned Total Knee Arthroplasty Versus Mako Robotic-arm Assisted Mechanically Aligned Total Knee Arthroplasty\n\nIncluded conditions:\n- Osteo Arthritis Knee\n- Osteoarthritis\n- Surgery\n\nStudy Armgroups:\n- {'label': 'Mechanically aligned', 'type': 'ACTIVE_COMPARATOR', 'description': \"Neutral limb alignment irrespective of the patient's native knee anatomy and joint mechanics\", 'interventionNames': ['Device: Total knee arthroplasy']}\n- {'label': 'Functionally aligned', 'type': 'EXPERIMENTAL', 'description': \"Restore the patient's own pre-arthritic knee anatomy\", 'interventionNames': ['Device: Total knee arthroplasy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Total knee arthroplasy', 'description': 'Surgical implantation of prosthetic knee using robotic-arm assist', 'armGroupLabels': ['Functionally aligned', 'Mechanically aligned']}\n\nPrimary Outcomes:\n- {'measure': 'Western Ontario and Mcmaster Universities Arthritis Index (WOMAC)', 'description': 'Patient recorded outcome questionnaire evaluating pain, stiffness and disability in affected joint', 'timeFrame': '2 years post-intervention'}\n\nPlease estimate the sample size based on the assumption: \nA two-tailed, two-sample t test with a power of 90%, a significance level of 5%, and an expected drop-out rate of 10% during the 2-year follow-up period.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n Using data from a previous study recording functional outcomes, the mean WOMAC score at 2\u00e2\u0080\u0089years using MA TKA was 26 (standard deviation 22.6) and using TKA with kinematic alignment was 15 (standard deviation 20.3) [14]. Using a two-tailed, two-sample t test with an effect size of 0.35, power of 90% with significance level of 5%, and accounting for an expected drop-out rate of 10% during the 2-year follow-up period, the study requires 100 patients to detect a minimal clinically important difference of 11 points in the total WOMAC score between the two treatment groups [13].", "id": 582, "split": "train"} +{"trial_id": "NCT04093219", "pmid": "33692183", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PANDORA: Scheduled Prophylactic 6-hourly Intravenous Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients\n\nIncluded conditions:\n- Delirium in Old Age\n- Delirium\n- Coronary Artery Disease\n\nStudy Armgroups:\n- {'label': 'IV Acetaminophen', 'type': 'EXPERIMENTAL', 'description': '1 g IV acetaminophen every 6 hours for 48 hours during the first 2 days postoperatively', 'interventionNames': ['Drug: IV acetaminophen']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'IV acetaminophen', 'description': 'use of IV tylenol for pain', 'armGroupLabels': ['IV Acetaminophen'], 'otherNames': ['ofirmev']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of postoperative delirium', 'description': 'Occurrence of delirium on any postoperative day, as assessed using the CAM, 3D CAM, CAM Only, or CAM-ICU daily until hospital discharge.', 'timeFrame': 'Participants will be followed for the duration of the hospital stay, an average of 5 days'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided significance level at alpha=0.05, power=0.9, and allowance for 10% potential dropouts.", "answer": 900, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation for the proposed trial is based on the primary outcome, in-hospital delirium up to day 30, adjusting for one planned interim analysis, which allows early stopping for efficacy. An effect size of 66% with a baseline incidence of 30% was seen in a pilot study conducted at BIDMC.27 In this trial, with the inclusion of a much broader group of patients including those with pre-existing cognitive dysfunction, it was determined that the effect size could be reduced to as low as 33%. Using O\u00e2\u0080\u0099Brien Fleming\u00e2\u0080\u0099s boundary to maintain the overall two-sided significance level at alpha=0.05\u00e2\u0080\u0089and power=0.9, 402 patients per arm will be needed to show a 33% reduction in in-hospital delirium, assuming the baseline postoperative delirium incidence is 30%. To allow for roughly 10% potential dropouts (attrition will accommodate both prerandomisation withdrawals\u00e2\u0080\u0094ie, cancelled surgery\u00e2\u0080\u0094as well as postrandomisation withdrawals\u00e2\u0080\u0094ie, intraoperative change in surgery type), the trial will enrol up to 900 patients.", "id": 583, "split": "train"} +{"trial_id": "NCT04094636", "pmid": "34454594", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Physical Training During Hospital Admission With Community-Acquired Pneumonia\n\nIncluded conditions:\n- Community-acquired Pneumonia\n\nStudy Armgroups:\n- {'label': 'No intervention: Control', 'type': 'NO_INTERVENTION', 'description': 'Control group'}\n- {'label': 'In-bed cycling', 'type': 'EXPERIMENTAL', 'description': 'Supervised in-bed cycling', 'interventionNames': ['Behavioral: In-bed cycling']}\n- {'label': 'Exercise booklet', 'type': 'EXPERIMENTAL', 'description': 'Supervised physical training with exercises from exercise booklet', 'interventionNames': ['Behavioral: Exercise booklet']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'In-bed cycling', 'description': 'Patients will daily perform 30 min of supervised in-bed cycling', 'armGroupLabels': ['In-bed cycling']}\n- {'type': 'BEHAVIORAL', 'name': 'Exercise booklet', 'description': 'Patients will daily perform 30 min of supervised physical training with exercises from the exercise booklet', 'armGroupLabels': ['Exercise booklet']}\n\nPrimary Outcomes:\n- {'measure': 'Length of hospital stay', 'description': 'Number of stays in hospital', 'timeFrame': 'From admission until discharge (an average of 5 days)'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an estimated drop-out rate of 15%, the study aims for a power of > 0.8 at a two-sided significance level of 0.025, adjusted for multiple comparisons.", "answer": 210, "answer_type": "ESTIMATED", "explanation": "Statistical power and sample size calculations\n The sample size calculation is performed using www.powerandsamplesize.com and is based on the primary outcome, length of hospital stay. The expected reduction in length of hospital stay is based on data from a previous study showing a reduction (3.9\u00e2\u0080\u0089days vs. 6.0\u00e2\u0080\u0089days) for patients hospitalized with CAP randomized to either early mobilization or standard usual care [18]. The number of patients with CAP is based on a 2-day difference in length of hospital stay between CAP patients receiving standard usual care compared to standard usual care combined with daily physical training. The standard deviation for this calculation is 3.5\u00e2\u0080\u0089days, as previous observed [18]. Assuming an estimated drop-out rate of 15%, inclusion of 210 patients (70 patients in each group) will provide a power of >\u00e2\u0080\u00890.8 at a two-sided significance level of 0.025, adjusted for multiple comparisons (0.05/2).", "id": 584, "split": "train"} +{"trial_id": "NCT04095234", "pmid": "36581960", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Integrative Medicine for Pain in Patients With Advanced Cancer Trial (IMPACT)\n\nIncluded conditions:\n- Cancer Pain\n\nStudy Armgroups:\n- {'label': 'Acupuncture', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive up to 10 treatments in the first 10 weeks (+/- 4 days) and then receive monthly booster treatments (+/- 7 days) for up to 26 weeks.', 'interventionNames': ['Procedure: Acupuncture']}\n- {'label': 'Massage', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive up to 10 treatments in the first 10 weeks (+/- 4 days) and then receive monthly booster treatments (+/- 7 days) for up to 26 weeks.', 'interventionNames': ['Procedure: Massage']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Acupuncture', 'description': 'Acupuncture, a therapy of traditional Chinese medicine (TCM), involves penetrating the skin with thin, solid, metallic needles that are manipulated by hand or electrical stimulation. If the patient has an electronically charged device, they will not receive TENS stimulation.', 'armGroupLabels': ['Acupuncture']}\n- {'type': 'PROCEDURE', 'name': 'Massage', 'description': 'Massage, which involves the manual manipulation of muscles and other soft tissue areas of the body, is one of the earliest known forms of pain relief.', 'armGroupLabels': ['Massage']}\n\nPrimary Outcomes:\n- {'measure': 'Worst Pain', 'description': 'Worst Pain Item from the short-form Brief Pain Inventory (BPI). The short-form BPI will be used to quantify pain severity and pain interference. The BPI contains 4 pain severity items and 7 pain interference items, all rated on a scale from 0 to 10 (higher ratings indicate worse pain intensity/interference).', 'timeFrame': '26 weeks from randomization'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a two-sided alpha of 0.05, 80% power, 20% lost to follow-up, and a correlation between baseline and 26-week BPI Worst Pain of 0.5.", "answer": 300, "answer_type": "ACTUAL", "explanation": "Power analysis and sample size\n For our sample size/power considerations, we calculated the smallest standardised effect size (ie, Cohen\u00e2\u0080\u0099s d) we will be able to detect with 80% power, given our sample size of 300 and other assumptions. Using the \u00e2\u0080\u0098power.mmrm\u00e2\u0080\u0099 function from the R package \u00e2\u0080\u0098longpower,\u00e2\u0080\u0099 we applied the formulas in Lu et al,71 to derive the smallest detectable effect size for the coefficient of the time-by-arm interaction term in our LMM, given our study design and assumptions, which we transformed to represent the standardised mean difference (ie, Cohen\u00e2\u0080\u0099s d) between the two arms at 26 weeks postrandomisation. Based on our prior experience72 73 and given that patients living with advanced cancer may have unanticipated health issues (eg, hospitalisations, death), we conservatively anticipate lost to follow-up to be 20% by 26 weeks. Assuming this 20% lost to follow-up, correlation between baseline and 26-week BPI Worst Pain of 0.5, and two-sided alpha of 0.05, and with 150 participants in each of the two active intervention arms, we will have 80% power to detect an effect size of 0.35 (standardised mean difference, Cohen\u00e2\u0080\u0099s d) at 26 weeks post-randomisation between acupuncture vs massage. Based on our own preliminary data in patients with stage IV cancer who experienced moderate to severe pain (N=284), the mean BPI Worst Pain score was 6.3 with SD of 1.7. A difference of 1 on the BPI Worst Pain score (considered a clinically meaningful difference in pain) based on SD of 1.7 equals an effect size (Cohen\u00e2\u0080\u0099s d) of 0.59. In this study, we have 99% power to detect this clinically meaningful mean difference of 1 point (Cohen\u00e2\u0080\u0099s d of 0.59) on the BPI Worst Pain score. Our trial is more than sufficiently powered to detect a clinically meaningful difference between acupuncture and massage at 26 weeks.", "id": 585, "split": "train"} +{"trial_id": "NCT04095338", "pmid": "32546491", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation\n\nIncluded conditions:\n- Hip Fractures\n- Frail Elderly\n- Robotic Rehabilitation\n\nStudy Armgroups:\n- {'label': 'control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks', 'interventionNames': ['Other: traditional rehabilitation']}\n- {'label': 'virtual reality games arm', 'type': 'EXPERIMENTAL', 'description': 'Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks.', 'interventionNames': ['Other: virtual reality games intervention']}\n- {'label': 'robotic treadmill arm', 'type': 'EXPERIMENTAL', 'description': 'Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks.', 'interventionNames': ['Other: robotic treadmill intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'traditional rehabilitation', 'description': 'Each session will include 50 minutes of traditional physical rehabilitation therapy', 'armGroupLabels': ['control group']}\n- {'type': 'OTHER', 'name': 'virtual reality games intervention', 'description': 'Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training by Tymo system (Tyromotion, Austria), a wireless platform for the balance and the postural control training that simulates floor walking and stairs climbing. Tymo system is connected to a screen and provides virtual reality games, adaptable to the functional capacity of the patient. Through the games proposed, the physiotherapist will decide to work in a dimension (antero-posterior or medio-lateral dimension) or in two dimensions (combining the antero-posterior and medio-lateral movements).', 'armGroupLabels': ['virtual reality games arm']}\n- {'type': 'OTHER', 'name': 'robotic treadmill intervention', 'description': 'Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training by Walker view (TecnoBody, Italy), a treadmill equipped with a sensorized belt with eight load cells and a 3D camera.to detect length, speed and symmetry of the pace and load, range of the trunk, hips and knees. Patients will be asked to walk at a comfortable speed, while the physiotherapist will be able to work on different parameters such as step length, load distribution, and step height. The setting will take place taking into account the clinical conditions of each patient, customizing the intervention. The Walker View will offer visual and auditory feedback to the patient, so as to correct gait in real time.', 'armGroupLabels': ['robotic treadmill arm']}\n\nPrimary Outcomes:\n- {'measure': 'difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm', 'description': 'falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). POMA test has two subscales, Balance and Gait sections. Total score is obtained by adding the scores of the two subscales (balance + gait) . Total score \\\\< 19 high fall risk, total score 19-24 medium fall risk, total score 25-28 low fall risk', 'timeFrame': 'before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, significance level of 0.05, three groups, five repeated assessments, and a 25% drop-out rate.", "answer": 195, "answer_type": "ESTIMATED", "explanation": "Sample size\n The POMA,18 a test widely used to assess walking ability and associated with equilibrium, was used to calculate the sample size.19 Assuming a small effect size of 10%,20 it is estimated that the overall sample size needed to capture this effect size is of 153 subjects, assuming a statistical power of 80%, a significance level of 0.05, three groups and five repeated assessments (a baseline and four follow-ups) in an analysis of variance (ANOVA) model within\u00e2\u0080\u0093between interactions. Even assuming a 25% drop-out rate, the total number required would be 195 subjects (65 for each arm).\n It is hypothesised that this sample dimension is more than sufficient to grasp a variation also for secondary outcomes for which a treatment effect size is assumed of a similar or higher magnitude than that identified for the primary outcome.17 21", "id": 586, "split": "train"} +{"trial_id": "NCT04095676", "pmid": "35264347", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intrapleural Fibrinolysis and DNase Versus VATS for the Treatment of Pleural Empyema: a Randomized, Controlled Trial\n\nIncluded conditions:\n- Pleural Empyema\n\nStudy Armgroups:\n- {'label': 'VATS / surgical group', 'type': 'EXPERIMENTAL', 'description': 'The VATS procedure must be completed as soon as possible and no later than 48 hours after randomisation. The surgery is performed with the patient in a 90 degree sideways position, using general anesthesia. Access is obtained through one to three ports, followed by purification and possibly decortication, and insertion of one pleural drain (sizes 24 - 32F) at the end of surgery. 20 ml Marcain is used as local analgetic and applied at the incision sites or as a nerve block. In the VATS group, suction on drain (- 15 cm H20) is applied in the first day after the procedure. Operator must have relevant training and competencies corresponding to the specialist level within the relevant specialty and be registered and approved by the steering committee.', 'interventionNames': ['Procedure: VATS group']}\n- {'label': 'Drain and intrapleural therapy group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Pigtail is applied as soon as possible and within 48 hours after randomisation. Drain placement is carried out using ULS. Operators (conductors of the procedure) must have relevant training and competencies corresponding to the specialist level within the relevant specialty and be approved by the steering committee to conduct the procedure. A pigtail catheter (minimum 10F) is inserted. Operator determines the size of drain and whether drain placement is done with one-step or Seldinger technic.\\n\\nThe intrapleural therapy consists of treatment with the following two drugs:\\n\\n* intrapleural Actilyse\u00ae (alteplase) 10 mg twice daily for three days\\n* intrapleural Pulmozyme\u00ae (DNase) 5 mg twice daily for three days', 'interventionNames': ['Procedure: Drain and intrapleural therapy group']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'VATS group', 'description': 'VATS procedure with drainage, including rinse with NaCl', 'armGroupLabels': ['VATS / surgical group']}\n- {'type': 'PROCEDURE', 'name': 'Drain and intrapleural therapy group', 'description': 'Drainage with pigtail and Intrapleural therapy', 'armGroupLabels': ['Drain and intrapleural therapy group']}\n\nPrimary Outcomes:\n- {'measure': 'Length of hospital stay', 'description': 'Admission time is defined as the time from first admission in the course of the hospitalization and to the completion of treatment defined as time of discharge from hospital without need of any additional invasive treatment.', 'timeFrame': 'Through study completion, an average of 1 year'}\n\nPlease estimate the sample size based on the assumption: \nThe distribution of hospitalisation time is expected to be skewed, requiring a logarithmic transformation. The study assumes 80% power, a coefficient of variation (CV) of 40%, and a significance level of 0.05. A 20% exclusion rate is also considered.", "answer": 184, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n The study is based on assumptions and knowledge about LOS, both from national and international publications. We calculated the sample size based on the following assumptions: the main effect target is the difference between the total time (primary endpoint) between the two groups of patients (VATS vs drainage). The distribution of the hospitalisation time is expected to be skewed to the right, so that a logarithmic transformation is needed to achieve normality.\n We assume a median hospitalisation period in the drainage group of 12 days, a minimum clinically relevant difference in hospitalisation of 2\u00e2\u0080\u0089days, 80% power and coefficient of variation (CV) of 40%.\n Significance level is set to 0.05. Thus, 77 patients in each group must be included. To account for excluded patients (set at 20%), we expect to include 92 patients in each group. A total of 184 patients is to be included.\n In terms of showing clinically relevant non-inferiority with a difference in hospitalisation of 1\u00e2\u0080\u0089day with an 80% power, and CV of 40%, 70\u00e2\u0080\u0089patients is needed in each group. This is based on a true improvement of 1 hospitalisation day. Based on the annual number of patients diagnosed with pleura empyema in Denmark, we find it feasible to include the needed number of patients in the trial during the inclusion period.", "id": 587, "split": "train"} +{"trial_id": "NCT04095923", "pmid": "39135010", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Social Media Game to Increase Physical Activity Among Older Adult Women\n\nIncluded conditions:\n- Aging\n\nStudy Armgroups:\n- {'label': 'Social media game', 'type': 'EXPERIMENTAL', 'description': 'Private Facebook group with weekly walking challenges, Fitbit wearable activity monitor, and brief counseling', 'interventionNames': ['Behavioral: Social media game']}\n- {'label': 'Standard self-regulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Fitbit wearable activity monitor and brief counseling', 'interventionNames': ['Behavioral: Standard self-regulation']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Social media game', 'description': 'Participants will engage in weekly challenges that require them to take photographs of interesting things they discover during their walks. They will post and discuss these photographs with other participants on a private social media page. They will track their steps using a wearable activity monitor and receive brief standard self-regulatory counseling.', 'armGroupLabels': ['Social media game']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard self-regulation', 'description': 'Participants will track their steps using a wearable activity monitor and receive brief standard self-regulatory counseling.', 'armGroupLabels': ['Standard self-regulation']}\n\nPrimary Outcomes:\n- {'measure': 'Walking physical activity as measured by daily steps at 12 months', 'description': 'Mean of daily steps taken from accelerometers worn for a 7 day period', 'timeFrame': 'Baseline to 12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power to detect the difference at 18 months. 99% power to detect the increase in autonomous regulation. 83% power to detect the mediator coefficient. 81% power to detect a mediated effect of 372. Significance level (\u03b1) = 0.05. Consideration for missing data.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical power\n Because effect size estimates taken directly from pilot studies can produce biased power estimates when used alone [62, 63] and our pilot trials could not provide the range of outcomes needed (e.g., steps at 6, 12, and 18 months), we used several sources to estimate the range of possible intervention effects. We estimated steps per day increases of approximately 1500, 1000, and 500 at the three follow-up points. These numbers were based on similar mHealth walking studies [36], preliminary research [32], and the clinical significance of 500-step-per-day increase for older adults [64\u00e2\u0080\u009366]. To achieve 80% power, a sample size of approximately 252 participants would be needed to detect this difference between groups at 18 months. Our most conservative estimates would require a sample size of 275. We will recruit 300 participants in case of any missing data that cannot be dealt with via imputation (e.g., extreme levels of missingness, or if there is reason to believe that data are missing not at random).\n Assuming at least 275 participants, we will have 99% power to detect that the intervention increases autonomous regulation by 0.6 units, as measured by the BREQ-3, when the standard deviation of BREQ-3 scores are 1 (as observed in our preliminary research). Furthermore, we will have 83% power to detect a mediator coefficient of 620, which was calculated assuming that the number of steps walked has a standard deviation of 3000 (as observed in our preliminary research), and adjusting for the confounding of intervention with BREQ-3 score. Therefore, we will have 81% power to detect a mediated effect of 372, which would explain 27.4% of the effect of the intervention through the indirect effect of autonomous regulation [67\u00e2\u0080\u009369]. All testing will be 2-sided with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05.", "id": 588, "split": "train"} +{"trial_id": "NCT04095962", "pmid": "33663414", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Body and Brain: Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia\n\nIncluded conditions:\n- Dementia\n- Alzheimer Disease\n- Vascular Dementia\n- Neurocognitive Disorders\n\nStudy Armgroups:\n- {'label': 'Experimental Group', 'type': 'EXPERIMENTAL', 'description': 'Training protocol will be held for 6 months, twice per week/ 60 min per sessions.', 'interventionNames': ['Other: Exercise']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will receive monthly sessions regarding physical activity and health related topics as a complement to standard care. No specific exercise intervention will be conducted for this group.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Exercise', 'description': 'The MT program will be conducted for 6 months, twice a week in 60 minutes sessions. Sessions will be divided in warm-up (10 minutes, including slow walk, postural and mobility exercises for general activation, and stretching exercises), specific training (35-45 minutes, including balance/coordination training, strength and aerobic exercises) and cool down (5 minutes with breathing and stretching exercises for the main worked joints and muscles) following the main guidelines recommended by the American College of Sports Medicine \\\\[18\\\\] and the WHO \\\\[19\\\\].', 'armGroupLabels': ['Experimental Group'], 'otherNames': ['Multicomponent training']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline on Short Physical Performance Battery (SPBB)', 'description': 'The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).', 'timeFrame': 'Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups'}\n- {'measure': \"Change from Baseline on Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)\", 'description': 'To evaluate cognitive function with a total scoring ranging between 0 - 68. A score of 68 represents the most severe impairment and 0 represents the least impairment.', 'timeFrame': 'Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha level of 0.05, estimated dropout of 25%", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size was estimated based on ANCOVA for the analysis of the differences [41]. To detect an adjusted 1 point (SD\u00e2\u0080\u0089=\u00e2\u0080\u00892.1) difference in SPPB after intervention between IG and CG with 80% power and an alpha level of 0.05, a total of 110 participants (55 participants per group) will be needed, already accounting for an estimated dropout of 25%. Sample size calculation was performed using G*Power 3.1.3 (Universit\u00c3\u00a4t D\u00c3\u00bcsseldorf, D\u00c3\u00bcsseldorf, Germany) [42].", "id": 589, "split": "train"} +{"trial_id": "NCT04098055", "pmid": "33649056", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Custom-made Foot Orthoses in Patients With Systemic Lupus Erythematous\n\nIncluded conditions:\n- Lupus Erythematosus, Systemic\n- Foot Orthoses\n- Musculoskeletal Pain\n\nStudy Armgroups:\n- {'label': 'Custom-made foot orthoses', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Custom-Made Foot Orthoses']}\n- {'label': 'Control Group', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Device: Placebo']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Custom-Made Foot Orthoses', 'description': 'The foot orthoses were custom made using phenolic foam molds of the feet. They consisted of a polypropylene layer of 2 mm from heel to just proximal to the metatarsal heads, an upper sheet of 30 Shore A polyethylene foam.', 'armGroupLabels': ['Custom-made foot orthoses']}\n- {'type': 'DEVICE', 'name': 'Placebo', 'description': 'The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': '11-point Numeric Pain Rating Scale', 'description': 'With a range of 0 = no pain to 10 = pain as bad as it can be.', 'timeFrame': '1 minute'}\n- {'measure': 'SF- 12 Quality of Life', 'description': 'To describe the relationships among functional health status measures. This has values between 0 and 100, with higher values corresponding to lower quality of life.', 'timeFrame': '10 minutes'}\n- {'measure': 'Foot Function', 'description': 'Foot Function Index', 'timeFrame': '5 minutes'}\n- {'measure': 'Foot Disability', 'description': 'Manchester Foot Pain and Disability Index', 'timeFrame': '5 minutes'}\n\nPlease estimate the sample size based on the assumption: \nType I error (\u03b1) is 0.05 (z(\u03b1/2) = 1.96), Type II error (\u03b2) is 0.20 (z_\u03b2 = 0.84), and the dropout rate is approximately 22%.", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size\n The minimum sample size was calculated using the following formula to compare mean values between populations:\n \n \n \n \n \n n\n =\n (\n 2\n s\n \u00e2\u0088\u00a7\n 2\n (\n \u00ce\u00b1\n \n /\n \n 2\n )\n +\n z\n _\n \u00ce\u00b2\n )\n )\n \n /\n \n d\n \u00e2\u0088\u00a7\n 2\n ,\n \n \n \n \n \n where s2 is the sample variance, \u00ce\u00b1 is the type I error, \u00ce\u00b2 is the type II error and d is the minimum difference to be detected. According to a previous study where the effect of foot orthoses on foot pain was investigated on patients with rheumatoid arthritis,10 the variance of the Visual Analogue Scale for pain is equal to 400, and the difference found is 16\u00e2\u0080\u00b3. Therefore, the following result was obtained:\n \n \n \n \n \n n\n =\n (\n 2\n s\n \u00e2\u0088\u00a7\n 2\n (\n \n z\n (\n \n \n \u00ce\u00b1\n \n \n /\n \n 2\n )\n +\n z\n _\n \n \u00ce\u00b2\n \n )\n )\n \n /\n \n d\n \u00e2\u0088\u00a7\n 2\n =\n \n \u00e3\u0080\u0096\n \n 2\n \u00e2\u0088\u0099\n 400\n \u00e2\u0088\u0099\n (\n 1.96\n +\n 0.84\n )\n \n \u00e3\u0080\u0097\n \n \n \u00e2\u0088\u00a7\n 2\n \n /\n \n 16\n \u00e2\u0088\u00a7\n 2\n =\n 24.525\n \n \n \n \n \n Thus, at least 25 people will be needed in each group to compare the mean values. In this study, 60 patients will be initially recruited, with 30 in each group, in consideration of possible losses similar to previous studies (about 22%).10", "id": 590, "split": "train"} +{"trial_id": "NCT04102371", "pmid": "34742327", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis\n\nIncluded conditions:\n- Shock\n- Septic\n\nStudy Armgroups:\n- {'label': 'Balanced fluids (BF)', 'type': 'EXPERIMENTAL', 'description': \"Balanced fluids (BF), including Lactated Ringer's and Plasma-Lyte (PL), will be administered to patients randomized to the experimental arm. BF will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calendar day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.\", 'interventionNames': ['Drug: Lactated Ringer', 'Drug: Plasma-lyte']}\n- {'label': '0.9% \"Normal\" Saline Fluid (NS)', 'type': 'ACTIVE_COMPARATOR', 'description': '0.9% \"normal\" saline (NS) fluid will be administered to patients randomized to the active comparator (control) arm. NS will be used for all fluid boluses and maintenance fluids (supplemental electrolytes are allowed) from time immediately after randomization through 11:59 pm of the next calendar day. The determination of when to give fluid, how much fluid to give, how fast to give fluid, and what access to use to administer fluid will remain at the discretion of the treating team.', 'interventionNames': ['Drug: Normal Saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lactated Ringer', 'description': 'LR is a sterile, nonpyrogenic \"balanced\" solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 \u00b7 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5).', 'armGroupLabels': ['Balanced fluids (BF)'], 'otherNames': ['LR']}\n- {'type': 'DRUG', 'name': 'Normal Saline', 'description': 'Normal saline solution is an \"unbalanced\" crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride.', 'armGroupLabels': ['0.9% \"Normal\" Saline Fluid (NS)'], 'otherNames': ['0.9% Saline', 'NS']}\n- {'type': 'DRUG', 'name': 'Plasma-lyte', 'description': 'PL is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO2\u20223H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl2\u20226H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0).', 'armGroupLabels': ['Balanced fluids (BF)'], 'otherNames': ['PL']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of participants with Major Adverse Kidney Events within 30 days (MAKE30)', 'description': 'A composite of death, initiation of new inpatient renal replacement therapy (RRT), or persistent kidney dysfunction, at 30 days following study enrollment or hospital discharge, whichever comes first.', 'timeFrame': 'Between randomization and 30 days post enrollment, discharge or death, whichever comes first.'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level (type I error) of 0.05, a power of 95% for the primary endpoint, and an 84% power to detect a decrease in mortality from 3% to 2%. It also assumes >99% power to detect a 1-day reduction in hospital-free days.", "answer": 8800, "answer_type": "ESTIMATED", "explanation": "Sample size\n A baseline incidence of MAKE30 in children with septic shock predominantly resuscitated with 0.9% saline was determined based on a prior pediatric study (9.6% MAKE30) [39], the proportion of patients aged 18\u00e2\u0080\u009321\u00e2\u0080\u0089years enrolled in the SMART trial (9.7% MAKE30) [17], and institutional registry data from two US study sites (5.0% and 7.8% MAKE30). We anticipate a conservative MAKE30 incidence of 6% among children treated in an ED for suspected septic shock largely resuscitated with 0.9% saline. Enrollment of 8800 total participants will provide 95% power to detect an absolute risk reduction (ARR) in MAKE30 from 6.0% for children treated with 0.9% saline to 4.3% for balanced/buffered fluids with a standard type I error of 0.05. This ARR corresponds to the 28% relative risk reduction in MAKE30 observed in the youngest subset of patients (18\u00e2\u0080\u009321\u00e2\u0080\u0089years) enrolled in SMART. Due to the small anticipated ARR with potential for type II error, we purposely selected a high power of 95% for the primary endpoint. This sample size will also provide 84% power to detect a decrease in mortality from 3% with saline to 2% with balanced/buffered fluids and >\u00e2\u0080\u008999% power to detect a 1-day reduction in hospital-free days.\n Recruitment of this large sample size requires collaboration across >\u00e2\u0080\u008940 sites from three research networks. Based on the enrollment of 85% of eligible patients in our pilot study [25], sites are anticipated to enroll >\u00e2\u0080\u008980% of eligible patients. Recruitment will be monitored, with targeted support provided to sites that consistently fall below this target. Targeted support will include local investigators meeting with the lead investigators from their respective networks to review the process for screening, determination of eligibility criteria, education of local emergency clinicians who assess for eligibility, location of enrollment materials relative to patient care in the emergency department, and tracking of reasons for missed enrollments. If enrollment fails to demonstrate improvement toward or above the >\u00e2\u0080\u008980% target despite these efforts, the site will be considered for removal from study participation and a replacement site will be identified.", "id": 591, "split": "train"} +{"trial_id": "NCT04103671", "pmid": "33619191", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Micro-invasive Pars-plana Vitrectomy vs Panretinal Photocoagulation for Severe Non-Proliferative Diabetic Retinopathy A Randomized Clinical Trial\n\nIncluded conditions:\n- Non Proliferative Diabetic Retinopathy\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'EXPERIMENTAL', 'description': 'Prompt panretinal photocoagulation', 'interventionNames': ['Procedure: Prompt panretinal photocoagulation']}\n- {'label': 'Group B', 'type': 'EXPERIMENTAL', 'description': 'Micro-invasive Pars-plana vitrectomy', 'interventionNames': ['Procedure: 25G Pars-plana vitrectomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Prompt panretinal photocoagulation', 'description': 'Study eyes that receive panretinal photocoagulation (prompt PRP eyes at baseline) should have 1200 to1600 burns with a spot size on the retina of approximately 500 microns given over 1 to 3 sittings and completed within 4 weeks of initiation', 'armGroupLabels': ['Group A']}\n- {'type': 'PROCEDURE', 'name': '25G Pars-plana vitrectomy', 'description': 'Study eyes that receive standard 25G Pars-plana vitrectomy that remove all the vitreous, without laser or Silicone oil tamponade, but filled with perfusion fluid. Surgery should be completed within 4 weeks after randomization.', 'armGroupLabels': ['Group B']}\n\nPrimary Outcomes:\n- {'measure': 'progression rate of severe non proliferative diabetic retinopathy', 'description': 'the number of patients with severe non proliferative diabetic retinopathy progressed to proliferative diabetic retinopathy in each group from the baseline to 12 months', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 90% statistical power at a two-sided significance level of 0.05, with an allowance for 20% loss to 1-year follow-up.", "answer": 272, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size estimate has been computed for the primary study objective, to determine whether disease progression rate in the PPV group is superior to that in the PRP group at 1 year. The sample size calculations are based on the published Diabetic Retinopathy Clinical Research Network clinical trials.9 23 Disease progression is defined as the transition from sNPDR to PDR according to the international definition of DR.6 It is assumed that the 1 year cumulative sNPDR progression rate after the PRP treatment would be approximately 40%, and that after the PPV treatment would be 20%. By using a balanced design, 109 participants per study group will be required to achieve 90% statistical power at a two-sided significance level of 0.05. Thus, allowing for 20% of participants loss to 1-year follow-up, 272 participants are required for this study.", "id": 592, "split": "train"} +{"trial_id": "NCT04103970", "pmid": "32933571", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Graded Activity and Pain Education (GAPE) for Patients Early After Lumbar Spinal Fusion\n\nIncluded conditions:\n- Low Back Pain\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Usual care:\\n\\nBefore surgery all patients are invited to participate in a pre-surgery seminar, where they receive information and advice about the time before, during and after the LSF. The seminar will be guided by nurses, surgeons, anesthesiologist, occupational therapists and physiotherapist.\\n\\nAfter the surgery the patient will be hospitalized on an average of 3-4 days. During hospitalization a physiotherapist consults the patients on a daily basis to provide information, guidance on mobilization and instructions in gradually progressing movement. The patients will have no restrictions on movement after surgery and should gradually return to normal activity level.\\n\\nThree months post-operatively all patients will receive physical rehabilitation delivered by physiotherapists in a community care center.'}\n- {'label': 'Intervention group: Graded Activity and Pain Education (GAPE)', 'type': 'EXPERIMENTAL', 'description': \"Patients in the intervention-group will receive usual care and 9 sessions of GAPE, 4 sessions at the hospital, 2 sessions in the patient's home and 3 sessions by telephone.\\n\\nPain education in GAPE is viewed as an approach which target cognitive attitudes and beliefs about pain. The pain education will target 3 overall questions: 1. What is pain and is my pain normal? 2. What can affect my pain? 3. What can I do to relieve my pain? The education will be individually adjusted to each patient, so the patient's context and concerns regarding pain and movement are included.\\n\\nThe aim of Graded activity is to improve the patient's functional ability by positive reinforcement of health behaviors and activity levels. Graded activity will be based on which short-term activity-goals the patient evaluates as the most important for the treatment outcome. In close collaboration with the patient the physiotherapist will set quotas for the selected exercises/activities.\", 'interventionNames': ['Behavioral: Graded Activity and Pain Education (GAPE)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Graded Activity and Pain Education (GAPE)', 'description': \"GAPE is based on a cognitive behavioral perspective that human behavior is affected by behavioral, cognitive and affective factors, this include the patient's perception of and response to pain. The perspective is a psycho-social perspective which amplify and interact with the individual patient's pathology.\\n\\nThe overall theoretical perspective in GAPE is that fear of movement and/or lack of self-efficacy for exercise can potentially lead to disuse and sedentary behavior, a perspective modified from the fear-avoidance model. In this modified version the patients\u00b4 and the physiotherapists\u00b4 former experiences, knowledge, and beliefs are factors influencing on the patients\u00b4 experience of pain and thereby their self-efficacy for exercise and fear of movement.\", 'armGroupLabels': ['Intervention group: Graded Activity and Pain Education (GAPE)']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in sedentary behavior (sitting or reclining/lying posture)', 'description': 'Sedentary behavior will in this study be defined as: \"Any waking behavior characterized by a sitting or reclining/lying posture\". Sedentary behavior will be assessed objectively as the number of minutes per day the patient is sedentary (lying down and sitting) measured by SENS motion activity measurement system. SENS is a small accelerometer placed within a small plaster to be worn on the patient\\'s thigh. The SENS motion system is considered a reliable and valid device for measuring sedentary behavior. The patients will wear the accelerometer for 7 consecutive days during the week before surgery, and in 7 days at three- and 12-months post-surgery.', 'timeFrame': '3 months post-surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe power calculation is based on achieving at least 80% power, with an assumption of a 20% dropout rate.", "answer": 144, "answer_type": "ACTUAL", "explanation": "Sample size\n The power calculation is based on the primary outcome, sedentary behaviour. A mean difference of 60\u00e2\u0080\u0089min per day is considered a clinically significant difference, with a standard deviation of 115 [63]. A sample size of 59 per group is required to obtain a power of at least 80% to detect the mean difference of 60\u00e2\u0080\u0089min. To account for a 20% drop-out, we will include 144 patients in total.", "id": 593, "split": "train"} +{"trial_id": "NCT04104113", "pmid": "33187543", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HEalth-Related Quality of Life-intervention in Survivors of Breast and Other Cancers Experiencing Cancer-related Fatigue Using TraditionAL Chinese Medicine: The HERBAL Trial\n\nIncluded conditions:\n- Cancer\n- Fatigue\n- Cognitive Impairment\n\nStudy Armgroups:\n- {'label': 'XBYRT decoction', 'type': 'EXPERIMENTAL', 'description': 'Participants assigned to receive the modifed Xiang Bei Yang Rong Tang granules', 'interventionNames': ['Other: Modified Xiang Bei Yang Rong Tang']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants assigned to receive placebo (contains 5% of XBYRT) granules', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Modified Xiang Bei Yang Rong Tang', 'description': 'Modified Xiang Bei Yang Rong Tang is a combination of 15 herbal components and it is available in granules form to be dissolved in hot water for consumption', 'armGroupLabels': ['XBYRT decoction']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo granules contain 5% XBYRT, colourant, bitterant and 95% starch filler', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in Global Health Status (GHS) score', 'description': 'Difference in Global Health Status (GHS) score from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) between XBYRT interventional and placebo arms from baseline to 8 weeks after baseline. The GHS scale ranges in score from 0-100. A higher score represents a better quality of life', 'timeFrame': '8 weeks from baseline'}\n\nPlease estimate the sample size based on the assumption: \n10% dropout rate.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n In order to ensure that the sample size is adequately powered to estimate a reliable standard deviation (SD) for a phase III trial, Teare et al. has recommended to include at least 70 subjects (35 per arm) for estimating the SD for a continuous outcome [31]. Therefore, to account for a 10% dropout, a total sample size of 80 patients (rounded up from 78), with 40 participants on each arm, is required for this study.", "id": 594, "split": "train"} +{"trial_id": "NCT04104607", "pmid": "33067297", "question": "Here is the design of a clinical trial:\n\nOfficial Title: First in Human Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma\n\nIncluded conditions:\n- Castration-Resistant Prostatic Cancer\n\nStudy Armgroups:\n- {'label': 'CC-1 therapy', 'type': 'EXPERIMENTAL', 'description': 'Infusion of CC-1 over 24 hours for 7 days with possible intra-patient dose-escalation. In case of clinical benefit, additional cycles with a total of up to six are possible.', 'interventionNames': ['Drug: CC-1, PSMAxCD3']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'CC-1, PSMAxCD3', 'description': 'Infusion of CC-1 over 24 hours for 7 days with possible intra-patient dose-escalation', 'armGroupLabels': ['CC-1 therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence and severity of adverse events (AEs) (CTCAE V5.0) over 21 days (i.e. until end of first treatment cycle (day 28))', 'description': 'Grade 1 No interruption- No dose adjustment Grade 2 Interrupt until Grade 0/1- No dose adjustment Any Grade \u2265 3 Interrupt until Grade 0/1 Permanently stop, except that no DLT is caused; if the latter and if AE is resolved to Grade 0/1, resume with dose reduction by two dose levels', 'timeFrame': 'Each cycle is 28 days; Safety Assessment on day 1-9,15,22,28'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, type one error of 5%, and a drop-out rate of 15%", "answer": 86, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Depending on the occurrence of DLT in the dose escalation part, the patient number to define the MTD varies. A minimum number of 24 patients are treated, but potentially up to 86 patients may be included into the trial. Based on the broad range of dose levels to be tested (absolute doses of 28\u00e2\u0080\u00931157\u00e2\u0080\u0089\u00c2\u00b5g) and the employed intraindividual dose escalation (figure 2A), sample size may vary considerably dependent on CC-1-induced AEs. The dose escalation calculation is rule based on the titration design by Simon et al.26 Once the maximum tested dose is reached, additional six patients are treated to define MTD (figure 3). Thus, the sample size varies in the dose escalation part of the study between n=10 patients required for definition of the MTD in the minimal and n=72 patients in the maximum case. Subsequently, a dose expansion part with 14 patients is foreseen to gain more information about the MTD level and to better define the recommended phase II dose of CC-1. Based on the planning, in total 20 patients will be treated at the MTD level, 6 patients from the dose escalation phase and 14 patients of the expansion cohort. Thus, we will be able to estimate within a single-stage phase II design an objective response defined as PSA drop \u00e2\u0089\u00a550% estimating P0 the maximum response proportion of a poor drug of \u00e2\u0089\u00a430% of the patients, and P1 the minimum response proportion of a good drug of \u00e2\u0089\u00a560% with a power of 80% and a type one error of 5%. To this aim we will need n=17 evaluable patients assuming a drop-out rate of 15% (n=3).\n Estimation of sample size:\n Minimum: (4 escalation+6 highest dose)+14 expansion-cohort=24 patients\n Maximum: 12\u00c3\u00976 escalation-cohort+14 expansion-cohort=86 patients", "id": 595, "split": "train"} +{"trial_id": "NCT04107948", "pmid": "34113593", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficiency of an Optimized Care Organization for Fibromyalgia Patients Within the Group of Hospitals of Loire Territory. Interventional Study Aimed at Changing Behaviour in Terms of Physical Activity and Sedentary\n\nIncluded conditions:\n- Fibromyalgia\n- Physical Activity\n\nStudy Armgroups:\n- {'label': 'fibromyalgia patients with physical activity program', 'type': 'EXPERIMENTAL', 'description': 'Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified \"Sports Health\" in the Loire (42) or Haute-Loire (43) for 2 months.', 'interventionNames': ['Other: physical activity program']}\n- {'label': 'fibromyalgia patients with physical activity at home', 'type': 'OTHER', 'description': 'Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).', 'interventionNames': ['Other: Advice and recommendations of physical activity at home']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'physical activity program', 'description': 'Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified \"Sports Health\" in the Loire (42), Haute-Loire (43) or Ard\u00e8che (07) for 2 months.', 'armGroupLabels': ['fibromyalgia patients with physical activity program']}\n- {'type': 'OTHER', 'name': 'Advice and recommendations of physical activity at home', 'description': 'Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).', 'armGroupLabels': ['fibromyalgia patients with physical activity at home']}\n\nPrimary Outcomes:\n- {'measure': 'physical activity', 'description': 'Measure the durability of adherence/therapeutic compliance of fibromyalgia patients based on an objective measurement of physical activity: average measured from 7 days of actimetry, Actigraph', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 5%, power set at 90%, and an expected dropout rate of 10%.", "answer": 330, "answer_type": "ESTIMATED", "explanation": "Sample Size\n Population size is calculated on an expected difference of 20% of the level of MVPA (\u00e2\u0089\u00a53 METs for metabolic equivalent tasks). Estimating that at baseline, patients are at 3.9 MET-h/week with a standard deviation between 2 and 4 (40), for an alpha risk of 5% and a potency set at 90%, we need to include 150 patients per group; adding an expected dropout rate of 10%, it is necessary to include 165 patients per group to meet the main goal, which means a total of 330 patients.", "id": 596, "split": "train"} +{"trial_id": "NCT04108130", "pmid": "37023031", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study\n\nIncluded conditions:\n- Postoperative Pulmonary Complications\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.'}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'This arm will receive the bundle of interventions.', 'interventionNames': ['Other: Preoperative Education', 'Procedure: Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization', 'Other: Individualization of Neuromuscular Blockade', 'Procedure: Postoperative Incentive Spirometry', 'Behavioral: Postoperative Ambulation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Preoperative Education', 'description': 'Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry.', 'armGroupLabels': ['Intervention']}\n- {'type': 'PROCEDURE', 'name': 'Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization', 'description': 'PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Individualization of Neuromuscular Blockade', 'description': 'Administration of neuromuscular blocking agents and their reversal will be done based on established protocol.', 'armGroupLabels': ['Intervention']}\n- {'type': 'PROCEDURE', 'name': 'Postoperative Incentive Spirometry', 'description': 'Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance.', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Postoperative Ambulation', 'description': 'Participants will be encouraged to adhere to prescription of early ambulation.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Number and Severity of Postoperative Pulmonary Complications between Participant Groups', 'description': 'The distribution of the number and severity of post-operative pulmonary complications (PPCs) between the control and intervention groups during the first 7 days after surgery.', 'timeFrame': 'Postoperative Days 0 through 7'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level (\u00ce\u00b1) of 0.05 (two-sided) and a power of 93%. The distribution of PPC severity among participants with PPCs is assumed to be 50% grade 1, 25% grade 2, 20% grade 3, and 5% grade 4.", "answer": 750, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size was estimated using simulations of the primary analysis of the distribution of highest PPC severity between the two groups. Based on these simulations, our sample size of 375/group (750 total) being studied has 93% power (\u00ce\u00b1 = 0.05, two-sided) for the primary analysis for the study. We formulated the treatment effect in this project as a relative percent reduction in PPC rate between groups, not an absolute difference between the two groups. For simplicity in these simulations, we assumed no change in the distribution of the severity of PPCs, so the reduction in PPC rate applied to the number of PPCs of each severity grade. The number of participants without any PPC (highest severity PPC grade 0) was then adjusted accordingly. We then assumed a PPC event rate in the usual care group of 40% [7, 14, 19, 34], and a treatment effect (relative reduction of PPC rate) of 35.29% (so an absolute PPC event rate of 25.88% in the group receiving the intervention bundle). The 35.29% reduction in the rate of any PPCs was the lower 10% bound (one-sided) of the highest posterior region based on previous studies using a Bayesian analysis. This means that we have a 90% expectation that the true treatment effect (reduction in the overall rate of PPCs) of the entire bundle would be greater than 35.29%. We assumed for the simulations that among participants with PPCs, approximately 50% would be grade 1, 25% grade 2, 20% grade 3, and 5% grade 4.", "id": 597, "split": "train"} +{"trial_id": "NCT04110977", "pmid": "32450921", "question": "Here is the design of a clinical trial:\n\nOfficial Title: RAdiotherapy RElated Skin Toxicity: a Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer\n\nIncluded conditions:\n- Radiation Dermatitis\n- Radiation-induced Oral Mucositis\n\nStudy Armgroups:\n- {'label': 'Standard Care supported by a Reminder App (Arm A)', 'type': 'EXPERIMENTAL', 'description': 'Treatment with Standard Care supported by a Reminder App, starting at the beginning of radiotherapy.', 'interventionNames': ['Device: mobile application (reminder app)']}\n- {'label': 'Standard Care alone (Arm B)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treatment with Standard Care alone, starting at the beginning of radiotherapy.', 'interventionNames': ['Device: mobile application (reminder app)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'mobile application (reminder app)', 'description': \"This app will remind the patients four times a day to perform skin and mouth care. Instructions are given how to properly perform skin and mouth care. The patients may postpone each required care procedure for up to 2 hours. Finally, the patients are asked to state for each procedure whether or not they performed it. To increase the patients' motivation, they will earn points for each successfully performed care procedure.\", 'armGroupLabels': ['Standard Care alone (Arm B)', 'Standard Care supported by a Reminder App (Arm A)']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of radiation dermatitis grade \u22652', 'description': 'at least moderate radiation-induced skin toxicity such as erythema and desquamation', 'timeFrame': 'until 60 Gy of radiotherapy'}\n\nPlease estimate the sample size based on the assumption: \nChi-square test, two-sided significance level of 5%, statistical power of 80%, and a 5% dropout rate.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n This study aims to show that standard skin care supported by a reminder app is superior to standard skin care alone regarding the avoidance of grade\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00892 dermatitis up to 60 Gy in patients irradiated for locally advanced head-and-neck cancers.\n The null hypothesis of equal grade\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00892 dermatitis rates in both groups is tested against the two-sided alternative hypothesis of unequal dermatitis rates. The calculation of the sample size considered the following assumptions:\nApplication of a chi-square testTwo-sided significance level of 5%Rates of grade\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00892 dermatitis of 86\u00e2\u0080\u009392% with standard care alone according to previous studiesAssumption of a grade\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00892 dermatitis rate of 85% in the standard care alone group (\u00e2\u0080\u009cworst-case\u00e2\u0080\u009d)Clinical importance of the impact of the reminder app\u00e2\u0080\u0089=\u00e2\u0080\u0089reduction of grade\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00892 dermatitis by 20%Statistical power of 80%\n When considering these assumptions, 80 patients are needed per arm within the full analysis set. Assuming that 5% of the recruited patients will not qualify for the full analysis set, 168 patients need to be randomized.", "id": 598, "split": "train"} +{"trial_id": "NCT04111315", "pmid": "34645660", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Metamizole Versus Ibuprofen and a Short Educational Intervention Versus Standard Care in Acute and Subacute Low Back Pain: A Randomized, Factorial Trial\n\nIncluded conditions:\n- Low Back Pain\n\nStudy Armgroups:\n- {'label': 'metamizole + educational intervention', 'type': 'ACTIVE_COMPARATOR', 'description': '(A) Metamizole (Novalgin\u00ae Oblong tablets 0,5 g) orally three times daily 2 capsules for 4 days followed by an as needed regimen (days 4 - 42). The treatment duration will depend on the duration of pain. Patients are considered to be recovered when their pain is below 2 (NRS 0-10) on 2 consecutive days after they stopped the pain medication (end of treatment).\\n\\n(B) Educational short intervention: patients receive two leaflets with information non-specific LBP and exercises to alleviate LBP. Further, patients receive a 10-minute standardized telephone intervention during the first 4 treatment days.', 'interventionNames': ['Drug: Metamizole Sodium', 'Behavioral: Patient education']}\n- {'label': 'metamizole + standard care', 'type': 'ACTIVE_COMPARATOR', 'description': '(A) Metamizole (Novalgin\u00ae Oblong tablets 0,5 g) orally three times daily 2 capsules for 4 days followed by an as needed regimen (days 4 - 42). The treatment duration will depend on the duration of pain. Patients are considered to be recovered when their pain is below 2 (NRS 0-10) on 2 consecutive days after they stopped the pain medication (end of treatment).\\n\\n(B) Standard care will be prescribed by the GP.', 'interventionNames': ['Drug: Metamizole Sodium']}\n- {'label': 'ibuprofen + educational intervention', 'type': 'ACTIVE_COMPARATOR', 'description': '(A) Ibuprofen (Ibufen-L\u00ae tablets 500 mg) orally three times daily 2 capsules for 4 days followed by an as needed regimen (days 4 - 42). The treatment duration will depend on the duration of pain. Patients are considered to be recovered when their pain is below 2 (NRS 0-10) on 2 consecutive days after they stopped the pain medication (end of treatment).\\n\\n(B) Educational short intervention: patients receive two leaflets with information non-specific LBP and exercises to alleviate LBP. Further, patients receive a 10-minute standardized telephone intervention during the first 4 treatment days.', 'interventionNames': ['Drug: Ibuprofen 600 mg', 'Behavioral: Patient education']}\n- {'label': 'ibuprofen + standard care', 'type': 'ACTIVE_COMPARATOR', 'description': '(A) Ibuprofen (Ibufen-L\u00ae tablets 500 mg) orally three times daily 2 capsules for 4 days followed by an as needed regimen (days 4 - 42). The treatment duration will depend on the duration of pain. Patients are considered to be recovered when their pain is below 2 (NRS 0-10) on 2 consecutive days after they stopped the pain medication (end of treatment).\\n\\n(B) Standard care will be prescribed by the GP.', 'interventionNames': ['Drug: Ibuprofen 600 mg']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Metamizole Sodium', 'description': 'Novalgin\u00ae Oblong tablets 0,5 g 2-2-2', 'armGroupLabels': ['metamizole + educational intervention', 'metamizole + standard care'], 'otherNames': ['Metamizole']}\n- {'type': 'DRUG', 'name': 'Ibuprofen 600 mg', 'description': 'Ibufen-L\u00ae tablets 500 mg 2-2-2', 'armGroupLabels': ['ibuprofen + educational intervention', 'ibuprofen + standard care'], 'otherNames': ['Ibuprofen']}\n- {'type': 'BEHAVIORAL', 'name': 'Patient education', 'description': 'Leaflet and phone call', 'armGroupLabels': ['ibuprofen + educational intervention', 'metamizole + educational intervention'], 'otherNames': ['Education']}\n\nPrimary Outcomes:\n- {'measure': 'Pain improvement', 'description': 'Change in pain on the numeric rating scale (NRS, range 0 (no pain) -10 (worst possible pain) points)', 'timeFrame': 'Baseline to 14 days follow-up'}\n- {'measure': 'Disability', 'description': 'Change in the Core Outcome Measures Index (COMI) sum-score (range 0-10). COMI sum score (0-10 points) is calculated by averaging the five domain scores (each on a 0-10 scale) for pain, back-related function, symptom-specific well-being, general quality of life and disability. Higher values represent a better or worse outcome.', 'timeFrame': 'Baseline to 42 days follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe type-I error rate is adjusted to 0.025 for each test to maintain an overall type-I error rate of 0.05. The power is set at 90%, and a drop-out rate of 10% is accounted for. The standard deviation (SD) for the NRS is assumed to be 1.6, and for the COMI, it is assumed to be 2.2 points.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Estimated sample size and power\n Both interventions are considered for determining the sample size for this factorial trial.34 We expect the two primary hypotheses to be independent of each other and do not expect an interaction between both interventions. Therefore, we powered each hypothesis individually, but accounted for multiple testing by adjusting the type-I error rate by setting the alpha level to 0.025 in each test to keep the overall type-I error rate at 0.05. Thus, we aimed to include 120 patients to account for a drop-out of 10% which will allow to proof non-inferiority of the metamizole treatment at a one-sided alpha-level of 2.5% with a power of 90%.\n The sample size calculation for the comparison of metamizole versus ibuprofen was based on a difference in the change of pain score in the Numeric Rating Scale (NRS; range 0\u00e2\u0080\u009310, higher score indicates more pain). We considered a change of \u00e2\u0089\u00a52 points between the two groups as clinically relevant and a change of \u00e2\u0089\u00a41 point as negligible.35 36 Therefore, we set the non-inferiority margin to \u00e2\u0088\u00921 score point. Based on a two-sample means test and an SD of 1.6,35 we will need 108 patients (54 per group) to proof non-inferiority of the metamizole treatment at a one-sided alpha-level of 2.5% with a power of 90%.\n The sample size for the primary outcome comparison short intervention versus usual care (superiority) is based on a change in Core Outcome Measures Index (COMI; range 0\u00e2\u0080\u009310, higher score indicates higher level of complaint, see primary outcomes) from baseline to week 6. We hypothesise that there is a difference between the two intervention groups regarding COMI. Mannion et al37 reported a minimal clinically important difference (MCID) for improvement in the COMI of 2.2 points and SD for changes in COMI ranging from 1.7 to 2.5 points. We see a difference of 2.2 points between the two groups as clinically relevant and assume a SD of 2.2 points. Based on a two-sample means test, we will need 54 patients (27 per group) to detect a difference in the change of the COMI at a two-sided alpha-level of 2.5% with a power of 90%.", "id": 599, "split": "train"} +{"trial_id": "NCT04111978", "pmid": "35524184", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer: a Randomized Double-blinded Placebo-controlled Multi-centre Phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO), Including LOGOS (Low Grade Ovarian Cancer Sub-study).\n\nIncluded conditions:\n- Ovarian Neoplasm Epithelial\n- Fallopian Tube Neoplasms\n- Peritoneal Neoplasms\n- High-grade Serous Ovarian Carcinoma (HGSOC)\n- Low-grade Serous Ovarian Carcinoma (LGSOC)\n- Ovarian Endometrioid Carcinoma\n\nStudy Armgroups:\n- {'label': 'Letrozole (aromatase inhibitor)', 'type': 'EXPERIMENTAL', 'description': 'Letrozole, 2.5 mg Femara tablet, administered once daily for 5 years or until symptoms of toxicity or progression of underlying disease', 'interventionNames': ['Drug: Letrozole 2.5mg']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo tablet of Femara (without aromatase inhibitor), 0 mg Femara tablet, administered once daily for 5 years or progression of underlying disease', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Letrozole 2.5mg', 'description': 'Aromatase inhibitor', 'armGroupLabels': ['Letrozole (aromatase inhibitor)'], 'otherNames': ['Femara']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo tablet of Femara', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Progression-free survival (PFS) for each study group', 'description': \"PFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression.\\n\\nAssessment of progression (recurrence) is generally indicated by SYMPTOMS and will be assessed by the investigator most commonly on the basis of CT scans of the pelvis, abdomen and thorax, according to RECIST v1.1 criteria recommended and mostly presented by an elevated CA-125 level. Elevated CA-125 levels alone shouldn't be considered as progression. Progression assessment according to local standard of care, however, is similarly acceptable.\", 'timeFrame': 'Up to approximately 12 years'}\n\nPlease estimate the sample size based on the assumption: \nFor the whole cohort, a two-sided alpha level of 5%, 90% power, and a 10% dropout rate are assumed. For the LOGOS cohort, a two-sided alpha level of 0.05, 80% power, a 15% dropout rate, and an O'Brien-Fleming group sequential design with one interim and one final look are assumed.", "answer": 540, "answer_type": "ESTIMATED", "explanation": "Sample size consideration and statistical analyses\n \n Sample size considerations of the whole cohort\n We estimated how many events are needed to achieve a 90% power to detect a hazard ratio (HR) of 0.70 between the two treatment arms (hazard letrozole/hazard placebo, assuming an exponential distribution of PFS). From the ICON7 adjuvant trial [10], which investigated bevacizumab in the adjuvant maintenance setting, it is expected that PFS is approximately exponentially distributed and the median PFS under standard care is 18\u00c2\u00a0months. The assumed HR of 0.70 would increase the median PFS in the treatment arm to 25.7\u00c2\u00a0months.\n Calculations were done assuming a two-sided alpha level of 5% and a log-rank test for comparison. The approximation described by Machin et al., (2009) resulted in a required sample size of 330 events, i.e., cases with progression over both study arms [45]. The recruitment will continue until this number of events is observed and the power of 90% has been achieved. When assuming, in addition to the aforementioned conditions, a uniform recruitment rate during three and a half years and a dropout rate of 10%, a total number of 540 patients would suffice to achieve the target number of 330 events five years after study start (calculated using the method by Lachin & Foulkes, 1986) [46].\n \n \n Sample size considerations specific for the low grade cohort, LOGOS\n Assumptions about efficacy for the power calculations are based on the retrospective analysis of Gershenson et al. [17]. We assume exponential PFS distributions, the analysis by a two-sided log-rank test with alpha level 0.05, and a power of 80%. With an accrual duration of 7\u00c2\u00a0years and a follow-up phase of 5\u00c2\u00a0years after accrual of the last patient, a dropout rate of 15%, and a median PFS of 36\u00c2\u00a0months in the control arm and 60\u00c2\u00a0months in the experimental arm (i.e. a hazard ratio of 0.6 between arms). Because the main protocol of the MATAO trial schedules its final PFS analysis at approximately 5\u00c2\u00a0years after inclusion of the last MATAO patient (while recruitment into the LOGOS stratum will still be ongoing) and states grade as a factor for subgrouping, technically, this constitutes an interim analysis of the LOGOS data. To account for this interim analysis, we plan an O\u00e2\u0080\u0099Brien-Fleming group sequential design with one interim look and one final look. The sample size / power calculations were performed using ADDPLAN version 6.1. Accounting for 15% dropout, 186 patients (i.e. approximately 2.2 patients per month) should be recruited into LOGOS in order to have the 158 evaluable patients, necessary to achieve a power of 80% with this O\u00e2\u0080\u0099Brien-Fleming group sequential design. The boundaries for the group sequential design at the interim look will be based on the actual number of observed events and will be calculated using the alpha-spending function for an O\u00e2\u0080\u0099Brien-Fleming design. The final analysis will be performed after observation of 121 events.", "id": 600, "split": "train"} +{"trial_id": "NCT04111978", "pmid": "35524184", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer: a Randomized Double-blinded Placebo-controlled Multi-centre Phase III Trial (ENGOT-ov54/Swiss-GO-2/MATAO), Including LOGOS (Low Grade Ovarian Cancer Sub-study).\n\nIncluded conditions:\n- Ovarian Neoplasm Epithelial\n- Fallopian Tube Neoplasms\n- Peritoneal Neoplasms\n- High-grade Serous Ovarian Carcinoma (HGSOC)\n- Low-grade Serous Ovarian Carcinoma (LGSOC)\n- Ovarian Endometrioid Carcinoma\n\nStudy Armgroups:\n- {'label': 'Letrozole (aromatase inhibitor)', 'type': 'EXPERIMENTAL', 'description': 'Letrozole, 2.5 mg Femara tablet, administered once daily for 5 years or until symptoms of toxicity or progression of underlying disease', 'interventionNames': ['Drug: Letrozole 2.5mg']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo tablet of Femara (without aromatase inhibitor), 0 mg Femara tablet, administered once daily for 5 years or progression of underlying disease', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Letrozole 2.5mg', 'description': 'Aromatase inhibitor', 'armGroupLabels': ['Letrozole (aromatase inhibitor)'], 'otherNames': ['Femara']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo tablet of Femara', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Progression-free survival (PFS) for each study group', 'description': \"PFS defined as the time from the date of first IMP administration until the date of progression (recurrence) or death by any cause in the absence of progression.\\n\\nAssessment of progression (recurrence) is generally indicated by SYMPTOMS and will be assessed by the investigator most commonly on the basis of CT scans of the pelvis, abdomen and thorax, according to RECIST v1.1 criteria recommended and mostly presented by an elevated CA-125 level. Elevated CA-125 levels alone shouldn't be considered as progression. Progression assessment according to local standard of care, however, is similarly acceptable.\", 'timeFrame': 'Up to approximately 12 years'}\n\nPlease estimate the sample size based on the assumption: \nFor the whole cohort, a two-sided alpha level of 5%, 90% power, and a 10% dropout rate are assumed. For the LOGOS cohort, a two-sided alpha level of 0.05, 80% power, a 15% dropout rate, and an O'Brien-Fleming group sequential design with one interim and one final look are assumed.", "answer": 540, "answer_type": "ESTIMATED", "explanation": "Sample size considerations of the whole cohort\n We estimated how many events are needed to achieve a 90% power to detect a hazard ratio (HR) of 0.70 between the two treatment arms (hazard letrozole/hazard placebo, assuming an exponential distribution of PFS). From the ICON7 adjuvant trial [10], which investigated bevacizumab in the adjuvant maintenance setting, it is expected that PFS is approximately exponentially distributed and the median PFS under standard care is 18\u00c2\u00a0months. The assumed HR of 0.70 would increase the median PFS in the treatment arm to 25.7\u00c2\u00a0months.\n Calculations were done assuming a two-sided alpha level of 5% and a log-rank test for comparison. The approximation described by Machin et al., (2009) resulted in a required sample size of 330 events, i.e., cases with progression over both study arms [45]. The recruitment will continue until this number of events is observed and the power of 90% has been achieved. When assuming, in addition to the aforementioned conditions, a uniform recruitment rate during three and a half years and a dropout rate of 10%, a total number of 540 patients would suffice to achieve the target number of 330 events five years after study start (calculated using the method by Lachin & Foulkes, 1986) [46].", "id": 601, "split": "train"} +{"trial_id": "NCT04117893", "pmid": "33109641", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Duloxetine Combined With Intra-articular Injection of Corticosteroid and Hyaluronic Acid Reduces Pain in the Treatment of Knee Osteoarthritis Patients\n\nIncluded conditions:\n- Osteoarthritis, Knee\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'Duloxetine combined with intra-articular injection', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Duloxetine', 'Drug: intra-articular injection of corticosteroid and hyaluronic acid']}\n- {'label': 'Intra-articular injection', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: intra-articular injection of corticosteroid and hyaluronic acid']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Duloxetine', 'description': 'Participants will start on duloxetine 30 mg per day for one week and then titrated up to duloxetine 60mg per day for 23 weeks.', 'armGroupLabels': ['Duloxetine combined with intra-articular injection']}\n- {'type': 'DRUG', 'name': 'intra-articular injection of corticosteroid and hyaluronic acid', 'description': 'Participants will receive a 3.5 ml intra-articular injection of 30mg of hyaluronic acid plus 10mg of triamcinolone acetonide.', 'armGroupLabels': ['Duloxetine combined with intra-articular injection', 'Intra-articular injection']}\n\nPrimary Outcomes:\n- {'measure': 'Weekly mean of the 24h average pain scores', 'description': \"Weekly mean of the 24h average pain scores in participants with osteoarthritis knee pain at the end of 24 weeks as reported in participants' diaries based on the 11-point Likert scale (an ordinal scale with 0 indicating 'no pain', and 10 indicating 'worst pain imaginable')\", 'timeFrame': 'Twenty-fourth weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power at a two-sided \u03b1 level of 0.05, with a drop-out rate of 10%.", "answer": 150, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Based on previous research,31 we estimate that the mean of the weekly mean of the 24\u00e2\u0080\u0089hours average pain scores after 24 weeks will be approximately \u00e2\u0088\u00922.92\u00c2\u00b11.725 in the experimental group (IA (HA+CS) combined with oral duloxetine) and \u00e2\u0088\u00922.08\u00c2\u00b11.745 in the control group (IA (HA+CS)). In total, 68 patients per group will be needed to achieve 80% power at a two-sided \u00ce\u00b1 level of 0.05. Considering a drop-out rate of 10%, in total, 75 patients per arm are needed; thus, in total, 150 patients will be needed for this trial.", "id": 602, "split": "train"} +{"trial_id": "NCT04118140", "pmid": "35058263", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Development and Preliminary Evaluation of an Evidence-based Somatic Acupressure Protocol for the Self-management of Symptom Cluster of Fatigue, Insomnia and Depression in Breast Cancer Patients\n\nIncluded conditions:\n- Cancer\n\nStudy Armgroups:\n- {'label': 'True SA (Somatic Acupressure ) group', 'type': 'EXPERIMENTAL', 'description': 'Receiving true somatic acupressure+usual care', 'interventionNames': ['Other: Somatic Acupressure', 'Other: Usual care']}\n- {'label': 'Sham SA group', 'type': 'SHAM_COMPARATOR', 'description': 'Receiving sham somatic acupressure+usual care', 'interventionNames': ['Other: Sham acupressure', 'Other: Usual care']}\n- {'label': 'Usual care group', 'type': 'OTHER', 'description': 'Receiving usual care only (an education booklet regarding knowledge of BC and FSD symptom cluster management advice)', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Somatic Acupressure', 'description': '7-week self-acupressure plus usual care (an education booklet)', 'armGroupLabels': ['True SA (Somatic Acupressure ) group']}\n- {'type': 'OTHER', 'name': 'Sham acupressure', 'description': 'Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)', 'armGroupLabels': ['Sham SA group']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Usual care only (an education booklet)', 'armGroupLabels': ['Sham SA group', 'True SA (Somatic Acupressure ) group', 'Usual care group']}\n\nPrimary Outcomes:\n- {'measure': 'FEASIBILITY: Eligibility rate', 'description': 'Eligibility rate as assessed by (the number of eligible participants / number of participants screened) x 100%', 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'FEASIBILITY: Recruitment rate', 'description': 'Recruitment rate as assessed by (the number of participants who participated in the study / number of eligible participants) x 100%', 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'FEASIBILITY: Retention rate', 'description': 'Retention rate as assessed by (the number of participants who completed the study / number of participants who enrolled in) x 100%', 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'FEASIBILITY: Attrition rate', 'description': 'Attrition rate as assessed by (the number of participants who dropped out after the randomization / number of participants who enrolled in) x 100%', 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'FEASIBILITY: subject recruitment', 'description': \"Feasibility of subject recruitment assessed by interviewing the participants' feedback regarding why they discontinued this study\", 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'FEASIBILITY: Duration for completing the subject recruitment', 'description': 'Time period from the recruitment of first participants to the last patient: assessed by months', 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'ACCEPTABILITY: Actual days of acupressure', 'description': 'The number of days that the participants perform the SA interventions, where the scheduled sessions should be 7 weeks of daily acupressure', 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'ACCEPTABILITY: duration of each acupressure session', 'description': 'Duration of each time (minutes) of acupressure where the scheduled time per session should be around 36 minutes', 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'ACCEPTABILITY: SA protocol', 'description': \"Participants' feedback and satisfaction with the SA intervention assessed by a self-designed feedback form and follow-up semi-structured interviews\", 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'FEASIBILITY: Questionnaire-Item-level missing value of each questionnaire', 'description': 'Item-level missing value of each questionnaire (%) assessed by the percentage of participants who do not answer any single item', 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'FEASIBILITY: Questionnaire-Scale-level missing value of the questionnaire', 'description': 'Scale-level missing value of the questionnaire (%) assessed by the percentage of participants who do not answer at least one item in the whole questionnaire', 'timeFrame': 'Immediately after completion of the intervention (T2)'}\n- {'measure': 'SAFETY: adverse events', 'description': 'Number of adverse events occur during the intervention', 'timeFrame': 'Immediately once an adverse event occurs'}\n\nPlease estimate the sample size based on the assumption: \nA completion rate of 73.4% from a previous study is used, and a possible attrition rate of 30% is considered.", "answer": 51, "answer_type": "ACTUAL", "explanation": "Participants and sample size\n Female BC survivors who meet the following inclusion criteria will be recruited: (1) confirmed BC diagnosis from stage I to IIIa (early-stage BC survivors without any distant metastasis); (2) have experienced at least a moderate level of the FSD symptom cluster, with a score of \u00e2\u0089\u00a54 on a 0\u00e2\u0080\u009310 Numeric Rating Scale (0=\u00e2\u0080\u0098no symptom\u00e2\u0080\u0099, 10=\u00e2\u0080\u0098worst symptom\u00e2\u0080\u0099) for all three symptoms (fatigue, sleep disturbance and depression) during the previous 1\u00e2\u0080\u0089month; (3) have completed adjuvant chemotherapy for at least 1\u00e2\u0080\u0089month and up to 3\u00e2\u0080\u0089years (to capture persistent symptoms); (4) have no scheduled chemotherapy and radiotherapy during the study period and (5) willing to participate in this RCT with written informed consent.\n Potential participants will be excluded if they meet any of the following exclusion criteria: (1) presently taking pharmaceutical agents to treat fatigue, sleep disturbance or depression, such as antidepressant medications, psychostimulants or hypnotics; (2) extremely weak and/or have cognitive impairment that make them unable (or would make it difficult for them) to follow the study procedures and instructions; (3) have received any type of SA treatment during the previous 6\u00e2\u0080\u0089months and (4) presently participating in any other research projects.\n Julious30 recommended that 12 subjects per group is necessary to justify a study\u00e2\u0080\u0099s feasibility and the precision of the mean and variance. Given that the primary objective of the proposed study is to evaluate the feasibility and acceptability of the RCTs methodological procedure, intervention protocol and questionnaires, a sample size of 12 per group will therefore be considered. According to one previous study,31 the completion rate of 6\u00e2\u0080\u0089weeks of daily self-administered acupressure to manage cancer-related fatigue in BC survivors was 73.4%. Given that the current study will consist of 7\u00e2\u0080\u0089weeks of daily self-administered acupressure to measure the FSD symptom cluster in BC survivors, a possible attrition rate of 30% will be considered. The final sample size will be 51, with 17 in each group.", "id": 603, "split": "train"} +{"trial_id": "NCT04119180", "pmid": "33980232", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sedation Versus Protective Stabilization for Dental Treatment of Children With Caries and Negative Behavior at the Dentist: a Non-randomized Clinical Trial\n\nIncluded conditions:\n- Child Behavior\n- Dental Caries in Children\n\nStudy Armgroups:\n- {'label': 'Sedation', 'type': 'EXPERIMENTAL', 'description': 'The child receives sedatives approved for use in an outpatient setting, directed by a doctor, to accomplish the dental treatment.', 'interventionNames': ['Drug: Ketamine 50 MG/ML', 'Drug: Midazolam Hcl 2Mg/Ml Syrup']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'The child does not receive sedatives. As s/he exhibits negative behavior for the dental procedure, s/he will be restrained by a family member and dental team.', 'interventionNames': ['Procedure: Protective stabilization']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ketamine 50 MG/ML', 'description': 'Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg', 'armGroupLabels': ['Sedation'], 'otherNames': ['Ketamin S, Cristalia, S\u00e3o Paulo, Brazil']}\n- {'type': 'DRUG', 'name': 'Midazolam Hcl 2Mg/Ml Syrup', 'description': 'Midazolam oral solution in a concentration of 2.0 mg/mL via oral route; dose of 0.5 mg/kg, maximum 5.0 mg when associated with ketamine;', 'armGroupLabels': ['Sedation'], 'otherNames': ['Dormire oral solution, Cristalia, Sao Paulo, Brazil']}\n- {'type': 'PROCEDURE', 'name': 'Protective stabilization', 'description': \"The legal guardian or accompanying person appointed by the legal guardian should sit in the dental chair with the child and contain leg and arm movements. A dental assistant keeps the child's head contained during care.\", 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Child behavior during the dental treatment', 'description': \"Children's behavior assessed by OSUBRS (Ohio State University Behavioral Rating Scale) in digital videos recorded during the administration. Scores: 1 - quiet, 2 - cry with movement, 3 - movement without cry; 4 - struggling. The higher the percentage of time of care in which the child behaves quietly, the better their behavior. Measurements for each group will be synthesized as mean (or median) and standard deviation (or interquartile range).\", 'timeFrame': 'Participants will be followed for the duration of the dental session, an expected average of 40 minutes'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a significance level of 5% (one-tailed), and a 20% addition to account for losses after 12 months of follow-up.", "answer": 152, "answer_type": "ESTIMATED", "explanation": "Sample size\n Preliminary estimates indicate that, based on adults prescribed an anxiolytic, the minimum clinically relevant difference in the VAS scale is between 10 and 15\u00c2\u00a0mm [26]. This study would require a sample size of 63 for each group to achieve a power of 80% and a significance level of 5% (one-tailed) to detect an actual difference average between the intervention groups of 15\u00c2\u00a0mm (assuming a grouped standard deviation of 30 units). To avoid significant losses in the final sample size, after 12\u00c2\u00a0months of follow-up, we will add 20% to each group, which implies 76 children/group, i.e., a total sample size of 152 children.\n According to age, the estimated sample will be distributed in 38 children aged 2\u00e2\u0080\u00933\u00c2\u00a0years and 38 children of 4\u00e2\u0080\u00936\u00c2\u00a0years in each center to perform subgroup analysis.\n The sample size will be recalculated when the minimum number of 30 cases in each center is reached, based on the values observed in this study's conditions (interim analysis).", "id": 604, "split": "train"} +{"trial_id": "NCT04120779", "pmid": "32248825", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study Protocol of the EMPOWER-SUSTAIN Project: A Pilot Randomised Controlled Trial of e-Health Intervention to Improve Patient Activation and Self-Management Behaviours Among Individuals With Metabolic Syndrome in Primary Care Setting\n\nIncluded conditions:\n- Metabolic Syndrome\n\nStudy Armgroups:\n- {'label': 'The EMPOWER-SUSTAIN e-Health Intervention', 'type': 'EXPERIMENTAL', 'description': 'The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategies based on the Chronic Care Model (CCM) and persuasive technology (PT) theory. It consists of training physicians and patients to use the EMPOWER-SUSTAIN web-based self-management intervention mobile apps, strengthening patient-physician relationship and reinforcing the use of relevant clinical practice guidelines for management and prescribing.', 'interventionNames': ['Device: The EMPOWER-SUSTAIN e-Health Self-Management Intervention']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'The control group will continue to receive usual care at the university primary care clinic. They will be given the EMPOWER-SUSTAIN Global CV Risks Self-Management Booklet\u00a9, as this is considered as usual care at the university primary care clinic. The EMPOWER-SUSTAIN web-based self-management tool will be made available to the control group at the end of the study. During the course of the study, there will be no limit to the number of clinic visits that a patient is allowed to make in either the intervention or control groups.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'The EMPOWER-SUSTAIN e-Health Self-Management Intervention', 'description': 'Multifaceted chronic disease management strategies involving web-based self-management intervention mobile apps based on chronic care model and persuasive technology theory to improve patient activation and self-management behaviours among patients with metabolic syndrome.', 'armGroupLabels': ['The EMPOWER-SUSTAIN e-Health Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'The mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM 13-M) questionnaire.', 'description': \"The PAM-13 consists of 13 items measuring patients' self-reported knowledge, skills and confidence for self-management. Each item is scored on a Likert scale of 1-5. The instrument reflects the 4 stages of activation in a progressing difficulty of the items: level 1 (patients believe that their role is important), level 2 (patients have confidence and knowledge to take action), level 3 (taking action) and level 4 (staying on course under stress). According to the scoring guidelines, the raw scores are transformed through natural logarithm to achieve a better expression of the relative distance between the scores. Then, items are transformed to a standardized metric ranging from 0 to 100 (0 = lower activation; 100 = highest activation). The score is calculated by summing up the raw scores and mapping up the sum onto a scale of 0-100. A higher score of PAM-13 indicates a high level of patients activation.\", 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on an 80% power, a 5% level of significance, and a 20% dropout rate.", "answer": 232, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n Sample size is calculated using Power and Sample Size Calculation software version 3.1.2 [84], based on the findings of a randomised controlled trial evaluating the effects of a web-based self-management intervention for adults with chronic conditions on patient activation scores, measured by the PAM-13 questionnaire [48]. In the intervention group, the mean patient activation score at baseline was 65.33, and the mean score after the intervention was 71.30 (mean difference, 5.97\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00899.70; t57\u00e2\u0080\u0089=\u00e2\u0080\u00894.683; P\u00e2\u0080\u0089<\u00e2\u0080\u00890.001) [48]. In the control group, the mean patient activation score at baseline was 66.89, and the mean score at the end of the study period was 68.93 (mean difference, 2.04\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008910.01; t67\u00e2\u0080\u0089=\u00e2\u0080\u00891.677; P\u00e2\u0080\u0089=\u00e2\u0080\u00890.10) [48]. Therefore, the mean difference between the two groups was 3.93.\n Based on this assumption, a sample size of 97 patients per group is sufficient to detect mean difference of \u00ce\u00b4\u00e2\u0080\u0089=\u00e2\u0080\u00893.93 in the patient activation score between the two groups, with a standard deviation of \u00cf\u0083\u00e2\u0080\u0089=\u00e2\u0080\u00899.70 using a two-tailed t test of difference between means with 80% power (power\u00e2\u0080\u0089=\u00e2\u0080\u00890.8), 5% level of significance (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), and sample size ratio of 1:1 between the two groups (m\u00e2\u0080\u0089=\u00e2\u0080\u00891). After considering a drop-out rate of 20%, the sample size required is 116 patients per group, giving a total of 232 patients to be recruited for this study.", "id": 605, "split": "train"} +{"trial_id": "NCT04123873", "pmid": "36190737", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Combinations of Paracetamol, Ibuprofen, and Dexamethasone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty. The RECIPE Randomized Clinical Trial\n\nIncluded conditions:\n- Pain, Acute\n- Hip Arthropathy\n- Analgesia\n- Postoperative Pain\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'EXPERIMENTAL', 'description': 'Paracetamol 1000 mg + Ibuprofen 400 mg administered orally 1 hour before surgery and given with 6-hour intervals to a total of 4 times the first postoperative day.\\n\\nPlus placebo (matching DXM) IV administered after induction of anaesthesia', 'interventionNames': ['Drug: Paracetamol', 'Drug: Ibuprofen', 'Drug: Placebo IV']}\n- {'label': 'Group B', 'type': 'EXPERIMENTAL', 'description': 'Paracetamol 1000 mg and placebo (matching ibuprofen) orally 1 hour before surgery and given with 6-hour intervals to a total of 4 times the first postoperative day.\\n\\nPlus DXM 24 mg IV after induction of anaesthesia', 'interventionNames': ['Drug: Paracetamol', 'Drug: Dexamethasone', 'Drug: Placebo oral capsules']}\n- {'label': 'Group C', 'type': 'EXPERIMENTAL', 'description': 'Placebo (matching paracetamol) + ibuprofen 400 mg orally 1 hour before surgery and given with 6-hour intervals to a total of 4 times the first postoperative day.\\n\\nPlus DXM 24 mg IV after induction of anaesthesia', 'interventionNames': ['Drug: Ibuprofen', 'Drug: Dexamethasone', 'Drug: Placebo oral capsules']}\n- {'label': 'Group D', 'type': 'EXPERIMENTAL', 'description': 'Paracetamol 1000 mg + ibuprofen 400 mg orally 1 hour before surgery and given with 6-hour intervals to a total of 4 times the first postoperative day.\\n\\nPlus DXM 24 mg IV after induction of anaesthesia', 'interventionNames': ['Drug: Paracetamol', 'Drug: Ibuprofen', 'Drug: Dexamethasone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Paracetamol', 'description': '1g x 4 p.o.', 'armGroupLabels': ['Group A', 'Group B', 'Group D'], 'otherNames': ['Acetaminophen']}\n- {'type': 'DRUG', 'name': 'Ibuprofen', 'description': '400mg x 4 p.o.', 'armGroupLabels': ['Group A', 'Group C', 'Group D']}\n- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': '24mg IV x 1 after induction om anaesthesia', 'armGroupLabels': ['Group B', 'Group C', 'Group D']}\n- {'type': 'DRUG', 'name': 'Placebo oral capsules', 'description': 'p.o. x 4', 'armGroupLabels': ['Group B', 'Group C']}\n- {'type': 'DRUG', 'name': 'Placebo IV', 'description': 'IV x 1', 'armGroupLabels': ['Group A']}\n\nPrimary Outcomes:\n- {'measure': 'Cumulative opioid consumption in the first 24 hours after surgery', 'description': 'Cumulative opioid consumption in units of intravenous morphine equivalents in the first 24 postoperative hours. This includes opioids administered as (a) patient-controlled analgesia (PCA); (b) supplemental opioid administered at the post-anaesthesia care unit the first hour after end of surgery (general anaesthesia) or the first hour after ceasing of spinal anaesthesia; and (c) any supplemental opioid given at the ward', 'timeFrame': '0-24 hours after end of surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is Bonferroni-adjusted to 0.0083 for six pairwise comparisons, with a power of 0.80. A surplus of 15% is added to adjust for presumed non-normal distribution of data. Missing data is expected to be less than 5%, and multiple imputation will be used if necessary.", "answer": 1060, "answer_type": "ACTUAL", "explanation": "Sample size estimation and power calculation\n Due to the four intervention groups in this trial, six comparisons, comparing each individual treatment group, will be of interest (A vs B, A vs C, A vs D, B vs C, B vs D and C vs D). To preserve a maximum family wise error rate of less than 0.05, the threshold for type 1 error rate is Bonferroni-adjusted for the pairwise comparisons to 0.05/6=0.0083.\n The PANSAID trial15 reported a mean of 28\u00e2\u0080\u0089mg (SD 24.5\u00e2\u0080\u0089mg) morphine over 24 hours for the combination of paracetamol 1000\u00e2\u0080\u0089mg+ibuprofen 400\u00e2\u0080\u0089mg. Furthermore, a recent systematic review with network meta-analysis found a mean morphine consumption of 22.8\u00e2\u0080\u0089mg/24 hours when combining paracetamol and ibuprofen in major surgical procedures.45\n A persisting challenge in clinical research on postoperative pain is the fact that the quantification of a minimal important difference (MID) in morphine consumption is uncertain. A newly published systematic review of 570 RCTs on differences in MID after total knee and hip arthroplasties reported an investigator perceived median MID of 10\u00e2\u0080\u0089mg intravenous morphine equivalent as absolute reduction.46 The MID chosen for this trial is prompted by previous results and has been thoroughly debated: with a reduction of 8\u00e2\u0080\u0089mg morphine/24 hours the percentage-reduction (28%\u00e2\u0080\u009335%) in morphine consumption will be similar to those previously reported in trials investigating multimodal postoperative analgesia.15 45 47 In addition, this trial also investigates the addition of a third adjunct non-opioid analgesic component. Hence, it is expected that the reduction in morphine consumption will be less than with addition of a second non-opioid analgesic. In the PANSAID trial investigating two non-opioids, an MID of 10\u00e2\u0080\u0089mg was chosen, and thus, the 8\u00e2\u0080\u0089mg MID of the RECIPE trial corresponds to a 20% smaller MID, as would be expected for an addition of a third non-opioid analgesic.\n Consequently, to detect or to discard a mean MID of 8\u00e2\u0080\u0089mg in 24-hour morphine-consumption, with an SD of 24.5\u00e2\u0080\u0089mg and a power of 0.80, enrolment of 920 (230 in each group) participants is needed. To adjust for a presumed non-normal distribution of data a surplus of 15% is added.48 Hence 265 participants will be included in each group, adding up to a total of 1060 included participants. In two previous large trials with a similar setup and design, missing data on the primary outcome was limited to less than 5%.15 24 Furthermore, if missing data will unexpectedly occur, we plan to use multiple imputation to minimise the power loss due to missing data. Consequently, we have not adjusted our sample size per missing data. Sample size is calculated with PS Power and Sample Size Calculations (V.3.0, January 2009, William D. Dupont and Walton D. Plummer) and double controlled with Stata.49", "id": 606, "split": "train"} +{"trial_id": "NCT04125121", "pmid": "32962743", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Neuroplasticity Induced by General Anaesthesia\n\nIncluded conditions:\n- Healthy Volunteers\n- General Anaesthesia\n- Neuroplasticity\n\nStudy Armgroups:\n- {'label': 'Sevoflurane-Propofol', 'type': 'ACTIVE_COMPARATOR', 'description': 'Session one: Sevoflurane as maintenance anaesthetic during general anaesthesia.\\n\\nSession two: Propofol as maintenance anaesthetic during general anaesthesia.', 'interventionNames': ['Drug: Sevoflurane-propofol']}\n- {'label': 'Propofol-Sevoflurane', 'type': 'ACTIVE_COMPARATOR', 'description': 'Session one: Propofol as maintenance anaesthetic during general anaesthesia.\\n\\nSession two: Sevoflurane as maintenance anaesthetic during general anaesthesia.', 'interventionNames': ['Drug: Sevoflurane-propofol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sevoflurane-propofol', 'description': 'General anaesthesia with a maintenance phase of two hours duration with either sevoflurane or propofol.', 'armGroupLabels': ['Propofol-Sevoflurane', 'Sevoflurane-Propofol'], 'otherNames': ['Propofol-sevoflurane']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in T1w3D', 'description': 'Volume and morphology of selected brain regions and anatomical structures as recorded by T1w3D anatomy MRI.', 'timeFrame': '8 days'}\n- {'measure': 'Changes in DTI', 'description': 'White matter microstructure as measured using Diffusion Tensor Imaging (DTI)', 'timeFrame': '8 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05, power of 0.80, and standard deviation of \u00b110%. After Bonferroni correction for multiple comparisons, the significance level is adjusted to 0.025.", "answer": 20, "answer_type": "ACTUAL", "explanation": "Sample size\n We base our sample size estimations on the following primary end points: (1) changes in grey-matter volume, and (2) DTI changes. The volunteers will serve as their own controls.\n(i)Sample size estimation based on changes in grey-matter volume: we base our sample size estimation for grey-matter volume changes on data extrapolated from the hippocampus. The mean volume of the hippocampus is approximately 2.50 mL (\u00c2\u00b1\u00e2\u0080\u00890.15 standard deviation (SD)) in the healthy population [54]. The pre-operative hippocampal volume has been found to be 6% smaller in patients suffering from POCD compared to patients not suffering from POCD [55]. We assume that GA will affect the grey-matter volume to a larger extent compared to e.g. vulnerability towards POCD. Thus, 25 subjects will be necessary to detect a difference of 8% in the hippocampal volume between groups, applying a two-tailed alpha value of 0.05, SD \u00c2\u00b1\u00e2\u0080\u008910% and a desired power of 0.80(ii)Sample size estimation based on DTI changes: our sample size estimation for detection of DTI changes is also based on data extrapolated from the hippocampus. We assume a 10% change in mean diffusivity, since we expect GA to induce larger changes than, e.g. a learning task by video gaming [56]. With a significance level of 0.05, a power of 80%, a SD of \u00c2\u00b1\u00e2\u0080\u008910%, this indicated a required sample size of 16 volunteers\n \n Correction for multiple comparisons\n Since it should be assumed that grey-matter changes and changes in DTI are inter-dependable variables, the significance level for each sample size estimation should be corrected for multiple comparisons. The desired corrected significance level is 0.025 (significance level of 0.05 Bonferroni corrected for two number of hypothesis). With a SD of \u00c2\u00b1\u00e2\u0080\u008910% and 80% power, this gives a sample size of 30 volunteers regarding detection of statistically significant differences in grey-matter volume. Regarding statistically significant differences in DTI, the calculation gives a sample size of 20 volunteers. We are therefore confident that a sample size of 30 volunteers will be sufficient to ensure the necessary statistical power.", "id": 607, "split": "train"} +{"trial_id": "NCT04128904", "pmid": "34168037", "question": "Here is the design of a clinical trial:\n\nOfficial Title: In Vitro Fertilisation Versus Intracytoplasmic Sperm Injection in Patients Without Severe Male Factor Infertility (INVICSI): a Randomised, Controlled, Multicentre Trial\n\nIncluded conditions:\n- Infertility\n\nStudy Armgroups:\n- {'label': 'Standard in vitro fertilisation (IVF)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oocytes are fertilised with standard IVF. For details please see \"Project Description\".', 'interventionNames': ['Procedure: IVF']}\n- {'label': 'Intracytoplasmic sperm injection (ICSI)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oocytes are fertilised with ICSI. For details please see \"Project Description\".', 'interventionNames': ['Procedure: ICSI']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'IVF', 'description': 'Fertilisation with standard in vitro fertilisation (IVF). For details please see \"Project Description\".', 'armGroupLabels': ['Standard in vitro fertilisation (IVF)']}\n- {'type': 'PROCEDURE', 'name': 'ICSI', 'description': 'Fertilisation with intracytoplasmic sperm injection (ICSI). For details please see \"Project Description\".', 'armGroupLabels': ['Intracytoplasmic sperm injection (ICSI)']}\n\nPrimary Outcomes:\n- {'measure': 'Cumulative live birth rate from first live birth episode of a study cycle', 'description': 'The cumulative first live birth from the oocyte collection. Includes transfer of fresh embryos and frozen-thawed embryos.', 'timeFrame': 'Minimum follow-up time is one year after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nThis is a superiority trial with a power of 80% and a two-sided p value of 5%. Postrandomisation exclusion is expected to be 5%.", "answer": 824, "answer_type": "ESTIMATED", "explanation": "Proposed sample size\n The rate of first live births after transfer of up to all of the transferable embryos from the first OPU is set to 45% in the conventional IVF group and 55% in the ICSI group. This is a superiority trial with a power of 80% and a two-sided p value of 5%. The sample size is estimated to be 392 patients in each group. Postrandomisation exclusion is expected to be 5%, resulting in a total of 824 patients.", "id": 608, "split": "train"} +{"trial_id": "NCT04129359", "pmid": "36597136", "question": "Here is the design of a clinical trial:\n\nOfficial Title: FamilieTrivsel i Almen Praksis: A General Practice-based Cluster-randomised Trial of the Impact of the Resilience Programme on Early Child Development\n\nIncluded conditions:\n- Parent-Child Relations\n- Child Development\n- Parenting\n\nStudy Armgroups:\n- {'label': 'FamilieTrivsel', 'type': 'EXPERIMENTAL', 'description': 'Enhanced care as usual in general practice plus training in the use of the online mentalisation programme', 'interventionNames': ['Behavioral: FamilieTrivsel', 'Other: enhanced care as usual']}\n- {'label': 'control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Enhanced care as usual in general practice', 'interventionNames': ['Other: enhanced care as usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'FamilieTrivsel', 'description': \"FamilieTrivsel is a modular internet-based low-cost and brief psychoeducation intervention based on the Robusthed (Resilience) programme (RP). Mentalisation approaches are used to increase resilience and ability to handle the challenges of life. The programme is licence free and can be used with low or high intensity and it can be combined with any other interventions. RP provides simple explanations and tools that can be used to discover, understand and regulate one's own thoughts and feelings by activating mental and physical resources and it provides examples and exercises that may promote communication about mental states between parents and the child. The content has been developed to include video-based training sessions based on different stages of pregnancy and early childrearing. RP appears suitable for use in general practice, where the GP sees young parents regularly and thus can direct patients towards components of the programme when need appears greatest.\", 'armGroupLabels': ['FamilieTrivsel'], 'otherNames': ['Robustbarn.dk (FamilieTrivsel is a customised variant focused on families with young children)']}\n- {'type': 'OTHER', 'name': 'enhanced care as usual', 'description': 'Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice', 'armGroupLabels': ['FamilieTrivsel', 'control'], 'otherNames': ['control']}\n\nPrimary Outcomes:\n- {'measure': 'Strengths and Difficulties Questionnaire Total Difficulties Score', 'description': 'Child psychiatric symptom score, range from 0-40, parent complete, lower scores indicate better outcome.', 'timeFrame': '30 months postnatal'}\n- {'measure': 'MacArthur-Bates Communicative Development Inventory (100 word Danish version)', 'description': 'Child expressive language measure - range 0-100 - parent complete - higher scores indicate better outcomes', 'timeFrame': '30 months postnatal'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 2.5% significance level, intra-class correlation coefficient (ICC) of 0.02, 22% attrition rate.", "answer": 624, "answer_type": "ACTUAL", "explanation": "Sample size\n A total sample of children was estimated to be needed to find a difference of two points in the SDQ Total Difficulties Scale score (an effect size of 0.3) with 80% power at a 2.5% significance level. The estimate of 488 was based on the assumption of an intra-class correlation coefficient (ICC) of 0.02 in 60 clinics (an average of eight children per clinic). Allowing for 22% attrition we therefore aimed to recruit 488/0.78\u00e2\u0080\u0089=\u00e2\u0080\u0089624 children in 60 clusters (of on average 11 children per GP). The ICC estimate was based on the distribution of HADS scores at baseline, suggesting that the impact of clustering effect by practice was modest.\n \n Allocation, sequence generation, and concealment\n The study is a cluster randomised controlled trial with the general practice as the unit of randomisation. General practices were randomised on a 1:1 basis to intervention or control groups using a computer algorithm. The computer randomised allocation sequence was concealed until all general practices were assigned.\n \n \n Blinding (masking)\n The design is open label with only the study statistician being blinded under the dataset locked after collection of primary outcome data so un-blinding will not occur.", "id": 609, "split": "train"} +{"trial_id": "NCT04129840", "pmid": "33478567", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa - A Randomized Controlled Trial\n\nIncluded conditions:\n- Arterial Hypertension\n\nStudy Armgroups:\n- {'label': 'Intervention 1: dual combination', 'type': 'ACTIVE_COMPARATOR', 'description': 'dual combination of half-dose Calcium Channel Blocker (CCB) and Angiotensin II Receptor Blocker (ARB), dosage increases at 4 and 8 weeks if target blood pressure is not reached at the respective time point', 'interventionNames': ['Other: dual combination']}\n- {'label': 'Intervention 2: triple combination', 'type': 'ACTIVE_COMPARATOR', 'description': 'triple combination of quarter-dose of Calcium Channel Blocker (CCB), Thiazide diuretic (TZD) and Angiotensin II Receptor Blocker (ARB) with dosage increases of all drugs at 4 and 8 weeks, if target blood pressure is not reached at the respective time point', 'interventionNames': ['Other: triple combination']}\n- {'label': 'Standard of care', 'type': 'PLACEBO_COMPARATOR', 'description': 'start normal dose Calcium Channel Blocker (CCB), add Thiazide diuretic (TZD) after 4weeks and increase of TZD dosage after 8 weeks, if target blood pressure is not reached at the respective time point', 'interventionNames': ['Other: Standard of care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'dual combination', 'description': 'Participants will be started on a dual therapy with half dose of CCB and an ARB. If needed, a) the dose of the CCB will be increased at 4 weeks, and b) the dose of the ARB at 8 weeks, if blood pressure remains uncontrolled ((if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP \\\\65years)', 'armGroupLabels': ['Intervention 1: dual combination']}\n- {'type': 'OTHER', 'name': 'triple combination', 'description': 'Participants will be started with low dose (1/4) triple combination treatment with CCB, TZD and ARB. If uncontrolled after 4 weeks, dosages of all drugs will be doubled. If after 8 weeks still uncontrolled dosage will be increased to full dose of all three drugs ((if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP \\\\65years)', 'armGroupLabels': ['Intervention 2: triple combination']}\n- {'type': 'OTHER', 'name': 'Standard of care', 'description': 'Participants will be started on regular dose of CCB with a) addition of TZD at 4 weeks, if needed, b) increase of dose of TZD after 8 weeks, if needed (if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP \\\\65years)', 'armGroupLabels': ['Standard of care']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patients reaching a target blood pressure', 'description': 'Proportion of patients reaching a target blood pressure (clinic blood pressure) of \\\\65years of age', 'timeFrame': 'at 12 weeks after enrolment'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha of 0.05 for the superiority comparison, one-sided alpha of 0.025 for the non-inferiority comparison, power of 85% for the non-inferiority comparison, power of 95% for the superiority comparison, and a 15% dropout rate.", "answer": 1268, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n We hypothesize that the proportion of participants reaching the primary endpoint will be higher in the triple combination arm compared to the control arm. Additionally, we hypothesize that the dual combination arm will be non-inferior to the control arm (Table\u00c2\u00a03). We assumed a response rate in the control arm of 40%, an improvement in the triple combination arm of 15 percentage points (two-sided alpha of 0.05) for the superiority comparison between the triple combination and control arms, and a non-inferiority margin of 10% (one-sided alpha of 0.025) for the non-inferiority comparison between the dual combination and control arms. Based on these assumptions, we calculated a sample size of 431 participants in each of the control and dual combination arms, and 216 participants in the triple combination arm (power of 85% for the non-inferiority comparison and 95% for the superiority comparison). The overall sample size is therefore 1078 participants, with the randomization ratio of 2:1:2 for the dual combination, triple combination, and control arms, respectively. Assuming 15% of participants will become lost-to-follow-up [29] brings the total required sample size to 1268 individuals.\nTable 3Assumptions for sample size calculationDual combination Guideline + incremental value of ARB in African patientsTriple combination quarter dose for 3 widely available drugs usedControlWHO standard of care starting with monotherapyLiteratureReported response in 67% of Africans (response\u00e2\u0080\u0089=\u00e2\u0080\u0089diastolic blood pressure\u00e2\u0080\u0089<\u00e2\u0080\u008990\u00e2\u0080\u0089mmHg or 10% decrease [10, 52])Reported response in 83% of patients* (response\u00e2\u0080\u0089=\u00e2\u0080\u0089blood pressure\u00e2\u0080\u0089<\u00e2\u0080\u0089135/85\u00e2\u0080\u0089mmHg [17])Reported response in 67% of patients in Nigeria (response\u00e2\u0080\u0089=\u00e2\u0080\u0089blood pressure\u00e2\u0080\u0089<\u00e2\u0080\u0089149/90\u00e2\u0080\u0089mmHg [53])Conservative effect estimation for higher target BP\u00c2\u00a360%75%50%Conservative effect estimation for lower target BP$40%55%40%Comparison with cited studiesAssumption of a smaller effect due to lower BP targetEffect might be lower (3 drugs instead of 4; no single pill)Effect might be higher as allowance to increase dosageEffect might be lower due to lower targetARB angiotensin receptor blocker, BP blood pressure, WHO World Health Organization\u00c2\u00a3140/90\u00e2\u0080\u0089mmHg$130/80\u00e2\u0080\u0089mmHg", "id": 610, "split": "train"} +{"trial_id": "NCT04131088", "pmid": "37463802", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"Follow-up of Midlines Placed Outside the Intensive Care Unit: What Happens Next, What Side Effects? A Multicenter Observational Study\"\n\nIncluded conditions:\n- Thrombosis\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Follow up of midlines', 'description': 'The follow-up data to be collected will be recorded on a monitoring logbook that will follow the patient (Appendix 4). The latter will be involved in the follow-up of his data insofar as he will be able to solicit the various professionals performing care on his midline in order to aim at the exhaustiveness of the filling of the book.'}\n\nPrimary Outcomes:\n- {'measure': 'assess numbers of adverse events', 'description': 'catheter related infection yes/no vein thrombosis yes/no occlusion yes/no exposition time to a midline catheter', 'timeFrame': 'through study completion, an average of 2 year'}\n\nPlease estimate the sample size based on the assumption: \nThe incidence of complications can be estimated with an accuracy ranging from 0.6% to 1.3%. Researchers expect between 40 and 200 events, and nearly 20% of the follow-up would be patients discharged from hospital.", "answer": 2000, "answer_type": "ACTUAL", "explanation": "Sample size\n In 2018, the authors identified 408 MC placements in our institution. Over a 24-month inclusion period, approximately 2000 patients were eligible for study inclusion. According to two recent studies,10 12 the rate of complications such as infection, thrombosis or occlusion varies from 2% to 10%. With the inclusion of 2000 patients, the team was able to estimate the incidence of complications with an accuracy ranging from 0.6% to 1.3%. In addition, researchers expect between 40 and 200 events, which would make it possible to search for risk factors associated with these complications. Regarding home care patients, in our institution, researchers estimated that nearly 20% of the follow-up would be patients discharged from hospital.", "id": 611, "split": "train"} +{"trial_id": "NCT04135781", "pmid": "33435909", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adjuvant Nab-paclitaxel Plus S-1 Versus Capecitabine Plus Oxaliplatin for Patients With Stage III Gastric Cancer After D2 Gastrectomy : a Randomised\uff0cOpen-label, Phase III Study\n\nIncluded conditions:\n- Stomach Cancer\n\nStudy Armgroups:\n- {'label': 'AS', 'type': 'EXPERIMENTAL', 'description': 'Arm A\uff1anab paclitaxel \uff08120mg/m2\uff1biv\uff1bd1\uff0c8\uff09+S-1 \uff08\\\\<1.25 m2, 40 mg; 1.25 to \u22641.5 m2, 50 mg; and \u2265 1.5 m2, 60 mg\uff1bpo\uff1bd1-14 bid\uff09Q3W\uff1bup to eight cycles', 'interventionNames': ['Drug: nab paclitaxel', 'Drug: Tegafur']}\n- {'label': 'XELOX', 'type': 'ACTIVE_COMPARATOR', 'description': 'Arm B\uff1aCapetabine\uff081000 mg/m2 po, d1-14 bid \uff09+ Oxaliplatin\uff08130mg/m2 , iv, d1\uff09Q3W\uff1bup to eight cycles', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Capecitabine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'nab paclitaxel', 'description': 'nab paclitaxel \uff08120mg/m2\uff1biv\uff1bd1\uff0c8\uff09', 'armGroupLabels': ['AS'], 'otherNames': ['albumin bound paclitaxel']}\n- {'type': 'DRUG', 'name': 'Tegafur', 'description': 'S-1 \uff08\\\\<1.25 m2, 40 mg; 1.25 to \u22641.5 m2, 50 mg; and \u2265 1.5 m2, 60 mg\uff1bpo\uff1bd1-14 bid\uff09', 'armGroupLabels': ['AS'], 'otherNames': ['S-1']}\n- {'type': 'DRUG', 'name': 'Oxaliplatin', 'description': 'Oxaliplatin\uff08130mg/m2 , iv, d1\uff09', 'armGroupLabels': ['XELOX']}\n- {'type': 'DRUG', 'name': 'Capecitabine', 'description': 'Capetabine\uff081000 mg/m2 po, d1-14 bid \uff09', 'armGroupLabels': ['XELOX']}\n\nPrimary Outcomes:\n- {'measure': '3 years Diseases-free Survival rate(3 years-DFS)', 'description': 'DFS is defined as time from the date of inclusion up to the date of disease progression or death', 'timeFrame': 'up to 3 years'}\n\nPlease estimate the sample size based on the assumption: \nType I error (bilateral) \u03b1=0.05, test efficacy \u03b2=0.8, hazard ratio (HR) of 0.66, and estimated drop-out rate of 10%.", "answer": 616, "answer_type": "ESTIMATED", "explanation": "Sample size\n In this trial, the patients will be hierarchically grouped by a network multicenter central stochastic system. The subjects will be randomized by the system after screening. This study uses DFS as the main evaluation index. According to the CLASSIC study, the 3-year DFS rates of patients with IIIA and IIIB gastric adenocarcinoma who received XELOX regimen are 66 and 61%, respectively [7]. According to the ACTS-GC trial, the 3-year recurrence-free survival (RFS) rate of patients with stage III gastric cancer who received S-1 adjuvant chemotherapy (sixth edition of International Union Against Cancer (UICC) TNM classification) is 69.1% in stage IIIA and 44.8% in stage IIIB [11]. The 3\u00e2\u0080\u0089year-DFS rate of patients with stage III gastric adenocarcinoma who received nab-paclitaxel combined with S-1 treatment is estimated to be 71%. Considering type I error (bilateral) \u00ce\u00b1=0.05 and the test efficacy \u00ce\u00b2=0.8, hazard ratio (HR) of 0.66, and estimated drop-out rate of 10%, about 616 patients will be randomly enrolled in the clinical study, with a total study period of about 60\u00e2\u0080\u0089months.", "id": 612, "split": "train"} +{"trial_id": "NCT04136041", "pmid": "31977910", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study Protocol for a Pilot Randomized Controlled Trial on a Smartphone Application-based Intervention for Subthreshold Depression\n\nIncluded conditions:\n- Subthreshold Depression\n\nStudy Armgroups:\n- {'label': 'Smartphone Application', 'type': 'EXPERIMENTAL', 'description': 'Participants watch a video using the Smartphone Application displaying positive word stimuli.', 'interventionNames': ['Device: Smartphone Application']}\n- {'label': 'No Intervention', 'type': 'NO_INTERVENTION', 'description': 'No Intervention.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Smartphone Application', 'description': 'The experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks.', 'armGroupLabels': ['Smartphone Application']}\n\nPrimary Outcomes:\n- {'measure': 'Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.', 'description': 'The CES-D is a 20-item self-report questionnaire used to measure depressive symptoms. The CES-D is a four-point Likert scale, with each item scored from 0 to 3. The total score ranges from 0 to 60 points. The higher the score, the stronger the depressive symptoms.', 'timeFrame': 'Change from Baseline CES-D at 5 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA pilot RCT does not require sample size calculations using significance level, power, difference between groups, and SD. However, 15 to 20 participants per group are required to ensure scientific validity.", "answer": 32, "answer_type": "ACTUAL", "explanation": "3.7\n Sample size\n Four factors are required to calculate the sample size: significance level, power, difference between groups, and standard deviation (SD).[35] However, considering that no previous 2-arm trial has used the SPSRS application for individuals with StD, values for the difference between groups and SD remain unknown. Although a pilot RCT does not require sample size calculations using the aforementioned 4 factors,[26] 15 to 20 participants per group are required to ensure scientific validity of the pilot study results.[36] Therefore, the present study will include a total of 32 participants with 16 participants per group. In addition, the results of this pilot study will provide information on the difference between groups and SD necessary for sample size calculation during the future full-scale study.", "id": 613, "split": "train"} +{"trial_id": "NCT04136418", "pmid": "36914185", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Designed Clinical Investigation of the Use of a Personalised Early Warning Decision Support System With Novel Saliva Bio-profiling to Predict and Prevent Acute Exacerbations of Chronic Obstructive Pulmonary Disease\n\nIncluded conditions:\n- Chronic Obstructive Pulmonary Disease\n\nStudy Armgroups:\n- {'label': 'Usual care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients currently self-manage their condition using antibiotics and steroids when their disease symptoms match the criteria in information provided by a clinician', 'interventionNames': ['Other: Usual care']}\n- {'label': 'Mobile App device', 'type': 'EXPERIMENTAL', 'description': 'Patients enter their health status onto an App which is relayed to the healthcare team, who can then provide further information or clinical intervention should they so choose', 'interventionNames': ['Device: COPDPredict mobile App']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'COPDPredict mobile App', 'description': \"An App on a mobile device is used by the patient to track the status of their COPD and inform the patient's care team\", 'armGroupLabels': ['Mobile App device']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Patients self-manage their COPD using prescribed medication in accordance with basic guidance information', 'armGroupLabels': ['Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'AECOPD-related hospital admissions', 'description': 'The number of AECOPD-related hospital admissions', 'timeFrame': 'For a period of 12 months post randomisation'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 5% type I error rate (two-sided), 25% loss to follow-up/drop-out rate", "answer": 384, "answer_type": "ESTIMATED", "explanation": "Sample size\n The justification of the sample size is based on previous evidence25 that had shown a mean estimate of 2.5 COPD admissions in the previous year in the control group. To detect a difference of 1 admission in the mean number of admissions between groups using the standard methods of difference between means and assuming SD of 2.6 with 90% power and a type I error rate of 5% (two-sided), 144 participants per group will need to be randomised, 288 in total. Assuming and adjusting for a 25% loss to follow-up/ drop-out rate, 384 participants will need to be recruited.", "id": 614, "split": "train"} +{"trial_id": "NCT04142996", "pmid": "37817124", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Naturalistic Study Comparing Uni- and Bi-lateral Theta Burst Stimulation in Major Depression\n\nIncluded conditions:\n- Major Depressive Episode\n\nStudy Armgroups:\n- {'label': 'Unilateral TBS', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Realistic sham continuous TBS (cTBS-sham) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).', 'interventionNames': ['Device: Theta burst stimulation']}\n- {'label': 'Bilateral TBS', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC and continuous TBS (cTBS) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).', 'interventionNames': ['Device: Theta burst stimulation']}\n- {'label': 'Maintenance Phase: Flexible', 'type': 'ACTIVE_COMPARATOR', 'description': 'The flexible maintenance protocol will be based on symptom emergence. Participants will receive a fixed TBS (2x/week) schedule for the first month. For the following months (2-6), they will come in for an assessment (HRSD-17) to determine how many TBS sessions (0, 1, or 2) they receive on a flexible basis.', 'interventionNames': ['Device: Theta burst stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Theta burst stimulation', 'description': 'Cool B70 coil (left DLPFC) and Cool B65 active/placebo coil (right DLPFC), with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)', 'armGroupLabels': ['Bilateral TBS', 'Maintenance Phase: Flexible', 'Unilateral TBS']}\n\nPrimary Outcomes:\n- {'measure': 'Response - Treatment Phase (Hamilton Rating Scale for Depression-17 score)', 'description': 'Response to treatment will be defined as a \\\\> 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.', 'timeFrame': 'Week 6'}\n- {'measure': 'Remission - Treatment Phase (Hamilton Rating Scale for Depression-17 Score)', 'description': 'Remission will be defined as a Hamilton Rating Scale for Depression-17 score \u2264 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.', 'timeFrame': 'End of treatment phase (week 4 or 6)'}\n- {'measure': 'Response - Maintenance Phase (Hamilton Rating Scale for Depression-17 score)', 'description': 'Response to treatment will be defined as a \\\\> 50% reduction in pre-treatment symptoms severity as measured by the mean Hamilton Rating Scale for Depression-17 score. The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome', 'timeFrame': '6 months'}\n- {'measure': 'Remission - Maintenance Phase (Hamilton Rating Scale for Depression-17 Score)', 'description': 'Remission will be defined as a Hamilton Rating Scale for Depression-17 score \u2264 8 The minimum value is 0 and the maximum value is 53. A higher score indicates a negative outcome.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nPower = 0.80, significance level (\u03b1) = 0.05, anticipated dropout rate = 6-8%.", "answer": 256, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on our power calculations and the findings from exemplary studies, our sample size offers sufficient statistical power for the planned statistical tests. For example, Plewnia et al. (2014), in n\u00e2\u0080\u0089=\u00e2\u0080\u008932 (16/group), found clinically meaningful differences in response to treatment rate (\u00e2\u0089\u00a5\u00e2\u0080\u008950% reduction in baseline MADRS score) when comparing 6\u00c2\u00a0weeks of bilateral sequential vs sham TBS (56% vs 25%, respectively) [42]. In n\u00e2\u0080\u0089=\u00e2\u0080\u008960 (15/group), Li et al. (2014) showed that 2\u00c2\u00a0weeks of bilateral sequential TBS had superior effectiveness in treating depressive symptoms (\u00e2\u0089\u00a5\u00e2\u0080\u008950% reduction in baseline HRSD-17 score) when compared to unilateral (iTBS or cTBS) or sham TBS [106]. For our primary (non-inferiority) statistical analysis (i.e., analysis of covariance, ANCOVA), a total sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u0089158 was calculated [Gpower Software V.3.1 [107]; power 0.80, \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, expected effect size Cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25 (medium; Cohen, 1988)]. For our analysis of predictors of response (i.e., regression analysis), a total sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008930\u00e2\u0080\u009339 will be required for a regression model that includes 3\u00e2\u0080\u00936 independent (and/or controlling) variables predicting 30% (R2) of variance in the outcome (dependent) variable (Gpower Software V.3.1 [107]; power 0.80, \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, expected effect size Cohen\u00e2\u0080\u0099s f2\u00e2\u0080\u0089=\u00e2\u0080\u00890.43) [108]. All other statistical tests are exploratory and, therefore, no sample size calculations were performed. Therefore, in order to achieve the calculated sample size (n\u00e2\u0080\u0089=\u00e2\u0080\u0089158), we aim to recruit a minimum of 171 individuals, considering an anticipated dropout rate of 6\u00e2\u0080\u00938% based on previous research [37]. Our recruitment efforts will be capped at a maximum of 256 participants, aligning with our capacity to provide TBS treatment over a five-year timeframe.", "id": 615, "split": "train"} +{"trial_id": "NCT04147312", "pmid": "33834863", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Study on the Clinical Value of Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (Deficiency of Qi and Blood)\n\nIncluded conditions:\n- Cancer-related Fatigue\n\nStudy Armgroups:\n- {'label': 'Treatment group', 'type': 'EXPERIMENTAL', 'description': \"Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21days each cycle, and use 2 cycles\", 'interventionNames': [\"Drug: Fufang E'Jiao Jiang\"]}\n- {'label': 'control group', 'type': 'PLACEBO_COMPARATOR', 'description': \"Placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles\", 'interventionNames': [\"Drug: placebo containing low-dose fufang E'Jiao Jiang\"]}\n\nInterventions:\n- {'type': 'DRUG', 'name': \"Fufang E'Jiao Jiang\", 'description': \"Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles\", 'armGroupLabels': ['Treatment group'], 'otherNames': ['A listed Chinese Medicine']}\n- {'type': 'DRUG', 'name': \"placebo containing low-dose fufang E'Jiao Jiang\", 'description': \"placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles\", 'armGroupLabels': ['control group'], 'otherNames': ['placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Fatigue degree with the Piper fatigue scale (Piper)', 'description': 'Piper is composed of 24 questions assessing total CRF, as well as subscales of behavioral, affective, sensory, and cognitive/mood fatigue. Each question is cored from 0 to10 points, where a higher score indicates severe symptoms; 1 to 3 point is mild, 4 to 6 point is moderate, and 7 to 10 point is severe. Piper is taken at the baseline, 1 weeks, 3 weeks,4 weeks, and 6 weeks after treatment', 'timeFrame': '6 weeks'}\n\nPlease estimate the sample size based on the assumption: \nUsing a 0.05 significance level, 90% power, and considering a 20% dropout rate.", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample Size\n The sample size calculation was based on a meta-analysis that was conducted. According to the meta-analysis, following the change in RPFS-CV score before and after TCM intervention, the mean and standard deviation of RPFS-CV were 3.2\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.9 and 4.2\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.9 for the experimental group and the placebo group.\n38\n For this study, the sample size was calculated based on the mean change in RPFS-CV score for CRF measured in 3 different cancer types. Using a 0.05 significance level, 90% power, it was determined that 77 cases were needed for each group of 3 different cancer types, as shown in Figure 2, according to the sample size calculation using 2 sample T-Test power analysis with PASS software. We defined the final sample size as 600 for all 3 different cancer type subgroups in consideration of 20% of the participants who may drop out and be lost to follow-up.\n \n Figure 2.\n \n Two-sample T-test power analysis.", "id": 616, "split": "train"} +{"trial_id": "NCT04149223", "pmid": "32552833", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial Evaluating the Effectiveness of a Standardized Order Set\n\nIncluded conditions:\n- Cirrhosis, Liver\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Current practice at baseline, routine cirrhosis care.'}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Use of a standardized cirrhosis order set.', 'interventionNames': ['Other: Evidence-based standardized Cirrhosis order set']}\n- {'label': 'Intervention + EMR', 'type': 'ACTIVE_COMPARATOR', 'description': 'Use of a standardized cirrhosis order set embedded within an electronic medical record.', 'interventionNames': ['Other: Evidence-based standardized Cirrhosis order set']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Evidence-based standardized Cirrhosis order set', 'description': 'Standardized order sets for guidance in ascites, varices, hepatic encephalopathy, infections, and medication reconciliation (optimizing HE medication, medication prophylaxis, withdrawal of non-indicated proton pump inhibitors).', 'armGroupLabels': ['Intervention', 'Intervention + EMR']}\n\nPrimary Outcomes:\n- {'measure': 'Cumulative hospital length of stay (LOS) per patient year', 'description': 'LOS', 'timeFrame': 'Baseline, 1 year, 2 year'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level that provides >90% power to detect the effect in the three largest sites and the whole cohort, with a conservative estimate that 50% of eligible patients would receive the pathway. The analysis accounts for patient factors, observation clustering, and uses interrupted time series models with random intercepts for sites and an over-dispersed Poisson distribution.", "answer": 3975, "answer_type": "ESTIMATED", "explanation": "Sample size, data collection and analysis\n \n Effectiveness outcomes - clinical outcomes, cost-utility\n \ni.)Sample size\n\n\n Consistent with the type 1 hybrid trial design, the overarching sample size calculation is based on the cumulative 90-day hospital length of stay (LOS) [48]. Based on 2015/2016 AHS administrative data (4176 cirrhosis-attributed admissions for 2652 patients at study sites) [62] and CCAB implementation time per site, we estimate a pre-intervention cohort of 3975 patients and post-intervention cohort of 3975 patients (n\u00e2\u0080\u0089=\u00e2\u0080\u00897950). Our calculations tested our ability to detect a 3-day reduction in average 90-day cumulative LOS from our historically observed average of 13.7\u00e2\u0080\u0089days. Computer simulations re-sampled historic LOS data to assess power to detect proposed effects for plausible scenarios using interrupted time series models with random intercepts for sites and an over-dispersed Poisson distribution. A scenario that assumed that 50% of eligible patients would receive the pathway (our most conservative estimate) and that there would be a rapid and sustained uptake of the pathway in the two years following implementation had >\u00e2\u0080\u008990% power to detect an effect in the three largest sites and the whole cohort [63].\nii.)Data collection and analysis\n The index population will be identified at admission with a validated Canadian algorithm of ICD9 and ICD10 codes (overall accuracy 87%) [58]. We will analyze administrative data (n\u00e2\u0080\u0089=\u00e2\u0080\u00897950) using linear effect modeling that accounts for patient factors and observation clustering within sites [64]. We will use segmented regression analyses of interrupted time series to model 90-day cumulative LOS and hospitalization rate in each period [65], comparing post-intervention changes with pre-intervention secular trends [66]. We will evaluate and account for autocorrelation or other serial dependencies in data. Each of five geographic zones and eight hospital sites will serve as its own control, enabling us to identify effectiveness within each jurisdiction. We will also combine site series into generalized linear mixed effects models [64], with a random intercept for each site, fixed effects for time, and an indicator variable for pre-and post-intervention periods for each site.\n Cost-utility evaluation will estimate expected incremental cost per Quality Adjusted Life Year (QALY) gained by implementing CCAB, within the Net Benefit Regression framework [67]. Analysis will control for differences in relevant patient cohort characteristics. The evaluation will adopt a health system perspective and within-study analysis (only study cohort costs and outcomes), comparing resource use and health outcomes (health-related quality of life, mortality) for CCAB and usual care cohorts. These will be combined to calculate within-study expected QALY for each cohort. Methods for economic evaluation (e.g., discount rate choice, uncertainty characterization, results presentation) will adhere to recent reference case recommendations (Canadian Agency for Drugs & Technologies in Healthcare) [68]. Stochastic analysis will be implemented with non-parametric bootstraps. Results will be presented as Expected Net Health Benefit and Cost Effectiveness Acceptability Curve. We will also report Value of Information to characterize residual decision uncertainty on value to Alberta of CCAB spread and scale at study completion.\n \n \n Effectiveness outcome - quality of care measures\n \ni.)Sample size\n\n\n We will randomly sample at least 50 charts per site. This will provide 95% confidence intervals with widths no greater than +/\u00e2\u0088\u0092\u00e2\u0080\u008910% for percentages of patients meeting quality measures (QMs) within each site.\nii.)Data collection and analysis\n Improvements in quality of care will be evaluated using QMs for each of the three CCAB order set domains [69] (see Table\u00c2\u00a03). The majority of QMs will be obtained from administrative and chart review data audits from randomly selected charts and will take place quarterly during the study. The data from these audits will be used to promote change at each site. The central data collection team will record survey results in a secure AHS database for analysis. We will use inverse sampling weights to estimate the percent of patients attaining the QMs for the province. Administrative data will be analyzed for clinical outcomes, with additional analyses to compare change in QMs based on patient-reported outcomes, using linear mixed effects models that account for patient factors and observation clustering within sites [64].\nTable 3Sample of Quality Measures (QMs)Cirrhosis Care Alberta Order Set DomainQuality Measure DefinitionManagement of Cirrhosis complications\u00e2\u0080\u0083Ascites*Patients undergoing large volume paracentesis (>\u00e2\u0080\u00895\u00e2\u0080\u0089l removed) should receive intravenous albumin (6\u00e2\u0080\u00938\u00e2\u0080\u0089g per liter removed)\u00e2\u0080\u0083Hepatic hydrothorax*Patients with ascites and/or hepatic hydrothorax should be managed with both sodium restriction and diuretics (unless there is a contraindication for diuretics)\u00e2\u0080\u0083Spontaneous bacterial peritonitis*Hospitalized patients with ascites, with an ascitic fluid polymorphonuclear count of \u00e2\u0089\u00a5250 cells/mm3, should receive empiric antibiotics and albumin within 12\u00e2\u0080\u0089h of the test result. The first dose of albumin should be 1.5\u00e2\u0080\u0089g per kg body weight followed by a second infusion of 1.0\u00e2\u0080\u0089g/kg on day 3\u00e2\u0080\u0083Spontaneous bacterial pleuritis*Hospitalized patients with a pleural fluid polymorphonuclear count of \u00e2\u0089\u00a5500 cells/mm3 (or\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u0089250 cells/mm3 with positive culture), should receive empiric antibiotics within 12\u00e2\u0080\u0089h of the test result\u00e2\u0080\u0083Renal dysfunctionPatients with acute kidney injury should be given an intravenous albumin challenge of up to 100\u00e2\u0080\u0089g\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00892\u00e2\u0080\u0089days.\u00e2\u0080\u0083Hepatorenal syndromePatients with cirrhosis and hepatorenal syndrome who have a MAP of <\u00e2\u0080\u008965\u00e2\u0080\u0089mmHg should receive a combination of vasoconstrictors and albumin therapy\u00e2\u0080\u0083Variceal bleed*Patients with cirrhosis who survive an episode of acute variceal hemorrhage should receive a combination of EVL (endoscopic variceal ligation) and \u00ce\u00b2 -blockers\u00e2\u0080\u0083Hepatic encephalopathy*Patients who are discharged after an acute episode of hepatic encephalopathy should receive secondary prophylaxis with lactulose and/or rifaximin\u00e2\u0080\u0083Alcoholic hepatitisPatients with ETOH hepatitis and a MELD score of >\u00e2\u0080\u008920 should be considered for prednisone therapy provided there are no contraindicationsManagement of Broader health needs\u00e2\u0080\u0083Advance care planning and goals of carePatients admitted with cirrhosis should have goals of care documented\u00e2\u0080\u0083Alcohol use disorder*Patients with cirrhosis should receive counseling or be referred to a substance abuse treatment program within 2\u00e2\u0080\u0089months of positive screening\u00e2\u0080\u0083Nutrition and physical activity optimizationPatients admitted with cirrhosis should be prescribed a high protein/high calorie (\u00c2\u00b1 as needed, a low sodium) dietPreparation for transition into the community\u00e2\u0080\u0083Standardized cirrhosis education for patients/caregiversPatients with cirrhosis should receive cirrhosis education prior to discharge\u00e2\u0080\u0083Post-discharge laboratory, diagnostic imaging and endoscopy appointmentsPatients with cirrhosis should receive information about when to have lab work done post discharge\u00e2\u0080\u0083Post-discharge follow-up with primary and/or specialty care*Recently discharged patients with cirrhosis should have a clinic visit with a health care provider within 4\u00e2\u0080\u0089weeks of dischargeTable includes a sample of the Quality Measures (QM) that will be evaluated from each domain of the Cirrhosis Care Alberta (CCAB) order set. Additional QMs will also be evaluated. QMs were selected based on consensus by either: *Practice Metrics Committee of the American Association for the Study of Liver Diseases [70], or consensus between the CCAB study team members\n \n \n Effectiveness outcome - patient and caregiver experience with the intervention\n \ni.)Sample size\n\n\n Purposeful maximum variation sampling will be used to ensure recruitment of a diverse group of patients and caregivers (rural, urban, socioeconomic status) to explore their experiences with the intervention. We estimate needing 40\u00e2\u0080\u009350 participants to achieve saturation, typical for this methodological approach and appropriate given the variation in cirrhosis disease experiences [70]. This data will be supplemented by patient phone surveys done in the pre and post implementation periods where patients with cirrhosis admitted to study sites will be contacted 7\u00e2\u0080\u009314\u00e2\u0080\u0089days post-discharge and administered a health-related quality of life measure (EQ-5D) [71] and care transitions survey (CTM-15) [72] to assess their experience with care. For patient phone surveys, we will take a convenience sample of patients pre and post implementation of the intervention based on the capacity of units to identify patients.\nii.)Data collection and analysis\n The data collection will begin after 1\u00e2\u0080\u00932\u00e2\u0080\u0089months post-implementation at each study site (to allow for intervention uptake). Patients and caregivers will be invited to participate in individual semi-structured qualitative interviews focusing on key areas such as self-management, self-efficacy for cirrhosis, and relationships with healthcare providers using qualitative description methods [70, 73, 74]. For comparable historical context, only patients with at least one hospital admission prior to implementation of the order set will be invited to participate. For participant convenience, interviews will be in-person or virtual, with these interviews being recorded and transcribed verbatim. Participant data will be coded into meaningful segments, then organized into areas of similar patterns or themes [75]. We will examine areas of commonality and difference in thematic analysis based on factors such as demographics, socioeconomic status and cirrhosis/hospitalization experiences [76, 77]. Data collection and analysis will be concurrent and iterative to enable refinement of the recruitment process and semi-structured interview guide [77].\n \n \n Implementation outcomes\n \ni.)Sample size\n\n\n Over the course of the project we anticipate surveying approximately 280 service providers (physicians, nurses and other health professionals), estimates derived from the number of providers involved with the management of cirrhosis at the sites. The qualitative evaluation of implementation will use a similar sampling strategy with the evaluation of patients\u00e2\u0080\u0099 experience described previously.\nii.)Data collection and analyses\n Implementation data will be collected from a variety of sources including AHS administrative database, chart reviews, provider surveys using validated questionnaires and interviews with physicians and nurses. The CCAB project repository and participant observations from throughout the project will be leveraged to obtain data on implementation context and processes. Implementation data will also be collected during monthly virtual learning session meetings and any on-site visits that occur during the study phases. The quantitative data will be analyzed descriptively to monitor reach, adoption and implementation fidelity following the PDSA cycles. Qualitative data will be analyzed using a framework analytic approach to evaluate the contextual factors impacting adoption, reach, implementation fidelity, implementation feasibility and maintenance of the CCAB order set rollout [78].", "id": 617, "split": "train"} +{"trial_id": "NCT04153214", "pmid": "34022938", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Cycling Workstation on Cardiometabolic Health for Workers With an Office-sitting Desk\n\nIncluded conditions:\n- Sedentary Behavior\n\nStudy Armgroups:\n- {'label': 'Cycling workstation', 'type': 'EXPERIMENTAL', 'description': 'Participants will have a portable pedal machine under their desk and will use it 60minutes per day (30minutes in the morning and 30minutes in the afternoon) during 6 months', 'interventionNames': ['Behavioral: cycling']}\n- {'label': 'control', 'type': 'PLACEBO_COMPARATOR', 'description': 'Daily activities unchanged during 3 months. Then they will have a portable pedal machine under their desk and will use it 60minutes per day (30minutes in the morning and 30minutes in the afternoon) during 3 months.', 'interventionNames': ['Behavioral: cycling']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'cycling', 'description': 'Participants will have a portable pedal machine under their desk and will use it 60minutes per day', 'armGroupLabels': ['Cycling workstation', 'control']}\n\nPrimary Outcomes:\n- {'measure': 'effects of the use of a cycling Workstation for 60 minutes per day (30 minutes twice a day) for 3 months among professionals with an office-sitting desk on overall quantity of physical activity time (work and non-work) and sedentary time', 'description': 'Quantify by the use of an accelerometer device wears at the hip', 'timeFrame': 'month 3'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided type I error at 5%, statistical power greater than 80%, and consideration of a 50% dropout rate.", "answer": 75, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n Sample size estimation is based on CONSORT 2010 statement for the comparison between randomized groups. In these statements, Eldridge et al. suggested \u00e2\u0080\u009cthat the size of a trial should be related to the size of the future definitive RCT and for such a trial designed with 90% power and two sided 5% significance\u00e2\u0080\u009d [109]. They \u00e2\u0080\u009crecommend trial sample sizes for each treatment arm of 75, 25, 15, and 10 for standardized effect sizes that are extra small (0.1), small (0.2), medium (0.5), or large (0.8), respectively\u00e2\u0080\u009d. Considering a two-sided type I error at 5% and a statistical power greater than 80%, an effect size of 1 can be assumed for the PA and SB levels score with 18 patients per group. To take into account the lost to follow-up, a maximum of 80 patients (20 by arm, 50% females) will be included in the study.", "id": 618, "split": "train"} +{"trial_id": "NCT04159467", "pmid": "37277833", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet Prior to Bariatric Surgery: an Assessor Blinded Randomized Controlled Trial\n\nIncluded conditions:\n- Urinary Incontinence\n- Obesity\n- Strength; Pelvic Floor\n\nStudy Armgroups:\n- {'label': 'Group 1- diet therapy (control)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Control group undergoing a low calorie diet will not receive supervised pelvic floor muscle training. This group will be assessed at baseline and after 12 weeks. For ethics reason at the end of the study women of the control group will be invited to receive the pelvic floor muscle training program. However, this will not be part of the study.', 'interventionNames': ['Other: Pelvic Floor Muscle Training']}\n- {'label': 'Grupo 2 - low calorie diet + PFMT (experimental)', 'type': 'EXPERIMENTAL', 'description': 'The experimental group will receive supervised pelvic floor muscle training in addition to a hypocaloric diet. Women will be instructed to perform daily pelvic floor muscle training at home. 4 sets of 10 maximal voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary contractions of the pelvic floor muscles. The 4 sets will be performed in 2 different positions (sitting and standing). Once a month, they will receive a supervised in-person session using the same protocol described above, in the other weeks of the month will receive a session supervised by telephysiotherapy once a week. In addition to supervised sessions, women will be encouraged to perform the protocol three more days a week. In addition, they will be instructed to perform \"the knack\" maneuver.', 'interventionNames': ['Other: Pelvic Floor Muscle Training']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Pelvic Floor Muscle Training', 'description': '4 sets of 10 maximal perceived voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary pelvic floor muscle contractions. The supervised 4 sets will be performed in 2 different positions (sitting and standing).', 'armGroupLabels': ['Group 1- diet therapy (control)', 'Grupo 2 - low calorie diet + PFMT (experimental)']}\n\nPrimary Outcomes:\n- {'measure': 'Self report of urinary incontinence by women', 'description': 'Self report of urinary incontinence measured using question 3 of the ICIQ-SF. Women will be considered incontinent if they choose option 1,2,3,4,5 of question 3. Women will be considered continent if they choose option 0 of question 3.', 'timeFrame': 'Women will be evaluated at baseline'}\n- {'measure': 'Severity and impact of Urinary incontinence in women\u00b4s quality of life', 'description': 'the severity and impact of Urinary incontinence in women\u00b4s quality of life will be measured using the ICIQ-SF score', 'timeFrame': 'Women will be evaluated at baseline'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level of 5%, power of 20%", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample calculation was estimated considering a significance level of 5%, power of 20%, and difference of 4 points on the final score of the primary outcome, ICIQ-SF, between groups at the end of treatment [10]. The value of 4 points is equivalent to the minimum value for change in the questionnaire score. Thus, the sample will be composed of 22 participants.", "id": 619, "split": "train"} +{"trial_id": "NCT04163172", "pmid": "32513252", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Elbow Hemiarthroplasty Versus Open Reduction and Internal Fixation for AO/OTA Type C2 and C3 Fractures of Distal Humerus in Patients Aged 50 Years or Above; a Randomized Controlled Trial\n\nIncluded conditions:\n- Distal Humerus Fracture\n- Comminuted Fracture\n- Intra-Articular Fractures\n\nStudy Armgroups:\n- {'label': 'Elbow hemiarthroplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'The Latitude anatomical hemiarthroplasty (WRIGHT -Memphis, Tennessee) for distal humeral fractures.', 'interventionNames': ['Procedure: Surgical treatment of distal humeral fracture with elbow hemiarthroplasty']}\n- {'label': 'Open reduction and internal fixation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States) for distal humeral fractures.', 'interventionNames': ['Procedure: Surgical treatment of distal humeral fracture with double plating.']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Surgical treatment of distal humeral fracture with elbow hemiarthroplasty', 'description': 'Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)', 'armGroupLabels': ['Elbow hemiarthroplasty']}\n- {'type': 'PROCEDURE', 'name': 'Surgical treatment of distal humeral fracture with double plating.', 'description': 'Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)', 'armGroupLabels': ['Open reduction and internal fixation']}\n\nPrimary Outcomes:\n- {'measure': 'Oxford Elbow Score (OES)', 'description': 'The OES is a 12-item patient-administrated questionnaire that measures the quality of life in patients with elbow disorder. There are three unidimensional domains: Elbow function, pain, and social-psychological status. Each question is answered on a 5-point scale with each question contributing equally to the total score.Thus, the total score ranges from 12-60, with 60 being the worst. For ease of presentation the score is converted to a scale from 0-48 with 48 being the best. The outcome can be interpreted based on a 48-point scale: 0 - 19 - poor; 20-29 - fair; 30-39 - good; and 40-48 - excellent. The Danish version which will be used in this study, has been translated and cultural adapted according to the guidelines by Guillemin, Bombardier and Beaton.', 'timeFrame': '2 years after surgery.'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation (SD) of 16, significance level at 0.005, power of 0.80, and an 18% dropout rate", "answer": 44, "answer_type": "ESTIMATED", "explanation": "Sample size calculation OES\n Oxford elbow score (OES) will be used to measure the primary outcome.\n Sample size calculation was performed with a standard deviation (SD) of 16, a MCID of 15, a significance level at 0.005, and power of 0.80, resulting in 18 participants in each group (44 participants in all with allowance for 18% drop-out).\n The estimation of SD\u00e2\u0080\u0089=\u00e2\u0080\u008916 is extrapolated from a study on 24 patients with distal humeral fractures treated with EHA [1]. There is no MCID defined for the total score of OES, but Dawson et al. have reported the MCID for each of the three domains\u00e2\u0080\u0094pain, function, and social-psychological\u00e2\u0080\u0094for a group of patients with different pathologies including TEA for osteoarthritis and rheumatoid arthritis. MCID for the three domains is 19, 9, and 18, respectively [5]. Accordingly, we chose the MCID to be 15.", "id": 620, "split": "train"} +{"trial_id": "NCT04164160", "pmid": "32384454", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of the Integrated Care Model Salut+Social in Patients With Chronic Conditions: a Mixed Methods Study Protocol\n\nIncluded conditions:\n- Integrated Care\n\nStudy Armgroups:\n- {'label': 'integrated-care-model benefiting group', 'type': 'EXPERIMENTAL', 'description': 'Chronic patients whose clinical and social data will be added in the integrated care model application software.', 'interventionNames': ['Other: integrated-care-model benefiting group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'integrated-care-model benefiting group', 'description': 'Patients will be called for the \ufb01rst interview of the study by the healthcare professional. Their data will be automatically entered in the Salut + Social app, they will be asked to respond to the study questionnaires (ad hoc questionnaire for sociodemographic data, EuroQol-5D, Zarit questionnaire and Morisky-Green test) and will take part in the future actions to be planned for them. Patients will receive an appointment to attend their PCC at 6, 9, and 12 months after their incorporation into the program. In those follow-up, the same questionnaires will be provided together with the IEXPAC questionnaire, which evaluates the experience of the chronic patient with the new care model.', 'armGroupLabels': ['integrated-care-model benefiting group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in life quality', 'description': 'to be evaluated with the EuroQol- 5 Dimension (EQ-5D). It will be measured by a scale Likert: 0 (worst) to 1 (best).', 'timeFrame': 'change from life quality at 6, 9 and 12 months after the beginning of the study.'}\n- {'measure': 'Change in caregiver burden', 'description': 'to be evaluated with the Zarit Caregiver Burden Inventory. It will be measured by a scale Likert: 22 (best) to 110 (worst).', 'timeFrame': 'change from Zarit Caregiver Burden Inventory at 6, 9 and 12 months after the beginning of the study.'}\n- {'measure': 'Change in adherence to treatment', 'description': 'be evaluated with the Morisky and Green test. It will be measured with a dichotomic variable: compliant (if response for the 4 questions is: No/Yes/No/No); noncompliant (if response for the 4 questions is different for: No/Yes/No/No).', 'timeFrame': 'change from Morisky and Green test at 6, 9 and 12 months after the beginning of the study.'}\n- {'measure': 'Change in patient experience about his/her care', 'description': \"Be evaluated with the IEXPAC (Instrument for the Evaluation of the Chronic Patient's Experience). Each of the 11 items will be measured with 5-point Likert scale. The global punctuation is an average of the score of the each of the items: 0 (worst experience) to 10 (best experience).\", 'timeFrame': 'change from IEXPAC at 6, 9 and 12 months after the beginning of the study'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence level, 80% power", "answer": 141, "answer_type": "ESTIMATED", "explanation": "2.2.1\n Study design and sample size\n We will carry out a single group clinical trial to evaluate the effect of the implementation of a new integrated care model. The principal dependent variable is quality of life. In order to detect a difference of at least 3 units in the EuroQol-5D questionnaire, with 95% confidence and a power of 80%, the sample size should be at least of 141 subjects. Convenience sampling will be used.", "id": 621, "split": "train"} +{"trial_id": "NCT04167059", "pmid": "33376177", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementing Telehealth Support to Increase Physical Activity in Girls and Women With Rett Syndrome\n\nIncluded conditions:\n- Rett Syndrome\n\nStudy Armgroups:\n- {'label': 'Waitlist-Control Group', 'type': 'EXPERIMENTAL', 'description': \"The 'waitlist control' group will receive the 12-week non-intervention period first, followed by 12 week intervention period.\", 'interventionNames': ['Behavioral: Telehealth-delivered participation strategies to increase physical activity']}\n- {'label': 'Immediate Treatment', 'type': 'EXPERIMENTAL', 'description': \"The 'immediate treatment' group will receive the 12-week intervention period first, followed by 12 week non-intervention period.\", 'interventionNames': ['Behavioral: Telehealth-delivered participation strategies to increase physical activity']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Telehealth-delivered participation strategies to increase physical activity', 'description': 'Therapists and primary caregivers will meet online on 6 occasions at fortnightly intervals over a 12 week period. Sessions will enable the development of strategies that will aim to increase the amount the participant stands and walks. Throughout, the therapists and primary caregivers will discuss physical activity needs, determine relevant activities, modify the program as necessary and plan additional goals.', 'armGroupLabels': ['Immediate Treatment', 'Waitlist-Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Average daily uptime (%)', 'description': 'Percentage of time spent active (uptime) over total awake time, measured with an ActivPAL', 'timeFrame': 'Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks'}\n- {'measure': 'Average daily step count', 'description': 'Number of daily steps measured by Stepwatch Activity Monitor', 'timeFrame': 'Average over 4 days, data capture at baseline, after 12 weeks and after 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe response is normally distributed with an SD of 11%. The significance level is 0.05, the power is 0.8, and there is an allowance for dropout.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n In preliminary Danish data,32 the response of individuals to the physical activity programme (per cent of sedentary behaviour) in a repeated measures design was normally distributed with an SD of 11%. If the true reduction, following the intervention, in the mean per cent of sedentary time is 5% and assuming a pairwise correlation of 0.5, we will need to study 50 individuals in a two-sample trial to be able to reject the null hypothesis that this response difference is 0, with probability (power) 0.8. The type I error probability associated with this test of the null hypothesis is 0.05. We will recruit 60 families, allowing for some dropout. A total of 26 individuals will be recruited from Australia, 14 from Denmark and 20 from Israel.", "id": 622, "split": "train"} +{"trial_id": "NCT04169646", "pmid": "32560714", "question": "Here is the design of a clinical trial:\n\nOfficial Title: On-site Multi-component Intervention to Improve Productivity and Reduce the Economic and Personal Burden of Neck Pain in Swiss Office-Workers\n\nIncluded conditions:\n- Neck Pain\n- Headache\n- Musculoskeletal Diseases\n- Adherence, Patient\n- Absenteeism\n- Workplace\n- Health Promotion\n- Ergonomics\n- Efficiency\n- Presenteeism\n- Occupational Health\n- Surveys and Questionnaires\n- Adult\n- Exercise Therapy\n- Work Performance\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'OTHER', 'description': 'Multi-component intervention', 'interventionNames': ['Other: Multi-component intervention']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'Control', 'interventionNames': ['Other: Control']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Multi-component intervention', 'description': \"Participants' workstation ergonomics will be assessed using an observation-based ergonomics assessment checklist for office-workers adapted to Swiss guidelines. Based on the initial assessment, best practice ergonomics will be applied individually using existing infrastructure. Participants will attend health promotion information group workshops for approximately one hour per week for 12 weeks. it. Participants will receive an individual progressive exercise programme aimed at conditioning the muscles of the neck and shoulder girdle. The exercises will be performed in groups (maximum of ten per group) at the workplace in a dedicated room, for approximately one hour (3x20 minutes) per week; once per week supervised by a physiotherapist, a human movement scientist, or a health scientist, and twice per week individually. Workshop session attendance will be recorded as an indication of adherence to health promotion. Adherence to neck exercises will be recorded with the Physitrack\u00ae app.\", 'armGroupLabels': ['Intervention'], 'otherNames': ['Workstation Ergonomics, Health promotion, Neck exercise, Adherence to intervention']}\n- {'type': 'OTHER', 'name': 'Control', 'description': 'No intervention takes place during the control phase.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Change in NP-related productivity loss', 'description': 'Change in NP-related productivity loss will be measured in percentages of the working time, using the Work Productivity and Activity Impairment Questionnaire for Specific Health Problem (WPAI German version) and converted into monetary units using individual earnings. Absenteeism is assessed by asking the participants about the number of hours missed because of NP as well as the number of hours they have actually worked. To assess presenteeism, the participants are asked to indicate on a 10-score scale how much the NP affected productivity while working, with 0 indicating no effect on productivity and 10 indicating total disability. Scoring rules of the developers of the questionnaire will then be used to obtain self-reported absenteeism and presenteeism expressed as impairment percentages. The monetary value for the lost productivity will be obtained for each individual by multiplying the impairment percentages by the individual gross wage.', 'timeFrame': 'change from baseline at 16 months'}\n\nPlease estimate the sample size based on the assumption: \nCluster size of seven subjects, intraclass correlations (Rho [1] = 0.1 or 0.2 and Rho [2] = 0.2 and 0.3), three or four steps, Type I Error (alpha) = 0.05, Type II Error (beta) = 0.20 (Power = 0.80), and an attrition rate of nearly 20%.", "answer": 120, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Based on the baseline results of an Australian study, we assumed a baseline productivity of 90% and an intervention attributable increase in productivity of 5% [23]. Also, in line with the Australian study, the cluster size was set to seven subjects. In order to test the sensitivity of the sample size calculations, we used varying cluster-specific and subject-specific intraclass correlations (Rho [1] = 0.1 or 0.2 and Rho [2] = 0.2 and 0.3 respectively) as well as varying number of steps (three or four steps). The underlying statistical model that was used in the simulations was a standard closed cohort mixed effects model comprising a random effect for the clusters, a random effect for the repeated measurements on the same cohort of individuals, a fixed effect to account for time trends, and a fixed effect representing the treatment effect [77, 78]. The linear mixed effect method from the R-package lme4 was used to estimate the models [79]. Furthermore, the acceptable probability for a Type I Error to occur was set to alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and the acceptable probability for a Type II Error to occur was set to beta\u00e2\u0080\u0089=\u00e2\u0080\u00890.20 (Power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80). From the four assessed scenarios, the solution with 72 participants, 12 clusters and three steps are optimal in the sense that three steps put much less burden on participants than four steps, i.e., there are less measurements per subject.\n An Australian study reported an attrition rate of nearly 20%. In order to prevent the risk to under-power our study, we will increase the number of clusters from 12 to 15 (>\u00e2\u0080\u008920%) and the number of subjects per cluster from 6 to 8 (>\u00e2\u0080\u008920%) [23]. Consequently, we aim to enrol and follow 120 participants in 15 clusters over four measurements (one baseline and three steps from the control to the intervention arm of the study) which yields a total of 420 observations.", "id": 623, "split": "train"} +{"trial_id": "NCT04169841", "pmid": "32778095", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Precision Medicine Phase II Study Evaluating the Efficacy of a Double Immunotherapy by Durvalumab and Tremelimumab Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes Mutation in Response or Stable After Olaparib Treatment\n\nIncluded conditions:\n- Immunotherapy\n\nStudy Armgroups:\n- {'label': 'GUIDE2REPAIR patients', 'type': 'EXPERIMENTAL', 'description': 'olaparib + immunotherapy (durvalumab + tremelimumab) during 4 months followed by durvalumab alone as maintenance in patients with solid cancer and in response or stable after prior molecular target therapy by olaparib based on molecular sequencing.', 'interventionNames': ['Drug: olaparib, durvalumab, tremelimumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'olaparib, durvalumab, tremelimumab', 'description': 'STEP 1:\\n\\nOlaparib 300 mg BID during 8 weeks. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food\\n\\nSTEP 2:\\n\\nOlaparib 300 mg during 4 months as per same requirement as below. Durvalumab 1500 mg plus tremelimumab 75 mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses followed by durvalumab monotherapy 1500 mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination and in response or stable after prior molecular target therapy by olaparib based on molecular sequencing.', 'armGroupLabels': ['GUIDE2REPAIR patients']}\n\nPrimary Outcomes:\n- {'measure': 'Safety Assessments: progression free survival', 'description': 'progression free survival', 'timeFrame': '6 months after the initiation of immunotherapy for all cohorts excepted for ovarian cohort where PFS will be evaluated at 12 months.'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided alpha risk = 10%, power = 90%, expected rate of patients non-evaluable for the primary endpoint is 5%.", "answer": 270, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size was determined using an A\u00e2\u0080\u0099Hern\u00e2\u0080\u0099s single stage design. The primary endpoint is progression PFS. It will be evaluated at 6\u00e2\u0080\u0089months (except for ovarian cancer with an evaluation at 18\u00e2\u0080\u0089months given the results of olaparib in SOLO-2 trial). The hypotheses are the following:\none-sided alpha risk =10%, a power\u00e2\u0080\u0089=\u00e2\u0080\u008990%,the expected rate of patients stable or in response after 6\u00e2\u0080\u0089weeks of olaparib is 80%,the expected rate of patients non-evaluable the primary endpoint is 5%,P0 and P1 are determined using hypotheses detailed above.\n P0 is the highest level of inefficacy for which the new treatment will be rejected (maximal inefficacity). P1 defines the minimum required level of efficacy. The design of the trial focuses on demonstrating that this level is plausible given that the trial results and the efficacy is greater than the first proportion, P0. Taking into account these hypotheses: 270 patients will be included in the study, and at least 213 are required for statistical analyses. At the end the study, analysis of the primary endpoint will be performed on evaluable patients who were in response or stable after 8\u00e2\u0080\u0089weeks of olaparib.", "id": 624, "split": "train"} +{"trial_id": "NCT04174755", "pmid": "35039057", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV\n\nIncluded conditions:\n- Obesity\n- HIV-1-infection\n\nStudy Armgroups:\n- {'label': 'Semaglutide 0.25/0.5/1 mg plus standard of care', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Semaglutide Injectable Product', 'Behavioral: Standard of care']}\n- {'label': 'Standard of care alone', 'type': 'OTHER', 'interventionNames': ['Behavioral: Standard of care']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Semaglutide Injectable Product', 'description': 'Semaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks.', 'armGroupLabels': ['Semaglutide 0.25/0.5/1 mg plus standard of care'], 'otherNames': ['Ozempic']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard of care', 'description': 'Diet and exercise advice for 40 weeks', 'armGroupLabels': ['Semaglutide 0.25/0.5/1 mg plus standard of care', 'Standard of care alone'], 'otherNames': ['Diet and exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in total body weight (in Kg)', 'description': 'Between-group differences in percent change from baseline to week 28 in total body weight', 'timeFrame': '28 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided alpha of 0.05.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n The target sample size for the SWIFT trial (the host trial) is 80 participants. Since this is a SWAT, the sample size will be decided by the SWIFT trial (the host trial), and no formal sample size calculation was performed. However, it is estimated that a difference of 15% (an effect size of 0.76) could be detected in DICCT scores with 80% power and a two-sided alpha of 0.05 with a sample size of 28 in each group. It is hoped that the results of this SWAT will ultimately be combined with the results from other similar SWAT in a meta-analysis.", "id": 625, "split": "train"} +{"trial_id": "NCT04180605", "pmid": "32763967", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Value of FEops HEARTguideTM Patient-Specific Computational Simulation in the Planning of Percutaneous Left Atrial Appendage Closure With the AmplatzerTM AmuletTM Device (PREDICT-LAA)\n\nIncluded conditions:\n- Atrial Fibrillation\n- Stroke Prevention\n\nStudy Armgroups:\n- {'label': 'Standard of care treatment arm', 'type': 'ACTIVE_COMPARATOR', 'description': \"When patients are randomized to the standard treatment arm, patients will be treated according to the participating site's routine practice. As pre-procedural imaging, a cardiac CT-scan has to be performed; this can also be complemented with TEE at the discretion of the operator. The LAA closure procedure should be performed according to routine practice of the participating site - either in general or local anesthesia.\\n\\nFor those cases randomized to the standard treatment arm, the pre-procedural CT-scans will still be collected at completion of the study and FEops HEARTguideTM simulations will be generated, blinded for the procedural images and outcome. These simulations will be compared with the final device size and implant position and will be used for an additional comparative PREDICT-LAA sub-study.\", 'interventionNames': ['Procedure: Left atrial appendage closure']}\n- {'label': 'Computational simulation arm', 'type': 'EXPERIMENTAL', 'description': \"When patients are randomized to the computational simulation arm, the procedure will still be performed according to the participating site's routine practice - however, the procedure will only be performed after careful review of the FEops HEARTguideTM simulation results. The only prerequisite is that all patients randomized to this arm will have to undergo a pre-procedural cardiac CT-scan that will be uploaded into the FEops HEARTguideTM platform. Following this upload, a pre-procedural simulation plan will be provided to the operator, containing a set of optimal and suboptimal closure device sizes and implant positions. Software and technology upgrades of the FEops HEARTguideTM platform will be allowed during the course of the study.\", 'interventionNames': ['Other: Additional support for preoperative planning of LAA closure procedures', 'Procedure: Left atrial appendage closure']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Additional support for preoperative planning of LAA closure procedures', 'description': 'The results of the computational simulations provided by FEops HEARTguideTM will be used in the \"computational simulation arm\" as an additional preoperative planning tool and their potential added value will be assessed by comparison to the standard of care arm.', 'armGroupLabels': ['Computational simulation arm']}\n- {'type': 'PROCEDURE', 'name': 'Left atrial appendage closure', 'description': 'Transcatheter device insertion to exclude the LAA from the cardiac circulation', 'armGroupLabels': ['Computational simulation arm', 'Standard of care treatment arm']}\n\nPrimary Outcomes:\n- {'measure': 'Incomplete LAA closure and definite device-related thrombosis (DRT)', 'description': 'The percentage of patients with incomplete LAA closure (defined as any remaining contrast leakage into the LAA distal of the Amulet lobe) and/or a definite DRT at post-procedural cardiac CT imaging at three months after the procedure. Definite DRT is defined as \"high-grade\" hypo-attenuating thickening at the atrial surface of the closure device - as previously described by Korsholm et al., Circ Cardiovasc Interv, 2019.', 'timeFrame': 'Post-procedural cardiac CT scan at 3 months after LAA closure'}\n\nPlease estimate the sample size based on the assumption: \nPower: 0.8, Significance level (\u00ce\u00b1): 0.05, Missing/dropout rate: 10% to 15%. The primary endpoint will be analyzed using Fisher's exact test or a \u03c72 test. Data/statistical analysis will be performed according to the 'intention-to-treat' principle as a first approach and 'as-treated' as a second approach.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary endpoint is expected to occur in 30% of patients in the standard treatment arm. An equal number of patients will be enrolled in both treatment arms. A 65% reduction of the primary endpoint requires inclusion of 174 patients in order to demonstrate superiority (power 0.8, \u00ce\u00b1 0.05). Taking into account an estimated loss at follow-up of 10% to 15% of patients (due to mortality and inconclusive CCT imaging at 3 months postprocedure), the total sample size needed to demonstrate superiority has been calculated to be 200 patients. The primary endpoint will be analysed using Fisher\u00e2\u0080\u0099s exact test or a \u00cf\u00872 test, as required. Data/statistical analysis will be performed according to the \u00e2\u0080\u0098intention-to-treat\u00e2\u0080\u0099 principle as a first approach and \u00e2\u0080\u0098as-treated\u00e2\u0080\u0099 as a second approach.", "id": 626, "split": "train"} +{"trial_id": "NCT04180865", "pmid": "32534583", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Dutch Parkinson and Cognition Study (DUPARC): A Prospective Study on Cognitive Pathology in de Novo Parkinson'Disease\n\nIncluded conditions:\n- Parkinson Disease\n\nStudy Armgroups:\n- {'label': \"Parkinson's disease patients\", 'description': \"150 de novo treatment naive Parkinson's disease patients.\"}\n- {'label': 'Healthy control subjects', 'description': '150 Healthy sex- and age-matched controls, also matched according to presence and severity of constipation, serving as a control group for microbiome composition analyses.'}\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': '[18F]FEOBV PET', 'description': 'Cortical and subcortical cholinergic innervation as measured by \\\\[18F\\\\] FEOBV PET imaging', 'timeFrame': 'Baseline'}\n\nPlease estimate the sample size based on the assumption: \nFor the vision domain, an effect size of 0.45, an alpha of 0.05, and a power of 0.80 were assumed. The sample size also accounts for a dropout rate, with 180 participants included at baseline to ensure 150 participants after accounting for 30 drop-outs and non-PD cases.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n Since most objectives of the DUPARC cohort study concern a first assessment in treatment-na\u00c3\u00afve de novo PD subjects, a formal power calculation is hampered, as no adequate estimation of the expected effect sizes can be provided. However, the effect sizes previously reported in already treated PD subjects with longer disease duration are mostly expected to be larger than the effect sizes in our cohort. Therefore, a power calculation based on previous reports will provide us with a minimum number of participants to include, to assess the most important endpoints within the domains of cognition, gastrointestinal function and vision.\n The primary objective related to the cognitive domain is to establish the relationship between cognitive impairment and pre-synaptic cholinergic degeneration in de novo PD patients. This will be analyzed using cholinergic PET-imaging with FEOBV in combination with neuropsychological assessments covering all cognitive domains, including complex attention, learning and memory, executive function, perceptual-motor function, language, and social cognition. Because of the novelty of FEOBV, previous research using FEOBV-PET in PD is limited. Significant results were found in a small group comparing PD and control subjects [18]. Cross-sectional comparisons between PD subgroups have included between 15 and 79 PD patients, with significant results [42]. The size of the DUPARC cognition data is therefore expected to be sufficient for group and sub-group analyses, as well as detailed correlational research on the specific cognitive domains. Because of the great heterogeneity at baseline in both cognitive performance and cortical cholinergic innervation in PD, such a large cohort is needed for correlational analyses [43, 44].\n The main objective within the gastrointestinal function domain is the comparison of the gut microbiome composition with HC. Though a power calculation for metagenomic analyses is not possible, we think our sample size will be sufficient to do these analyses, because previous studies already reported significant differences with far smaller sample sizes varying between 10 and 72 included PD subjects. Only two treatment-na\u00c3\u00afve subgroups of 12 and 39 PD subjects have been investigated in previous studies, reporting fewer taxonomic differences in the treatment-na\u00c3\u00afve group, compared to already treated subjects. The DUPARC gut microbiome data therefore surpasses most PD gut microbiome studies in sample size, and is by far the largest treatment-na\u00c3\u00afve dataset, allowing for more robust microbiome composition signatures and correction for confounders.\n Regarding the domain of vision, the most recent meta-analysis on OCT imaging in PD has reported overall mean effect sizes of 0.45 for several retinal cell layers, comparing HC to PD subjects [33]. For a similar effect size, with an alpha of 0.05, and a two-tailed comparison of means, a sample size of 79 subjects for each group would be sufficient to achieve a power of 0.80.\n The sample size of 150 participants therefore clearly surpasses the expected numbers needed to assess the primary objectives within the key domains of DUPARC. Nevertheless, a sample size of 150 participants is still necessary, as the anticipated effect sizes of various biomarkers in treatment-na\u00c3\u00afve de novo PD subjects is expected to be lower, compared to treated PD subjects with longer disease duration. In addition, to find biomarkers indicative of PD subtypes, the PD sample not only has to provide both case and control samples for a subtype comparison, but also the intergroup differences are expected to be lower if PD subgroups are compared. Our sample size of 150 participants will most likely allow for binary and trinary subtype comparisons, given the aforementioned samples sizes required to distinguish PD from HC. Lastly, the sample size also needs to be larger than calculated to account for participants who will be lost to follow-up. For this purpose, 180 participants will be included at baseline to account for 30 drop-outs and non-PD cases, in order to ensure a sample size of 150 participants.", "id": 627, "split": "train"} +{"trial_id": "NCT04181996", "pmid": "37949621", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Canadian Study of Arterial Inflammation in Patients With Diabetes and Recent Vascular Events: EvaluatioN of Colchicine Effectiveness (CADENCE)\n\nIncluded conditions:\n- Cardiovascular Diseases\n- Atherosclerosis\n- Inflammation\n- Diabetes\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: Sugar pill manufactured to mimic colchicine 0.6 mg capsule. Placebo to be taken once a day.', 'interventionNames': ['Drug: Placebo oral capsule']}\n- {'label': 'Colchicine', 'type': 'EXPERIMENTAL', 'description': 'Colchicine: 0.6 mg colchicine capsule to be taken once a day.', 'interventionNames': ['Drug: Colchicine Oral Product']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Colchicine Oral Product', 'description': 'Patients will be randomized to receive either placebo or colchicine', 'armGroupLabels': ['Colchicine']}\n- {'type': 'DRUG', 'name': 'Placebo oral capsule', 'description': 'Patents will be randomized to receive either placebo or colchicine', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': '6 month change in FDG uptake TBR (Tissue to Blood Ratio) in the MDS (Maximum Disease Segment)', 'description': 'The primary endpoint will be the change over 6 months in the FDG uptake TBR (Tissue-to-blood ratio) as a marker of arterial plaque inflammation in the maximum disease segment (MDS)(the segment with the highest TBR at baseline) in any vasculature imaged whether it be left or right carotid or aorta.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nFor a 10% reduction compared with placebo with a power of 80%, alpha 0.05, considering 10% withdrawal, and 2% of patients who complete baseline measures but do not start study drug.", "answer": 115, "answer_type": "ESTIMATED", "explanation": "Sample size\n There are no previously published studies evaluating FDG over time in patients with T2DM or pre-diabetes who have suffered recent CV events (our study population) on which to base a definitive sample size calculation. We evaluated the ascending aorta as a non-culprit region in patients from our prior study17 with diabetes and recent events where the aorta was in the field of view (n=6): TBRmax=3.38\u00c2\u00b10.60. In the culprit carotid arteries in patients with diabetes (n=12) TBRmax was 3.58\u00c2\u00b10.00.88.\n Based on the literature and feedback from experts, the minimal clinically important difference (MCID) in TBRmax reduction is 10%\u00e2\u0080\u009315%. This is feasible since FDG differences between treatments in prior studies was also 10%\u00e2\u0080\u009314%.20 21 Taking a conservative approach based on our TBRmax values in our patients with T2DM with recent events, for a 10% reduction compared with placebo with a power of 80%, alpha 0.05, we will need 50 patients per group. Considering 10% withdrawal, and 2% of patients who complete baseline measures but do not start study drug, 115 patients will be recruited (12/115 (10.4%) withdrawal and 3/115 (2.6%) not starting drug), both similar to the LoDoCo trial.36 Prior studies have included 21\u00e2\u0080\u009334 patients/group.20 21 37 38 Thus, our sample size is expected to enable us to address our hypothesis.", "id": 628, "split": "train"} +{"trial_id": "NCT04183712", "pmid": "36854604", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.\n\nIncluded conditions:\n- Gallbladder Carcinoma\n\nStudy Armgroups:\n- {'label': 'Afatinib with GEMOX', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive targeted therapy(Afatinib 40mg orally from day 1 to day 21 combined with GEMOX chemotherapy(gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion)', 'interventionNames': ['Drug: gemcitabine and oxaliplatin.', 'Drug: Afatinib']}\n- {'label': 'GEMOX', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive conventional GEMOX chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion\uff09', 'interventionNames': ['Drug: gemcitabine and oxaliplatin.']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'gemcitabine and oxaliplatin.', 'description': 'GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.', 'armGroupLabels': ['Afatinib with GEMOX', 'GEMOX'], 'otherNames': ['Gemzar(Eli Lilly and Company) and Aiheng(Jiangsu Hengrui Medicine Co., Ltd.)']}\n- {'type': 'DRUG', 'name': 'Afatinib', 'description': 'Target therapy Drug: afatinib', 'armGroupLabels': ['Afatinib with GEMOX'], 'otherNames': ['Gilotrif(Boehringer-Ingelheim)']}\n\nPrimary Outcomes:\n- {'measure': '3-year DFS', 'description': '3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.', 'timeFrame': 'up to 3 years'}\n\nPlease estimate the sample size based on the assumption: \nThe trial is designed with a two-sided significance alpha level of 0.05, an estimated 90% power, and a 10% dropout rate.", "answer": 102, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We expect that the 3-year DFS rate for patients in the experimental group can rise to about 52% given that the study indicates that the 3-year DFS rate for patients with GBC in the control group is approximately 21%.13 14 28 The trial is designed with a two-sided significance alpha level of 0.05 and an estimated 90% power. Calculated by PASS 11, this trial requires 46 patients to be enrolled in each group. Considering a 10% drop-off rate, a total sample size of 102 is required in order to have a 90% probability of drawing a conclusive conclusion about the difference in the 3-year DFS rate between two groups.\n The annual average number of visits for resectable GBC is about 40 in each hospital and the frequency of ErbB pathway mutations is roughly 36.8%. About 59 patients from 4 hospitals are expected to have GBC with ErbB pathway mutations each year. Within 3\u00e2\u0080\u0089years, it is anticipated that at least 102 patients will have signed up for the study, taking into account factors for all potential reasons for non-participation, such as patient refusal or abrupt termination.", "id": 629, "split": "train"} +{"trial_id": "NCT04185259", "pmid": "32978188", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Acupuncture vs Sham Acupuncture or Waitlist Control for Patients With Chronic Planter Fasciitis: Study Protocol for a 2-center Randomized Controlled Trial\n\nIncluded conditions:\n- Plantar Fasciitis\n\nStudy Armgroups:\n- {'label': 'Acupuncture group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Acupuncture']}\n- {'label': 'Sham acupuncture', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Other: Sham acupuncture']}\n- {'label': 'Waitlist control group', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive no treatment for their heel pain for a period of 16 weeks after randomization, and subsequently have the option of 4 weeks (12 sessions) of acupuncture with free of charge at the end of follow-up.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Acupuncture', 'description': 'The investigators will apply two Ashi points (the two most severe tender points in the most sensitive area over the anteromedial aspect of the heels), Chengshan (BL57), Taixi (KI3) and Kunlun (BL60) in this trial. With the patient in a prone position, the local skin will be routinely sterilized followed by a 10mm diameter and 5mm thick sterile adhesive pad pasting onto each selected acupoint. Ashi points will be perpendicularly inserted through the pad to the plantar fascia layer with a depth of approximately 15-20mm depending on the location. BL57, KI3 and BL60 will be punched perpendicularly 10-15mm deep into the skin through the pad. All needles except Ashi points will be manually stimulated by small, equal manipulations of lifting, thrusting, twirling and rotating to achieve De qi. Needles will be retained for 30 minutes per treatment. During each treatment, every needle will be manipulated three times every 10 minutes.', 'armGroupLabels': ['Acupuncture group']}\n- {'type': 'OTHER', 'name': 'Sham acupuncture', 'description': \"Sham Ashi (0.5 cun away from Ashi, one 'cun' is equivalent to the greatest width of the individual patients' thumb, \\\\~1.5 cm), sham BL57 (0.5 cun lateral to true BL57 horizontally), sham KI3 (midway between true KI3 and heel tendon) and sham BL60 (midway between true BL60 and heel tendon) will be used. Treatment protocol will be similar to that of the acupuncture group. The Hwato-brand disposable blunt-tipped needles (size 0.30 \u00d7 25 mm) will be inserted at sham points through adhesive pads to the skin without skin penetration. The needles will then be lifted, thrusted, twirled, and rotated evenly three times every ten minutes. No specific de qi response will be elicited.\", 'armGroupLabels': ['Sham acupuncture']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of participants with treatment response 4 weeks after randomization', 'description': 'A treatment responder is defined as a participant having a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with baseline.', 'timeFrame': 'at week 4'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided significance level of 0.05, 10% loss to follow-up", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on the results of a previous study,12 a sample size of 120 participants will be enrolled to provide 80% power to detect a difference of 35% between the combined acupuncture group and waiting-list group in the proportion of participants with treatment response 4 weeks after randomisation at a two-sided significance level of 0.05. The proportion of participants with treatment response after 4 weeks was assumed to be roughly 12% for the waiting-list group,12 with an anticipated 10% loss to follow-up.", "id": 630, "split": "train"} +{"trial_id": "NCT04189159", "pmid": "35794522", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PROMPT to Improve Speech Motor Abilities in Children With Cerebral Palsy\n\nIncluded conditions:\n- Cerebral Palsy\n- Dysarthria\n\nStudy Armgroups:\n- {'label': 'PROMPT Treated', 'type': 'EXPERIMENTAL', 'description': 'PROMPT treatment, twice a day, for 5 days a week, for 3 consecutive weeks', 'interventionNames': ['Behavioral: PROMPT']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Usual treatment'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'PROMPT', 'description': \"PROMPT treatment is consistent with the principles of motor learning, in that every session includes a blocked pre-practice followed by variable and distributed practice and a gradual, hierarchical increase of complexity. Speech motor goals are integrated in goals for language and functional communication. During a PROMPT session tactile-kinesthetic-proprioceptive inputs are consistently provided, in order to shape speech movements, to give information on sequencing and timing and to introduce constraints for the reduction of degrees of freedom at the articulators' level in favour of motor control.\", 'armGroupLabels': ['PROMPT Treated'], 'otherNames': ['motor speech treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Verbal Motor Production Assessment for Children (VMPAC)', 'description': 'Standardized motor speech assessment, which includes 5 subscales, where higher scores mean better performance: Global motor control (range 20-0); Focal oromotor control (range 268-0); Sequencing (range 46-0); Connected speech and language (range 45-0); Speech Characteristics (range 7-0)', 'timeFrame': 'after the end of treatment period (4 weeks from baseline)'}\n- {'measure': 'Phonetic Inventory', 'description': 'motor speech measure', 'timeFrame': 'after the end of treatment period (4 weeks from baseline)'}\n- {'measure': 'the Intelligibility in Context Scale - Italian version', 'description': 'motor speech measure, range 1-5, where higher scores mean better performances', 'timeFrame': 'after the end of treatment period (4 weeks from baseline)'}\n- {'measure': 'Viking Speech Scale (VSS)', 'description': 'Ordinal scale for intelligibility, range 1-4, with lower scores corresponding to better performances', 'timeFrame': 'after the end of treatment period (4 weeks from baseline)'}\n\nPlease estimate the sample size based on the assumption: \n20% attrition rate, recruitment over 2 years, group randomization, standards of research consent.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the yearly number of children referred to the recruiting center for clinical management and rehabilitation, we expect to reach a convenient final sample of 60 subjects with CP and motor speech disorders (including intervention and wait-list) over a 2 years period, by considering a conservative 20% attrition rate for clinical trials. Recruitment will be completed according to the standards of research consent, followed by group randomization by a team member other than the SLPs in charge of treatment and assessment.", "id": 631, "split": "train"} +{"trial_id": "NCT04190342", "pmid": "34408044", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of a Traditional Chinese Exercise Program- Tai Chi on Symptom Cluster of Fatigue-sleep Disturbance-depression in Female Breast Cancer Patients: a Preliminary Randomized Controlled Trial\n\nIncluded conditions:\n- Breast Neoplasm Female\n- Symptom Cluster\n- Tai ji\n\nStudy Armgroups:\n- {'label': 'control group', 'type': 'OTHER', 'description': 'standard care (intervention provided after the completion of the trial)', 'interventionNames': ['Other: control group']}\n- {'label': 'tai chi group', 'type': 'EXPERIMENTAL', 'description': 'Tai chi intervention + standard care', 'interventionNames': ['Behavioral: tai chi group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'control group', 'description': 'A booklet on the self-management of cancer symptoms. After the pilot RCT is completed, if the participants allocated to the control group are interested in practising tai chi, the intervention will be provided', 'armGroupLabels': ['control group']}\n- {'type': 'BEHAVIORAL', 'name': 'tai chi group', 'description': 'Around 60 minutes practising easy tai chi movements/postures twice per week', 'armGroupLabels': ['tai chi group']}\n\nPrimary Outcomes:\n- {'measure': 'Time taken to recruit planned sample', 'description': 'the time that was taken to recruit the planned sample size of participants', 'timeFrame': 'From baseline (T1) to the completion of the 8-week intervention (T2)'}\n- {'measure': 'Referral rate', 'description': 'The number of referrals made by clinicians in different departments and hospitals divided by all referrals', 'timeFrame': 'From baseline (T1) to the completion of the 8-week intervention (T2)'}\n- {'measure': 'Recruitment rate', 'description': 'The number of subjects who enrolled in the study divided by all subjects eligible for enrolment', 'timeFrame': 'From baseline (T1) to the completion of the 8-week intervention (T2)'}\n- {'measure': 'Retention rate', 'description': 'The number of subjects who completed the study divided by all subjects who enrolled in the study', 'timeFrame': 'From baseline (T1) to the completion of the 8-week intervention (T2)'}\n- {'measure': 'Dropout rate', 'description': 'The number of subjects who dropped out after randomization divided by all subjects who enrolled in the study', 'timeFrame': 'From baseline (T1) to the completion of the 8-week intervention (T2)'}\n- {'measure': 'Reasons for dropping out', 'description': 'Feedback from the dropout subjects to identify their reasons for dropping out', 'timeFrame': 'From baseline (T1) to the completion of the 8-week intervention (T2)'}\n- {'measure': 'Feasibility of the questionnaires', 'description': 'The percentage of missing values for each item of the scales used, including the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-Breast (FACT-B)', 'timeFrame': 'Baseline (T1), immediately after completion of the 8-week intervention (T2), and four weeks after completion of the intervention (T3)'}\n- {'measure': 'Adherence rates', 'description': 'The adherence rates will be measured by the number of tai chi sessions performed divided by the total possible tai chi sessions', 'timeFrame': 'Immediately after completion of the 8-week intervention (T2)'}\n- {'measure': 'Participant feedback', 'description': \"Participants' feedback on and satisfaction with the intervention using a self-designed feedback form\", 'timeFrame': 'Immediately after completion of the 8-week intervention (T2)'}\n- {'measure': 'Adverse events associated with the intervention', 'description': 'In each tai chi session, the subjects in the intervention group will record whether they had any uncomfortable feelings', 'timeFrame': 'Immediately after completion of the 8-week intervention (T2)'}\n- {'measure': 'Number of patients completed the exercise log', 'description': 'The participants in the tai chi group will be required to keep a diary to monitor their tai chi exercise after each tai chi session', 'timeFrame': 'Immediately after completion of the 8-week intervention (T2)'}\n\nPlease estimate the sample size based on the assumption: \nA conservative anticipation of a 20% drop-out rate is considered.", "answer": 72, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Thirty or more participants per group are usually recommended as sufficient for a pilot study to examine intervention feasibility21 and to estimate a between-group effect for a subsequent power analysis that can be used in the main study\u00e2\u0080\u0099s sample size estimation.22 Given that the primary purpose of this study will be exploring the feasibility and acceptability of the study\u00e2\u0080\u0099s methodological procedures, intervention protocol and questionnaires, 30 participants per group were, therefore, determined to be an appropriate sample size. Taking into account a conservative anticipation of a 20% drop-out rate, the final sample size will therefore be 36 in each group, with a total of 72 participants.23", "id": 632, "split": "train"} +{"trial_id": "NCT04196244", "pmid": "33028554", "question": "Here is the design of a clinical trial:\n\nOfficial Title: INtravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal functiOn (INCARO) - a Multicentre, Open-label, Randomised Controlled Trial\n\nIncluded conditions:\n- Acute Abdomen\n- Radiocontrast Nephropathy\n\nStudy Armgroups:\n- {'label': 'Abdominal or body CT with intravenous contrast', 'type': 'EXPERIMENTAL', 'description': 'Abdominal or body CT with intravenous contrast', 'interventionNames': ['Diagnostic Test: Abdominal or body CT with intravenous contrast']}\n- {'label': 'Abdominal or body CT without intravenous contrast (native CT)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Abdominal or body CT without intravenous contrast (native CT)', 'interventionNames': ['Diagnostic Test: Abdominal or body CT without intravenous contrast (native CT)']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Abdominal or body CT with intravenous contrast', 'description': 'Abdominal or body CT with intravenous contrast', 'armGroupLabels': ['Abdominal or body CT with intravenous contrast']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Abdominal or body CT without intravenous contrast (native CT)', 'description': 'Abdominal or body CT without intravenous contrast (native CT)', 'armGroupLabels': ['Abdominal or body CT without intravenous contrast (native CT)']}\n\nPrimary Outcomes:\n- {'measure': 'Mortality or renal replacement therapy', 'description': 'A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients)', 'timeFrame': 'Within 90 days from CT'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed with 90% power and a 5% significance level. Additionally, a 5% crossover rate from the native CT group to the intravenous contrast CT group is assumed.", "answer": 994, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A previous study conducted at the Helsinki University Hospital on patients with diffuse peritonitis showed a 90-day overall mortality of 22%. In patients with eGFR less than 45\u00e2\u0080\u0089mL/min/1.73\u00e2\u0080\u0089m2, the mortality was 39%. Patients with any perforation of the gastrointestinal (GI) tract had an overall mortality of 13%, whereas patients with eGFR less than 45\u00e2\u0080\u0089mL/min/1.73\u00e2\u0080\u0089m2 had a mortality of 25%.16 The documented incidence of AKI in hospitalised patients is 1.9%, and in ICU patients, the incidence exceeds 40%.17 A recent meta-analysis of post-CT AKI showed an incidence of AKI of 7.17% in contrast CT group and 7.42% in native CT group. In contrast and non-contrast groups, RRT was necessary in 0.56% and 0.68% of patients, respectively.8 The incidence of AKI after major abdominal surgery is 13.4% and rates of postoperative RRT vary from 0% to 3% between studies.18 After general surgery procedure, the incidence of AKI is 1%, and the post-surgery RRT rate is 0.68%.19 Risk factors for postoperative AKI include emergency surgery, intraperitoneal surgery, and mild or moderate renal insufficiency,19 all leading to a higher than 1% rate of AKI and RRT.\n All patients included in this trial will not have a GI tract perforation. Some patients might not have abdominal pathology, although it was suspected when ordering the CT scan. Thus, the mortality rate in the trial cohort will likely be lower than 25%. On the other hand, a composite outcome comprising all-cause mortality, RRT and renal transplantation will likely increase the rate of the primary outcome. We estimate that the primary outcome rate is 27% in the native CT group and 9\u00e2\u0080\u0089percentage points less (ie, 18%) in the intravenous contrast CT group. With 90% power and 5% alpha, the study requires 896 patients to show the difference. We estimate that 5% of patients randomised to native CT group will undergo intravenous contrast CT (cross-over from native CT to intravenous contrast CT group). Taking this into account, the final adjusted sample size will be 994.", "id": 633, "split": "train"} +{"trial_id": "NCT04197856", "pmid": "38105176", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Direct Letters to Relatives at Risk of Hereditary Cancer- a Multi-centre Randomised Controlled Trial of Healthcare-assisted Versus Family-mediated Risk Disclosure at Swedish Cancer Genetics Clinics (DIRECT-study)\n\nIncluded conditions:\n- Familial Breast Cancer\n- Familial Colorectal Cancer\n- Hereditary Breast and Ovarian Cancer Syndrome\n- Hereditary Breast Cancer\n- Lynch Syndrome\n\nStudy Armgroups:\n- {'label': 'Control / Family-mediated disclosure (standard care)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Genetic counseling according to current clinical practice', 'interventionNames': ['Other: Standard care encouraging family-mediated disclosure of hereditary cancer risk']}\n- {'label': 'Intervention / Health-care assisted disclosure', 'type': 'EXPERIMENTAL', 'description': 'Genetic counseling according to current clinical practice with the addition of an offer from health care provider to mail letters directly to eligible at-risk relatives.', 'interventionNames': ['Other: Standard care encouraging family-mediated disclosure of hereditary cancer risk', 'Other: Offer of health-care assisted disclosure by sending direct letters to at-risk relatives']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Standard care encouraging family-mediated disclosure of hereditary cancer risk', 'description': 'At counseling, eligible at-risk relatives (who may benefit from disclosure of risk information) are listed on a specified protocol in collaboration between health care provider and the participant.', 'armGroupLabels': ['Control / Family-mediated disclosure (standard care)', 'Intervention / Health-care assisted disclosure']}\n- {'type': 'OTHER', 'name': 'Offer of health-care assisted disclosure by sending direct letters to at-risk relatives', 'description': 'The participant is offered that the health care provider at the cancer genetic unit mail a direct letter with personalized family risk information to all at-risk relatives that participant approve contact with.', 'armGroupLabels': ['Intervention / Health-care assisted disclosure']}\n\nPrimary Outcomes:\n- {'measure': \"Uptake of genetic counselling among the patient's at-risk relatives\", 'description': 'Number of potential at-risk relatives who have contacted a Swedish cancer genetic unit out of the total number of potential at-risk relatives for each patient.', 'timeFrame': 'One year (12 months) following the first counselling session when implications of the cancer genetic investigation for the patient\u00b4s at-risk relatives is discussed, hence 12 months after t=0.'}\n\nPlease estimate the sample size based on the assumption: \nThe study aimed for a power of 0.8 and a two-sided 5% significance level. The power analysis was performed using R version 4.2.1 with the pwr package. The effect size was defined using Cohen's h formula.", "answer": 490, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n In 2019, there was no available published data on the uptake of genetic counselling after family-mediated risk disclosure in Sweden. Due to this lack of certainty, we decided to make the sample size calculations based on the assumption that each proband has 4 ARRs in average and the uptake in the control group is 50%. We wanted to be able to detect if at least one more ARR in every second family contacted a cancer genetics clinic in one of the study arms, i.e.., 5 out of 8 ARRs. Based on this, we determined that the study needed the power to detect a difference of 12.5 percentage units (62.5% in intervention, 50% in control group). To detect this difference with a power of 0.8 and a two-sided 5% significance level required 490 listed ARRs (half in each study group). The power analysis was performed in R version 4.2.1 using the pwr package. Effect was defined as Cohens h\u00e2\u0080\u0089=\u00e2\u0080\u00892*asin(sqrt(p1))-2*asin(sqrt(p2)) where p1\u00e2\u0080\u0089=\u00e2\u0080\u00890.625 and p2\u00e2\u0080\u0089=\u00e2\u0080\u00890.50.\n To allow for subgroup analyses, the recruitment target was set to 600 ARRs. During the study period, clinical guidelines in Sweden changed, putting less focus on familial cancer and more on predictive testing. To adapt to this change, the initial recruitment target of 600 ARRs in total was adopted to 490 ARRs in the most prioritized subgroup, i.e., families with a pathogenic variant identified in a high-risk gene (hereditary breast and ovarian cancer and Lynch syndrome: BRCA1, BRCA2, PALB2, MSH2, MSH6, MLH1, or PMS2).", "id": 634, "split": "train"} +{"trial_id": "NCT04201119", "pmid": "34244250", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Oxiris\u00ae Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).\n\nIncluded conditions:\n- Surgery\n- Cardiac Event\n\nStudy Armgroups:\n- {'label': 'With Oxiris', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Oxiris']}\n- {'label': 'Without Oxiris', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Oxiris', 'description': 'Oxiris membrane used on the Prismaflex device (Baxter) dedicated to that type of membrane at blood pump flow of 450 ml min-1', 'armGroupLabels': ['With Oxiris']}\n\nPrimary Outcomes:\n- {'measure': 'Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time.', 'timeFrame': 'Day 1'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided test with a type 1 error of 0.05 and a power of 90%. No intermediate analysis is planned. A p value of 0.05 will be considered as significant.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Statistical method and sample size calculation\n According to a recent study, we predict a baseline mean MFI of 2.8 with an SD of 0.5.5\n Admitting that the SD of MFI at D1 is 0.5 in both groups, we calculated a sample size of 70 patients to show a difference in MFI of 0.4 at D1 after surgery in a two-sided test with a type 1 error of 0.05 and a power of 90%. Approximately 450 cardiac surgery procedures with bypass surgery are performed per year at Amiens University Hospital. If we consider that 30% of patients will be eligible, this represents a potential inclusion of 130 patients per year. Taking into account possible non-inclusions due to vacations and operating room closures, a total inclusion time of 7 months is expected for a total of 70 patients. Thirty-five patients in each group (standard and interventional groups).\n Primary endpoint will be compared by a Student\u00e2\u0080\u0099s test or Wilcoxon-Mann-Whitney test as appropriate. Secondary endpoints will be assessed using an analysis of variance test for repeated measures. MACE and mortality rate will be compared with a \u00cf\u00872 test. ICU and hospital stay will be compared using a Student\u00e2\u0080\u0099s test. Cumulative event curves will be estimated with the Kaplan-Meier procedure (censored at 30 days). Variables or parameters between usual and intervention groups will be compared with a Student\u00e2\u0080\u0099s test, a Wilcoxon-Mann-Whitney test, a \u00cf\u00872 or a Fisher\u00e2\u0080\u0099s exact test as appropriate. A p value of 0.05 will be considered as significant. No intermediate analysis is planned in the trial.", "id": 635, "split": "train"} +{"trial_id": "NCT04201561", "pmid": "34132071", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Efficacy of High Dose Inorganic seLenium for Preventing Chemotherapy Induced pEripheral Neuropathy in platINUM Sensitive Recurrent Ovarian, Fallopian, Primary Peritoneal Cancer: Phase III Randomised Controlled Trial\n\nIncluded conditions:\n- Chemotherapy-induced Peripheral Neuropathy\n- Recurrent Ovarian Carcinoma\n- Ovarian Cancer\n- Fallopian Tube Cancer\n- Primary Peritoneal Carcinoma\n\nStudy Armgroups:\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'The patient will receive an intravenous selenium 2000 \u03bcg/40 ml dose just before chemotherapy begins every cycle (every 3 weeks for 6 cycles). Afterward, the same dose will be continued during the maintenance period if it is medically required or if the patient desires to do so.', 'interventionNames': ['Drug: sodium selenite pentahydrate', 'Drug: Chemotherapy']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'The patient will receive an intravenous normal saline 40 ml dose just before chemotherapy begins every cycle (every 3 weeks for 6 cycles). Afterward, the same dose will be continued during the maintenance period if it is medically required or if the patient desires to do so.', 'interventionNames': ['Drug: Normal saline', 'Drug: Chemotherapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'sodium selenite pentahydrate', 'description': 'High-dose inorganic selenium (2000 \u03bcg/40 ml) will be administered before chemotherapy in patients assigned to the experimental group.', 'armGroupLabels': ['Experimental group'], 'otherNames': ['Selentab inj. A12CE02']}\n- {'type': 'DRUG', 'name': 'Normal saline', 'description': 'Normal saline (40 ml) will be administered before chemotherapy in patients assigned to the control group.', 'armGroupLabels': ['Placebo group'], 'otherNames': ['sodium chloride 0.9%']}\n- {'type': 'DRUG', 'name': 'Chemotherapy', 'description': 'Paclitaxel (175mg/m2), carboplatin (AUC 5.0 or 6.0) IV, and bevacizumab IV (15mg/kg) D1, every three weeks.', 'armGroupLabels': ['Experimental group', 'Placebo group'], 'otherNames': ['Paclitaxel, carboplatin and bevacizumab']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of chemotherapy-induced peripheral neuropathy (3m)', 'description': 'To evaluate the incidence of CIPN by evaluating paresthesia, pain and motor based on WHO-CIPN criteria.', 'timeFrame': 'Examined at 3 months after last paclitaxel chemotherapy'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level of 0.05, 80% completion rate for six cycles, and an additional dropout rate of 10%.", "answer": 68, "answer_type": "ESTIMATED", "explanation": "SAMPLE SIZE JUSTIFICATION\n In previous studies, the incidence rate of CIPN was 25% when combined with antioxidants [19], whereas it was at least 62.5% without antioxidants three months after chemotherapy using paclitaxel or cisplatin [20]. We expect that 25% of patients will develop CIPN when treated with selenium and chemotherapy, while 62.5% of patients in the control group will develop CIPN. Group sample sizes of 24 in each group are needed to achieve 80% power to detect a difference between the group proportions of \u00e2\u0088\u00920.37, and the test statistic used is the two-sided Z-Test with unpooled variance, and the significance level of the test is 0.05. However, to evaluate the effect of selenium on the prevention of CIPN, the proportion of patients who can complete six cycles of chemotherapy using paclitaxel, carboplatin, and bevacizumab should be maintained above the lowest proportion. In the Gynecologic Oncology Group (GOG)-213 study, the percentage of patients who completed the planned 4\u00e2\u0080\u00936 cycles was found to be 85.8% [15]. Therefore, a total of 68 cases, comprising 34 cases per group, is required to evaluate the efficacy of selenium administration, to assume 80% of completion rate for six cycles with consideration of the additional dropout rate of 10%.", "id": 636, "split": "train"} +{"trial_id": "NCT04201717", "pmid": "36415000", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter Randomized Clinical Trial Comparing Surgical Site Infection After Intracorporeal Anastomosis and Extracorporeal Anastomosis for Left Colon Cancer (STARS)\n\nIncluded conditions:\n- Colon Cancer\n\nStudy Armgroups:\n- {'label': 'laparoscopic assisted left colectomy (extracorporeal anastomosis group)', 'type': 'ACTIVE_COMPARATOR', 'description': 'All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. A small incision is made in the middle of the abdomen to trim the mesentery, remove the specimen, and complete the anastomosis. After completing the anastomosis, the incision will be sutured.', 'interventionNames': ['Procedure: laparoscopic assisted left colectomy (extracorporeal anastomosis group)']}\n- {'label': 'total laparoscopic left colectomy (intracorporeal anastomosis group)', 'type': 'EXPERIMENTAL', 'description': 'All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. Mesentery resection is performed under laparoscopy, and anastomosis is completed under laparoscopy. A small incision is made to extract the specimen after the anastomosis is completed.', 'interventionNames': ['Procedure: total laparoscopic left colectomy (intracorporeal anastomosis group)']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'laparoscopic assisted left colectomy (extracorporeal anastomosis group)', 'description': \"For patients in the control group, the surgeon uses wound edge protectors to exteriorize the colon through a small incision in the midline of the abdomen. A ruler and methylene blue solution are employed to mark the area for colon resection. This guarantees a 10-cm margin from the tumor. Guided by these markers, the marginal vessels and mesentery are divided outside the body. The method of anastomosis is at the surgeon's discretion. A side-to-side anastomosis (including antiperistaltic, isoperistaltic, or overlapping anastomosis) is recommended. Side-to-end or end-to-end anastomosis (sewn by hand or by inserting a circular stapler through the anus or proximal colon) is also allowed. After completing the anastomosis, the incision is sutured. An abdominal drainage tube is inserted at the end of the operation.\", 'armGroupLabels': ['laparoscopic assisted left colectomy (extracorporeal anastomosis group)']}\n- {'type': 'PROCEDURE', 'name': 'total laparoscopic left colectomy (intracorporeal anastomosis group)', 'description': 'In the experimental group, the surgeon will use a 10-cm medical suture and methylene blue solution to mark the resection margin. The marginal vessels and mesentery will be divided inside the body. The proximal and distal colons are resected using a 60mm linear laparoscopic stapler. Side-to-side intracorporeal anastomotic techniques like anti-peristaltic, iso-peristaltic, or overlap methods will be applied. Once the anastomosis is completed, the specimen is retrieved. The surgeon can place the specimen in a sterile plastic bag for retrieval. Alternatively, the surgeon can use a disposable incision retraction fixator to protect the wound. An abdominal drainage tube is inserted.', 'armGroupLabels': ['total laparoscopic left colectomy (intracorporeal anastomosis group)']}\n\nPrimary Outcomes:\n- {'measure': 'The Count of Participants With Surgical Site Infection (SSI)', 'description': 'The primary outcome was the incidence of SSI based on the Definitions of CDC guidelines: superficial incisional, deep incisional, and organ/space infections . Infections involving both organ/space and the incisional site (superficial or deep) were categorized as organ/space infections. Surgeons and nurses assessed the presence of infection daily during hospitalization. After hospital discharge, all patients were followed up until 30 days after surgery at outpatient clinics to check the wound.', 'timeFrame': 'one month after surgery'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided level of significance is 0.025, power is 0.80, and dropout rate is 20%.", "answer": 354, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n This study is multicenter, randomized, controlled, non-inferiority trial for patients aged 18\u00e2\u0080\u009380 years old with left-sided colon cancer. According to the previous data of our single center, the incidence of SSI after extracorporeal anastomosis left colon cancer surgery was 23.3%, and the incidence of SSI after intracorporeal anastomosis was 16.7%. Intracorporeal anastomosis is believed to be inferior to extracorporeal anastomosis when there is a difference in SSI rate of more than 5% 30 days after surgery [23]. Therefore, sample size is calculated based on non-inferiority with a difference of 5% with a one-sided level of significance of 0.025, a ratio of 1:1, a power of 0.80 and a 20% drop-out rate. A total of 354 patients is needed, 177 patients in the experiment group and 177 patients in the control group.", "id": 637, "split": "train"} +{"trial_id": "NCT04203147", "pmid": "34749788", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HOME DM-BAT: Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM\n\nIncluded conditions:\n- Type 2 Diabetes\n\nStudy Armgroups:\n- {'label': 'Home DM-BAT Intervention', 'type': 'EXPERIMENTAL', 'description': 'A trained nurse educator will deliver the manualized Home DM-BAT intervention. Subjects will receive 8-weekly sessions of behavioral activation and monthly booster sessions from months 3-12 via telephone.', 'interventionNames': ['Behavioral: Home DM-BAT']}\n- {'label': 'Control Group (GHE+ST)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to the control group will receive in-home 8-weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly booster sessions from months 3-12 via telephone.', 'interventionNames': ['Behavioral: Supportive Therapy (Control)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Supportive Therapy (Control)', 'description': 'Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.', 'armGroupLabels': ['Control Group (GHE+ST)']}\n- {'type': 'BEHAVIORAL', 'name': 'Home DM-BAT', 'description': 'Description: 8-weekly sessions of in-home, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) and monthly booster sessions from months 3-12 via telephone.', 'armGroupLabels': ['Home DM-BAT Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Glycemic control (HbA1c)', 'description': 'About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for HbA1c.', 'timeFrame': 'Change in baseline HbA1c at 12 months post intervention follow-up'}\n- {'measure': 'Systolic and Diastolic Blood Pressure', 'description': 'Blood pressure readings will be obtained using automated BP monitors (OMRON IntelliSenseTM HEM-907XL). The device will be programmed to take 3 readings at 2-minute intervals, and give an average of the 3 BP readings.', 'timeFrame': 'Change in baseline blood pressure at 12 months post intervention follow-up'}\n- {'measure': 'LDL-Cholesterol', 'description': 'About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for LDL-Cholesterol.', 'timeFrame': 'Change in baseline cholesterol at 12 months post intervention follow-up'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level alpha=0.05 (two-tailed), 4 repeated measures for each participant, correlation between repeated measures rho ranging from 0.5 to 0.7, 20% increase in sample size to account for missing information and ITT analysis dilution effect.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n For comparing the difference in outcome means for Home DM-BAT versus GHE/ST in an individually randomized design, measured at baseline and 3, 6, 9, and 12 months, with 80 participants per group, there will be 85% power to detect a standardized effect size ranging from 0.34 to 0.39 for the primary endpoint at 12 months [assuming levels of significance alpha=0.05 (two-tailed); 4 repeated measures for each participant; the correlation between repeated measures, rho, ranging from 0.5 to 0.7. Using the following pooled standard deviations from previous studies: 1.8 percentage point for HbA1c, 19.9 mmHg for SBP, 20.0 mmHg for LDL, and 12 points for SF-12, we will be able to detect raw differences (raw effect sizes) of approximately 0.61 to 0.70 percentage points in HbA1c, 6.77 to 7.77 mmHg in SBP, 6.8 to 7.8 mg/DL in LDL, and 4.08\u00e2\u0080\u00934.68 points for SF-12 between the Home-DMBAT and GHE/ST groups. With 80% power, the standardized effect sizes that can be detected range from 0.32 to 0.36 for the given assumptions. The corresponding raw effect sizes are HbA1c (0.57 to 0.66 percentage points), SBP (6.33 to 7.27 mmHg), LDL (6.36 to 7.30 mg/DL), and SF-12 (3.82 to 4.38 points). To account for missing information in the ITT sample and the dilution effect of ITT analyses, we increase the sample size by 20% to achieve a final ITT sample size of 100 participants randomized 1:1 to each treatment group (total N=200 randomized participants).", "id": 638, "split": "train"} +{"trial_id": "NCT04205799", "pmid": "34563169", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Study Assessing Safety and Efficacy of Cabozantinib for Advanced or Metastatic Cervical Carcinoma After Platinum Treatment Failure\n\nIncluded conditions:\n- Advanced/Metastatic Cervical Cancer\n\nStudy Armgroups:\n- {'label': 'CABOZANTINIB', 'type': 'EXPERIMENTAL', 'description': 'Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.', 'interventionNames': ['Drug: Cabozantinib']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Cabozantinib', 'description': 'Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.', 'armGroupLabels': ['CABOZANTINIB']}\n\nPrimary Outcomes:\n- {'measure': 'efficacy of cabozantinib: proportion of patients with disease control rate', 'description': 'Efficacy assessed by the proportion of patients with disease control rate', 'timeFrame': '3 months after cabozantinib treatment initiation.'}\n- {'measure': 'Safety of cabozantinib: proportion of patients with clinical gastro-intestinal (GI) perforation/fistula, GI-vaginal fistula and genito-urinary (GU) fistula events grade \u2265 2 (NCI CTCAE v 5.0)', 'description': 'Safety assessed by the proportion of patients with clinical gastro-intestinal (GI) perforation/fistula, GI-vaginal fistula and genito-urinary (GU) fistula events grade \u2265 2 (NCI CTCAE v 5.0)', 'timeFrame': 'toxicities occurring up to 1 month after the end of treatment'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 5% for efficacy, 10% for toxicity, power of 80%, and a 10% drop-out rate.", "answer": 57, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n We plan to use a single arm two-stage multicenter phase II trial based on a Bryant-and-Day design, selected in order to simultaneously assess efficacy and safety and to minimize the expected number of patients treated in case of insufficient efficacy and/or safety of cabozantinib monotherapy.\n In accordance with literature estimating a median PFS around 3.4\u00e2\u0080\u0089months for advanced cervical cancer patients under bevacizumab monotherapy and 4\u00e2\u0080\u0089months for pazopanib, the null hypothesis for efficacy is a 3-month disease control rate of 30% and we expect a rate of 50% to conclude to efficacy of cabozantinib [11, 30].\n Toxicity, defined as clinical significant (grade\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00892 NCI CTCAE version 5) fistula and perforation rate, will be considered as acceptable if it concerns at most 10% of patients and intolerable if it exceeds 25%.\n According to these hypotheses, considering an alpha risk of 5% for efficacy and 10% for toxicity and a power of 80%, assuming a 10% drop-out rate, 57 patients are required in this study (25 for the first stage and 32 additional for the second stage).\n Especially, 22 assessable patients will be included in the first stage. If disease control is observed in less than 8 patients at 3\u00e2\u0080\u0089months or if more than 4 patients experiment fistula or perforation, the study will be stopped at the interim analysis to conclude to insufficient efficacy or unacceptable toxicity of Cabozantinib. Eventually, observation of a minimum of 21 patients with disease control with less than 9 patients with toxicity will allow to conclude to efficacy and tolerance.\n To be noted, enrolment were not initially planned to be halted to conduct the interim analysis. However, due to the quickness of recruitment in the study, the protocol was amended to suspend the inclusions to perform the interim analysis, in order to have a sufficient perspective on the tolerance and efficacy of Cabozantinib single-agent treatment.", "id": 639, "split": "train"} +{"trial_id": "NCT04211662", "pmid": "33323445", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of a Tailored Multidimensional Intervention on the Care Burden Among Family Caregivers of Stroke Survivors\n\nIncluded conditions:\n- Stroke\n- Caregiver Burden\n- Caregiver Burnout\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Tailored Multidimensional Intervention', 'interventionNames': ['Behavioral: Tailored Multidimensional Intervention. the tailored intervention will be implemented through 6 months using a multidimensional approach (skill building, psychoeducation and peer support).']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Regarding the control group, the participants will receive a simple educational booklet through one home visit.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Tailored Multidimensional Intervention. the tailored intervention will be implemented through 6 months using a multidimensional approach (skill building, psychoeducation and peer support).', 'description': \"Skill-building can be defined as training the family caregivers the following skills (1) hands-on training in such skills as positioning, transferring and mobility techniques and assistance with activities of daily living; (2) coping strategies and stress management (3) communicating with healthcare professionals. Psycho-education is teaching and provision the family caregivers the knowledge and information regarding stroke (stroke definition, types of stroke, risk factors, prevention of recurrent stroke, medication management, stroke complications and measures for prevention and management of these complications). Besides, family caregivers will be taught and given the knowledge and information regarding managing stroke survivors' emotions and behaviors. Peer support can be defined as engaging the family caregivers of stroke survivors in interactions with their peers for support and exchanging advices and experiences.\", 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Measuring the change of the Care burden among family caregivers of stroke survivors (Zarit Burden Interview)', 'description': 'Care burden can be defined in this context as the personal strain and role strain that the family caregiver experienced due to caring for one of the family. members having stroke. Consequently, the family caregivers will suffer from physical or psychological or emotional or social or financial complains. The Short version (12 items) of Zarit Burden Interview will be used. Items are rated on a 5-point Likert scale from 0 (never) to 4 (almost always). the validated Arabic version will be used.', 'timeFrame': 'baseline, 3 months, 6 months'}\n\nPlease estimate the sample size based on the assumption: \nConfidence level of 0.95, statistical power of 0.90, and an estimated dropout rate of 30%.", "answer": 110, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was estimated using G power software V.3.1.9.4 (Psychonomic Society, Madison, Wisconsin, USA)103 with an effect size of 0.72, which was based on a similar previous study on care burden among the family caregivers using ZBI.104 Assuming power analysis results for the difference between two independent means (two groups) and a confidence level of 0.95, statistical power of 0.90 and fair division, the sample size was required to be 84 caregivers. An additional 26 caregivers need to be recruited to compensate for an estimated dropout rate of 30%.105 106 The final sample size is 110 participants (55 in the IG and 55 in the CG).", "id": 640, "split": "train"} +{"trial_id": "NCT04216277", "pmid": "35279069", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Procalcitonin Guided Antibiotics in Respiratory Infections in General Practice\n\nIncluded conditions:\n- Acute Respiratory Tract Infection\n\nStudy Armgroups:\n- {'label': 'Procalcitonin in addition to usual care', 'type': 'EXPERIMENTAL', 'description': 'Procalcitonin values will be disclosed to the attending physician and assist in antibiotic guidance in addition to usual care', 'interventionNames': ['Diagnostic Test: Procalcitonin']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Usual best standard care. No procalcitonin values disclosed to attending physician .'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Procalcitonin', 'description': 'In addition to usual care diagnostic and handling of acute respiratory tract infections in general practice to attending physician in the intervention arm has access to antibiotic stewardship by a procalcitonin point-of-care test. The following criteria for initiating og withholding antibiotics will be used.\\n\\n* Antibiotics treatment is recommended with Procalcitonin levels above 0.25 ng/ml\\n* Antibiotic treatment is discouraged if Procalcitonin levels are below 0.25 ng/ml', 'armGroupLabels': ['Procalcitonin in addition to usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Duration of illness and symptoms from acute respiratory tract infections.', 'description': \"The patient reported primary outcome will be assessed as number of days to a patient's daily activities (work or recreation) are no longer restricted by symptoms from a respiratory tract infection.The non-inferiority margin between the intervention and control group is set at a one day difference. The recovery measure will be the specific day indicated by the participants using the validated Acute Respiratory Tract Infections Questionaire (ARTIQ).\", 'timeFrame': 'up to 14 days'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 85% and the significance level (\u03b1) at 0.025. The study also assumes a 10% dropout rate.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size\n A comparable study by Briel et al. [18] showed that the number of days when patients experienced restrictions from an ARTI had a standard deviation of 4 days. The PARI project\u00e2\u0080\u0099s non-inferiority design allows for a clinical non-important difference in sickness of max. 1\u00c2\u00a0day in the PCT group compared to the standard care group. We expect an ARTI to last on average 9 days [21, 22]. The power (1-\u00ce\u00b2) is set at 85% and \u00ce\u00b1 at 0.025 (non-inferiority study design). We believe these are relevant estimates since non-inferiority of a PCT-guided antibiotic treatment has previously been demonstrated [18, 19].\n The two arms of the study will be randomized 1:1 with 231 participants in each arm. We estimate that 10% of participants will not complete the project, so a total of 508 participants will be needed.", "id": 641, "split": "train"} +{"trial_id": "NCT04216823", "pmid": "35927745", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients\n\nIncluded conditions:\n- Supraclavicular Brachial Plexus Block\n\nStudy Armgroups:\n- {'label': 'Sevoflurane Group', 'description': 'sevoflurane is used for anesthetic induction', 'interventionNames': ['Device: perfusion index']}\n- {'label': 'Propofol Group', 'description': 'intravenous anesthetic propofol is used for anesthetic induction', 'interventionNames': ['Device: perfusion index']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'perfusion index', 'description': 'perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients', 'armGroupLabels': ['Propofol Group', 'Sevoflurane Group']}\n\nPrimary Outcomes:\n- {'measure': 'perfusion index', 'description': 'Correlation between success of supraclavicular brachial plexus block and perfusion index', 'timeFrame': 'the time span between 1 day preoperative and 24 hours after surgery'}\n\nPlease estimate the sample size based on the assumption: \nType I Error (Alpha) levels considered are 0.20, 0.10, 0.05, and 0.01. Type II Error (Beta) levels considered are 0.20, 0.10, 0.05, and 0.01. The withdrawal rate is assumed to be 10%.", "answer": 104, "answer_type": "ACTUAL", "explanation": "Sample size\n According to literature reports [15], the probability of ulnar nerve insufficiency is less than 20%; the sample size is calculated: As shown in Table 1, the preliminary estimated sample size is 47 cases, and the withdrawal rate is assumed to be 10%. The calculation is 52 cases per group, so 104 children will be included in this experiment.Table 1Sample size estimation resultsType I Error- Alpha0.200.100.050.01Type II Error -Beta0.2016 + 423 + 630 + 846 + 120.1021 + 629 + 837 + 1054 + 140.0526 + 735 + 943 + 1162 + 160.0137 + 1047 + 1257 + 1578 + 20", "id": 642, "split": "train"} +{"trial_id": "NCT04217330", "pmid": "35410931", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HomeBase2: An Implementation Trial to Improve Access to Pulmonary Rehabilitation in People With Chronic Obstructive Pulmonary Disease\n\nIncluded conditions:\n- Chronic Obstructive Pulmonary Disease\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Pulmonary rehabilitation programs assigned to the intervention group will offer eligible participants the choice of participating in an 8-week program of either home-based pulmonary rehabilitation or traditional centre-based pulmonary rehabilitation.', 'interventionNames': ['Behavioral: Choice of home-based or centre-based pulmonary rehabilitation']}\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Pulmonary rehabilitation programs assigned to the control group will offer eligible participants the opportunity to participate in an 8-week centre-based pulmonary rehabilitation program, as per current practice.', 'interventionNames': ['Behavioral: Centre-based pulmonary rehabilitation']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Choice of home-based or centre-based pulmonary rehabilitation', 'description': 'Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Centre-based pulmonary rehabilitation', 'description': 'Participants will be offered a traditional centre-based pulmonary rehabilitation program', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'All cause, non-elective hospitalisation', 'description': 'The number of participants hospitalised at least once will be compared between groups', 'timeFrame': '12 months after completing pulmonary rehabilitation'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed to detect this difference with 80% power and a two-sided 0.05 significance level. The completion rate is anticipated to be 80% in the intervention group. An intracluster correlation coefficient of 0.01 and a 10% loss to follow-up are assumed.", "answer": 490, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome is unplanned hospitalisation (inpatient admissions) in the 12 months following pulmonary rehabilitation. In our published Phase II trial,23 57% of the centre-based group were free from hospitalisation at 12 months, whereas 78% of rehabilitation completers were free from hospitalisation (regardless of group). Completion was 91% for HomeBase, and 49% for centre based.23 The novel aspect of the current study is that intervention participants will be offered a choice of models. Based on our experience recruiting for HomeBase, we expect that 75% of individuals may select a home programme of whom 91% will complete, and 25% will select centre-based of whom 49% will complete. We thus anticipate a completion rate of 80% in the intervention (choice) group.\n At 80% completion, our data indicate that 72% of the intervention group would remain free from admission at 12 months, compared with the observed rate of 57% in centre-based (control) participants.23 We thus expect 15% reduction in hospitalisations in the intervention group (choice of home-based or centre-based rehabilitation) compared with control (centre-based rehabilitation only). To detect a difference in remaining free from hospitalisation between intervention and control groups of 15% (72% vs 57%) with 80% power and a two-sided 0.05 significance level, 312 participants (156 in each group) are required. Adjusting for clustering by programme (intracluster correlation coefficient of 0.01, based on our published two-site trial and 35 participants per cluster), the total required sample is 418. Our previous study had 10% loss to follow-up, so to allow for this we will recruit a total of 490 participants from 14 pulmonary rehabilitation programmes.", "id": 643, "split": "val"} +{"trial_id": "NCT04217421", "pmid": "35197082", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass\n\nIncluded conditions:\n- Congenital Heart Disease in Children\n- Neuroprotection\n\nStudy Armgroups:\n- {'label': 'Allopurinol', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Allopurinol']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Mannitol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Allopurinol', 'description': 'Allopurinol powder for solution for infusion (PFI) 20 mg/kg body weight per administration will be administered early postnatally (within 45 minutes and 12 hours after the first dose), preoperatively (12 hours before surgery), intraoperatively (during surgery) and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Allopurinol PFI will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.', 'armGroupLabels': ['Allopurinol']}\n- {'type': 'DRUG', 'name': 'Mannitol', 'description': 'Mannitol powder for solution (PFI) placebo will be administered early postnatally (within 45 minutes and 12 hours after birth), preoperatively (12 hours before surgery), intraoperatively (during surgery), and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Mannitol PFI-placebo will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Relevant parenchymatous brain injury on postoperative MRI', 'description': 'The presence or absence of relevant (moderate/severe) parenchymatous (ischemic or hemorrhagic) brain injury on postoperative MRI will be assessed, using the T1/T2/DWI and SWI weighted images.', 'timeFrame': 'between birth and 1 month after cardiac surgery'}\n- {'measure': \"Rate of children that are considered 'too unstable for postoperative MRI'\", 'description': 'This decision is based on the circulatory and respiratory status of the child before the planned postoperative MRI, as included in local guidelines (not part of this protocol) of each participating center.', 'timeFrame': 'between birth and 1 month after cardiac surgery'}\n- {'measure': 'Incidence of mortality', 'description': 'Defined as death until one month postoperatively.', 'timeFrame': 'between birth and 1 month after cardiac surgery'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided alpha of 5%, hierarchical testing strategy, and rare occurrence of participant substitution due to unexpected non-requirement of cardiac surgery or consent withdrawal.", "answer": 236, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is calculated based on an assumed reduction in (absolute) incidence of 20% in the more prevalent subgroup of prenatal diagnosis (\u00c2\u00b1 80% of the total population, control event rate assumed 71%) and a reduction of 9% in the postnatal diagnosis group (\u00c2\u00b1 20% of the population, control event rate assumed 55%). With a total sample size of 236 CCHD neonates, of which 188 in the prenatal subgroup and 48 in the postnatal subgroup, the study has approximately 80% power to demonstrate the advantage of allopurinol in the total group with a two-sided alpha of 5%. The power of the hierarchical testing strategy is only slightly affected, given the large proportion of the prenatal group (80%). The effect sizes are a relevant and viable expectation and are based on the results of previous neuroprotective studies on head cooling in neonatal encephalopathy and perioperative allopurinol administration in CCHD neonates [26, 59]. RStudio version 3.6.1 was used for the sample size analysis.\n Participants will be substituted in the following cases: (1) when cardiac surgery with CPB in the first month of life is unexpectedly not required or (2) when there is consent withdrawal before postoperative MRI. It is to be expected that these cases rarely occur.", "id": 644, "split": "val"} +{"trial_id": "NCT04219696", "pmid": "32847916", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Determining the Optimal Dose of Reactive Balance Training After Stroke - a Pilot Study\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': '1 session', 'type': 'ACTIVE_COMPARATOR', 'description': \"Participants will complete one 45-minute session of reactive balance training. Participants will experience 40-60 perturbations during this session. Participants will also complete 5 45-minute 'traditional' balance training sessions.\", 'interventionNames': ['Other: Reactive balance training']}\n- {'label': '3 sessions', 'type': 'EXPERIMENTAL', 'description': \"Participants will complete three 45-minute sessions of reactive balance training. Participants will experience 40-60 perturbations during each session. Participants will also complete 3 45-minute 'traditional' balance training sessions.\", 'interventionNames': ['Other: Reactive balance training']}\n- {'label': '6 sessions', 'type': 'EXPERIMENTAL', 'description': 'Participants will complete six 45-minute sessions of reactive balance training. Participants will experience 40-60 perturbations during each session.', 'interventionNames': ['Other: Reactive balance training']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Reactive balance training', 'description': \"A research physiotherapist will oversee reactive balance training (RBT) to ensure consistent RBT delivery across participants. Training strategies will be individualized to each participant, based on their balance impairments and rehabilitation goals. The RBT program includes multi-directional 'internal' and 'external' balance perturbations. Internal perturbations are achieved by asking the participant to complete tasks that challenge balance control, such that they lose balance when attempting to perform the task (e.g., kicking a soccer ball). External perturbation are delivered manually using a push or pull from the physiotherapist. As participants improve their reactive balance control, difficulty will be increased by shifting task requirements along a continuum from stable to mobile, and from predictable to unpredictable, and by increasing perturbation magnitude or imposing sensory or environmental challenges.\", 'armGroupLabels': ['1 session', '3 sessions', '6 sessions']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of falls in daily life', 'description': 'Participants will be asked to report falls (\"an event that results in a person coming to rest unintentionally on the ground or other lower level\") in the 6 months post-training. Participants will be provided with stamped, addressed postcards to mail to the research team every 2 weeks for 6 months post-training. Postcards will contain a calendar, on which participants will record falls. The research assistant will call participants who do not return the postcard to determine if any falls occurred. The research assistant will contact participants reporting a fall to complete a short questionnaire determining the cause and consequences of the fall.', 'timeFrame': '6 months post-discharge'}\n\nPlease estimate the sample size based on the assumption: \nPilot study recommendation", "answer": 36, "answer_type": "ACTUAL", "explanation": "Sample size\n We will aim to recruit 12 participants per group (36 participants total), as recommended for pilot studies.38", "id": 645, "split": "val"} +{"trial_id": "NCT04222504", "pmid": "39806604", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Community-based Venues for Delivery of Healthcare Services in Umlazi, South Africa: Proof of Concept Pilot Conducted in Hair Salons\n\nIncluded conditions:\n- Pre-Exposure Prophylaxis\n- STI\n- Contraceptive Usage\n\nStudy Armgroups:\n- {'label': 'Intervention Salons', 'type': 'EXPERIMENTAL', 'description': 'Intervention: Behavioral: Provision of sexual health preventative services in the salon setting', 'interventionNames': ['Behavioral: Provision of sexual health preventative services in the salon setting']}\n- {'label': 'Control Salon', 'type': 'NO_INTERVENTION', 'description': 'No Intervention'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Provision of sexual health preventative services in the salon setting', 'description': 'Participants at intervention salons will be offered a choice of receiving daily PrEP and/or contraceptives (oral and injectables). Participants that elect to receive at least PrEP or contraceptives will also be offered STI testing.\\n\\nFollow-up visits will be planned for 3, 6, 9, and 12-months. Attendance at follow-up visits for monitoring and medication refill will be encouraged using text message reminders, WhatsApp support groups, and lottery-based incentives for free salon services.', 'armGroupLabels': ['Intervention Salons'], 'otherNames': ['PrEP (combined tenofovir/emtricitabine)', 'STI testing', 'Hormonal birth control (Oral, Injectable)']}\n\nPrimary Outcomes:\n- {'measure': 'Uptake of Preventative Sexual Health Services', 'description': 'We will measure uptake of the intervention as the proportion of eligible women who agree to salon-based contraception (first-time users and new users) and separately to salon-based PrEP.', 'timeFrame': 'Months 4 to 16'}\n\nPlease estimate the sample size based on the assumption: \nNo formal statistical comparisons (p-values) are planned. The 95% confidence limits for uptake and retention are 33%-47% and 39%-61%, respectively.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size\n We will measure uptake of the intervention as the proportion of eligible women who agree to salon-based PrEP and separately to salon-based contraception. We will assess feasibility by collecting process measures, such as additional time spent in the salon receiving the intervention. We will evaluate retention as continued use of PrEP and contraception separately, defined as one additional visit within 6 months with continued treatment (PrEP, contraception or both). After 12 months, we will perform exit interviews as described above. We plan to enrol 250 individuals in the intervention arm, with a goal of 100 of those individuals starting PrEP (40% PrEP uptake), and 250 individuals in the control arm, for a total of 500 participants. These enrolment goals are based on budget constraints and goals of a pilot study to assess feasibility and acceptability. We anticipate that 50 of the 100 participants who accept PrEP will be retained at 1 year. The 95% confidence limit would be 33%\u00e2\u0080\u009347% for uptake (40%) and 39%\u00e2\u0080\u009361% for retention (50%). We did not perform formal sample size calculations, since the primary focus of the study is to assess feasibility and determine if there is a signal for potential efficacy. No formal statistical comparisons (p-values) are planned between the two treatment arms. While it is clusters that are being randomised, analysis will be conducted at the individual level. We will summarise each group separately and not do comparisons between groups. Differences between clusters will be assessed for planning of future studies.", "id": 646, "split": "val"} +{"trial_id": "NCT04223401", "pmid": "32629639", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Personalized Trimodal Prehabilitation for Gastrectomy\n\nIncluded conditions:\n- Gastric Cancer\n\nStudy Armgroups:\n- {'label': 'Prehabilitation group', 'type': 'EXPERIMENTAL', 'description': 'Patients in the experimental group will undergo prehabilitation before the elective surgery for gastric cancer.', 'interventionNames': ['Other: Prehabilitation']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Patients in the control group will not undergo prehabilitation.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Prehabilitation', 'description': 'Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up \\\\& Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve:\\n\\n1. Nutritional intervention\\n2. Psychological intervention\\n3. Exercise intervention', 'armGroupLabels': ['Prehabilitation group']}\n\nPrimary Outcomes:\n- {'measure': 'Postoperative morbidity rate by Clavien-Dindo', 'timeFrame': 'At 90 days postoperatively'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided level of significance of 5%, and a drop-out rate of up to 10%.", "answer": 128, "answer_type": "ESTIMATED", "explanation": "2.10\n Sample size\n The sample size calculation was done using G\u00e2\u0088\u0097Power 3.1.9.4 software using the reduction of 90 days postoperative complication rates as the primary outcome. Based on the assumption that the percentage of patients developing postoperative complications after gastrectomy is approximately 50% for the control group (based on our centers historical experience and results from RCTs)[2,3] and can be reduced to 25% in the prehabilitation group (based on results of recent RCT showing 50% reduction of postoperative complications by prehabilitation),[15] a group sample size of 58 patients is needed to achieve 80% power in detecting this difference in 90-days postoperative morbidity at a two-sided level of significance of 5%. Under the assumption of a drop-out rate of up to 10%, a total of 128 patients (64 per group) needs to be enrolled in the study.", "id": 647, "split": "val"} +{"trial_id": "NCT04227951", "pmid": "33596959", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Multicentre Controlled Trial of Gastrectomy With or Without Prophylactic Abdominal Drainage. The Abdominal Drain in Gastrectomy Trial (ADiGe Trial)\n\nIncluded conditions:\n- Gastric Cancer\n\nStudy Armgroups:\n- {'label': 'Drain', 'type': 'SHAM_COMPARATOR', 'description': 'Participants enrolled in this arm have an abdominal drain positioned at the end of the operation (any type, inserted from right flank with the tip close to the esophago-jejunal or Gastro-jejunal anastomosis and the duodenal stump). Drain will stay in place until postoperative day (POD) 4th (drain output and quality will be registered). If normal drain debt and patient have no abdominal complications that need reoperation and/or percutaneous drain placement until POD 4, a methylene-blue test is be performed (200 ml water + 5 ml blue orally, check drain after 60 minutes: negative test if no blu was seen in the drain). If negative-blue test drain can be removed according to centre preference (no strict POD defined); if positive-blue test complication will be treated according to centre preference. Only in this arm drain related complications are registered. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.', 'interventionNames': ['Device: Drain placement']}\n- {'label': 'No Drain', 'type': 'EXPERIMENTAL', 'description': 'Participants enrolled in this arm do not have any abdominal drain placed at the end of the operation. Postoperative management (e.g. resume of oral intake, anastomosis integrity tests) is left to centre preference. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.', 'interventionNames': ['Device: Avoid drain placement']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Avoid drain placement', 'description': 'In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.', 'armGroupLabels': ['No Drain']}\n- {'type': 'DEVICE', 'name': 'Drain placement', 'description': 'In Drain arm (sham comparator) an abdominal drain is inserted in the abdomen from the right flank, passing below the liver (close to the duodenal stump) with the apex behind the esophago-jejunal (in total gastrectomy) or gastro-jejunal (in subtotal gastrectomy) anastomosis.', 'armGroupLabels': ['Drain']}\n\nPrimary Outcomes:\n- {'measure': '30 day reoperation AND/OR additional drain placement', 'description': 'Incidence of reoperation AND/OR percutaneous placement of an additional drain within postoperative day 30 (composite outcome)', 'timeFrame': '30 days after the operation'}\n\nPlease estimate the sample size based on the assumption: \n80% power, one-sided significance level of 5%, 10% dropout rate, one-sided Z test (unpooled).", "answer": 404, "answer_type": "ACTUAL", "explanation": "Sample size\n According to a systematic review published in May 2020 [8], the cumulative incidence of reoperation in two RCTs was 7/115\u00e2\u0080\u0089=\u00e2\u0080\u00896.1% (95% CI 2.5\u00e2\u0080\u009312.1%) in the drain group and 3/115\u00e2\u0080\u0089=\u00e2\u0080\u00892.6% (95% CI 0.5\u00e2\u0080\u00937.4%) in the no drain group. Cumulative incidence of additional drain was 1/86\u00e2\u0080\u0089=\u00e2\u0080\u00891.2% (95% CI 0.03\u00e2\u0080\u00936.3%) in the drainage group and 2/84\u00e2\u0080\u0089=\u00e2\u0080\u00892.4% (95% CI 0.3\u00e2\u0080\u00938.3%) in the no drain group. Assuming a 70% of overlap between the two procedures in the drain group, the estimated proportion of the composite outcome is 6.44%, while assuming a 35% overlap in the no drain group, the estimated proportion of the composite outcome is 4.16%.\n Hence, we assumed a reference group proportion of 6.44%, and a treated group proportion of 10% under the null hypothesis of inferiority and 4.16% under the alternative hypothesis of non-inferiority. A sample size of 182 in each group, corresponding to 364 patients overall, achieves 80% power to detect a non-inferiority margin difference between the group proportions of 3.56% (=\u00e2\u0080\u008910\u00e2\u0080\u00936.44%), with a one-sided significance level of 5%. A power curve for treated group proportion ranging from 3 to 7% under the alternative hypothesis of non-inferiority is presented in Fig.\u00c2\u00a03.\nFig. 3Power curve as a function of treated group proportion ranging from 3 to 7% under the alternative hypothesis of non-inferiority. P0 (proportion in the control group)\u00e2\u0080\u0089=\u00e2\u0080\u00896.4%; alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05; n1\u00e2\u0080\u0089=\u00e2\u0080\u0089n2\u00e2\u0080\u0089=\u00e2\u0080\u0089182; P1.0 (proportion in the treated group under the null hypothesis of inferiority)\u00e2\u0080\u0089=\u00e2\u0080\u008910%. The test statistic used is the one-sided Z test (unpooled)\n Considering a 10% dropout rate, 404 patients (202 in each group) are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 patients for each type of gastrectomy.", "id": 648, "split": "val"} +{"trial_id": "NCT04228146", "pmid": "33036655", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Parallel Group Randomized Controlled Trial on the Effect of a Smartphone-delivered Cognitive Behavioral Therapy for Insomnia on People With Major Depression and Insomnia\n\nIncluded conditions:\n- Sleep Initiation and Maintenance Disorders\n- Depression\n\nStudy Armgroups:\n- {'label': 'CBT-I condition', 'type': 'EXPERIMENTAL', 'description': 'Participants in the CBT-I condition start the 6-week CBT-I immediately after randomization, complete the post-intervention assessment right after they finish the treatment, and complete the follow-up assessment six weeks after the post-intervention assessment.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Insomnia']}\n- {'label': 'Waitlist control condition', 'type': 'OTHER', 'description': 'Participants in the waitlist control group complete the post-intervention assessment six weeks after the baseline assessment, start CBT-I (equivalent to that of the CBT-I group) immediately after completing the post-intervention assessment, and complete the follow-up assessment right after they finish the 6-week CBT-I.', 'interventionNames': ['Other: Waitlist Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive Behavioral Therapy for Insomnia', 'description': 'Immediate access to the self-help CBT-I treatment, content of which is based on the translated Chinese version of a well-established CBT-I treatment manual entitled \"Insomnia: A Clinician\\'s Guide to Assessment and Treatment\". CBT-I aims at changing dysfunctional cognitive beliefs and maladaptive behaviors that contribute to the maintenance of insomnia. The self-help CBT-I treatment is delivered in Chinese language in six consecutive weekly modules via a smartphone application known as proACT-S. Duration of each module is around 45 to 60 minutes.', 'armGroupLabels': ['CBT-I condition']}\n- {'type': 'OTHER', 'name': 'Waitlist Control', 'description': 'Delay access to the self-help CBT-I treatment.', 'armGroupLabels': ['Waitlist control condition']}\n\nPrimary Outcomes:\n- {'measure': 'Changes over the measurement points in Center for Epidemiologic Studies Depression Scale', 'description': 'Measures the severity of depressive symptoms during the past week. Range from 0 to 60, where a higher value indicates more severe depressive symptoms.', 'timeFrame': 'Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up'}\n- {'measure': 'Changes over the measurement points in Insomnia Severity Index', 'description': 'Measures the severity of insomnia symptoms and the associated daytime impairment over the past two weeks. Range from 0 to 21, where a higher value indicates more severe insomnia symptoms.', 'timeFrame': 'Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up'}\n- {'measure': 'Changes over the measurement points in Pittsburgh Sleep Quality Index', 'description': 'Measures sleep quality and disturbances during the past month. It has seven components, namely, sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of hypnotics, and daytime dysfunction. Range from 0 to 21, where a higher value indicates poorer sleep quality.', 'timeFrame': 'Baseline, post-intervention: 6 weeks after CBT-I initiation, 6-week follow up'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an alpha value set at 0.05 (two-sided), 80% power, and an attrition rate of 30%. The sample size calculation is based on mixed ANCOVA using GPower 3.1, controlling for 12 covariates.", "answer": 285, "answer_type": "ESTIMATED", "explanation": "Sample size\n The most updated meta-analysis of 28 self-help CBT-I RCTs [19] showed a significant treatment effect in alleviating depressive symptoms (Hedges\u00e2\u0080\u0099 g\u00e2\u0080\u0089=\u00e2\u0080\u00890.35) and insomnia symptoms (Hedges\u00e2\u0080\u0099 g\u00e2\u0080\u0089=\u00e2\u0080\u00890.79). It also found that the mean cumulative study attrition rates were 21.25% (SD\u00e2\u0080\u0089=\u00e2\u0080\u008915.31%) and 18.4% (SD\u00e2\u0080\u0089=\u00e2\u0080\u008918.21%) in the treatment and the waiting list/routine care/no treatment/psychoeducation groups, respectively. Hence, a conservative small effect size (Cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u00890.2) and an attrition rate of 30% are estimated for the present study.\n The sample size calculation for each of the three primary outcomes (i.e., insomnia severity, poor sleep quality, and depression severity) is based on mixed ANCOVA using GPower 3.1. To conduct a 2 (condition: CBT-I versus waitlist control)\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00892 (assessment: baseline versus post-intervention) mixed ANCOVA with an alpha value set at 0.05, two-sided, 80% power to detect a small effect of 0.2 (Cohen\u00e2\u0080\u0099s f) between two groups while controlling for 12 covariates (demographics, clinical comorbidity, treatment expectancy, and acceptability of treatment), a total sample size of 199 will be required. In order to account for 30% attrition, a total sample of 285 participants will be sufficient to detect a small effect size (Cohen\u00e2\u0080\u0099s f\u00e2\u0080\u0089=\u00e2\u0080\u00890.2) for the difference in the change in each of the three primary outcomes (i.e., insomnia severity, poor sleep quality, and depression severity) from baseline to post-intervention between CBT-I condition and waitlist control condition with a two-sided 5% significance level and a power of 80%.", "id": 649, "split": "val"} +{"trial_id": "NCT04229875", "pmid": "34645661", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Specialized Treatment for Bipolar Disorder - the CAG Bipolar RCT\n\nIncluded conditions:\n- Bipolar Disorder\n\nStudy Armgroups:\n- {'label': 'CAG Bipolar', 'type': 'EXPERIMENTAL', 'description': '1. Patients will be treated in a localized CAG Bipolar clinic within each psychiatric centre increasing the number of bipolar patients for each clinician\\n2. All clinicians will get certified in diagnosing and treating bipolar disorder by joining an educational course and ongoing courses continuously\\n3. Treatment will include a group-based psychoeducation program\\n4. Coordinated targets to improve quality of life of patients by increasing concordance between clinicians, patients and relatives on well-defined treatment goals\\n5. Continued ongoing supervision of patient cases in CAG Bipolar staff by the Copenhagen Affective Disorder Clinic\\n6. Three-month bidirectional exchange of two clinical staff members between the Copenhagen Affective Disorder Clinic and each CAG Bipolar clinic\\n7. Recovery mentors', 'interventionNames': ['Other: CAG Bipolar']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Standard treatment'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'CAG Bipolar', 'description': 'See description of CAG Bipolar', 'armGroupLabels': ['CAG Bipolar']}\n\nPrimary Outcomes:\n- {'measure': 'Risk of psychiatric hospitalization', 'description': 'Data on hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status', 'timeFrame': 'During the entire study period of 12 months pr participant'}\n- {'measure': 'Cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register', 'description': 'Data on cumulated duration of hospitalization according to data from the population-based Danish Psychiatric Central Research Register will be collected and analyzed with survival statistics. Assessed blinded for the intervention status', 'timeFrame': 'During the entire study period of 12 months pr participant'}\n\nPlease estimate the sample size based on the assumption: \nThe trial assumes a power of 80%, a type 1 error risk of 0.05, and a dropout rate of 30%.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Statistical power and sample size calculation\n All prevalent and newly referred approximately 2000 outpatients with a bipolar disorder diagnosis will be invited to participate in the present CAG Bipolar RCT during the planned 3-year study period. The RCT will run until at least 1000 patients have been included. It is estimated that more than two-thirds will accept participation in the trial as the alternative will be to wait for 1\u00e2\u0080\u0089year and at that time to be included in CAG Bipolar as part of the implementation of CAG Bipolar.\n A total of 70% of outpatients with bipolar disorder will be randomised to treatment in the CAG Bipolar clinic within each of the five psychiatric centres and 30% to continue their usual outpatient standard treatment during the 1\u00e2\u0080\u0089year intervention period in the centre.\n According to data from the Mental Health Services, Capital Region of Denmark (2017), at least 20% of outpatients in standard care will be hospitalised for a mean of 26 days (SD: 15 days) during the 1\u00e2\u0080\u0089year intervention period. We conservatively expect to be able to reduce the proportion of hospitalisations among patients with at least 5% per year (from 20% per year to 15% per year) and the average duration of hospitalisation days per year with at least 10% (from 43 days to 39 days, SD: 25) in CAG Bipolar versus standard treatment. With a power of 80% and a type 1 error risk of 0.05, we need to randomise 161 and 644 patients, respectively for the two primary measures, to the trial (http://powerandsamplesize.com). Drop out of the RCT during the 1\u00e2\u0080\u0089year study period is estimated to be 30%. Thus, 1000 patients need to be included to detect a statistically significant difference in duration of hospitalisation. Interim analyses are not feasible as the primary outcome measure is based on data from the Danish Psychiatric Central Research Register with a time lack of 1\u00e2\u0080\u0089year (data are not available until 1\u00e2\u0080\u0089year after the actual incident).", "id": 650, "split": "val"} +{"trial_id": "NCT04230369", "pmid": "38802281", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Internet-delivered Cognitive Behaviour Therapy for Anxiety Related to Asthma: A Randomized Controlled Trial\n\nIncluded conditions:\n- Asthma\n- Anxiety\n\nStudy Armgroups:\n- {'label': 'Internet-CBT', 'type': 'EXPERIMENTAL', 'description': 'The internet-CBT will comprise 8 weekly modules with therapist-support, encouraging exposure for fear of asthma symptoms while ensuring a stable asthma medication through a written medical plan on medical adherence Participants work independently from home with the treatment and receive weekly support from their psychologist through written messages online.', 'interventionNames': ['Behavioral: Exposure-based Internet-CBT']}\n- {'label': 'Treatment as usual', 'type': 'OTHER', 'description': 'Patients randomized to treatment as usual will receive the same medical information that participants in the Internet-CBT get, with physiological information about asthma and the importance of medical adherence to achieve well controlled asthma, but without the exposure-based treatment and no therapist support. All participants in both conditions can use any other available treatment, but psychological, from pre-assessments to 2 months after treatment completion. Participants in this arm will be crossed over to Internet-CBT after the primary endpoint at to 2 months follow up.', 'interventionNames': ['Other: Treatment as usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Exposure-based Internet-CBT', 'description': 'Internet-CBT for anxiety-related asthma 8 weekly modules of CBT delivered over the internet and targeting enhanced function and decreased symptoms of anxiety. Participants work independently from home with the treatment and receive support from experienced Internet-CBT Psychologists through written messages in the secure platform. All participants in both conditions can use any other available treatment (TAU), but psychological, from pre-assessments to 2 months after treatment completion.', 'armGroupLabels': ['Internet-CBT'], 'otherNames': ['Online exposure therapy']}\n- {'type': 'OTHER', 'name': 'Treatment as usual', 'description': 'Patients randomized to treatment as usual will receive the same medical information that participants in the Internet-CBT get, with physiological information about asthma and the importance of medical adherence to achieve well controlled asthma, but without the exposure-based treatment and no therapist support. All participants in both conditions can use any other available treatment (TAU), but psychological, from pre-assessments to 2 months after treatment completion.', 'armGroupLabels': ['Treatment as usual'], 'otherNames': ['TAU']}\n\nPrimary Outcomes:\n- {'measure': 'Catastrophizing about asthma Scale', 'description': 'Change in catastrophizing cognitions about asthma measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.', 'timeFrame': 'Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.'}\n\nPlease estimate the sample size based on the assumption: \n80% power at alpha-level 0.05, SD of 1.0", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size and power\n A power analysis using G*power demonstrated that the sample size of 90 will provide 80% power at alpha-level 0.05 to detect a moderate between-group effect size (Cohen\u00e2\u0080\u0099s d=0.6) on the primary outcome (catastrophising about asthma) from prerandomisation to 16 weeks postrandomisation. The analysis is based on the treatment effects in the feasibility study. We assumed an SD of 1.0.", "id": 651, "split": "val"} +{"trial_id": "NCT04230590", "pmid": "34670760", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Health Outcomes Via Positive Engagement in Schizophrenia (HOPE-S)\n\nIncluded conditions:\n- Schizophrenia Spectrum Disorders\n\nStudy Armgroups:\n- {'label': 'Participants with schizophrenia spectrum disorders', 'description': 'Within 8 weeks post discharge from hospitalization at the Institute of Mental Health', 'interventionNames': ['Other: Observational']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Observational', 'description': \"Participants will not receive any study intervention.\\n\\nDuring the 24-week study period, participants will complete five assessment visits and passive digital data from participant's smartphone and study-provided wrist wearable device will be collected.\", 'armGroupLabels': ['Participants with schizophrenia spectrum disorders']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical Global Impression scale - Severity', 'description': \"A single item measuring severity of illness at the point of assessment relative to a clinician's experience with patients of the same diagnosis on a 7-point scale; a higher rating indicates greater severity.\", 'timeFrame': 'up to 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA 10% drop-out rate is assumed, and the study aims for an 80% probability to observe at least 30 participants who relapse within 6 months.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n As this is an observational study, sample size was determined based on feasibility. Several studies suggested that a sample size of at least 30 participants generally allow adequate hypothesis testing while providing reasonable effect size.50\u00e2\u0080\u009352 Assuming a 10% drop-out rate, a sample size of 100 will provide 80% probability to observe at least 30 participants who relapse within 6 months, if true relapse rate is 37%. This relapse rate is an assumption derived based on binomial distribution as information on relapse rates is unavailable. If the true relapse rate is lower than 37%, the probability to observe at least 30 participants who relapse within 6 months will be less than 80%. If the true relapse rate is higher than 37%, then the probability will be more than 80%.", "id": 652, "split": "val"} +{"trial_id": "NCT04231838", "pmid": "33906842", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Controlled International Multicentre Study Evaluating Changes in Metabolic Syndrome in Smokers With Type 2 Diabetes Mellitus After Switching From Tobacco Cigarettes to Combustion-Free Nicotine Delivery Systems: DIASMOKE Study\n\nIncluded conditions:\n- Cardiovascular Risk Factor\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'Standard Arm (Arm A)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participant continues smoking their own cigarette brand.', 'interventionNames': ['Other: TOBACCO CIGARETTES']}\n- {'label': 'Intervention Arm (Arm B)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participant switches to using C-F NDS', 'interventionNames': ['Other: COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'TOBACCO CIGARETTES', 'description': 'Participants in Arm A will continue smoking their own cigarette brand as usual.', 'armGroupLabels': ['Standard Arm (Arm A)']}\n- {'type': 'OTHER', 'name': 'COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)', 'description': 'Participants in Arm B will trial and familiarize with their allocated products to select the C-F NDS of their preference. They will be trained and counselled on the chosen C-F NDS; participants will also have the option to try and choose among a selection of either 3 e-liquids or 3 tobacco sticks (depending on the C-F NDS they have chosen). Participants wishing to use a heated tobacco device (HTD) will receive one kit and a full 1 week supply of tobacco sticks of their choice (they will receive a number of tobacco sticks/day corresponding to the number of cigarettes smoked at baseline); those wishing to use a vaping product will receive one vaping kit and a full 1 week supply of e-liquids of their choice (they will receive 4 x 10 ml refill containers).', 'armGroupLabels': ['Intervention Arm (Arm B)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Metabolic Syndrome Prevalence', 'description': 'Percentage (%) change in Metabolic Syndrome Prevalence', 'timeFrame': 'Changes in the prevalence of Metabolic Syndrome from baseline will be assessed at 3 months, 6 months, 1 year, and 2 years'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level was set at 5% (\u03b1=0.05), with a power of 80% (\u03b2=0.20). An estimated 50% proportion of patients randomised to C-F NDS are expected to achieve sustained reduction in cigarette consumption of at least 80%. The expected number of patients in both arms withdrawing from the trial over 2 years is estimated at 20%.", "answer": 576, "answer_type": "ESTIMATED", "explanation": "Powering and sample size calculation\n For this study, the following input assumptions were considered:\n \n \n The absolute reduction in MetS prevalence following substantial smoking cessation is expected to be 15%, based on the results of a range of lifestyle modification interventions.24\u00e2\u0080\u009328\n\n \n \n The baseline prevalence of MetS in T2DM is expected to be 70%.29\u00e2\u0080\u009332\n\n \n \n Sample size was calculated on the basis of demonstration of superiority, using an assumption of normal distribution, as described by Pocock.33 Significance level was set at 5% (\u00ce\u00b1=0.05), with a power of 80% (\u00ce\u00b2=0.20). On this basis, the minimum number of patients with analysable data required is 160 per treatment arm (N).\n Further assumptions at the planning stage included an estimated 50% proportion of patients randomised to C-F NDS who are expected to achieve sustained reduction in cigarette consumption of at least 80% for the duration of the study (%SusRed).34\u00e2\u0080\u009338\n\n The adjusted number of patients in the intervention arm (N2) was therefore increased to 320:\n N2=N/%SusRed=320 (N2 indicating the final number of patients required after taking into consideration the 50% sustained reduction figure).\n Additionally, the expected number of patients in both arms withdrawing from the trial over 2 years is estimated at 20%.39\u00e2\u0080\u009341 The total number of patients recruited to each treatment arm was therefore increased by this amount:\n Intervention arm: 320\u00c3\u00971.2=384.\n Control arm: 160\u00c3\u00971.2=192.\n Total patients both arms=576.\n In order to reach the target sample size patients with diabetes will be informed about the potential benefits of switching to C-F NDS as well as the ability to report their health problems to their site investigator via a mobile application.", "id": 653, "split": "val"} +{"trial_id": "NCT04233996", "pmid": "32423462", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Extended Infusion of \u03b2-lactam Antibiotics for the Treatment of Febrile Neutropenia in Haematologic Patients: a Randomised, Multicentre, Open-label, Superiority Clinical Trial (BEATLE)\n\nIncluded conditions:\n- Febrile Neutropenia\n\nStudy Armgroups:\n- {'label': 'Extended infusion', 'type': 'EXPERIMENTAL', 'description': 'Piperacillin-tazobactam, cefepime or meropenem will be administered in half time of the dosing interval', 'interventionNames': ['Drug: Piperacillin-Tazobactam 4 g-0.5 g', 'Drug: Cefepime 2000 mg', 'Drug: Meropenem 1000 mg']}\n- {'label': 'Intermittent infusion', 'type': 'ACTIVE_COMPARATOR', 'description': 'Piperacillin-tazobactam, cefepime or meropenem will be administered in 30 minutes', 'interventionNames': ['Drug: Piperacillin-Tazobactam 4 g-0.5 g', 'Drug: Cefepime 2000 mg', 'Drug: Meropenem 1000 mg']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Piperacillin-Tazobactam 4 g-0.5 g', 'description': 'Patients with FN who empirical treatment with piperacillin-tazobactam 4g/6h', 'armGroupLabels': ['Extended infusion', 'Intermittent infusion']}\n- {'type': 'DRUG', 'name': 'Cefepime 2000 mg', 'description': 'Patients with FN who required empirical treatment with cefepime 2g/8h', 'armGroupLabels': ['Extended infusion', 'Intermittent infusion']}\n- {'type': 'DRUG', 'name': 'Meropenem 1000 mg', 'description': 'Patients with FN who required empirical treatment with meropenem 1g/8h', 'armGroupLabels': ['Extended infusion', 'Intermittent infusion']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical efficacy of extended infusion: Number of patients with defervescence', 'description': 'Number of patients with defervescence (\\\\<37.5 \u00baC, for 24 hours) without modifying the antibiotic treatment', 'timeFrame': '5 days'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast are assumed, with the sample size allowing up to 20% losses to follow-up.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on determining whether the administration of BLA by EI (study group) will be clinically more effective than the administration of BLA by II (control group), for the treatment of FN in haematological patients. Previous data suggest that the clinical efficacy rate in the control group is expected to be 0.45 [20, 21]. A relevant clinical efficacy rate in the study group is expected to be 0.70. Each therapy group will required 75 participants (total of 150) to detect statistically significant differences in clinical efficacy. An alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast are assumed, and the sample size allows up to 20% losses to follow-up.\n \n Interim analysis\n An interim analysis will be carried out once 50% of the cases of each arm are recruited. This analysis will evaluate if the estimated sample size is adequate. The results will be issued by an independent committee of experts not participating in this study.", "id": 654, "split": "val"} +{"trial_id": "NCT04234191", "pmid": "33579359", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparing Rapid Micro-Induction and Standard Induction of Buprenorphine/Naloxone for Treatment of Opioid Use Disorder: A Randomized Controlled Trial\n\nIncluded conditions:\n- Opioid Use Disorder\n\nStudy Armgroups:\n- {'label': 'Rapid Micro-Induction', 'type': 'EXPERIMENTAL', 'description': 'On Day 1, participants will receive 0.5mg bup/nx sublingually (SL) every 3 hours (Q3H) - total daily dose of 4mg. On Day 2, they will receive 1mg bup/nx SL Q3H - total daily dose of 8mg. On Day 3, they will receive 8mg bup/nx SL once and 1-4mg bup/nx SL Q3H as needed (PRN) for withdrawal symptoms and/or craving and/or pain - maximum daily dose of 32mg. Afterwards, their day 3 total dose will be consolidated to once daily dosing - maximum daily dose of 32mg. On Days 1 and 2, participants will concurrently receive 1-48mg hydromorphone orally, intravenously, subcutaneously, or intramuscularly (PO/IV/SC/IM) Q1 to 3H PRN for withdrawal symptoms and/or craving and/or pain, titrated to effect (start at lower end of dosing range). Hydromorphone will be discontinued on Days 3 onwards.', 'interventionNames': ['Drug: Buprenorphine/naloxone', 'Drug: Hydromorphone']}\n- {'label': 'Standard Induction', 'type': 'ACTIVE_COMPARATOR', 'description': 'Day 1 is initiated when participants score 11 or above on the Clinical Opiate Withdrawal Scale (COWS), and when they have been abstinent from short-acting opioids for at least 6-12 hours or from long-acting opioids for 24-72 hours. On Day 1, participants will start with 2 or 4mg bup/nx SL. If their COWS score increases, bup/nx will be held. If their COWS score remains the same or decreases, additional dosing can be done in increments of 2mg bup/nx SL every 2 hours (Q2H) as needed (PRN). On Day 2, dosing will be consolidated to once daily dosing. The maximum total daily dose for Day 1 and 2 is 32mg.', 'interventionNames': ['Drug: Buprenorphine/naloxone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Buprenorphine/naloxone', 'description': 'Buprenorphine/naloxone is an opioid agonist treatment for opioid use disorder. It is administered via sublingual tablet form.', 'armGroupLabels': ['Rapid Micro-Induction', 'Standard Induction'], 'otherNames': ['Suboxone']}\n- {'type': 'DRUG', 'name': 'Hydromorphone', 'description': 'Hydromorphone is an opioid used for managing pain, craving, and withdrawal. It is administered orally via tablet or liquid form; or administered intravenously, subcutaneously, or intramuscularly via liquid form.', 'armGroupLabels': ['Rapid Micro-Induction'], 'otherNames': ['Dihydromorphinone, Dilaudid']}\n\nPrimary Outcomes:\n- {'measure': 'Successful induction of bup/nx with low levels of withdrawal', 'description': 'This is defined as the following: participants who remain in treatment until they have received a total daily dose of \u2265 8mg of bup/nx (successful induction), and score \u2264 12 on the COWS (low levels of withdrawal) from baseline to when they reach that dose.', 'timeFrame': 'Baseline to Day 1 (Standard Induction Arm) or Day 2 (Rapid Micro-Induction Arm)'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 0.05, Type II error of 0.1, and an attrition rate of 10%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n The sample size calculation for the binary primary outcome is based on testing for superiority in a parallel group clinical trial. As only case reports have been published on rapid micro-induction, we expect a success rate of 95% in the experimental arm based on the opinion of two addiction psychiatry experts familiar with the method. We expect a success rate of 10% in the control arm, as most participants in the arm are anticipated to experience moderate to higher levels of withdrawal, which is defined as having a COWS score of \u00e2\u0089\u00a5\u00e2\u0080\u008913. A difference of such a magnitude, 85%, is deemed clinically meaningful. Using G*Power 3.1 software, the minimum required sample size to power a Fisher\u00e2\u0080\u0099s exact test to detect this difference between the two arms with a type I error of 0.05 and a type II error of 0.1 will be 12 (6 in each arm). Adjusting for an attrition rate of 10% (participants with incomplete COWS data, participants who have discontinued the treatment they were randomized, and participants who have discontinued both treatment and data collection procedures), the required sample size is 14. We aim for a sample size of 50 (25 each arm), as a larger sample size is not feasible due to cost and constraints.", "id": 655, "split": "val"} +{"trial_id": "NCT04236739", "pmid": "33036661", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trial Comparing Clinical Outcomes of Instant MSC Product Accompanying Autologous Chondron Transplantation (IMPACT) for Focal Articular Cartilage Lesions of the Knee to Conservative Treatment\n\nIncluded conditions:\n- Cartilage Damage\n\nStudy Armgroups:\n- {'label': 'IMPACT', 'type': 'EXPERIMENTAL', 'description': \"Application of a mixture of allogenic MSC's and autologous chondrons with a fibrin cell carrier (Tisseel\u00ae) during one surgical procedure.\", 'interventionNames': ['Drug: Instant MSC Product accompanying Autologous Chondron Transplantation']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': \"Optional physical therapy or pain medication, according to participants' desire for 9 months.\"}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Instant MSC Product accompanying Autologous Chondron Transplantation', 'description': \"Application of a mixture of allogenic MSC's and autologous chondrons with a fibrin cell carrier (Tisseel\u00ae) in the cartilage defect of the knee during one surgical procedure.\", 'armGroupLabels': ['IMPACT']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical change on scale of 0-100', 'description': 'KOOS-questionnaire (Knee injury and Osteoarthritis Outcome Score, 100 indicating no symptoms and 0 indicating extreme symptoms)', 'timeFrame': 'At baseline, 3, 6 and 9 months'}\n- {'measure': 'Quality of life change on scale of 0-100', 'description': \"EQ-5d-questionnaire (The EQ-5D-5L has 5 dimensions, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.)\", 'timeFrame': 'At baseline, 3, 6 and 9 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, alpha of 0.05, potential loss to follow-up", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size was calculated for the primary objective (treatment effect up to 9\u00c2\u00a0months postoperatively) based on the Hotelling-Lawley trace [24, 25]. Based on a standard deviation of 15 [23], correlation of the repeated measures of 0.7 (data from our phase I trial [21]), and with a power of 0.8 and alpha of 0.05, a minimum of 44 patients should be included to detect a minimal clinical relevant treatment effect of 10 for KOOS [23]. To account for potential loss to follow-up, and uncertainties in the correlation pattern and standard deviation for nonsurgical treatment, this was rounded up to 60 patients in total.", "id": 656, "split": "val"} +{"trial_id": "NCT04238390", "pmid": "33888139", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicentre, Parallel Group Open-label Randomised Controlled Non-Inferiority Phase 3 Trial, of Ceftolozane-tazobactam Versus Meropenem for Definitive Treatment of Bloodstream Infection Due to Extended-Spectrum Beta-Lactamase (ESBL) and AmpC-producing Enterobacterales\n\nIncluded conditions:\n- Bacteremia Caused by Gram-Negative Bacteria\n\nStudy Armgroups:\n- {'label': 'Ceftolozane-tazobactam', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive ceftolozane-tazobactam 3 grams (comprising ceftolozane 2 grams and tazobactam 1 gram) administered, every 8 hours, three times a day, intravenously over 60 mins', 'interventionNames': ['Drug: Ceftolozane-Tazobactam']}\n- {'label': 'Meropenem', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will receive meropenem 1 gram, every 8 hours, three times a day, intravenously over 30 mins.', 'interventionNames': ['Drug: Meropenem']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ceftolozane-Tazobactam', 'description': 'Ceftolozane-tazobactam 3 grams (comprising ceftolozane 2 grams and tazobactam 1 gram) administered, every 8 hours, three times a day, intravenously over 60 mins. Dose adjusted for renal function.', 'armGroupLabels': ['Ceftolozane-tazobactam']}\n- {'type': 'DRUG', 'name': 'Meropenem', 'description': 'Meropenem 1 gram, every 8 hours, three times a day, intravenously over 30 mins. Dose adjusted for renal function.', 'armGroupLabels': ['Meropenem']}\n\nPrimary Outcomes:\n- {'measure': 'Mortality rate at 30 days', 'description': 'To compare the 30-day mortality from day of randomisation of each regimen', 'timeFrame': '30 days post randomisation'}\n\nPlease estimate the sample size based on the assumption: \n80% power to declare non-inferiority, 5% significance level, and considering a dropout rate to achieve 600 patients contributing to the primary outcome analysis.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The sample size is driven by the maximum achievable power with the constraint of a predefined quantity of ceftolozane-tazobactam to be supplied by MSD. We anticipate that a trial with 600 patients contributing to the primary outcome analysis (corresponding to 630 patients randomised) may be possible. Such a trial would have 80% power to declare non-inferiority with a 5% non-inferiority margin, assuming a 30-day mortality of 5% in both randomised groups. The decision to choose 5% as the expected 30-day mortality reflects the 30-day mortality rate of 4\u00e2\u0080\u00935% reported by our group in the meropenem arm of the MERINO trial [11]. However, a similar study has assumed a 30-day mortality rate of 12.5% in the meropenem arm [17]. This mortality rate was based on both arms of the MERINO trial and contemporary observational studies [4]. If the control rate is higher than 5% we will have less power to detect non-inferiority (assuming equivalent rates in the two arms). If the control rate is 5%, the non-inferiority margin of 5% may be deemed by some to be too large. As recommended by the CONSORT statement, we will report relative risk ratios as well as absolute risk differences.\n \n Recruitment {15}\n We plan to conduct this trial over a 4-year period. Participants will be recruited from a maximum of 40 sites across 6 countries. Of those participants screened, we anticipate approximately 25% will be enrolled successfully in the trial. This estimate was generated from the MERINO trial.\n The table below highlights the minimum projected monthly and annual recruitment numbers to reach target (630) depending upon the number of sites. It assumes all sites are recruiting simultaneously, however, it is projected that the majority of the sites will be recruiting within a 9-month period, and the early adoptive sites will recruit ahead of the initial target thereby balancing timelines.\n In the event of delayed recruitment milestones, pre-defined contingency measures including, the addition of eligible sites and the introduction of further rapid antibiotic susceptibility testing (e.g. AcceleratePheno\u00e2\u0084\u00a2) will be implemented (Table 4).\nTable 4Predicted recruitment per site and timeline# SitesPer monthPer annum113.1157.5101.315.7150.910.5200.77.9250.56.3300.45.2350.44.5400.33.9", "id": 657, "split": "val"} +{"trial_id": "NCT04238546", "pmid": "35449070", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty\n\nIncluded conditions:\n- Peripheral Arterial Disease\n\nStudy Armgroups:\n- {'label': 'Sirolimus-coated group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: sirolimus-coated balloon catheter']}\n- {'label': 'Uncoated group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: uncoated balloon catheter']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'sirolimus-coated balloon catheter', 'description': 'angioplasty with sirolimus-coated balloon catheter', 'armGroupLabels': ['Sirolimus-coated group']}\n- {'type': 'DEVICE', 'name': 'uncoated balloon catheter', 'description': 'angioplasty with uncoated balloon catheter', 'armGroupLabels': ['Uncoated group']}\n\nPrimary Outcomes:\n- {'measure': 'unplanned major amputation of the target limb', 'description': 'An unplanned major amputation is defined as any amputation above the ankle on the target limb, which was not planned or not expectable at the time of screening or randomization. Patients with scheduled amputation undergoing re-vascularization to improve wound healing are referred to as planned amputation and will not count for the primary outcome', 'timeFrame': 'one year'}\n- {'measure': 'endovascular or surgical target lesion re-vascularization for critical limb ischemia', 'description': 'Critical limb ischemia is defined according to a Fontaine stage (classes III-IV)', 'timeFrame': 'one year'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% and a type I error rate of \u03b1 = 2.5% one-sided. Assuming a drop-out rate of 5%, including randomization failures.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size calculation is based on previous studies reporting MALE rates in PAD patients after re-vascularization procedures. These studies were heterogeneous in study design, patient selection, techniques (proportion of patients with endovascular approach), and findings [13\u00e2\u0080\u009324]. Hess et al. reported a MALE incidence of 10% at 12\u00e2\u0080\u0089months among 381,415 re-vascularized patients that were included in the Premier Healthcare Database between April 2009 and September 2014 [19]. In addition, there were two larger interventional studies reporting 30-day MALE incidence after surgical or endovascular therapy of symptomatic PAD patients. Fashandi et al. reported a MALE incidence of 3.2% in patients with claudication at 1\u00e2\u0080\u0089month following therapy [21]. Mehaffey et al. reported a MALE incidence of 12.2% in patients with critical limb ischemia (CLI) [22]. The COMPASS trial estimated a MALE incidence of 2.0% among 6.341 patients with PAD at 21\u00e2\u0080\u0089months, of which 35% were asymptomatic. The MALE incidence was 3.6% among the subgroup of patients with previous re-vascularization procedures [24]. A subgroup analysis of the Fourier trial estimated a MALE incidence of 1.5% among 3.642 patients with PAD (31% asymptomatic) at 12\u00e2\u0080\u0089months [23]. In the XTOSI study, the 6-month amputation-free survival was 90% in patients receiving sirolimus-coated balloon catheters.\n Based on these studies, assuming a 10% event rate (MALE) within 12\u00e2\u0080\u0089months in both the control and intervention group, and a non-inferiority margin of 5% expressed as absolute risk difference, a total of 1132 patients (566 patients per treatment group) allow to show non-inferiority of the intervention group with a power of 80% and a type I error rate of \u00ce\u00b1 = 2.5% one-sided. Assuming a drop-out rate of 5%, including randomization failures, a total of 1200 patients will be randomized in the study.", "id": 658, "split": "val"} +{"trial_id": "NCT04239014", "pmid": "32878963", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 2 Randomized, Multi-Centre Study to Investigate the Efficacy and Tolerability of a Second Maintenance Treatment in Patients With Platinum Sensitive Relapsed Epithelial Ovarian Cancer, Who Have Previously Received PARP Inhibitor Maintenance Treatment\n\nIncluded conditions:\n- Ovarian Cancer\n\nStudy Armgroups:\n- {'label': 'Arm 1 (ceralasertib+olaparib)', 'type': 'EXPERIMENTAL', 'description': 'Participants received ceralasertib 160 mg QD PO on Days 1 to 7 plus olaparib 300 mg BD PO continuous (28 day cycle).', 'interventionNames': ['Drug: Olaparib', 'Drug: Ceralasertib']}\n- {'label': 'Arm 2 (olaparib monotherapy)', 'type': 'EXPERIMENTAL', 'description': 'Olaparib 300 mg BD PO daily continuous.', 'interventionNames': ['Drug: Olaparib']}\n- {'label': 'Arm 3 (placebo)', 'type': 'EXPERIMENTAL', 'description': 'Placebo to match olaparib BD PO daily continuous.', 'interventionNames': ['Drug: Placebo to match olaparib']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Olaparib', 'description': 'Olaparib 300 mg BD (2 \u00d7 150 mg tablets) continually in the olaparib monotherapy and ceralasertib+olaparib treatment arms.', 'armGroupLabels': ['Arm 1 (ceralasertib+olaparib)', 'Arm 2 (olaparib monotherapy)'], 'otherNames': ['AZD2281']}\n- {'type': 'DRUG', 'name': 'Ceralasertib', 'description': 'Ceralasertib 160 mg QD (2 \u00d7 80 mg tablets) from Days 1 to 7 (inclusive) of every 28-day cycle.', 'armGroupLabels': ['Arm 1 (ceralasertib+olaparib)'], 'otherNames': ['AZD6738']}\n- {'type': 'DRUG', 'name': 'Placebo to match olaparib', 'description': 'Per olaparib', 'armGroupLabels': ['Arm 3 (placebo)']}\n\nPrimary Outcomes:\n- {'measure': 'Progression free survival (PFS)', 'description': 'To assess the efficacy of maintenance olaparib monotherapy and ceralasertib+olaparib combination therapy compared with placebo.', 'timeFrame': 'To assess from the time of randomization until the date of objective disease progression or death (by any cause in the absence of progression) or approximately up to 2.5 years.'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 83% power to show a statistically significant difference in progression-free survival at the two-sided 4.5% level for olaparib, and 96% power at the two-sided 0.5% level for the olaparib combination arm. The smallest statistically significant HRs at primary analysis are 0.65 for olaparib and 0.55 for the combination arm. An interim futility analysis will be triggered after 25 patients per arm have been assessed for at least 8 weeks. The proportion of patients with non-progressive disease at Week 8 is expected to be 72.6% in the placebo group.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample Size\n Approximately 192 patients will be randomized in a 1:1:1 ratio to the three treatment arms.\n Assuming the true treatment effect of olaparib compared with placebo has a HR of 0.53 (this translates to an approximate 3.5-month improvement in median progression-free survival over an assumed 4-month median progression-free survival for placebo), 90 progression-free survival events must be observed for the study to have 83% power to show a statistically significant difference in progression-free survival at the two-sided 4.5% level. The smallest treatment difference that would be statistically significant at the primary analysis is a progression-free survival HR of 0.65.\n Assuming the true treatment effect of the olaparib combination arm (ceralasertib + olaparib) compared with placebo has a HR of 0.38 (this translates to an approximate 6.5-month improvement in median progression-free survival for the combination treatment over an assumed 4-month median progression-free survival for placebo), 90 progression-free survival events must be observed for the study to have 96% power to show a statistically significant difference in progression-free survival at the two-sided 0.5% level. The smallest treatment difference that would be statistically significant at the primary analysis is a progression-free survival HR of 0.55.\n An interim futility analysis will be triggered when approximately 25 patients (75 patients overall) have been recruited into each of the treatment arms and have been assessed for at least 8\u00e2\u0080\u0089weeks. Assuming progression-free survival is exponentially distributed, and the placebo treatment group has a median progression-free survival of 4 months, it is expected that the proportion of patients with non-progressive disease at Week 8 will be 72.6%. If the 80% two-sided exact upper limit of the CI for the proportion of patients with non-progressive disease in the ceralasertib + olaparib\u00e2\u0080\u0089arm or olaparib monotherapy arm is less than 72.6%, with consideration of this analysis in context with the totality of the clinical data (safety and efficacy) available, the Independent Data Monitoring Committee may recommend recruitment cessation.\n An initial overall survival analysis will be performed at the same time as the primary analysis of progression-free survival; a further analysis of overall survival will be performed when the overall survival data are approximately 60% mature (approximately 115 deaths).", "id": 659, "split": "val"} +{"trial_id": "NCT04241276", "pmid": "39833722", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Phase IIb Randomised Clinical Trial Repurposing ATRA as a Stromal Targeting Agent in a Novel Drug Combination for Pancreatic Cancer\n\nIncluded conditions:\n- Pancreatic Cancer\n\nStudy Armgroups:\n- {'label': 'Gemcitabine + nab-paclitaxel', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive Gemcitabine and nab-Paclitaxel in 28 day cycles until disease progression.', 'interventionNames': ['Drug: Gemcitabine', 'Drug: nab-paclitaxel']}\n- {'label': 'Gemcitabine + nab-paclitaxel + ATRA', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive ATRA, Gemcitabine and nab-Paclitaxel in 28 day cycles. ATRA will be administered for 6 cycles whereas Gemcitabine/nab-Paclitaxel will be administered until disease progression.', 'interventionNames': ['Drug: ATRA', 'Drug: Gemcitabine', 'Drug: nab-paclitaxel']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'ATRA', 'description': '45 mg/m2 orally (in two divided doses) from days 1 to 15 of each cycle', 'armGroupLabels': ['Gemcitabine + nab-paclitaxel + ATRA'], 'otherNames': ['Tretinoin', 'Vesanoid']}\n- {'type': 'DRUG', 'name': 'Gemcitabine', 'description': '1000mg/m2 IV on days 1, 8 and 15 of a 28 day cycle', 'armGroupLabels': ['Gemcitabine + nab-paclitaxel', 'Gemcitabine + nab-paclitaxel + ATRA']}\n- {'type': 'DRUG', 'name': 'nab-paclitaxel', 'description': '125mg/m2 IV on days 1, 8 and 15 of a 28 day cycle', 'armGroupLabels': ['Gemcitabine + nab-paclitaxel', 'Gemcitabine + nab-paclitaxel + ATRA'], 'otherNames': ['Abraxane']}\n\nPrimary Outcomes:\n- {'measure': 'To assess the efficacy of ATRA when given in combination with gemcitabine and nab-paclitaxel based on progression free survival (PFS).', 'description': 'PFS defined as the time from the date of randomisation to the date of first documented tumour progression or death from any cause, whichever occurs first.', 'timeFrame': 'Assessed 8 weekly until progression or death or end of trial, whichever comes first'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed to have 90% power at the 20% one-sided level of statistical significance (equivalent to 80% power at the 10% one-sided level of statistical significance), with no dropouts expected. An informal assessment for futility may be conducted at 43 PFS events using a Lan-DeMets spending function with a Pocock type boundary.", "answer": 170, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is based on the primary outcome measure. The estimated median PFS is 10\u00c2\u00a0months for the control arm (gemcitabine\u00e2\u0080\u0089+\u00e2\u0080\u0089nab-paclitaxel). Using a group sequential design, this study is designed to have 90% power at the 20% one-sided level of statistical significance (equivalent to 80% power at the 10% one-sided level of statistical significance) to detect a 50% improvement in median PFS (i.e. an estimated hazard ratio of 0.667) leading to an estimated median PFS of 15\u00c2\u00a0months. This design requires 170 patients (129 PFS events), randomised 1:1 between the two arms (85 patients in the control arm and 85 patients in the experimental arm), with no dropouts expected. It may be possible to conduct an informal assessment for futility at 43 PFS events (estimated at approximately 20\u00c2\u00a0months)( using a Lan-DeMets spending function with a Pocock type boundary). If the observed hazard ratio is greater than 1.121 in favour of the control arm, the trial may be stopped for futility, if considered appropriate.", "id": 660, "split": "val"} +{"trial_id": "NCT04242069", "pmid": "34414154", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Healthy for my Baby- A Randomized Controlled Trial Assessing a Preconception Clinically Integrated Technological Intervention to Improve the Lifestyle of Overweight Women and Their Partners\n\nIncluded conditions:\n- Overweight and Obesity\n- Pregnancy Complications\n- Health Behavior\n- Life Style\n- Preconception Care\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Healthy for my Baby Intervention', 'interventionNames': ['Behavioral: Healthy for my Baby']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'Usual care', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Healthy for my Baby', 'description': 'Participants will start the preconception intervention by meeting with a health professional for a motivational interview session on healthy lifestyle habits. Following this interview, participants will have access to a mobile phone application that will allow them to track daily lifestyle modification goals. After a month, they will meet the health professional for a second motivational interview and review their progression. Participants will continue to make lifestyle changes through the preconception period by accomplishing smart goals followed daily in the mobile phone application.\\n\\nIf the woman becomes pregnant, the couple will participate in two more in-person motivational interviews, a month apart. The mobile application will be put in pregnancy mode, and participants will adapt their daily lifestyle goals for the pregnancy. Participants will continue to make lifestyle changes throughout pregnancy by accomplishing smart goals followed daily in the mobile phone application.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Participants in the control group will receive standard advice on healthy lifestyle habits as provided by their usual care provider. They will receive standard medical care in preconception and pregnancy.\\n\\nTo improve compliance with the study follow-up, participants in this group will have access to a simplified version of the mobile application that contains a fertility calendar and a research visit calendar. This version of the application does not include lifestyle goals or any information on healthy lifestyle habits.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': \"Women's diet quality in preconception measured with the Canadian-Healthy Eating Index- 2007\", 'description': \"Women's C-HEI score will be measured with two or three online 24 hour dietary recalls (R24W tool) at each time point. Value range 0-100 with a higher score indicating better diet quality. The change of the score in time during the preconception period will be compared between the groups.\", 'timeFrame': '0, 2, 4, and 6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a significance level (alpha) of 5%, a power of 80%, and a 20% attrition rate.", "answer": 68, "answer_type": "ESTIMATED", "explanation": "Sample Size Calculation and Analysis Plan\n \n Sample Size Calculation\n Since no minimally clinically important effect size has been defined for the HEI score, our effect size has been estimated as a plausible effect of the intervention based on the preliminary results of the Obesity Fertility trial (71), which demonstrated a 12.5 \u00c2\u00b1 13.0 points increase in the average HEI score of women with obesity and infertility after a 6-month lifestyle intervention (unpublished data). An increase of 12 points in the average HEI score was also observed in breast cancer survivors with obesity who received a 6-month dietetic intervention (75). To detect a 10% difference in the average HEI score between groups with a 13-point standard deviation, an alpha value of 5% and 80% power, we will need to recruit 27 women per group (76). To account for a 20% attrition rate (77), a total of 68 women and their partners will be recruited.\n \n \n Statistical Analysis Plan\n Study results will be analyzed at the end of the trial following intent-to-treat principles. Participants' baseline characteristics will be reported to assess group comparability at baseline in preconception and at the beginning of pregnancy. A statistical significance threshold of 5% will be used for all analyses. Statistical analyses will be performed using the Statistical Package for the Social Sciences (SPSS version 26) and R (Version 4.0.2) software. No interim analysis will be performed.\n \n \n Primary Outcome Analysis\n Our primary endpoint is the difference in the evolution of the HEI score between study groups in time, which will be assessed using a mixed linear model of the HEI score integrating the effects of time as a continuous variable, study group, and the interaction between the study group and time. This statistical model has been chosen because it will allow us to account for (1) the different lengths of preconception follow-up that will arise as a result of women becoming pregnant throughout the study; and (2) variable timing and number of the R24W questionnaires performed by the participants (due to non-adherence to the protocol) (78). The average HEI score in each group at 2, 4, and 6 months will also be compared using standard mixed-model repeated measures ANOVA with post-hoc Student's t-tests with Bonferroni correction for multiple comparisons. As a secondary analysis, Kaplan-Meier survival curves of women who have increased their HEI score by 10 points or more will be produced, with censoring for dropout or occurrence of pregnancy.\n \n \n Secondary Outcome Analysis\n For the main secondary outcome for the pregnancy phase of the trial, we will use a Chi-squared test to compare the proportion of women who have an adequate gestational weight gain in each group.\n For the targeted analysis of urine biomarkers, the concentration of around 40 metabolites will be compared between baseline, 2 months in preconception and 24\u00e2\u0080\u009326 weeks of pregnancy using repeated measures ANOVA or Friedman test with a Bonferroni adjustment for multiple comparisons. The correlation between the metabolite derived diet quality score and the C-HEI score will be evaluated using Pearson's correlation.\n Although our sample size is fairly small, an exploratory multivariate analysis of non-targeted metabolome profiles will be realized using both unsupervised \u00e2\u0080\u0098natural clustering\u00e2\u0080\u0099 analysis and Supervised Random Forest classification.\n For the other secondary outcomes, continuous variables will be assessed using Student's t-tests or Mann-Whitney tests as appropriate. Dichotomic variables will be analyzed using Chi-squared tests or Fisher's exact test as appropriate.\n For participants who achieve a pregnancy prior to the 2-month food recall and/or 3-month preconception visit, lifestyle and anthropometric outcomes at the first pregnancy visit will be used to complete the preconception analysis. Women will be able to signal the occurrence of a pregnancy through the mobile application as soon as a period is missed. The application software will immediately notify the research team which will allow completion of data collection prior to the occurrence of significant pregnancy symptoms such as hyperemesis.", "id": 661, "split": "val"} +{"trial_id": "NCT04242069", "pmid": "34414154", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Healthy for my Baby- A Randomized Controlled Trial Assessing a Preconception Clinically Integrated Technological Intervention to Improve the Lifestyle of Overweight Women and Their Partners\n\nIncluded conditions:\n- Overweight and Obesity\n- Pregnancy Complications\n- Health Behavior\n- Life Style\n- Preconception Care\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Healthy for my Baby Intervention', 'interventionNames': ['Behavioral: Healthy for my Baby']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'Usual care', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Healthy for my Baby', 'description': 'Participants will start the preconception intervention by meeting with a health professional for a motivational interview session on healthy lifestyle habits. Following this interview, participants will have access to a mobile phone application that will allow them to track daily lifestyle modification goals. After a month, they will meet the health professional for a second motivational interview and review their progression. Participants will continue to make lifestyle changes through the preconception period by accomplishing smart goals followed daily in the mobile phone application.\\n\\nIf the woman becomes pregnant, the couple will participate in two more in-person motivational interviews, a month apart. The mobile application will be put in pregnancy mode, and participants will adapt their daily lifestyle goals for the pregnancy. Participants will continue to make lifestyle changes throughout pregnancy by accomplishing smart goals followed daily in the mobile phone application.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Participants in the control group will receive standard advice on healthy lifestyle habits as provided by their usual care provider. They will receive standard medical care in preconception and pregnancy.\\n\\nTo improve compliance with the study follow-up, participants in this group will have access to a simplified version of the mobile application that contains a fertility calendar and a research visit calendar. This version of the application does not include lifestyle goals or any information on healthy lifestyle habits.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': \"Women's diet quality in preconception measured with the Canadian-Healthy Eating Index- 2007\", 'description': \"Women's C-HEI score will be measured with two or three online 24 hour dietary recalls (R24W tool) at each time point. Value range 0-100 with a higher score indicating better diet quality. The change of the score in time during the preconception period will be compared between the groups.\", 'timeFrame': '0, 2, 4, and 6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a significance level (alpha) of 5%, a power of 80%, and a 20% attrition rate.", "answer": 68, "answer_type": "ESTIMATED", "explanation": "Sample Size Calculation\n Since no minimally clinically important effect size has been defined for the HEI score, our effect size has been estimated as a plausible effect of the intervention based on the preliminary results of the Obesity Fertility trial (71), which demonstrated a 12.5 \u00c2\u00b1 13.0 points increase in the average HEI score of women with obesity and infertility after a 6-month lifestyle intervention (unpublished data). An increase of 12 points in the average HEI score was also observed in breast cancer survivors with obesity who received a 6-month dietetic intervention (75). To detect a 10% difference in the average HEI score between groups with a 13-point standard deviation, an alpha value of 5% and 80% power, we will need to recruit 27 women per group (76). To account for a 20% attrition rate (77), a total of 68 women and their partners will be recruited.", "id": 662, "split": "val"} +{"trial_id": "NCT04242992", "pmid": "36549749", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Testing the Effectiveness of an Evidence-based Transdiagnostic Cognitive Behavioral Therapy Approach for Improving HIV Treatment Outcomes Among Violence-affected and Virally Unsuppressed Women in South Africa\n\nIncluded conditions:\n- HIV/AIDS\n- Violence\n\nStudy Armgroups:\n- {'label': 'CETA (Common Elements Treatment Approach)', 'type': 'EXPERIMENTAL', 'description': 'CETA is a modular, multi-problem, flexible psychotherapy approach that trains a lay provider in nine evidence-based cognitive behavioral therapy (CBT) elements so the provider can treat a variety of common problems, including violence, substance use, depression, anxiety, risky behaviors (sexual, non-adherence), and other trauma-related symptoms. Patients randomized to CETA will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.', 'interventionNames': ['Behavioral: CETA', 'Other: Short Message Service (SMS) text reminders']}\n- {'label': 'Active control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Our comparison arm will be an active control receiving usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.', 'interventionNames': ['Other: Short Message Service (SMS) text reminders']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'CETA', 'description': 'CETA is a modular, multi-problem, flexible psychotherapy approach that trains a lay provider in nine evidence-based CBT elements so providers can treat a variety of common problems, including violence, substance use, depression, anxiety, risky behaviors (sexual, non-adherence), and other trauma-related symptoms. Patients randomized to CETA will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include SMS reminders of their HIV care appointments, similar to the active control group.', 'armGroupLabels': ['CETA (Common Elements Treatment Approach)']}\n- {'type': 'OTHER', 'name': 'Short Message Service (SMS) text reminders', 'description': 'Short Message Service (SMS) text reminders for upcoming appointments will be sent monthly.', 'armGroupLabels': ['Active control', 'CETA (Common Elements Treatment Approach)']}\n\nPrimary Outcomes:\n- {'measure': '12 month viral suppression', 'description': 'The proportion of participants who are virally suppressed (\\\\<50 copies/mL) by 12 months post randomization', 'timeFrame': '12 months post randomization'}\n\nPlease estimate the sample size based on the assumption: \nWith 80% power and a two-sided \u03b1=0.05, using a \u03c72 test for independent proportions.", "answer": 400, "answer_type": "ACTUAL", "explanation": "Outcomes, randomisation and sample size\n We will randomise participants to CETA or control 1:1 using computer generated block randomisation (generated by the study team in Boston) with allocation generated automatically at the time of completing eligibility. Participants and study team members will not be blinded to which arm they are in. Our primary outcome is the proportion of participants who are retained and virally suppressed by 12 months postrandomisation. We will define the primary outcome to be suppression (ie, a viral load <50 copies/mL) any time up to 18 months after enrolment (to account for variation in the timing of the 12 months viral load). We will use routine clinic data collection to determine outcomes. Secondary outcomes will include: (1) viral suppression at 3 and 24 months; (2) attrition at 12 and 24 months; (3) changes in IPV, post-traumatic stress disorder, Center for Epidemiological Studies-Depression Scale (CES-D), alcohol and other substance use from baseline to 3 and 12 months and (4) cost and cost-effectiveness. The routine clinic data have been used extensively in prior research and has been found to be of high quality and fit for research purposes.39 40 Further, we have used these data approach for several other clinical trials.41 42 Details on outcomes are provided in table 2.\n \n Table 2\n \n Primary and secondary outcomes\n \n \n \n \n Outcome\n Description\n \n \n \n \n Retained and virally suppressed at 12 months\n Viral load testing is routinely done at the clinic at 6 and 12 months post-ART initiation and every 12 months thereafter. Due to the variability in when viral load testing is done, we will define the primary outcome to be suppression (ie, a viral load <50 copies/mL) any time up to 18 months. As our primary outcome includes retention, we are not able to contact patients who miss routine viral loads as this would affect attrition. Instead, we will use routine clinic data collection to determine outcomes. Missing viral loads will be a negative outcome. A combined retention/viral suppression outcome is looked at to better understand the impact of the intervention on both negative outcomes. This is because looking at suppression without considering retention rates only considers the clients retained in care and misses the large proportion of patients who drop out of HIV care\n \n \n Viral suppression at 3 and 24 months\n CETA may have some effects on suppression and retention over the first year of treatment mediated through the increased contact with patients that CETA entails. It is not clear for how long after the CETA intervention effects will be sustained. Thus, we will look at suppression at 24 months, long after CETA is complete. As our population should be monitored for suppression more frequently than every 12 months, we will also examine suppression within 3 months\n \n \n Attrition at 12 and 24 months\n Attrition (the opposite of retention) will be defined as being more than 90 days late for a study visit\n \n \n IPV, mental/behavioural health, alcohol and other substance use\n We will measure the effectiveness of CETA in reducing IPV and stress-related problems commonly associated with IPV and HIV, mental health (trauma, depression, anxiety, post-traumatic stress) and alcohol and substance use. We will also assess whether a change in these factors mediates the effectiveness of CETA on the primary outcome\n \n \n Cost and cost-effectiveness\n We will estimate the incremental cost-effectiveness of CETA vs active control in achieving the primary study outcome, retained in care and virally suppressed by 12 months, from the provider perspective. If found to be effective, a budget impact analysis will be conducted to estimate the affordability of routine implementation of the intervention at scale\n \n \n \n \n \n ART, antiretroviral therapy; CETA, Common Elements Treatment Approach; IPV, intimate partner violence.\n \n \n \n We estimate that only 40% of those who are unsuppressed (or at high risk of poor adherence) will be retained in care and virally suppressed 12 months postbaseline in the control arm.43 We believe a 20 percentage point increase in the proportion suppressed and retained between the CETA and control arms would be clinically meaningful. With 80% power and a two-sided \u00ce\u00b1=0.05, using a \u00cf\u00872 test for independent proportions our sample size required is 91 per arm (182 total).26 We increased the sample size to 400 total with a minimum of 75 women in the CETA arm who include partners (up to 100) to allow for assessment of mediation outcomes and other secondary outcomes. We are ensuring reaching our targeted enrolment by increasing the number of study sites if enrolment is less than optimal.", "id": 663, "split": "val"} +{"trial_id": "NCT04247711", "pmid": "36064643", "question": "Here is the design of a clinical trial:\n\nOfficial Title: On Track Chile For First Episode Psychosis\n\nIncluded conditions:\n- Psychosis\n\nStudy Armgroups:\n- {'label': 'OTCH', 'type': 'EXPERIMENTAL', 'description': 'OTCH is based on OTNY, a Coordinated Specialty Care program for people with first-episode psychosis. The program is implemented by a multidisciplinary team, who provide coordinated, evidence-based services based on the interests, needs, and preferences of each participant.', 'interventionNames': ['Behavioral: OTCH']}\n- {'label': 'Usual FEP services', 'type': 'PLACEBO_COMPARATOR', 'description': 'This is generally provided in mental health outpatient clinics which serve a population enrolled in the public health care system.', 'interventionNames': ['Behavioral: Usual FEP Services']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'OTCH', 'description': 'OTCH is structured in three phrases (i. engagement and initial needs assessment, ii. ongoing intervention and monitoring, and iii. transition to long-term services) and lasts an average of two years. OTCH will maintain the central characteristics of the OnTrack model, as well as its core principles, which include (1) Person-centered care, (2) Shared decision-making, (3) Recovery orientation, and (4) Culturally-competent care.', 'armGroupLabels': ['OTCH']}\n- {'type': 'BEHAVIORAL', 'name': 'Usual FEP Services', 'description': 'These include services such as psychiatric medication, psychotherapy, and psychoeducation for people with FEP and are usually provided at outpatient mental health clinics.', 'armGroupLabels': ['Usual FEP services']}\n\nPrimary Outcomes:\n- {'measure': 'Adapted version of the OTNY Fidelity Scale', 'description': 'This scale will assess the degree to which the participating clinics deliver OTCH. The scale 24 dimensions rated on a 3-score rating where 0=unmet, 1=partially met, and 2=totally met. Higher scores mean better Fidelity.', 'timeFrame': '24 months'}\n- {'measure': \"Change on Providers' attitudes using the Evidence-Based Practice Attitude Scale\", 'description': \"Providers' attitudes to evidence-based practices will be measured by the evidence-based attitude scale (EBPAS). The EBPAS consists of 15 items rated on a five-point scale from 0=Not at all to 4=Very great extent. Higher scores mean better attitudes to evidence-based practices.\", 'timeFrame': 'baseline, 12 months, 24 months'}\n- {'measure': 'Change on Adoption of OTCH among patients using the CollaboRATE', 'description': 'This is a 3-item scale rated on a ten-point scale from 0=No effort was made to 9=Every effort was made. Higher scores mean better Adoption.', 'timeFrame': 'baseline, 12 months, 24 months'}\n- {'measure': 'Change on Adoption of OTCH among providers using the Shared Decision Making Questionnaire Physician Version', 'description': 'This questionnaire continues with nine items about the steps in the adoption of the shared-decision making approach, one of the key components of OTCH. Each item is rated on a six-point scale from 0=Completely disagree to 5=Completely agree. Higher scores indicate more shared-decision making.', 'timeFrame': 'baseline, 12 months, 24 months'}\n- {'measure': 'Change on Adoption of OTCH among both patients and providers using the Recovery Self-Assessment scale', 'description': 'This is a 32-item, self-administered rating scale that will measure perceptions about recovery principles and overall quality of services. Each item is rated on a five-point scale from 1=Strongly disagree to 5=Strongly agree. Higher scores indicate greater quality care.', 'timeFrame': 'baseline, 12 months, 24 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, 80% power, intra-class correlation of 0.05, 10% dropout rate, and 2-tailed tests. For mediation effects, path a=.26 and b=.26 with over 80% power.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size and power analysis\n The first phase of the study which focused on the qualitative data collection did not include any formal power calculation to determine the sample size. Instead, we took a multistakeholder approach to include participants at different levels involved in the care for people with FEP including users and their family members. To incorporate a variety of stakeholder perspectives, we aimed to conduct 10 focus groups with 6\u00e2\u0080\u00938 stakeholders.\n For the cluster trial, power was calculated conservatively based on the participation of 270 participants (rather than the full 300 to be enrolled), anticipating a possible participant drop-out of ~10%. We estimated that, with at least 10 clinics in each condition, we will have 80% power to detect a difference in mean outcomes between study conditions with a moderate effect size of Cohen\u00e2\u0080\u0099s d = 0.35 following the standard detectible effect size formula for clustered randomized trials [15, 16]. This power calculation was derived assuming an intra-class correlation of 0.05 for outcomes by clinic (15 participants nested within 21 clinics). We also assume an alpha of 0.05 and that all tests are 2-tailed. Previous research has shown interventions like OTCH to have moderate to large effects on implementation and service outcomes, such as medication adherence, service utilization, and engagement in treatment [5, 17]. We have also shown that FEP providers in Chile rely primarily upon medication and are usually not trained to promote shared decision-making, recovery orientation, or person-centered care [9]. Then it is reasonable to anticipate at least moderate (and probably large) effects of OTCH on these indicators of implementation. Finally, evidence for the expected effect on participant-level symptoms and functioning comes from the RAISE Connection Program study, which indicated improvement over 24 months for participants enrolled (e.g., PANSS improvement effect size 0.91, occupational functioning 1.2, and social functioning 0.72) [17]. Power to detect mediation effects (Aim 2b) depends on the size of the effect of intervention on implementation and service outcomes (path a), and the correlation between implementation and services outcomes and participant level symptoms, functioning, and recovery (path b). Based on tabulated recommendations for sample sizes needed to test mediation effects with a sample of size N=270 with follow-up data, we have over 80% power to detect a significant mediation effect with path a=.26 and b=.26. Path a is expected to be >0.35 (argued for Aim 1 above), and we expect based on our previous work that there will be at least moderate associations between implementation and clinical outcomes (r>0.40), assuming no confounding of mediator-outcome relationship.", "id": 664, "split": "val"} +{"trial_id": "NCT04252261", "pmid": "33067279", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Sulforaphane on Cognitive Function in Patients With Frontal Brain Damage: Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Frontal Lobe Dysfunction\n\nStudy Armgroups:\n- {'label': 'sulforaphane', 'type': 'EXPERIMENTAL', 'description': 'To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage', 'interventionNames': ['Drug: sulforaphane']}\n- {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'To evaluate the effect of sulforaphane treatment on the cognitive deficits of patients with frontal brain damage', 'interventionNames': ['Drug: placedo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'sulforaphane', 'description': 'To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage', 'armGroupLabels': ['sulforaphane']}\n- {'type': 'DRUG', 'name': 'placedo', 'description': 'To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage', 'armGroupLabels': ['placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Changes from baseline cognitive tests scores at 3 months', 'description': 'The battery of cognitive tests include different domains of cognitive tests, higher scores indicates better cognition.', 'timeFrame': 'Week 1 and week 12.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided p value of 0.05, 20% inflation for dropout and loss of patients to follow-up, SD in total scores estimated at 14 at 0 and 3 months.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculation will be carried out using the SAS software. Since there were no previous studies of sulforaphane in patients with frontal brain damage, we estimated the sample size based on our unpublished study of sulforaphane treatment on cognitive impairment for other diseases (ClinicalTrials.gov: NCT02880462). 90 was calculated as the number necessary to detect an average difference of 18.5 in multiple cognitive domains between baseline and 3 months in the treatment group, and of 11.9 in the placebo groups at 80% power with a two-sided p value of 0.05. These calculations include a 20% inflation for dropout and loss of patients to follow-up. SD in total scores are estimated at 14 at 0 and 3 months. However, without knowledge of the within-person correlation between data points, it is impossible to predict the increase in power calculation.", "id": 665, "split": "val"} +{"trial_id": "NCT04252807", "pmid": "34233989", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Impact of a Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction in a Low Resource Community Setting of Rural Pakistan\n\nIncluded conditions:\n- Maternal Distress\n- Perinatal Depression\n- Development Delay\n- Language Delay\n- Cognitive Developmental Delay\n- Nutrition Poor\n- Growth Delay\n- Motor Delay\n- Maternal Behavior\n- Infant Development\n- Infant Malnutrition\n- Infant Behavior\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'Distressed mothers randomized to intervention arm will receive a common elements based integrated intervention that combines evidence based elements from packages of care addressing early stimulation, responsive feeding and perinatal depression. The integrated intervention is expected to a) improve mother psychological distress, b) improve family support, c) improve child development and d) promote mother-infant interaction.\\n\\nThe participants will receive 15 monthly sessions at home by lay health workers. First three sessions will be delivered to the participants in the third trimester of pregnancy, followed by 12 monthly sessions afterwards.', 'interventionNames': ['Behavioral: Intervention arm']}\n- {'label': 'Treatment as Usual (TAU)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The participants in the control arm will receive the routine monthly visits by the trained Lady Health Workers (LHWs) of their respective areas.', 'interventionNames': ['Other: Treatment as Usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Intervention arm', 'description': \"In addition to the routine care delivered by Lady Health Workers (LHWs), the participants in the intervention arm will receive common elements based integrated intervention. The providers of the intervention are lay health workers who will be trained in the intervention using an online course. The lay health worker will complete the online training course in a group, with interactive group activities and role plays. Lay health workers will be supported online and in-person by the trainers in monthly supervision meetings. The lay health workers will deliver intervention to distressed mothers in 15 monthly sessions. The intervention consists of three modules including 1) mothers' well-being, 2) infant nutrition,early stimulation and breastfeeding and 3) mother-infant interaction.\", 'armGroupLabels': ['Intervention arm']}\n- {'type': 'OTHER', 'name': 'Treatment as Usual', 'description': 'The participants in the control arm will receive the routine visits by LHWs of their respective areas. The LHWs are trained to provide antenatal care and referral, immunization services and support to community mobilization, provision of family planning and basic curative care via door to door visits to the households of their allocated areas.', 'armGroupLabels': ['Treatment as Usual (TAU)']}\n\nPrimary Outcomes:\n- {'measure': 'Observation of Mother and Child Interaction Tool (OMCI)', 'description': \"Maternal responsive caregiving behaviours will be assessed using the Observation of Mother and Child Interaction (OMCI) tool . OMCI tool is based on responsive parenting framework proposed by Landry and colleagues. The research assistants will observe a live 5-minute mother-infant interaction while mother and infant will play together with a picture book. The tool comprises of 19 items covering maternal affect, maternal touch, maternal verbalization, sensitivity and contingent responses, scaffolding, language stimulation, focus, child affect, child focus, child's communication efforts, and mutual enjoyment. The scoring format is based on the frequency of the occurrence of behaviours with higher scores indicating more responsive interactions. The OMCI tool has been validated for use in similar population in Pakistan.\", 'timeFrame': 'At 12-months postpartum'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include 80% power, 0.05 significance level, a two-sided hypothesis test, and a 20% attrition rate.", "answer": 250, "answer_type": "ACTUAL", "explanation": "Sample size calculations\n The power calculations are based on one primary outcome, that is, mother\u00e2\u0080\u0093child interaction on OMCI tool22 at 12 months\u00e2\u0080\u0099 postpartum. The scoring of tool is based on the frequency of the occurrence of responsive behaviours of mother with higher scores indicating more responsive interactions. The effect size for the present study was estimated based on the findings of a similar study conducted in Pakistan, where OMCI was used as one of the outcomes to evaluate the effect of responsive stimulation intervention on caregiver\u00e2\u0080\u0093child interaction at 12 and 24\u00e2\u0080\u0089months postpartum.8 The findings of the study showed mother\u00e2\u0080\u0093child dyads receiving responsive caregiving intervention had significantly higher mean scores on OMCI at 12 months (mean 32.3 (SD: 8.3) vs mean 27.1 (SD: 8.2), p<0.0001) than those who were allocated to control arm. Moreover, repeated-measures analysis showed that effects were sustained at 24\u00e2\u0080\u0089months. As the effect sizes for OMCI in Yousafzai et al 2015\u00e2\u0080\u0099s study ranged between 0.6 and 0.9; therefore, a conservative effect size of 0.4 (two-sides hypothesis) at 12\u00e2\u0080\u0089months post-partum was proposed in the present study. The effect size was calculated using the two-sided t-test. Assuming an effect size of 0.4, with 80% power, 0.05 significance and a two-sided hypothesis test and accounting for 20% attrition, we will need 250 caregiver\u00e2\u0080\u0093child dyads (125 in each arm).", "id": 666, "split": "val"} +{"trial_id": "NCT04253457", "pmid": "34583762", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Soft Tissue Injection of Corticosteroid And Local Anaesthetic Study - A Single Site, Non-inferiority Randomised Control Trial Evaluating Pain After Soft Tissue Corticosteroid Injections With and Without Local Anaesthetic\n\nIncluded conditions:\n- Carpal Tunnel Syndrome\n- De Quervains Tenosynovitis\n- Trigger Finger\n\nStudy Armgroups:\n- {'label': 'Corticosteroid injection', 'type': 'EXPERIMENTAL', 'description': 'Single injection of 1ml of triamcinolone (40mg/1ml)', 'interventionNames': ['Drug: 1ml of triamcinolone (40mg/1ml)']}\n- {'label': 'Corticosteroid and local anaesthetic injection', 'type': 'ACTIVE_COMPARATOR', 'description': 'Single injection of 1ml of triamcinolone (40mg/1ml) + 1ml 1% Lidocaine', 'interventionNames': ['Drug: 1ml of triamcinolone (40mg/1ml)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '1ml of triamcinolone (40mg/1ml)', 'description': 'Single injection of 1ml of triamcinolone (40mg/1ml)', 'armGroupLabels': ['Corticosteroid and local anaesthetic injection', 'Corticosteroid injection']}\n\nPrimary Outcomes:\n- {'measure': 'Pain visual analog scale scores at 1 hour', 'description': 'Investigate whether there is a difference in pain visual analog scale scores (where 0 is no pain and 10 is the worst pain possible) at 1-hour after a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic.', 'timeFrame': '1 hour'}\n\nPlease estimate the sample size based on the assumption: \nStandard deviation of 25 mm, 95% power, 5% significance level, 20% dropout rate, and 95% confidence intervals.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n As part of the literature review, it was identified that a 20-mm MCID on a 100-mm scale has been utilised in other studies evaluating post procedural pain [16], one of which was also investigating pain following soft tissue corticosteroid injections in the hand [14]. The authors are not aware of any studies that have specifically evaluated and set a standardised minimally clinical important difference (MCID) in pain VAS score following soft tissue corticosteroid injection in the hand and wrist. Although this is recognised as a limitation, it was felt that the ubiquitousness of the VAS as previously validated tool in multimodal and multisite pain, and its previously demonstrated utility and patient comprehension meant that it can be regarded as the most appropriate patient-reported pain score.\n A MCID of 20\u00e2\u0080\u0089mm will be used as the clinically admissible margin of non-inferiority. From previous studies, a standard deviation of 25\u00e2\u0080\u0089mm and with a 95% power calculations have determined a required sample size of 41 per study arm, when including a 20% fall out rate a total sample size of 100 patients will be required [14]. All sample size calculations were conducted at the two-sided 5% significance level and 95% CIs with Stata 14 (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP).", "id": 667, "split": "val"} +{"trial_id": "NCT04253951", "pmid": "35739502", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Lung Ultrasound for Early Detection of Silent and Apparent aspiratioN in Infants and Young CHildren With Cerebral Palsy and Other Developmental Disabilities: a New Fast, Safe, Cost-effective Infant-friendly Imaging Tool to Easily Monitor Feeding , Improve Outcomes and Reduce Morbidities (LUNCH)\n\nIncluded conditions:\n- Cerebral Palsy\n- Pediatric Neurological Disorder\n- Developmental Disability\n\nStudy Armgroups:\n- {'label': 'LUS-monitored management (LUS-m)', 'type': 'EXPERIMENTAL', 'description': 'In the first 3 months, participants will be evaluated a minimum of 1 time per month, in-hospital, for a total of 3 evaluations (T1, T2 and T3), plus baseline (T0). At any time point, they will undergo at least one LUS-monitored (before and after) feeding trial (different consistencies might be tested in separate repeated trials according to clinical evaluation). A further LUS evaluation will be performed at a distance of 3 hours, before the next meal to check for resolution of after-meal abnormalities.', 'interventionNames': ['Diagnostic Test: Lung Ultrasound (LUS)-monitored feeding trial']}\n- {'label': 'Standard care management (SC-m)', 'type': 'SHAM_COMPARATOR', 'description': 'Sham protocol with LUS performed at the same timepoints. LUS results in the SC-m group will be available only at the time of data analyses for comparison by investigators. They will not be used for clinical decisions.', 'interventionNames': ['Diagnostic Test: Lung Ultrasound (LUS)-monitored feeding trial']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Lung Ultrasound (LUS)-monitored feeding trial', 'description': 'LUS-monitored (before and after) feeding trial (different consistencies might be tested in separate repeated trials according to clinical evaluation). A further LUS evaluation will be performed at a distance of 3 hours, before the next meal to check for resolution of after-meal abnormalities. All pulmonary fields will be explored according to semeiotics and previous literature.', 'armGroupLabels': ['LUS-monitored management (LUS-m)', 'Standard care management (SC-m)']}\n\nPrimary Outcomes:\n- {'measure': 'respiratory', 'description': 'respiratory illness rate (including pneumonia, wheezing, chronic cough, and apnoea rate)', 'timeFrame': 'long term (T4, at 6 months)'}\n- {'measure': 'respiratory', 'description': 'respiratory illness rate (including pneumonia, wheezing, chronic cough, and apnoea rate)', 'timeFrame': 'short term (T3, at 3 months)'}\n- {'measure': 'growth', 'description': 'growth rate', 'timeFrame': 'long term (T4, at 6 months)'}\n- {'measure': 'growth', 'description': 'growth rate', 'timeFrame': 'short term (T3, at 3 months)'}\n- {'measure': 'invasive diagnostic', 'description': 'VFSS/FEES execution rates', 'timeFrame': 'long term (T4, at 6 months)'}\n- {'measure': 'invasive diagnostic', 'description': 'VFSS/FEES execution rates', 'timeFrame': 'short term (T3, at 3 months)'}\n\nPlease estimate the sample size based on the assumption: \nalpha = 0.05, power = 80%, attrition rate = 15%", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n The required sample size was calculated according to one of the primary outcome measures, which is the difference in LUS scores at T1 between assignment groups, based on preliminary results (alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, power (1-\u00c3\u009f err prob)\u00e2\u0080\u0089=\u00e2\u0080\u008980%, effect size f\u00e2\u0080\u0089=\u00e2\u0080\u00891.6) (unpublished data).\n Estimating a conservative attrition rate of 15%, our sample size will include 150 participants over 30\u00c2\u00a0months.", "id": 668, "split": "val"} +{"trial_id": "NCT04256473", "pmid": "35945566", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dual Thrombolytic Therapy With Mutant Pro-urokinase (M-pro-urokinase, HisproUK) and Low Dose Alteplase for Ischemic Stroke\n\nIncluded conditions:\n- Ischemic Stroke\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Bolus of IV alteplase (5 mg) followed by continuous infusion of HisproUK 40 mg/hr during 60 minutes.\\n\\nDepending on results of interim analyses, the alternate dose may be revised to a lower dose (30mg/hr during 60 minutes) or a higher dose (50mg/hr during 60 minutes).', 'interventionNames': ['Drug: mutant pro-urokinase']}\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Usual care with alteplase 0.9 mg/kg in 60 minutes', 'interventionNames': ['Drug: Alteplase']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'mutant pro-urokinase', 'description': 'Intravenous administration', 'armGroupLabels': ['Intervention'], 'otherNames': ['HisproUK']}\n- {'type': 'DRUG', 'name': 'Alteplase', 'description': 'Intravenous administration', 'armGroupLabels': ['Control'], 'otherNames': ['Actilyse']}\n\nPrimary Outcomes:\n- {'measure': 'Any intracranial hemorrhage according to the Heidelberg Bleeding Classification on MRI', 'timeFrame': '24-48 hours post-treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size will provide a power of at least 77% to detect a statistically significant effect on the primary outcome. Up to 20% of the included patients may not have a final diagnosis of ischemic stroke.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size\n We will include 200 patients with a final diagnosis of ischemic stroke randomized 1:1 to either standard thrombolytic treatment or dual thrombolytic treatment. We assume that the primary outcome, any ICH, will occur with a probability of 20% with standard thrombolytic treatment and a probability of 7% in the patients treated with dual thrombolytic therapy [24]. This leads to an overall effect (odds ratio (OR)) of 0.3. This sample size will provide us with a power of at least 77% to detect a statistically significant effect on the primary outcome. This estimate does not take into account the use of multivariable adjustment for differences in baseline characteristics in the primary analysis.\n To ensure sufficient power in the targeted modified on-treatment analysis, an additional patient will be randomized and included (i.e., replaced) for each patient whodid not give consent for participation in the study, orfor any reason did not receive the full dose of thrombolytics as assigned, orhad a final diagnosis other than ischemic stroke (i.e., stroke mimic).\u00e2\u0097\u00a6 We estimate that up to 20% of the included patients will not have a final diagnosis of ischemic stroke [25].", "id": 669, "split": "val"} +{"trial_id": "NCT04258709", "pmid": "36927811", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Antenatal Milk Expression on Breastfeeding Outcomes Among Overweight and Obese Women\n\nIncluded conditions:\n- Breastfeeding\n\nStudy Armgroups:\n- {'label': 'Antenatal Milk Expression (AME) Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.', 'interventionNames': ['Behavioral: AME']}\n- {'label': 'Video-based Infant Care Education Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).', 'interventionNames': ['Behavioral: Video-based infant care education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'AME', 'description': 'Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.', 'armGroupLabels': ['Antenatal Milk Expression (AME) Intervention Group']}\n- {'type': 'BEHAVIORAL', 'name': 'Video-based infant care education', 'description': 'Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.', 'armGroupLabels': ['Video-based Infant Care Education Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Breastfeeding Exclusivity', 'description': 'Whether participant is feeding 100% breast milk at 2 weeks postpartum', 'timeFrame': '2 weeks postpartum'}\n- {'measure': 'Breastfeeding Self-efficacy', 'description': 'Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome)', 'timeFrame': '2 weeks postpartum'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level of .017, power of .80, and an intervention drop-out/attrition rate of 25% by 2 weeks postpartum.", "answer": 280, "answer_type": "ACTUAL", "explanation": "Sample size\n Our targeted enrollment sample size is 280 birthing parents. This sample size was based on an anticipated intervention drop-out/attrition by 2\u00e2\u0080\u0089weeks postpartum of 25%, current national breastfeeding exclusivity rates at 1\u00e2\u0080\u00932\u00e2\u0080\u0089weeks postpartum, effects sizes for lactation support interventions in similar populations [19, 44], and anticipated challenges of recruitment within our eligiblity and geographical contraints. With a sample size of at least 210 (105 per group), we can detect with .80 power between-group differences in the prevalence of breastfeeding exclusivity at 2\u00e2\u0080\u0089weeks postpartum as small as .17 (medium effect size of OR\u00e2\u0080\u0089=\u00e2\u0080\u00892.55 using likelihood ratio chi-square test statistics) at an adjusted test-wise significance level of .017. In addition, with this sample size, we will be able to detect small to medium interaction effects between treatment groups over time as small as f\u00c2\u00a0=\u00e2\u0080\u0089.32 when using repeated measures F-tests with at least four postpartum outcome time points.", "id": 670, "split": "val"} +{"trial_id": "NCT04259112", "pmid": "32600358", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Pneumoperitoneum Pressure and the Extent of Neuromuscular Block on Renal Function in Patients With Diabetes Undergoing Laparoscopic Pelvic Surgery\n\nIncluded conditions:\n- Diabetes Mellitus\n- Acute Kidney Injury\n- Laparoscopic Surgical Procedure\n- Neuromuscular Blockade\n\nStudy Armgroups:\n- {'label': 'high pressure + deep block', 'type': 'EXPERIMENTAL', 'description': 'Intra-abdominal pressure will be set to 12-15 mmHg during the surgery. Deep neuromuscular block will be induced by rocuronium bolus 1 mg/kg, maintained by a continuous infusion of rocuronium (0.6mg/kg/h), and titrated towards post-tetanic count (PTC) 1-2.', 'interventionNames': ['Procedure: high pressure', 'Drug: deep neuromuscular block']}\n- {'label': 'high pressure + moderate block', 'type': 'EXPERIMENTAL', 'description': 'Intra-abdominal pressure will be set to 12-15 mmHg during the surgery. Moderate neuromuscular block will be induced by rocuronium bolus 0.6 mg/kg, maintained by a continuous infusion of rocuronium (0.3mg/kg/h), and titrated towards train-of-four (TOF) twitch 1-2.', 'interventionNames': ['Procedure: high pressure', 'Drug: moderate neuromuscular block']}\n- {'label': 'low pressure + deep block', 'type': 'EXPERIMENTAL', 'description': 'Intra-abdominal pressure will be set to 7-10 mmHg during the surgery. Deep neuromuscular block will be induced by rocuronium bolus 1 mg/kg, maintained by a continuous infusion of rocuronium (0.6mg/kg/h), and titrated towards PTC 1-2.', 'interventionNames': ['Drug: deep neuromuscular block', 'Procedure: low pressure']}\n- {'label': 'low pressure + moderate block', 'type': 'EXPERIMENTAL', 'description': 'Intra-abdominal pressure will be set to 7-10 mmHg. Moderate neuromuscular block will be induced by rocuronium bolus 0.6 mg/kg, maintained by a continuous infusion of rocuronium (0.3mg/kg/h), and titrated towards TOF twitch 1-2.', 'interventionNames': ['Drug: deep neuromuscular block', 'Drug: moderate neuromuscular block']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'high pressure', 'description': 'High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.', 'armGroupLabels': ['high pressure + deep block', 'high pressure + moderate block']}\n- {'type': 'DRUG', 'name': 'deep neuromuscular block', 'description': 'Deep neuromuscular block is defined as PTC 1-2.', 'armGroupLabels': ['high pressure + deep block', 'low pressure + deep block', 'low pressure + moderate block']}\n- {'type': 'PROCEDURE', 'name': 'low pressure', 'description': 'Low-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg.', 'armGroupLabels': ['low pressure + deep block']}\n- {'type': 'DRUG', 'name': 'moderate neuromuscular block', 'description': 'Moderate neuromuscular block is defined as TOF twitch 1-2.', 'armGroupLabels': ['high pressure + moderate block', 'low pressure + moderate block']}\n\nPrimary Outcomes:\n- {'measure': 'Serum cystatin C (CysC) level', 'description': 'CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).', 'timeFrame': '30 minutes before pneumoperitoneum insufflation'}\n- {'measure': 'Serum cystatin C (CysC) level', 'description': 'CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).', 'timeFrame': '30 minutes after pneumoperitoneum deflatation'}\n- {'measure': 'Serum cystatin C (CysC) level', 'description': 'CysC is a sensitive indicator for early kidney injury, and can be used to estimate glomerular filtration rate (GFR).', 'timeFrame': 'Postoperative 24 hours'}\n\nPlease estimate the sample size based on the assumption: \nThe power analysis was conducted to achieve 90% power at a 5% significance level. A 10% dropout rate was also considered. Statistical analysis will use a two-sided P value < 0.05 as significant.", "answer": 648, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and statistical analysis\n A previous study [15] reported that the standard deviation of serum CysC level after laparoscopic procedures is 0.738\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.186\u00e2\u0080\u0089mg/dl. For a CysC difference of 0.05\u00e2\u0080\u0089mg/dl to be considered clinically significant, a power analysis program (G* power 3.1) calculated that a total sample size of 582 patients is needed to achieve 90% power at the 5% significance level. Considering a 10% dropout rate, a total of 648 patients (162 per group) is necessary. Approximately 5000 patients are scheduled for elective major pelvic surgery in PUMCH every year, and approximately 15% of them have diabetes; thus, one year is estimated as necessary to achieve adequate participant enrollment.\n We will first compare the two SPP groups with the two LPP groups and then compare the two deep-NMB groups with the two moderate-NMB groups. Finally, all four groups will be compared.\n The baseline characteristics and intraoperative factors of the enrolled patients will be evaluated using descriptive analysis. Continuous variables will be summarized as the mean\u00e2\u0080\u008a\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u0089\u00e2\u0080\u008astandard deviation (SD) or median (interquartile range, IQR) as appropriate, whereas categorial variables will be summarized as the number (percentage). The baseline characteristics will be compared between groups using the standardized difference, and a standardized difference\u00e2\u0080\u0089<\u00e2\u0080\u00890.2 will be considered an acceptable balance between groups. Unbalanced variables at baseline will be included in the ANOVA or mixed-effects model to adjust for the potential confounding effect.\n Considering the multiple measures of CysC, Cr, surgical condition rating scale, and renal tissue oxygen saturation at different time points, the effect of intervention in the whole timeframe will be analyzed by a mixed-effects model. Other continuous variables will be compared by two-sided independent Student\u00e2\u0080\u0099s t tests or the Mann\u00e2\u0080\u0093Whitney U test, as appropriate. Categorical variables will be analyzed by a Chi-square test or Fisher\u00e2\u0080\u0099s exact test, as appropriate. The Bonferroni method will be used to correct the potential increase in the probability of a type I error when analyzing the differences between the four groups.\n We will also investigate the interaction between pneumoperitoneum pressure and NMB on postoperative renal function. The difference in serum Cysc levels at T2 between the S\u00e2\u0080\u0089+\u00e2\u0080\u0089D and L\u00e2\u0080\u0089+\u00e2\u0080\u0089D groups will be compared with that between the S\u00e2\u0080\u0089+\u00e2\u0080\u0089M and L\u00e2\u0080\u0089+\u00e2\u0080\u0089M groups. If there is no significant difference, we will assume there is no interaction.\n We will perform statistical analysis using R (version 3.4.4). Two-sided P values <\u00e2\u0080\u00890.05 will be considered significant.\n Based on ITT principle, we will analyze all the post-randomization cases, including the ones with missing data. The missing data of the repeatedly measured outcomes will be imputed using the \u00e2\u0080\u009clast observation carried forward\u00e2\u0080\u009d method, while the missing data of other outcomes will be imputed by baseline data. Sensitivity analysis will be performed to assess the bias that may be introduced due to nonadherence to protocol or missing data.", "id": 671, "split": "val"} +{"trial_id": "NCT04263038", "pmid": "33444199", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Surveillance Vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial\n\nIncluded conditions:\n- Pulmonary Embolism\n- Embolism\n- Embolism and Thrombosis\n- Lung Diseases\n- Cardiovascular Diseases\n- Respiratory Tract Diseases\n- Venous Thromboembolism\n- Anticoagulant-induced Bleeding\n- Bleeding\n\nStudy Armgroups:\n- {'label': 'Anticoagulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in the anticoagulation group will receive rivaroxaban 15 mg twice daily for the first 21 days, followed by 20 mg once daily for an overall treatment duration of 90 days.', 'interventionNames': ['Drug: Rivaroxaban']}\n- {'label': 'No anticoagulation', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients in the group without anticoagulation will receive placebo twice daily for the first 21 days, followed by one tablet daily for an overall treatment duration of 90 days.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rivaroxaban', 'description': 'Anticoagulation', 'armGroupLabels': ['Anticoagulation']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Study drug without active agent', 'armGroupLabels': ['No anticoagulation']}\n\nPrimary Outcomes:\n- {'measure': 'Recurrent venous thromboembolism', 'description': 'Proportion of recurrent, clinically symptomatic, objectively confirmed venous thromboembolism (defined as recurrent fatal or nonfatal pulmonary embolism or lower limb deep vein thrombosis)', 'timeFrame': 'Within 90 days of randomization'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided type I error of 5%, 80% power, and 5% attrition rate.", "answer": 276, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Assumptions on VTE recurrence risk are based on data from 127 low-risk patients with isolated SSPE who received anticoagulants (warfarin or low-molecular-weight heparin), showing a VTE recurrence risk of 0.8% at 90 days after diagnosis.23 We chose an absolute non-inferiority margin of 3.5% on the basis of recruitment feasibility, clinical acceptability and previous studies. This corresponds to a difference which is considered acceptable by most physicians and patients for the following reasons. First, our margin is within the range of the 3-month VTE recurrence proportion (0.5%\u00e2\u0080\u00935%) below which thrombosis specialists would not initiate anticoagulation for PE.61 Second, the definition of a clinically acceptable non-inferiority margin for recurrent VTE must also take into account the potential benefits of withholding anticoagulation, that is, the substantially lower risk of clinically significant bleeding (<1% vs 7% within 3 months for patients receiving anticoagulants).5 23 25 62 Indeed, a patient group with PE who was involved in the trial planning process indicated that given the bleeding risk associated with anticoagulants, a VTE recurrence proportion of <5% seemed acceptable. Finally, similar non-inferiority margins (3%\u00e2\u0080\u00935%) have been used in key studies comparing different drug treatment regimens and inpatient versus outpatient management for acute VTE.42 44 63\u00e2\u0080\u009367\n To determine the sample size, we used a Monte-Carlo simulation approach based on an Agresti-Caffo CI for risk difference.68 Assuming a baseline VTE recurrence proportion of 1.0% at 90 days in both treatment groups, an absolute margin of 3.5% defining non-inferiority for clinical surveillance and a sampling ratio of 1:1 allowing 5% attrition (dropouts, including patients who died from non-VTE-related causes) in each group during 90 days, we estimated that 276 patients (138 per group) would result in at least 80% power to establish non-inferiority at an one-sided type I error of 5%.", "id": 672, "split": "val"} +{"trial_id": "NCT04264949", "pmid": "36963800", "question": "Here is the design of a clinical trial:\n\nOfficial Title: E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain\n\nIncluded conditions:\n- Chronic Low Back Pain\n\nStudy Armgroups:\n- {'label': 'group application (GA)', 'type': 'EXPERIMENTAL', 'description': 'benefit from conventional care in a rehabilitation center, therapeutic education program and education in the use of the smartphone application \"mon coach dos\"', 'interventionNames': ['Other: Education in the use of smartphone app (Mon coach dos)', 'Other: conventional care']}\n- {'label': 'Groupe conventional care (GCC)', 'type': 'ACTIVE_COMPARATOR', 'description': 'benefit from conventional care in a rehabilitation center and therapeutic education program', 'interventionNames': ['Other: conventional care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Education in the use of smartphone app (Mon coach dos)', 'description': 'In addition to conventional care and the therapeutic education program, GA will benefit from three education sessions (one per week) on the use of the smartphone app mon coach dos', 'armGroupLabels': ['group application (GA)']}\n- {'type': 'OTHER', 'name': 'conventional care', 'description': 'conventional care and the therapeutic education program', 'armGroupLabels': ['Groupe conventional care (GCC)', 'group application (GA)']}\n\nPrimary Outcomes:\n- {'measure': 'EARS : exercise adherence rating scale', 'description': 'EARS assess the adherence in physical activity program.', 'timeFrame': 'day1'}\n- {'measure': 'EARS : exercise adherence rating scale', 'description': 'EARS assess the adherence in physical activity program.', 'timeFrame': 'day 15'}\n- {'measure': 'EARS : exercise adherence rating scale', 'description': 'EARS assess the adherence in physical activity program.', 'timeFrame': 'day 180'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 5%, statistical power of 90%, and an intraclass correlation coefficient (ICC) of 0.05. The design accounts for between-session and within-session variability, and an average of 5 participants per session.", "answer": 120, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n The sample size estimation for this pilot trial was determined according to the 2010 CONSORT Statement extension for randomised pilot and feasibility trials51 and Cohen\u00e2\u0080\u0099s recommendations52 that define effect-size (ES) limits as small (ES: 0.2), medium (ES: 0.5) and large (ES: 0.8, \u00e2\u0080\u0098grossly perceptible and therefore large\u00e2\u0080\u0099). According to data reported in the literature and considering this study as a pilot, it seems suitable to include 60 patients per randomised group.\n To achieve an ES of 0.8 at 6 months post-randomisation with a type I error of 5% and statistical power of 90%, 33 participants are required per group. However, because of the design of the randomisation, with session as a unit cluster of randomisation, the sample size should be increased to take into account between-session and within-session variability. More precisely, the assumption in randomised controlled trials that the outcome for an individual is completely unrelated to that of any other individual is violated in cluster randomised trials because individuals in any one cluster (session in our case) are more likely to respond in a similar manner. This similarity is known as the intraclass correlation coefficient (ICC). For an average of 5 participants per session and an ICC of 0.05, 38 participants are required in each group. Therefore, to account for losses to follow-up, we will include 120 individuals (ie, 60 patients per randomised group).", "id": 673, "split": "val"} +{"trial_id": "NCT04265950", "pmid": "39871186", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multicenter, Randomized, Open-Label Trial in Children and Adolescents to Establish Optimal Number of Doses for HPV Vaccination in Children and Adolescents Living With HIV\n\nIncluded conditions:\n- HIV Infection\n\nStudy Armgroups:\n- {'label': 'Arm 1 (3 doses of 9vHPV vaccine)', 'type': 'EXPERIMENTAL', 'description': 'Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment, and at 2 and 6 months. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 30 months.', 'interventionNames': ['Biological: Recombinant Human Papillomavirus Nonavalent Vaccine']}\n- {'label': 'Arm 2 (2 doses of 9vHPV vaccine)', 'type': 'EXPERIMENTAL', 'description': 'Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment and at 6 months. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 30 months.', 'interventionNames': ['Biological: Recombinant Human Papillomavirus Nonavalent Vaccine']}\n- {'label': 'Arm 3 (1 dose of 9vHPV vaccine)', 'type': 'EXPERIMENTAL', 'description': 'Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 24 months and recombinant human papillomavirus nonavalent vaccine completion dose IM at 30 months.', 'interventionNames': ['Biological: Recombinant Human Papillomavirus Nonavalent Vaccine']}\n- {'label': 'Arm 4 (1 dose of 9vHPV vaccine)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants without HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment . Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 24 months and recombinant human papillomavirus nonavalent vaccine completion dose IM at 30 months.', 'interventionNames': ['Biological: Recombinant Human Papillomavirus Nonavalent Vaccine']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Recombinant Human Papillomavirus Nonavalent Vaccine', 'description': 'Given IM', 'armGroupLabels': ['Arm 1 (3 doses of 9vHPV vaccine)', 'Arm 2 (2 doses of 9vHPV vaccine)', 'Arm 3 (1 dose of 9vHPV vaccine)', 'Arm 4 (1 dose of 9vHPV vaccine)'], 'otherNames': ['Gardasil 9', 'Nonavalent HPV VLP Vaccine', 'Recombinant HPV Nonavalent Vaccine', 'Recombinant Human Papillomavirus 9-valent Vaccine']}\n\nPrimary Outcomes:\n- {'measure': 'Human papillomavirus type 16 (HPV16) neutralizing antibody geometric mean titers (GMTs) (Arm 1 versus [vs.] Arm 2)', 'description': 'Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 neutralizing antibody GMT.', 'timeFrame': 'At 24 months after the last dose of each vaccine regimen'}\n\nPlease estimate the sample size based on the assumption: \n74-97% power for the primary comparison using a non-inferiority margin of 0.35 for the ratio of GMT between the 2- and 3-dose arms.", "answer": 97, "answer_type": "ACTUAL", "explanation": "Sample size and power\n In absence of any previously collected data on HPV16 GMT 24 months after 2 vs. 3 doses in CLWH, assumptions were made on the distribution of the primary endpoint based on data accrued in previous trials [6, 10]. We used estimates for HPV16 neutralizing antibody GMT 12 months after 2 or 3 doses for HIV-negative children [6] and data for HPV16 neutralizing antibody GMT values after 3 doses in CLWH and HIV-negative children [10]. These data were used to bridge estimates for the mean GMT level for CLWH for both of those dose groups. Under reasonable assumptions for the pooled standard deviation, we anticipate having 74\u00e2\u0080\u009397% power for the primary comparison using a non-inferiority margin of 0.35 for the ratio of GMT between the 2- and 3-dose arms, i.e. 74\u00e2\u0080\u009397% power to show that the response in Arm 2 is at least 35% of the response in Arm 1.", "id": 674, "split": "val"} +{"trial_id": "NCT04266236", "pmid": "37718446", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ultrasound-guided Lumbar Plexus Combined with Quadratus Lumborum Block Using Single-needle Technique with Shamrock Method for Hip Arthroplasty\n\nIncluded conditions:\n- Hip Osteoarthritis\n- Anesthesia, Local\n- Hip Fractures\n- Osteonecrosis of Femoral Head\n\nStudy Armgroups:\n- {'label': 'L3 LPB technique (P group)', 'type': 'ACTIVE_COMPARATOR', 'description': 'ultrasound-guided shamrock approach L3 lumbar plexus block with single-needle technique', 'interventionNames': ['Procedure: L3 LPB', 'Drug: 0.375%ropivacaine 25 ml (Raropin)', 'Procedure: General anesthesia with tracheal intubation']}\n- {'label': 'T12 combined with L3 and L4 LPB technique (TP group)', 'type': 'ACTIVE_COMPARATOR', 'description': 'ultrasound-guided posterior approach thoracic 12 combined with L3 and L4 lumbar plexus block with mulitple-needle technique', 'interventionNames': ['Procedure: L3 LPB', 'Procedure: L4 LPB', 'Procedure: T12 block', 'Drug: 0.375%ropivacaine 40 ml (Raropin)', 'Procedure: General anesthesia with tracheal intubation']}\n- {'label': 'L3 LPB combined with QLB (LPQLB-SNT, PQ group)', 'type': 'EXPERIMENTAL', 'description': 'ultrasound-guided shamrock approach L3 lumbar plexus block combined with quadratus lumborum block with single-needle technique', 'interventionNames': ['Procedure: L3 LPB', 'Procedure: L3 QLB', 'Drug: 0.375%ropivacaine 40 ml (Raropin)', 'Procedure: General anesthesia with tracheal intubation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'L3 LPB', 'description': 'ultrasound-guided L3 lumbar plexus block', 'armGroupLabels': ['L3 LPB combined with QLB (LPQLB-SNT, PQ group)', 'L3 LPB technique (P group)', 'T12 combined with L3 and L4 LPB technique (TP group)']}\n- {'type': 'PROCEDURE', 'name': 'L4 LPB', 'description': 'ultrasound-guided L4 lumbar plexus block', 'armGroupLabels': ['T12 combined with L3 and L4 LPB technique (TP group)']}\n- {'type': 'PROCEDURE', 'name': 'T12 block', 'description': 'ultrasound-guided thoracic 12th segment nerve block', 'armGroupLabels': ['T12 combined with L3 and L4 LPB technique (TP group)']}\n- {'type': 'PROCEDURE', 'name': 'L3 QLB', 'description': 'ultrasound-guided quadratus lumborum block at L3 level', 'armGroupLabels': ['L3 LPB combined with QLB (LPQLB-SNT, PQ group)']}\n- {'type': 'DRUG', 'name': '0.375%ropivacaine 25 ml (Raropin)', 'description': '0.375%ropivacaine (Raropin) 25ml will be given', 'armGroupLabels': ['L3 LPB technique (P group)']}\n- {'type': 'DRUG', 'name': '0.375%ropivacaine 40 ml (Raropin)', 'description': '0.375%ropivacaine (Raropin) 40ml will be given', 'armGroupLabels': ['L3 LPB combined with QLB (LPQLB-SNT, PQ group)', 'T12 combined with L3 and L4 LPB technique (TP group)']}\n- {'type': 'PROCEDURE', 'name': 'General anesthesia with tracheal intubation', 'description': 'General anesthesia with tracheal intubation will be induced with sufentanil, propofol, vecuronium for every patient before the operation and maintained with sevoflurane during the operation', 'armGroupLabels': ['L3 LPB combined with QLB (LPQLB-SNT, PQ group)', 'L3 LPB technique (P group)', 'T12 combined with L3 and L4 LPB technique (TP group)']}\n\nPrimary Outcomes:\n- {'measure': 'sensory block assessment', 'description': 'The sensory block will be assessed by cold alcohol swab and pinprick at lateral, anterior and medial areas of thigh and postero-lateral area of gluteus using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.', 'timeFrame': '30 minutes after nerve block procedure'}\n\nPlease estimate the sample size based on the assumption: \nChi-square test, 90% power, two-tailed 5% significance level, including possible dropouts.", "answer": 84, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Due to lack of referencedata in previous published study, calculation of the sample size was based on our pilot study with 24 subjects. We estimated the success rates of the three groups to be 20%, 70%, and 65%, respectively. Using chi-square test, sample size of 28 for each group will achieve 90% power to detect the difference with a two-tailed 5% significance level. The total sample size will be 84 including the possible dropouts.", "id": 675, "split": "val"} +{"trial_id": "NCT04267471", "pmid": "33413354", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tai Chi for Patients With Essential Hypertension: Study Protocol of an Open-label Single-center Randomized Controlled Trial\n\nIncluded conditions:\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Tai Chi', 'type': 'EXPERIMENTAL', 'description': '3 sessions of Tai Chi per week for 12 weeks', 'interventionNames': ['Behavioral: Tai Chi']}\n- {'label': 'Walking', 'type': 'ACTIVE_COMPARATOR', 'description': '3 sessions of walking per week for 12 weeks', 'interventionNames': ['Behavioral: Walking']}\n- {'label': 'Waiting-list', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Tai Chi', 'description': 'Tai Chi is a traditional Chinese mind-body exercise, which combines deep-breath relaxation and gentle movements in sequence with meditation. Each session of Tai Chi will last 60 minutes, including a 10-minute warm-up, a 40-minute Tai Chi practice and a 10-minute cool-down.', 'armGroupLabels': ['Tai Chi'], 'otherNames': ['Tai Ji Quan']}\n- {'type': 'BEHAVIORAL', 'name': 'Walking', 'description': 'Each session of walking will last 60 minutes, including a 10-minute warm-up, a 40-minute walking and a 10-minutes cool-down.', 'armGroupLabels': ['Walking']}\n\nPrimary Outcomes:\n- {'measure': 'average 24-h Systolic Blood Pressure (SBP)', 'timeFrame': 'change from baseline to 12 weeks after intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation used One-Way analysis of variance, F-Tests with PASS 15.0 software. The study aims for a power of 80% at a significance level of 5%. A 20% dropout rate is considered.", "answer": 234, "answer_type": "ESTIMATED", "explanation": "Sample size\n This study is an RCT, the intervention group is the Tai Chi group, and the control groups are walking group and waiting-list group. The reduction of Systolic Blood Pressure (SBP) is set as the primary outcome. According to previous study [31], the mean difference and standard deviation of SBP was \u00e2\u0088\u0092\u00e2\u0080\u008913.33\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008946.73, \u00e2\u0088\u0092\u00e2\u0080\u008912.46\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008933.37 and 3.37\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u008946.01 for Tai Chi compared with walking and waiting-list control. The sample size was calculated using One-Way analysis of variance, F-Tests with the PASS 15.0 software. The standard deviation is set as 20. A total of 65 participants per arm are needed to achieve a power of 80% at a significant level of 5%. A sample size of 195 participants is required to sufficiently detect a target effect size. Considering a 20% drop-out rate, we intend to enroll a total of 234 participants, with 78 participants in each group.", "id": 676, "split": "val"} +{"trial_id": "NCT04269018", "pmid": "34242256", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Mobile Text Message on Behavioral Risks of Cancer Among College Students, Northeast Ethiopia: A Randomized Controlled Trial\n\nIncluded conditions:\n- Behavioral Risks of Cancer\n\nStudy Armgroups:\n- {'label': 'Cancer specific Mobile text message', 'type': 'EXPERIMENTAL', 'description': 'This arm will receive daily mobile text message related with cancer risks and prevention', 'interventionNames': ['Behavioral: Cancer specific Mobile text message']}\n- {'label': 'general health messages', 'type': 'ACTIVE_COMPARATOR', 'description': 'This arm will receive general health message once a week', 'interventionNames': ['Behavioral: General health messages']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cancer specific Mobile text message', 'description': 'The intervention is cancer specific lifestyle mobile text messages daily for 2 months', 'armGroupLabels': ['Cancer specific Mobile text message']}\n- {'type': 'BEHAVIORAL', 'name': 'General health messages', 'description': 'Daily text related with general health message', 'armGroupLabels': ['general health messages']}\n\nPrimary Outcomes:\n- {'measure': 'Physical activity level', 'description': 'For measuring physical activity International Physical Activity Questionnaires (IPAQ) will be used. The questions will ask the time study participants spent being physically active in the last 7 days. Then, it will be summarized as Metabolic Equivalents (METs).', 'timeFrame': 'on average 6 months'}\n- {'measure': 'Health dietary score', 'description': 'Healthy diet score will be assessed the health diet score adapted from the WHO list of healthy diet foods, which is a Likert scale ranged from 1 to 6.', 'timeFrame': 'on average 6 months'}\n- {'measure': 'Tobacco use', 'description': 'Tobacco smoking will be assessed using a series of questions adopted from the World Health Organization (WHO), which used to assess the duration, quantity and frequency of smoking within one month.', 'timeFrame': 'on average 6 months'}\n- {'measure': 'Alcohol intake', 'description': 'Alcohol consumption will be assessed using a tool adopted from National Institute on Alcohol Abuse and Alcoholism (NIAAA), which used to assess participants consumption in the past 1 month.', 'timeFrame': 'on average 6 months'}\n- {'measure': 'Risk perception', 'description': 'Risk perception will be measured using health belief model variables: perceived susceptibility towards cancer, perceived severity of cancer, perceived benefits of adopting behaviors, perceived barriers to adopting behaviors, perceived self-efficacy for adopting dietary behaviors and internal cues for adopting dietary behaviors, the items of this subscale will be measured on a Likert scale ranging from 1= \"Strongly disagree\" to 5 = \"Strongly agree\".', 'timeFrame': 'on average 6 months'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence level, 80% power, 10% loss to follow up", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size and sampling strategy\n The sample size for the study was determined using the assumption of a design to demonstrate the superiority of a new intervention or text message compared to the control group in improving self-efficacy (superiority trial design), assuming a 2.9 mean difference of perceived self-efficacy to adopt healthy behavior between text message and control group, a 6.22 pooled standard deviation [22], 95% confidence level, 80% power, and an expectation of 10% loss to follow up. With a 1:1 ratio, the sample size was estimated to be 160 (80 intervention and 80 control group). The sample size will be allocated to Woizero Siheen Polytechnic College and Dessie College of teacher\u00e2\u0080\u0099s education based on proportional to the number of students. Students\u00e2\u0080\u0099 ID numbers will be obtained from the registrar\u00e2\u0080\u0099s office of each college and used as a sampling frame. Then; a simple random sampling method will be used to select study subjects.", "id": 677, "split": "val"} +{"trial_id": "NCT04274439", "pmid": "32590959", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness and Cost-Effectiveness of a Tele-Rehabilitation Program in the Treatment of Chronic Musculoskeletal Pain\n\nIncluded conditions:\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'Internet-Based Pain Education and Exercise', 'type': 'EXPERIMENTAL', 'description': 'Patients allocated to the intervention group will receive a login and password for individual access to the website designed for the study. The content of this intervention will include videos and animations based on pain education, physical activity promotion and general exercises. The pain education component will be based on the E-pain intervention developed by Reis et al (2017), which includes nine main features: (1) acceptance, (2 and 3) education about pain, (4) sleep hygiene, (5) recognizing stress and negative emotions, (6) increasing positive coping in lifestyle, (7) exercises, (8) communication and (9) relapse prevention. The exercise component will include general exercises aiming to improve strength, flexibility, control and coordination.\\n\\nPatients in this group will also receive weekly text messages and a health coaching over the telephone. The text messages will include information on the benefits of exercises, motivation, and positive messages about dealing with pain.', 'interventionNames': ['Other: Internet-Based Pain Education and Exercise']}\n- {'label': 'Online Booklet', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients allocated to the control group will have access to an online booklet containing general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits and promotion of exercises. They will also receive one phone call at week 4 and text messages once a week during the study period.', 'interventionNames': ['Other: Online Booklet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Internet-Based Pain Education and Exercise', 'description': 'Telerehabilitation is defined as providing techniques for therapeutic rehabilitation remotely or off-site using telecommunication technologies. Thus, our intervention will be based on the use of a website created and registered especially for the study that will have the shooting of 1 video of pain education and 1 video of exercises for the subjects of the study, totaling 8 videos of pain education and 8 exercise videos. We will provide complimentary materials along with the triggered videos and a booklet of chronic pain information. We will also make weekly calls for a health coaching service and the sending of smartphone messages for the motivation and accountability of the subjects.', 'armGroupLabels': ['Internet-Based Pain Education and Exercise'], 'otherNames': ['Telerehabilitation']}\n- {'type': 'OTHER', 'name': 'Online Booklet', 'description': 'An online booklet containing information about chronic pain and suggestions for lifestyle modifications and behavior will be delivered, as well as an incentive to perform physical exercises.', 'armGroupLabels': ['Online Booklet']}\n\nPrimary Outcomes:\n- {'measure': 'Pain Intensity at post-treatment follow-up', 'description': 'The primary outcome will be pain intensity measured using the Pain Numerical Rating Scale, a numerical scale of 11 domains, where 0 indicates no pain and 10 indicates maximum pain intensity.', 'timeFrame': 'Post-treatment follow-up (8 weeks)'}\n\nPlease estimate the sample size based on the assumption: \ntwo-sided alpha level of 0.05, loss to follow up rate of up to 15%", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We determined that a minimum of 160 individuals (80 per group) would be required to provide the trial with 90% power to detect a between-group difference of 1.5 point in a 0 to 10 Pain Numerical Rating Scale, with an estimated standard deviation of 2.75 points and two-sided alpha level of 0.05. The estimated sample size would also allow for loss to follow up rate of up to 15%.", "id": 678, "split": "val"} +{"trial_id": "NCT04274530", "pmid": "36273187", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Behavioral Therapy to Optimize Post-Operative Recovery (COPE): A Randomized Controlled Trial\n\nIncluded conditions:\n- Pain, Postoperative\n- Pain, Acute\n- Pain, Chronic\n- Fractures, Closed\n- Fractures, Open\n\nStudy Armgroups:\n- {'label': 'Intervention - CBT', 'type': 'EXPERIMENTAL', 'description': 'Participants in this arm will receive cognitive behavioural therapy (CBT). Participants will complete a series of online modules via a mobile application in addition to standard of care for their fracture injury. Participants will be assigned a dedicated CBT therapist, and receive feedback and support from their therapist via in-app messaging. The CBT program will last approximately 6-8 weeks.', 'interventionNames': ['Behavioral: Cognitive Behavioural Therapy']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control arm of the study will receive standard of care treatment for their fracture(s) but will not receive any Cognitive Behavioral Therapy.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive Behavioural Therapy', 'description': \"Participants who are randomized to the CBT intervention will be encouraged to begin CBT immediately following randomization. The CBT intervention will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses to baseline questionnaires. All other aspects of post-operative care will be at the discretion of participant's surgeon.\", 'armGroupLabels': ['Intervention - CBT'], 'otherNames': ['CBT']}\n\nPrimary Outcomes:\n- {'measure': \"The prevalence of moderate to severe Persistent Post-Surgical Pain at 12 months' post-fracture\", 'description': \"The primary outcome is PPSP according to the World Health Organization's (WHO) proposed definition.\\n\\nThe WHO's definition requires 4 criteria for the diagnosis of PPSP: 1) Pain that began after surgery or a tissue trauma is experienced; 2) The pain is in an area of preceding surgery or tissue trauma, 3) The pain persisted for at least three months after the initiating event, and 4) The pain is not better explained by an infection, a malignancy, a pre-existing pain condition or any other alternative cause.\", 'timeFrame': '12 months post-fracture'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered at 80% with a significance level (alpha) of 0.05. A 20% loss to follow-up is anticipated.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n The choice of sample size is based on a comparison of CBT versus usual care for the primary outcome of the prevalence of moderate to severe persistent post-surgical pain over 12\u00c2\u00a0months post-fracture (Table 2). The anticipated rate of moderate to severe persistent pain is 67%, based on findings from 1218 patients with open extremity fractures enrolled in the FLOW trial, and followed for 1\u00c2\u00a0year [11]. If we select a control group event rate of 50% and assume a 20% relative risk reduction with CBT, our required sample size per arm is 408. We will recruit 500 participants/arm, for a total of 1000 participants, to accommodate up to a 20% loss to follow-up.Table 2Sample size per arm (80% study power, alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05). Difference in the proportion of persistent post-surgical pain, between treatment and control groupsRelative risk reduction in moderate to severe persistent pain15%20%25%Proportion of moderate to severe persistent pain in control group (p1)40%104958937645%86648831350%71940826255%600342221\n Table 2 shows the number of participants required per arm across a range of plausible baseline risks in the control group and risk differences of persistent post-surgical pain between treatment and control groups. Bolded numbers represent sample sizes/arm for which the trial is adequately powered to detect clinically important differences.", "id": 679, "split": "val"} +{"trial_id": "NCT04280003", "pmid": "34373315", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in Ischemic Stroke. A Phase IIB Multicenter Double Blind Placebo Controlled Clinical Trial\n\nIncluded conditions:\n- Ischemic Stroke\n- Adipose Tissue-derived Stem Cell\n- Functional Status\n\nStudy Armgroups:\n- {'label': 'Treatment group', 'type': 'EXPERIMENTAL', 'description': '15 patients will receive intravenous alogenic adipose tissue-derived stem cells in a single dose of one million cells per kg.', 'interventionNames': ['Other: Alogenic adipose tissue-derived stem cells']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': '15 patients will receive a single intravenous placebo solution with the same appearance as the treatment group.', 'interventionNames': ['Drug: Placebo solution']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Alogenic adipose tissue-derived stem cells', 'description': 'Concentration of the cells: 10 million cells / ml', 'armGroupLabels': ['Treatment group']}\n- {'type': 'DRUG', 'name': 'Placebo solution', 'description': 'Placebo intravenous solution, same appearance stem cells solution', 'armGroupLabels': ['Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'Safety of administration of adipose tissue-derived mesenchymal stem cells measured as reported adverse events', 'description': 'Adverse events reported spontaneously or in response to questions not addressed.', 'timeFrame': 'Up to 24 months after treatment or placebo administration'}\n- {'measure': 'Safety of administration of adipose tissue-derived mesenchymal stem cells measured as neurological o systemic complications', 'description': 'Neurological or systemic complications', 'timeFrame': 'Up to 24 months after treatment or placebo administration'}\n\nPlease estimate the sample size based on the assumption: \nNo systematic sample size calculation applies.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n Given this is a pilot phase II clinical trial focused on the assessment of safety, no systematic sample size calculation applies. Based on the previous clinical trial, AMASCIS-01, it seems feasible to recruit 30 patients between the two participating centres.", "id": 680, "split": "val"} +{"trial_id": "NCT04280497", "pmid": "36898751", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy\n\nIncluded conditions:\n- Sepsis\n\nStudy Armgroups:\n- {'label': 'Biomarker CIRCI neg: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker CIRCI neg: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker endocan: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker endocan: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker GILZ: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker GILZ: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker CPD: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker CPD: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker Transcriptomic SRS: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker Transcriptomic SRS: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker Endotype B: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}\n- {'label': 'Biomarker Endotype B: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Administration procedures', 'description': 'Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours;\\n\\n9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 \u03bcg tablet via a nasogastric tube once per day in the morning.\\n\\nStudy drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off.', 'armGroupLabels': ['Biomarker CIRCI neg: Corticosteroid arm', 'Biomarker CIRCI neg: Placebo arm', 'Biomarker CPD: Corticosteroid arm', 'Biomarker CPD: Placebo arm', 'Biomarker Endotype B: Corticosteroid arm', 'Biomarker Endotype B: Placebo arm', 'Biomarker GILZ: Corticosteroid arm', 'Biomarker GILZ: Placebo arm', 'Biomarker Transcriptomic SRS: Corticosteroid arm', 'Biomarker Transcriptomic SRS: Placebo arm', 'Biomarker endocan: Corticosteroid arm', 'Biomarker endocan: Placebo arm']}\n\nPrimary Outcomes:\n- {'measure': '3-month mortality', 'description': \"Patient's vital status.\", 'timeFrame': 'Daily up to 3 months'}\n- {'measure': 'Persistent organ dysfunction', 'description': 'Persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) and with SOFA score \u22646 up to 90 days.', 'timeFrame': 'At baseline, 1 month and 3 months'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (alpha) is 0.05, and the power is 80.04% for vasopressor-free days and 80% for 90-day all-cause mortality. The sample size is inflated fourfold to handle potential dropouts, and Bayesian inference will be used for sequential analyses.", "answer": 1800, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sequential analyses will use the number of vasopressor-free days at day 28 as the measure of efficacy, and the occurrence of severe adverse events within the first 28 days as the measure of toxicity. In a recent study,8 the number of vasopressor-free days at day 28 with HC+FC was 17.1\u00c2\u00b110.8 vs 15.0\u00c2\u00b111.1 in placebos. Thus, a sample of 176\u00c3\u00972=352 patients achieves 80.04% power to reject the null hypothesis of equal means when the mean difference between arms is 3\u00e2\u0080\u0089days with SD of 10 days, and with a significant level (alpha) of 0.05 using a two-sample t-test. For interactions to be detected with the same power as the overall effect, sample sizes should be inflated,29 estimated here at a multiple of fourfold; therefore, to handle potential dropouts, a sample was estimated at 1800 patients. Bayesian inference will be used for sequential analyses.\n To detect a 10% absolute risk reduction from 45% to 35% in 90-day all-cause mortality,8 a sample size of 373 evaluable patients per arm (thus a total of 746 patients) is required to reach 80% power. The planned sample of 1800 patients will achieve a 99.16% power to reject the null hypothesis of equal mortality when the difference between arms is 10% overall, and with a 5% alpha level. Sample sizes were computed using PASS V.15 software (2017).\n The power to detect this difference within each group of analysis will depend on the prevalence of each biomarker of interest.", "id": 681, "split": "val"} +{"trial_id": "NCT04281667", "pmid": "34244284", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial\n\nIncluded conditions:\n- Rectal Adenocarcinoma\n- Rectum Neoplasm\n- Rectum Carcinoma\n- Colorectal Cancer\n- Colorectal Neoplasms\n- Colorectal Carcinoma\n- Surgical Site Infection\n- Surgery--Complications\n\nStudy Armgroups:\n- {'label': 'Mechanical Bowel Preparation and Oral Antibiotics', 'type': 'EXPERIMENTAL', 'description': 'Mechanical Bowel Preparation and Oral Antibiotics', 'interventionNames': ['Drug: Oral Antibiotics', 'Drug: Mechanical Bowel Preparation']}\n- {'label': 'Mechanical Bowel Preparation Only', 'type': 'ACTIVE_COMPARATOR', 'description': 'Mechanical Bowel Preparation Only', 'interventionNames': ['Drug: Placebo', 'Drug: Mechanical Bowel Preparation']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oral Antibiotics', 'description': 'Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)', 'armGroupLabels': ['Mechanical Bowel Preparation and Oral Antibiotics']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)', 'armGroupLabels': ['Mechanical Bowel Preparation Only']}\n- {'type': 'DRUG', 'name': 'Mechanical Bowel Preparation', 'description': 'Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)', 'armGroupLabels': ['Mechanical Bowel Preparation Only', 'Mechanical Bowel Preparation and Oral Antibiotics']}\n\nPrimary Outcomes:\n- {'measure': 'Comprehensive Complication Index', 'description': 'Comprehensive Complication Index score', 'timeFrame': 'Within 30 days from surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe power is set at 90% and the margin of error at 5%. Approximately 5% of patients are estimated to become lost to follow-up.", "answer": 604, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In Helsinki University Hospital, the number of leakages/abscesses related to low anterior resections performed in 2005\u00e2\u0080\u00932011 was 12.8%, but minor wound complications were not reported.23 In our previous randomised MOBILE study comparing MOABP to NBP, patients undergoing colon resection had leakage/abscess rate of approximately 6%\u00e2\u0080\u00938% and a CCI of 9\u00e2\u0080\u009310 with SD 13\u00e2\u0080\u009316.13 Based on these figures, we estimate that the CCI is higher in rectal surgery than in colon surgery and the SD may also be higher. Sample size was calculated with the aim of showing a difference of 5 CCI points between the groups (hypothesis: 12.5 points in the MOABP group, 17.5 points in the MBP group). The SD is estimated to be 18 in both groups. With a power of 90% and a margin of error of 5%, 574 patients need to be recruited (Willcoxon-Mann-Whitney test). About 5% of patients are estimated to become lost to follow-up, resulting in a final sample size of 604 patients.", "id": 682, "split": "val"} +{"trial_id": "NCT04284059", "pmid": "34135055", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adjuvant Effects of Vitamin A and Vitamin D Supplementation on Treatment of Children With ADHD:A Randomized, Double Blind, Placebo-controlled, Multicentric Trial.\n\nIncluded conditions:\n- ADHD\n\nStudy Armgroups:\n- {'label': 'vitamin AD group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin A 6000 IU/day and vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks.', 'interventionNames': ['Dietary Supplement: vitamin AD']}\n- {'label': 'vitamin D group', 'type': 'EXPERIMENTAL', 'description': 'The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks. After the study, vitamin D group will be administrated with vitamin A on the basis of serum retinol concentration after the study.', 'interventionNames': ['Dietary Supplement: vitamin D']}\n- {'label': 'placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive placebo once a day in addition to methylphenidate for 8 weeks. After the study, the placebo group will be prescribed with vitamin A and vitamin D supplementation on the grounds of retinol and 25 (OH)D concentration.', 'interventionNames': ['Drug: Placebos']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Placebos', 'description': 'Placebo, vitamin AD and vitamin D are identical in the appearance to guarantee blind. The patients need to administrate 3 capsules once a day for 8 weeks.', 'armGroupLabels': ['placebo group']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'vitamin AD', 'description': 'A vitamin AD capsule contains vitamin A 2000 IU and vitamin D 700 IU. The patients need to administrate 3 capsules once a day for 8 weeks.', 'armGroupLabels': ['vitamin AD group']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'vitamin D', 'description': 'A vitamin D capsule contains vitamin D 400 IU. The patients need to asministrate 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks.', 'armGroupLabels': ['vitamin D group']}\n\nPrimary Outcomes:\n- {'measure': 'The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent assessment scale', 'description': 'The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.\\n\\nThe scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.', 'timeFrame': 'at baseline'}\n- {'measure': 'The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher assessment scale', 'description': 'The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.\\n\\nThe scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.', 'timeFrame': 'at baseline'}\n- {'measure': 'The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent assessment scale', 'description': 'The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.\\n\\nThe scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.', 'timeFrame': 'at baseline'}\n- {'measure': 'The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher assessment scale', 'description': 'The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.\\n\\nThe scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.', 'timeFrame': 'at baseline'}\n- {'measure': 'The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent assessment scale', 'description': 'The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.\\n\\nThe scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome.', 'timeFrame': 'at baseline'}\n- {'measure': 'The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher assessment scale', 'description': 'The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic.\\n\\nThe scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome.', 'timeFrame': 'at baseline'}\n- {'measure': 'The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment', 'description': 'The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).\\n\\nThe scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.', 'timeFrame': 'at weeks 4 and 8'}\n- {'measure': 'The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment', 'description': 'The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).\\n\\nThe scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.', 'timeFrame': 'at weeks 4 and 8'}\n- {'measure': 'The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment', 'description': 'The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).\\n\\nThe scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.', 'timeFrame': 'at weeks 4 and 8'}\n- {'measure': 'The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment', 'description': 'The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).\\n\\nThe scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.', 'timeFrame': 'at weeks 4 and 8'}\n- {'measure': 'The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent follow-up assessment', 'description': 'The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).\\n\\nThe scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.', 'timeFrame': 'at weeks 4 and 8'}\n- {'measure': 'The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher follow-up assessment', 'description': 'The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic).\\n\\nThe scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.', 'timeFrame': 'at weeks 4 and 8'}\n- {'measure': 'The changes in ADHD clinical symptoms', 'description': \"The Questionnaire - Children with Difficulties (QCD) measures the daily-life problems in children aged 6-18 years during the special time of the day, including in the morning, during school, after school, in the evening, and overall difficulties over the entire day and night. It has been proved the Chinese version of QCD has good validity and reliability. Filled in by the parents, the scale consists of 20 questions with regard to ADHD-related difficulties. Each question is scored on a four-point scale: 0 = completely disagree, 1 = somewhat (partially) agree, 2 = mostly agree, and 3 = completely agree. Score of 30 - 35 is considered as cut-off value for functional impairment and score of less than 30 is considered as functional impairment (Full marks: 57). The lower scores indicate lower life functioning and more difficulty in children's daily activities.\", 'timeFrame': 'at baseline, weeks 4 and 8'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha of 0.05, power of 80%, and a dropout rate of 10% were assumed.", "answer": 504, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on an alpha of 0.05, power of 80% and a dropout rate of 10%, we adopted an analysis of variance F-test by using the PASS software 2020 to evaluate the sample size. This study is a randomised double-blind controlled trial. Intervention groups are vitamin AD group and vitamin D group, while the control is the placebo group. The primary outcome index is changes in ADHD symptoms as evaluated by Vanderbilt assessment scales at weeks 4 and 8 compared with that at baseline. In the study conducted by Mohammadpour et al,25 where the score generated using Conner\u00e2\u0080\u0099s Parent Rating Scale (CPRS) was considered the main outcome, the mean\u00c2\u00b1SD of ADHD index in CPRS was 55.84\u00c2\u00b110.20 for the vitamin D+methylphenidate group (n=25) and 56.79\u00c2\u00b19.60 for the placebo +methylphenidate group (n=29). The Vanderbilt assessment scale is considered as effective as the CPRS in assessing the changes of ADHD symptoms.31 Based on the hypothesis described above, vitamin A, along with vitamin D, promotes the improvement of ADHD symptoms. We cautiously presume that the mean score\u00c2\u00b1SD for vitamin AD+methylphenidate group is lower than that of vitamin D+methylphenidate group, while the control group scores the highest using the Vanderbilt assessment scales, with a score of 54.00\u00c2\u00b19.88 for the vitamin AD+methylphenidate group, 55.84\u00c2\u00b110.20 for the vitamin D+methylphenidate group and 56.79\u00c2\u00b19.60 for the control group. The number of subjects to be enrolled in the study is 504.", "id": 683, "split": "val"} +{"trial_id": "NCT04287088", "pmid": "35428621", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prebiopsy Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer - A Multi-centre Trial on Clinical Utility of IMPROD bpMRI in a Shared Decision Making Setting\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'After IMPROD bpMRI all men undergo prostate biopsies. In men with Likert scores of 1-2, TRUS guided systematic biopsies are performed. In men with Likert 3-5 score, in addition to systematic biopsies, two targeted biopsies are taken from each lesion (up to two lesions).'}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'After IMPROD bpMRI prostate biopsies are performed according to shared decision-making by the treating urologist and the patient. If biopsies are to be performed, in men with IMPROD bpMRI likert scores of 1-2, 12-core systematic TRUS guided biopsies are performed and in men with Likert 3-5 score lesions systematic biopsies are performed and two targeted biopsies are taken from each lesion (up to two lesions). If biopsies are not performed, men are referred for a PSA follow-up.', 'interventionNames': ['Diagnostic Test: A shared decision making']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'A shared decision making', 'description': 'Based on prostate cancer risk calculation (age, usage of 5-ARI medication, baseline PSA, IMPROD bpMRI Likert, prostate volume) a shared decision making whether to perform prostate biopsies or not', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Gleason 4+3=7 prostate cancer, baseline', 'description': 'The proportion of men with clinically significant prostate cancer (Gleason 4+3 \\\\[ISUP grade group, the GGG, 3\\\\]) prostate cancer or higher) in the control and intervention arms after primary diagnostic pathway', 'timeFrame': 'baseline'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level of 0.05, beta level of 0.2, and a dropout rate of 2%.", "answer": 600, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The concept of sample size recalculation was brought up in protocol V.2.0 (4 January 2021). A two-stage sample size calculation was performed: first, an initial calculation before the start of the trial; second, a predetermined blinded re-estimation after the recruitment of the first 300 subjects.\n \n \n The estimation of the clinically significant prostate cancer rate was based on data from our previous prospective trials (the IMPROD and the multi-IMPROD).7 8 Using a clinically significant cancer rate of 25% in both arms, a non-inferiority margin of \u00e2\u0088\u00928%, a beta level of 0.2 and an alpha level of 0.05, it was estimated that 600 subjects would be needed.\n \n \n The re-estimation of sample size is based on the observation that clinically significant prostate cancer is present in 20% of the first 300 subjects. Also, regarding the potential difference in clinically significant cancer rates between the arms, the sample size is evaluated in three different scenarios. Using a non-inferiority margin of \u00e2\u0088\u00928%, a beta level of 0.2 and an alpha level of 0.05, the scenarios are as follows:\n \n \n with a rate of 20.0% in both arms, 624 participants will be needed.\n \n \n With rates of 20.5% (control arm) and 19.5% (intervention arm), 814 subjects will be needed.\n \n \n With rates of 21.0% (control arm) and 19.0% (intervention arm), 1104 subjects will be needed.\n \n \n \n \n It is decided that the final sample size will be calculated according to scenario b. Using a dropout rate of 2%, 830 subjects will be recruited. The recalculated sample size was implemented in the latest protocol amendment (V.2.1, 21 September 2021).", "id": 684, "split": "val"} +{"trial_id": "NCT04287959", "pmid": "39521467", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomised Control Trial Comparing High Flow Weaning Strategies for Infants with Bronchiolitis: Pilot Study\n\nIncluded conditions:\n- Respiratory Disease\n- Bronchiolitis, Viral\n- Infant Morbidity\n\nStudy Armgroups:\n- {'label': 'A: wean to 30%', 'type': 'ACTIVE_COMPARATOR', 'description': 'wean to 30% oxygen on high flow and then turn off high flow support and place onto standard low flow oxygen.', 'interventionNames': ['Device: High flow nasal cannula support']}\n- {'label': 'B: wean to 21%', 'type': 'ACTIVE_COMPARATOR', 'description': 'wean to 21% oxygen on high flow and then turn off high flow support and place directly into air.', 'interventionNames': ['Device: High flow nasal cannula support']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'High flow nasal cannula support', 'description': 'airvo2 highflow devices will be used.', 'armGroupLabels': ['A: wean to 30%', 'B: wean to 21%']}\n\nPrimary Outcomes:\n- {'measure': 'Examine the feasibility of different weaning strategies for infants with bronchiolitis requiring HFNC.', 'description': 'we will assess the following objective in this feasibility trial:\\n\\n\u2022 identify the proportion of eligible patients approached who consent to the study; We will use a traffic light system to determine progress to a multi-centre RCT.', 'timeFrame': 'This will be during the recruitment time of the study (2 years)'}\n- {'measure': 'Identify the proportion of recruited patients who supply secondary outcome data.', 'description': 'We will assess the following objective:\\n\\nidentify the proportion (percentage) of recruited patients who supply primary outcome data(time spent in hospital).', 'timeFrame': 'This will be during the recruitment time of the study (2 years)'}\n- {'measure': 'Assess the adherence of the teams on the ward to the weaning protocol assigned during randomisation.', 'description': 'We will assess the following objective:\\n\\nto review the adherence to the weaning protocol assigned during randomisation, in particular if this can be complied with in a ward setting with a large number of healthcare staff. This will be measured as a yes or no response and calculated as a percentage/proportion.', 'timeFrame': 'This will be during the recruitment time of the study (2 years)'}\n- {'measure': 'Assess the acceptability of HFNC and the weaning strategy by parents and healthcare staff.', 'description': 'We will assess the following objectives:\\n\\nto assess the acceptability of HFNC and the weaning strategy by parents and healthcare staff via questionnaires only.', 'timeFrame': 'This will be during the recruitment time of the study (2 years)'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size\n Local data at the Noah\u00e2\u0080\u0099s Ark Children\u00e2\u0080\u0099s Hospital for Wales had an average of 75 patients needing HFNC support on the ward over the last 2 years. We aim to 20 patients into the trial. This number should be sufficient in order to assess the primary feasibility criteria.", "id": 685, "split": "val"} +{"trial_id": "NCT04288362", "pmid": "32560689", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Patient Activation Through Community Empowerment/Engagement for Diabetes Management (PACE-D) Protocol: A Non-randomised Controlled Trial of Personalised Care and Support Planning for Persons Living With Diabetes\n\nIncluded conditions:\n- Diabetes Mellitus\n- Chronic Disease\n- Patient Care Planning\n- Patient Participation\n- Self Care\n- Empowerment\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Intervention Group']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Control Group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Intervention Group', 'description': 'Participants in this arm will undergo the new care model for management of diabetes mellitus polyclinics.', 'armGroupLabels': ['Intervention Group']}\n- {'type': 'OTHER', 'name': 'Control Group', 'description': 'Participants in this arm will continue to undergo the existing care model for management of diabetes mellitus in the polyclinics.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in HbA1c levels', 'description': 'Change in HbA1c levels in patients receiving the CSP intervention compared with patients receiving standard care.', 'timeFrame': 'From baseline to study endpoint, one year in general'}\n\nPlease estimate the sample size based on the assumption: \n1:1 allocation into Intervention and Control groups, 6 pre-specified subgroups, 90% power, alpha value of 0.05, and a 30% attrition rate.", "answer": 1620, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size calculation was based on HbA1c, the primary outcome measure, for which a difference of 0.5 percentage points was taken to be clinically meaningful. The sample size of 1620 was calculated based on 1:1 allocation into the Intervention and Control, 6 pre-specified subgroups (with 3 age tertiles and 2 gender groups), at a power of 90%, with an alpha value of 0.05 (95% confidence interval) and accounting for an attrition rate of 30%. The study team aims to recruit a total of 1620 patients across the four sites.", "id": 686, "split": "val"} +{"trial_id": "NCT04288999", "pmid": "37586869", "question": "Here is the design of a clinical trial:\n\nOfficial Title: JCOG1801: A Phase III Randomized Controlled Trial Comparing Surgery Plus Adjuvant Chemotherapy With Preoperative Chemoradiotherapy Followed by Surgery Plus Adjuvant Chemotherapy for Locally Recurrent Rectal Cancer (RC-SURVIVE Study)\n\nIncluded conditions:\n- Rectal Cancer Recurrent\n\nStudy Armgroups:\n- {'label': 'Arm A', 'type': 'EXPERIMENTAL', 'description': 'Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy\\n\\nPreoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)\\n\\nAdjuvant chemotherapy: CAPOX (capecitabine+oxaliplatin) or mFOLFOX6 (5-fluorouracil+l-leucovorin+oxaliplatin) or capecitabine or 5-fluorouracil (FU) +l-leucovorin (LV)\\n\\nCAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14)\\n\\nmFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours.\\n\\nCapecitabine: 2000 mg/m2/day, twice daily, days 1-14\\n\\n5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours', 'interventionNames': ['Drug: Chemotherapy', 'Radiation: Preoperative radiotherapy', 'Other: Procedure']}\n- {'label': 'Arm B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Surgery plus Adjuvant chemotherapy\\n\\nAdjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV\\n\\nCAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14)\\n\\nmFOLFOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours.\\n\\nCapecitabine: 2000 mg/m2/day, twice daily, days 1-14\\n\\n5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours', 'interventionNames': ['Drug: Chemotherapy', 'Other: Procedure']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Chemotherapy', 'description': 'Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV\\n\\nCAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14)\\n\\nmFOLOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours.\\n\\nCapecitabine: 2000 mg/m2/day, twice daily, days 1-14\\n\\n5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours', 'armGroupLabels': ['Arm A', 'Arm B'], 'otherNames': ['CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV']}\n- {'type': 'RADIATION', 'name': 'Preoperative radiotherapy', 'description': 'Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy\\n\\nPreoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)', 'armGroupLabels': ['Arm A'], 'otherNames': ['Capecitabine plus radiotherapy']}\n- {'type': 'OTHER', 'name': 'Procedure', 'description': 'Surgery for Locally Recurrent Rectal Cancer (LRRC) will be performed within 42 days from registration for the patients in arm A, and between days 56 and 98 from the completion of the preCRT for the patients in arm B.\\n\\nAppropriate surgical procedure will be performed to achieve R0 resection, such as low anterior resection, super low anterior resection, intersphincteric resection, Hartmann procedure, rectal amputation, pelvic exenteration, tumor resection, or lateral lymph node dissection', 'armGroupLabels': ['Arm A', 'Arm B'], 'otherNames': ['Surgery']}\n\nPrimary Outcomes:\n- {'measure': 'Locally recurrent free survival', 'description': 'the period from registration in the trial to either the first event of local relapse or death from any cause and censored at the last date of contact for a living patient', 'timeFrame': '3-years after registration'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided alpha of 0.1 is assumed, with an estimated statistical power within the range of 0.80-0.99, anticipated to remain at or above 0.8.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n The planned sample size of JCOG1801 is 110 participants, with approximately 40 expected to be enrolled in this correlative study. This is because the present investigation is a prospective observational study, with approximately 60 patients already enrolled at its inception, we have established a maximum sample size of 40 patients based on eligibility and the availability of blood samples. At the time of the primary analysis, JCOG1801 anticipates 56 events for LRFS, which equates to approximately 21 events among participants in JCOG1801A1. Based on the results from the GALAXY study,8 an observational study evaluating the association of ctDNA dynamics with clinical outcomes for patients with colorectal cancer in CIRCULATE-Japan, we conjectured that the proportion of ctDNA-positive patients would be 0.2\u00e2\u0080\u00930.3 and an HR for LRFS comparing ctDNA-positive to ctDNA-negative would be 0.1\u00e2\u0080\u00930.3. With the assumption of a one-sided alpha of 0.1, the estimated statistical power is within the range of 0.80\u00e2\u0080\u00930.99, and it is anticipated to remain at or above 0.8.\n The analyses of this study, comparing the ctDNA status and clinical end points such as the proportion of patients with a pathological R0 resection, response rate of pre-CRT, and pCR rate in the pre-CRT arm, will be conducted prior to the primary analysis of JCOG1801. The analysis is intended to use follow-up data collected after March 2025, subject to the approval of the JCOG Data and Safety Monitoring Committee. Conversely, the prognostic end points will be analysed following the completion of the primary analysis of JCOG1801.", "id": 687, "split": "val"} +{"trial_id": "NCT04289142", "pmid": "33849856", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial\n\nIncluded conditions:\n- Delirium\n- Cognitive Dysfunction\n- Cognition Disorder\n- Neurocognitive Disorders\n- Mental Disorders\n- Confusion\n- Neurobehavioral Manifestations\n- Neurologic Manifestations\n- Nervous System Diseases\n- Signs and Symptoms\n- Dexmedetomidine\n- Hypnotics and Sedatives\n- Central Nervous System Depressants\n- Physiological Effects of Drugs\n- Analgesics, Non-Narcotic\n- Analgesics\n- Molecular Mechanisms of Pharmacological Action\n\nStudy Armgroups:\n- {'label': 'Dexmedetomidine Hydrochloride Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive a loading dose of 1.2 \u03bcg/kg dexmedetomidine prior to transfer to CVICU over 20 min immediately postoperative, followed by continuous infusion of 0.3 \u03bcg/kg/h for up to 12 hours or until patient is ready for discharge from CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.', 'interventionNames': ['Drug: Dexmedetomidine Hydrochloride Group']}\n- {'label': 'Standard of Care Group', 'type': 'NO_INTERVENTION', 'description': 'Standard sedation protocols will be followed at the discretion of the attending physician.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine Hydrochloride Group', 'description': 'Dexmedetomidine will be initiated prior to transfer to the CVICU with loading dose of 1.2 ug/kg over approximately 20 minutes. This will be followed by an infusion at 0.3 ug/kg/h in CVICU for up to 12 hours from the time DEX infusion started or until the patient is ready for discharge from the CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.', 'armGroupLabels': ['Dexmedetomidine Hydrochloride Group'], 'otherNames': ['Dexmedetomidine Hydrochloride']}\n\nPrimary Outcomes:\n- {'measure': 'Post-operative cognitive dysfunction', 'description': 'Presence of POCD assessed by CogState Brief Battery (CBB)', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1=0.05, two-sided and \u00ce\u00b2=0.2. To account for loss to follow-up (estimated at ~10%).", "answer": 2400, "answer_type": "ESTIMATED", "explanation": "Statistical analysis and sample size estimation\n \n Sample size calculation\n The sample size is based on the binary, primary outcome of major P-NCD at 3 months with the following assumptions and considerations:\n \n \n \u00ce\u00b1=0.05, two-sided and \u00ce\u00b2=0.2.\n \n \n Estimated incidence of major P-NCD at 3 months with standard care 25%.\n \n \n Estimated effect size of DEX 20% (relative risk reduction 20% and absolute risk reduction 5% for major P-NCD).\n \n \n This yields a sample size of 1092 per group (2184 total). To account for loss to follow-up (estimated at ~10%), 1200 participants per group (2400 total) will be recruited. There is no minimally clinically important difference for the incidence of P-NCD. The estimated effect size was selected as a balance between clinical relevance and a pragmatic sample size.", "id": 688, "split": "val"} +{"trial_id": "NCT04289142", "pmid": "33849856", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients: CODEX Trial\n\nIncluded conditions:\n- Delirium\n- Cognitive Dysfunction\n- Cognition Disorder\n- Neurocognitive Disorders\n- Mental Disorders\n- Confusion\n- Neurobehavioral Manifestations\n- Neurologic Manifestations\n- Nervous System Diseases\n- Signs and Symptoms\n- Dexmedetomidine\n- Hypnotics and Sedatives\n- Central Nervous System Depressants\n- Physiological Effects of Drugs\n- Analgesics, Non-Narcotic\n- Analgesics\n- Molecular Mechanisms of Pharmacological Action\n\nStudy Armgroups:\n- {'label': 'Dexmedetomidine Hydrochloride Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive a loading dose of 1.2 \u03bcg/kg dexmedetomidine prior to transfer to CVICU over 20 min immediately postoperative, followed by continuous infusion of 0.3 \u03bcg/kg/h for up to 12 hours or until patient is ready for discharge from CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.', 'interventionNames': ['Drug: Dexmedetomidine Hydrochloride Group']}\n- {'label': 'Standard of Care Group', 'type': 'NO_INTERVENTION', 'description': 'Standard sedation protocols will be followed at the discretion of the attending physician.'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine Hydrochloride Group', 'description': 'Dexmedetomidine will be initiated prior to transfer to the CVICU with loading dose of 1.2 ug/kg over approximately 20 minutes. This will be followed by an infusion at 0.3 ug/kg/h in CVICU for up to 12 hours from the time DEX infusion started or until the patient is ready for discharge from the CVICU (whichever is earlier). Any additional sedatives necessary at the discretion of ICU.', 'armGroupLabels': ['Dexmedetomidine Hydrochloride Group'], 'otherNames': ['Dexmedetomidine Hydrochloride']}\n\nPrimary Outcomes:\n- {'measure': 'Post-operative cognitive dysfunction', 'description': 'Presence of POCD assessed by CogState Brief Battery (CBB)', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n\u00ce\u00b1=0.05, two-sided and \u00ce\u00b2=0.2. To account for loss to follow-up (estimated at ~10%).", "answer": 2400, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size is based on the binary, primary outcome of major P-NCD at 3 months with the following assumptions and considerations:\n \n \n \u00ce\u00b1=0.05, two-sided and \u00ce\u00b2=0.2.\n \n \n Estimated incidence of major P-NCD at 3 months with standard care 25%.\n \n \n Estimated effect size of DEX 20% (relative risk reduction 20% and absolute risk reduction 5% for major P-NCD).\n \n \n This yields a sample size of 1092 per group (2184 total). To account for loss to follow-up (estimated at ~10%), 1200 participants per group (2400 total) will be recruited. There is no minimally clinically important difference for the incidence of P-NCD. The estimated effect size was selected as a balance between clinical relevance and a pragmatic sample size.", "id": 689, "split": "val"} +{"trial_id": "NCT04289792", "pmid": "33154057", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Chemotherapy-based Split Stereotactic Body Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: Study Protocol of a Prospective, Single-arm Phase II Trial\n\nIncluded conditions:\n- Pancreatic Neoplasms\n\nStudy Armgroups:\n- {'label': 'SBRT with concurrent chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'SBRT with nab-Paclitaxel plus Gemcitabine (nab-P+Gem) chemotherapy', 'interventionNames': ['Drug: nab-Paclitaxel+Gemcitabine', 'Radiation: split-course SBRT']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'nab-Paclitaxel+Gemcitabine', 'description': 'Drug: nab-Paclitaxel 125 mg/m2 IV over approximately 30-45 min on Days 1 and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 min on Days 1 and 15 of each 28-day cycle for 6 cycles.', 'armGroupLabels': ['SBRT with concurrent chemotherapy']}\n- {'type': 'RADIATION', 'name': 'split-course SBRT', 'description': 'Radiation: During the first 1 and 2 cycles of chemotherapy, SBRT was given as a single irradiation of 10 Gy \u2179 4 times (Days 2 and 16 of each 28-day cycle).', 'armGroupLabels': ['SBRT with concurrent chemotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Kaplan-Meier Estimate of Progression-Free Survival (PFS)', 'description': 'Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free.', 'timeFrame': 'From enrollment to 2 years after the end of treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a one-sided alpha of 0.05, 80% power, a 10% dropout rate, and a minimum follow-up period of 1 year. Statistical normality for continuous variables will be assessed, and comparisons will be performed using analysis of variance or non-parametric equivalents. Categorical data will be compared using chi-squared tests or Fisher's exact tests. OS and PFS curves will be plotted using the Kaplan-Meier method, and the log-rank test will be used for comparisons. Proportional hazard Cox regression will be used when necessary. Data analysis will be performed on both intention-to-treat and per-protocol basis, with a significance level of 0.05 for all p values.", "answer": 27, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n The primary endpoint for this study is the median PFS. The null (Ho) and alternative (Ha) hypotheses for this endpoint are as follows, where M is the median PFS and 6.8 months is the median PFS based on the data of our research centre and the previous research reports25 28\u00e2\u0080\u009330: Ho: M\u00e2\u0089\u00a46.8 Ha: M>6.8.\n A total sample size of 27 subjects will have 80% power to detect an increase in the median PFS of 6.8\u00e2\u0080\u009312 months. The sample size is calculated assuming a one-sided alpha of 0.05 that subjects will be enrolling for 24 months, and that each subject will be followed up for a minimum of 1\u00e2\u0080\u0089year. Twenty-seven subjects will be enrolled assuming a 10% drop-out rate.\n For continuous variables, statistical normality will be first assessed. Comparisons between these main effects will be then performed by analysis of variance or its two non-parametric equivalents as appropriate. Categorical data will be compared by \u00cf\u00872 tests or Fisher\u00e2\u0080\u0099s exact tests. The OS and PFS curves will be plotted by the Kaplan-Meier method. The log-rank test will be employed for comparisons of OS and PFS. Proportional hazard Cox regression adjusted for variables will be used when necessary. Data analysis will be performed on both intention-to-treat and per-protocol basis. All p values will be reported using a significance level of 0.05.", "id": 690, "split": "val"} +{"trial_id": "NCT04290156", "pmid": "33028560", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Joint Transition Visits on Quality of Life in Adolescents With Inflammatory Bowel Diseases: a Protocol for a Prospective, Randomized, Multicentre, Controlled Trial (TRANS-IBD)\n\nIncluded conditions:\n- Inflammatory Bowel Diseases\n- Crohn's Disease\n- Ulcerative Colitis\n\nStudy Armgroups:\n- {'label': 'Joint visits', 'type': 'EXPERIMENTAL', 'description': 'Subjects in the intervention arm attend a total of four joint transition visits performed with the participation of both the adult and the pediatric gastroenterologist.', 'interventionNames': ['Other: joint visits']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': \"Adolescents meet only the pediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologists with respect the patient's treatment plan.\"}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'joint visits', 'description': 'The intervention is the implementation of joint transition visits with the participation of both the pediatric and the adult gastroenterologist. One-year intervention period was chosen. In total, there are four joint visits every third months for the adolescents aged 17-18. Each joint visit lasts for at least for 20 minutes, although in case of complex medical history, there is no restriction with respect to the length of the visit. Joint transition visits 1, 2 and 3 (V1-3) are led by the pediatric gastroenterologist, and visit 4 (V4) is led by the adult gastroenterologist.', 'armGroupLabels': ['Joint visits']}\n\nPrimary Outcomes:\n- {'measure': 'Change in patient reported health-related quality of life (HRQoL) one year after transfer', 'description': 'HRQoL is measured with a validated and IBD-specific questionnaire, called IMPACT III (HR) (unabbreviated scale title is not existing). It consists of 35-items, using a five-point Likert self-completed response scale. The questions are related to the severity and frequency of the following symptoms over the last two weeks: bowel symptoms, systemic symptoms, emotional functioning, social functioning, body image and treatments or interventions. The lowest score is 35, that can be achieved, and the maximum is 175 points. Higher scores indicate better HRQoL.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \n21% drop-out rate, 80% power, and 95% significance level", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculation was based on the article of Cohen et al and was performed by the biostatistician team of the Institute of Translational Medicine.54 Based on the available data, we expect nine points difference between the mean IMPACT-III points of the intervention and control group at the end of the study. In order to detect this difference between the two study groups, 160 patients are needed to be recruited (80/group) using a 21% drop-out rate, 80% power and 95% significance level.", "id": 691, "split": "val"} +{"trial_id": "NCT04291482", "pmid": "33234638", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Theory-based Digital Intervention to Promote Weight Loss and Weight Loss Maintenance (Choosing Health): A Randomised Controlled Trial With Within Person Assessment\n\nIncluded conditions:\n- Overweight and Obesity\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'The intervention group participants will be assessed with EMA and they will provide daily data regarding their predictors of weight loss outcomes and their adherence to the personal weight loss plan (phase I, month 0-3). Then participants will receive tailored information regarding the most predictive factors relevant to their weight loss trajectories (phase II, month 3-6). The information will be tailored and delivered through emails and text messages.', 'interventionNames': ['Behavioral: Choosing Health Intervention']}\n- {'label': 'Control arm', 'type': 'OTHER', 'description': 'Control group participants will receive basic educational weight loss information in a form of educational factual emails and text messages.', 'interventionNames': ['Behavioral: Choosing Health Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Choosing Health Intervention', 'description': 'The intervention consists of information materials provided at baseline in a form of eBook or a physical book depending on participants preferences. The book includes the rationale for the intervention, basic information on healthy eating and behaviour change and tables allowing self-monitoring of weight, physical activity and eating (i.e., brief food diary). The book is non-tailored and it has weekly tasks for the participants to complete during 26 weeks (initial 6 months) to support their weight loss. The intervention group will also receive a series of daily text messages and weekly email messages supporting their weight loss and promoting weight loss maintenance. In phase I (month 0-3), the messages and emails will be generic and factual; in the phase II of the intervention, participants will receive text messages and emails tailored to the strongest predictors of outcomes identified in phase I.', 'armGroupLabels': ['Intervention arm']}\n- {'type': 'BEHAVIORAL', 'name': 'Choosing Health Control', 'description': 'The control consists of information materials provided at baseline in a form of eBook or a physical book depending on participants preferences. The book includes the rationale for the intervention and basic information on healthy eating and physical activity. The control group will also receive monthly email messages with generic and factual information.', 'armGroupLabels': ['Control arm']}\n\nPrimary Outcomes:\n- {'measure': 'Weight', 'description': 'Mean difference in weight loss between groups at 6 months, in kilograms', 'timeFrame': 'Change from baseline to 6 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, alpha set at 0.05, 30% dropout rate, and scenarios with alpha at 0.1 for within participant components.", "answer": 285, "answer_type": "ACTUAL", "explanation": "Sample size\n Projected sample size was calculated based on a statistical power analysis using the G*Power software. In order to detect a medium-to-large effect size for weight between the intervention and control groups (4 kg of weight loss difference with a SD of 10 kg at 6 months and a mean comparison condition body weight at 6 months follow-up of 85 kg), we estimate that a total of 100 participants per group would be required to achieve 80% power with alpha set at 0.05. Based on an estimated average drop out of 30% from online tailored interventions,40 a sample size of 285 participants is required to ensure 80% power.\n To estimate statistical power for the within participant components (ie, the required number of observations per participant), we conducted a simulation study (online supplemental material 2). As effect sizes and autocorrelation will likely differ between participants, as found in previous work,9 we describe the power for a range of parameters. We also consider a reduced type II error rate (false negative) with a corresponding increased type I error rate (false positive) preferable for the identification of potential predictors and so include power scenarios where alpha is set at 0.1. Results showed that 60 observations per participant in each study phase (phase I and phase II) would provide the following power for the two within participant study components: (1) for the identification of predictors of weight loss behaviour in phase I only, 60 observations will provide 80% power for an 0.5 effect size (d) with an autocorrelation of 0.5 and alpha at 0.10; alternatively, 50 observations would suffice to provide 80% power for an 0.5 effect size with an autocorrelation of 0.1 and alpha at 0.05; (2) for the interrupted time series component, 60 observations per phase would provide 77% power for an 0.8 effect size with an autocorrelation of 0.2 and alpha at 0.05.\n \n 10.1136/bmjopen-2020-040183.supp2\n Supplementary data", "id": 692, "split": "val"} +{"trial_id": "NCT04291573", "pmid": "34702317", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy\n\nIncluded conditions:\n- Chronic Post Stroke Individuals\n\nStudy Armgroups:\n- {'label': 'HD-tDCS and Virtual Reality Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive their usual rehabilitation program each day, which includes a conventional session (30min) and virtual reality therapy session (Armeo Spring) combined with real stimulation (30min) over 13 consecutive training days (3 weeks)', 'interventionNames': ['Device: HD-tDCS']}\n- {'label': 'Sham stimulation and Virtual Reality Therapy', 'type': 'SHAM_COMPARATOR', 'description': 'Patients will receive their usual rehabilitation program each day, which includes a conventional session (30min) and virtual reality therapy session (Armeo Spring) combined with Sham stimulation (30min) over 13 consecutive training days (3 weeks)', 'interventionNames': ['Device: Sham HD-tDCS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'HD-tDCS', 'description': 'Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes \\\\~4cm away', 'armGroupLabels': ['HD-tDCS and Virtual Reality Therapy'], 'otherNames': ['Starstim8 (Neuroelectrics, Spain)']}\n- {'type': 'DEVICE', 'name': 'Sham HD-tDCS', 'description': 'Sham stimulation (2mA, ramp up and down phases of 30s) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes \\\\~4cm away', 'armGroupLabels': ['Sham stimulation and Virtual Reality Therapy'], 'otherNames': ['Starstim8 (Neuroelectrics, Spain)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Functional Motor capacity of the upper extremity', 'description': 'Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)', 'timeFrame': 'Change from Baseline at Day 21(after intervention) and 3 months after day 21'}\n- {'measure': 'Change in Functional Motor capacity of the upper extremity', 'description': 'Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)', 'timeFrame': 'Change from Day 21 at 3 months (retention)'}\n- {'measure': 'Change in Motor deficit of the upper extremity', 'description': 'Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)', 'timeFrame': 'Change from Baseline at Day 21 (after intervention) and 3 months after day 21'}\n- {'measure': 'Change in Motor deficit of the upper extremity', 'description': 'Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)', 'timeFrame': 'Change from Day 21 at 3 months (retention)'}\n- {'measure': 'Change in Hand dexterity', 'description': 'Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)', 'timeFrame': 'Change in Baseline at Day 21 (after intervention) and 3 months after day 21'}\n- {'measure': 'Change in Hand dexterity', 'description': 'Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)', 'timeFrame': 'Change in Day21 at 3 months (retention)'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha bilateral risk of 5%, a power of 80%, and a 10% loss of patients are assumed.", "answer": 58, "answer_type": "ESTIMATED", "explanation": "Sample size\n Allman et al. [1] reported that compared to sham, real anodal tDCS (1 mA, conventional montage, ipsilesional motor cortex) combined with 9 days of UL rehabilitation in chronic stroke patients had a moderate effect size d = 0.4 on the WMFT at 3 months after the intervention. In the meta-analysis of Chhatbar et al. [16], UL motor recovery (FM-UE) in a chronic stroke population was superior in the group receiving a real tDCS (in comparison to sham) with higher current density and smaller electrode size (large effect size g = 1.23). Because we will use anodal HD-tDCS with a higher current density (2 mA) and longer rehabilitation dose (13 days) in chronic stroke patients, we estimate that our protocol should have an effect size of d = 0.8 on the WMFT at 3 months. Using an alpha bilateral risk of 5% and a power of 80%, 26 patients per group are needed for analysis. If we count a loss of 10% of the patients, we will have to recruit 58 patients (n = 29 per group).", "id": 693, "split": "val"} +{"trial_id": "NCT04291768", "pmid": "37156588", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Short Course Antibiotic Treatment of Gram-negative Bacteremia: A Multicenter, Randomized, Non-blinded, Non-inferiority Interventional Study\n\nIncluded conditions:\n- Gram-negative Bacteremia\n- Urinary Tract Infection Bacterial\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Shortened antibiotic treatment of 5 days', 'interventionNames': ['Other: Shortened antibiotic treatment']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard antibiotic treatment of minimum 7 days at the discretion of treating physician', 'interventionNames': ['Other: Standard antibiotic treatment']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Shortened antibiotic treatment', 'description': 'Shortened antibiotic treatment of 5 days. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.', 'armGroupLabels': ['Intervention group']}\n- {'type': 'OTHER', 'name': 'Standard antibiotic treatment', 'description': 'Standard antibiotic treatment of minimum 7 days at the discretion of treating physician. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': '90-day survival without clinical or microbiological failure to treatment', 'description': '90-day survival without clinical or microbiological failure to treatment as defined:\\n\\n1. All-cause mortality from day of randomization and until day 90\\n2. Microbiological failure: Recurrent bacteremia due to the same microorganism as verified by sequence analysis occurring from day of randomization and until day 90\\n3. Clinical failure: Re-initiation of therapy against Gram-negative bacteremia for more than 48 hours due to clinical worsening suspected to be due to the initial infecting organism and for which there is no alternate diagnosis/pathogen suspected from the day of randomization and until day 90\\n\\n 1. Distant complications of initial infection, defined by growth of the same bacteria as in the initial bacteremia (e.g. endocarditis, meningitis)\\n 2. Local suppurative complication that was not present at infection onset (e.g. renal abscess in pyelonephritis)', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nGiven an \u03b1 of 5% and a \u03b2 of 90%, a sample size re-estimation (SSR) will be considered at the first planned interim analysis. If the overall event rate falls outside the expected event rate of 12%, an SSR based on a blinded review of overall data will be performed. The non-inferiority margin may be reduced to ensure an appropriate margin relative to the event rate. Any sample size adjustment will be reported to the regulatory authorities as a protocol amendment.", "answer": 380, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on a similar previous study, short-term mortality is expected to be approximately 12% in both treatment arms. Failure is expected to be 8% in both study arms.19 Because individuals who are not stable by day 5, who have complicated infections, who have a polymicrobial infection or infection with Pseudomonas spp, Brucella spp and Fusobacterium spp are not eligible, we anticipate these rates to be lower at 8% and 4%, respectively. This corresponds to an estimated event rate for the primary outcome of approximately 12%, equivalent to a 90-day survival without clinical or microbiological failure to treatment or relapse of 88% in both treatment arms.\n Non-inferiority is defined as an absolute risk difference or margin in the primary endpoint of up to 10%, as recommended by the European Medicines Agency.26 Given an \u00ce\u00b1 of 5% and a \u00ce\u00b2 of 90% then 362 randomised individuals are required to be sure that the lower limit of a one-sided 95% CI will exclude a difference in favour of the longer course of antibiotics of more than 10%. Allowing for a dropout rate of 5%, 380 individuals will be included.\n A sample size re-estimation (SSR) will be considered at the first planned interim analysis. If the overall event rate falls outside the expected event rate of 12%, an SSR based on a blinded review of overall data (ie, without knowledge of the group-specific event rates) will be performed. If the overall event rate is lower than expected, then the final sample size will be reduced, using the original sample size formula and replacing the initial estimate with the observed rate. The non-inferiority margin may be reduced to ensure an appropriate margin relative to the event rate. If the overall event rate is higher than expected, the sample size will be increased correspondingly. Any sample size adjustment will be reported to the regulatory authorities as a protocol amendment.", "id": 694, "split": "val"} +{"trial_id": "NCT04292054", "pmid": "33239101", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"Antibioprophylaxis for Excision-graft Surgery in Burn Patient: a Multicenter Randomized Double-blind Study: A2B Trial\"\n\nIncluded conditions:\n- Burns Surgery\n\nStudy Armgroups:\n- {'label': 'active group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The antibiotic prophylaxis will be cefazolin 2 g powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump, in case of absence of colonization to Pseudomonas aeruginosa prior to the surgical procedure.\\n\\nThe dose administer is 2g.\\n\\nAntibiotic prophylaxis will be piperacilline-tazobactam 4 g powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe driver in patients with burn wound colonized to Pseudomonas aeruginosa.\\n\\nThe dose administer is 4g.', 'interventionNames': ['Drug: active intervention']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'The control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.', 'interventionNames': ['Other: placebo intervention']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'active intervention', 'description': 'The antibiotic prophylaxis will be cefazolin 2 g, or piperacilline-tazobactam 4 g, powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.', 'armGroupLabels': ['active group'], 'otherNames': ['Cefazolin or piperacilline-tazobactam 4 g']}\n- {'type': 'OTHER', 'name': 'placebo intervention', 'description': 'The control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.', 'armGroupLabels': ['Placebo group'], 'otherNames': ['NaC 0,9%l']}\n\nPrimary Outcomes:\n- {'measure': 'Post-operative infection defined as Post-operative sepsis and/or Surgical site infection, and/or Graft lysis requiring a new graft within 7 days after surgery.', 'description': 'Postoperative infection will be collected by the intensivists or infectious disease specialist consultant blinded to the interventional or control arm. Skin infection and skin graft lysis requiring a new graft procedure will be assess by a surgeon blinded of the arm of the study.', 'timeFrame': '7 days after surgery'}\n- {'measure': 'Post-operative sepsis', 'description': 'Sepsis is defined as life-threatening organ dysfunction (defined by an increase of Sepsis related organ failure assessment \\\\[SOFA\\\\] score of 2 points or more) in response to infection. The minimum value is 0 and maximum value is 24. 0 meaning no organ dysfunction and 24 the maximum organ dysfunction.', 'timeFrame': '7 days after surgery'}\n- {'measure': 'Surgical site infection', 'description': 'Surgical site (operated skin) infection with general signs is considered as a systemic infection originated from skin (Presence of a local or loco-regional inflammatory reaction; Unfavourable and unexpected local evolution; Lysis of grafts; Necrosis of fat located under the graft)', 'timeFrame': '7 days after surgery'}\n- {'measure': 'Graft lysis needing a new graft procedure', 'description': 'Graft lysis is defined as a skin graft lysis in the 7 days post operative, and needing a new skin graft assessed be a surgeon blinded of the randomization group.', 'timeFrame': '7 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk is set at 4.9% (adjusted for interim analysis) and power is set at 80%.", "answer": 506, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n The incidence of the primary endpoint is estimated to be 25% (based on investigators\u00e2\u0080\u0099 personal data). With an alpha risk of 4.9% (adjusted for interim analysis) and power\u00e2\u0080\u0089=\u00e2\u0080\u008980%, the number of patients to include to show an absolute reduction of 10% of the primary endpoint, we need to enroll 506 patients (253 in the intervention group and 253 in the control group).", "id": 695, "split": "val"} +{"trial_id": "NCT04295928", "pmid": "34749777", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mise en Place d'un Plan Pharmaceutique Personnalis\u00e9 Chez Les Patients transplant\u00e9s r\u00e9naux ou h\u00e9patiques : Essai randomis\u00e9 en Cluster de Type Stepped-wedge.\n\nIncluded conditions:\n- Personalized Pharmaceutical Plan After Transpantation\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': \"Implementation of a personalized pharmaceutical plan with a view to increasing the patient's therapeutic education in the hospital and in the community (entrance and discharge reconciliation, 3 pharmaceutical interviews in the hospital, strengthening of the community-hospital link , 3 outpatient pharmaceutical consultations)\", 'interventionNames': ['Behavioral: PPP']}\n- {'label': 'Usual care period', 'type': 'NO_INTERVENTION', 'description': 'No changes to usual center practices'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'PPP', 'description': 'Personalized Pharmaceutical Plan on therapeutic adherence to immunosuppressive treatments after the transplantation', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Therapeutic adhesion', 'description': 'The Investigator will consider that a patient is in therapeutic adhesion thanks to two methods : use of the BAASIS\u00ae questionnaire (if answer \\\\<1 for at least one of the 4 questions in the score, the patient will be considered as a non-adherent) and use of the health insurance data from the national health data system (checking that 100% of the days are covered by possession of immunosuppressive drugs)', 'timeFrame': '1 year after transplantation'}\n\nPlease estimate the sample size based on the assumption: \nThe study design is a stepped-wedge with 12 sequences, 14 periods, 11 patients per cluster-period, 90% power, and an intraclass correlation coefficient of 0.01. A 25% exclusion rate is also considered.", "answer": 1716, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Currently, non-adherence to immunosuppressive treatment is approximately 30% [4]. The objective of the intervention is to reduce this percentage by one-third, i.e. to 20%. Considering a stepped-wedge design with 12 sequences (one cluster per sequence) of fourteen 7-week periods (one of which is a transition period), with a mean number of 11 patients recruited per cluster-period, this provides a 90% power to the study, taking into account an intraclass correlation coefficient of 0.01. Consequently, the total number of patients needed is 1716 of whom 132 are expected to be included in a transition period. Sample size calculation has been done using the shiny cluster randomized calculator [10, 11].\n According to the French regulatory Agency\u00e2\u0080\u0099s 2017 data, the 12 recruited clusters could in turn recruit 2461 patients over 23 months. Considering that 25% of transplanted patients will have at least one exclusion criterion, 1846 patients will be included over 23 months.", "id": 696, "split": "val"} +{"trial_id": "NCT04296916", "pmid": "32993769", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Medically Lowering Intraocular Pressure in Glaucoma Suspects With High Myopia: A Randomized Controlled Trial\n\nIncluded conditions:\n- Glaucoma, Suspect\n- High Myopia\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'medical reduction of IOP by eyedrops', 'interventionNames': ['Drug: IOP lowering eye drops']}\n- {'label': 'control arm', 'type': 'NO_INTERVENTION', 'description': 'follow up without medication'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'IOP lowering eye drops', 'description': '1. Latanoprost 0.005% eye drops will be the first choice. If an IOP reduction of 20% is not achieved within three months, timolol 0.5% will be added as second medication. If an IOP reduction of 20% is then not achieved, alphagan 0.2% or alphagan-P 0.15% will be added. If an IOP reduction of 20% is then not achieved, the individual will be excluded from the study.\\n2. If necessary, latanoprost will be switched to other prostaglandin eye drops, alphagan (or alphagan-P) will be switched to brinzolamide 1% eye drops.\\n3. If necessary, latanoprost and timolol will be switched to Xalacom eye drops, timolol and alphagan will be switched to Combigan eye drops, timolol and brinzolamide will be switched to Azarga eye drops.\\n4. Once daily in the evening for prostaglandin eye drops, and twice daily for other eye drops.', 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'The number of subjects whose visual filed progressed during the follow up', 'timeFrame': '36 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided significance level of 0.05, 90% power, and a 20% attrition rate over 3 years.", "answer": 264, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size calculation was based on the primary outcome, the incidence of glaucoma suspect progression over 36\u00e2\u0080\u0089months. The hypothesis was formed according to the findings of the relevant publications. The Early Manifest Glaucoma Trial (EMGT) [17, 20] reported that the 2-year progression rate among patients with early primary open-angle glaucoma was 24% in the non-medication group and 11% in the medication group. The United Kingdom Glaucoma Treatment Study (UKGTS) [21, 22] reported that the 2-year progression rate of patients with early and middle primary open-angle glaucoma was 25.6% in the placebo group and 15.2% in the IOP-lowering medication group. The risk of progressing to open-angle glaucoma among patients with HM was nearly five times that of the non-myopia individuals [5, 6]. In this study, it is expected that the IOP-lowering medication can reduce the 36-month progression rate of GSHM by 18%, assuming an incidence of 30% in the control group. At a two-sided significance level of 0.05, in order to achieve 90% power, 106 participants will be required in each study group. Considering a 20% of attrition rate over 3\u00c2\u00a0years, the final sample size will be 132 participants per group and a total 264 for the two groups [23\u00e2\u0080\u009327]. The sample size was calculated using PASS 11.0 software (NCSs, LLC, Kaysville, UT, USA).", "id": 697, "split": "val"} +{"trial_id": "NCT04297215", "pmid": "34895292", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pragmatic Randomized Controlled Multi Center Trial Comparing the Effectiveness of Antibacterial Therapeutic Clothing Based on Silver or Chitosan as Compared With Non-antibacterial Therapeutic Clothing in Patients With Moderate to Severe Atopic Dermatitis\n\nIncluded conditions:\n- Atopic Dermatitis\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'This group will receive therapeutic clothing without antimicrobial agents', 'interventionNames': ['Device: Binamed\u00ae therapeutic clothing without antimicrobial agents']}\n- {'label': 'Chitosan group', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will receive antimicrobial therapeutic clothing based on chitosan', 'interventionNames': ['Device: DermaCura\u00ae Chitosan based antimicrobial therapeutic clothing']}\n- {'label': 'Silver group', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group will receive antimicrobial clothing based on silver.', 'interventionNames': ['Device: Binamed\u00ae silver based antimicrobial therapeutic clothing']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'DermaCura\u00ae Chitosan based antimicrobial therapeutic clothing', 'description': 'DermaCura\u00ae antimicrobial therapeutic clothing (D\\\\&M) consists of 98% TENCEL\u00ae and 2% elastane. 1% chitosan has been added to TENCEL\u00ae\\n\\nThe therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day. Usual care including application of emollients, corticosteroid ointments or creams only if needed and/or antihistamines is continued, with standardized steroid ointments and treatment regimens for comparability purposes.', 'armGroupLabels': ['Chitosan group']}\n- {'type': 'DEVICE', 'name': 'Binamed\u00ae silver based antimicrobial therapeutic clothing', 'description': 'The Binamed\u00ae antimicrobial therapeutic clothing (BAP Medical) consists of micro-modal, lycra and woven silver filaments as antibacterial agent.\\n\\nThe therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day. Usual care including application of emollients, corticosteroid ointments or creams only if needed and/or antihistamines is continued, with standardized steroid ointments and treatment regimens for comparability purposes.', 'armGroupLabels': ['Silver group']}\n- {'type': 'DEVICE', 'name': 'Binamed\u00ae therapeutic clothing without antimicrobial agents', 'description': 'The Binamed\u00ae therapeutic clothing without antimicriobial agents (BAP Medical) is therapeutic clothing made of micro-modal and lycra. Micro-madal is a semi-synthetic wood cellulose fiber. This fiber has a high strength hand elasticity, a high moisture-permeability and feels soft. Lycra ensures an optimal fit on the skin.\\n\\nThe therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day. Usual care including application of emollients, corticosteroid ointments or creams only if needed and/or antihistamines is continued, with standardized steroid ointments and treatment regimens for comparability purposes.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the Eczema Area and Severity Index (EASI)', 'description': 'Change in disease severity measured by the EASI between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. Minimum score is 0, maximum score is 72. A higher score indicates more sever eczema', 'timeFrame': 'Two weeks for baseline, baseline, 1 month, 3 months 6 months and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha of 0.05, a power of 0.80, and a 20% loss to follow-up were assumed. The study includes 3 groups, 5 measurements, and a 0.6 correlation between EASI scores.", "answer": 165, "answer_type": "ESTIMATED", "explanation": "Sample size\n The null hypothesis of this study is that there is no difference between the antimicrobial therapeutic clothing (based on silver and chitosan) and therapeutic clothing without antimicrobial agents.\n We used a standard deviation (SD) of 13 (based on the CLOTHES study [16]) and used the 6.6 minimal clinical important difference (MCID) for EASI as proposed by Schram et al. [17] resulting in an expected 0.51 Cohen\u00e2\u0080\u0099s D effect size. An alpha of 0.05 and a power of 0.80 were used.\n Based on the inclusion of 3 groups, 5 measurements (baseline, 1 month, 3 months, 6 months, 12 months) and a 0.6 correlation between EASI scores (correlation is based on the CLOTHES study), while assuming a 20% loss to follow-up, we will include 55 patients per group and 165 patients in total.", "id": 698, "split": "val"} +{"trial_id": "NCT04298450", "pmid": "33334839", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ED to EPI: Using SMS (Text) Messaging to Improve the Transition from the Emergency Department to Early Psychosis Intervention for Young People with Psychosis\n\nIncluded conditions:\n- First Episode Psychosis\n- Psychosis\n- Psychotic Episode\n- Psychoses, Affective\n- Bipolar Disorder\n- Depressive Psychosis\n- Schizoaffective Disorder\n- Schizophreniform Disorders\n- Schizophrenia\n- Schizophrenia Spectrum and Other Psychotic Disorders\n- Substance Induced Psychoses\n\nStudy Armgroups:\n- {'label': 'Active SMS Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants assigned to the experimental arm will receive the active SMS intervention. Participants in the active intervention group who consent to participate will be asked to complete a web-based survey. Based on survey findings, purposive sampling will be used to select a subsample of 12 to 20 participants for qualitative interviews.', 'interventionNames': ['Behavioral: Active SMS Intervention']}\n- {'label': 'Sham SMS', 'type': 'SHAM_COMPARATOR', 'description': 'Participants assigned to the sham comparator will receive the sham SMS intervention. They will not be re-contacted.', 'interventionNames': ['Behavioral: Sham SMS']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Active SMS Intervention', 'description': \"Welcome message letting participant know they will be contacted to book an appointment, followed by appointment reminders and other clinic information, psychoeducational materials, and a distress check-in with two-way feedback to their care team, all sent by SMS/text message at the participant's preferred time of day. If they indicate that they are in high distress, or they request, their care provider will be notified and asked to reach out to them. They will also receive crisis resources.The intervention will continue until the patient attends the first consultation appointment, or for up to 30 days if the patient does not attend, which reflects the program's practice of closing referrals for non-attending patients.\", 'armGroupLabels': ['Active SMS Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Sham SMS', 'description': 'Single welcome message letting participant know they will be contacted to book an appointment.', 'armGroupLabels': ['Sham SMS']}\n\nPrimary Outcomes:\n- {'measure': 'Attendance at the first early psychosis intervention (EPI) consultation appointment', 'description': 'Attendance at the outpatient EPI consultation appointment will be assessed through chart reviews and categorized as: Yes - attended at original appointment time, Yes - attended at later date within 30 days, No - did not attend appointment within 30 days.', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study is designed to have >80% power with a significance level of alpha <0.05. Non-compliance and loss to follow-up are not a concern as they are counted as non-attendance.", "answer": 186, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our sample size calculations are based on the primary outcome of rate of attendance at the EPI programme consultation appointment. The current rate of attendance at the first consultation appointment for patients referred from the ED and Bridging Clinic is 50%; we have powered our study to detect the treatment effect with an anticipated rate of attendance of 70%, which is the average for all referral sources other than the ED and Bridging Clinic. A total of 186 participants (93 per group) will provide >80% power to detect a change in attendance from 50% to 70% at alpha <0.05. Non-compliance and loss to follow-up are not a concern for our primary outcome since these are counted in the outcome as non-attendance at the consultation. Adjusting analyses for covariates expected to affect attendance (eg, age, sex) is expected to further increase power.", "id": 699, "split": "val"} +{"trial_id": "NCT04299932", "pmid": "33414139", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Electroacupuncture for Stress-predominant Mixed Urinary Incontinence: a Three-armed Randomized Controlled Trial\n\nIncluded conditions:\n- Mixed Urinary Incontinence\n\nStudy Armgroups:\n- {'label': 'Electroacupuncture(EA) group', 'type': 'EXPERIMENTAL', 'description': 'Participants in EA group will receive treatment at bilateral Bladder Meridian (BL) 33 \\\\[Zhongliao\\\\], BL35 \\\\[Huiyang\\\\] and Spleen Meridian (SP) 6 \\\\[Sanyinjiao\\\\]. The EA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks.', 'interventionNames': ['Procedure: Electroacupuncture']}\n- {'label': 'Sham Electroacupuncture (SA) group', 'type': 'SHAM_COMPARATOR', 'description': 'Participants in SA group will receive treatment at bilateral sham BL33 \\\\[Zhongliao\\\\], sham BL35 \\\\[Huiyang\\\\] and sham SP6 \\\\[Sanyinjiao\\\\]. The SA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks.', 'interventionNames': ['Procedure: Sham electroacupuncture']}\n- {'label': 'Waiting List (WL) group', 'type': 'NO_INTERVENTION', 'description': 'Participants in WL group will be followed up for 20 weeks. Participants only receive healthcare education and advice on lifestyle modification, which will be received by all the participants in the three groups.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Electroacupuncture', 'description': 'BL33 is located in the third posterior sacral foramen; BL35, 0.5 cun (\u224810mm) lateral to the extremity of the coccyx; and SP6 posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus. BL33 will be inserted by needles of 0.30\u00d775mm size at the angle of 45\u00b0, inward and downward, till the depth of 60-70mm. BL35 will be inserted by needles of 0.30\u00d775mm size, slightly outward and upward, till the depth of 60-70mm. SP6 will be inserted by needles of 0.30\u00d740mm till the depth of 25-30mm. All the needles will be lifted, thrust and twisted evenly for three times, right after insertion, to induce the sensation of deqi. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20 Hertz (Hz), electric current of 2-6.5 milliampere (mA) for BL33 and BL35, and 1mA-3.5mA for SP6.', 'armGroupLabels': ['Electroacupuncture(EA) group'], 'otherNames': ['EA']}\n- {'type': 'PROCEDURE', 'name': 'Sham electroacupuncture', 'description': 'Sham BL33 is in the area of 1 cun (\u224820mm) horizontally outside BL33; sham BL35, 1 cun (\u224820mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons. The three pairs of acupoints will be inserted by needles of 0.30\u00d740mm size to a depth of 2-3mm till the needles can stand still. No manipulations will be conducted, and the sensation of deqi will not be induced. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20Hz and minimal electric current (ideally at a degree which participant can just percept). In about 30 seconds, the electric current will be turned down, leaving the indicator light and ticking sound on.', 'armGroupLabels': ['Sham Electroacupuncture (SA) group'], 'otherNames': ['SA']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline.', 'description': 'The stress IEF will be documented in 3-day voiding diary.', 'timeFrame': 'week 8'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided significance level of 0.05%, 10% dropouts.", "answer": 232, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on our previous study,14 15 we assume that 25% of participants in the SA group will have at least 50% reduction of mean stress IEF from baseline to week 8. To detect a difference of 23% between the EA and SA group, a sample size of 232 participants will need to provide the trial with 80% power with a two-sided significance level of 0.05% and 10% dropouts.", "id": 700, "split": "val"} +{"trial_id": "NCT04301102", "pmid": "35654467", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intraoperative Hemodynamic Optimization Using the Hypotension Prediction Index and Its Impact of Tissular Perfusion\n\nIncluded conditions:\n- Intraoperative Hypotension\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': 'Hemodynamic management will be based on the functional hemodynamic parameters provided by Hemosphere platform with the Acumen IQ sensor, including cardiac output, stroke volume, SVV and Acumen IQ specific parameters: maximal arterial pressure rise (dP/dtmax), dynamic arterial elastance (Eadyn) and HPI\\n\\nAs a pattern replacement of interstitial space, we will use balanced crystalloid (Isofundin\u00ae) at 1-3 ml / kg / h in case of laparoscopic surgery and 5 to 7 ml / kg / h in case of open surgery.\\n\\nThe protocol of action on the intravascular space will be based on the maintenance of systolic volume with colloids (hydroxyethyl starch - Voluv\u00e9n\u00ae).', 'interventionNames': ['Device: Hemosphere platform\u00ae together with the FloTrac Acumen IQ\u00ae sensor']}\n- {'label': 'Control', 'type': 'OTHER', 'description': 'Hemodynamic management will be based on the functional hemodynamic parameters provided by the HemoSphere platform\u00ae with the FloTrac\u00ae sensor, including cardiac output (CO), stroke volume (SV), and stroke volume variation (SVV)\\n\\nAs a pattern replacement of interstitial space, we use balanced crystalloid (Isofundin\u00ae) at 1-3 ml / kg / h in case of laparoscopic surgery and 5 to 7 ml / kg / h in case of open surgery.\\n\\nThe protocol action for the intravascular space will be based on a recently published hemodynamic optimization algorithm (Heming N, Moine P, Coscas R, Annane D. Perioperative fluid management for major elective surgery. British Journal of Surgery. 2020;107:e56-62). The fluid used will be hydroxyethyl starch (Voluven\u00ae).', 'interventionNames': ['Device: Hemosphere platform\u00ae together with the FloTrac\u00ae sensor']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Hemosphere platform\u00ae together with the FloTrac Acumen IQ\u00ae sensor', 'description': 'Clinical platform that, analyzing the pulse wave contour, obtained from the previously catheterized radial artery, is able to make available to the clinician both a continuous monitoring of blood pressure and advanced hemodynamic parameters that help patient management. It incorporates predictive parameters such as the hypotension prediction index and decision support parameters such as dynamic arterial elastance and maximum dP / dT.\\n\\nIt also has the possibility of assessing regional oxygen saturation, measured by near-infrared light photoplethysmography, and the sensor can be applied in different locations (cerebral, muscular ...).', 'armGroupLabels': ['Experimental']}\n- {'type': 'DEVICE', 'name': 'Hemosphere platform\u00ae together with the FloTrac\u00ae sensor', 'description': 'Clinical platform that, analyzing the pulse wave contour, obtained from the previously catheterized radial artery, is able to make available to the clinician both a continuous monitoring of blood pressure and advanced hemodynamic parameters that help patient management.\\n\\nIt also has the possibility of assessing regional oxygen saturation, measured by near-infrared light photoplethysmography, and the sensor can be applied in different locations (cerebral, muscular ...).', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'TWA-MAP< 65 mmHg', 'description': 'Area between 65 mmHg threshold and the curve of the MAP measurements divided by the total continuous reading time mmHg for a minimum duration of 1 minute (3 consecutive records from one minute to more between two consecutive falls).', 'timeFrame': 'Intraoperatively'}\n- {'measure': 'Number of intraoperative hypotension episodes', 'description': 'defined as an event of MAP \\\\< 65 mmHg of at least 1-minute duration', 'timeFrame': 'Intraoperatively'}\n- {'measure': 'Total time of hypotension per case', 'description': 'Intraoperative Total time of hypotension (MAP \\\\< 65 mmHg)', 'timeFrame': 'Intraoperatively'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 5% significance level, 10% drop-out rate.", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size and data analysis\n The literature indicates that a cumulative hypotension time of more than 10\u00e2\u0080\u0089min during surgery is clinically relevant.25 Given the novelty of the HPI parameter and the lack of publications during the design of this study, a pilot study in 31 patients undergoing major surgery was performed at the Virgen del Roc\u00c3\u00ado Hospital. In this preliminary study, two groups were defined: a control group with invasive and continuous arterial pressure monitoring but without the use of HPI; and an intervention group with invasive and continuous blood pressure monitoring, in which the anaesthesiologist also had access to the HPI value and the additional parameters during surgery. In both groups, the haemodynamic objective during the intraoperative period was to maintain the MAP above 65\u00e2\u0080\u0089mm Hg. The results from this preliminary study revealed that in the control group (15 patients), 68.75% of the patients accumulated more than 10\u00e2\u0080\u0089min of hypotension (11 patients), while in the intervention group with HPI (16 patients), only 31.25% of the patients accumulated periods of a MAP <65\u00e2\u0080\u0089mm Hg more than 10\u00e2\u0080\u0089min (5 patients).\n Based on this pilot study, to achieve a 90% power, and a significance level of 5%, 72 patients will be required (36 in each group). Assumed a drop-out rate of 10%, a total of 80 patients will be required (40 patients per group).", "id": 701, "split": "val"} +{"trial_id": "NCT04301505", "pmid": "33632282", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Checklist Based Method for Improvement of COPD Care in Elderly in General Practice: Cluster Randomized Controlled Trial Using Electronic Health Records\n\nIncluded conditions:\n- Chronic Obstructive Pulmonary Disease (COPD)\n\nStudy Armgroups:\n- {'label': 'control', 'type': 'NO_INTERVENTION', 'description': 'Usual care.'}\n- {'label': 'Intervention 1', 'type': 'OTHER', 'description': 'COPD management checklist will be delivered at the beginning of the study.', 'interventionNames': ['Other: Intervention 1']}\n- {'label': 'Intervention 2', 'type': 'OTHER', 'description': 'COPD management checklist will be delivered at the beginning of the study and repeated after 6 months.', 'interventionNames': ['Other: Intervention 2']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Intervention 1', 'description': 'Checklist will be delivered at the beginning of the study. The educational intervention program will consist of a checklist that provides family physicians with COPD management for the elderly.', 'armGroupLabels': ['Intervention 1']}\n- {'type': 'OTHER', 'name': 'Intervention 2', 'description': 'The same checklist will be delivered at the beginning of the study and repeated after 6 months.', 'armGroupLabels': ['Intervention 2']}\n\nPrimary Outcomes:\n- {'measure': 'The proportion of elderly patients hospitalized with the J-44 code as a main reason for admission after interventions vs. control.', 'description': 'Variables from BIG DATA databases, such as the electronic health record (EHR) of patients from the National Health Found, associated with checklist will be used to assess hospitalization of elderly patients with the J-44 code as a main reason for admission after 1 year.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, a two-tailed alpha of 0.05, and intra-cluster correlation of 0.01. Adjustments for clustering and potential loss to follow-up are considered.", "answer": 2520, "answer_type": "ACTUAL", "explanation": "Sample size\n A minimum number of 84 GP clinics with at least 30 J-44 patients per clinic is required to provide a sufficient sample size for a three-arm cluster randomized controlled trial: 84 clusters and at least 2520 subjects are needed (28 clusters in each study arm) to detect a difference of 0.026 between mean event rates of hospitalization with ICD-10 code J-44 as the main reason for admission. This assumes a 25% reduction in total number of events after the intervention in the first arm (receiving checklist once) and 50% reduction in total number of events after the interventions in the second arm (receiving checklist twice) compared to the control group not receiving any intervention (standard care). It is also assumed the tests will have 80% power, a two-tailed alpha of 0.05, and intra-cluster correlation of 0.01.\n Data collected from electronic health records in 2016 indicate that the mean event rate of \u00e2\u0080\u009chospitalized with ICD-10 code J-44 as the main reason for admission\u00e2\u0080\u009d in the control group is 0.105, and the standard deviation is 0.306. The unadjusted sample size was calculated for differences between three means for one-way ANOVA.\n To compare the individuals hospitalized with the J-44 code in the three arms after 1\u00c2\u00a0year, the difference between the mean event rates of the three groups was calculated according to Donner and Klar [16].\n A standard sample size formula was used to calculate the initial unadjusted sample size requirements, followed by appropriate adjustment for clustering by general practice according to Campbell et al. [17], with expected small clustering effect (ICC\u00e2\u0080\u0089=\u00e2\u0080\u00890.01) [18, 19].\n To prevent loss to follow-up among practices/participants, an enlarged overall sample size will be deemed appropriate to ensure adequate power.", "id": 702, "split": "val"} +{"trial_id": "NCT04302454", "pmid": "35501744", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Radiotherapy without hormonal therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Metastase-directed radiotherapy without the addition of hormonal therapy', 'interventionNames': ['Radiation: Radiotherapy']}\n- {'label': 'Radiotherapy combined with hormonal therapy', 'type': 'EXPERIMENTAL', 'description': 'Metastase-directed radiotherapy with the addition of of short-term hormonal therapy (6 months)', 'interventionNames': ['Radiation: Radiotherapy', 'Drug: Leuprorelin']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Radiotherapy', 'description': 'Radiotherapy', 'armGroupLabels': ['Radiotherapy combined with hormonal therapy', 'Radiotherapy without hormonal therapy'], 'otherNames': ['MDRT', 'Metastase-directed radiotherapy', 'SBRT', 'Stereotactic body radiotherapy']}\n- {'type': 'DRUG', 'name': 'Leuprorelin', 'description': 'Hormonal therapy', 'armGroupLabels': ['Radiotherapy combined with hormonal therapy'], 'otherNames': ['Eligard']}\n\nPrimary Outcomes:\n- {'measure': 'Metastases progression-free survival (MPFS)', 'description': 'The primary aim of this project is to test the hypothesis that the addition of ADT to MDRT in well-selected PCa patients with oligo-metastatic disease (OM) prolongs the metastases progression-free survival (MPFS) compared to MDRT alone', 'timeFrame': '2.5 years after treatment'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha of 5%, power of 80%, and a dropout rate of 18% at 30 months are assumed.", "answer": 280, "answer_type": "ESTIMATED", "explanation": "Sample size\n From a previous meta-analysis, we know that the median progression-free survival in patients treated with MDRT is 21\u00c2\u00a0months [6]. This corresponds to an event rate of 50% in the MDRT group at 21\u00c2\u00a0months. For the MDRT\u00e2\u0080\u0089+\u00e2\u0080\u0089ADT group we assume a decreased event rate to 35% (65% event-free). Assuming a constant hazard of 0.0330 in the MDRT group and 0.0205 in the MDRT\u00e2\u0080\u0089+\u00e2\u0080\u0089ADT group, the metastases progression-free survival at 2.5\u00c2\u00a0years is expected to be 37.1% in the MDRT group and 54.0% in the MDRT\u00e2\u0080\u0089+\u00e2\u0080\u0089ADT group. This is associated with a hazard ratio of 0.621. Assuming an alpha of 5%, power of 80%, and a dropout of 18% at 30\u00c2\u00a0months, we need to recruit 140 patients per treatment arm and 280 patients in total.", "id": 703, "split": "val"} +{"trial_id": "NCT04303065", "pmid": "33546038", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dexamethasone for the Treatment of Traumatic Brain Injured Patients With Brain Contusions and Pericontusional Edema: Study Protocol for a Prospective, Randomized and Double Blind Trial.\n\nIncluded conditions:\n- Traumatic Brain Injury\n- Cerebral Edema\n\nStudy Armgroups:\n- {'label': 'Dexamethasone', 'type': 'EXPERIMENTAL', 'description': 'Dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days).\\n\\nDexamethasone (Fortecortin\u00ae) will be acquired from ERN, SA. Laboratories (Barcelona, Spain). The Son Espases Pharmacy Department will be in charge of developing and conditioning the 4mg, 2mg and 1mg dexamethasone / placebo capsules needed for 12 days of treatment, keeping the researchers blind', 'interventionNames': ['Drug: Dexamethasone Oral']}\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'The preparation and conditioning of the capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Espa\u00f1ola del Medicamento (AEMPS).\\n\\nThe Son Espases Pharmacy Department will be responsible for identifying the containers and sending them by courier to the participating hospitals. A record of the dispensing of test samples will be kept and will be sent in acknowledgment of receipt for control', 'interventionNames': ['Drug: Placebo oral tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexamethasone Oral', 'description': 'It will be a short and descending course of oral dexamethasone: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days).', 'armGroupLabels': ['Dexamethasone']}\n- {'type': 'DRUG', 'name': 'Placebo oral tablet', 'description': 'The preparation and conditioning of the placebo capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Espa\u00f1ola del Medicamento (AEMPS).', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Glasgow Scale Outcome Extended (GOSE).', 'timeFrame': 'one month'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 2-sided alpha = 5%, 10% inflation due to non-adherence", "answer": 600, "answer_type": "ESTIMATED", "explanation": "3.10\n Sample size and treatment effect size that should be detectable\n Since the data available in this type of patients with this treatment is scarce and inconclusive, we will perform a randomized, triple-blind, placebo controlled trial with an interim futility analysis (interim analysis). The primary endpoint for the DEXCON TBI trial is the good recovery (GOSE 7\u00e2\u0080\u00938) one month after the TBI.\n A study with 600 patients would have about 80% power (2 sided alpha\u00e2\u0080\u008a=\u00e2\u0080\u008a5%) to detect a 12% absolute increased (from 50% to 62%) in good recovery (GOSE 7\u00e2\u0080\u00938). It includes an inflation of 10% due to non-adherence (withdrawal of consent, loss to follow-up, cross-over or change of treatment).", "id": 704, "split": "val"} +{"trial_id": "NCT04305769", "pmid": "37474181", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection: a Randomized, Double-blind, Placebo-controlled Trial\n\nIncluded conditions:\n- Clostridioides Difficile Infection\n- Clostridium Difficile Infection\n- Clostridium Difficile Diarrhea\n- Clostridia Difficile Colitis\n\nStudy Armgroups:\n- {'label': 'Alanyl-glutamine 0g', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Alanyl-glutamine']}\n- {'label': 'Alanyl-glutamine 4g', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Alanyl-glutamine']}\n- {'label': 'Alanyl-glutamine 24g', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Alanyl-glutamine']}\n- {'label': 'Alanyl-glutamine 44g', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Alanyl-glutamine']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Alanyl-glutamine', 'description': 'The study agent is AQ, a dipeptide with a glutamine amino group joined to an alanyl residue. It has the following chemical structure: C8H15N3O4. It is a non-animal product available in the form of white crystals or crystalline powder. It is odorless, tasteless, stable and highly soluble.', 'armGroupLabels': ['Alanyl-glutamine 0g', 'Alanyl-glutamine 24g', 'Alanyl-glutamine 44g', 'Alanyl-glutamine 4g'], 'otherNames': ['Alagln', 'AQ', 'glutamine']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with recurrent CDI.', 'description': 'Documented C difficile infection defined by presence of recurrent diarrhea with stool positive for C difficile assay necessitating treatment with anti-C. difficile antibiotic.', 'timeFrame': 'Within 60 days post-treatment'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level of 0.05, power of 90%, 17% mortality during 60 days post-treatment follow-up, and a loss of 60-days follow-up rate not more than 10%.", "answer": 260, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n Sample size estimations are based on the presence of four study groups (placebo, 4\u00e2\u0080\u0089mg dose, 24\u00e2\u0080\u0089mg dose and 44\u00e2\u0080\u0089mg dose), a 40% recurrence rate of CDI in the standard treatment control arm (placebo) with a 15% difference between best intervention and the standard control treatment, alpha level of 0.05 and power of 90%. With these specifications, 59 participants per group (total n=236) are required using a single stage approach for randomised phase II trial designs with multiple groups. Fifty-nine persons per group will also achieve 80% power for a minimum difference of 12%. Assuming a 17% mortality during 60 days post-treatment follow-up in this population, the proposed sample size of 236 provides 90% power for a minimum detectable difference of 10% in mortality between the active treatment groups and control group. Assuming a loss of 60-days follow-up rate not more than 10%, 260 participants (65 persons per group) will be required to meet our primary objectives.", "id": 705, "split": "val"} +{"trial_id": "NCT04307953", "pmid": "35650602", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Saracatinib Trial TO Prevent FOP\n\nIncluded conditions:\n- Fibrodysplasia Ossificans Progressiva\n\nStudy Armgroups:\n- {'label': 'AZD0530', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: AZD0530 Difumarate']}\n- {'label': 'Placebo/AZD0530', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Matching placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'AZD0530 Difumarate', 'description': 'AZD0530 for the duration of the trial', 'armGroupLabels': ['AZD0530'], 'otherNames': ['Saracatinib']}\n- {'type': 'DRUG', 'name': 'Matching placebo', 'description': 'Matching placebo during 6 month RCT, AZD0530 thereafter', 'armGroupLabels': ['Placebo/AZD0530']}\n\nPrimary Outcomes:\n- {'measure': 'The objective change between the two arms measured in heterotopic bone volume measured by low-dose whole body CT over the initial 6 month RCT', 'timeFrame': 'Baseline, month 6'}\n\nPlease estimate the sample size based on the assumption: \nUsing a t-test with two-sided alternative, with unequal variances, the trial is 80% powered to detect the minimum clinically meaningful difference with an \u03b1 = 0.05. An expected drop-out rate of 20% is also considered.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Based on the Natural History Study of FOP, progression of HO in FOP is estimated at 120,000\u00e2\u0080\u0089mm3 on average per 6-month period with a standard deviation of 48,000\u00e2\u0080\u0089mm3 [24]. Expert consensus defines a meaningful decrease in the rate of HO progression as at least 50% reduction in treated vs. control patients, or 60,000\u00e2\u0080\u0089mm3, with a standard deviation of 24,000\u00e2\u0080\u0089mm3. Using this projected impact, using a t-test with two-sided alternative, with unequal variances, a trial with treatment and placebo arms of n\u00c2\u00a0=\u00e2\u0080\u00898 each would be 80% powered to detect this minimum clinically meaningful difference with an \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 during the initial 6-month study.\n Taking into account an expected drop-out rate of 20%, we calculated the necessary number of participants to be 20 at the start of the study.", "id": 706, "split": "val"} +{"trial_id": "NCT04307992", "pmid": "39009453", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation\n\nIncluded conditions:\n- Abdominal Aortic Aneurysm\n- Endoleak\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Device: ANEUFIX', 'interventionNames': ['Device: Prophylactic sac filling with AneuFix']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Prophylactic sac filling with AneuFix', 'description': 'ANEUFIX is administered by injection into the AAA via transferal access at the time of EVAR placement using imaging techniques to guide the place of injection.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Technical Success', 'description': 'Technical Success as demonstrated by the feasibility to fill the AAA sac after EVAR during the same procedure, and by the rate of (all) endoleaks after EVAR followed by the AneuFix procedure', 'timeFrame': '24 hours'}\n- {'measure': 'Clinical Success rate', 'description': 'Clinical Success as demonstrated by the occurrence of type II endoleaks at 6 months after EVAR, and aneurysmal sac growth at 6 months after EVAR', 'timeFrame': '6 months'}\n- {'measure': 'Clinical Success rate', 'description': 'Clinical Success as demonstrated by the occurrence of type II endoleaks at 12 months after EVAR, and aneurysmal sac growth at 12 months after EVAR', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 5, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n First, a pilot study will be conducted with five patients. After DSMB approval, this sample size will be raised to 25 patients by treating another 20 patients. A sample size of 25 has been calculated adequate and sufficient to assess the goals of the study with an independent statistician and instructed by the CE-notified body.", "id": 707, "split": "val"} +{"trial_id": "NCT04314193", "pmid": "33076885", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The PREDMETH Trial: Effectiveness of Methotrexate Versus Prednisone As First-line Therapy for Pulmonary Sarcoidosis - a Randomized Controlled Trial\n\nIncluded conditions:\n- Sarcoidosis, Pulmonary\n\nStudy Armgroups:\n- {'label': 'methotrexate', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Methotrexate']}\n- {'label': 'prednisone', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Prednisone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Methotrexate', 'description': 'Oral methotrexate (15 mg weekly to be increased to 25 mg weekly) for 24 weeks.', 'armGroupLabels': ['methotrexate']}\n- {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Oral prednisone (start 40 mg daily, to be tapered to 10 mg daily) for 24 weeks.', 'armGroupLabels': ['prednisone']}\n\nPrimary Outcomes:\n- {'measure': 'Forced Vital Capacity (FVC)', 'description': 'Change in hospital-measured FVC between baseline and 24 weeks', 'timeFrame': '24 weeks after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided test with a power of 80% (\u03b2) and a type 1 error of 5% (\u03b1). Allowance for 20% drop-out.", "answer": 138, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The power calculation is based on data from a previous observational study with prednisone in newly treated patients with pulmonary sarcoidosis. In this study, the mean increase in FVC with prednisone was 15%, with a standard deviation of 10.5% [8]. In a case series of 50 patients with sarcoidosis treated with methotrexate, treatment effect was in line with the findings for prednisone; 66% of patients had more than 15% improvement in vital capacity after 6\u00e2\u0080\u0089months [24]. We chose a non-inferiority margin of 5%, because FVC measurements show biological variation and thus variation <\u00e2\u0080\u00895% is not considered clinically relevant. Based on these numbers, using a one-sided test with a power of 80% (\u00ce\u00b2) and a type 1 error of 5% (\u00ce\u00b1), the estimated sample size of this study is 110 patients. To allow for 20% drop-out, we aim to randomize 138 patients.", "id": 708, "split": "val"} +{"trial_id": "NCT04316130", "pmid": "33902546", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hospital-home Linkage Short-term Rehabilitation Therapy Using Real-time Interactive Digital Healthcare System in Frozen Shoulder; Randomized Controlled Trial, Assessor Blinding, Multi-center Study\n\nIncluded conditions:\n- Frozen Shoulder\n\nStudy Armgroups:\n- {'label': 'Exercise using Uincare Homeplus', 'type': 'EXPERIMENTAL', 'description': 'Uincare Homeplus', 'interventionNames': ['Device: Uincare Homeplus']}\n- {'label': 'Exercise using brochure', 'type': 'ACTIVE_COMPARATOR', 'description': 'brochure', 'interventionNames': ['Other: Brochure']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Uincare Homeplus', 'description': 'Interactive digital healthcare system', 'armGroupLabels': ['Exercise using Uincare Homeplus'], 'otherNames': ['digital healthcare']}\n- {'type': 'OTHER', 'name': 'Brochure', 'description': 'Brochure', 'armGroupLabels': ['Exercise using brochure']}\n\nPrimary Outcomes:\n- {'measure': 'Range of motion (ROM) in affected shoulder', 'description': 'Evaluation of change of ROM in the affected shoulder from baseline to 12 weeks', 'timeFrame': 'Enrollment, 4 week, 8 week, 12 week, 18 weeks, 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5% (0.05/4 for each hypothesis), 80% statistical power, and an expected dropout rate of 25%.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The target sample size was calculated through consultation with an in-hospital statistics team. The primary hypothesis was that there would be a significant difference in the amount of change in PROM before and after 3\u00e2\u0080\u0089months for the digital health care and control groups. The ROM consists of flexion, abduction, external rotation, and internal rotation of the shoulder joint. When the standard deviation of the variation is 18.64, 16.79, 11.22, and 11.65, respectively, and the difference between the two groups variation is expected to be 15, 15, 10, 10, or more, respectively, based on the results of the existing studies [21\u00e2\u0080\u009325], 35 people per group are required for a significance level of 5% (a significant level of 0.05/4*100% of each hypothesis) and 80% statistical power. Assuming an expected dropout rate of 25%, we require at least 47 participants per group.", "id": 709, "split": "val"} +{"trial_id": "NCT04316286", "pmid": "32393279", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Telemedicine With Mobile Internet Devices for Innovative Multidisciplinary Patient-centred Care of Patients With Narcolepsy\n\nIncluded conditions:\n- Narcolepsy\n\nStudy Armgroups:\n- {'label': 'Tele-multidisciplinary participants', 'type': 'EXPERIMENTAL', 'description': 'Patients undergoing televisit', 'interventionNames': ['Procedure: Tele-multidisciplinary care']}\n- {'label': 'In-office standard participants', 'type': 'OTHER', 'description': 'Patients undergoing in-office visits', 'interventionNames': ['Other: Standard care']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Tele-multidisciplinary care', 'description': 'Scheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists', 'armGroupLabels': ['Tele-multidisciplinary participants']}\n- {'type': 'OTHER', 'name': 'Standard care', 'description': 'Scheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists', 'armGroupLabels': ['In-office standard participants']}\n\nPrimary Outcomes:\n- {'measure': 'excessive daytime sleepiness', 'description': 'Measured by the Epworth Sleepiness Scale. The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can received 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score). The proposed range for normal subjects is 0-10', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set to ensure the 95% lower limit of one-sided CI is above the non-inferiority limit, with 80% power. A 15% dropout rate is considered. Repeated measures ANOVA will be used for comparison.", "answer": 202, "answer_type": "ACTUAL", "explanation": "Sample size and statistical considerations\n A total of 176 patients (88 per arm) are required to prove that the 95% lower limit of one-sided CI will be above the non-inferiority limit of \u00e2\u0088\u0092\u00e2\u0080\u00891.5 ESS points difference (standard deviation of 4), with 80% of power. A previous RCT used a non-inferiority margin of 2 ESS points and 80% as minimal power to compare pitolisant versus modafinil in patients with narcolepsy [30]. As the TMC study will not test drugs, we decided to adopt a stricter margin (1.5 ESS points). The standard deviation value (\u00c2\u00b14) was based on the Italian validation study of ESS [28]. Considering 15% of dropouts, the sample was enlarged to 202 (101 per arm). Repeated measures ANOVA will be used to compare EDS between groups at baseline and after 1-yr of follow-up.", "id": 710, "split": "val"} +{"trial_id": "NCT04318496", "pmid": "33950945", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Acupuncture for Blunt Chest Trauma: A Protocol for a Double-Blind Randomized Control Trial\n\nIncluded conditions:\n- Chest Trauma\n- Rib Fractures\n\nStudy Armgroups:\n- {'label': 'Acupuncture with press tack needle group (Acu)', 'type': 'EXPERIMENTAL', 'description': 'the press tack needles (PYONEX \u03a60.20\u00d70.6 mm made by Seirin Corporation) has a diameter of 0.2 mm and length of 0.6 mm will be used on the following bilateral points; GB 36 (Waiqiu), GB 34 (YangLingQuan), ST 36 (Zusanli), LI 4 (HeGu), LU 7 (LieQue), TH 5 (Waiguan) press tack needles retention time will be 4 days.', 'interventionNames': ['Other: Press Tack Acupuncture']}\n- {'label': 'Placebo group (Con)', 'type': 'PLACEBO_COMPARATOR', 'description': 'The pess tack placebo is PYONEX sticker and pack that is identical to the press needle, except that the needle part was removed. The acupuncturist will apply the stickers on the following bilateral acupoints: GB 36 (Waiqiu), GB 34 (YangLingQuan), ST 36 (Zusanli), LI 4 (HeGu), LU 7 (LieQue), TH 5 (Waiguan) press tack stickers retention time will be 4 days.', 'interventionNames': ['Other: Press Tack Placebo']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Press Tack Acupuncture', 'description': 'PYONEX \u03a60.20\u00d70.6 mm made by Seirin Corporation', 'armGroupLabels': ['Acupuncture with press tack needle group (Acu)'], 'otherNames': ['Press Tack Needle/ sticker needle/ PYONEX']}\n- {'type': 'OTHER', 'name': 'Press Tack Placebo', 'description': 'PYONEX placebo sticker made by Seirin Corporation', 'armGroupLabels': ['Placebo group (Con)'], 'otherNames': ['PYONEX placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Numerical Rating Scale (NRS) - rest', 'description': 'pain scale form 1-10 when 10 is the most painful', 'timeFrame': '3 months'}\n- {'measure': 'Numerical Rating Scale (NRS) - mobile', 'description': 'pain scale form 1-10 when 10 is the most painful', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \n95% power, 20% dropout rate", "answer": 72, "answer_type": "ACTUAL", "explanation": "2.16\n Sample size calculation\n In a previous similar study,[11] the pain scale reduced significantly as recorded immediately after acupuncture treatment. We utilized the result of this study to calculate sample size as generated by G\u00e2\u0088\u0097power version 3.1.9.2 software. Accordingly, in the condition of 95% power being calculated with an effect size of 1.124365. The patient number in each group should be a minimum of 18 participants. However, we also considered that a previous study included 29 patients in each group with a total of 58 patients. With respect to a dropout rate of 20%, we decided to include 36 patients in each group, for a total of 72 patients.", "id": 711, "split": "val"} +{"trial_id": "NCT04319614", "pmid": "35717263", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy? The RARPEX (Robotic Assisted Radical Prostatectomy With TranEXamic Acid) Study.\n\nIncluded conditions:\n- Robotic-assisted Radical Prostatectomy\n\nStudy Armgroups:\n- {'label': 'Tranexamic acid', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Tranexamic Acid Injectable Product']}\n- {'label': 'Saline', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebos']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tranexamic Acid Injectable Product', 'description': 'A single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline, will be administered in the beginning of procedure.', 'armGroupLabels': ['Tranexamic acid']}\n- {'type': 'DRUG', 'name': 'Placebos', 'description': '100 ml of saline will be administered in the beginning of the procedure.', 'armGroupLabels': ['Saline']}\n\nPrimary Outcomes:\n- {'measure': 'Reduction of blood loss', 'description': 'The drop of hemoglobin level, weighted on gram of prostate or creatinin level.', 'timeFrame': '7 days after the procedure'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sample T tests allowing unequal variance, significance level (\u00ce\u00b1) = 1%, power (1-\u00ce\u00b2) = 90%, expected dropout rate = 33%.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size calculation is based on the data from our pilot study [29]. We used two-sample T tests allowing unequal variance with respect to the primary endpoint, which is the difference in hemoglobin level drop on postoperative day (POD) 1. The level of significance is set to 5 g. With \u00ce\u00b1 = 1% and \u00ce\u00b2 = 10%, a sample size of 64 patients per group is necessary to detect a clinically significant difference between the groups. With an expected dropout rate over 33%, we plan to enroll 200 patients in the study.", "id": 712, "split": "val"} +{"trial_id": "NCT04325061", "pmid": "32799933", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19\n\nIncluded conditions:\n- Acute Respiratory Distress Syndrome Caused by COVID-19\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Patients will be treated with standard intensive care'}\n- {'label': 'Dexamethasone', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard intensive care plus dexamethasone', 'interventionNames': ['Drug: Dexamethasone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily from Day 6 to 10 of randomization', 'armGroupLabels': ['Dexamethasone'], 'otherNames': ['dexamethasone Indukern']}\n\nPrimary Outcomes:\n- {'measure': '60-day mortality', 'description': 'All-cause mortality at 60 days after enrollment', 'timeFrame': '60 days'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-sided significance level of alpha = 0.05, up to 5% potential losses to follow-up, no formal interim analysis, conditional power analysis if conditional power is \u2265 70% but < 80%, no adjustment to alpha required.", "answer": 19, "answer_type": "ACTUAL", "explanation": "Sample size calculations\n The trial was designed to be initiated in rapid response to the COVID-19 public health emergency. We estimated the sample size on the assumption that treatment with dexamethasone could reduce all-cause 60-day mortality by 20%. Our baseline reference was 50\u00e2\u0080\u009355% based on recent observational studies from China [4]. Depending on the estimated 60-day mortality, we studied various group-size scenarios with cohorts of 93 to 100 patients in each arm to detect a 20% difference with a power of 80%, at a two-sided significance level of alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05. The R function power.prop.test was used to estimate the sample size requirement which is based on a z test. A population size of 192 patients (96 in each arm) will provide 80% power to detect a 20% absolute reduction, from 55% on the control group to 35% in the experimental group. To account for up to 5% potential losses to follow-up, we will randomize 200 patients. We will only analyze patients that are enrolled and randomized to receive treatment. There will not be a formal interim analysis. However, after recruitment of 70% of the patients, an independent statistician will perform a conditional power analysis. If the conditional power at that time is \u00e2\u0089\u00a5\u00e2\u0080\u008970% but <\u00e2\u0080\u008980%, the external Data and Safety Monitoring Board (DSMB) can recommend an increase in sample size to achieve 80% power. The conditional power analysis will be performed at the Applied Health Research Center, Li Ka Shing Knowledge Institute of St. Michael\u00e2\u0080\u0099s Hospital, Toronto, Canada. Since the conditional power analysis will not be used to stop the trial early due to a treatment difference, no adjustment to alpha is required. The DSMB could decide to stop the trial at any point for safety reasons. Also, in a context of a pandemic, it is plausible to discontinue the trial if no new patients are enrolled during a prolonged period of time. The decisions of the DSMB will be communicated to the principal investigators in a letter (sent by email). If the DSMB reaches a decision that the trial must be terminated early for safety reasons, they will email and call either one of the PIs within 24\u00e2\u0080\u0089h of making this decision.", "id": 713, "split": "val"} +{"trial_id": "NCT04328675", "pmid": "33277290", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Registration Study of Natural History and Clinical Characteristics of Amyotrophic Lateral Sclerosis (ALS) in Mainland China\n\nIncluded conditions:\n- Amyotrophic Lateral Sclerosis\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Effective Survival', 'description': 'The length of time from the date of diagnosis to patient death or tracheotomy or ventilator-assisted breathing.', 'timeFrame': 'through study completion, an average of 3 month'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 4752, "answer_type": "ESTIMATED", "explanation": "Study sites and sample sizes\n This study will be performed at centres spread across approximately 20 provinces, four municipalities and four autonomous regions in mainland China (figure 2). At least one tertiary first-class hospital from each of the participating provinces will take part in the study. A total of 88 hospitals will be involved.\n \n Figure 2\n \n Regions of mainland China with centres participating in CHALSR. NA, not available.\n \n \n \n According to the pilot study, the median of patients diagnosed with ALS and completing the detailed clinical follow-ups in our participating hospitals is 18 per year. Thus, based on clinical experience, the total number of patients included in this 3-year study is theoretically estimated to reach 4752. The leading research institution formulating the overall study design is PUTH, which is the largest ALS centre in China, with an ALS cohort of more than 2000 patients and approximately 500 newly diagnosed ALS patients per year.22", "id": 714, "split": "val"} +{"trial_id": "NCT04329624", "pmid": "35063963", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Perioperative LevosIMendan Administration on Postoperative N-terminal pRo Brain Natriuretic Peptide Concentration in Patients With Increased cardiOVascular Risk Factors Undergoing Noncardiac surgEry - A Double-blinded Randomized Clinical Trial\n\nIncluded conditions:\n- Cardiovascular Risk Factor\n\nStudy Armgroups:\n- {'label': 'Levosimendan', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive a continuous infusion of 12.5mg solved in 50mL Levosimendan for up to 24 hours. Infusion will be started with surgical skin incision.', 'interventionNames': ['Drug: Levosimendan']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients receive a continuous infusion containing a placebo solved in 50mL for up to 24 hours. Infusion will be started with surgical skin incision.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Levosimendan', 'description': 'Levosimendan 2.5 mg/ml injection contains levosimendan 2.5 mg, povidone 10.0 mg, citric acid, anhydrous 2.0 mg and ethanol, anhydrous to 1.0 mL. Levosimendan injection is a clear, yellow to orange solution. Immediately after skin incision patients allocated to the verum group will receive a dose of 12.5 mg in 500 mL of levosimendan.', 'armGroupLabels': ['Levosimendan']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo 2.5 mg/ml injection contains riboflavine sodium phosphate 0.4 mg, dehydrated alcohol 100 mg and water for injection to 1 mL.\\n\\nImmediately after skin incision patients allocated to the placebo group will receive 500 mL of 5% Glucose.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Postoperative maximum NT-proBNP concentration', 'description': 'The administration of levosimendan improves LVEF and myocardial oxygen perfusion, which will be reflected in a decrease of postoperative NT-proBNP concentration.Since NT-proBNP is a strong predictor for postoperative cardiovascular complications in patients undergoing noncardiac surgery, we want to test the efficiency of levosimendan to decrease postoperative maxNT-proBNP concentrations in patients with increased cardiac risk factors undergoing moderate- to high-risk noncardiac surgery.', 'timeFrame': 'First 5 Postoperative Days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level adjusted using O'Brien-Flemming's design for interim analysis, 80% power, 5% dropout rate, 10,000 bootstrap samples for Wilcoxon test statistics.", "answer": 230, "answer_type": "ACTUAL", "explanation": "Sample size considerations\n For the control group, data from a previous study were available, where NT-pro-BNP was measured within 1 hour after surgery and on postoperative day 1 and 3.7 The maximum of these values was calculated. For the calculation of the sample size, we assume median maximum NT-pro-BNP is reduced by 37%20 in the treatment group. To estimate the power, the distribution of the z-approximations of the Wilcoxon test statistics was estimated using the bootstrap method. A total of 10 000 bootstrap samples were drawn. The data for the control group were sampled from the data from the previous study.7 The data for the treatment group was sampled from the same data set, where all values were reduced by 37%. We considered a drop-out rate of 5%. With a total sample size of 230 (115 per group, with a planned interim analysis after 38 patients per group) the overall estimated power (ie, the power to reject either at interim or at the final analysis) is 80%. To correct for multiple testing due to the interim analysis, O'Brien-Flemming\u00e2\u0080\u0099s design will be used (see statistical analysis).", "id": 715, "split": "val"} +{"trial_id": "NCT04330638", "pmid": "32493441", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Other: Usual Care']}\n- {'label': 'Anakinra', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Anakinra']}\n- {'label': 'Siltuximab', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Siltuximab']}\n- {'label': 'Anakinra + Siltuximab', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Anakinra', 'Drug: Siltuximab']}\n- {'label': 'Tocilizumab', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Tocilizumab']}\n- {'label': 'Anakinra + Tocilizumab', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Anakinra', 'Drug: Tocilizumab']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Usual Care', 'armGroupLabels': ['Usual Care']}\n- {'type': 'DRUG', 'name': 'Anakinra', 'description': 'Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first', 'armGroupLabels': ['Anakinra', 'Anakinra + Siltuximab', 'Anakinra + Tocilizumab'], 'otherNames': ['KINERET\u00ae']}\n- {'type': 'DRUG', 'name': 'Siltuximab', 'description': 'Siltuximab will be given via single IV infusion at a dose of 11 mg/kg', 'armGroupLabels': ['Anakinra + Siltuximab', 'Siltuximab'], 'otherNames': ['SYLVANT\u00ae']}\n- {'type': 'DRUG', 'name': 'Tocilizumab', 'description': 'Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection', 'armGroupLabels': ['Anakinra + Tocilizumab', 'Tocilizumab'], 'otherNames': ['ROACTEMRA\u00ae']}\n\nPrimary Outcomes:\n- {'measure': 'Time to Clinical Improvement', 'description': 'Time to Clinical Improvement is defined as the time from randomization to either an increase of at least two points on a six category ordinal scale from the status at randomization or live discharge from the hospital.The 6-point ordinal scale for clinical improvement is defined as 1 = Death; 2 = Hospitalized, on invasive mechanical ventilation or ECMO; 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = Hospitalized, requiring supplemental oxygen; 5 = Hospitalized, not requiring supplemental oxygen; 6 = Not hospitalized. A higher score represent a better outcome', 'timeFrame': 'at day 15'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the paragraph.", "answer": 342, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n A total of 342 participants will be enrolled: 76 patients will receive usual care, 76 patients will receive Siltuximab alone, 76 patients will receive Tocilizumab alone, 38 will receive Anakinra alone, 38 patients will receive Anakinra and Siltuximab and 38 patients will receive Anakinra and Tocilizumab.", "id": 716, "split": "val"} +{"trial_id": "NCT04332172", "pmid": "35922101", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy\n\nIncluded conditions:\n- Fetal Alcohol Spectrum Disorders\n- Fetal Alcohol Syndrome\n- Fetal Alcohol Effect\n\nStudy Armgroups:\n- {'label': 'General information', 'type': 'PLACEBO_COMPARATOR', 'description': 'Control', 'interventionNames': ['Other: General information']}\n- {'label': 'General information + SMS', 'type': 'EXPERIMENTAL', 'description': 'SMS refers to tailored text messaging.', 'interventionNames': ['Other: General information', 'Behavioral: SMS']}\n- {'label': 'Baseline brief intervention', 'type': 'EXPERIMENTAL', 'description': 'Brief technology-delivered intervention for alcohol use during pregnancy', 'interventionNames': ['Behavioral: Baseline brief intervention']}\n- {'label': 'Baseline brief intervention + SMS', 'type': 'EXPERIMENTAL', 'description': 'Brief technology-delivered intervention for alcohol use during pregnancy, plus tailored text messaging', 'interventionNames': ['Behavioral: Baseline brief intervention', 'Behavioral: SMS']}\n- {'label': 'Baseline brief intervention + 2 booster sessions', 'type': 'EXPERIMENTAL', 'description': \"Brief technology-delivered intervention for alcohol use during pregnancy, plus two very brief (\\\\<5 minutes) online boosters using the participants' own mobile device.\", 'interventionNames': ['Behavioral: Baseline brief intervention', 'Behavioral: Remote online booster sessions']}\n- {'label': 'Baseline brief intervention + 2 booster sessions + SMS', 'type': 'EXPERIMENTAL', 'description': \"Brief technology-delivered intervention for alcohol use during pregnancy, plus two very brief (\\\\<5 minutes) online boosters using the participants' own mobile device, plus tailored SMS.\", 'interventionNames': ['Behavioral: Baseline brief intervention', 'Behavioral: Remote online booster sessions', 'Behavioral: SMS']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'General information', 'description': 'General information related to pregnancy is provided electronically.', 'armGroupLabels': ['General information', 'General information + SMS']}\n- {'type': 'BEHAVIORAL', 'name': 'Baseline brief intervention', 'description': \"Interactive brief motivational intervention is delivered electronically. Provides an introduction, describing the purpose and duration, emphasizing the non-judgmental nature of the brief intervention (BI). Uses a high-quality video featuring gain-framed messaging, quit recommendation, and testimonial from a race-matched woman; tailored on race-ethnicity, efficacy, binge frequency, and level of concern regarding her own alcohol use. The e-BI poses a question regarding the participant's willingness to avoid alcohol throughout her pregnancy. Responses to this question will sort participants into one of three major branches, each using motivational principles to promote alcohol abstinence during pregnancy.\", 'armGroupLabels': ['Baseline brief intervention', 'Baseline brief intervention + 2 booster sessions', 'Baseline brief intervention + 2 booster sessions + SMS', 'Baseline brief intervention + SMS']}\n- {'type': 'BEHAVIORAL', 'name': 'Remote online booster sessions', 'description': \"Two \\\\< 5-minute online e-BI boosters will be sent to participants via text link (one at 6 weeks post-baseline and one at 30 weeks gestation). The boosters will include a brief summary of the prior session in terms of the participant's concerns and goals. It will also include an assessment of her current status regarding (a) use of alcohol, and (b) intentions regarding future use of alcohol. A brief (1-2 minute) video tailored on her current status and prior goal will be provided. Finally, the boosters will contain optional goal-setting regarding reaching or maintaining abstinence.\", 'armGroupLabels': ['Baseline brief intervention + 2 booster sessions', 'Baseline brief intervention + 2 booster sessions + SMS']}\n- {'type': 'BEHAVIORAL', 'name': 'SMS', 'description': 'Tailored text messages (SMS) will be sent to participants twice a week from baseline throughout her pregnancy (or until she opts out). The messages will be tailored on her quit status, goals, efficacy, level of concern, gestation, and perceived advantages of change. Messages will follow current state of the art regarding messaging preferences, tailoring, and gain-framing. The current list includes messages regarding fetal development, nutrition, exercise, and stress management, as well as alcohol.', 'armGroupLabels': ['Baseline brief intervention + 2 booster sessions + SMS', 'Baseline brief intervention + SMS', 'General information + SMS']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants abstinent from alcohol as measured by Timeline FollowBack Calendar Recall and Ethyl Glucuronide (EtG)', 'description': 'The primary outcome of abstinence will be defined as no self-report of alcohol use in the past 90 days via Timeline FollowBack, and no evidence of use via EtG. The Timeline FollowBack will be administered at 34 weeks gestation and biospecimens for EtG are collected at approximately 37 weeks gestation (36 weeks for fingernails; 38 weeks for toenails).', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error rate of 0.05, 80% power, and approximately 15% dropout rate.", "answer": 384, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n For our primary hypothesis that 90-day alcohol abstinence will be greatest with a single baseline session plus boosters, followed by a single baseline session alone, compared with no BI (BI+booster>BI alone>no intervention), we plan a test for linear trend based on the Mantel-extension test. We also considered a second dose\u00e2\u0080\u0093response pattern, that is, a plateau pattern (BI+booster=BI alone and BI with and without booster>no intervention), which would be tested with a one-sided \u00ce\u00a72 test based on isotonic regression and the restricted likelihood ratio statistic.42 A priori power analyses were calculated for Mantel-extension and \u00cf\u00872 tests using a Monte-Carlo simulation of over 2000 iterations. We estimated that with a type 1 error rate of 0.05, 110 participants per dose level (330 participants in total) would be sufficient to achieve at least 80% power to detect small values (effect size=0.05) of the linear slope (or step values for the plateau pattern). Our proposed sample size is 128 participant per dose level (384 total) to allow for roughly 15% dropout or other unforeseen threats.", "id": 717, "split": "val"} +{"trial_id": "NCT04333485", "pmid": "35932062", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tuberculosis (TB) Aftermath: a Hybrid Type I Effectiveness-implementation Non-inferiority Randomized Trial in India Comparing Two Active Case Finding (ACF) Strategies Among Individuals Treated for TB and Their Household Contacts\n\nIncluded conditions:\n- Tuberculosis (TB)\n\nStudy Armgroups:\n- {'label': 'Home-based Active Case Finding (HACF)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Home-based Active Case Finding (HACF)']}\n- {'label': 'Telephonic Active Case Finding (TACF)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Telephonic Active Case Finding (TACF)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Home-based Active Case Finding (HACF)', 'description': 'Existing healthcare workers at the participating NTEP TB units will visit all patient homes at 6 and 12 months post-treatment completion. They will administer a standardized TB symptom screen questionnaire to treated TB cases and their household contacts (HHC). All those who screen positive will have a spot sputum taken at the home for microbiological testing at the TB unit.', 'armGroupLabels': ['Home-based Active Case Finding (HACF)']}\n- {'type': 'OTHER', 'name': 'Telephonic Active Case Finding (TACF)', 'description': 'Existing healthcare workers at the participating NTEP TB Units will administer a standardized TB symptom screen questionnaire to the index patient via telephone calls at 6 and 12 months post-treatment completion. The index patient will also be asked about any TB symptoms among household contacts (HHCs). If TB is suspected among any HH members, a home visit will be conducted and spot sputum specimens will be collected for microbiological testing at the TB unit.', 'armGroupLabels': ['Telephonic Active Case Finding (TACF)']}\n\nPrimary Outcomes:\n- {'measure': 'Rate per 100 person-years of people diagnosed with new or recurrent TB by study arm.', 'description': 'TB disease will be diagnosed as microbiologically confirmed (positive acid fast bacilli smear or positive Xpert\u00ae Mycobacterium tuberculosis/resistance to rifampin (MTB/RIF) assays or positive culture) or clinically diagnosed (initiated on TB treatment with no microbiological confirmation).', 'timeFrame': \"Within 12 months following index TB patient's treatment completion date.\"}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered at 90% to detect non-inferiority with a 10% projected loss to follow-up. For the secondary outcome, there is an assumption of 90% power to see a difference of 60% vs 20% and 80% power to see a difference of 50% vs 25%.", "answer": 3228, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size for index patients (n\u00e2\u0080\u0089=\u00e2\u0080\u00891076) includes 538 in the HACF arm and 538 in the TACF arm (1:1 ratio). On average, we will enroll two HHCs per index patient (n\u00e2\u0080\u0089=\u00e2\u0080\u00892152). The total estimated sample size for index patients and HHCs is 3228 individuals.\n Data from relevant studies suggest that 10\u00e2\u0080\u009313% of index patients will develop recurrent TB in each arm [21, 22] and an additional 1\u00e2\u0080\u00932% of HHCs will develop TB during the study period [58]. Assuming a rate of 12\u00e2\u0080\u0089TB cases per 100 person-years among index patients and 1\u00e2\u0080\u0089TB case per 100 person-years among HHCs, we are powered at 90% to determine that the TACF arm is non-inferior to the HACF arm with a non-inferiority interval of 1.7 per 100 person-years and a sample size of 1076 index patients and two HHCs per index patient (n\u00e2\u0080\u0089=\u00e2\u0080\u00892152). This sample size for the primary outcome is adjusted for 10% projected losses to follow-up. For the secondary outcome, we anticipate that 10% (215/2152) of HHCs will be children <\u00e2\u0080\u00896\u00e2\u0080\u0089years of age. Data from Pune suggest that approximately 30% of child contacts will have been screened for TB and either initiated on TB therapy or TPT [59]. Thus, we anticipate 70 eligible children in each study arm and hypothesize >\u00e2\u0080\u008960% to be screened and initiated on TB therapy or TPT in the HACF arm and less than 20% in the TACF arm. We will have at least 90% power to see a difference of 60% vs 20% and 80% power to see a difference of 50% vs 25%.\n For objective 2, we will conduct a total of 40 in-depth interviews with index patients (20 with and 20 without recurrent TB) and one HHC for each patient (40 total). We will also interview 20 HCWs to achieve a total sample size of 100. We will use purposive sampling to obtain a maximum variation sample by study arm, as well as gender and age group for index patients, HHCs, and a range of HCW types and levels.", "id": 718, "split": "val"} +{"trial_id": "NCT04334265", "pmid": "32513299", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Anluohuaxian combined with regular treatment group', 'type': 'EXPERIMENTAL', 'description': 'Anluohuaxian: 6g each time, twice a day', 'interventionNames': ['Drug: Anluohuaxian']}\n- {'label': 'regular treatment group', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Anluohuaxian', 'description': '6g each time, twice a day', 'armGroupLabels': ['Anluohuaxian combined with regular treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in high-resolution computer tomography of the lung', 'description': 'Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography', 'timeFrame': '3 months'}\n- {'measure': 'Change in 6-minute walking distance', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 750, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomised (sample size)\n 750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2 (Anluohuaxian combined with regular treatment group):1 (regular treatment group).", "id": 719, "split": "val"} +{"trial_id": "NCT04335968", "pmid": "34952881", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Melatonin for Prevention of Postoperative Delirium After Lower Limb Fracture Surgery in Elderly Patients: a Randomized Controlled Trial\n\nIncluded conditions:\n- Orthopedic Surgery\n\nStudy Armgroups:\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery', 'interventionNames': ['Drug: Melatonin 4 mg']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'placebo of this drug with the same schedule, during the same period of time.', 'interventionNames': ['Drug: Placebo oral tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Melatonin 4 mg', 'description': 'melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery.', 'armGroupLabels': ['Experimental group']}\n- {'type': 'DRUG', 'name': 'Placebo oral tablet', 'description': 'placebo of this drug with the same schedule, during the same period of time.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Postoperative delirium incidence', 'description': 'The Confusion Assessment Method (CAM) score, for patients hospitalized in surgery, or CAM-ICU score, for patients hospitalized in ICU will be applied daily during the first 10 days after surgery or end of hospital stay if shorter', 'timeFrame': '10 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nA bilateral type I error of 5%, a power of 90%, and a 10% dropout rate are assumed.", "answer": 790, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In the literature, incidence rates of delirium in elderly populations in control groups in the first week after surgery or hospital admission range from 20.8% to 32.6%.19 20 29 We therefore expect a cumulative incidence of delirium of 25% at day 10 after surgery in the control group.\n Literature data are discordant on melatonin\u00e2\u0080\u0099s effect on the risk of delirium. In medical wards, meta-analyses11 30 found in elderly patients a decreased in the incidence of delirium between 60% and 75% with melatonin supplementation. In a postoperative setting the effect seems smaller but there are fewer studies, with discordant results, going from no effect to a 70% decrease of delirium incidence.19 20 29 We therefore expect a 40% risk reduction in the melatonin group with respect to placebo, which corresponds to a cumulative incidence of delirium of 15% at day 10 after surgery in the melatonin group. Adding to this assumption a bilateral type I error of 5% and a power 90%, we need to randomise 718 patients (359/group) in order to have 129 events and to detect a significant difference between arms (including 10% of patients that could not be evaluated). Sample size was computed with a Fine and Gray methods using R package cmprsk.31 We expect that 10% of included subjects will be secondarily excluded (not randomised) due to presence of delirium at inclusion. Therefore, we need to include 790 patients in order to randomise 718 subjects. Inclusions will continue until 718 patients are randomised.", "id": 720, "split": "val"} +{"trial_id": "NCT04340063", "pmid": "39097695", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI Trial)\n\nIncluded conditions:\n- Incomplete Spinal Cord Injury\n\nStudy Armgroups:\n- {'label': 'Treadmill group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill.', 'interventionNames': ['Device: Gait training performed on a treadmill']}\n- {'label': 'Movement Amplification group', 'type': 'EXPERIMENTAL', 'description': 'The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment.', 'interventionNames': ['Device: Gait training performed in a Movement Amplification Environment']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Gait training performed on a treadmill', 'description': 'Participants randomized to the Control group will complete high intensity gait training on a treadmill.', 'armGroupLabels': ['Treadmill group'], 'otherNames': ['Treadmill Group']}\n- {'type': 'DEVICE', 'name': 'Gait training performed in a Movement Amplification Environment', 'description': 'The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking', 'armGroupLabels': ['Movement Amplification group'], 'otherNames': ['Movement Amplification Group']}\n\nPrimary Outcomes:\n- {'measure': 'Daily Stepping', 'description': 'The investigators will assess the amount of daily stepping in the home and community during three 1-week periods. Daily stepping will be measured and recorded using an activity monitor.', 'timeFrame': '10 Week Change from Baseline, 3 Month Change from Baseline'}\n- {'measure': 'Lane Width Optimization Test', 'description': \"The Lane width Optimization test will be used to quantify the capacity of individuals to control their lateral center of mass motion during treadmill walking. Participants will walk on the treadmill for 2 minutes. During the test a narrow lane will be projected on the treadmill belt surface. Individuals will be asked to maintain their body position within the lane during walking. If successful the lane will become progressively more narrow. If unsuccessful, the lane will become progressively wider. The width of the lane at the completion of the test will provide a quantitative measure of the individual's ability to control the center of mass motion during walking.\", 'timeFrame': '5 Week Change from Baseline, 10 Week Change from Baseline, 3 Month Change from Baseline'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is set at 0.05, and the power is set at 80%. We also account for a 20% dropout rate based on a recent study with a 12% dropout rate.", "answer": 36, "answer_type": "ACTUAL", "explanation": "Statistical analysis and sample size\n Our primary clinical outcome measures are the FGA, to assess functional walking balance, and the 10MWT, to assess walking speed. Our primary biomechanical gait assessment measure is the minimum lateral COM excursion during walking. Our primary measure of walking participation is the average number of steps taken per day.\n To test between group differences in walking balance following intervention, we will compare changes in participants\u00e2\u0080\u0099 COM lateral excursion, calculated across the four assessment periods (BSL, Mid, Post, Follow Up) and between intervention groups (control and experimental). To account for the correlation that arises from measuring multiple data points within each participant over time (i.e., data measured from the mid- assessment period from a specific participant will bear more resemblance to data measured from the BSL- assessment period from the same participant than a different participant), we will use a linear mixed effects model. An indicator variable will be used for group assignment, 1\u00e2\u0080\u0089=\u00e2\u0080\u0089experimental, 0\u00e2\u0080\u0089=\u00e2\u0080\u0089control, to test for the effect of intervention while controlling for potential confounders such as initial walking speed, location of the iSCI, and age. The strength of the linear mixed effects models is that it can accommodate multiple data points from a single participant and can also manage missing data when data is missing at random. A similar strategy will be applied to examine changes in preferred walking biomechanical characteristics (average and variability of step width, step length, and minimum lateral MOS) and clinical outcome measures (10MWT, FGA, ABC etc.) across the four assessment periods and between intervention groups.\n To test if changes in steps per day are different following the two interventions, changes in participants\u00e2\u0080\u0099 average steps per day across the three assessment periods (BSL, Post, Follow Up) and between intervention groups will be compared using linear mixed effects model. Potential confounders will be accounted for in the model to ensure the robustness of the findings.\n We estimated our target sample size using our primary biomechanical gait assessment measure, walking balance, which we quantified by evaluating participants\u00e2\u0080\u0099 maximum ability to control mediolateral COM excursion during treadmill walking with visual feedback (Fig.\u00c2\u00a02b). We performed a power analysis to determine the minimum sample size needed to detect a 20% difference in improvements in walking balance between groups. We estimated the population variability from 13 people with iSCI performing unassisted, preferred-speed, treadmill walking who had a lateral COM excursion per stride of 0.083\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.014\u00c2\u00a0m (mean\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u0089standard deviation) [67]. To estimate effect size, we used pre- and post-intervention data from pilot testing of three people with iSCI who received 16\u00e2\u0080\u009318 locomotor training sessions performed in the movement amplification environment. These people decreased their lateral COM excursion during walking by 32\u00e2\u0080\u009336%. Thus, at \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and a power of 80%, we estimate that we will need a minimum sample size of 7 people per group. A recent locomotor training intervention in people with iSCI had a 12% drop out rate [21]. Thus, we plan to enroll 36 people with a conservative estimate that we will lose 20% of participants to drop out, which would ultimately yield 14 people per group.", "id": 721, "split": "val"} +{"trial_id": "NCT04340076", "pmid": "34656148", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dose Reduction of the New Generation Biologicals (IL17 and IL23 Inhibitors) in Psoriasis: A Pragmatic, Multicentre, Randomized, Controlled, Non-inferiority Study - BeNeBio Study\n\nIncluded conditions:\n- Psoriasis\n- Psoriasis Vulgaris\n\nStudy Armgroups:\n- {'label': 'Dose reduction', 'type': 'EXPERIMENTAL', 'description': 'Dose reduction by interval prolongation in 2 steps to a maximum decrease of 50% of the original dose when disease activity (PASI) and quality of life index (DLQI) remain low.', 'interventionNames': ['Drug: Secukinumab', 'Drug: Ixekizumab', 'Drug: Brodalumab', 'Drug: Guselkumab', 'Drug: Risankizumab', 'Drug: Tildrakizumab', 'Drug: Bimekizumab']}\n- {'label': 'Normal dose', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will continue treatment with the normal/maintenance dose of the biologicals.', 'interventionNames': ['Drug: Secukinumab', 'Drug: Ixekizumab', 'Drug: Brodalumab', 'Drug: Guselkumab', 'Drug: Risankizumab', 'Drug: Tildrakizumab', 'Drug: Bimekizumab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Secukinumab', 'description': 'Maintenance/normal dose is 300 mg/4 weeks. First dose reduction step: 300 mg/6 weeks. Second dose reduction step: 300 mg/8 weeks.', 'armGroupLabels': ['Dose reduction', 'Normal dose'], 'otherNames': ['Cosentyx']}\n- {'type': 'DRUG', 'name': 'Ixekizumab', 'description': 'Maintenance/normal dose is 80 mg/4 weeks. First dose reduction step: 80 mg/6 weeks. Second dose reduction step: 80 mg/8 weeks', 'armGroupLabels': ['Dose reduction', 'Normal dose'], 'otherNames': ['Taltz']}\n- {'type': 'DRUG', 'name': 'Brodalumab', 'description': 'Maintenance/normal dose is 210 mg/2 weeks. First dose reduction step: 210 mg/3 weeks. Second dose reduction step: 210 mg/4 weeks.', 'armGroupLabels': ['Dose reduction', 'Normal dose'], 'otherNames': ['Kyntheum']}\n- {'type': 'DRUG', 'name': 'Guselkumab', 'description': 'Maintenance/normal dose is 100 mg/8 weeks. First dose reduction step: 100 mg/12 weeks. Second dose reduction step: 100 mg/16 weeks.', 'armGroupLabels': ['Dose reduction', 'Normal dose'], 'otherNames': ['Tremfya']}\n- {'type': 'DRUG', 'name': 'Risankizumab', 'description': 'Maintenance/normal dose is 150 mg every 12 weeks. First dose reduction step: 150mg/18 weeks. Second dose reduction step: 150mg/24 weeks.', 'armGroupLabels': ['Dose reduction', 'Normal dose'], 'otherNames': ['Skyrizi']}\n- {'type': 'DRUG', 'name': 'Tildrakizumab', 'description': 'Maintenance/normal dose is 100 mg or 200 mg every 12 weeks. First dose reduction step: 100 mg or 200 mg/18 weeks. Second dose reduction step: 100 mg or 200 mg/24 weeks.', 'armGroupLabels': ['Dose reduction', 'Normal dose'], 'otherNames': ['Ilumetri']}\n- {'type': 'DRUG', 'name': 'Bimekizumab', 'description': 'Maintenance/normal dose is 320 mg/8 weeks. First dose reduction step: 320 mg/12 weeks. Second dose reduction step: 320 mg/16 weeks.', 'armGroupLabels': ['Dose reduction', 'Normal dose'], 'otherNames': ['Bimzelx']}\n\nPrimary Outcomes:\n- {'measure': 'Non-inferiority of the incidence proportion of persistent flares (Psoriasis Area and Severity Index (PASI) >5 for \u2265 3 months).', 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided testing with \u03b1 = 0.025, power (1 \u2212 \u03b2) = 0.8, and a randomization ratio of 2:1 (DR vs. UC). Dropout rate is assumed to be 10%.", "answer": 244, "answer_type": "ESTIMATED", "explanation": "Power and sample size analyses\n The primary outcome is non-inferiority of persistent flares (PASI >\u00e2\u0080\u00895 for \u00e2\u0089\u00a5 3\u00e2\u0080\u0089months) in the intervention group with a non-inferiority margin of 15%. If the upper limit of the 95% confidence interval of the difference in persistent flares between the intervention group versus control group exceeds 15% at 18\u00e2\u0080\u0089months of follow-up, it must be concluded that non-inferiority could not be demonstrated for DR [36]. A margin of 15% was chosen based on clinical grounds, and on previous DR studies [8, 37]. Inherent to the intervention, there could be a small increase in disease flares (i.e., loss of disease control) as drug dosages are lowered. However, it is expected, based on other studies [8, 35], that most flares will be easy to control in the end without residual damage for patients, for example by reintroduction of a higher dose or switch to another biologic. It is therefore expected that persistent flares will not occur very frequently, as has also been shown in the CONDOR trial [8]. In addition, in the UC arm, there will be disease flares as well, as PASI scores might fluctuate over time and some patients might experience loss of effectiveness of their biologic [38]. The chosen non-inferiority margin of 15% is to some extent arbitrary, but refers to a clinically acceptable difference in persistent flares. Of note, the point estimate should be much lower than the margin of 15%, because the margin refers to the upper limit of the 95% confidence interval of the difference in persistent flares which should not exceed 15%. Therefore, we found a margin of 15% (hence a point estimate <<\u00e2\u0080\u008915%) for the difference in persistent flares acceptable, especially because we know that effectiveness could often be regained in patients with persistent flares in studies on other biologics [8, 35]. With an expected chance of being able to reduce biologic dosages in >\u00e2\u0080\u008950% of patients [8], the benefit-harm ratio seems well balanced by accepting this anticipated increase of persistent flares in patients undergoing DR compared to UC.\n With this margin, one-sided testing (\u00ce\u00b1 = 0.025; 1 \u00e2\u0088\u0092 \u00ce\u00b2 = 0.8) and a randomization ratio of 2:1 DR versus UC, we calculated that 222 patients need to be included to reject the null-hypothesis of inferiority. Taking a drop-out rate of 10% into account, 244 patients need to be included, with 162 in the DR arm and 82 in the UC arm.", "id": 722, "split": "val"} +{"trial_id": "NCT04341194", "pmid": "33046026", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Parents as Pain Management in Swedish Family-centred Neonatal Care. A Mixed Methods Approach\n\nIncluded conditions:\n- Infant Pain Management\n- Parent-driven Pain Management\n\nStudy Armgroups:\n- {'label': 'Standard care with glucose', 'type': 'NO_INTERVENTION', 'description': \"Control Group with standard care comprises facilitated tucking done by a nurse or the parent, oral glucose (300 mg/ml) and the opportunity to suck on a pacifier or on a parent's or a nurse's plastic gloved finger. The infant is placed on an examination table for the venipuncture.\"}\n- {'label': 'Skin-to-skin contact', 'type': 'EXPERIMENTAL', 'description': \"Skin-to-skin contact is a method widely used in neonatal care globally. The infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest.\", 'interventionNames': ['Behavioral: Parent-driven pain management with skin-to-skin contact']}\n- {'label': 'Skin-to-skin contact/breastfeeding/parental singing', 'type': 'EXPERIMENTAL', 'description': 'Parent-driven interventions are skin-to-skin care, breastfeeding and multi-sensory stimulation like vocalisation. They are all a combination of multiple sensory inputs comprising auditory, tactile and olfactory recognition. Research has started to investigate breastfeeding in combination with Kangaroo-mother- care for example, which has shown to be an effective mix. A multimodal approach that includes a combination of non-pharmacological approaches is considered more effective during venipuncture than single strategies and provides greater pain relief.', 'interventionNames': ['Behavioral: Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Parent-driven pain management with skin-to-skin contact', 'description': \"The infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest.\", 'armGroupLabels': ['Skin-to-skin contact']}\n- {'type': 'BEHAVIORAL', 'name': 'Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing', 'description': 'Live parental infant-directed lullaby singing is an individually tailored, non-verbal, multisensory, multimodal and affective tool to regulate the infant before, during and after venipuncture. Direct breast-feeding has demonstrated efficacy that is equal to, or greater than, sweet taste interventions in reducing behavioral and physiological responses to pain in full-term infants undergoing venipuncture with no demonstrated adverse outcomes. Direct breast-feeding should be considered the preferred first-line analgesic intervention for painful procedures performed on full-term infants.', 'armGroupLabels': ['Skin-to-skin contact/breastfeeding/parental singing']}\n\nPrimary Outcomes:\n- {'measure': 'Pain in infants', 'description': 'The primary outcome in the randomized controlled trial is pain in infants measured with the Premature Infant Pain Profile Revised (PIPP-R). The PIPP-R evaluates three behavioral facial actions (brow bulge, eye squeeze and nasolabial furrow), two physiological items (heart rate, transcutaneous oxygen saturation), and two contextual items (gestational age and behavioral state). The PIPP is weighted for younger gestational age and sleep state. Scores can range from 0 to 21, and a difference of two points between conditions can be considered clinically important.', 'timeFrame': 'Through study completion, an average of 1 year.'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.8 and a significance level set to 0.05. To compensate for possible dropouts and incomplete data, 75 infants per group will be enrolled.", "answer": 225, "answer_type": "ACTUAL", "explanation": "Sample size\n No previous RCT has examined the effects of parent-driven pain management in newborn infants by combining SSC, breastfeeding and live parental lullaby singing. Based on previous studies using PIPP-R or its predecessor PIPP in pain alleviation projects, a difference of two PIPP-R points between standard care (group 1) and the full parent driven pain management (group 3) is considered clinically important. Based on those studies we also assume a standard deviation around 2 points. A power calculation sets the number of infants to include in the study to 63 in each group, with a power of 0.8 and a significance level set to 0.05 (www.clincalc.com). To compensate for possible dropouts, incomplete data, such as equipment malfunction or blood sample collection failure, 75 infants per group will be enrolled, making a total of 225 infants.", "id": 723, "split": "val"} +{"trial_id": "NCT04341350", "pmid": "33608400", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation : INASED Study\n\nIncluded conditions:\n- Prevention of Delirium\n\nStudy Armgroups:\n- {'label': 'Usual sedation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug.', 'interventionNames': ['Drug: Propofol + analgesic drug']}\n- {'label': 'Inhaled sedation', 'type': 'EXPERIMENTAL', 'description': 'Sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA \u2122 associated with the administration of an analgesic drug.', 'interventionNames': ['Drug: Isoflurane + analgesic drug']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Propofol + analgesic drug', 'description': 'sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opio\u00efd adjuncts (acetaminophen, NSAIDs, nefopam), opio\u00efds (per os opio\u00efds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl', 'armGroupLabels': ['Usual sedation']}\n- {'type': 'DRUG', 'name': 'Isoflurane + analgesic drug', 'description': 'sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA \u2122 associated with the administration of a analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opio\u00efd adjuncts (acetaminophen, NSAIDs, nefopam), opio\u00efds (per os opio\u00efds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl.', 'armGroupLabels': ['Inhaled sedation']}\n\nPrimary Outcomes:\n- {'measure': 'Occurrence of a delirium in intensive care', 'description': 'Occurrence of delirium in intensive care will be observed (yes / no)', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-sided alpha level of 0.05, 3% lost to follow-up.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size\n We determined that enrolment of 250 patients would provide a power of 80% to show a reduction by half (30% vs 15%) in the rate of delirium occurrence between the control group using intravenous sedation and the interventional group using inhaled sedation at a two-sided alpha level of 0.05, accounting for 3% lost to follow-up.\n \n Recruitment\n \n The initial duration of patient enrolment expected is 2 years, starting in July 2020. The 2020: approval by an independent Ethics Committee; 2020\u00e2\u0080\u00932022: recruitment period; 2022: end of recruitment, monitoring of participating centres and queries to investigators; blind review to determine protocol violation, to define intention-to-treat and per-protocol analysis populations; new queries to investigators, cleaning and closure of the database; 2023: data analysis, writing of the manuscript and submission for publication.", "id": 724, "split": "val"} +{"trial_id": "NCT04341688", "pmid": "32928313", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Double Blind, Randomized Controlled Pilot Trial of Gargling Agents in Reducing Intraoral Viral Load Among Laboratory Confirmed COVID-19 Patients: GARGLES STUDY\n\nIncluded conditions:\n- Covid-19\n\nStudy Armgroups:\n- {'label': 'Povidone-Iodine 0.2% (BETADINE\u00ae)', 'type': 'EXPERIMENTAL', 'description': '0.2% Povidone-Iodine (BETADINE\u00ae) 10 ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days.', 'interventionNames': ['Drug: Gargle/Mouthwash']}\n- {'label': 'Hydrogen peroxide 1% (ActiveOxy)', 'type': 'EXPERIMENTAL', 'description': 'ActiveOxy (1% Hydrogen peroxide) 10 ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days.', 'interventionNames': ['Drug: Gargle/Mouthwash']}\n- {'label': 'Neem extract (Azadirachta indicia)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Neem extract (Azadirachta indicia) gargle will be prepared by chemistry laboratory. patients will do 10ml gargle and nasal lavage for 20-30 seconds, thrice daily for 6 days.', 'interventionNames': ['Drug: Gargle/Mouthwash']}\n- {'label': 'Hypertonic saline (2%NaCl)', 'type': 'ACTIVE_COMPARATOR', 'description': '10 ml gargle and nasal lavage using Hypertonic saline for 20-30 seconds, thrice daily for 6 days.', 'interventionNames': ['Drug: Gargle/Mouthwash']}\n- {'label': 'Positive controls', 'type': 'PLACEBO_COMPARATOR', 'description': '10 ml gargle and nasal lavage using distilled water for 20-30 seconds, thrice daily for 6 days.', 'interventionNames': ['Drug: Gargle/Mouthwash']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Gargle/Mouthwash', 'description': 'There will be 50 patients in six study groups. Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene\u00ae) for 20-30 seconds, thrice daily for 6 days.\\n\\nGroup B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (ActiveOxy\u00ae) for 20-30 seconds, thrice daily for 6 days.\\n\\nGroup C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated locally) for 20-30 seconds, thrice daily for 6 days.\\n\\nGroup D (n=10) patients will use 2% hypertonic saline (Plabottle\u00ae) gargle and nasal lavage for a similar time period.\\n\\nGroup E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days Whereas Group F (n=5) will comprise of negative controls, who will not use any gargles or nasal lavage during study period.', 'armGroupLabels': ['Hydrogen peroxide 1% (ActiveOxy)', 'Hypertonic saline (2%NaCl)', 'Neem extract (Azadirachta indicia)', 'Positive controls', 'Povidone-Iodine 0.2% (BETADINE\u00ae)'], 'otherNames': ['Gargling agent', 'Mouthrinse']}\n\nPrimary Outcomes:\n- {'measure': 'Intraoral viral load', 'description': 'Intraoral viral load as deciphered by RT-PCR', 'timeFrame': 'Five days of using gargles'}\n\nPlease estimate the sample size based on the assumption: \nThe present study will serve as a pilot trial.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomised (sample size)\n As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. The present study will serve as a pilot trial. We intend to study 50 patients in five study groups with 10 patients in each study group. For details, please refer to Fig.\u00c2\u00a01 for details.", "id": 725, "split": "val"} +{"trial_id": "NCT04343768", "pmid": "32493468", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-\u03b2 1a', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Hydroxychloroquine', 'Drug: Lopinavir / Ritonavir', 'Drug: Interferon Beta-1A']}\n- {'label': 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-\u03b2 1b', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Hydroxychloroquine', 'Drug: Lopinavir / Ritonavir', 'Drug: Interferon Beta-1B']}\n- {'label': 'Control group: hydroxychloroquine + Lopinavir / Ritonavir', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Hydroxychloroquine', 'Drug: Lopinavir / Ritonavir']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Hydroxychloroquine', 'description': 'This Drug will be used in all arms.', 'armGroupLabels': ['Control group: hydroxychloroquine + Lopinavir / Ritonavir', 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-\u03b2 1a', 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-\u03b2 1b']}\n- {'type': 'DRUG', 'name': 'Lopinavir / Ritonavir', 'description': 'This Drug will be used in all arms.', 'armGroupLabels': ['Control group: hydroxychloroquine + Lopinavir / Ritonavir', 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-\u03b2 1a', 'Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-\u03b2 1b']}\n- {'type': 'DRUG', 'name': 'Interferon Beta-1A', 'description': 'This drug will be only used in Arm 1.', 'armGroupLabels': ['Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-\u03b2 1a']}\n- {'type': 'DRUG', 'name': 'Interferon Beta-1B', 'description': 'This drug will be only used in Arm 2.', 'armGroupLabels': ['Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-\u03b2 1b']}\n\nPrimary Outcomes:\n- {'measure': 'Time to clinical improvement', 'description': 'Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\\\\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.', 'timeFrame': 'From date of randomization until 14 days later.'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Numbers to be Randomized (Sample Size)\n Of the 60 patients who underwent randomization, 20 patients were assigned to receive Interferon beta-1a, 20 patients were assigned to receive Interferon beta 1b plus standard care and the rest of patients were assigned to receive the standard care alone.", "id": 726, "split": "val"} +{"trial_id": "NCT04343963", "pmid": "33066761", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pyridostigmine in Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2 Infection\n\nIncluded conditions:\n- COVID-19\n- SARS-CoV-2\n\nStudy Armgroups:\n- {'label': 'Pyridostigmine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Pyridostigmine bromide tablet (60mg P.O. once per day for 14 days)', 'interventionNames': ['Drug: Pyridostigmine Bromide']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo tablet (60mg P.O. once per day for 14 days)', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Pyridostigmine Bromide', 'description': 'One 60mg tablet P.O. once per day for 14 days', 'armGroupLabels': ['Pyridostigmine'], 'otherNames': ['Mestinon', 'Pyridostigmine']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'One tablet P.O. once per day for 14 days', 'armGroupLabels': ['Placebo'], 'otherNames': ['Starch (pharmaceutical grade)']}\n\nPrimary Outcomes:\n- {'measure': 'Critical condition or death', 'description': 'Composite of death, Need for mechanical ventilation, or an increase of 2 or more points in the SOFA score', 'timeFrame': '28 days'}\n- {'measure': 'IL-6', 'description': 'Kinetics of circulating IL-6', 'timeFrame': '14 days in-hospital, hospital discharge, or death'}\n\nPlease estimate the sample size based on the assumption: \nFirst phase: One-sided 80% confidence limit. Second phase: 80% power, 0.05 significance level, two-sided t-test, 10% dropout rate.", "answer": 436, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n First (security) phase\n We estimate that a sample size of 40 participants (20 in each group) would produce a one-sided 80% confidence limit that would exclude us finding a 10%-point difference that would be statistically significant in the complete trial [15]. However, calculating a 10% loss, we will recruit 44 participants for this part of the study.\n \n \n Second phase\n We estimate that a sample size of 436 participants (218 per group) estimating a 10% reduction in the occurrence of the primary outcome in the intervention group to be clinically significant. Based on recent evidence from China, we estimate that 25% of patients hospitalized with severe SARS-CoV-2 infection will develop complications leading to the need of invasive mechanical ventilation or death [16] Accordingly, we estimate that this sample size will allow us to identify with an 80% power a reduction in the need of invasive mechanical ventilation or death of 10% in the group receiving pyridostigmine in comparison with the group on placebo, using a two-sided t-test at the 0.05 significance level.", "id": 727, "split": "val"} +{"trial_id": "NCT04345484", "pmid": "34416849", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Action for Positive Brain Health Now: Ready, Set, Go\n\nIncluded conditions:\n- Hiv\n\nStudy Armgroups:\n- {'label': 'GMT Intervention + Health Lifestyle Program', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will participate in GMT, a standardized cognitive rehabilitation program which will be given as per the manual and which consists of 9 sessions each 2-hours in duration. They will also participate in the Healthy Lifestyle Program (HLP), which includes physical activity monitoring (step count, calories burned and sleep) with the Garmin v\u00edvofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability.', 'interventionNames': ['Behavioral: Goal-management training']}\n- {'label': 'Health Lifestyle Program', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group enters directly into the HLP without any other study visits. The HLP includes physical activity monitoring (step count, calories burned and sleep) with the Garmin v\u00edvofit 4 Activity Tracker, and recording and monitoring of goals with the My Goals app. Moreover, participants will be offered an exercise program with weaning to community-based resources and home exercise recommendations for longer-term sustainability.', 'interventionNames': ['Behavioral: Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Goal-management training', 'description': '9-week goal-management program', 'armGroupLabels': ['GMT Intervention + Health Lifestyle Program']}\n- {'type': 'BEHAVIORAL', 'name': 'Control', 'description': 'Healthy Lifestyle Program', 'armGroupLabels': ['Health Lifestyle Program']}\n\nPrimary Outcomes:\n- {'measure': 'Change in physical activity', 'description': 'Number of weeks in which physical activity guidelines are met (150 min of moderate to vigorous activity in bouts of 10 minutes)', 'timeFrame': '0 and 12 months'}\n- {'measure': 'Change in social activity', 'description': 'Number of weeks in which at least one organized social activity was attended', 'timeFrame': '0 and 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered at 90% with a Type I error risk of 0.05. The variance is adjusted by 15% to account for dropouts and data imputation.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculations were based on estimates of usual rates of adherence to physical activity for Canadian adults estimated at 10\u00e2\u0080\u009320% of the time [68], translating to approximately 9 of 52\u00c2\u00a0weeks for the control group and a desired 22\u00c2\u00a0weeks (50% of 43\u00c2\u00a0weeks) in the GMT priming group, which is the targeted adherence rate for interventions for cardiovascular risk factor improvement [69]. As we expect that elements of the HLP program will lead to some activity improvement in the control group (+\u00e2\u0080\u00894\u00c2\u00a0weeks), we will power our study to detect a minimum difference of 9 activity weeks between groups over 43\u00c2\u00a0weeks with an estimated SD of 11\u00c2\u00a0weeks. With adjustment of the variance (standard deviation) by 15% to account for dropouts and the need to impute data, this yields an effect size of 0.71 [70]. For 90% power and risk of Type I error of 0.05, the required number of people is 38 participants per group. We will therefore target a total sample of 100 (50 per group) to account for uncertainty in our sample size assumptions and incomplete data. This sample size will also be sufficient to permit other statistical models to be used in the case of non-normality, such as ordinal regression.\n Taking advantage of the trial being embedded in the cohort, we will also compare platform outcomes for trial participants with platform outcomes for people who were eligible for the trial but not enrolled, including those at other sites, providing information about how the HLP with or without GMT compares to tailored brain health risk recommendations alone.", "id": 728, "split": "val"} +{"trial_id": "NCT04347772", "pmid": "36435838", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intensive Perioperative Nutrition Therapy\n\nIncluded conditions:\n- Perioperative Complication\n\nStudy Armgroups:\n- {'label': 'Supplements Group - SS', 'type': 'EXPERIMENTAL', 'description': 'The SS will be received tailored and more intensive and ongoing nutrition support and lifestyle advice as compared with the NN and will be supplemented with ONS, available in 400g/can, providing 226 kcal/serving and 9.6 g protein/serving. Participants will be encouraged to consume the ONS in small, frequent, in between meals.\\n\\nAll participants will receive standard post-operative care from clinical and nurse staff with commencement of free fluids and reintroduction of normal diet without interference by the researcher or protocol. The postoperative course will be carefully monitored. While complications will be noted as major or minor by using validated criteria (Buzby et al., 1988).', 'interventionNames': ['Dietary Supplement: Oral Nutrition Support']}\n- {'label': 'Control Group - NN', 'type': 'NO_INTERVENTION', 'description': 'While participants in NN which referred as control group will received the standard care of the clinic without supplemented with ONS. Nutritional advice will be based on a guideline specifically focused on treatment of symptoms such as nausea, vomiting, loss of appetite and diarrhoea, and how to deal with the symptoms through nutritional approaches. Basically, the advice will be given by the oncologist or nurses in the clinic.\\n\\nAll participants will receive standard post-operative care from clinical and nurse staff with commencement of free fluids and reintroduction of normal diet without interference by the researcher or protocol. The postoperative course will be carefully monitored. While complications will be noted as major or minor by using validated criteria (Buzby et al., 1988).'}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Oral Nutrition Support', 'description': 'Intensive Nutrition Intervention', 'armGroupLabels': ['Supplements Group - SS']}\n\nPrimary Outcomes:\n- {'measure': 'Length of Bowel function', 'description': 'To compare the effect of intensive perioperative nutrition therapy versus usual care on the length of bowel function. The duration of bowel start function post-operatively in hours or days will be recorded. The duration covers from zero hours after surgery until the first day of bowel function presented. The start of bowel function is the first day of commencement of any type of fluids or solid food given', 'timeFrame': '2 months'}\n- {'measure': 'Length of solid food toleration', 'description': 'To compare the effect of intensive perioperative nutrition therapy versus usual care on the length of solid food toleration. The duration of solid food toleration post-operatively in hours or days will be recorded. The duration covers from zero hours after surgery until the first day of reintroduction of solid food.', 'timeFrame': '2 months'}\n- {'measure': 'Length of hospital stay', 'description': 'To compare the effect of intensive perioperative nutrition therapy versus usual care on the length of hospital stay. The duration of hospital stay in days will be recorded. The duration covers from the day of ward admission (before operation) until discharge (after operation).', 'timeFrame': '2 months'}\n\nPlease estimate the sample size based on the assumption: \nA power (\u03b2) of 90%, a significance level (\u03b1) of 0.05, and a dropout rate of 20% were assumed.", "answer": 68, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A systemic review study in 2016 showed that early feeding has a significantly shorter length of hospital stay (p<0.01) compared to the late timing of feeding with a difference of \u00e2\u0088\u00921.72 days and not associated with an increase in clinically relevant complications [26]. Several other studies also support early nutrition for surgery patients significantly shortening the length of hospital stay [27\u00e2\u0080\u009329].\n LOS was chosen to calculate the sample size because it has been used widely as a primary outcome in most nutrition-related RCT studies [30\u00e2\u0080\u009332] among patients undergoing surgery. The sample size was calculated based on the data from a study conducted on colorectal cancer patients undergoing surgery [30]. The primary outcome was calculated based on the difference in LOS between two groups (control and intervention group) which was 3.45 days.\n A large effect size of 0.8 for clinical significance was assumed, and practicality for this research was considered, with a power (\u00ce\u00b2) of 90% and a probability (\u00ce\u00b1) of 0.05. Allowing for a \u00e2\u0080\u009cdrop-out\u00e2\u0080\u009d rate of 20% for the RCT study, we aim to recruit participants who will be included in each group, with the final sample size calculated as 68 participants with 34 participants in each group, respectively.", "id": 729, "split": "val"} +{"trial_id": "NCT04348513", "pmid": "32586399", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection (Thy-Support)\n\nIncluded conditions:\n- Pulmonary Infection\n- Covid-19\n\nStudy Armgroups:\n- {'label': 'T3 solution for injection', 'type': 'EXPERIMENTAL', 'description': 'T3 Solution for injection 10 \u03bcg/ml, each vial contains 150\u03bcg of liothyronine in a total volume of 15ml. The dose administered will be 0.8g/kg i.v. bolus starting within 60min after respiratory support and will be followed by an infusion of 0.113g. kg-1.h-1 i.v. for 48 hours (therapeutic dose). After the first 48h, a maintenance dose will be administered corresponding to 50% of the therapeutic dose (0.057g. kg-1.h-1 i.v.). Drug administration will stop after successful weaning or end of followup (maximum 30 days).', 'interventionNames': ['Drug: T3 solution for injection']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Composition identical apart from the active substance. Same dosage.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'T3 solution for injection', 'description': 'For example, for a patient of 77Kg of weight, a dose of 6ml (60 \u03bcg) will be administered as a bolus intravenously over 2-3 min within 60 min of respiratory support initiation. Then, the patient for the next 24 hours will receive 21ml of the product (total of 210 \u03bcg of T3) that will be diluted in NaCl 0.9% and administered with a pump at a steady flow rate of 10.4 ml/h for a total duration of 48 hours. From day 3 till successful weaning or end of follow-up, the patient will receive 50% of this dose, 10.5 ml of the product (total of 105 \u03bcg of T3) that will be diluted in NaCl 0.9% and administered with a pump at a steady flow rate of 5.2 ml/h.', 'armGroupLabels': ['T3 solution for injection']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Same as with T3 solution for injection.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Assessment of weaning from cardiorespiratory support', 'description': 'The primary objective of the study is to determine whether the administration of intravenous triiodothyronine in ICU patients diagnosed with pulmonary infection due to COVID-19 facilitates weaning from cardiorespiratory support compared to placebo. Successful weaning is defined as no requirement for ventilatory support after extubation (mechanical support) or support from ECMO for 48 hours. The primary objective will be measured as percentage of patients successfully weaned after 30 days of follow-up.', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \n84% power, significance level (alpha) of 0.05, 2-tailed test", "answer": 5, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n The sample size of 60 patients (that indicates 30 subjects for each group) will have 84% power to detect the estimated difference between the two study groups. The criterion for significance (alpha) has been set at 0.05 and the test is 2-tailed.", "id": 730, "split": "val"} +{"trial_id": "NCT04351516", "pmid": "32650818", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trial of Hydroxychloroquine Versus Placebo in Early Ambulatory Diagnosis and Treatment of Elderly COVID19 Patients\n\nIncluded conditions:\n- SARS-CoV 2\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'hydroxychloroquine', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Hydroxychloroquine']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Hydroxychloroquine', 'description': 'dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days', 'armGroupLabels': ['hydroxychloroquine']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo: Film Coated Tablette', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': '\u25cf Rate of hospitalization or death at day 7 after study inclusion', 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \n10% dropout rate is assumed.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n In the first stage of an adaptive design 120 patients in a 2:1 ration: 72 Verum and 36 Placebo, plus an increase for 10% drop outs. After interim analysis, the total sample size will be calculated based on the effect seen in the first stage. Total sample size is estimated approximately n = 300-400 patients.", "id": 731, "split": "val"} +{"trial_id": "NCT04351776", "pmid": "33380482", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials\n\nIncluded conditions:\n- Pain, Postoperative\n- Pain\n- Anxiety Postoperative\n\nStudy Armgroups:\n- {'label': 'VR-Biofeedback', 'type': 'OTHER', 'interventionNames': ['Other: VR-Biofeedback']}\n- {'label': 'VR-Distraction', 'type': 'OTHER', 'interventionNames': ['Other: VR-Distraction']}\n- {'label': '360 Video', 'type': 'OTHER', 'interventionNames': ['Other: 360 Video']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'VR-Biofeedback', 'description': 'Participants will be instructed to use the Mindful Aurora application', 'armGroupLabels': ['VR-Biofeedback']}\n- {'type': 'OTHER', 'name': 'VR-Distraction', 'description': 'Participants will be instructed to use one of three applications', 'armGroupLabels': ['VR-Distraction']}\n- {'type': 'OTHER', 'name': '360 Video', 'description': 'Participants will be instructed which video to view', 'armGroupLabels': ['360 Video']}\n\nPrimary Outcomes:\n- {'measure': 'Effect of VR-biofeedback on pain', 'description': 'Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.', 'timeFrame': 'Postoperatively 24 - 90 hours.'}\n- {'measure': 'Effect of VR-distraction on pain', 'description': 'Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.', 'timeFrame': 'Postoperatively 24 - 90 hours.'}\n- {'measure': 'Effect of 360 video on pain', 'description': 'Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.', 'timeFrame': 'Postoperatively 24 - 90 hours.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) is 0.025 to control for two comparisons. The power is 80%.", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Sample size calculation is based on preliminary data assessing the impact of VR-D to affect changes in pain intensity in children and adolescents following surgery (unpublished). Preliminary data showed that the average change in pain intensity across time was \u00e2\u0088\u00921, with SD 1.2 and correlation between measurement pairs of 0.88. Assuming similar results in the passive control group, sample size of 30 per group will have 80% power to detect differences in mean changes of one between VR-GR and the two control groups. We expect a difference of \u00e2\u0089\u00a51 between VR-GR and VR-D to emerge with multiple sessions as proposed with this study. Significance (alpha) is 0.025 to control for two comparisons. We are recruiting 90 patients, 30 per group.", "id": 732, "split": "val"} +{"trial_id": "NCT04354233", "pmid": "32620149", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A National, Multicenter, Randomized Controlled Trial to Assess the Efficacy of a Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Women With Metastatic Breast Cancer\n\nIncluded conditions:\n- Metastatic Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Physical activity intervention with connected devices', 'type': 'EXPERIMENTAL', 'description': 'Women randomized to the intervention arm will follow a 6-month physical activity intervention using a connected device that includes an activity tracker, a smartphone and a mobile application. Patients will also receive physical activity international recommendations', 'interventionNames': ['Device: Physical activity intervention with connected devices']}\n- {'label': 'Standard care', 'type': 'NO_INTERVENTION', 'description': 'Women will receive stardard care and physical activity international recommendations, without further intervention'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Physical activity intervention with connected devices', 'description': 'Participants randomized in the intervention arm will receive recommandations in physical activity. They will also receive an activity tracker Withings Steel to wear during 6 months. The tracker will be connected to the \"Withings Health Mate\" application and the ABLE02 application. Participants will be encouraged to practice at least three walking sessions weekly of more than 10 consecutive minutes. Concerning the number of steps per day, the first objective will be determined according to the 6-min walking distance and to participants\\' preferences and capacities. The objective will be recalculated monthly according to the number of steps performed the previous week and will be adapted by the physical activity (PA) instructor and participants. Phone calls with the participants are regularly planned. Weekly quizzes on PA and nutrition will be proposed through the ABLE02 application. A messaging system and a phone line will be available for participants to contact the study team.', 'armGroupLabels': ['Physical activity intervention with connected devices']}\n\nPrimary Outcomes:\n- {'measure': 'time to deterioration of global health status (GHS) score of EORTC QLQ C30', 'description': 'Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact). Participants will answer to a Likert scale ranging from \"not at all\" to \"very much\" and from \"very bad\" to \"excellent\" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden.\\n\\nDeterioration is defined as a 5-point decrease relative to baseline in GHS score, with no subsequent increase above this threshold.', 'timeFrame': 'Month 18'}\n- {'measure': 'time to deterioration of fatigue score of EORTC QLQ C30', 'description': 'Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact). Participants will answer to a Likert scale ranging from \"not at all\" to \"very much\" and from \"very bad\" to \"excellent\" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden.\\n\\nA deterioration of fatigue is defined as a 5-point increase relative to baseline fatigue score, with no subsequent decrease above this threshold.', 'timeFrame': 'Month 18'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha of 0.05 split among co-primary endpoints (0.04 for TTD1 and 0.01 for TTD2); 90% power for TTD1 and 77% power for TTD2; 30-month accrual, 18-month follow-up, 1% exponential dropout rate.", "answer": 244, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study design was based on Burris et al. [64] using the time to deterioration (TTD) on the EORTC QLQ-C30 with comparable population and treatment for the global HRQoL (primary objective) and fatigue symptom domain (co-primary objective).\n The overall two-sided alpha of 0.05 will be split among the co-primary endpoints, with 0.04 for time to definitive deterioration of HRQoL (TTD1) and 0.01 for time to definitive deterioration of fatigue (TTD2). We estimate that about 244 randomized participants with a minimum of 189 deterioration events observed will be required to achieve a 90% statistical power to detect an improvement in median TTD1 from 8 (control) to 13\u00e2\u0080\u0089months (intervention) (HR\u00e2\u0080\u0089=\u00e2\u0080\u00890.615), using a two-sided alpha of 0.04, and assuming a 30-month accrual and 18-month follow-up, and an 1% exponential dropout rate. This sample size will permit to detect the same improvement in median TTD2 from 8 to 13\u00e2\u0080\u0089months with a 77% power and using a two-sided alpha of 0.01 (nQuery Advisor V7.0).", "id": 733, "split": "val"} +{"trial_id": "NCT04356248", "pmid": "33573608", "question": "Here is the design of a clinical trial:\n\nOfficial Title: High Intensity Training and Energy Management Education vs. Standard Training and Muscle Relaxation, to Improve Quality of Life in Persons With Multiple Sclerosis, a Randomized Controlled Superiority Trial With Six Months' Follow-up\n\nIncluded conditions:\n- Multiple Sclerosis\n\nStudy Armgroups:\n- {'label': 'High-intensity interval training + energy management education', 'type': 'EXPERIMENTAL', 'description': '* High-intensity interval training (HIIT): physiologically defined heart rate-controlled cycling with 80-100 rounds per minute (rpm) at 95-100% of maximum heart rate (HRmax). Participants will perform 5 \u00d7 1.5-min high-intensive exercise bouts at 95-100% of their HRmax followed by active breaks of unloaded pedalling over 2 min with the aim to achieve 60% of HRmax.\\n* Energy management education (IEME): face-to-face education sessions of 6.5 h in duration over a 3-week period, all conducted by a trained occupational therapist. Participants acquire knowledge and understanding about factors that influence energy and the consequences of fatigue on their habits and lifestyle. Six weeks after returning home, the participants will receive a reinforcement letter in the form of information material to remember the content of the IEME and to reinforce the implementation of the behaviour change in managing energy.', 'interventionNames': ['Behavioral: Endurance Training', 'Behavioral: Education']}\n- {'label': 'Low-intensity training + progressive muscle relaxation', 'type': 'ACTIVE_COMPARATOR', 'description': \"* Low-intensity training (ST): participants will exercise for 24 min continuously at 65% of participants' HRmax (60-70 rpm).\\n* Progressive muscle relaxation (PMR): The aim of PMR is to achieve enhanced mental relaxation by reducing muscle tension. Participants will attend six 1-h group sessions over the 3-week intervention period, instructed by a trained physical therapist. Six weeks after returning home, the participants will receive a reinforcement letter with information material for remembering the content of the PMR techniques and to reinforce the implementation of the exercises at home.\", 'interventionNames': ['Behavioral: Endurance Training', 'Behavioral: Education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Endurance Training', 'description': 'Treatment in both arms consists of specific endurance exercise modalities (HIIT or ST). Treatments differ in the applied training intensities. Participants in both arms will exercise 3 times per week over a period of 3 weeks on a bicycle ergometer. Exercise sessions will be supervised by a trained physical therapist. Exercise intensity will be heart rate monitored based on the maximum heart rate (HRmax) assessed during the initial cardiopulmonary exercise test. Exercise sessions in both arms will include a warm-up and a cool-down period at low intensity (50% HRmax) for 3 min each.', 'armGroupLabels': ['High-intensity interval training + energy management education', 'Low-intensity training + progressive muscle relaxation']}\n- {'type': 'BEHAVIORAL', 'name': 'Education', 'description': 'Treatment in both arms consists of specific energy management education interventions (IEME or PMR). Treatments differ in the applied education approaches. Participants in both arms will exercise 2 times per week over a period of 3 weeks.', 'armGroupLabels': ['High-intensity interval training + energy management education', 'Low-intensity training + progressive muscle relaxation']}\n\nPrimary Outcomes:\n- {'measure': 'Short-form 36 (SF-36)', 'description': 'Changes of health-related quality of life will be assessed with the SF-36. The SF-36 questionnaire comprises 36 items. Scores range from 0 to 100 with higher values indicating better QoL.', 'timeFrame': '6 months (day 0 - day 183) with time points set after three weeks (day 21) and 4 months (day 122).'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level (\u03b1) of 0.025 with Bonferroni correction for multiple comparisons, power (1-\u03b2) of 0.8, correlation between baseline and T3 scores of \u03c1 = 0.65, and an 18% dropout rate", "answer": 106, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The a priori sample size calculation was conducted using G*Power 3.1.9.2 software [44]. It was carried out for the investigation of a between-group difference in the primary endpoint (changes in the HRQoL (PCS and MCS) from baseline to T3) in an analysis of covariance model (ANCOVA).\n Based on our IEME feasibility randomized clinical trial [16] with four months follow-up of HRQoL, we assume a medium between-group effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 on changes in the primary endpoint HRQoL. Level of significance (\u00ce\u00b1) with Bonferroni for multiple comparisons (two primary outcomes) was set at 0.025 and power (1\u00e2\u0080\u0093\u00ce\u00b2) at 0.8. According to Borm et al. 2007 [45], the required sample size for the ANCOVA model was calculated with the formula (1\u00e2\u0080\u0093\u00cf\u00812)*n. A correlation between participant\u00e2\u0080\u0099s scores at baseline and at T3 of \u00cf\u0081\u00e2\u0080\u0089=\u00e2\u0080\u00890.65 was used. The calculation revealed that 90 participants (EG: 45 / CG: 45) would need to be recruited. Based on previous studies that apply similar interventions [16, 22], we have allowed for 18% dropout and plan to recruit 106 participants.", "id": 734, "split": "val"} +{"trial_id": "NCT04356963", "pmid": "34848527", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adjunct Virtual Reality Pain Management in Acute Brain Injury\n\nIncluded conditions:\n- Traumatic Brain Injury\n- Headaches Posttraumatic\n- Trauma\n- Pain, Acute\n\nStudy Armgroups:\n- {'label': 'All patients', 'type': 'EXPERIMENTAL', 'description': 'All patients were intended to engage in three different 20-30 min sessions run by research coordinators and spaced a minimum of 4 hours apart to allow for washout of effects, including 1) a commercially available, immersive VR environment, theBlu (WEVR, Inc, Venice, California, USA) delivered via Oculus Rift (Oculus VR, Irvine, California, USA) headset (VR Blu), 2) a non-immersive two-dimensional mimic delivered via a tablet computer (Tablet Blu), and 3) a VR control session delivered via a content-less Oculus Rift headset (VR Blank). The three sessions were run by research coordinators and spaced a minimum of 4 hours apart. The intervention order was counterbalanced using a randomized sequence generator.', 'interventionNames': ['Behavioral: Virtual Reality Session (VR Blu)', 'Behavioral: Tablet-based Session (Tablet Blu)', 'Behavioral: Use of Virtual Reality Head Mounted Display without Content (VR Blank)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Virtual Reality Session (VR Blu)', 'description': '20-30 minute session of virtual reality immersive content.', 'armGroupLabels': ['All patients']}\n- {'type': 'BEHAVIORAL', 'name': 'Tablet-based Session (Tablet Blu)', 'description': '20-30 minute session of tablet-based content that mimics the content from virtual reality sessions.', 'armGroupLabels': ['All patients']}\n- {'type': 'BEHAVIORAL', 'name': 'Use of Virtual Reality Head Mounted Display without Content (VR Blank)', 'description': '20-30 minutes session using head mounted display to reduce light and sound.', 'armGroupLabels': ['All patients']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Pain Score', 'description': 'Pre- vs. Post-Intervention Ratings on Numeric Pain Rating Scale. Numeric Pain Rating scale range is from 0 (no pain) -10 (severe pain)', 'timeFrame': 'Pre- and Post-Intervention (approximately 30 minutes)'}\n\nPlease estimate the sample size based on the assumption: \n30% dropout rate, 80% power, one-sided 0.05 significance level", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Prior work suggests that a 33% pain intensity difference or a 2-point difference on a 0\u00e2\u0080\u009310 pain numeric rating scale is an appropriate surrogate for a patient-determined clinically important response.42 We will enrol 60 patients, projecting a study dropout of 30%, leaving us with 42 patients to give us an 80% likelihood to detect a treatment difference at a one-sided o.05 significance level.43 44", "id": 735, "split": "val"} +{"trial_id": "NCT04357808", "pmid": "32907638", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection\n\nIncluded conditions:\n- Covid-19\n\nStudy Armgroups:\n- {'label': 'Sarilumab plus standard of care', 'type': 'EXPERIMENTAL', 'description': 'Sarilumab 200 mg, 2 sc injections in pre-filled syringe or pen, single dose. Treatment with drugs or procedures in routine clinical practice that the clinician responsible for the patient deems necessary is allowed', 'interventionNames': ['Drug: Sarilumab']}\n- {'label': 'Standard of care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treatment with drugs or procedures in routine clinical practice', 'interventionNames': ['Other: Standar of care']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sarilumab', 'description': 'Single dose treatment with sarilumab 2 x 200 mg subcutaneously', 'armGroupLabels': ['Sarilumab plus standard of care'], 'otherNames': ['Kevzara', 'SAR153191']}\n- {'type': 'OTHER', 'name': 'Standar of care', 'description': 'Usual clinical care', 'armGroupLabels': ['Standard of care']}\n\nPrimary Outcomes:\n- {'measure': 'Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation', 'description': 'Score ranges 1-7\\n\\n1. Death;\\n2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);\\n3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices;\\n4. Hospitalized, requiring supplemental oxygen;\\n5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)\\n6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care\\n7. Not hospitalized', 'timeFrame': '7 days from enrolment'}\n- {'measure': 'Duration of hospitalisation (days)', 'description': 'Days from the date of enrolment to the date of discharge', 'timeFrame': '30 days from enrolment'}\n- {'measure': 'Death', 'description': 'Number of deaths', 'timeFrame': '30 days from enrolment'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n 30 patients treated by COVID-19 infection who require hospitalisation: 20 will receive sarilumab plus Standard of Care and 10 will receive Standard of Care.", "id": 736, "split": "val"} +{"trial_id": "NCT04360408", "pmid": "35190440", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Energy Conservation Education Intervention For People With End-stage Kidney Disease Receiving Haemodialysis (EVEREST)\n\nIncluded conditions:\n- Fatigue\n- End Stage Kidney Disease\n- Quality of Life\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participant of the cluster randomised to the intervention group will receive both the usual care from their healthcare providers and EVEREST delivered by the researcher who is a nurse.', 'interventionNames': ['Other: Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants of the cluster randomised to the control group will receive usual care (standard care with no formalised, structured or tailored interventional to reduce symptom/s) from their healthcare providers'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis', 'description': 'The total program consisting of three educational sessions (at Week -1, week -3 and week -5) and one booster session (week -10) over a period of 12 weeks. Participants will receive individual, face to face education during their regular HD session. Education will be provided over 30-45 minutes for the first session, 30 minutes in the next two sessions and 30-45 minutes for the booster session. The lead researcher, who is a nurse, will deliver the entire intervention to avoid information bias. The simple language will be used, and emphasis will be given on the objectives of each session.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in Fatigue Symptom Inventory (FSI)', 'description': 'Fatigue Symptom Inventory (FSI) will be used to assess the severity, frequency, interference associated with fatigue and daily pattern of fatigue. The scale consists of 14 items rated on the 11-point items.', 'timeFrame': 'Baseline and week 4'}\n- {'measure': 'Changes in Fatigue Symptom Inventory (FSI)', 'description': 'The scale consists of 14 items rated on the 11-point items.', 'timeFrame': 'Baseline and week 8'}\n- {'measure': 'Changes in Fatigue Symptom Inventory (FSI)', 'description': 'The scale consists of 14 items rated on the 11-point items.', 'timeFrame': 'Baseline and week 12'}\n\nPlease estimate the sample size based on the assumption: \n80% power, significance level of 0.05, moderate intra-cluster coefficient of 0.03, 20% inflation for attrition, and 15% inflation for non-normality of data.", "answer": 126, "answer_type": "ESTIMATED", "explanation": "Sample size\n G power software was used to calculate the sample size by performing the priori power analysis for an independent group two-tailed t-test. The sample size was calculated based on a large effect size (Cohen\u00e2\u0080\u0099s d from 0.90 to 1.5) taken from a previous study in patients with breast cancer on management of fatigue (measured with fatigue symptom inventory (FSI)) with yoga intervention.39 To have resultant 80% power, an effect size of 0.8 and a significance of 0.05, 52 participants are needed (26 in each group). As this study uses a cluster design, and assuming a moderate intra-cluster coefficient of 0.03, the sample size is adjusted to compensate for design effect. To compensate for attrition and to avoid the possibility of non-normality of data, the calculation is further inflated by 20% and again 15%, respectively. After adjusting for these, a final sample size of 126 (63 in each group) is required.", "id": 737, "split": "val"} +{"trial_id": "NCT04360980", "pmid": "32503620", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'ACTIVE_COMPARATOR', 'description': '40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment', 'interventionNames': ['Drug: Colchicine Tablets']}\n- {'label': 'Standard treatment', 'type': 'NO_INTERVENTION', 'description': '40 RT-PCR positive COVID-19 patients without hypoxemia receiving vitamin C 3grams daily , 400 mg Tiamine, Selenium , Omega-3 500 mg daily, Vit A , Vit D, Azithromycine, Ceftriaxone, Kaletra 400 BID 10 days'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Colchicine Tablets', 'description': '1.5 mg loading then 0.5 mg BID P.O', 'armGroupLabels': ['Intervention'], 'otherNames': ['Colchicine']}\n\nPrimary Outcomes:\n- {'measure': 'CRPxN/R ratio change', 'description': 'increasing inflammatory status', 'timeFrame': '2 weeks'}\n- {'measure': 'Clinical deterioration by the WHO definition', 'description': 'including change in fever or O2 Saturation', 'timeFrame': '2 weeks'}\n- {'measure': 'PCR Viral Load', 'description': 'change in RT-PCR', 'timeFrame': '2 weeks'}\n- {'measure': 'CT severity involvement index', 'description': 'change in CT involvement', 'timeFrame': '2weeks'}\n\nPlease estimate the sample size based on the assumption: \nBased on the center's capacity to hospitalize confirmed COVID-19 patients", "answer": 80, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n Regarding the pandemic crisis and our center capacity to hospitalize confirmed COVID-19 patients, a total of 80 patients was found to be logical to be randomized into two groups of 40- patients.", "id": 738, "split": "val"} +{"trial_id": "NCT04361435", "pmid": "32620174", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Two Methods to Airway Clearance in Patients Admitted to Intensive Care Unit for COVID-19: A Pilot Corssover Randomized Controlled Trial\n\nIncluded conditions:\n- COVID-19\n- Physiotherapy\n\nStudy Armgroups:\n- {'label': 'NIOD first', 'type': 'OTHER', 'description': 'In this arm, we will apply for NIOD first which will be performed by non-physiotherapists such as respiratory therapists and bedside nurses. This arm of patients will receive standard CPT at least 3 hours after the NIOD intervention.', 'interventionNames': ['Procedure: Chest physiotherapy using a non-invasive oscillating device']}\n- {'label': 'CPT first', 'type': 'OTHER', 'description': 'In this arm, we will apply for CPT first which will be performed by physiotherapists. This arm of patients will receive NIOD procedures which will be performed by non-physiotherapists such as respiratory therapists and bedside nurses at least 3 hours after the CPT intervention.', 'interventionNames': ['Procedure: Chest physiotherapy using a non-invasive oscillating device']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Chest physiotherapy using a non-invasive oscillating device', 'description': 'NIOD will be implemented on four different parts of the chest walls, 3 minutes for each part and 12 minutes in total per each session. Left and right front and posterior chest walls will be stimulated, particularly, on the anterior chest, intercostal spaces 1-2 above nipple line and lateral side of the mid-clavicular line 1-2 below intercostal spaces. The intensity of the NIOD can be selected between 80-100%, which is pre-specified on the machine.', 'armGroupLabels': ['CPT first', 'NIOD first']}\n\nPrimary Outcomes:\n- {'measure': 'SpO2/FIO2 Ratio', 'description': 'Difference before the procedure and 10 minutes from the end of the procedure', 'timeFrame': '10 minutes and 30 minutes from the end of the procedure'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.90, significance level (alpha) of 0.05", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomized (sample size)\n We estimate the necessary sample size as 25 for each arm (total 50 cases), with a power of 0.90 and an alpha of 0.05, with a non-inferiority design.", "id": 739, "split": "val"} +{"trial_id": "NCT04361695", "pmid": "35761383", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preemptive Analgesia for Hemorrhoidectomy\n\nIncluded conditions:\n- Hemorrhoidectomy\n\nStudy Armgroups:\n- {'label': 'Ketoprophenum', 'type': 'ACTIVE_COMPARATOR', 'description': 'A tablet with 10 mg Ketoprophenum is taken per os 2 hours before surgery', 'interventionNames': ['Procedure: Hemorrhoidectomy', 'Drug: Ketoprophenum']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'A tablet containing starch is taken per os 2 hours before surgery', 'interventionNames': ['Procedure: Hemorrhoidectomy', 'Drug: Placebo']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Hemorrhoidectomy', 'description': 'The patient receives spinal anaesthesia and is placed in lithotomy position. A complex of external and internal haemorrhoid or internal haemorrhoid only is excised with monopolar electrocautery or bipolar electrosurgery device. Haemorrhoid pedicle is tied with absorbable polyfilament suture. One, two or three nodes can be removed per a procedure.', 'armGroupLabels': ['Ketoprophenum', 'Placebo']}\n- {'type': 'DRUG', 'name': 'Ketoprophenum', 'description': 'Ketoprophenum', 'armGroupLabels': ['Ketoprophenum']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'The frequency of opioid analgesics usage', 'description': 'The frequency of opioid administration per day', 'timeFrame': '0-7 days postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nThis is a superiority study using a 1-sided Blackwelder test with a significance level (alpha) of 0.05, a statistical power of 80%, a noninferiority margin of 5%, and a 1:1 allocation ratio.", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size\n Considering that this is a superiority study, the sample size was calculated using a 1-sided Blackwelder test. According to published data, the incidence of opioid intake after hemorrhoidectomy varies from 20 to 30% [7]. The expected incidence of opioid intake after hemorrhoidectomy with preemptive analgesia is not more than 10%. The purpose of this study is to show that the opioids intake in patients with preemptive analgesia is lower than without it. Considering that a = 0.05. the statistical power of the study is 80%, the patients are randomized into 2 groups with 1:1 allocation ratio, the noninferiority margin D = 5%, and the required sample size is 144 patients (72 patients in each of the 2 groups).", "id": 740, "split": "val"} +{"trial_id": "NCT04362618", "pmid": "38199628", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Exercise Therapy for Osteoarthritis Pain: How Does it Work?\n\nIncluded conditions:\n- Knee Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'Muscle Strengthening Training (MST)-group', 'type': 'EXPERIMENTAL', 'description': 'Subjects allocated to the MST group (n=30) will perform a muscle strengthening training program of 12 weeks.', 'interventionNames': ['Other: Muscle Strengthening Training']}\n- {'label': 'Behavioral Graded Activity (BGA)-group', 'type': 'EXPERIMENTAL', 'description': 'Subjects allocated to the BGA group (n=30) will perform a rehabilitation program according to the principles of behavioural graded activity for a period of 12 weeks.', 'interventionNames': ['Behavioral: Behavioral graded activity']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Subjects allocated to the control group (n=30) have to maintain their current life-style and treatment (if any) and to refrain from other new interventions during 24 weeks.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Muscle Strengthening Training', 'description': 'Muscle strengthening training will take place for a period of 12 weeks, in which participants will have 36 exercise sessions (18 at the hospital under supervision of a physiotherapist; 18 unsupervised at home) planned. Muscles of the leg (i.e. quadriceps, hip ab- and adductors) will be trained at 3 set of 10 repetitions at 80% of 1RM with the use of elastic bands. 1RM will be assessed at baseline and the exercise intensity will be progressively increased by 10% of 1RM every two sessions from 50 up to 70-80 % of 1RM. Every 6 sessions, the 1RM will be reassessed and the training resistances will be adapted.', 'armGroupLabels': ['Muscle Strengthening Training (MST)-group']}\n- {'type': 'BEHAVIORAL', 'name': 'Behavioral graded activity', 'description': \"Subjects will receive a behavioural treatment integrated within the concepts of operant conditioning with exercise therapy for a period of 12 weeks, in which the subjects will have maximum 36 BGA sessions (min. 13- max. 18 at the hospital under supervision of a physiotherapist; 18 unsupervised at home) planned. The purpose of BGA is to increase the level of activities in a time-contingent manner and increase the level of physical activity in the subject's daily lives. BGA consists of 3 phases: pain education (phase 1), treatment phase in which subjects increase their level of activity gradually (phase 2) and integration of learned principles in daily live (phase 3).\", 'armGroupLabels': ['Behavioral Graded Activity (BGA)-group']}\n\nPrimary Outcomes:\n- {'measure': 'Knee pain as primary study outcome', 'description': 'Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.', 'timeFrame': 'Baseline'}\n- {'measure': 'Knee pain as primary study outcome', 'description': 'Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.', 'timeFrame': 'during intervention: week 2 (acute)'}\n- {'measure': 'Knee pain as primary study outcome', 'description': 'Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.', 'timeFrame': 'during intervention: week 10 (acute)'}\n- {'measure': 'Knee pain as primary study outcome', 'description': 'Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.', 'timeFrame': 'post-intervention: week 13'}\n- {'measure': 'Knee pain as primary study outcome', 'description': 'Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.', 'timeFrame': 'post-intervention: week 26'}\n- {'measure': 'Knee pain as primary study outcome', 'description': 'Pain is the primary outcome as it is the primary and most disabling symptom in OA. The pain subscale of the WOMAC Osteoarthritis Index LK3.0 questionnaire will be used for the assessment of pain severity. The Knee injury and Osteoarthritis Outcome Score (KOOS) includes WOMAC Osteoarthritis Index LK3.0 in its complete and original format (with permission). WOMAC (and therefore the pain and symptoms subscale of the KOOS) is a valid tool for subjects with KOA. The KOOS is proven to generate valid and reliable scores.', 'timeFrame': 'post-intervention: week 64'}\n\nPlease estimate the sample size based on the assumption: \nExpected correlation over time of 0.3, type I error of 0.025, type II error of 0.2, and a 20% loss to follow-up.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample sizes were calculated to detect a clinically relevant difference between the treatment arms and the control of 0.49 (0.39 to 59). The effect size is based on results from a recent Cochrane meta-analysis (including 44 studies, 3537 participants).7 Because for each patient three measurements are obtained (at 0, 12 and 26 weeks), the effect size is transformed into an F-test statistic of 0.245 to be used within a sample size calculation for repeated measures analysis of variance. A sample size of 24 per treatment arm is obtained with an expected correlation over time of 0.3, allowing for a type I error of 0.025 and a type II error of 0.2. A 20% loss to follow-up is expected based on earlier studies and is added so that the total required sample size is estimated at 30 patients per study arm, resulting in 90 KOA patients to be recruited.", "id": 741, "split": "val"} +{"trial_id": "NCT04363463", "pmid": "35803621", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress\n\nIncluded conditions:\n- COVID19\n- Oxygen Therapy\n- Prone Position\n- Spontaneous Ventilation\n- Respiratory Distress Syndrome\n\nStudy Armgroups:\n- {'label': 'Conventional positioning', 'type': 'NO_INTERVENTION', 'description': 'semi-seated in bed or seated in a chair during the day. The prone position is not allowed during the day (it is allowed at night if it is the natural sleeping position).'}\n- {'label': 'Interventional positioning : prone position', 'type': 'EXPERIMENTAL', 'description': 'Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.', 'interventionNames': ['Other: prone position']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'prone position', 'description': 'Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.', 'armGroupLabels': ['Interventional positioning : prone position']}\n\nPrimary Outcomes:\n- {'measure': 'Percent age of patients who will have endotracheal intubation or non-invasive ventilation at two pressure levels and/or die, in each of the 2 randomization groups.', 'description': 'To show that PP in spontaneously ventilation patients could reduce the risk of acquiring the following event (composite endpoint):\\n\\n* Endotracheal intubation\\n* Or non-invasive ventilation (NIV) with two pressure levels\\n* And/or death', 'timeFrame': 'Day 28'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided alpha risk is set at 5%, statistical power at 80%, and a lost to follow-up rate of less than 2%.", "answer": 268, "answer_type": "ACTUAL", "explanation": "Sample size\n There are few studies in COVID-19 patients in medical wards comparing awake prone position to usual care. In two small studies in hypoxaemic COVID-19 patients in medical wards, the rate of intubation was 0% and mortality was 0% or 3.7% in both groups (prone position and usual care).21 35 In a small, cluster randomised study, the rate of transfer to ICU was 0% in the usual care group and 10% in the prone position group.26 In a randomised controlled trial on prone position versus standard of care, the rate of intubation was 13% in both groups and the rate of mortality was 6.7% in prone position vs 10% in usual care group.5\n In the above small-sized studies in non-severe COVID-19 patients hospitalised in medical wards, the most useful information was that patients were frequently capable to self-prone positioning. Overall, data on intubation rate in non-severely hypoxaemic COVID-19 patients are scarce. Therefore, despite the progression of the pandemic since the beginning of our project, the calculation of a necessary number of subjects remains highly speculative.\n We initially planned to enrol 400 patients (200 in each group) assuming a global treatment failure rate of 15%, an 8% difference in treatment failure rate between groups and a lost to follow-up rate of 10%. In the beginning of October 2021, while the spread of COVID-19 was dramatically slowing down, we anticipated that the targeted number of 400 patients would be difficult to reach in a reasonable time. Therefore, we asked the data manager to let us know the lost to follow-up rate in the 232 included patients on 1 October 2021, for whom outcomes were available in the centralised CRF and to estimate the global rate of treatment failure (without unblinding the group of randomisation), as to recalculate a target number of patients to enrol. Lost to follow-up rate was 0% and the global rate of treatment failure was 12.5%, that is, both lower than anticipated. Based on these new data, we hypothesised that the treatment failure rate will be 4% and 14% in the intervention and usual care group, respectively. With a two-sided alpha risk set at 5% and a statistical power of 80%, 134 patients in each group were needed to demonstrate a difference of 10% in treatment failure rate (use of noninvasive ventilation, intubation or death) between the two groups with a lost to follow-up rate of less than 2%. This calculation slightly overestimates the necessary sample size because it does not consider the stratified design. This new enrolment target of 268 patients was approved by the ethics committee on 9 November 2021.", "id": 742, "split": "val"} +{"trial_id": "NCT04364256", "pmid": "38728244", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Neuromuscular Electrical Stimulation for Physical Function Maintenance During Hematopoietic Stem Cell Transplantation\n\nIncluded conditions:\n- Autologous Hematopoietic Stem Cell Transplant\n\nStudy Armgroups:\n- {'label': 'Active NMES', 'type': 'ACTIVE_COMPARATOR', 'description': 'asymmetric biphasic waveforms at 71 pulses per second frequency (Hz), 400 s pulse duration, 5:10s on:off time (50% duty cycle), and 1.5s ramp-up time. Participants will be in control of the muscle stimulator devices at all times and will be instructed to perform all sessions in the supine position. Bilateral NMES will be delivered via asymmetric, biphasic using four cutaneous parallel channels delivered simultaneously using 2\"x4\" or 3\"x5\" self-adhesive electrodes. For the active NMES group, participants will be encouraged to increase the amplitude to a level of moderate discomfort, such as that experienced during conventional exercise, but not to induce pain. At minimum, the amplitude should induce visible muscle contraction.', 'interventionNames': ['Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)']}\n- {'label': 'Sham NMES', 'type': 'SHAM_COMPARATOR', 'description': 'The amplitude of the muscle stimulators for the Sham group will be capped at 15 milliamperes so patients will only feel cutaneous sensation without achieving muscle contraction.', 'interventionNames': ['Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)', 'description': 'Active or Sham Neuromuscular electrical stimulation. US Food and Drug Administration-approved 2012', 'armGroupLabels': ['Active NMES', 'Sham NMES'], 'otherNames': ['NMES, e-stim']}\n\nPrimary Outcomes:\n- {'measure': '6-Minute Walk Test', 'description': 'Manual and mobile application assessment', 'timeFrame': 'change from before to 1month after transplant'}\n\nPlease estimate the sample size based on the assumption: \nType I error probability \u03b1 = 0.05, power = 0.9, 1:1 NMES:sham participant randomization, and a 33% attrition rate.", "answer": 46, "answer_type": "ACTUAL", "explanation": "Statistical analysis and sample size calculation\n The primary outcome is between-group difference in 6MWT change from Pre-HCT to FU1 (manual assessment). Our laboratory previously reported ~41 \u00c2\u00b1 15m reduction in 6MWT in Autologous recipients between the same Pre and FU1 time points [31]. We expect the sham group in the current project to display a similar change, and for NMES to attenuate this change by 50%, resulting in a between-group difference in 6MWT change of -20.7 \u00c2\u00b1 16.0m. Along with a Type I error probability \u00ce\u00b1 = 0.05, power = 0.9, and 1:1 NMES:sham participant randomization, we will need to enrol 15 minimum participants per group. This is consistent with the recent finding from Bewarder and colleagues in which a combined group of autologous/allogenic HCT patients and hematologic cancer patients undergoing intensive chemotherapy without HCT displayed a mean reduction in 6MWT of 24m after NMES [25]. We estimate a 33% attrition rate, and therefore aim to enrol 23 participants/group (46 total). Approximately 100 HCT are performed each year at the MTU at VAPSHCS with roughly 70 being autologous HCT. The enrolment rate for our prior observational trial was 20 autologous HCT recipients/year, and we estimate enrolment of 17 patients/year for this project which would allow for completion of enrolment (N = 46 total), accounting for attrition, and primary outcome (FU1) assessment 2.5\u00e2\u0080\u00933 years after study initiation and completion of final (FU2) assessment 3\u00e2\u0080\u00933.5 years after study initiation.\n All variables will be summarized descriptively using N, mean, and standard error using the latest version of SPSS. The study cohort will be described using Pre-HCT data, both overall and comparing between study arms using t-tests for continuous variables and X2 tests for categorical variables. Testing of statistical significance will be 2-tailed, with a p-value \u00e2\u0089\u00a40.05. An intent-to-treat analyses will be conducted using paired-sample t-tests for continuous variables and X2 for categorical variables for within-group comparisons of outcomes between Pre and FU1; independent t-tests will be used for between-group comparisons of change variables (FU1 minus Pre-HCT). Exploratory analyses will include multiple linear regression models to test whether Pre-HCT 6MWT is a predictor of physical function or patient-reported fatigue (FACIT-F or MJM) at FU2. The model will control for group assignment, adherence, hemoglobin, and age as well as any potential confounding variables found to be unbalanced between groups in bivariate testing described above.", "id": 743, "split": "val"} +{"trial_id": "NCT04370327", "pmid": "35762773", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effects of Claudication Severity on Functional Outcomes in Patients With Intermittent Claudication\n\nIncluded conditions:\n- Intermittent Claudication\n\nStudy Armgroups:\n- {'label': 'Pain Free Exercise (PF)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will be randomised to twice weekly for 24 weeks of pain free exercise in a supervised exercise programme', 'interventionNames': ['Other: Pain Free Exercise (PF)']}\n- {'label': 'Moderate Claudication Pain Exercise (MOD-P)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will be randomised to twice weekly for 24 weeks of moderate claudication pain exercise in a supervised exercise programme', 'interventionNames': ['Other: Moderate Claudication Pain Exercise (MOD-P)']}\n- {'label': 'Maximal Claudication Pain Exercise (MAX-P)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will be randomised to twice weekly for 24 weeks of maximal claudication pain exercise in a supervised exercise programme', 'interventionNames': ['Other: Maximal Claudication Pain Exercise (MAX-P)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Pain Free Exercise (PF)', 'description': 'Patients will exercise until the onset on claudication (1 on the rating scale)', 'armGroupLabels': ['Pain Free Exercise (PF)']}\n- {'type': 'OTHER', 'name': 'Moderate Claudication Pain Exercise (MOD-P)', 'description': 'Patients will exercise until they experience moderate claudication pain (2 on the rating scale)', 'armGroupLabels': ['Moderate Claudication Pain Exercise (MOD-P)']}\n- {'type': 'OTHER', 'name': 'Maximal Claudication Pain Exercise (MAX-P)', 'description': 'Patients will exercise until they experience maximal claudication pain (4 on the rating scale)', 'armGroupLabels': ['Maximal Claudication Pain Exercise (MAX-P)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Maximal Walking Distance (MWD)', 'description': 'Metres walked until maximal claudication pain', 'timeFrame': '12 and 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA power of 90%, a significance level of 5%, and a dropout rate of approximately 30%.", "answer": 51, "answer_type": "ESTIMATED", "explanation": "Sample size\n Power analysis performed in G*Power\n31\n showed that 39 patients (total) would be needed to attain statistical\nsignificance. Based on previously published data investigating a UK-based SEP\nthat adopted a similar exercise circuit\n32\n and converting the interquartile range to standard deviation,\n33\n a median change in MWD of 143 m and a pooled standard deviation of 111.3\nm was calculated. A power of 90% and a significance level of 5% were assumed. A\ndrop-out of approximately 30% will be allowed, yielding a required sample size\nof 51 patients (17 per group) to be randomised.", "id": 744, "split": "val"} +{"trial_id": "NCT04370457", "pmid": "34728446", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Clinical Trial of the MyPal ePRO-based Early Palliative Care System in Adult Patients With Hematologic Malignancies\n\nIncluded conditions:\n- Chronic Lymphocytic Leukemia\n- Myelodysplastic Syndromes\n\nStudy Armgroups:\n- {'label': 'Experimental arm', 'type': 'EXPERIMENTAL', 'description': 'Administration of the MyPal ePRO system', 'interventionNames': ['Other: Administration of the MyPal ePRO system']}\n- {'label': 'Standard care arm', 'type': 'NO_INTERVENTION', 'description': 'No further intervention besides standard palliative care approach if needed'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Administration of the MyPal ePRO system', 'description': 'Patients will be asked to complete self-report questionnaires at baseline, and every month for the first six months and at 12-month follow-up', 'armGroupLabels': ['Experimental arm']}\n\nPrimary Outcomes:\n- {'measure': 'Improvement in EORTC Quality of Life Questionnaire (QLQ)-C30 General Questionnaire', 'description': 'The primary objective is to determine whether - compared to standard care - the MyPal-ADULT intervention can lead to improved QoL as evidenced by statistically significant higher scores in EORTC Quality of Life Questionnaire (QLQ)-C30 General Questionnaire', 'timeFrame': 'through study completion, an average of 1 year'}\n- {'measure': 'Improvement in EuroQol (EQ)-five dimensions (5D)', 'description': 'The primary objective is to determine whether - compared to standard care - the MyPal-ADULT intervention can lead to improved QoL as evidenced by statistically significant higher scores in EuroQol (EQ)-five dimensions (5D).', 'timeFrame': 'through study completion, an average of 1 year'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 0.05, power over 90%, attrition rate of 20%, and missing data rate of 30%.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Assuming relatively acceptable values for the attrition rate (ie, 20%) and the missing data (ie, 30%), the sample size analysis concluded that 300 recruited patients with CLL or MDS at any ratio providing one measure at enrolment (baseline) and seven repeated measures (at months 1, 2, 3, 4, 5, 6 and 12) are sufficient for the power of the intended statistical testing to be over 90% in all cases, given (a) a 0.05 significance level and (b) an effect size of 0.2; the employed value of the effect size was based on a priori knowledge of the domain.", "id": 745, "split": "val"} +{"trial_id": "NCT04370951", "pmid": "33596968", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of the Erector Spinae Plane (ESP) Block for Quality of Recovery in Posterior Thoraco-Lumbar Spinal Decompression Surgery: A Randomised Control Trial\n\nIncluded conditions:\n- Spinal Surgery\n\nStudy Armgroups:\n- {'label': 'Erector Spinae Plane Block', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will receive a ESP block with 20mls 0.25% Levobupivicaine bilaterally, pre incision plus standardised multimodal analgesia', 'interventionNames': ['Procedure: Erector Spinae Plane Block - Ultrasound guided']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'no ESP block, standardised multimodal analgesia'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Erector Spinae Plane Block - Ultrasound guided', 'description': '20mls 0.25% Levobupivicaine ultrasound guided bilaterally', 'armGroupLabels': ['Erector Spinae Plane Block']}\n\nPrimary Outcomes:\n- {'measure': 'QoR 15 score', 'description': 'a objective assessment of quality of recovery post surgery', 'timeFrame': '24 hours post operatively'}\n\nPlease estimate the sample size based on the assumption: \nType I error = 0.05, Type II error = 0.2 (80% power), and an allowance for participant withdrawal.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size and justification\n The primary outcome of this study will be the QoR-15 score at 24\u00e2\u0080\u0089h postoperatively. The established minimum clinically important difference in QoR-15 is 8.0 and the mean SD of QoR-15 scores after major spinal surgery is in the order of 14 [range of QoR score is 1\u00e2\u0080\u0093150]. Therefore, assuming type I error\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and type II error\u00e2\u0080\u0089=\u00e2\u0080\u00890.2 (80% power to detect this difference), then n\u00c2\u00a0=\u00e2\u0080\u008925 patients will be required in each group. To accommodate for participants who may withdraw from the study, we will aim to recruit n\u00c2\u00a0=\u00e2\u0080\u008926 patients to each study arm.", "id": 746, "split": "val"} +{"trial_id": "NCT04371757", "pmid": "34412668", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Influence of the Autonomic Nervous System on Endothelial Function as an Acute Response to Exercise in Hypertensive Individuals: a Randomized Double-blind Protocol Study\n\nIncluded conditions:\n- Autonomic Nervous System\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'Aerobic exercise session', 'type': 'EXPERIMENTAL', 'description': 'The aerobic exercise session will be performed on a horizontal cycle ergometer. A warm-up will be performed (5 minutes), followed by 40 minutes with moderate intensity (60% HRreserve) and controlled by a heart rate monitor, as well as the subjective effort scale (Borg 6 to 20 points). Blood pressure, heart rate and the Borg scale will be assessed at the beginning of aerobic exercise and every 5 minutes until the end.', 'interventionNames': ['Drug: \u03b11-adrenergic block', 'Other: Placebo']}\n- {'label': 'Resistance exercise session', 'type': 'EXPERIMENTAL', 'description': 'The resistance exercise session will be structured with knee extension, knee flexion, leg pressure and plantar flexion, in a station with guided weights, with 4x12 repetitions and 60% intensity of 1-RM; the cadence will be adjusted to 2:2 (concentric: eccentric) and controlled by a metronome. The rest between sets and exercises will be 90 seconds (total duration: 40 minutes). Blood pressure, heart rate and Borg scale will be recorded at the beginning and at the end of the 4th series of each exercise.', 'interventionNames': ['Drug: \u03b11-adrenergic block', 'Other: Placebo']}\n- {'label': 'Combined exercise session', 'type': 'EXPERIMENTAL', 'description': 'The combined exercise session will be structured with 20 minutes of resistance exercise + 20 minutes of aerobic exercise, as already described, except that the resistance exercises will have 2 sets of each exercise. As with other sessions, blood pressure, heart rate and the Borg scale will be assessed at the beginning and end of the second series of resistance exercise, as well as at the beginning and every 5 minutes of aerobic exercise up to 15 minutes after end of exercises.', 'interventionNames': ['Drug: \u03b11-adrenergic block', 'Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '\u03b11-adrenergic block', 'description': 'Ninety minutes before starting the experimental exercise protocol, participants will be offered a capsule containing an \u03b1-1 adrenoreceptor blocker (Drozazosin; 0.05 mg / kg-1 body weight) and will be instructed to lie down. All capsules will be handled by a specialized pharmacy.', 'armGroupLabels': ['Aerobic exercise session', 'Combined exercise session', 'Resistance exercise session'], 'otherNames': ['Doxazosin']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Ninety minutes before starting the experimental exercise protocol, participants will be offered a capsule containing an placebo (microcrystalline cellulose; 0.05 mg.kg-1 body weight) and will be instructed to lie down. All capsules will be handled by a specialized pharmacy.', 'armGroupLabels': ['Aerobic exercise session', 'Combined exercise session', 'Resistance exercise session'], 'otherNames': ['Microcrystalline cellulose']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in the endothelial function of hypertensive individuals after a session of aerobic exercise, resistance exercise and combined exercise in \u03b11-adrenoreceptor blocker and placebo condition.', 'description': 'The method of assessing the flow-mediated dilation (FMD) of the brachial artery by ultrasonography is an indirect method to assess endothelial function. To analyze the FMD of the brachial artery a rapid deflation cuff will be placed around the forearm 5 cm distal to the antecubital fossa and the image of the brachial artery will be obtained in the distal third of the arm. Baseline diameters will be recorded for 1 minute, before the forearm cuff is inflated at 50 mmHg above the SBP, for 5 minutes. The recording of the images will be resumed 30 seconds before the deflation of the cuff and maintained for 3 minutes after deflation. The video signal of the Doppler Ultrasound will be recorded in real time by a USB video card and saved for offline analysis. The analysis of diameter will be performed using edge detection and wall tracking software. The FMD will be calculated as the percentage change in the peak diameter after deflating the cuff from the baseline diameter.', 'timeFrame': 'Ten minutes before the exercise session and 10, 40 and 70 minutes after the exercise session.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power = 80%, and a 30% dropout rate.", "answer": 39, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is calculated according to Atkinson et al. [26]. In their study, they compared endothelium-dependent vasodilation (by FMD) after a single session of moderate-intensity AE for 30\u00e2\u0080\u0089min in healthy individuals receiving an \u00ce\u00b11-adrenergic blocker (prazosin 0.05\u00e2\u0080\u0089mg/kg\u00e2\u0088\u00921) or placebo and reported a difference in means of 3.1% with standard deviations (SDs) of 1.13% for placebo and 1.91% for prazosin. For finding a similar difference in FMD (3.1%) between these two conditions (\u00ce\u00b11-adrenergic receptor block versus placebo) after our protocol\u00e2\u0080\u0099s exercise session (AE, RE, and CE) considering \u00ce\u00b1 = 0.05 and 80% power, a sample of five volunteers per group (n = 15) is required.\n For a comparison of FMD measurements among exercise types (AE, RE, and CE), our sample calculation is based on pre-exercise SD (1.18%) and post-exercise SD (1.91%) for the prazosin group as described by Atkinson et al. Thus, to find a difference in FMD of 1.62% considering \u00ce\u00b1 = 0.05 and 80% power, a sample of 10 individuals per group (n = 30) is required. Assuming a 30% loss, a sample of 39 individuals would be required (n = 13 per group).", "id": 747, "split": "val"} +{"trial_id": "NCT04371783", "pmid": "38719320", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Trial Comparing the Live Birth Rate of Immediate Versus Delayed Frozen Embryo Transfer (FET) Replacing a Single Blastocyst in the First FET of the First Stimulated IVF Cycle Following a Freeze-all Strategy\n\nIncluded conditions:\n- IVF\n- Frozen Embryo Transfer\n\nStudy Armgroups:\n- {'label': 'Immediate FET group', 'type': 'OTHER', 'description': 'FET will be performed in the first menstrual cycle following the stimulated IVF cycle', 'interventionNames': ['Procedure: Immediate FET']}\n- {'label': 'Delayed FET group', 'type': 'OTHER', 'description': 'FET will be performed in the second menstrual cycle following the stimulated IVF cycle', 'interventionNames': ['Procedure: Delayed FET']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Immediate FET', 'description': 'FET is performed in the first menstrual cycle following the stimulated IVF cycle', 'armGroupLabels': ['Immediate FET group']}\n- {'type': 'PROCEDURE', 'name': 'Delayed FET', 'description': 'FET is performed in the second menstrual cycle following the stimulated IVF cycle', 'armGroupLabels': ['Delayed FET group']}\n\nPrimary Outcomes:\n- {'measure': 'live birth', 'description': 'deliveries \u226522 weeks gestation with heartbeat and breath', 'timeFrame': '1 year after FET'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (\u03b2) = 0.80, Dropout rate = 10%", "answer": 828, "answer_type": "ESTIMATED", "explanation": "Sample size calculations and statistical analysis\n \n Sample size estimation\n According to our previous study, the live birth rates in the delayed and immediate FET groups were 37% and 47%, respectively, per transfer, representing a 10% difference between the two groups.19 The calculated sample size was 376\u00e2\u0080\u0089women in each group (\u00ce\u00b1=0.05\u00e2\u0080\u0089and \u00ce\u00b2=0.80). Allowing for 10% drop-out, 828 participants or 414 participants in each arm will be needed.", "id": 748, "split": "val"} +{"trial_id": "NCT04371783", "pmid": "38719320", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Trial Comparing the Live Birth Rate of Immediate Versus Delayed Frozen Embryo Transfer (FET) Replacing a Single Blastocyst in the First FET of the First Stimulated IVF Cycle Following a Freeze-all Strategy\n\nIncluded conditions:\n- IVF\n- Frozen Embryo Transfer\n\nStudy Armgroups:\n- {'label': 'Immediate FET group', 'type': 'OTHER', 'description': 'FET will be performed in the first menstrual cycle following the stimulated IVF cycle', 'interventionNames': ['Procedure: Immediate FET']}\n- {'label': 'Delayed FET group', 'type': 'OTHER', 'description': 'FET will be performed in the second menstrual cycle following the stimulated IVF cycle', 'interventionNames': ['Procedure: Delayed FET']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Immediate FET', 'description': 'FET is performed in the first menstrual cycle following the stimulated IVF cycle', 'armGroupLabels': ['Immediate FET group']}\n- {'type': 'PROCEDURE', 'name': 'Delayed FET', 'description': 'FET is performed in the second menstrual cycle following the stimulated IVF cycle', 'armGroupLabels': ['Delayed FET group']}\n\nPrimary Outcomes:\n- {'measure': 'live birth', 'description': 'deliveries \u226522 weeks gestation with heartbeat and breath', 'timeFrame': '1 year after FET'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (\u03b2) = 0.80, Dropout rate = 10%", "answer": 828, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n According to our previous study, the live birth rates in the delayed and immediate FET groups were 37% and 47%, respectively, per transfer, representing a 10% difference between the two groups.19 The calculated sample size was 376\u00e2\u0080\u0089women in each group (\u00ce\u00b1=0.05\u00e2\u0080\u0089and \u00ce\u00b2=0.80). Allowing for 10% drop-out, 828 participants or 414 participants in each arm will be needed.", "id": 749, "split": "val"} +{"trial_id": "NCT04373902", "pmid": "35304395", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born with Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial\n\nIncluded conditions:\n- Hernias, Diaphragmatic, Congenital\n- Hernia; Diaphragm Defect, Congenital\n- Pulmonary Hypertension\n\nStudy Armgroups:\n- {'label': 'Physiological-based cord clamping', 'type': 'EXPERIMENTAL', 'description': 'In PBCC, the Concord will be placed next to the bed of the mother and all equipment will be checked before the second stage of labour has started. The infant will be placed on the platform of the Concord immediately after birth, avoiding any traction or pressure on the cord and avoiding heat loss by radiation heating. The umbilical cord will not be clamped until the infant is considered respiratory stable, which is defined as the presence of a heart rate \\\\>100 bpm and preductal oxygen saturation \\\\>85%, while using an fraction of inspired oxygen (FiO2) of \\\\<0.5. The minimum and maximum times of cord clamping are three and ten minutes after birth, respectively. Oxytocin administration will be postponed until after cord clamping if there are no obstetric concerns. At any time, the attending neonatologist and obstetrician can decide that PBCC should not be performed or be interrupted. In that case, the infant can be placed on the standard resuscitation table for (further) stabilisation.', 'interventionNames': ['Procedure: Physiological-based cord clamping']}\n- {'label': 'Immediate cord clamping', 'type': 'NO_INTERVENTION', 'description': 'In the immediate cord clamping group, the cord will be clamped immediately after birth. The infant will then be transferred to the standard neonatal resuscitation table. After cord clamping, all infants will be managed according to the standardised neonatal management protocol for infants with a CDH, which is a consensus of current clinical guidelines by the CDH EURO consortium.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Physiological-based cord clamping', 'description': \"See 'Arm'\", 'armGroupLabels': ['Physiological-based cord clamping']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.', 'description': 'Pulmonary hypertension is present if at least 2 of the following 4 criteria are present or if the infant requires extracorporeal membrane oxygenation (ECMO) in the first 24 hours after birth:\\n\\n1. Right ventricular systolic pressure (RVSP) \u22652/3 systemic systolic pressure\\\\*\\n2. Right ventricle (RV) dilatation/septal displacement or RV dysfunction +/- left ventricle (LV) dysfunction\\\\*\\n3. Pre-post ductal SpO2 difference \\\\>10% for at least 15 consecutive minutes\\n4. Oxygenation Index \\\\>20\\\\*\\\\* \\\\*as found on first ultrasound in first 24 hours after birth; \\\\*\\\\*highest value measured in first 24 hours after birth\\n\\nThe following echocardiographic parameters will be collected to objectify these criteria:\\n\\n* RV size\\n* Pulmonary artery acceleration time (PAAT), right ventricular ejection time (RVET), PAAT:RVET ratio\\n* Intraventricular septum configuration\\n* LV systolic eccentricity index\\n* Mean airway pressure\\n* PaO2\\n* FiO2\\n* Preductal+postductal SpO2', 'timeFrame': 'First 24 hours after birth'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 0.05 significance level, and good overall adherence to the protocol based on previous feasibility studies.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size estimates\n The background incidence of pulmonary hypertension in infants with a CDH can be estimated based on historical cohorts. The largest registry available is the CDH Study Group registry consisting of data from 70 participating centres in 13 countries. A recent review of 3367 patients of this cohort (2007\u00e2\u0080\u00932014) reports a 69.7% incidence of pulmonary hypertension in the first week after birth (median of 0\u00e2\u0080\u0089days (0\u00e2\u0080\u00938)).35 As this is the first human clinical study evaluating PBCC with pulmonary hypertension as primary outcome, we cannot estimate the effect size. Thus, we suggest using a clinically relevant change in incidence of pulmonary hypertension to determine the sample size. We consider that a relative decrease by one-third in the incidence of pulmonary hypertension in the first 24 hours after birth is realistic and is significant enough to influence change in the neonatal management of infants with a CDH. Based on the background incidence of pulmonary hypertension, we calculated that at least 140 infants (70 in each group) are needed to detect a 1/3 reduction, with 80% power and 0.05 significance level. It will be difficult to estimate the number of cases that will have the umbilical cord clamped earlier than the times within the PBCC protocol. However, based on the results from two small human feasibility studies, it can be expected that we will have good overall adherence to the protocol.", "id": 750, "split": "val"} +{"trial_id": "NCT04374747", "pmid": "36153518", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk: Effects on Breast Cell DNA Methylation, Breast Inflammation,and Weight\n\nIncluded conditions:\n- Breast Cancer Female\n- Inflammation\n- Postpartum Weight Retention\n- Diet, Healthy\n- Risk Reduction\n\nStudy Armgroups:\n- {'label': 'Dietary Intervention', 'type': 'EXPERIMENTAL', 'description': 'Intensive dietary counseling and fruit and vegetable box delivery.', 'interventionNames': ['Behavioral: Dietary Counseling']}\n- {'label': 'Information', 'type': 'NO_INTERVENTION', 'description': 'Control condition of information on healthy eating during breastfeeding'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Dietary Counseling', 'description': 'The counseling approach will employ strategies shown to be successful in previous and ongoing dietary modification studies including supportive and motivational interviewing techniques. Each woman in the diet intervention group will be assigned a trained nutrition coach/counselor. Counselors will focus on helping participants identify and address barriers to achieving the goal of consuming at least 8 to 10 servings of nutrient dense fruits and vegetables each day (e.g., modifying recipes and food preparation). Participants will also receive weekly boxes of fruits and vegetables .', 'armGroupLabels': ['Dietary Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'DNA methylation', 'description': '% methylation in 300,000 CpG sites in DNA from sloughed breast epithelial cells from milk', 'timeFrame': '20 weeks'}\n- {'measure': 'Inflammatory markers in milk', 'description': 'Adiponectin, CRP, IFN-y, IL1-beta, Leptin, IL-6, IL-8, TNF-alpha, b-FGF, FLT-1, PLGF, VegF-D', 'timeFrame': '20 weeks'}\n- {'measure': 'Early weight', 'description': 'maternal weight', 'timeFrame': '20 weeks'}\n- {'measure': 'Early waist circumference', 'description': 'maternal waist circumference', 'timeFrame': '20 weeks'}\n- {'measure': 'One-year Weight', 'description': 'maternal weight', 'timeFrame': 'One-year'}\n- {'measure': 'One-year Waist Circumference', 'description': 'maternal weight circumference', 'timeFrame': 'one year'}\n\nPlease estimate the sample size based on the assumption: \nBonferroni correction to maintain overall Type I error at 0.05. Significance level set at p = 0.05/300000 for CpG measurements. Power of 99% (82%) for CpG measurements with \u03c1 = 0.5 (0.3). Power of 94% (84%) for inflammatory markers with \u03c1 = 0.5 (0.3). Power of 98% for body weight, waist circumference, and fruit/vegetable consumption with a type I error of 0.05.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Power and sample size calculations\n Power calculations for linear mixed models with adjustment for multiple testing were carried out through simulation studies. Due to computational considerations, adjustment for multiple testing was carried out through a conservative Bonferroni correction procedure to maintain the overall type I error at 0.05. CpG measurements (1a): In each dataset, we simulated repeated measurements of CpG levels according to a multivariate normal distribution with unit variance, assuming a within-subject correlation \u00cf\u0081, a mean difference in levels in the control group comparing baseline to the 20-week (T2) visit equal to 0.1 SD units and a mean difference in the intervention group between the 20-week (T2) and baseline (T0) of \u00ce\u0094 SD units. The threshold for statistical significance was set at p\u00e2\u0080\u0089=\u00e2\u0080\u00890.05/300000, corresponding to a Bonferroni correction to maintain the overall Type I error at 0.05. When the correlation between the repeated CpG measurements is set to \u00cf\u0081\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 (\u00cf\u0081\u00e2\u0080\u0089=\u00e2\u0080\u00890.3), a sample size of 200 per group results in 99% (82%) power to detect a mean difference in the intervention arm between baseline and T2 of \u00ce\u0094\u00e2\u0080\u0089=\u00e2\u0080\u00890.75 SD units, obtained by averaging over 100 simulated datasets. For the analysis of the 12 inflammatory markers, we simulated repeated measurements of inflammatory marker levels according to a multivariate normal distribution as described above. Assuming a Bonferroni correction to maintain the overall Type I error at 0.05 and when the correlation between the repeated inflammatory measurements is set to \u00cf\u0081\u00e2\u0080\u0089=\u00e2\u0080\u00890.5 (\u00cf\u0081\u00e2\u0080\u0089=\u00e2\u0080\u00890.3), a sample size of 200 per group results in 94% (84%) power to detect a mean difference in the intervention arm between baseline and T2 of \u00ce\u0094\u00e2\u0080\u0089=\u00e2\u0080\u00890.45 SD units, obtained by averaging over 100 simulated datasets.\n Power calculations for the analyses of body weight, waist circumference and fruit and vegetable consumption at 1\u00c2\u00a0year were based on a generalized linear model, using the R package pwr [32]. A sample size of 400 subjects results in 98% power to detect an effect size of 0.05 or larger, assuming a two-sided test and a type I error 0.05. We assumed the same variability at the two time points so the power is the same for 20\u00c2\u00a0weeks and one year.\n Previous studies found a reduction of 3.90\u00c2\u00a0kg in the intervention arm compared to the control group in weight change from baseline, with an associated SD of approximately 4.8\u00c2\u00a0kg [33]. A 98% power to detect an effect size of 0.05 or larger would correspond to a difference in weight change of 0.24\u00c2\u00a0kg or larger between the two randomized groups. Previous studies found a reduction of 7.4\u00c2\u00a0cm in the diet-intervention arm compared to the control group in waist circumference change from baseline, with an associated SD of approximately 15\u00c2\u00a0cm [34]. A 98% power to detect an effect size of 0.05 or larger would correspond to a difference in waist circumference change of 0.75\u00c2\u00a0cm between the two randomized groups. Our preliminary data showed a mean increase in fruit/vegetable consumption in the diet intervention arm of 7.3 servings with an associated SD of approximately 3 servings [35]. A 98% power to detect an effect size of 0.05 or larger would correspond to a difference in fruit/vegetable consumption change of 0.15 servings between the two randomized groups.", "id": 751, "split": "val"} +{"trial_id": "NCT04377386", "pmid": "32871891", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Oral Vitamin D Supplementation in Reducing Body Mass Index and Lipid Profile in Adolescents and Young Adults in Colombia: a Pilot Clinical Trial Protocol Nested in the SIMBA Cohort\n\nIncluded conditions:\n- Overweight and Obesity\n- Overweight Adolescents\n- Vitamin D Deficiency\n\nStudy Armgroups:\n- {'label': 'Intervention group: 1000 IU DV', 'type': 'EXPERIMENTAL', 'description': 'The 75 participants assigned to the intervention group will take 1 DV capsule of 1000 IU daily for 15 weeks.', 'interventionNames': ['Dietary Supplement: 1000 IU D vitamin']}\n- {'label': 'Control group: 200 IU DV', 'type': 'PLACEBO_COMPARATOR', 'description': 'The 75 participants of the control group will take 1 DV capsule of 200 IU daily for 15 weeks, this dose being the minimum recommended for children. The above, considering that it is ethical for the control group to receive a minimum dose of supplementation.', 'interventionNames': ['Dietary Supplement: 200 IU D vitamin']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': '1000 IU D vitamin', 'description': 'Participants in the intervention group will receive 105 DV doses of 1000 IU. The supplementation will be given by the Farma de Colombia laboratory, known commercially as Farma D, whose presentation is in soft gelatin capsules. It is recommended to take one dose per day at the same time and participants should record the daily intake time of the supplement for 15 weeks on a calendar.', 'armGroupLabels': ['Intervention group: 1000 IU DV'], 'otherNames': ['Supplementation with 1000 IU vitamin D', 'Farma D 1000 IU']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': '200 IU D vitamin', 'description': 'Participants in the control group will receive 105 DV doses of 200 IU. The supplementation will be given by the same laboratory; it will have the same characteristics and recommendations for the intake as for the intervention group.', 'armGroupLabels': ['Control group: 200 IU DV'], 'otherNames': ['Supplementation with 200 IU vitamin D', 'Farma D 200 IU']}\n\nPrimary Outcomes:\n- {'measure': 'Change in body mass index between baseline and week 15', 'description': 'Change in body mass index (BMI) will be made through of the measure of body weight will be in kilograms (kg) to one decimal place, and the size in meters (m) to two decimal places. From these measurements the body mass index will be obtained using the formula: BMI = Weight (kg) / size (m)2.', 'timeFrame': 'Baseline and week 15'}\n- {'measure': 'Change in lipid profile (Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides) between baseline and week 15', 'description': 'Serum is measured from the same blood samples drawn for vitamin D levels. The processing and analysis of the samples will be done respectively through enzymatic technique, selective liquid detergent, selective detergent accelerator and Glycerol Phosphate Oxidase.', 'timeFrame': 'Baseline and week 15'}\n- {'measure': 'Change in 25-hydroxyvitamin D [25(OH)D] levels between baseline and week 15', 'description': 'After a 10-12 hour fast, in peripheral venous blood 25-hydroxyvitamin D \\\\[25(OH)D\\\\] is quantified in serum by chemiluminescent microparticle immunoassay (CMIA).', 'timeFrame': 'baseline and week 15'}\n\nPlease estimate the sample size based on the assumption: \nA power of 90%, an alpha of 5%, an intervention group/control group ratio of 1:1, and a 20% adjustment for losses to follow-up", "answer": 150, "answer_type": "ACTUAL", "explanation": "3.3\n Sample size\n The simple size was calculated considering the following parameters: an expected difference in the study outcomes (overweight, obesity, and alteration of the lipid profile) of 20% between the intervention group and the control group; a power of 90%, an alfa of 5%, an intervention group/control group ratio of 1:1, and a 20% adjustment for losses to follow-up, resulting in a sample of 270 participants (n\u00e2\u0080\u008a=\u00e2\u0080\u008a135 intervention and n\u00e2\u0080\u008a=\u00e2\u0080\u008a135 control group). The OpenEpi software was used for the calculation. Since this is a pilot study and considering the feasibility, the research team decided on a sample size of 150 participants (n\u00e2\u0080\u008a=\u00e2\u0080\u008a75 intervention group and n\u00e2\u0080\u008a=\u00e2\u0080\u008a75 control group).", "id": 752, "split": "val"} +{"trial_id": "NCT04378868", "pmid": "34580704", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Role of Delay and Antibiotics on PERForation Rate While Waiting appendECTomy - Randomized Non-inferiority Trial\n\nIncluded conditions:\n- Appendicitis\n\nStudy Armgroups:\n- {'label': 'Surgery within 8 hours, no antibiotics', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients are planned for urgent operation, that should be done within 8 hours. Operation can be done during the night time. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision.', 'interventionNames': ['Drug: No antibiotics', 'Other: urgent schedule']}\n- {'label': 'Surgery within 24 hours, no antibiotics', 'type': 'EXPERIMENTAL', 'description': 'Patients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision.', 'interventionNames': ['Drug: No antibiotics', 'Other: less urgent schedule']}\n- {'label': 'Surgery within 8 hours, antibiotics', 'type': 'EXPERIMENTAL', 'description': 'Patients are planned for urgent operation, that should be done within 8 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery.', 'interventionNames': ['Drug: Antibiotics, cefuroxime and metronidazole', 'Other: urgent schedule']}\n- {'label': 'Surgery within 24 hours, antibiotics', 'type': 'EXPERIMENTAL', 'description': 'Patients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery.', 'interventionNames': ['Drug: Antibiotics, cefuroxime and metronidazole', 'Other: less urgent schedule']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Antibiotics, cefuroxime and metronidazole', 'description': 'Patient receives antibiotics while waiting appendectomy', 'armGroupLabels': ['Surgery within 24 hours, antibiotics', 'Surgery within 8 hours, antibiotics']}\n- {'type': 'DRUG', 'name': 'No antibiotics', 'description': 'No antibiotics are given while waiting surgery.', 'armGroupLabels': ['Surgery within 24 hours, no antibiotics', 'Surgery within 8 hours, no antibiotics']}\n- {'type': 'OTHER', 'name': 'urgent schedule', 'description': 'Patients can wait up to 8 hours for surgery.', 'armGroupLabels': ['Surgery within 8 hours, antibiotics', 'Surgery within 8 hours, no antibiotics']}\n- {'type': 'OTHER', 'name': 'less urgent schedule', 'description': 'Patients can wait up to 24 hours for surgery.', 'armGroupLabels': ['Surgery within 24 hours, antibiotics', 'Surgery within 24 hours, no antibiotics']}\n\nPrimary Outcomes:\n- {'measure': 'Complicated appendicitis', 'description': 'Surgical finding is complicated appendicitis (AAST Grade III-V)', 'timeFrame': 'during surgery'}\n\nPlease estimate the sample size based on the assumption: \nTo declare non-inferiority, a power of 90 per cent with a significance level (alpha) of 0.05 is required. An assumed dropout rate of 2 to 3 per cent is considered.", "answer": 1800, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Twenty-two per cent of patients with uncomplicated appendicitis on CT were found to be perforated at operation in adults when median in-hospital waiting time for the surgery was over 8 hours5. In the same study, it was estimated that the risk of perforation increases by 2 per cent every hour. On the other hand, in patients with CRP less than 100 mg/l on admission, the rate of perforated appendicitis was 14 per cent8.\n The aim is to show that in patients with presumed uncomplicated appendicitis, scheduling appendicectomy within 24 hours does not lead to absolute increase in the rate of perforated appendicitis (AAST grade III\u00e2\u0080\u0093V) compared with scheduling the appendicectomy within 8 hours. It is assumed that in this patient population the rate of perforated appendicitis would be 15 per cent. The non-inferiority margin was set at 5 percentage points in difference of proportions of perforated appendicitis between the arms. To declare the non-inferiority, 1748 patients are needed to achieve a power of 90 per cent (\u00cf\u00872) with 0.05 alpha. To take into account an assumed 2 to 3 per cent drop off rate, sample size is set to 1800 patients.\n In the antibiotic layer, an identical (5 percentage points) non-inferiority margin in difference of proportions of perforated appendicitis was set with identical sample size calculation.\n Patient recruiting started in May 2020 and the recruitment is estimated to take 2 years.", "id": 753, "split": "val"} +{"trial_id": "NCT04379570", "pmid": "37828596", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions\n\nIncluded conditions:\n- Anatomic Stage I Breast Cancer AJCC v8\n- Anatomic Stage II Breast Cancer AJCC v8\n- Anatomic Stage III Breast Cancer AJCC v8\n- HER2 Negative Breast Carcinoma\n- Hormone Receptor Positive Breast Carcinoma\n- Invasive Breast Carcinoma\n- Prognostic Stage I Breast Cancer AJCC v8\n- Prognostic Stage II Breast Cancer AJCC v8\n- Prognostic Stage III Breast Cancer AJCC v8\n\nStudy Armgroups:\n- {'label': 'Arm I (TMR)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive online educational information about ET at the start of their ET medication. Patients also receive daily text message reminders to take their ET medication and monthly text messages about how they are doing with taking their ET medication. These text messages continue for 9 months.', 'interventionNames': ['Other: Educational Intervention', 'Other: Text Message-based Navigation Intervention', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}\n- {'label': 'Arm II (MI)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive online educational information about ET at the start of their ET medication. Patients also receive a total of 5 motivational interviewing counseling sessions via telephone over 30-90 minutes for up to 9 months. These sessions are designed to support patients while they take their ET medication, develop health goals, and stay on track in achieving those goals.', 'interventionNames': ['Other: Educational Intervention', 'Behavioral: Motivational Interviewing', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}\n- {'label': 'Arm III (TMR + MI)', 'type': 'EXPERIMENTAL', 'description': 'Patients receive online educational information about ET at the start of their ET medication. Patients also receive text messages as in Arm I and motivational interviewing counseling sessions as in Arm II.', 'interventionNames': ['Other: Educational Intervention', 'Other: Text Message-based Navigation Intervention', 'Behavioral: Motivational Interviewing', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}\n- {'label': 'Arm IV (enhanced usual care)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients attend usual care clinic visits every 3-6 months and receive online educational information about ET at the start of their ET medication. Patients also receive optional online information about living a healthy life after breast cancer.', 'interventionNames': ['Other: Educational Intervention', 'Other: Best Practice', 'Other: Questionnaire Administration', 'Other: Quality-of-Life Assessment']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Educational Intervention', 'description': 'Receive online educational information about ET medication', 'armGroupLabels': ['Arm I (TMR)', 'Arm II (MI)', 'Arm III (TMR + MI)', 'Arm IV (enhanced usual care)']}\n- {'type': 'OTHER', 'name': 'Text Message-based Navigation Intervention', 'description': 'Receive text messages', 'armGroupLabels': ['Arm I (TMR)', 'Arm III (TMR + MI)']}\n- {'type': 'BEHAVIORAL', 'name': 'Motivational Interviewing', 'description': 'Receive motivational interviewing counseling sessions', 'armGroupLabels': ['Arm II (MI)', 'Arm III (TMR + MI)']}\n- {'type': 'OTHER', 'name': 'Best Practice', 'description': 'Attend usual care clinic visits', 'armGroupLabels': ['Arm IV (enhanced usual care)'], 'otherNames': ['Standard of Care']}\n- {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (TMR)', 'Arm II (MI)', 'Arm III (TMR + MI)', 'Arm IV (enhanced usual care)']}\n- {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (TMR)', 'Arm II (MI)', 'Arm III (TMR + MI)', 'Arm IV (enhanced usual care)']}\n\nPrimary Outcomes:\n- {'measure': 'Endocrine therapy (ET) adherence at 12 months post-randomization', 'description': 'ET adherence at 12 months post-randomization will be measured by electronic pill monitoring cap (Pillsy-reported) and defined as the proportion of patients within each arm who have taken their ET medication for at least 292 of 365 days.', 'timeFrame': 'At 12 months post-randomization'}\n\nPlease estimate the sample size based on the assumption: \nThe study maintains a primary family-wise two-sided type I error rate of \u03b1 = 0.05, with two chi-square tests conducted at a nominal \u03b1 = 0.025. The study aims for at least 80% power at a 2.5% two-sided significance level. An 11% ineligible and loss to follow-up rate is anticipated.", "answer": 1180, "answer_type": "ESTIMATED", "explanation": "Sample size\n Enhanced usual care adherence at 12\u00c2\u00a0months is assumed to be 69%, based on our preliminary studies of pharmacy refill data from claims in Medicare, Medicaid, and private insurance populations, using weighted estimates of 12-month adherence among Black women\u00e2\u0080\u0089<\u00e2\u0080\u008950\u00c2\u00a0years old, non-Black women\u00e2\u0080\u0089<\u00e2\u0080\u008950\u00c2\u00a0years old, Black women\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008950\u00c2\u00a0years old, and non-Black women\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008950\u00c2\u00a0years old. We hypothesize 81% adherence for the TMR-only and MI-only intervention arms based on preliminary data from the GETSET MI counseling pilot intervention [37, 45]. To maintain a primary family-wise two-sided type I error rate of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, the two chi-square tests will be conducted with nominal \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.025. At a 2.5% two-sided significance level, the study will have at least 80% power to detect differences in adherence (81% in single component intervention arms vs 69% in enhanced usual care) if 263 evaluable patients are randomized each to the TMR-only, MI-only, and enhanced usual care arms. Because we anticipate ineligible and loss to follow-up of approximately 11%, consistent with other clinical trials of cancer survivors, we will over-recruit, rendering a recruitment target of 1180 randomized patients total (295 per arm). Power Analysis and Sample Size (PASS) software (PASS v15, NCSS, Kaysville, UT) was used to conduct the power analysis.\n Young age and self-reported Black race have been shown to be risk factors for low ET adherence [13, 19, 20]. As such, the study is designed to accrue 30% (or 354 of 1180) of patients who self-identify as Black as well as 30% who are\u00e2\u0080\u0089<\u00e2\u0080\u008950\u00c2\u00a0years old at time of recruitment. Additionally, the ideal case is for race and age to be uncorrelated with one another so that they have independent effects on the outcome of interest. To achieve this, we have defined distinct accrual targets for four non-overlapping groups (i.e., Black women\u00e2\u0080\u0089<\u00e2\u0080\u008950\u00c2\u00a0years old, non-Black women\u00e2\u0080\u0089<\u00e2\u0080\u008950\u00c2\u00a0years old, Black women\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008950\u00c2\u00a0years old, and non-Black women\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008950\u00c2\u00a0years old) and close accrual for each group independently. The target accrual numbers for each group are shown in Table 2.\nTable 2Accrual targets by race and age strataAge (years)BlackNon-BlackTotal\u00e2\u0080\u0089<\u00e2\u0080\u008950106248354\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008950248578826Total3548261180", "id": 754, "split": "val"} +{"trial_id": "NCT04381871", "pmid": "32891160", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Phase II ,III Randomized Double Blind Parallel Arms Clinical Trial of Potential Role of Gum Arabic ( Acacia Senegal) as Immunomodulatory Agent Among COVID 19 Patients in Sudan\n\nIncluded conditions:\n- COVID 19\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose', 'interventionNames': ['Dietary Supplement: Acacia Senegal']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'This group will be provided with pectin powder provided as one-gram-dose', 'interventionNames': ['Dietary Supplement: Pectin']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Acacia Senegal', 'description': 'Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks', 'armGroupLabels': ['Intervention Group'], 'otherNames': ['Gum Arabic']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Pectin', 'description': 'Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Mean change from baseline score of Immune Response to end of the trial ( Time Frame: up to 4 weeks )', 'description': 'Changes of the level of Tumor Necrosis Factor (TNF), interleukin IL8,IL6,IL10 from the baseline values', 'timeFrame': '4 weeks'}\n- {'measure': 'Mortality rate', 'description': 'The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo', 'timeFrame': 'from the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to two months'}\n\nPlease estimate the sample size based on the assumption: \nNot specified in the provided paragraph.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomised (sample size)\n 110 eligible patients will be randomly assigned to either GA (n=55) or placebo (n=55) groups.", "id": 755, "split": "val"} +{"trial_id": "NCT04385771", "pmid": "33455938", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation - Randomized, Controlled, Open-label Intervention, Multi-center Trial (CYCOV-II-study)\n\nIncluded conditions:\n- Coronavirus Infection\n- COVID\n- SARS-CoV 2\n- Respiratory Failure\n- Cytokine Storm\n- Extracorporeal Membrane Oxygenation\n\nStudy Armgroups:\n- {'label': 'vv-ECMO + cytokine adsorption', 'type': 'EXPERIMENTAL', 'description': 'after indication of treatment with vv-ECMO in acute respiratory failure in COVID-19-disease, patients will additionally receive cytokine adsorption using a Cytosorb adsorber', 'interventionNames': ['Device: vv-ECMO + cytokine adsorption (Cytosorb adsorber)']}\n- {'label': 'vv-ECMO (no cytokine adsorption)', 'type': 'OTHER', 'description': 'treatment with vv-ECMO in acute respiratory failure in COVID-19-disease (standard treatment without additional cytokine adsorption)', 'interventionNames': ['Device: vv-ECMO only (no cytokine adsorption)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'vv-ECMO + cytokine adsorption (Cytosorb adsorber)', 'description': 'in COVID-19-diseased vv-ECMO patients additional treatment with cytokine adsorption using a Cytosorb adsorber will be randomized (vs. control group)', 'armGroupLabels': ['vv-ECMO + cytokine adsorption']}\n- {'type': 'DEVICE', 'name': 'vv-ECMO only (no cytokine adsorption)', 'description': 'COVID-19-diseased treated with vv-ECMO', 'armGroupLabels': ['vv-ECMO (no cytokine adsorption)']}\n\nPrimary Outcomes:\n- {'measure': 'IL-6 reduction by 75% or more after 72 hours as compared to the baseline measurement', 'description': 'measurement of IL-6 levels in patient blood after 72 hours of cytokine adsorption (in relation to level before initiation of cytokine adsorption)', 'timeFrame': '72 hours'}\n- {'measure': 'time to successful ECMO-explantation', 'description': 'time to successful ECMO-explantation within 30 days after randomization', 'timeFrame': '30 days'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical comparisons will be performed at a two-sided significance level alpha of 0.05. The power for detecting differences is set at 80%. No alpha correction is necessary for the individual statistical tests. The analysis for endpoint 2 will use a Fine and Gray model considering death as a competing event.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculation and power considerations are based on the two primary endpoints: (1) IL-6 reduction by 75% or more after 72 hours as compared with the baseline measurement and (2) time to successful ECMO explantation within 30 days after randomisation. If there is no difference between treatment arms with respect to endpoint 1, that is, a clinically relevant IL-6 reduction, it is assumed that there is also no difference between treatment arms with respect to the clinically relevant endpoint 2. Therefore, statistical comparisons (at two-sided significance level alpha of 0.05) between treatment arms will be performed in this a priori specified sequence, that is, the statistical comparison with respect to endpoint 2 will only be performed if a difference between treatment arms with respect to endpoint 1 had been shown at a two-sided significance level alpha of 0.05. Thus, no alpha correction of the individual statistical tests is necessary.\n For sample size calculation with respect to endpoint 1, it is assumed that the probability of IL-6 reduction by 75% or more after 72 hours is 80% in the intervention group and 50% in the control group. This assumption is based on the results in the first 10 patients of the ongoing CYCOV I trial (NCT04324528 and DRKS00021300). In the intervention group, IL-6 could be reduced by 75% or more in three out of four patients; the fourth patient was considered as not representative due to pretreatment and extremely high IL-6 values at baseline. In the control group, IL-6 could be reduced by 75% or more in two out of six patients. Under this assumption, a sample size of 39 patients per treatment arm would be required to show a difference in the probability of IL-6 reduction between treatments at two-sided significance level of 0.05 with a power of 80%. This was calculated with formula \u00e2\u0080\u0098[3]\u00e2\u0080\u0099 in Campbell et al33 for the \u00cf\u00872 test of the hypothesis that the difference between the probabilities is equal to zero using nQuery V.8.3.1 (Module PTT0), which is adequate also for the analysis with logistic regression.34 Therefore, the 1:1 randomisation of a total of 80 patients between treatment arms is planned.\n With respect to endpoint 2, nothing is known about the expected treatment effect. It is assumed that the mortality within 30 days is high and that only a small difference between treatment arms can be expected (probability of 0.7 in the intervention group and of 0.75 in the control group). With regard to the probability of successful ECMO explantation within 30 days after randomisation, an analysis of the time to successful ECMO explantation considering death as a competing event using a Fine and Gray model will be performed. With a total of 80 patients, a difference between treatment arms can be shown at two-sided significance level of 0.05 with a power of 80 %, if the probability of successful ECMO explantation within 30 days after randomisation is 0.30 in the intervention group and 0.08 in the control group.35 This corresponds to a subdistribution HR of 4.28 and a required number of 15 patients with successful ECMO explantation.", "id": 756, "split": "val"} +{"trial_id": "NCT04385966", "pmid": "33874993", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Diaphragmatic Paralysis After Interscalene Brachial Plexus Block: A Randomized, Double-blinded, Unicenter and Controlled Clinical Trial to Reduce the Dose of Levobupivacaine 0,25% 20 ml to 10 ml Undergoing Arthroscopic Shoulder Surgery\n\nIncluded conditions:\n- Diaphragmatic Paralysis\n- Brachial Plexus Block\n\nStudy Armgroups:\n- {'label': 'Standard Volume Dose', 'type': 'ACTIVE_COMPARATOR', 'description': '24 patients will be included in the Standard Volume Dose arm. 20 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery.', 'interventionNames': ['Procedure: Interscalene brachial plexus block', 'Drug: Levobupivacaine Hydrochloride 2.5 MG/ML']}\n- {'label': 'Low Volume Dose', 'type': 'EXPERIMENTAL', 'description': '24 patients will be included in the Low Volume Dose arm. 10 ml Levobupivacaine Hydrochloride 2.5 MG/ML will be administered in the Interscalene brachial plexus block before the arthroscopic shoulder surgery.', 'interventionNames': ['Procedure: Interscalene brachial plexus block', 'Drug: Levobupivacaine Hydrochloride 2.5 MG/ML']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Interscalene brachial plexus block', 'description': 'Interscalene brachial plexus block is a locorregional anaesthesia technique which is indicated in shoulder and upper arm surgery. The goal of this block is to place the needle in the tissue space between the anterior and middle scalene muscles and inject local anesthetic until the spread around the brachial plexus is documented by ultrasound.', 'armGroupLabels': ['Low Volume Dose', 'Standard Volume Dose'], 'otherNames': ['MeSH Unique ID: D065527', 'CIE-10 code 3E0T3CZ', 'Interscalene block']}\n- {'type': 'DRUG', 'name': 'Levobupivacaine Hydrochloride 2.5 MG/ML', 'description': \"Levobupivacaine Hydrochloride 2.5 MG/ML is an anesthestic product intended for epidural, intradural and perineural administration. Levobupivacaine is chemically described as (S)-l-butyl-2-piperidylformo-2',6'-xylidide hydrochloride. It is a white crystalline powder with a molecular formula of C18H28N2O. HCl, with a molecular weight 324.9.\\n\\nFDA approval: NDA-20997 (1999).\", 'armGroupLabels': ['Low Volume Dose', 'Standard Volume Dose'], 'otherNames': ['Chirocaine\u00ae 2.5 MG/ML']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Diaphragmatic Thickness Ratio at 4 hours', 'description': 'The primary outcome is the difference in the proportion of patients with Hemidiaphragmatic paralysis acute (HDPA) according to diaphragmatic thickness ratio (DTR) in ultrasounds between the Treatment and Control groups. DTR will be the result of Inspiratory Diaphragmatic Thickness and Expiratory Diaphragmatic Thickness. The ratio will be defined by DTR=IDT/EDT. HDPA after IBPB at 4 hours will be diagnosed with a DTR\\\\<1.2.', 'timeFrame': 'Before (Baseline) and 4-hour after interscalene brachial plexus block'}\n\nPlease estimate the sample size based on the assumption: \nThe trial is powered to identify a mean difference of 90-33% with a two-sided significance level of 1% and a power of 90%, assuming a 10% dropout rate.", "answer": 48, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Drawing on previous studies, this trial will assume an IBPB-induced HDP rate of 90% for the control group and of 33% for the treatment group [6, 15, 26]. These findings suggest that decreasing the IBPB LA dose (10\u00e2\u0080\u0089ml, 0.25%, or 25\u00e2\u0080\u0089mg) should result in less IBPB-induced HDP.\n Therefore, powering this trial to identify a mean difference of 90\u00e2\u0080\u009333% with a two-sided significance level of 1% and a power of 90% with the same allocation to the two arms will require 21 patients in each arm. Assuming a 10% dropout rate, 24 patients will be enrolled per arm, i.e., 48 participants will be the total sample size, as calculated using Epidat\u00c2\u00ae software [27, 28].", "id": 757, "split": "val"} +{"trial_id": "NCT04387318", "pmid": "37580800", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Patients With Chronic Obstructive Pulmonary Disease\n\nIncluded conditions:\n- Chronic Obstructive Pulmonary Disease\n\nStudy Armgroups:\n- {'label': 'Multimodal training', 'type': 'EXPERIMENTAL', 'description': 'IMT + NMES + Pulmonary Rehabilitation\\n\\nIMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus \u00ae, SP, BR).\\n\\nNMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, S\u00e3o Paulo/S\u00e3o Paulo, Brazil).\\n\\nPulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.', 'interventionNames': ['Device: Multimodal training']}\n- {'label': 'IMT + Pulmonary Rehabilitation', 'type': 'EXPERIMENTAL', 'description': 'IMT will be performed using a device with linear load pressure (POWERbreathe Medic Plus \u00ae, SP, BR).\\n\\nPulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.', 'interventionNames': ['Device: IMT + Pulmonary Rehabilitation']}\n- {'label': 'NMES + Pulmonary Rehabilitation', 'type': 'EXPERIMENTAL', 'description': 'NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, S\u00e3o Paulo/S\u00e3o Paulo, Brazil).\\n\\nPulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.', 'interventionNames': ['Device: NMES + Pulmonary Rehabilitation']}\n- {'label': 'Pulmonary Rehabilitation', 'type': 'PLACEBO_COMPARATOR', 'description': 'Pulmonary Rehabilitation: The physical training part of pulmonary rehabilitation will consist of aerobic and resistance exercise.', 'interventionNames': ['Device: Pulmonary Rehabilitation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Multimodal training', 'description': 'IMT will be performed using the POWERbreathe\u00ae Medic Plus inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. The IMT wil be performed two times per week for 8 weeks.\\n\\nNMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, S\u00e3o Paulo/S\u00e3o Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 \u00b5s, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks.\\n\\nPulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.', 'armGroupLabels': ['Multimodal training']}\n- {'type': 'DEVICE', 'name': 'IMT + Pulmonary Rehabilitation', 'description': 'IMT will be performed using the POWERbreathe\u00ae Medic Plus (POWERbreathe Medic Plus \u00ae, SP, BR) inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. After that, load increases occurred as follows: 35% of MIP in week 3, 40% of MIP in week 4, 45% of MIP in week 5, 50% of MIP at week 6, 55% of MIP in week 7, and 60% of MIP in weeks 8.\\n\\nPulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.', 'armGroupLabels': ['IMT + Pulmonary Rehabilitation']}\n- {'type': 'DEVICE', 'name': 'NMES + Pulmonary Rehabilitation', 'description': 'NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, S\u00e3o Paulo/S\u00e3o Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 \u00b5s, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks.\\n\\nPulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.', 'armGroupLabels': ['NMES + Pulmonary Rehabilitation']}\n- {'type': 'DEVICE', 'name': 'Pulmonary Rehabilitation', 'description': 'Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.', 'armGroupLabels': ['Pulmonary Rehabilitation']}\n\nPrimary Outcomes:\n- {'measure': 'Static postural balance', 'description': 'Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI\u00ae, MA, USA) using the center of pressure displacement amplitude in the anteroposterior direction (COP) (cm).', 'timeFrame': 'Post-intervention (change after 8 weeks of training)'}\n- {'measure': 'Static postural balance', 'description': 'Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI\u00ae, MA, USA) using the area of ellipse (AE) (cm2).', 'timeFrame': 'Post-intervention (change after 8 weeks of training)'}\n- {'measure': 'Static postural balance', 'description': 'Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI\u00ae, MA, USA) using the velocity of displacement of center of pressure (COPvel) (cm/s).', 'timeFrame': 'Post-intervention (change after 8 weeks of training)'}\n- {'measure': 'Static postural balance', 'description': 'Static postural balance will be assessed on a portable force platform (AccuSway Plus, AMTI\u00ae, MA, USA) using the center of area of pressure and area of ellipse (AE) (cm2).', 'timeFrame': 'Post-intervention (change after 8 weeks of training)'}\n\nPlease estimate the sample size based on the assumption: \np value <0.05, power of 80%, and loss of 20%", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Based on the data from a previous study, performed by Mekki et al. [13] (n=45 participants, conducted in Tunisia), it will be necessary in a minimum sample size of 10 individuals per group and a total of 40 patients, considering the variable of mean lateral displacement of the pressure center mid-lateral displacement amplitude (COPml) in the follow-up of the intervention group, which performed NMES associated with PR program (\u00c2\u00b112.1 mm) and the control group that only performed standard PR (\u00c2\u00b17.2 mm). We also considered p value <0.05, power of 80% and loss of 20%.", "id": 758, "split": "val"} +{"trial_id": "NCT04387383", "pmid": "34526079", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Acupuncture for Irritable Bowel Syndrome Patients: A Single-blinded Randomized Sham-controlled Clinical Trial\n\nIncluded conditions:\n- Irritable Bowel Syndrome\n\nStudy Armgroups:\n- {'label': 'Acupuncture group', 'type': 'EXPERIMENTAL', 'description': 'Electro-acupuncture will be conducted for 2 sessions per week over 6 consecutive weeks. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable.', 'interventionNames': ['Device: Acupuncture']}\n- {'label': 'sham-acupuncture group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Sham-acupuncture will be conducted for 2 sessions per week over 6 consecutive weeks. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli). The sham points are non-acupuncture points nor located on meridians', 'interventionNames': ['Device: Sham-acupuncture']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Acupuncture', 'description': 'Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable.', 'armGroupLabels': ['Acupuncture group']}\n- {'type': 'DEVICE', 'name': 'Sham-acupuncture', 'description': 'Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli). The sham points are non-acupuncture points nor located on meridians', 'armGroupLabels': ['sham-acupuncture group']}\n\nPrimary Outcomes:\n- {'measure': 'Change on IBS-symptom severity scale', 'description': 'Value from 0-500. The higher the score, the more severe the symptoms. When there is lowering of the sore between baseline and treatments, it indicates clinical improvement.', 'timeFrame': '0,8,14 weeks'}\n- {'measure': 'Change on Hamilton Depression Rating Scale (HAMD-17)', 'description': 'Value from 0-57. Scoring 8-16: mild depression, 17-23: moderate depression, over 24: severe depression. When there is lowering of the sore between baseline and treatments, it indicates improvement on depressive symptoms.', 'timeFrame': '0,8,14 weeks'}\n- {'measure': 'Change on Clinical Global Impression-severity (CGI-S)', 'description': 'Rating from 1-7, the higher rate indicates more severe of the mental problem. The subject is rated by researcher from his clinical experience. When there is lowering of the rating between baseline and treatments, it indicates improvement.', 'timeFrame': '0,8,14 weeks'}\n- {'measure': 'Change on Self-Rating Depression Scale (SDS)', 'description': 'Value from 20-80. Scoring 50-69: depression, over 70: severe depression. When there is lowering of the sore between baseline and treatments, it indicates improvement.', 'timeFrame': '0,8,14 weeks'}\n- {'measure': 'Change on IBS Quality of Life (IBS-QoL)', 'description': 'Value from 35-170. The higher the score, the lower the quality of life. When there is lowering of the sore between baseline and treatments, it indicates improvement.', 'timeFrame': '0,8,14 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided \u03c72 test without continuity correction, significance level of 0.025, 15% dropout rate.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to a previous study, placebo is associated with high rates of resolution in a functional bowel disorder. Assuming that a difference of at least 30% between acupuncture and placebo is needed for a clinically important outcome, 51 patients per treatment group were deemed sufficient to achieve 80% power in detecting a treatment difference, based on a two-sided \u00cf\u00872 test without continuity correction at a significance level of 0.025 (used to maintain the overall significance level at 5%). Further assuming a 15% dropout rate, we concluded that we needed to recruit a total of 120 patients (60 per arm) for this trial to ensure statistically significant results. The calculation was performed using the StudySize 3.0 software (V. Frolunda, Sweden).", "id": 759, "split": "val"} +{"trial_id": "NCT04392921", "pmid": "34098992", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation\n\nIncluded conditions:\n- Atrial Fibrillation\n\nStudy Armgroups:\n- {'label': 'Intervention Arm', 'type': 'EXPERIMENTAL', 'description': 'Patients randomized to amiodarone treatment', 'interventionNames': ['Drug: Amiodarone']}\n- {'label': 'Control Arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients randomized to placebo treatment', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Amiodarone', 'description': 'Patients will undergo one of the two regimens of amiodarone, based on their ability to tolerate po (per os) intake in the post-operative period:\\n\\n\u2022 All patient will receive 1050mg of amiodarone in 100mL of 5% dextrose administered intravenously initiated at the time of anesthesia induction at a rate of 0.73mg/min or 43.75mg/h and continued over 24 hours followed by:\\n\\n* If able to tolerate po intake: 400mg po BID for post-operative days 1 to 5 or until the day of discharge (whichever occurs first).\\n* If unable to tolerate po intake: daily infusion of 1050mg in 100mL of 5% dextrose for postoperative days 1 to 5 or until the day of discharge (whichever occurs first).', 'armGroupLabels': ['Intervention Arm']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Patients will undergo one of the two schedules or intravenous infusion, based on their ability to tolerate po intake in the post-operative period:\\n\\n* All patients will receive 100mL of 5% dextrose administered intravenously initiated at the time of anesthesia induction at a rate of 0.73mg/min or 43.75mg/h and continued over 24 hours followed by:\\n\\n o If able to tolerate po intake: 400mg po BID for post-operative days 1 to 5 or until the day of discharge (whichever occurs first).\\n* Esophagectomy patient will receive 100mL of 5% dextrose at the time of anesthesia induction at a rate of what would be 0.73mg/min or 43.75mg/h if it contained 1050mg of amiodarone, followed by daily infusion of 100mL of 5% dextrose for 4 days or until the day of discharge (whichever occurs first).', 'armGroupLabels': ['Control Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Capability for enrolment', 'description': 'Capacity for enrolment will be assessed, in order to determine recruitment potential and an optimal sample size estimated for a full-scale RCT, by measuring the following outcomes: proportion of patients risk stratified and screened, proportion of eligible individuals consenting to involvement in the study, proportion of recruited individuals who are enrolled in the study.', 'timeFrame': 'Upon study completion, 1 year following study initiation'}\n- {'measure': 'Proportion of patients randomized who receive the intervention', 'description': 'Feasibility of the randomization process will be evaluated including the proportion of patients randomized who receive the intervention', 'timeFrame': 'Upon study completion, 1 year following study initiation'}\n- {'measure': 'Knowledge of which patients received intervention and placebo', 'description': 'Feasibility of blinding of participant, care provider, investigator, and outcomes assessor to the intervention allocation of participants will be evaluated by administering a survey to assess their knowledge of which patients received the intervention and placebo', 'timeFrame': 'Upon study completion, 1 year following study initiation'}\n- {'measure': 'Intervention delivery', 'description': 'Intervention delivery will be assessed by determining if protocol adherence rates exceed \\\\>90% and recording observational data on the quality of intervention delivery using a data collection sheet', 'timeFrame': 'Upon study completion, 1 year following study initiation'}\n- {'measure': 'Protocol compliance', 'description': 'Monitoring of protocol compliance will be measured by the frequency, rate, and rationale of events when study activities diverge from the REB-approved protocol', 'timeFrame': 'Upon study completion, 1 year following study initiation'}\n- {'measure': 'Adherence to safety protocol', 'description': 'Monitoring of safety will be assessed by determining the rate and efficiency of reporting adverse events if they occur and monitoring adherence rates to safety and monitoring protocols', 'timeFrame': 'Upon study completion, 1 year following study initiation'}\n- {'measure': 'Proportion of patients for which data could be abstracted', 'description': 'Feasibility of data extraction analysis will be evaluated by the proportion of patients for which the required data could be abstracted: medication use, incidence of post-operative atrial fibrillation, post-operative outcomes, etc.', 'timeFrame': 'Upon study completion, 1 year following study initiation'}\n- {'measure': 'Resources', 'description': 'Resources required to conduct a future multi-centre PREP-AF trial will be assessed by evaluating the administrative capacity of the POAF research team, including the required number of hours of research assistant time, as well as the feasibility of the designated study budget', 'timeFrame': 'Upon study completion, 1 year following study initiation'}\n\nPlease estimate the sample size based on the assumption: \nNo specific assumptions on significance level, power, or missing/dropout rate were made.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n No sample size calculation was conducted for this feasibility study. We aim to recruit 80 patients for randomization during this 12-month trial. Our institution conducts approximately 200 major thoracic surgeries annually and we anticipate 100 of those patients to be eligible for inclusion based on POAF risk and assume a recruitment rate of 80. Patients will follow the schedule activities described in the \u00e2\u0080\u009cParticipant timeline {13}\u00e2\u0080\u009d section including a 30-day follow-up.", "id": 760, "split": "val"} +{"trial_id": "NCT04392947", "pmid": "34146143", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation\n\nIncluded conditions:\n- Major Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'combined iTBS/cTBS', 'type': 'ACTIVE_COMPARATOR', 'description': 'Combined theta burst stimulation (TBS) of the left (intermittent TBS, iTBS) and right (continuous TBS, cTBS) dorsolateral prefrontal cortex (dlPFC; F3 and F4 according to EEG10/20 system). Each stimulation session will comprise 2 trains of 600 stimuli each applied in bursts of three pulses at 50 Hz given every 200 ms. iTBS will be applied 20 times for 2 s every 10 s. In the same session, stimulation with cTBS will be applied continuously for 40 s. Intensity of iTBS/cTBS will be standardized at 80 % of the resting motor threshold (rMT).\\n\\nAdditionally, patients receive an electrical co-stimulation of the forehead. One electrode is fixed to FZ and the 2nd one is either fixed to the left forehead (iTBS) or the right forehead (cTBS), rectangular aligned to the upper edge of the FZ-electrode with a distance of 0.5 cm. Intensity of the co-stimulation is applied with 50% of TBS-intensity.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation']}\n- {'label': 'sham stimulation', 'type': 'SHAM_COMPARATOR', 'description': 'Setup is identical to combined active iTBS/cTBS but TBS is not actively delivered', 'interventionNames': ['Device: Sham Transcranial Magnetic Stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Transcranial Magnetic Stimulation', 'description': 'MagVenture Coil Cool B70 A/P', 'armGroupLabels': ['combined iTBS/cTBS']}\n- {'type': 'DEVICE', 'name': 'Sham Transcranial Magnetic Stimulation', 'description': 'MagVenture Coil Cool B70 A/P without TMS being actively delivered', 'armGroupLabels': ['sham stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'Response rate of Montgomery-Asberg Depression Rating Scale (MADRS)', 'description': 'MADRS reduction of at least 50% of baseline value after end of treatment period between active combined iTBS / cTBS and the sham condition.\\n\\n(rater questionnaire; MADRS raw score ranges between 0 and 60; the higher the score, the more severe depression)', 'timeFrame': '6 weeks'}\n\nPlease estimate the sample size based on the assumption: \nChi-square test, alpha = 0.05 two-sided, beta = 0.2, and a 10% dropout rate.", "answer": 236, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In an own pilot study (n\u00e2\u0080\u0089=\u00e2\u0080\u008932) we found 9/16 (56%) responders (MADRS\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u008950% of baseline) in the verum group and 4/16 (25%) responders in the sham group [28]. In a second pilot study (n\u00e2\u0080\u0089=\u00e2\u0080\u008960) of another group [29] response rates (HDRS-17\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u008950% of baseline) were 66.7% vs. 13.3% after 2\u00c2\u00a0weeks treatment and 4/15 (27%) vs. 1/15 (7%) after week 14. In the third pilot study (n\u00e2\u0080\u0089=\u00e2\u0080\u008956) [30] response rates (HDRS-17\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u008950% of baseline) were 55% (bilateral TBS) and 30% (sham TBS), 7\u00c2\u00a0weeks after initiation of a 3\u00c2\u00a0weeks treatment. In a recent large (total n\u00e2\u0080\u0089=\u00e2\u0080\u0089385) clinical trial [18] comparing iTBS (n\u00e2\u0080\u0089=\u00e2\u0080\u0089193) with 10\u00c2\u00a0Hz rTMS (n\u00e2\u0080\u0089=\u00e2\u0080\u0089192) the outcome criterion of HDRS-17\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u008950% of baseline was achieved by 49% of patients treated with iTBS. Based on these studies, we conservatively assume a response rate of 49% vs. 30% (combined bilateral TBS vs. sham TBS) using the criterion MADRS reduction of at least 50% compared to baseline. This leads to a sample size of 103 subjects per group (Chi-square test, alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 two-sided, beta\u00e2\u0080\u0089=\u00e2\u0080\u00890.2), totally 206 evaluable subjects. As we will recruit in seven centers we increase the sample size by n\u00e2\u0080\u0089=\u00e2\u0080\u00896 to compensate for degrees of freedom in a stratified analysis which leads to 212 patients. The analysis will be done on the full set of patients except for those refusing consent during the study or not receiving at least one treatment. We expect a low dropout rate and therefore, we increase the sample size by 24 subjects to adjust for 10% dropouts, which leads to a total n of 236 patients.", "id": 761, "split": "val"} +{"trial_id": "NCT04393337", "pmid": "35046004", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Gestational Age Versus Nasal-tragus Length for Estimating Endotracheal Tube Insertion Depth in Newborns - A Randomised Trial\n\nIncluded conditions:\n- Endotracheal Tube Tip Position\n- Bronchopulmonary Dysplasia\n- Pneumothorax\n- Death\n- Duration, Ventilator\n\nStudy Armgroups:\n- {'label': 'Gestational Age Chart Method', 'type': 'EXPERIMENTAL', 'description': 'In this method, the endotracheal tube insertion depth is obtained from the gestational age chart provided in the 7th edition textbook of neonatal resuscitation program (adapted from Kempley et al. PubMed identifier number: 18372092)', 'interventionNames': ['Other: Gestational Age Chart Method']}\n- {'label': 'Nasal-Tragus Length Method', 'type': 'ACTIVE_COMPARATOR', 'description': 'In this method, the endotracheal tube insertion depth is calculated based on the formula-the distance from nasal septum tip to ear tragus+1 cm', 'interventionNames': ['Other: Nasal-Tragus Length Method']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Gestational Age Chart Method', 'description': 'The endotracheal tube insertion depth is obtained by the gestational age chart', 'armGroupLabels': ['Gestational Age Chart Method']}\n- {'type': 'OTHER', 'name': 'Nasal-Tragus Length Method', 'description': 'The endotracheal tube insertion depth is obtained by the nasal-tragus method formula', 'armGroupLabels': ['Nasal-Tragus Length Method']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of infants with optimally positioned endotracheal tube tip on the chest X-ray', 'description': \"Endotracheal tube tip is considered optimally positioned if the tip lies between upper border of first thoracic vertebra (T1) and the lower border of second thoracic vertebra (T2) on the chest X-ray. While obtaining the antero-posterior view chest X-ray in supine position, the infant's head, neck and chest is placed in the midline with no tension on the endotracheal tube and neck being in neutral position (i.e. neck neither flexed nor extended). Just before obtaining the film, the investigator/research assistant should re-confirm that the endotracheal tube is secured in a standardize manner at the estimated depth based on the treatment arm assigned.\", 'timeFrame': 'within 4 hours of endotracheal intubation'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 454, "answer_type": "ESTIMATED", "explanation": "Sites and sample size\n The trial is aimed to recruit 454 infants over 3\u00e2\u0080\u0089years across tertiary level NICUs.", "id": 762, "split": "val"} +{"trial_id": "NCT04393337", "pmid": "35046004", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Gestational Age Versus Nasal-tragus Length for Estimating Endotracheal Tube Insertion Depth in Newborns - A Randomised Trial\n\nIncluded conditions:\n- Endotracheal Tube Tip Position\n- Bronchopulmonary Dysplasia\n- Pneumothorax\n- Death\n- Duration, Ventilator\n\nStudy Armgroups:\n- {'label': 'Gestational Age Chart Method', 'type': 'EXPERIMENTAL', 'description': 'In this method, the endotracheal tube insertion depth is obtained from the gestational age chart provided in the 7th edition textbook of neonatal resuscitation program (adapted from Kempley et al. PubMed identifier number: 18372092)', 'interventionNames': ['Other: Gestational Age Chart Method']}\n- {'label': 'Nasal-Tragus Length Method', 'type': 'ACTIVE_COMPARATOR', 'description': 'In this method, the endotracheal tube insertion depth is calculated based on the formula-the distance from nasal septum tip to ear tragus+1 cm', 'interventionNames': ['Other: Nasal-Tragus Length Method']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Gestational Age Chart Method', 'description': 'The endotracheal tube insertion depth is obtained by the gestational age chart', 'armGroupLabels': ['Gestational Age Chart Method']}\n- {'type': 'OTHER', 'name': 'Nasal-Tragus Length Method', 'description': 'The endotracheal tube insertion depth is obtained by the nasal-tragus method formula', 'armGroupLabels': ['Nasal-Tragus Length Method']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of infants with optimally positioned endotracheal tube tip on the chest X-ray', 'description': \"Endotracheal tube tip is considered optimally positioned if the tip lies between upper border of first thoracic vertebra (T1) and the lower border of second thoracic vertebra (T2) on the chest X-ray. While obtaining the antero-posterior view chest X-ray in supine position, the infant's head, neck and chest is placed in the midline with no tension on the endotracheal tube and neck being in neutral position (i.e. neck neither flexed nor extended). Just before obtaining the film, the investigator/research assistant should re-confirm that the endotracheal tube is secured in a standardize manner at the estimated depth based on the treatment arm assigned.\", 'timeFrame': 'within 4 hours of endotracheal intubation'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 454, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our unpublished data showed using the NTL method for estimating ETT insertion depth in term and preterm infants result in 35% of correctly positioned ETT tips. The data is similar to the randomised20 and non-randomised21 studies that showed similar accuracy (32%\u00e2\u0080\u009337%) with the NTL method for estimating ETT insertion depth. With 90% power and two-sided 5% significance, to detect an absolute increase of 15% in optimally positioned ETT tips using the gestational age method, we will require 454 participants. We calculated sample size using nQuery Advisor Sample Size Calculator V.8.3.0.0.22", "id": 763, "split": "val"} +{"trial_id": "NCT04394169", "pmid": "34303381", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Early Care, Therapeutic Education, and Psychological Intervention for the Management of Post-intensive Care Syndrome and Chronic Pain After Coronavirus Disease 2019 Infection. Simple-blind, Controlled, Randomized Trial.\n\nIncluded conditions:\n- Post ICU Syndrome\n- Chronic Pain\n- Covid-19\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'The intervention is a program that includes early patient care, therapeutic education, and psychological intervention. It will be performed through three medical visits and a psychological intervention that requires seven face-to-face sessions.', 'interventionNames': ['Behavioral: Intervention program']}\n- {'label': 'Standard care arm', 'type': 'NO_INTERVENTION', 'description': 'Standard medical practice: patient follow-up is carried out by their referring physicians (primary care physicians or specialists) who are outside the study.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Intervention program', 'description': \"Medical visits:\\n\\nThere will be three medical visits stipulated as follows:\\n\\n* Visit 1 Intervention Group, four weeks after hospital discharge.\\n* Visit 2 Intervention Group, eight weeks after hospital discharge.\\n* Visit 3 Intervention Group, 18 weeks after hospital discharge.\\n\\nComponents of visits:\\n\\n* Interview and physical examination.\\n* Therapeutic education about the intensive care syndrome orally and with a specific document that will be delivered at the end of the visit.\\n* Therapeutic education around pain. If the patient reports pain, a specific document will be prepared that will be delivered at the end of the visit.\\n\\nPsychological intervention:\\n\\nInclusion criteria for psychological intervention: Patients with a score higher than 8 on the HAD (hospital anxiety and depression) test depression subscale.\\n\\nDescription :\\n\\nThe intervention protocol consists of 7 weekly sessions lasting one hour and a half. The intervention in depression is based on Rehm's model of self-control.\", 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'Impact of intervention program on health-related quality of life (VAS)', 'description': 'Health-related quality of life reported by the patient assessed through the visual analogue scale of the EQoL 5D/5L questionnaire at six months after discharge.\\n\\n\\\\[European quality of life 5 dimensions/5 levels ; from 0 (the worst imaginable health) to 100 (the best imaginable health) \\\\]', 'timeFrame': 'Six months after discharge'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 0.05, power of 80%, and a loss to follow-up rate of 20%.", "answer": 102, "answer_type": "ACTUAL", "explanation": "Sample size\n To calculate the sample size of the PAIN COVID clinical trial with an assumed average of 50 points on the visual analog scale of the EuroQOL-5D-5L for the control group, and a clinically relevant difference between the groups of 20%, for distribution of a tail with a type I error of 0.05 and a power of 80%, the sample size has been calculated as 84 patients, 42 for each arm. Assuming a loss to follow-up of 20%, the sample size needed is 102 patients (51 in each group).", "id": 764, "split": "val"} +{"trial_id": "NCT04394585", "pmid": "36490244", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Study Evaluating Effect of Smart Phone App-based Human Coaching Program on QOL in Patients Who Underwent Gastrectomy for Stage I Gastric Cancer\n\nIncluded conditions:\n- Stage I Gastric Cancer\n\nStudy Armgroups:\n- {'label': 'Smart phone app group', 'type': 'EXPERIMENTAL', 'description': 'Patients used smart phone app based human coaching program for 3 months postoperatively.', 'interventionNames': ['Behavioral: smart phone app based human coaching program']}\n- {'label': 'Nutritional consultation group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients have two consulting with clinical nutritionist at 1 month and 3 months postoperatively.', 'interventionNames': ['Behavioral: smart phone app based human coaching program']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'smart phone app based human coaching program', 'description': '1. experimental arm\\n\\n * 1:1 coaching using smart phone app\\n * Patients are provided several articles about postoperative care (symptom management, diet, and exercise) in the app.\\n * Patients are encouraged to report their diet diaries and exercise everyday by the coach.\\n * Patients can ask to the coach using the app and the coach answer when they check them.\\n2. Comparator arm - Patient have consulting with clinical nutritionist at 1 month and 3 months postoperatively.', 'armGroupLabels': ['Nutritional consultation group', 'Smart phone app group']}\n\nPrimary Outcomes:\n- {'measure': 'Eating restriction score (XEatR) at 3 months postoperatively', 'description': 'Eating resection scale is calcuated according to the following equation.\\n\\n1. Add questionnaire items 41,42, 43 and 46 and divide this sum by the number of items (4):\\n\\n EatR = (Q41+Q42+Q43+Q46)/4\\n2. Carry out a linear transformation to convert to a 1-100 scale:\\n\\nXEatR = (EatR-1)\\\\*100/3\\n\\nThe 4 items are belong to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) STO22.\\n\\nEach item has a value among 1, 2, 3, and 4 according to the answer and the scale score has a value ranging 0 (minimum) to 100 (maximum).\\n\\nHigher scores mean having more symptom and worse quality of life.', 'timeFrame': '3 months postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nType I error of 0.05, 80% statistical power, 1:1 enrolment ratio, and a 30% dropout rate.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated based on the results of our pilot study and previous QoL studies which evaluated EORTC QLQ-STO22. In this study, the primary outcome is the eating restriction scale score of the EORTC QLQ-STO22, which was 30 points at postoperative 1 month in the pilot study. We also assume an intergroup difference of 5 points and standard deviation of 10 based on the results of previous QoL studies, yielding an effect size of 0.5 [14\u00e2\u0080\u009317]. Given a type I error of 0.05, 80% statistical power, and 1:1 enrolment ratio, 126 participants were calculated using a 2-tailed t-test. Allowing for an 30% of dropout rate based on the results of the pilot study, we planned to recruit 180 participants (90 in each group) for this study.", "id": 765, "split": "val"} +{"trial_id": "NCT04398888", "pmid": "33579349", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of a Modified Banxia Xiexin Decoction (BXD) for the \"Wei-Pi\" Syndrome (Postprandial Distress Syndrome): a Randomized, Waitlist Controlled Trial\n\nIncluded conditions:\n- Postprandial Distress Syndrome\n\nStudy Armgroups:\n- {'label': 'BXD treatment', 'type': 'EXPERIMENTAL', 'description': 'Participants will be diagnosed and treated by Chinese medicine practitioners (CMPs) with at least 5 years of clinical experience. CMPs will differentiate syndrome and prescript herbs in a semi-standardized protocol, which consists of a base Chinese medicine decoction, Banxia Xiexin Decoction (BXD), and the additional syndrome-specific herbs.\\n\\nThe modified decoction will be prepared in a conventional decocting method at the Chinese medicine pharmacy in the clinic (HKBA-HKU CMCTR) and will be packaged into bags by the auto-decocting machines. Participants will take the decoction twice per day, 5 days per week, for 3 weeks.', 'interventionNames': ['Other: Banxie Xiexin Decoction (BXD)']}\n- {'label': 'Waitlist', 'type': 'NO_INTERVENTION', 'description': 'Participants in the waiting list control group will be observed for a three-week waiting period. Rescue medication is not restricted.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Banxie Xiexin Decoction (BXD)', 'description': 'A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation.', 'armGroupLabels': ['BXD treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Change of the Quality of Life Questionnaire for Functional Digestive Disorders', 'description': 'Quality of Life Questionnaire for Functional Digestive Disorders (FDDQL)', 'timeFrame': 'Change from baseline score at 3 weeks.'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 0.05, the power is 80%, and a 15% dropout rate is considered.", "answer": 88, "answer_type": "ACTUAL", "explanation": "Sample size\n In our pilot observations, the global score of FDDQL pertaining to the patients who received BXD showed improvements with an effect size of 0.3\u00e2\u0080\u00930.88. In the current study, the sample size was estimated with an average effect size of 0.6. The sample size required to achieve a statistical difference was estimated to be 22 patients per group (at \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, power\u00e2\u0080\u0089=\u00e2\u0080\u008980%, with a 95% confidence interval). Taking the dropout rate of 15% into consideration, a sample size of 84 patients (42 patients per group) is preferred. An interim analysis will be conducted to determine the adequacy of the sample size.", "id": 766, "split": "val"} +{"trial_id": "NCT04399018", "pmid": "36207039", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Development and Prospective Validation of a Standardized Flow Cytometric Assay of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes.\n\nIncluded conditions:\n- Myelodysplastic Syndromes\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Diagnostic Test: Flow cytometry analysis of neutrophil myeloperoxidase expression', 'description': 'Flow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood samples will be performed within 24 h of MDS diagnostic evaluation and blinded to the reference standard. Peripheral blood samples will be collected in 5 ml (EDTA) anticoagulant plastic tubes and processed within 24 h maximum of collection.\\n\\nBlood sample will be stained according to the manufacturers\\' recommendations with a lyophilized cocktail (\"LyotubeTM ready-to-use\", BD Bioscience).\\n\\nAt least 10,000 neutrophils will be acquired on a 3-laser, 8-color BD FACSCanto-II TM flow cytometer (BD Biosciences, San Jos\u00e9, CA).\\n\\nEach marker will be expressed as median, geometric and arithmetic mean, regular and robust coefficient of variation.'}\n\nPrimary Outcomes:\n- {'measure': 'Reference diagnosis of MDS or CMML established by bone marrow examination', 'description': 'The primary outcome is the reference diagnosis of MDS or CMML established by bone marrow examination (with Perls staining) by two independent experienced hematopathologists blinded to the index test results. Disagreements will be solved by a third hematopathologist. Bone marrow aspirate will be repeated within 4 to 6 months for patients with idiopathic cytopenia of uncertain significance (ICUS) or non-conclusive bone marrow examination.', 'timeFrame': 'Baseline'}\n\nPlease estimate the sample size based on the assumption: \n22% prevalence of MDS, 20% rate of uninterpretable or inconclusive bone marrow aspirates", "answer": 103, "answer_type": "ACTUAL", "explanation": "Sample size\n Assuming an area under the ROC curve point estimate of 0.90, we estimated that an effective sample size of 82 participants with a 22% prevalence of MDS would provide a precision of \u00c2\u00b10.10 (95% CI ranging from 0.80 to 1.00). Anticipating a 20% rate of uninterpretable or inconclusive bone marrow aspirates, 21 additional patients will be recruited, leading to an overall sample size of 103 patients. The sample size was estimated with PASS V.15 (NCSS, LLC. Kaysville, Utah, USA).", "id": 767, "split": "val"} +{"trial_id": "NCT04399317", "pmid": "32917259", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Flow Controlled Ventilation in ARDS Associated With COVID-19\n\nIncluded conditions:\n- ARDS Associated With COVID-19\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'EXPERIMENTAL', 'description': 'This is the treatment group. Patients will be ventilated using the new device (Evone) applying flow controlled ventilation for 48 hours. Ventilation parameters will be assessed every 6-8 hours. All other treatment will be unchanged and according to institutional standards.', 'interventionNames': ['Device: Flow controlled ventilation (Evone-ventilator)']}\n- {'label': 'Group B', 'type': 'NO_INTERVENTION', 'description': 'These patients will be treated according to institutional standards. Only data will be collected. This is the control group.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Flow controlled ventilation (Evone-ventilator)', 'description': 'The new ventilation technique will be applied', 'armGroupLabels': ['Group A']}\n\nPrimary Outcomes:\n- {'measure': 'arterial oxygen partial pressure (PaO2)', 'timeFrame': 'during 48 hours of treatment'}\n\nPlease estimate the sample size based on the assumption: \nintended power of 80%, an alpha error of 5%, and an equal sample ratio", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomised (sample size)\n The sample size calculation based on the assumption of an effect size (change in PaO2) of 1.5 SDS in the primary endpoint (PaO2), an intended power of 80%, an alpha error of 5% and an equal sample ratio results in n=7 patients needed to treat. However, to compensate for dropouts we will include 10 patients in each group, which means in total 20 patients.", "id": 768, "split": "val"} +{"trial_id": "NCT04399369", "pmid": "34348775", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventing Early Childhood Caries with Silver Diamine Fluoride - a 12-month Randomised Clinical Trial\n\nIncluded conditions:\n- Dental Caries\n\nStudy Armgroups:\n- {'label': 'SDF', 'type': 'EXPERIMENTAL', 'description': '38% silver diamine fluoride solution', 'interventionNames': ['Device: SDF']}\n- {'label': 'NaF', 'type': 'ACTIVE_COMPARATOR', 'description': '5% sodium fluoride varnish', 'interventionNames': ['Device: NaF']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'SDF', 'description': '38% silver diamine fluoride solution', 'armGroupLabels': ['SDF']}\n- {'type': 'DEVICE', 'name': 'NaF', 'description': '5% sodium fluoride varnish', 'armGroupLabels': ['NaF']}\n\nPrimary Outcomes:\n- {'measure': 'caries prevention', 'description': 'the number of sound tooth surfaces that become cavitated caries per child', 'timeFrame': 'at 12-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical power was set at 0.9 and the type I error was set at 5%. The dropout rate was estimated at 15%.", "answer": 688, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The data utilised for the sample size calculation is from a previous study conducted in Hong Kong [12]. The mean number of decayed teeth of 3-year-old children was 5. The mean numbers of newly developed carious surfaces in SDF and NaF groups were 0.47 (SD 0.87) and 0.70 (SD 0.84), respectively. The difference in the preventive effects between the two groups was 33%. When the statistical power was set at 0.9 and the type I error was set at 5%, 292 children were required in each group. With the dropout rate estimated at 15%, 688 children should be enrolled at baseline, with 344 children in each group.", "id": 769, "split": "val"} +{"trial_id": "NCT04402047", "pmid": "35413861", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Electroacupuncture vs Topical Diclofenac Sodium Gel for Patients With Hand Osteoarthritis: Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Hand Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'Electroacupuncture group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Electroacupuncture']}\n- {'label': 'Topical DSG group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Topical diclofenac sodium gel']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Electroacupuncture', 'description': 'We will apply Ashi points, Ex-UE9, SI3, and TE5. Sterile needles (0.3mm\u00d7 40mm) and SDZ-V EA apparatus will be utilized. Acupuncturists will insert needles perpendicularly into Ashi points for approximately 2-3mm until they pierce into the bone surface; acupuncturists will insert needles horizontally into Baxie points towards the wrist with a depth of 5-10mm; and acupuncturists will insert needles perpendicularly into SI3 and TE5 for approximately 5-10mm. All needles except Ashi points will be manually manipulated to achieve De qi. The needles at Baxie 1 and Baxie 4 will be connected using alligator clips from the EA apparatus. The electrical stimulation will last for 30 minutes with a continuous wave of 10 Hz and a fixed current intensity of 0.5 to 2 mA. All the needles will be retained for 30 minutes. Participants will undergo EA treatment three times per week for a total of 12 sessions in four consecutive weeks. If bilateral hands were affected, both sides will be treated.', 'armGroupLabels': ['Electroacupuncture group']}\n- {'type': 'DRUG', 'name': 'Topical diclofenac sodium gel', 'description': 'The gel will be gently rubbed over the affected joints without excessive joint movement four times per day for 4 weeks and will be asked not to wash hands for one hour after application. Each hand treatment will be used in identical dispensing doses of gel (4 cm strip, approximately 2g, which was judged sufficient for approximately half the surface of each hand (200 cm2)). Dosing times should be distributed evenly over waking hours.If bilateral hands were affected, both sides will be treated.', 'armGroupLabels': ['Topical DSG group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in average overall finger joints pain intensity in the dominant hand over the past 48h from baseline to week 4', 'description': 'Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.', 'timeFrame': 'at baseline and week 4'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed test, 5% significance level, 80% power, and a 10% dropout rate.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This trial hypothesizes that 4\u00c2\u00a0weeks of EA treatment will be superior to topical DSG in terms of pain relief in the dominant hand for patients with hand OA. Based on the results of a previous study [15], the OA pain intensity in the dominant hand on the 0\u00e2\u0080\u0093100 VAS scale was reduced by an average of 31.1 points in the topical DSG group and 23.9 points in the vehicle group. We predict that EA will display superiority over topical DSG by at least a 7-point better relative reduction in VAS score with a standard deviation of 12. Assuming a two-tailed test with a possible drop-out of 10% of the patients, a total of 108 patients (54 in the EA group and 54 in the topical DSG group) will be required for 80% power on a 5% alpha level.", "id": 770, "split": "val"} +{"trial_id": "NCT04402463", "pmid": "34682453", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Global Postural Exercises Versus Specific Therapeutic Neck Exercises on Pain, Disability, Postural Control, and Neuromuscular Efficiency in Women With Chronic Nonspecific Neck Pain\n\nIncluded conditions:\n- Neck Pain\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'GPR Group', 'type': 'EXPERIMENTAL', 'description': 'Global Postural Reeducation with 2 parts in each session:\\n\\n1. st: 2 postures in lying position - without gravity load (15 minutes each posture): The aim of these postures is to achieve and maintain postural balance and to stretch the posterior muscle chain. In order to achieve this, specific exercises in the lying position are used. That exercises involve a precise use of contractions, stretch reflexes, light and controlled manual tractions and sustained elongations.\\n\\n The maintenance of alignment during posture will be achieved by verbal commands and manual contact of the therapist, guaranteeing the active engagement of patient to reach the correct posture.\\n2. st: Standing posture - integration under gravity load (10 minutes): With the participant standing the physiotherapist makes final corrections for postural integration.', 'interventionNames': ['Other: Global Postural Reeducation']}\n- {'label': 'Exercise Group', 'type': 'EXPERIMENTAL', 'description': 'Therapeutic exercises. That they will be divided into 3 phases:\\n\\nThe exercises in these phases will consist in active exercises of the cervical spine and shoulder girdle, motor control exercises, and finally strength and endurance of the cervical flexors and extensors and of the musculature of the shoulder girdle.', 'interventionNames': ['Other: Exercise Therapeutic']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Global Postural Reeducation', 'description': 'The participants will receive treatment along 4 weeks, 2 sessions per week, and 40-45 minutes each session.\\n\\nIn the treatment 3 of the therapeutic postures of GPR method to will carry out following Souchard\\'s principles of \"Global Postural Reeducation\"', 'armGroupLabels': ['GPR Group']}\n- {'type': 'OTHER', 'name': 'Exercise Therapeutic', 'description': 'The participants will receive treatment along 4 weeks, 2 sessions per week, and 40-45 minutes each session.\\n\\nThe treatment will be divided into 3 phases, where it initially starts with phase 1 (3 treatments) and progresses to phase 2 (3 treatments) until reaching stage 3 (2 treatments).', 'armGroupLabels': ['Exercise Group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in neck pain intensity before, during and after the intervention', 'description': 'Numerical Pain Rating Scale (NPRS) will be used. It is a scale used to quantify the patient\\'s pain level on an 11-point numerical scale 0-10 with 0 being \"no pain\" and 10 being the \"worst possible pain.\"', 'timeFrame': '5 weeks. 4 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) 1st post-intervention after four sessions (1+2 weeks later); 4) Final, 2nd post-intervention (1+4 weeks later)'}\n- {'measure': 'Changes in disability before, during and after the intervention', 'description': 'The Neck Disability Index (NDI) will be used. It is a modification of the Oswestry Low Back Pain Disability Index. It is a scale used to measure disability associated with cervical pain due to acute or chronic conditions. He has 10 items: 7 related to activities of daily living, 2 related to pain and 1 related to concentration. The test can be interpreted with a maximum score of 50.\\n\\n0 - 4 = no disability 5 - 14 = mild 15 - 24 = moderate 25 - 34 = severe above 34 = complete', 'timeFrame': '5 weeks. 3 time points: 1) Baseline (pre-intervention); 2) Second pre-intervention (1 week later); 3) Final, 2nd post-intervention (1+4 weeks later)'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes an alpha risk of 0.05, a beta risk of 0.2 (power of 80%), and a 15% loss rate during the study.", "answer": 52, "answer_type": "ACTUAL", "explanation": "2.2. Participants, Recruitment and Sample Size Calculation\n A sample of 62 women with CNSNP were recruited between 30 and 65 years old from the community in Guarda, Portugal. Participants were recruited through an online google form, with a questionnaire in Google Docs format, which was disseminated through social network postings (Facebook and Instagram) and the sending of institutional emails from Polytechnic Institute of Guarda to its workers. There were two physiotherapist assessors, who initially assessed participants that responded to the advertisements, and they were different from the physiotherapists who performed the interventions in both groups. In the first visit, the participants provided oral and written forms of all necessary information about the trial, including the study purpose and procedure. After voluntarily signing the informed consent statement, if through a detailed interview they met all inclusion, exclusion, and withdrawal criteria (Table 1), they enrolled into the trial to begin with an initial evaluation with the assessors.\n The sample size calculation has been made based on the potential modification of the primary outcomes, neck pain intensity, and neck disability (NPRS and the NDI-PT) from baseline to final assessments. For repeated measurements of the estimated sample size, accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 26 subjects were necessary in the first group and 26 in the second to recognize a statistically significant difference greater than or equal to 2 units (SD = 1.75) (NPRS) or 7 units (SD = 6) (NDI), and to detect small differences in standardized means between groups (Cohen\u00e2\u0080\u0099s d = 0.8), since the intervention with therapeutic exercise is known to have a beneficial effect and we want to assess whether the intervention with GPR has similar or even greater effects. Finally, considering a 15% loss rate during the study, and in order to end up with a sample of 52 subjects, based on the power analysis results, the final sample to be recruited was 62 subjects, 31 in each group. The sample size calculation was made with the software \u00e2\u0080\u009cPASS 15 (NCSS statistical software)\u00e2\u0080\u009d and \u00e2\u0080\u009cThe R Project for Statistical Computing\u00e2\u0080\u009d.", "id": 771, "split": "val"} +{"trial_id": "NCT04406129", "pmid": "35209934", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Fecal Microbiota Transplantation on Primary Hypertension and the Underlying Mechanism of Gut Microbiome Restoration: a Randomized Clinical Trial\n\nIncluded conditions:\n- Hypertension\n\nStudy Armgroups:\n- {'label': 'FMT capsules', 'type': 'EXPERIMENTAL', 'description': 'Intervention: FMT capsules containing extensively screened donor stool. FMT capsules will be orally taken on Day 1, Day 7 (Week 1) and Day 14 (Week 2).', 'interventionNames': ['Biological: FMT capsules']}\n- {'label': 'Placebo capsules', 'type': 'PLACEBO_COMPARATOR', 'description': 'Intervention: Placebo capsules that do not contain donor stool or any active drug. Placebo capsules will be orally taken on Day 1, Day 7 (Week 1) and Day 14 (Week 2).', 'interventionNames': ['Other: Placebo capsules']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'FMT capsules', 'description': 'Intervention: FMT capsules containing extensively screened donor stool.', 'armGroupLabels': ['FMT capsules']}\n- {'type': 'OTHER', 'name': 'Placebo capsules', 'description': 'Intervention: Placebo capsules that do not contain donor stool or any active drug.', 'armGroupLabels': ['Placebo capsules']}\n\nPrimary Outcomes:\n- {'measure': 'Change for Office Systolic Blood Pressure (SBP)', 'description': 'Change for Office Systolic Blood Pressure (SBP)', 'timeFrame': 'From baseline to Day 30'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of > 80% to demonstrate a > 5 mmHg difference between arms at a 1-sided alpha level of 0.025, with a 20% rate of loss-of-follow-up considered.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size calculation was performed via PASS version 15 software before trial initiation based on the following: (1) no relevant current data for the effect of FMT on hypertension; (2) a clinically significant improvement of a decrease in office SBP at least 5\u00e2\u0080\u0089mmHg associated with reduction in stroke (14%), cardiovascular disease (9%), and mortality (7%) [32]; (3) meta-analysis of the effectiveness of probiotics on hypertension based on randomized controlled clinical trials that revealed a reduction of SBP of 3.56\u00e2\u0080\u0089mmHg (95% CI, 6.46 to 0.66) [33]. Assuming a true SBP difference between the \u00e2\u0080\u009cFMT capsule group\u00e2\u0080\u009d and \u00e2\u0080\u009cplacebo group\u00e2\u0080\u009d with a mean of 5\u00e2\u0080\u0089mmHg and a standard deviation of 8.6\u00e2\u0080\u0089mmHg for SBP change per arm, a sample size of 96 grade one hypertensive patients yields >\u00e2\u0080\u008980% statistical power to demonstrate a > 5\u00e2\u0080\u0089mmHg difference between arms at a 1-sided alpha level of 0.025. Given the potential for premature withdrawal or failure before the primary end point data were collected, a 20% rate of loss-of-follow-up was considered, resulting in 120 participants with grade one hypertension according to the \u00e2\u0080\u009c2010 Chinese Guidelines for Prevention and Treatment of Hypertension\u00e2\u0080\u009d [28]. Participants were recruited and randomized 1:1 to receive FMT by capsule or placebo capsules.", "id": 772, "split": "val"} +{"trial_id": "NCT04407650", "pmid": "35854327", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomised Controlled Trial of Gestational Treatment With Ursodeoxycholic Acid Compared to Metformin to Reduce Effects of Diabetes Mellitus\n\nIncluded conditions:\n- Gestational Diabetes\n\nStudy Armgroups:\n- {'label': 'Metformin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral 1000 mg BD', 'interventionNames': ['Drug: Metformin']}\n- {'label': 'Ursodeoxycholic acid', 'type': 'EXPERIMENTAL', 'description': 'Oral 500 mg BD', 'interventionNames': ['Drug: Ursodeoxycholic Acid']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Metformin', 'description': 'Patients will be randomized to each intervention using minimisation:\\n\\n* BMI category (Overweight/Obese),\\n* Previous history of GDM,\\n* Disease severity (baseline fasting glucose \u22646.2 or \\\\>6.2),\\n* Recruitment centre', 'armGroupLabels': ['Metformin']}\n- {'type': 'DRUG', 'name': 'Ursodeoxycholic Acid', 'description': 'Patients will be randomized to each intervention using minimisation:\\n\\n* BMI category (Overweight/Obese),\\n* Previous history of GDM,\\n* Disease severity (baseline fasting glucose \u22646.2 or \\\\>6.2),\\n* Recruitment centre', 'armGroupLabels': ['Ursodeoxycholic acid']}\n\nPrimary Outcomes:\n- {'measure': 'Glycaemic control', 'description': 'Maternal fasting glucose concentration in blood sample', 'timeFrame': 'Gestational week 36'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated, 90% power, 18% withdrawal rate, SD 0.6 mmol/L, correlation between repeated measures 0.46", "answer": 158, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A study size of 158 participants will provide sufficient statistical power to detect a 6% reduction of 0.304\u00c2\u00a0mmol/L in maternal fasting glucose at 36\u00c2\u00a0weeks, while allowing for a 18% withdrawal rate (complete data on 130 women).\n Based on data from the UPBEAT study [54], we anticipate a mean of 5.06\u00c2\u00a0mmol/L, reduced to 4.756 in the intervention group (6% reduction), SD 0.6\u00c2\u00a0mmol/L, correlation between repeated measures 0.46. Complete data on 130 subjects (65 per arm) will give approximately 90% power to detect a difference in maternal fasting glucose at 36\u00c2\u00a0weeks of 6% (from 5.06 to 4.75\u00c2\u00a0mmol/L).\n The 6% reduction is based on a previous study that reported differences with UDCA treatment for nonalcoholic fatty liver disease (NAFLD) in a population of similar body mass index and age to our study group [55]. This difference in glucose concentration is considered clinically relevant as it is equivalent to the difference in glucose categories between which differences in LGA, primary caesarean section, cord blood serum C-peptide level\u00e2\u0080\u0089>\u00e2\u0080\u008990th centile, and clinical neonatal hypoglycemia were evident in the HAPO study [1].", "id": 773, "split": "val"} +{"trial_id": "NCT04409912", "pmid": "34930401", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SIroliMus Coated angioPlasty Versus Plain Balloon Angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION)\n\nIncluded conditions:\n- End Stage Renal Failure on Dialysis\n- Arteriovenous Graft Occlusion\n\nStudy Armgroups:\n- {'label': 'Sirolimus coated balloon', 'type': 'EXPERIMENTAL', 'description': 'The trial product is MagicTouch sirolimus drug coated balloon (Concept Medical). Sirolimus will be transferred from the balloon to the vessel wall by inflating the sirolimus coated balloons at 2 minutes at rated burst pressure (typically 12 to 14ATM). All the lesions within the dialysis circuit with sirolimus coated balloon.', 'interventionNames': ['Device: Sirolimus coated balloon']}\n- {'label': 'Plain balloon', 'type': 'PLACEBO_COMPARATOR', 'description': 'The plain balloon or placebo will not be coated. The plain balloon will be inflated at 2 minutes at rated burst pressure (typically 12 to 14 ATM). Plain balloon will be applied to all the narrowed segment of the dialysis circuit', 'interventionNames': ['Device: Plain balloon']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Sirolimus coated balloon', 'description': 'Sirolimus has a high transfer rate to the vessel wall and effectively inhibit neointimal hyperplasia in the porcine coronary model. In coronary artery interventions, preliminary clinical studies using sirolimus coated balloon have shown excellent procedural and 6 month patency. The effectiveness of sirolimus coated balloon in patients with dialysis access dysfunction has been shown in a small pilot study in the salvage of thrombosed arteriovenous graft.\\n\\nWhen compared to Paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety.', 'armGroupLabels': ['Sirolimus coated balloon']}\n- {'type': 'DEVICE', 'name': 'Plain balloon', 'description': 'Plain balloon angioplasty is the current standard therapy to treat stenosis in dialysis access. However, the mid and long term patency of plain balloon angioplasty in patients with end stage renal disease is poor. The average primary patency is around 40 to 50 percent at 1 year and multiple repeated angioplasty is required to maintain the patency of the vascular access.', 'armGroupLabels': ['Plain balloon']}\n\nPrimary Outcomes:\n- {'measure': 'Primary patency of the AVF at 6 months', 'description': 'This is measured by the percentage of patients whose AVF remain patent at 6 months after the procedure', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nA dropout rate of 10%, 80% power, and a significance level to detect a difference between the two groups at 6 months.", "answer": 170, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We assume that the SCB will have a similar effectiveness as the PCB based on a previous meta-analysis of published RCT, the 6-month target lesion primary patency 73.7% with PCB vs. 55.2% with plain balloon angioplasty. Considering a dropout rate of 10%, a sample size of 170 patients randomized into a 1:1 ratio will have 80% power to detect a difference between the two groups at 6 months.", "id": 774, "split": "val"} +{"trial_id": "NCT04409964", "pmid": "33712080", "question": "Here is the design of a clinical trial:\n\nOfficial Title: the Effect of Opioid-free General Anesthesia on the Recovery Quality After Gynecological Laparoscopy\n\nIncluded conditions:\n- Gynecologic Disease\n\nStudy Armgroups:\n- {'label': 'opioid-free anesthesia', 'type': 'EXPERIMENTAL', 'description': 'The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.', 'interventionNames': ['Drug: Dexmedetomidine Hydrochloride', 'Drug: Lidocaine Hydrochloride']}\n- {'label': 'opioid anesthesia', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy.', 'interventionNames': ['Drug: Remifentanil Hydrochloride']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine Hydrochloride', 'description': 'dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia', 'armGroupLabels': ['opioid-free anesthesia'], 'otherNames': ['precedex']}\n- {'type': 'DRUG', 'name': 'Lidocaine Hydrochloride', 'description': 'lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia', 'armGroupLabels': ['opioid-free anesthesia'], 'otherNames': ['lidocaine']}\n- {'type': 'DRUG', 'name': 'Remifentanil Hydrochloride', 'description': 'remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia', 'armGroupLabels': ['opioid anesthesia'], 'otherNames': ['remifentanil']}\n\nPrimary Outcomes:\n- {'measure': 'the quality of recovery', 'description': 'The quality of recovery is assessed using questionnaire. This questionnaire includes 40 items. The score range is from 40 to 200. The higher score means the better quality of recovery after surgery.', 'timeFrame': 'at 24 hour after the completion of surgery'}\n\nPlease estimate the sample size based on the assumption: \npower of 80%, type 1 error of 0.05, 15% loss to follow-up", "answer": 78, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary outcome is the QoR-40 score on POD 1. Based on a previous study that reported a 13-point difference in QoR-40 scores between different anesthetic techniques [13], a sample size of 34 was calculated to be as necessary to achieve a power of 80% with a type 1 error of 0.05. An additional 15% of participants are added to account for possible loss to follow-up. Thus, the final sample size will be 78 participants (39 in each group).", "id": 775, "split": "val"} +{"trial_id": "NCT04414124", "pmid": "33810796", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients With Mild-Moderate COVID-19\n\nIncluded conditions:\n- Mild-to-moderate COVID-19\n\nStudy Armgroups:\n- {'label': 'KB109 + Self Supportive Care (SSC)', 'type': 'OTHER', 'interventionNames': ['Other: KB109 + Self Supportive Care (SSC)']}\n- {'label': 'Self Supportive Care (SSC) Alone', 'type': 'OTHER', 'interventionNames': ['Other: Self Supportive Care (SSC) Alone']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'KB109 + Self Supportive Care (SSC)', 'description': 'KB109 is a novel glycan', 'armGroupLabels': ['KB109 + Self Supportive Care (SSC)']}\n- {'type': 'OTHER', 'name': 'Self Supportive Care (SSC) Alone', 'description': 'Self Supportive Care (SSC) Alone', 'armGroupLabels': ['Self Supportive Care (SSC) Alone']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Day 1 to Day 35'}\n\nPlease estimate the sample size based on the assumption: \nNot specified in the provided paragraph.", "answer": 350, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n K031 will enroll approximately 350 to 400 (175\u00e2\u0080\u0093200 patients per group) whereas K032 will enroll approximately 50 patients (25 per group).", "id": 776, "split": "val"} +{"trial_id": "NCT04414449", "pmid": "34972764", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ICT-enabled Social-emotional Learning: Development of Responsibility and Well-being in the Educational Environment\n\nIncluded conditions:\n- Adolescent - Emotional Problem\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'During the tutoring time, the intervention program is carried out in the experimental group, through emoTIC. EmoTIC is an emotional education program focused on the development of social-emotional competences through an application that can be used in mobile devices and tablets.', 'interventionNames': ['Other: ICT-enabled Social-emotional Learning']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'During the period in which the intervention program is conducted in the experimental group, the control group will remain in the waitlist (will not participate in the intervention), and will carry out the program once the study is finished.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ICT-enabled Social-emotional Learning', 'description': 'ICT-enabled Social-emotional Learning', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Emotional Intelligence', 'description': 'Trait Meta-Mood Scale (TMMS-24)', 'timeFrame': 'Time 1 (first month)'}\n- {'measure': 'Emotional Intelligence', 'description': 'Trait Meta-Mood Scale (TMMS-24)', 'timeFrame': 'Time 2 (4th month)'}\n- {'measure': 'Emotional Intelligence', 'description': 'Trait Meta-Mood Scale (TMMS-24)', 'timeFrame': 'Time 3 (up to 1 year)'}\n- {'measure': 'Subjective Well-Being', 'description': 'Life satisfaction and positive and negative affects', 'timeFrame': 'Time 1 (first month)'}\n- {'measure': 'Subjective Well-Being', 'description': 'Life satisfaction and positive and negative affects', 'timeFrame': 'Time 2 (4th month)'}\n- {'measure': 'Subjective Well-Being', 'description': 'Life satisfaction and positive and negative affects', 'timeFrame': 'Time 3 (up to 1 year)'}\n- {'measure': 'Emotional Competence', 'description': 'Emotional Skills and Competence Questionnaire', 'timeFrame': 'Time 1 (first month)'}\n- {'measure': 'Emotional Competence', 'description': 'Emotional Skills and Competence Questionnaire', 'timeFrame': 'Time 2 (4th month)'}\n- {'measure': 'Emotional Competence', 'description': 'Emotional Skills and Competence Questionnaire', 'timeFrame': 'Time 3 (up to 1 year)'}\n\nPlease estimate the sample size based on the assumption: \n95% confidence level, 5% margin of error.", "answer": 385, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to the National Statistics Institute,36 the population of adolescents (10\u00e2\u0080\u009319\u00e2\u0080\u0089years) in Spain is 4\u00e2\u0080\u0089912\u00e2\u0080\u0089519. By choosing a 95% confidence level and a 5% margin of error, the representative sample size would be 385 participants. Participants will be randomly assigned to the control group and the experimental group using a computer-generated random numbers. The allocation sequence will be computer generated using a purpose-built application.", "id": 777, "split": "val"} +{"trial_id": "NCT04414631", "pmid": "33397449", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19).\n\nIncluded conditions:\n- Coronavirus Infections\n\nStudy Armgroups:\n- {'label': 'active treatment arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'treatment with conestat alfa in addition to standarf of care', 'interventionNames': ['Drug: Conestat alfa']}\n- {'label': 'Standard of care treatment arm', 'type': 'NO_INTERVENTION', 'description': 'Standard of care treatment established at the centers'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Conestat alfa', 'description': 'Conestat alfa (8400 Units (U) followed by 4200 U every 8 hours, 9 administrations in total) will be administered as a slow intravenous injection (5-10 minutes) over a 72 hour period.', 'armGroupLabels': ['active treatment arm']}\n\nPrimary Outcomes:\n- {'measure': 'Disease severity', 'description': 'Disease severity on the 7-point Ordinal World Health Organization (WHO) scale (for the current study, score 0 will be omitted and score 6 and 7 will be combined). The ordinal scale measures illness severity over time. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19.', 'timeFrame': 'on day 7'}\n\nPlease estimate the sample size based on the assumption: \nTwo interim analyses after 40 and 80 patients with Pocock adjusted levels \u03b1p = 0.0221.", "answer": 80, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n We will randomise approximately 120 individuals (80 in the active treatment arm, 40 in the SOC group). Two interim analyses after 40 and 80 patients are planned according to the Pocock adjusted levels \u00ce\u00b1p = 0.0221. The results of the interim analysis will allow adjustment of the sample size (Lehmacher, Wassmer, 1999).", "id": 778, "split": "val"} +{"trial_id": "NCT04414748", "pmid": "38521533", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients Undergoing PGT-A\n\nIncluded conditions:\n- Preimplantation Genetic Testing\n- Progestin-primed Ovarian Stimulation\n- Euploid Rate\n- GnRH Antagonist\n\nStudy Armgroups:\n- {'label': 'Antagonist group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.', 'interventionNames': ['Drug: GnRH antagonist']}\n- {'label': 'PPOS group', 'type': 'EXPERIMENTAL', 'description': 'Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.', 'interventionNames': ['Drug: oral Duphaston']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'GnRH antagonist', 'description': 'GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger', 'armGroupLabels': ['Antagonist group'], 'otherNames': ['Cetrorelix']}\n- {'type': 'DRUG', 'name': 'oral Duphaston', 'description': 'oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.', 'armGroupLabels': ['PPOS group'], 'otherNames': ['Duphaston']}\n\nPrimary Outcomes:\n- {'measure': 'euploidy rate', 'description': 'euploidy rate of blastocysts', 'timeFrame': '1 month after oocyte retrieval'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, type I error of 0.05, and a 10% drop-out rate.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size calculations and statistical analysis\n \n Sample size estimation\n According to our data of the centre, in a group of 284\u00e2\u0080\u0089women (mean age 36.9 years and SD 3.5 years) undergoing PGT-A for advanced maternal age, recurrent pregnancy loss or repeated implantation failure, the mean euploid rate of blastocysts was 42.0% with SD of 34.0%. We hypothesise that a difference in the euploid rate of 10% between the PPOS versus GnRH antagonist group, the sample size required would be 182 in each arm to give a power of 0.8 and type I error of 0.05. Allowing 10% drop-out, 400\u00e2\u0080\u0089women or 200 in each arm will be needed.", "id": 779, "split": "val"} +{"trial_id": "NCT04414748", "pmid": "38521533", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients Undergoing PGT-A\n\nIncluded conditions:\n- Preimplantation Genetic Testing\n- Progestin-primed Ovarian Stimulation\n- Euploid Rate\n- GnRH Antagonist\n\nStudy Armgroups:\n- {'label': 'Antagonist group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.', 'interventionNames': ['Drug: GnRH antagonist']}\n- {'label': 'PPOS group', 'type': 'EXPERIMENTAL', 'description': 'Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.', 'interventionNames': ['Drug: oral Duphaston']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'GnRH antagonist', 'description': 'GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger', 'armGroupLabels': ['Antagonist group'], 'otherNames': ['Cetrorelix']}\n- {'type': 'DRUG', 'name': 'oral Duphaston', 'description': 'oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.', 'armGroupLabels': ['PPOS group'], 'otherNames': ['Duphaston']}\n\nPrimary Outcomes:\n- {'measure': 'euploidy rate', 'description': 'euploidy rate of blastocysts', 'timeFrame': '1 month after oocyte retrieval'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, type I error of 0.05, and a 10% drop-out rate.", "answer": 400, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n According to our data of the centre, in a group of 284\u00e2\u0080\u0089women (mean age 36.9 years and SD 3.5 years) undergoing PGT-A for advanced maternal age, recurrent pregnancy loss or repeated implantation failure, the mean euploid rate of blastocysts was 42.0% with SD of 34.0%. We hypothesise that a difference in the euploid rate of 10% between the PPOS versus GnRH antagonist group, the sample size required would be 182 in each arm to give a power of 0.8 and type I error of 0.05. Allowing 10% drop-out, 400\u00e2\u0080\u0089women or 200 in each arm will be needed.", "id": 780, "split": "val"} +{"trial_id": "NCT04415203", "pmid": "39075454", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Frequent Premature Ventricular Complexes: A Randomized Controlled Trial\n\nIncluded conditions:\n- Premature Ventricular Complexes\n\nStudy Armgroups:\n- {'label': 'TAVNS plus usual care', 'type': 'EXPERIMENTAL', 'description': 'TAVNS on Erzhong and Xin (Auricular Acupuncture Point with Vagus nerve distribution); Usual Care: usual medicine treatment for PVCs.', 'interventionNames': ['Device: Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)']}\n- {'label': 'Sham-TAVNS plus usual care', 'type': 'PLACEBO_COMPARATOR', 'description': 'Sham-TAVNS on Erzhong and Xin (Auricular Acupuncture Point); the same acupoints as the treatment group without any current.\\n\\nUsual Care: usual medicine treatment for PVCs.', 'interventionNames': ['Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Transcutaneous Auricular Vagus Nerve Stimulation (TAVNS)', 'description': 'Patients in TAVNS group will receive TAVNS and usual care. TAVNS will be performed on Erzhong and Xin (Auricular Acupuncture Point with vagus nerve distribution) for 6 weeks by using the Huato type SDZ-V stimulator; Usual Care: usual medicine treatment for PVCs.', 'armGroupLabels': ['TAVNS plus usual care']}\n- {'type': 'DEVICE', 'name': 'Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham-TAVNS)', 'description': 'Patients in sham-TAVNS group will receive sham-TAVNS and usual care. Sham-TAVNS will be also performed on Erzhong and Xin (Auricular Acupuncture Point with vegas nerve stimulation) for 6 weeks by using a special Huato type SDZ-V stimulator. We cut the inner electric wire of the stimulator; therefore, there is no current output. Usual Care: usual medicine treatment for PVCs.', 'armGroupLabels': ['Sham-TAVNS plus usual care']}\n\nPrimary Outcomes:\n- {'measure': 'the proportion of participants with a 50% decrease of PVCs from baseline', 'description': 'The PVCs will be assessed by a 24-hour Holter monitoring. The investigators will calculate the decrease of PVCs between baseline and week 6 (at the end of the treatment), then we will obtain the proportion of patients with a 50% decrease.', 'timeFrame': 'week 6'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed test with 90% power, 5% significance level, and 15% loss to follow-up rate.", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The null hypothesis is that there would be no difference between the two groups in the proportion of participants with a\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008950% reduction of PVCs from baseline after 6 weeks of treatment, and the alternative hypothesis is that there would be a significant difference between the two groups. In our pilot study, the proportion in taVNS and sham-taVNS groups were 58.3% and 21.1%, separately. Ninety participants are required (45 in each group) with a two-tailed test setting power as 90% and alpha as 5%, and considering the rate of loss to follow-up as 15%. To balance the three sites with two groups, 30 participants need to be enrolled in each site (15 per group in one site).", "id": 781, "split": "val"} +{"trial_id": "NCT04415632", "pmid": "34620653", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of an Iso-energetic Low Glycemic Index (GI) Diet on Liver Fat Accumulation and Gut Microbiota Composition in Patients With Non- Alcoholic Fatty Liver Disease (NAFLD)\n\nIncluded conditions:\n- Fatty Liver\n- Nutritional and Metabolic Disease\n\nStudy Armgroups:\n- {'label': 'LGI Diet', 'type': 'EXPERIMENTAL', 'description': 'low glycemic index diet', 'interventionNames': ['Other: low glycemic index diet']}\n- {'label': 'HGI Diet', 'type': 'OTHER', 'description': 'High glycemic index diet', 'interventionNames': ['Other: High glycemic index diet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'low glycemic index diet', 'description': '\u2022 Three-day cycle menu of LGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.', 'armGroupLabels': ['LGI Diet'], 'otherNames': ['LGI']}\n- {'type': 'OTHER', 'name': 'High glycemic index diet', 'description': 'Three-day cycle menu of HGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.', 'armGroupLabels': ['HGI Diet'], 'otherNames': ['HGI']}\n\nPrimary Outcomes:\n- {'measure': 'liver fat content', 'description': 'To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S', 'timeFrame': 'At baseline'}\n- {'measure': 'liver fat content', 'description': 'To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S', 'timeFrame': '2 weeks'}\n\nPlease estimate the sample size based on the assumption: \nTwo-group t-test (cross-over ANOVA) with a 0.05 two-sided significance level, 80% power, and a dropout rate of 33-40%.", "answer": 16, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and justification\n The sample size is calculated using nQuery based on previous completed study by Bawden et al.21 Based on their pilot data, baseline liver fat fractions of both diet groups were 2.4\u00c2\u00b11%\u00e2\u0080\u00931.2%, and after 1\u00e2\u0080\u0089week were HGI (High GI)=4.7% \u00c2\u00b1 2%\u00e2\u0080\u0089and LGI=1.6 \u00c2\u00b1 0.7%. Using a two-group t-test (cross-over analysis of variance (ANOVA)) between the post-diet values with a 0.05 two-sided significance level, this produces a sample size of n=8 in each diet sequence (a total sample size of 16). This sample size has an 80% power to detect a difference in means of 3.1 (the difference between a Treatment 1, \u00c2\u00b51, of 4.7 and a Treatment 2, \u00c2\u00b52, of 1.6) with the assumption that the crossover ANOVA sqrt (MSE) is 2.828 (the SD of differences, \u00cf\u0083, is 4). Assuming that 40% of people would drop out from cross-over study design, it is expected that at least 24 participants would need to be recruited.\n The effect from the pilot study by Bawden et al pilot study (n=7) was an average 1.6%\u00c2\u00b10.7% decrease in liver fat fraction after following a 1-week LGI diet (p<0.05). Given that baseline liver fat fraction was 2.4%, in order to see such change with 80% power (p<0.05) we have doubled the participant numbers to n=16 using nQuery software to detect statistically significant differences.21 Our group has recently completed a study (ClinicalTrials.gov Identifier: NCT03844165) in which 84 participants with NAFLD followed either an LGI food enriched diet or their normal diet. Patients who changed their diet were found to have a significant decrease in liver fat after 16 weeks (from 20.4% to 18.8%) and had a statistically significant decrease in fasting glucose levels after the diet compared with the control group patients following their normal diet. This provides strong support to our hypothesis and demonstrates that a simple dietary change can have measurable impact on NAFLD symptoms in a short period. In another previous randomised crossover trial, metabolic changes were seen within 2\u00e2\u0080\u0089weeks in a dietary intervention with 10 participants.66 Based on these different approaches, we conclude that a sample size of 16 at the end of the study is sufficient. Assuming a 33% drop-out rate we estimate that it will be necessary to enrol n=24 NAFLD participants to achieve n=16 completing the two diet-interventions. This dropout rate has been reported in other dietary interventional studies.67", "id": 782, "split": "val"} +{"trial_id": "NCT04416334", "pmid": "34488841", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19)\n\nIncluded conditions:\n- SARS-CoV-2 Infection (COVID-19)\n\nStudy Armgroups:\n- {'label': 'Colchicine plus symptomatic treatment (paracetamol).', 'type': 'EXPERIMENTAL', 'description': 'Patients in this arm will receive study medication colchicines 0.5 mg orally (PO) twice daily for the first 3 days and then once daily for the last 18 days. If a dose is missed, it should not be replaced.\\n\\nAll patients should also receive best symptomatic treatment (mainly paracetamol), based on clinical practice.', 'interventionNames': ['Drug: Colchicine plus symptomatic treatment (paracetamol)']}\n- {'label': 'Symptomatic treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).', 'interventionNames': ['Drug: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Colchicine plus symptomatic treatment (paracetamol)', 'description': 'Colchicine plus symptomatic treatment (paracetamol).', 'armGroupLabels': ['Colchicine plus symptomatic treatment (paracetamol).']}\n- {'type': 'DRUG', 'name': 'Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)', 'description': 'Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).', 'armGroupLabels': ['Symptomatic treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants who die due to COVID-19 infection', 'timeFrame': '21 days post-randomization'}\n- {'measure': 'Number of participants who require hospitalization due to COVID-19 infection', 'timeFrame': '21 days post-randomization'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 5%, beta risk of 80%, and a proportion of 2/1 between the colchicine/placebo groups.", "answer": 70, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n According to the literature [3], an estimated incidence of the primary outcome of 10% in the group treated with placebo and 5% in the group treated with colchicine, in a bilateral contrast, for an alpha risk of 5% and a beta risk of 80%, with a proportion of 2/1 between the colchicine/placebo groups, 636 and 318 are required in the groups treated with colchicine and placebo, respectively.\n Randomization will be stratified by sex and age groups: 60\u00e2\u0080\u009370, 70\u00e2\u0080\u009380, and 81 and more years.\n In the current COVID daily cases from the primary health care areas, it is estimated about 5\u00e2\u0080\u009310 cases of patients to randomize.\n The total number of patients to be included is 954 patients.", "id": 783, "split": "val"} +{"trial_id": "NCT04416815", "pmid": "36973667", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Integrating Health Promotion With and for Older People - eHealth: a Randomised Controlled Trial, in the Context of Good Quality Local Health Care\n\nIncluded conditions:\n- Frailty\n- Old Age\n\nStudy Armgroups:\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'The participants allocated to the control group received no intervention. However, they could, on their own initiative, approach the usual range of community or health services (e.g., home help services, rehabilitation, or medical care).'}\n- {'label': 'eHealth', 'type': 'EXPERIMENTAL', 'description': 'The intervention will be delivered for 6 months on top of usual care.', 'interventionNames': ['Other: Integrating Health promotion with and for Older People - eHealth']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Integrating Health promotion with and for Older People - eHealth', 'description': \"The intervention will be delivered for 6 months on top of usual care. It will be provided by HCPs. If needed one home visit to install the digital platform will be conducted. A HCP will introduce how to use the digital platform and create a personal account. The intervention starts with a person-centred phone-call where a health plan is co-created and potential team members to support this are identified and invited. The health plan includes the older persons' goals, internal and external resources, and need of support from health and/or social-services. This plan will be the point of departure for the forthcoming dialogue. A digital platform will open up for extended and safe communication and visualize the health planning between the older person and team-members in different settings. The older person and the HCP and involved team members on the digital platform will regularly evaluate the health plan and commonly agreed goals.\", 'armGroupLabels': ['eHealth']}\n\nPrimary Outcomes:\n- {'measure': 'A composite of changes in general self-efficacy and need for hospital care', 'description': \"The primary outcome is a composite of changes in general self-efficacy and need for hospital care for unscheduled reasons. Each participant will be classified as improved, deteriorated or unchanged if at 3 months:\\n\\n* Deteriorated: the participant's self-efficacy has decreased by \u2265 5 units (the minimal change of clinical significance), or the participant has been admitted to hospital for unscheduled reasons two times or more.\\n* Improved: general self-efficacy has increased by \u2265 5 units and the participant has been admitted to hospital no more than once.\\n* Unchanged: Neither deteriorated nor improved. (Questionnaire and medical record)\", 'timeFrame': 'Baseline, 3'}\n\nPlease estimate the sample size based on the assumption: \n80% power, p-value of 0.05, margin for dropouts and withdrawals", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculation\n In the full-scale RCT and health economic evaluation a minimum of 220 patients must be randomised to the two arms based on the primary outcome measure. To achieve 80% power based on a p-value of 0.05 and allow an increase in the proportion of improved or unchanged patients from 20 to 40%, 91 participants in each group (control and intervention) are required. We plan to include 110 patients in each group to have a comfortable margin for dropouts and withdrawals.", "id": 784, "split": "val"} +{"trial_id": "NCT04420741", "pmid": "32847626", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of 72-hour Infusion of Prostacyclin (1 Nanogram(ng)/ Kilo(kg)/Minute(Min)) in Patients With COVID-19 Induced Pulmonary Endotheliopathy\n\nIncluded conditions:\n- COVID-19\n- Respiratory Failure\n\nStudy Armgroups:\n- {'label': 'Iloprost', 'type': 'EXPERIMENTAL', 'description': 'Patients randomized to active treatment (n=40 patients) will receive continuous infusion of iloprost for 72 hours after inclusion or until discharge to ward or death, whichever comes first.', 'interventionNames': ['Drug: Iloprost']}\n- {'label': 'Isotonic saline', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients randomized to placebo treatment (n=40 patients) will receive continuous infusion of placebo for 72 hours after inclusion or until discharge to ward or death, whichever comes first.', 'interventionNames': ['Drug: Isotonic saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Iloprost', 'description': 'Continuously infusion for 72 hours at 3 ml/hours. Treatment dose 1 ng/kg/min', 'armGroupLabels': ['Iloprost'], 'otherNames': ['Ilomedin']}\n- {'type': 'DRUG', 'name': 'Isotonic saline', 'description': 'Continuously infusion for 72 hours at 3 ml/hours', 'armGroupLabels': ['Isotonic saline']}\n\nPrimary Outcomes:\n- {'measure': 'Mechanical ventilation free days', 'description': 'Days alive without mechanical ventilation in the ICU within 28 days', 'timeFrame': 'Until ICU discharge, maximun 28 days after randomization'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 80, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n Forty patients are planned to be randomized to each group, with a total sample size of 80 patients.", "id": 785, "split": "val"} +{"trial_id": "NCT04422340", "pmid": "34230013", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicentric Survey on Patients Over 60 Admitted to Intensive Care for Severe Forms of COVID Infection: Search for Prognostic Criteria Associated With Survival\n\nIncluded conditions:\n- COVID-19 Disease, Severe Form\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Group1', 'description': \"* Comorbidities (CIRS-G scale),\\n* Functional status of the patient with\\n\\n * Clinical frailty scale (1 month before infection)\\n * ADL score (1 month before infection)\\n* Biological data\\n\\n * Blood group\\n * TP, D-dimers, CRP, creatinine level at the patient's entry, triglyceridemia, fibrinogen, ferritin\\n * Parameters derived from the platelet formula count on D1 of the start of intensive care (lymphocytes, neutrophils, platelets, average platelet volume, red blood cell distribution index), SYSMEX data (IG: Immature granulocytes; HFLC: high fluorescent lymphocyte count)\\n* Resuscitation outcomes\\n\\n * LDH rate at the start of intensive care\\n * PaO2 / FiO2 ratio at the start of intensive care\\n * IGSII / SASPII score (simplified acute physiology score) on D1 of the start of intensive care\\n * SOFA score (sepsis-related organ failure assessment): a posteriori estimate based on IGSII / SASPII\\n * Delay between the appearance of the first signs of infection and admission to intensive care\"}\n\nPrimary Outcomes:\n- {'measure': 'Evaluation of the impact of age on mortality at 30 days after admission to intensive care', 'description': \"First hypothesis: considering a single analysis variable (age), with expected mortality of 30% in patients under 70, and 70% in patients over 70 (with 40% of patients over 70), a total of 130 patients is necessary to show a statistically significant difference between these two groups with a power of 90% (bilateral alpha risk test of 5%). Since the multivariate analysis considers the integration of several factors, considering 15 factors, hoping for a coefficient of determination of 0.5 of the model, to achieve an optimism of less than 10%, it will be necessary to include 185 patients.\\n\\nAfter the publication of data on mortality in ICU in Lombardy region, Italy in April 2020, it was considered that a stopping of the trial at 185 patients would impair its statistical power and induce a potential risk of patients' selection bias. As a consequence the scientific committee decided that all the patients admitted to ICU until May 7th would be proposed the study.\", 'timeFrame': '30 days after resuscitation admission'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, bilateral alpha risk test of 5%, considering 15 factors with a coefficient of determination of 0.5 to achieve an optimism of less than 10%.", "answer": 185, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n To assess the effect of age on mortality in ICU, it is planned to compare mortality between patients under 70 years old and over 70 years old. Based on the results from a Chinese retrospective study,1 the hypothesis of the Senior-COVID-Rea study was the following: considering a single analysis variable (age), and an expected mortality of 30% for patients under 70 years old and 70% for patients over 70 years old (patients over 70 years old representing 40% of the study population), it will be necessary to include a total of 130 patients to show a statistically significant difference between these two groups with a power of 90% (bilateral alpha risk test of 5%). Since the analysis considers the integration of several factors, considering 15 factors, hoping for a coefficient of determination of 0.5 of the model, to achieve an optimism of less than 10%, it will be necessary to include 185 patients (criterion 1 of Riley et al\n28).\n After the publication of data on mortality in ICU from Lombardy, Italy, in April 2020,2 it was considered that closing the inclusion process after 185 inclusions would impair the statistical power of the study and induce a potential patient selection bias. As a consequence, the scientific committee decided on 7 May 2020 that all the patients admitted to ICU before that date\u00e2\u0080\u0094that corresponded to the end of the first COVID-19 wave in France\u00e2\u0080\u0094were eligible and proposed no limitation in terms of number of inclusions for this study. This sample size calculation was modified on Clinicaltrials.gov site accordingly (28 July 2020).", "id": 786, "split": "val"} +{"trial_id": "NCT04422821", "pmid": "33653744", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Gestational Diabetes Mellitus\n\nStudy Armgroups:\n- {'label': 'FreeStyle Libre\u2122', 'type': 'EXPERIMENTAL', 'description': 'FreeStyle Libre\u2122 will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will receive subcutaneous sensor for glucose monitoring (FreeStyle Libre\u2122; Abbott Diabetes Care, Alameda, CA) for 4 weeks.', 'interventionNames': ['Device: Flash Glucose Monitoring']}\n- {'label': 'iXell\u00ae', 'type': 'ACTIVE_COMPARATOR', 'description': 'iXell\u00ae will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will monitor glycemia through use of standard glucose meter (iXell\u00ae; Genexo sp; Warsaw, Poland) for 4 weeks.', 'interventionNames': ['Device: Self-Monitoring of Blood Glucose']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Flash Glucose Monitoring', 'description': 'Flash Glucose Monitoring FreeStyle Libre\u2122 (Abbott Diabetes Care, Alameda, CA) sensor placed subcutaneously that will be applied for 14 days, then removed and changed for the second sensor for the next 14 days.', 'armGroupLabels': ['FreeStyle Libre\u2122'], 'otherNames': ['FreeStyle Libre\u2122 (Abbott Diabetes Care, Alameda, CA)']}\n- {'type': 'DEVICE', 'name': 'Self-Monitoring of Blood Glucose', 'description': 'Self-Monitoring of Blood Glucose with a standard glucose meter (iXell\u00ae; Genexo sp; Warsaw, Poland) performed through a skin-puncturing 4 times a day for 28 days.', 'armGroupLabels': ['iXell\u00ae'], 'otherNames': ['iXell\u00ae; Genexo sp; Warsaw, Poland']}\n\nPrimary Outcomes:\n- {'measure': 'Mean glycemia results (fasting and 1-h postprandial glucose concentrations)', 'description': 'Glycemia results analysis according to Polish Society of Obstetricians and Gynecologists (PSOG) recommendations for gestational diabetes mellitus.', 'timeFrame': '28 days after the recruitment visit'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level of 5%, two-sided. Continuous data will be compared using the Mann-Whitney U test, and for categorical variables the \u03c72 test will be applied. The relationship between glucose, HbA1c and fructosamine concentrations, and selected maternal-fetal parameters will be examined with the use of Pearson\u2019s correlation coefficient. Multivariable logistic regression analysis will be performed to evaluate the potential impact of selected predictors on primary outcomes. All tests will be carried out at a significance level of 0.05.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size calculation and statistical analysis\n The performed power analysis (power of 80%, significance level of 5%, two-sided) estimated a required sample size of a total of 80 patients (40 patients in each group). The analysis was based on the results of a previous report comparing FGM with SMBG and estimation to detect a difference in the percentage of results in the target glycaemic range between study and control groups.21 Sample size is further increased to 100 patients to account for a potential exclusions and drop out of approximately 10%.\n Continuous data will be compared using the Mann-Whitney U test, and for categorical variables the \u00cf\u00872 test will be applied. The results will be presented as medians and IQRs or as a frequency (%). For comparison between groups, Bland Altman and Passing-Bablok method will be performed. The relationship between glucose, HbA1c and fructosamine concentrations, and selected maternal\u00e2\u0080\u0093fetal parameters will be examined with the use of Pearson\u00e2\u0080\u0099s correlation coefficient. Multivariable logistic regression analysis will be performed to evaluate the potential impact of selected predictors on primary outcomes. All tests will be carried out at a significance level of 0.05.\n Statistical analyses will be performed using SAS software, V.9.2 or later (SAS Institute).", "id": 787, "split": "val"} +{"trial_id": "NCT04423276", "pmid": "34627332", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficiency of Donepezil in Elderly Patients Undergoing Orthopedic Surgery Due to Underlying Postoperative Cognitive Dysfunction, a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Total Knee Arthroplasty\n- Fracture of Head of Femur Articular Displaced\n- Protrusion of Intervertebral Disc\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Donepezil', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Donepezil']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Donepezil', 'description': 'Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.', 'armGroupLabels': ['Donepezil']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'The incidence of POCD after the surgery.', 'timeFrame': 'up to 7 days'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80, two-sided significance level of 5%, and a dropout rate of 10%.", "answer": 360, "answer_type": "ESTIMATED", "explanation": "Sample size\n In the previous study, we found that the POCD incidence in the elderly patients undergoing orthopaedic surgery is about 25% [20]. The anticipated effect size of donepezil is 50%. That means the power analysis for the primary outcome of POCD prevalence assumes a reduction from 25 to 12.5%. The results of a conventional analysis to detect differences in proportions (POCD) between the intervention and control groups, using PASS19.0, led to a total of 300 patients with a 1:1 randomisation, given a power of 1 \u00e2\u0088\u0092 \u00ce\u00b2 = 0.80 and a two-side \u00ce\u00b1 level of 5%. Assuming a dropout rate of 10%, this results in a requirement of about 360 total patients.", "id": 788, "split": "val"} +{"trial_id": "NCT04424290", "pmid": "35978329", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A First-in Human Trial to Study Safety and Tolerability of Single Rising Intravitreal dOses (Open Label, Non-randomized, Uncontrolled) and in Addition the Early Biological Response of Multiple intravitReal Dosing (Single-masked, raNdomized, Sham-controlled) of BI 764524 in panretinaL Photocoagulation (PRP) Treated proLiferative Diabetic Retinopathy (PDR) Patients With Diabetic Macular Ischemia (DMI) - the HORNBILL Study\n\nIncluded conditions:\n- Diabetic Retinopathy\n\nStudy Armgroups:\n- {'label': 'Single-rising dose part - low dose BI 764524', 'type': 'EXPERIMENTAL', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.', 'interventionNames': ['Drug: BI 764524']}\n- {'label': 'Single-rising dose part - medium dose BI 764524', 'type': 'EXPERIMENTAL', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.', 'interventionNames': ['Drug: BI 764524']}\n- {'label': 'Single-rising dose part - high dose BI 764524', 'type': 'EXPERIMENTAL', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.', 'interventionNames': ['Drug: BI 764524']}\n- {'label': 'Multiple dosing part - Sham', 'type': 'SHAM_COMPARATOR', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks.', 'interventionNames': ['Drug: Sham control of BI 764524']}\n- {'label': 'Multiple dosing part - high dose BI 764524', 'type': 'EXPERIMENTAL', 'description': 'Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks.', 'interventionNames': ['Drug: BI 764524']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'BI 764524', 'description': 'BI 764524', 'armGroupLabels': ['Multiple dosing part - high dose BI 764524', 'Single-rising dose part - high dose BI 764524', 'Single-rising dose part - low dose BI 764524', 'Single-rising dose part - medium dose BI 764524']}\n- {'type': 'DRUG', 'name': 'Sham control of BI 764524', 'description': 'Sham control of BI 764524', 'armGroupLabels': ['Multiple dosing part - Sham']}\n\nPrimary Outcomes:\n- {'measure': 'Single-rising Dose (SRD) Part - The Number of Patients With Dose Limiting Events (DLEs) From Drug Administration Until Day 8', 'description': 'Single-rising dose (SRD) part - The number of patients with dose limiting events (DLEs) from drug administration until Day 8 (7 days after treatment).', 'timeFrame': 'From drug administration (day 1) till day 8, Up to 7\u00b12 days.'}\n- {'measure': 'Multiple Dosing (MD) Part - the Number of Patients With Drug-related Adverse Events (AEs) From Drug Administration Until End of Trial.', 'description': 'Multiple dosing (MD) part - the number of patients with drug-related Adverse Events (AEs) from drug administration until End of Trial.', 'timeFrame': 'From drug administration (day 1) till End of Trial, up to 23 weeks.'}\n\nPlease estimate the sample size based on the assumption: \nNo formal statistical power calculations for the SRD part as it is explorative. The sample size for the MD part is based on the estimated likelihood of observing a treatment effect given the mean intraindividual variability of FAZ estimates.", "answer": 45, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n No formal statistical power calculations to determine sample size will be performed for the SRD part as it is an explorative phase. Based on the simulation study conducted to evaluate operating characteristics of the BLRM, about 15 evaluable subjects are expected to be treated in the dose-escalation part for the model to ensure reasonable operating characteristics relating to the maximum feasible dose recommendation. Sample size was calculated for the MD part based on the estimated likelihood of observing a treatment effect given the mean intraindividual variability of FAZ estimates, which have been previously derived [30]. Assuming a mean treatment difference of 10%, with 20 subjects in the BI 764524 arm and 10 subjects in the sham arm, the likelihood of observing a treatment effect larger than 6% (reduction in size of the FAZ of 0.0462 mm2) is 81.7%, and the likelihood of observing a treatment effect smaller than 4% (reduction in size of the FAZ of 0.0308 mm2) is 10.2%. With an assumed mean treatment difference of 0%, the likelihood of observing a treatment effect larger than 6% would be 12.3%, and the likelihood of observing a treatment effect smaller than 4% is 78.7%.", "id": 789, "split": "val"} +{"trial_id": "NCT04424589", "pmid": "37796870", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Myofascial Release Compared With Sham Therapy on Joint Range of Motion in Patients With Axial Spondyloarthritis.\n\nIncluded conditions:\n- Ankylosing Spondylitis\n\nStudy Armgroups:\n- {'label': 'Myofascial release', 'type': 'EXPERIMENTAL', 'description': 'Myofascial release or induction (MFR) is a widely used manual therapy treatment involving specifically guided, low-load, long-lasting mechanical forces to manipulate the myofascial complex, aimed at restoring optimal length, decreasing pain, and improving function. Manual therapists often use their hands using their knuckles, elbows, or other instrumental tools to slowly penetrate the layers of the fascia, using applied pressure with a few kilograms of force that can strain the restricted fascia, this implies a guided gentle stretch.\\n\\nThe experimental group will receive 1 examination session and 6 myofascial release sessions carried out by a physiotherapist specialized in orthopedic manual therapy, superficial and deep techniques will be applied in the cervical region, for the spinal at the level of the quadratus lumborum, sacroiliac region and upper trapezius. 2 sessions per week over the course of 3 weeks.', 'interventionNames': ['Other: Myofascial release']}\n- {'label': 'Sham Therapy', 'type': 'SHAM_COMPARATOR', 'description': 'The control group will receive 1 examination session and 6 simulated myofascial releasesessions, where a physiotherapist will apparently apply the same techniques and maneuvers of myofascial release, however, they will not follow the basic principles of technique execution, which does a procedure with a placebo effect.', 'interventionNames': ['Other: Sham therapy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Myofascial release', 'description': 'Myofascial release or induction (IMF) is a widely used manual therapy treatment involving specifically guided, low-load, long-lasting mechanical forces to manipulate the myofascial complex, aimed at restoring optimal length, decreasing pain, and improving function. The experimental group will receive 1 examination session and 6 myofascial induction sessions carried out by a physiotherapist specialized in orthopedic manual therapy, superficial and deep techniques will be applied in the cervical region, for spinal at the level of the lumbar square, sacroiliac region and upper trapezius. 2 sessions per week over the course of 3 weeks.', 'armGroupLabels': ['Myofascial release']}\n- {'type': 'OTHER', 'name': 'Sham therapy', 'description': 'The control group will receive 1 examination session and 6 simulated myofascial induction sessions, where a physiotherapist will apparently apply the same techniques and maneuvers of myofascial induction, however, they will not follow the basic principles of technique execution, which does a procedure with a placebo effect.', 'armGroupLabels': ['Sham Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Bath Ankylosing Spondylitis Metrology Index (BASMI)', 'description': 'Index that examines 4 axial measurements (cervical rotation, Schober test, lateral trunk flexion, tragus wall distance), also includes a measurement of peripheral mobility (intermaleolar distance), The measurement of these variables is carried out comparatively, in at least two attempts, obtaining the averages of the measurements to calculate the final score based on the 11-point table.', 'timeFrame': '3 weeks'}\n\nPlease estimate the sample size based on the assumption: \nloss of 20%, alpha one sided of 0.05%, power of 0.80, mean difference test for a clinical trial of superiority (repeated measures ANOVA)", "answer": 82, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated in the program R Studio version 3.5.3, package of superiority clinical trials, based on a mean difference of 4.0 in the BASMI with a standard deviation of 2, an r (ratio) between groups of 1, and assuming a loss of 20%. An alpha one sided of 0.05% and a power of 0.80 were estimated based on mean difference test corresponding to a clinical trial of superiority (repeated measures ANOVA). The total number of people was 82 (42 per arm). Non probabilistic purposive sampling will be used.", "id": 790, "split": "val"} +{"trial_id": "NCT04424680", "pmid": "33087061", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Efficacy of an Advanced Care Planning Program for Health Decisions in Patients With Advanced Heart Failure\n\nIncluded conditions:\n- Heart Failure\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Patients will be followed in heart failure outpatients units according to the usual established protocol. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed.\\n\\nTreatment for heart failure will be the same in both groups.'}\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Patients will participate in the Advanced Care Planning Program. In the first visit, patients from both control and intervention groups will complete the questionnaires with the help of researchers. After one year of follow-up, the questionnaires will be submitted again to all patients and three new questionnaires will be proposed.\\n\\nTreatment for heart failure will be the same in both groups.', 'interventionNames': ['Behavioral: Advanced Care Planning program of health decisions']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Advanced Care Planning program of health decisions', 'description': 'Application of an Advanced Care Planning program program for decision-making in patients with advanced Heart Failure, in comparison to usual follow up and care.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'To evaluate the efficacy of an Advanced Care Planning program for decision-making in patients with advanced Heart Failure in comparison to usual follow up and care: questionnaire', 'description': \"This objective will be evaluated by the PAM (Patient Activation Measure) test, which measures the participation and self-management of the patient in decision making. PAM measures the activation (participation and self-management) of the patient in decision-making. It evaluates the knowledge, skills and confidence of patients' self-management classifying patients in levels of self-management activation. Level 1: They do not feel responsible for their own health and care. (Score 47.0 or lower); Level 2: They may lack basic understanding about their condition, treatment options, and / or self-care. (47.1 to 55.1); Level 3: They know the basic facts of their illness and treatments. (55.2 to 67); Level 4: They have made most of the decisions, but they may have difficulties in maintaining behaviours over time or in stressful situations (67.1 or higher).\", 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, confidence level of 95%, 10% added for possible losses or errors in follow-up", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size estimate has been made assuming a power of 80%, a confidence level of 95% in order to detect a standardized significant difference of at least 0.5. We consider 0.5 to be a clinically relevant difference based on the article by Norman et al. [20], being 128, the minimum sample size needed to detect this difference, 64 people in each group. A 10% sample size is added to compensate possible losses or errors in the follow-up, which represents 140 patients.", "id": 791, "split": "val"} +{"trial_id": "NCT04425473", "pmid": "35473735", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery\n\nIncluded conditions:\n- Depressive Symptoms\n- Esketamine\n- Perioperative Complication\n- Major Surgery\n\nStudy Armgroups:\n- {'label': 'Esketamine', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Esketamine']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Normal saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Esketamine', 'description': 'Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.', 'armGroupLabels': ['Esketamine']}\n- {'type': 'DRUG', 'name': 'Normal saline', 'description': 'Equivalent amount of normal saline will be administrated intravenously suturing incision.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Depressive symptoms remission', 'description': 'Remission is defined as MADRS total score no more than 10', 'timeFrame': 'Postoperative 3-day'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided significance level of 0.05, 1 interim analysis, and a 10% attrition rate.", "answer": 564, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n It has been reported that the remission rate difference in the antidepressant effects between esketamine and ketamine was 3.8% in treatment-resistant depression patients.26 In the perioperative population with depressive symptoms, the remission rate was reported to be 23.1% in the ketamine group and 9.3% in the placebo group based on the PASSION study at our research site. We assumed that the remission rate in the esketamine group will be 19.3% and that in the placebo group will be 10%. A sample size of 506 participants will provide 80% power to show the difference between the esketamine group and the placebo group (with a ratio of 1:1), including 1 interim analysis by using a two-sided significance level of 0.05.27 With the consideration of a 10% attrition rate, the total sample size is planned to be 564.", "id": 792, "split": "val"} +{"trial_id": "NCT04427787", "pmid": "37752423", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Trial Aiming to Assess the Safety and Activity of the Combination of Cabozantinib Plus Lanreotide in Gastroenteropancreatic (GEP) and Thoracic Neuroendocrine Tumor (NET): The LOLA Trial\n\nIncluded conditions:\n- Metastatic Well Differentiated Neuroendocrine Neoplasm\n- Neuroendocrine Tumors\n\nStudy Armgroups:\n- {'label': 'Cabozantinib+lanreotide', 'type': 'EXPERIMENTAL', 'description': 'Cabozantinib will be administered orally at a dose of 60 mg/day continuously in combination with Lanreotide 120 mg injection every 28 days. Both treatments will start the same day', 'interventionNames': ['Drug: Cabozantinib', 'Drug: Lanreotide']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Cabozantinib', 'description': 'Cabozantinib will be administered orally at a dose of 60 mg/day', 'armGroupLabels': ['Cabozantinib+lanreotide'], 'otherNames': ['Cabometyx']}\n- {'type': 'DRUG', 'name': 'Lanreotide', 'description': 'Lanreotide will be administrated 120 mg injection every 28 days', 'armGroupLabels': ['Cabozantinib+lanreotide'], 'otherNames': ['IPSTYL']}\n\nPrimary Outcomes:\n- {'measure': 'Objective Response Rate (ORR)', 'description': 'according to RECIST, v1.1 defined as complete response or partial response after treatment administration', 'timeFrame': '42 months'}\n- {'measure': 'Primary Safety Endpoint', 'description': 'Adverse Events (AE) grade 3-5 according to NCI-CTCAE v5.0 grade', 'timeFrame': '42 months'}\n\nPlease estimate the sample size based on the assumption: \nNominal type I error = 0.05, nominal type II error = 0.20. Considering a drop-out rate of 5%. Thresholds to identify significant level at 5% and exact binomial test\u2019s power will be determined based on the real number of patients to be analyzed (e.g., 0 out of 20 patients [test\u2019s power: 36%], 3 out of 39 patients [test\u2019s power: 87%], 6 out of 58 patients [test\u2019s power: 97%]).", "answer": 69, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical design\n The statistical design is adaptive, according to three sequential stages (see the study flow-chart depicted in Fig.\u00c2\u00a02).Fig. 2Study design N: number; pNETs: pancreatic neuroendocrine tumors; ORR: Overall response rate; OS: overall survival; PFS: progression-free survival; WD: well-differentiated\n Two cohorts of patients will be enrolled in the study according to different histotypes: the first cohort includes pNETs; the second cohort includes carcinoids (i.e. small intestine NETs, stomach NETs, colon and rectum NETs, typical and atypical lung and thymus NETs) and NETs of unknown origin. Enrolment in the pancreatic and carcinoid arms will be competitive in the first stage (i.e. run-in stage).\n I stage. The primary objective of I stage is to find the optimal dose of cabozantinib in combination with lanreotide and to evaluate the safety and the tolerability of the combination. Starting dose of cabozantinib is 60\u00c2\u00a0mg daily plus lanreotide 120\u00c2\u00a0mg every 28\u00c2\u00a0days. No more than 7 patients will be enrolled in the I stage. If G3-5 adverse events (AEs)\u00e2\u0080\u0094excluded not clinically relevant laboratory abnormalities according to NCI-CTCAE version 5.0 or clinically manageable and reversible G3 AEs within 7\u00c2\u00a0days of onset\u00e2\u0080\u0094are observed in more than one patient out of the first seven enrolled patients, cabozantinib starting dose of 60\u00c2\u00a0mg will be considered too toxic and ruled out (H0: % grade 3\u00e2\u0080\u00935 toxicities\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00895%; nominal p-value: 0.05; actual p-value: 0.044) and 40\u00c2\u00a0mg will be chosen as starting dose of cabozantinib in the subsequent stage. Otherwise, 60\u00c2\u00a0mg will be chosen as starting dose of cabozantinib in the subsequent stage. An interim safety analysis will be performed when 7 patients will be observed on treatment for at least 8\u00c2\u00a0weeks.\n In order to preserve internal validity, outcomes\u00e2\u0080\u0099 assessment will be re-started de novo in the II stage (i.e. I and II stages are distinct phases of an operationally seamless, not inferentially seamless design).\n II-III stage. In stages II-III the optimal Simon two-stage design will be used for both cohorts [35]. The primary endpoint of the II and III stages is ORR according to RECIST version 1.1. Co-primary endpoint will be the evaluation of the percentage of G 3\u00e2\u0080\u00935 toxicities according to NCI-CTCAE version 5.0. Secondary endpoints will be PFS and OS.\n The uninteresting antitumor activity (H0) is fixed in ORR\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00895%. The useful antitumor activity to be detected (H1) is fixed in ORR\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008920%. For both arms (pNET and carcinoids), 10 patients will be accrued in the stage II. If no responses are observed in these 10 patients, the arm will be stopped (nominal type II error\u00e2\u0080\u0089=\u00e2\u0080\u00890.20). Otherwise, other 19 patients will be accrued in stage III, for a total of 29 patients. The null hypothesis will be rejected if 4 or more responses are observed in 29 eligible patients (nominal type I error\u00e2\u0080\u0089=\u00e2\u0080\u00890.05). Considering a drop-out rate of 5% (i.e. eligible patients without the assessment of objective response) the maximum number of enrolled patients will be 69 (including the 7 patients included in the interim analysis after stage I).\n Regarding the safety co-primary endpoint, the null hypothesis to be rejected is a percentage of AEs greater or equal to 20% (i.e. H0:\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008920%, nominal type I error\u00e2\u0080\u0089=\u00e2\u0080\u00890.05) against an alternative hypothesis H1:\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00895%. Because the statistical design is adaptive (i.e. a couple of Simon\u00e2\u0080\u0099s two stage designs are planned after the first run-in stage), the total number of patients that could be analyzed for safety is uncertain prior to study execution. It will be 20 patients if both arms stop at stage II, 39 patients if only one arm stops at stage II and 58 patients if both arms participate to stage III. Thresholds to identify significant level at 5% and exact binomial test\u00e2\u0080\u0099s power will be determined based on the real number of patients to be analyzed (i.e. 0 out of 20 patients [test\u00e2\u0080\u0099s power: 36%], 3 out of 39 patients [test\u00e2\u0080\u0099s power: 87%]; 6 out of 58 patients [test\u00e2\u0080\u0099s power: 97%] are the maximum number of patients with observed G3-G5 AEs to reject H0:\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008920% at a 5% significant level). Patients who did not receive treatment for any cause or severely violated protocol inclusion/exclusion criteria will be excluded from the primary and secondary analyses of all stages.", "id": 793, "split": "val"} +{"trial_id": "NCT04430790", "pmid": "37817255", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Doxapram Versus Placebo in Preterm Newborns: An International Double Blinded Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Apnea of Prematurity\n- Respiratory Insufficiency\n\nStudy Armgroups:\n- {'label': 'Doxapram', 'type': 'EXPERIMENTAL', 'description': \"Blinded doxapram (2mg/ml, in glucose 5%) loading dose of 2.0 to 2.5 mg/kg administered in 5 to 10 minutes, followed by a continuous infusion of 0.5 - 1.0 mg/kg/hr ('www.kinderformularium.nl') as long as needed. Therapy is down titrated or stopped based on the patients' respiratory condition. If endotracheal intubation is needed study drug is stopped. After extubation study drug may be restarted. Switch to gastro-enteral administration is allowed if no iv-access is needed for other reasons.\", 'interventionNames': ['Drug: Doxapram']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo (glucose 5%) will also be administered with a loading dose and continuous infusion (in equal amounts of fluid as in experimental arm) by intravenous or gastro-intestinal infusion. The treatment protocol will be equal to the protocol in the doxapram arm.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Doxapram', 'description': 'Loading dose and continuous doxapram infusion.', 'armGroupLabels': ['Doxapram'], 'otherNames': ['Dopram']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Loading dose and continuous placebo infusion.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Placebo (for Doxapram)']}\n\nPrimary Outcomes:\n- {'measure': 'Death or severe disability', 'description': 'Disability will be defined as cognitive delay, cerebral palsy, severe hearing loss, or bilateral blindness. Cognitive delay will be defined as a Mental Development Index score of less than 85 on the Bayley Scales of Infant and Toddler Development, Bayley Score of Infant Development (BSID) III scores. Cerebral palsy will be diagnosed if the child had a non-progressive motor impairment characterized by abnormal muscle tone and decreased range or control of movements. The level of gross motor function will be determined with the use of the Gross Motor Function Classification System. Audiometry will be performed to determine the presence or absence of hearing loss. Blindness will be defined as a corrected visual acuity less than 20/200', 'timeFrame': '2 years corrected age'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, power over 80%, and a loss to follow-up rate of 10% per treatment arm.", "answer": 396, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation is based on a cohort study that investigated the long-term neurodevelopmental outcome of preterm infants who received doxapram therapy compared to non-treated matched control patients [20]. This paper described that 30% of the doxapram-treated patients had the composite outcome death or neurodevelopmental delay at 2 years corrected age compared to 50.8% in the non-treated control patients. We therefore consider an absolute decrease of 15% in the composite outcome as clinically relevant, and we aim to reduce the outcome from 50 to 35% with a number needed to treat of around 7 patients. With an alpha of 0.05 and a power over 80%, a sample size of 170 patients is needed per treatment arm when we use a continuity correction. Because we expect approximately 10 patients to be part of twins and a loss to follow-up rate (excluding death) of 10% per treatment arm, the sample size is 198 patients per treatment arm, adding up to a total of 396 patients to be included. Next to the formal consent letter, an animation and flyer are designed providing additional study information to optimize consent and to reach the targeted sample size.", "id": 794, "split": "val"} +{"trial_id": "NCT04433104", "pmid": "33986057", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Allogeneic Human Umbilical Cord-derived Mesenchymal Stem/Stromal Cells for Chronic Obstructive Pulmonary Disease (COPD): Study Protocol for a Matched Case-control, Phase I/II Trial\n\nIncluded conditions:\n- COPD\n\nStudy Armgroups:\n- {'label': 'Treatment (UC-MSC trasnplatation)', 'type': 'EXPERIMENTAL', 'description': '1 x 10\\\\^6 umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 3 months after the first transplantation and combination with Vietnames MOH procedure', 'interventionNames': ['Biological: Umbilical Cord Mesenchymal Stem Cells transplantation', 'Drug: drug therapy according to Vietnamese MOHS procedure']}\n- {'label': 'control arm', 'type': 'OTHER', 'description': 'drug therapy according to Vietnamese MOHS procedure', 'interventionNames': ['Drug: drug therapy according to Vietnamese MOHS procedure']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Umbilical Cord Mesenchymal Stem Cells transplantation', 'description': 'Patients assigned to UC-MSC administration groups will receive two administrations at a dose of 1 million cells/kg patient body weight via the IV route with a 3-month intervening interval', 'armGroupLabels': ['Treatment (UC-MSC trasnplatation)']}\n- {'type': 'DRUG', 'name': 'drug therapy according to Vietnamese MOHS procedure', 'description': 'Salbutamol, Terbutaline', 'armGroupLabels': ['Treatment (UC-MSC trasnplatation)', 'control arm']}\n\nPrimary Outcomes:\n- {'measure': 'Adverse events and serious adverse events', 'description': 'To assess safety, the number of AEs or SAEs during stem cell administration (72 h) at 3 months, 6 months, and 12 months after discharge will be evaluated', 'timeFrame': 'up to the 12-month period following treatment'}\n\nPlease estimate the sample size based on the assumption: \n\u03b1 = 0.05, \u03b2 = 0.2", "answer": 40, "answer_type": "ACTUAL", "explanation": "Sample size\n As a previous study indicated that the FEV1 (%) of patients with COPD was reduced to 35.4%\u00c2\u00b17.1% (6% reduction) after 6 months postadministration, we set this indicator at 18% reduction after 12 months postadministration to calculate the minimum sample size for the proposed study.18 21 According to the continuous endpoint of two independent sample studies,22 we assumed \u00ce\u00b1 was 0.05 and type-II error \u00ce\u00b2 was 0.2; thus, the smallest sample size was 40 patients. The calculated sample size was 20 for each group.", "id": 795, "split": "val"} +{"trial_id": "NCT04435938", "pmid": "37098494", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 2 Study of SBRT for Squamous Cell Carcinoma of the Head and Neck\n\nIncluded conditions:\n- Head and Neck Neoplasms\n- Squamous Cell Carcinoma\n- Squamous Skin Carcinoma\n\nStudy Armgroups:\n- {'label': 'Stereotactic Body Radiotherapy (SBRT)', 'type': 'EXPERIMENTAL', 'description': 'The dose prescribed in the study will be 45Gy in 5 fractions, delivered once every 3-4 days, such that treatment is completed within 15 days. (e.g. treatment given on Monday/Thursday/Mon/Thurs/Mon) (Exceptions: treatment duration of up to 18 days will be allowed to account for cancer centre closures and unforeseen patient issues.)', 'interventionNames': ['Radiation: Stereotactic Body Radiotherapy (SBRT)']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Stereotactic Body Radiotherapy (SBRT)', 'description': '45 Gy in 5 fractions delivered once every 3-4 days', 'armGroupLabels': ['Stereotactic Body Radiotherapy (SBRT)']}\n\nPrimary Outcomes:\n- {'measure': 'Tumour response rate', 'description': 'Tumour response rate defined as complete or partial response according to Tumour response rate will be defined by RECIST 1.1 criteria', 'timeFrame': 'The best overall response across all time points during the study period - up to 24 months after completion of SBRT.'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is 0.10, and the power (\u03b2) is 0.10. The true \u03b1 is 0.097 and the true \u03b2 is 0.096. The probability of termination at the end of stage I is 0.467.", "answer": 38, "answer_type": "ESTIMATED", "explanation": "Sample size calculation and assumptions\n Up to a total of 38 patients will participate in this single institution, single arm, phase 2 study. Based on prior research, the response rate for patients treated using the\u00e2\u0080\u00990\u00e2\u0080\u00937-21\u00e2\u0080\u0099 regimen was 82%, however, 6-month progression-free survival was only 39%. Given the expected relative minimal toxicity and ease of treatment using this regimen, a similar response rate of around 80% would be of considerable interest, while a response rate of 60% or lower would indicate that there would not be any interest in studying this regimen further. Hence, for sample size calculations, it will be assumed that H0: p\u00e2\u0080\u0089=\u00e2\u0080\u008960% versus HA: p\u00e2\u0080\u0089=\u00e2\u0080\u008980%, with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.10 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.10. Using the Simon optimal two-stage design, 11 patients will be recruited in the first stage. If 6 or less patients have a response, the study will be stopped at the end of stage I, however, if 7 or more patients have a response the study will continue to stage II, in which an additional 27 patients (for a total of 38) will be recruited. At the end of stage II, if 26 or less patients have a response, then H0 will be accepted and the treatment regimen deemed not worthy of further study, however, if 27 or more patients have a response, the treatment regimen will be recommended for further study in phase III. The true \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.097 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.096 for this design, with a probability of termination at the end of stage I of 0.467.", "id": 796, "split": "val"} +{"trial_id": "NCT04438980", "pmid": "33430891", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial\n\nIncluded conditions:\n- Covid-19 Pneumonia\n\nStudy Armgroups:\n- {'label': 'Methylprednisolone Arm', 'type': 'EXPERIMENTAL', 'description': 'Standard of care plus Methylprednisolone', 'interventionNames': ['Drug: Methylprednisolone']}\n- {'label': 'Placebo Arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Standard of care plus placebo', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Methylprednisolone', 'description': '-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusi\u00f3n', 'armGroupLabels': ['Methylprednisolone Arm']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': '-An infusion bag of 100 mL of 0.9% saline', 'armGroupLabels': ['Placebo Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patients developing treatment failure', 'description': '\u2022 Death', 'timeFrame': 'At 14 days after randomization'}\n- {'measure': 'Proportion of patients developing treatment failure', 'description': '\u2022 Need for admission in an intensive care unit (ICU)', 'timeFrame': 'At 14 days after randomization'}\n- {'measure': 'Proportion of patients developing treatment failure', 'description': '\u2022 Need for mechanical ventilation', 'timeFrame': 'At 14 days after randomization'}\n- {'measure': 'Proportion of patients developing treatment failure', 'description': '\u2022 Decrease in SpO2 \\\\<90% (in ambient air) or PaO2 \\\\<60 mmHg (in ambient air) or PaO2FiO2 \\\\<300 mmHg, associated with radiological impairment', 'timeFrame': 'At 14 days after randomization'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed type I error of 0.05, type II error of 0.2, and a loss to follow-up rate of 20%.", "answer": 72, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n The percentage of patients with treatment failure (primary endpoint) is currently unknown. Assuming an absolute difference of 25% in the primary outcome between the two groups (35% in the control group and 10% in the intervention group), we estimate that 60 patients (30 per group) are required to detect this difference with a two-tailed type I error of 0.05 and a type II error of 0.2. Estimating a loss to follow-up of 20%, we should recruit a total sample size of 72 patients (36 per group).", "id": 797, "split": "val"} +{"trial_id": "NCT04439097", "pmid": "32957420", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Short and Medium-term Effects of a Multicomponent Physical Exercise Program With a Mediterranean Diet on Bone Mineral Density, Gait, Balance, and Fall Risk for Patients With Alzheimer's Disease: Randomized Controlled Clinical Trial Study Protocol\n\nIncluded conditions:\n- Alzheimer Disease\n- Physical Exercise\n- Bone Density\n- Fall\n\nStudy Armgroups:\n- {'label': 'Experimental Group', 'type': 'EXPERIMENTAL', 'description': 'Patients allocated to the intervention group will perform a MPEP during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session. In addition, they will have a Mediterranean Diet.\\n\\nThe patients in the MPEP will be carried out in small groups of 5-8 people. Structure of sessions: 3 different parts: an initial warm-up, a main part and a final cool-down and relaxation.', 'interventionNames': ['Other: Multicomponent physical exercise program associated with a Mediterranean diet']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants allocated to the control group will receive usual care and continue with their life normally, without participating in a standardized exercise program. They will be instructed to maintain their current physical activity level.', 'interventionNames': ['Other: Usual care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Multicomponent physical exercise program associated with a Mediterranean diet', 'description': 'In this basic structure of each sessions, traditional exercises of mobility, strength, balance and coordination are included with the main objective of improving functional capacities. But, besides, games and some activities are also included with the aim, not only of improving the functional capacity, but also working the cognitive functions to reinforce the global effects.\\n\\nThe Mediterranean diet will based in these main foods: 1) vegetables; 2) fruits; 3) fish or seafood; 4) legumes; 5) nuts; 6) bread or cereals; 7) white meat; 8) eggs; and 9)olive oil.', 'armGroupLabels': ['Experimental Group']}\n- {'type': 'OTHER', 'name': 'Usual care', 'description': 'Usual care and participants continue with their life normally, without participating in a standardized exercise program, and they will be instructed to maintain their current physical activity level.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in gait and balance 1', 'description': \"Tinetti's Performance Oriented Mobility Assessment (POMA-T) will be used (points). the original POMA-T 28-point version. It consists of a balance scale (Balance performance oriented mobility assessment (POMA-B) can score 16 points) and a gait scale (Gait performance oriented mobility assessment (POMA-G) can score 12 points )\", 'timeFrame': '6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]'}\n- {'measure': 'Change in gait and balance 2', 'description': 'Timed up and go test (TUG) will be used (s). IT measures the time in seconds for the subjects to get up from a standard armchair, walk 3 metres, turn, walk back to the chair and sit down. The cut-off point for normal mobility is 12 seconds and values \\\\> 30 s indicate a high level of dependence. (a time \\\\<10s it is considered normal; \\\\<20s mobility difficulties and low or moderate risk of falls; \\\\> 20 mobility problems with need of help and high risk of falls)', 'timeFrame': '6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]'}\n- {'measure': 'Change in Bone Mineral Density (BMD)', 'description': 'Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the estimated BMD (g/cm2).', 'timeFrame': '6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]'}\n- {'measure': 'Change in T-Score as primary parameter of bone health', 'description': 'Bone health status will be assessed by ultrasound calcaneus densitometry/sonometry. As primary outcome we will assess the T-Score. A T-score shows how much the BMD is higher or lower than the BMD of a healthy 30-year old adult. (-1.0 or above normal BMD; From -1.0 to -2.5 low BMD or osteopenia; -2.5 or below very low BMD and diagnosis of osteoporosis.', 'timeFrame': '6 months. 4 time points: 1) Baseline (pre-intervention); 2) 1st post-intervention (1 month); 3) 2nd post-intervention (3 months); 4) Final, 3rd post-intervention (6 months)]'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, beta risk of 0.2 (power of 80%), and a dropout rate of 33%.", "answer": 84, "answer_type": "ESTIMATED", "explanation": "2.8\n Sample size calculation\n The sample size calculation has been made based on the potential modification of the score of the POMA-T. For this, we have considered the results obtained in the previous pilot study with 9 patients in a 1-month follow-up, and the preliminary trial with 72 participants with a ratio of 3:1 to the intervention group and the control one during 6 months. In the pilot study, the POMA-T was modified by 1.7 points. Then, in the preliminary trial, we accepted to calculate the sample size, as statistically significant, with a difference greater than or equal to 1.7 points with a dropTout rate of 15%.\n In our current study, the sample size has been estimated to conduct a randomized controlled clinical trial with a 1:1 ratio between the 2 groups. In this new calculation, considering the data from the pilot study and some of the available data from the preliminary trial, we have reduced the minimal detectable change in the POMA-T to 1.5 points, with a standard deviation of 2 points and we have increased the drop-out estimated rate during the study to 33% by the difficulty to avoid intervention biases in the control group fundamentally. Therefore, with this, and accepting an alpha risk of 0.05 and a beta risk of 0.2 in a 2-sided test, 84 subjects are necessary, 42 in each group. The sample size calculation was made with the software \u00e2\u0080\u009cGRANMO sample size and power calculator\u00e2\u0080\u009d (7.12 version).", "id": 798, "split": "val"} +{"trial_id": "NCT04444154", "pmid": "33588930", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of the Effectiveness of 3 Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients: Prospective Randomized Controlled Clinical Study\n\nIncluded conditions:\n- Orthodontic Appliance\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'oral hygiene advice given orally', 'interventionNames': ['Behavioral: Control group']}\n- {'label': 'Group with active participation', 'type': 'ACTIVE_COMPARATOR', 'description': 'oral hygiene advice given orally and demonstration of brushing methods in the sink with active participation', 'interventionNames': ['Behavioral: Group with active participation']}\n- {'label': 'Group with video and quizz', 'type': 'EXPERIMENTAL', 'description': 'oral hygiene advice given orally and an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).', 'interventionNames': ['Behavioral: Group with video and quizz']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Control group', 'description': 'oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment.', 'armGroupLabels': ['Control group']}\n- {'type': 'BEHAVIORAL', 'name': 'Group with active participation', 'description': 'oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with a demonstration of brushing methods in the sink with active participation (use of plate developer and then the Oral B electric toothbrush with special orthodontic head) during the bonding appointment as well than at each check-up appointment.', 'armGroupLabels': ['Group with active participation']}\n- {'type': 'BEHAVIORAL', 'name': 'Group with video and quizz', 'description': 'oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with have an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).', 'armGroupLabels': ['Group with video and quizz']}\n\nPrimary Outcomes:\n- {'measure': 'Compare the effectiveness of 3 methods of teaching oral hygiene in terms of controlling biofilm formation: MOP (Modified Orthodnotic Plaque Index) classification', 'description': \"The average plaque index at six months after inclusion according to the MOP (Modified Orthodnotic Plaque Index) classification. It is evaluated on macro photography in a standardized manner by a blind examiner of the patient's randomization arm. The values range from 0 to 4 for each tooth, which makes an average score of 0 to 48 for the maxillary arch. 0 is the absence of plaque while 48 is an abundance of plaque on all teeth, the worst situation. The score is expressed in absolute value without unit.\", 'timeFrame': '6 months of intervention'}\n\nPlease estimate the sample size based on the assumption: \nrisk alpha = 5%, power of 80%, ANOVA type analysis, 3 groups, possible dropouts", "answer": 90, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size calculation is based on the primary outcome: comparison of the mean MOP between the 3 experimental groups after 6\u00e2\u0080\u0089months of treatment. For a risk alpha\u00e2\u0080\u0089=\u00e2\u0080\u00895%, a power of 80%, an effect size of 0.35, with an ANOVA type analysis and 3 groups, a total of 81 subjects is necessary (27 per group). To consider possible dropouts, we plan to recruit 30 patients per group, i.e., 90 patients in total.", "id": 799, "split": "val"} +{"trial_id": "NCT04444817", "pmid": "32991411", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Impact of Tacrolimus-based Immunosuppression on Heidelberg Liver Transplant Cohort (HDTACRO): Study Protocol for an Investigator Initiated, Non-interventional Prospective Study\n\nIncluded conditions:\n- Liver Transplantation\n\nStudy Armgroups:\n- {'label': 'Tacrolimus-based immunosuppression', 'description': 'Similar to the clinical routine, as soon as a patient is able to swallow and has a sufficient gastrointestinal activity, Tacrolimus-based immunosuppression using Prograf\u00ae, Advagraf\u00ae or Envarsus\u00ae will be started.', 'interventionNames': ['Drug: Tacrolimus']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tacrolimus', 'description': \"Similar to the clinical routine, as soon as a patient is able to swallow and has a sufficient gastrointestinal activity, Tacrolimus-based immunosuppression using Prograf\u00ae, Advagraf\u00ae or Envarsus\u00ae will be started. Furthermore, calcineurin inhibitors-based immunosuppression will be used (initial dose based on the patients' body weight) with the goal of tough levels of 3-7 ng/mL in the first seven days after liver transplantion, depending on immune status and indication for transplantation. Further tough levels will be determined based on factors such as patients' history and indication for liver transplant.\", 'armGroupLabels': ['Tacrolimus-based immunosuppression']}\n\nPrimary Outcomes:\n- {'measure': 'The number of required dose adjustments of Tacrolimus formulations used in clinical routine for achieving the target tough level', 'timeFrame': 'Six months'}\n\nPlease estimate the sample size based on the assumption: \nNo formal sample size estimation was carried out. The study is not confirmatory, and no specific assumptions on significance level, power, or missing/dropout rate were mentioned.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "2.9.1\n Sample size\n Since no confirmatory approach will be followed in this non-interventional study, no formal sample size estimation was carried out. For practical reasons, the number of included subjects was set to 100, which are deemed to be sufficient to provide stable estimates of the primary variable.", "id": 800, "split": "val"} +{"trial_id": "NCT04445935", "pmid": "32895056", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Anticoagulation in Patients Suffering From COVID-19 Disease-The Anti-Co Trial\n\nIncluded conditions:\n- Anticoagulation in COVID-19 ARDS\n\nStudy Armgroups:\n- {'label': 'Standard treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'In this arm the patients will be treated according to our standard anticoagulation protocol.\\n\\nThe patients will not be treated with Bivalirudin (the investigational drug).', 'interventionNames': ['Drug: Standard treatment']}\n- {'label': 'Bivalirudin arm', 'type': 'EXPERIMENTAL', 'description': 'The patients will be anticoagulated according to the institutional HIT-protocol which uses Bivalirudin as anticoagulant.', 'interventionNames': ['Drug: Bivalirudin Injection']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Bivalirudin Injection', 'description': 'The patients will receive iv Bivalirudin according to the institutional HIT protocol.', 'armGroupLabels': ['Bivalirudin arm'], 'otherNames': ['anticoagulation']}\n- {'type': 'DRUG', 'name': 'Standard treatment', 'description': 'This group will receive standard anticoagulation with LMWH/UFH', 'armGroupLabels': ['Standard treatment']}\n\nPrimary Outcomes:\n- {'measure': 'P/F ratio', 'description': 'the P/F ratio is a surrogate parameter for oxygenation in ARDS.', 'timeFrame': 'three days of intervention'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% and a dropout rate of approximately 10% are assumed.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomised (sample size)\n We performed a sample size calculation and assumed the data for P/F ratio (according to literature) is normally distributed and used the mean which would be: 160 and SD is 80. We expect the treatment will improve this by 30%. In order to reach a power of 80% we would need 44 patients per group (in total 88 patients). Taking approximately 10% of dropout into account we will include 100 patients (50 in each group).", "id": 801, "split": "val"} +{"trial_id": "NCT04446585", "pmid": "37816557", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Cluster Randomized Clinical Trial of Strategic AED Deployment in High-risk Residential Areas Combined With Activation of Local Residents\n\nIncluded conditions:\n- Out-Of-Hospital Cardiac Arrest\n\nStudy Armgroups:\n- {'label': 'Control sites', 'type': 'NO_INTERVENTION', 'description': '* For all 1-1-2 calls with suspected cardiac arrest to the emergency dispatch center will activate a two-tiered response consisting of dispatch of an ambulance with an emergency medical technician, a physician-staffed mobile emergency care unit, and citizen first responders through the Heart Runner app.\\n* The medical dispatcher offers telephone assisted cardiopulmonary resuscitation (CPR) to bystanders. Furthermore, if more than two bystanders are present and an AED is accessible within 1\u00bd minute travel distance (depending on the type of terrain), then one bystander is guided to localize and retrieve the AED.'}\n- {'label': 'Intervention sites', 'type': 'EXPERIMENTAL', 'description': 'As a supplement to the standard care as described in the control arm, the following will be supplied:\\n\\n* Strategical deployment of AEDs with 24:7 availability and 1\u00bd minute walking distance to every residence within the area. The AEDs will be registered with the AED network and thus linked to the emergency dispatch center.\\n* The emergency dispatch center will retrieve data from used AEDs.\\n* For each interventional area, approximately 120 residents will receive a course in CPR and AED use and subsequently be recruited as citizen responders so that they can be activated through the HeartRunner app in case of a nearby cardiac arrest.', 'interventionNames': ['Device: Automated External Defibrillator (AED)', 'Other: Training in cardiopulmonary resuscitation and AED use', 'Other: Activation of citizen responders']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Automated External Defibrillator (AED)', 'description': 'Deployment of AEDs', 'armGroupLabels': ['Intervention sites']}\n- {'type': 'OTHER', 'name': 'Training in cardiopulmonary resuscitation and AED use', 'description': 'Residents will undergo 30-minute courses at study start and if needed during the trial period. During the course they will also be recruited as citizen responders', 'armGroupLabels': ['Intervention sites']}\n- {'type': 'OTHER', 'name': 'Activation of citizen responders', 'description': 'Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app.', 'armGroupLabels': ['Intervention sites']}\n\nPrimary Outcomes:\n- {'measure': 'Bystander defibrillation', 'description': 'Proportion of bystander defibrillation of witnessed cardiac arrests', 'timeFrame': 'Up to five years after implementation of the intervention'}\n\nPlease estimate the sample size based on the assumption: \nDesired power of 80%, significance level of 5%, varying ICCs and effect sizes, study duration of 5 years.", "answer": 260, "answer_type": "ESTIMATED", "explanation": "Sample size\n From 2016 to 2018, 167 witnessed OHCAs occurred within the areas in which one received bystander defibrillation. Based on prior evidence and assessed clinical relevance, we will strive to improve the proportion of patients with bystander-witnessed OHCA who receive bystander defibrillation from 1% to 10%.46 With the desired power of 80% and a significance level of 5%, power calculations were conducted with varying ICCs and effect sizes to determine a conservative sample size estimation (see online supplemental material B). We estimate study duration of 5\u00e2\u0080\u0089years which should ensure 260 OHCAs.", "id": 802, "split": "val"} +{"trial_id": "NCT04446611", "pmid": "35610666", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes\n\nIncluded conditions:\n- Sexually Transmitted Infection\n- HIV/AIDS\n- Cost-effectiveness\n- Birth Outcomes\n- Vaginal Microbiome\n- Neisseria Gonorrhoeae\n- Chlamydia Trachomatis\n- Trichomonas Vaginalis\n- Antenatal Care\n- Pregnancy\n\nStudy Armgroups:\n- {'label': 'Test at 1st ANC + Test-of-Cure (Treatment 1)', 'type': 'EXPERIMENTAL', 'description': 'Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment', 'interventionNames': ['Diagnostic Test: First antenatal care + test-of-cure']}\n- {'label': 'Test at 1st ANC + 30-34 gestation (Treatment 2)', 'type': 'EXPERIMENTAL', 'description': 'Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation', 'interventionNames': ['Diagnostic Test: First antenatal care + week 30-34 gestation (no test-of-cure)']}\n- {'label': 'Syndromic Management (Control)', 'type': 'NO_INTERVENTION', 'description': 'Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'First antenatal care + test-of-cure', 'description': 'Single point-in-time molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and infection-specific test-of-cure 3 weeks post-treatment. Women with a positive test-of-cure will be re-treated. As CT/NG is a combined Xpert test, women who present with an incident infection (newly diagnosed infection) will be treated and managed accordingly.', 'armGroupLabels': ['Test at 1st ANC + Test-of-Cure (Treatment 1)']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'First antenatal care + week 30-34 gestation (no test-of-cure)', 'description': 'Repeated molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and at week 30-34 gestation. No test-of-cure will be conducted for women with positive test results; however, additional treatment will be provided to women with persistent/recurrent vaginal discharge.', 'armGroupLabels': ['Test at 1st ANC + 30-34 gestation (Treatment 2)']}\n\nPrimary Outcomes:\n- {'measure': 'Frequency of adverse birth outcomes among study arms', 'description': 'Adverse birth outcomes as defined by a composite measure of preterm birth (born alive before 370/7 weeks gestation) or low birth weight (less than 2500g) as recorded in the maternity case records', 'timeFrame': 'Recorded within 2 weeks of delivery'}\n\nPlease estimate the sample size based on the assumption: \nThe calculations assume a significance level that provides at least 80% power, with base rates for adverse birth outcomes ranging from 30 to 50% and pregnancy STI rates from 30 to 50%. An attrition rate of 15% is also assumed.", "answer": 2500, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculations\n Aim 1 analyses will explore intervention effects on reducing probabilities for adverse birth outcomes and STI prevalence at time of delivery. Based on a total sample size of 2500 participants (833\u00e2\u0080\u0093834 participants in each study arm), calculations show that we will have at least 80% power to detect study arm absolute differences of approximately 10% or larger in the frequency of adverse birth outcomes. We conducted two sets of calculations. (1) Calculations for the probability of an adverse birth event were conducted in PASS 2008 software (https://www.ncss.com/) for differences in proportions at a single time point (i.e., at birth). Calculations were run for a range of base rates ranging from 30 to 50%; this is in line with base rates from preliminary data (~\u00e2\u0080\u008940%). (2) We calculated changes in STI prevalence based on two time points (i.e., first ANC visit and birth) and conducted simulation studies in two steps. First, we simulated STI data from a binomial distribution with parameter values based on preliminary data. Preliminary results gave pregnancy STI rates around 40%; simulations used a range of pregnancy STI rates from 30 to 50%. Based on preliminary data, we anticipate that the intervention will reduce STI rates by 20% (absolute). We assumed an attrition rate of 15%.", "id": 803, "split": "val"} +{"trial_id": "NCT04447352", "pmid": "34715810", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventive HIPEC in Combination With Perioperative FLOT Versus FLOT Alone for Resectable Diffuse Type Gastric and Gastroesophageal Junction Type II/III Adenocarcinoma - The Phase III \"PREVENT\" Trial of the AIO /CAOGI /ACO\n\nIncluded conditions:\n- Gastric Cancer\n- Gastroesophageal Junction Adenocarcinoma\n\nStudy Armgroups:\n- {'label': 'Arm A - FLOT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to treatment Arm A already received 3-6 cycles of FLOT in 2-week treatment cycles prior to undergoing surgery. Following surgery, patients will receive four further 2-week cycles FLOT. FLOT can be deescalated to FLO, FLT or FL in case of chemorelated toxicity at any time and at the discretion of investigator.\\n\\nFLOT = Docetaxel 50 mg/m\u00b2, Oxaliplatin 85 mg/m\u00b2, Leucovorin 200 mg/m\u00b2, 5-FU 2600 mg/m\u00b2.', 'interventionNames': ['Drug: 5-Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin', 'Drug: Docetaxel']}\n- {'label': 'Arm B - FLOT/HIPEC', 'type': 'EXPERIMENTAL', 'description': 'Patients randomized to treatment Arm B already received 3-6 cycles of FLOT in 2-week treatment cycles prior to undergoing surgery including Intraoperative Hyperthermic IntraPEritoneal Chemoperfusion (HIPEC) during gastric-/ esophagogastric resection using Cisplatin 75mg/m\u00b2. Following surgery, patients will receive four further 2-week cycles FLOT. FLOT can be deescalated to FLO, FLT or FL in case of chemorelated toxicity at any time and at the discretion of investigator.\\n\\nFLOT = Docetaxel 50 mg/m\u00b2, Oxaliplatin 85 mg/m\u00b2, Leucovorin 200 mg/m\u00b2, 5-FU 2600 mg/m\u00b2.', 'interventionNames': ['Drug: 5-Fluorouracil', 'Drug: Leucovorin', 'Drug: Oxaliplatin', 'Drug: Docetaxel', 'Drug: Cisplatin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '5-Fluorouracil', 'description': 'Day 1 q2w: 2600 mg/m\u00b2 IV over 24 hours', 'armGroupLabels': ['Arm A - FLOT', 'Arm B - FLOT/HIPEC'], 'otherNames': ['5-FU']}\n- {'type': 'DRUG', 'name': 'Leucovorin', 'description': 'Day 1 q2w: 200 mg/m\u00b2 IV over 30 minutes', 'armGroupLabels': ['Arm A - FLOT', 'Arm B - FLOT/HIPEC'], 'otherNames': ['Calciumfolinat']}\n- {'type': 'DRUG', 'name': 'Oxaliplatin', 'description': 'Day 1 q2w: 85 mg/m\u00b2 IV over 2 hours', 'armGroupLabels': ['Arm A - FLOT', 'Arm B - FLOT/HIPEC']}\n- {'type': 'DRUG', 'name': 'Docetaxel', 'description': 'Day 1 q2w: 50 mg/m\u00b2 IV over 1 hour', 'armGroupLabels': ['Arm A - FLOT', 'Arm B - FLOT/HIPEC']}\n- {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'intraoperative: 75mg/m\u00b2 intraabdominal solution over 1 hour and 30 minutes', 'armGroupLabels': ['Arm B - FLOT/HIPEC']}\n\nPrimary Outcomes:\n- {'measure': 'Comparison of progression-/disease-free survival (PFS/DFS) between arms', 'description': 'To compare PFS/DFS in patients with localized and advanced diffuse or mixed type adenocarcinoma of the stomach and Type II/III GEJ (i.e. \u2265cT3 any N or any T N-positive) with exclusion of distant metastases and after receiving neoadjuvant FLOT- therapy will be included in this trial after a central review, receiving 3-6 cycles perioperative FLOT versus FLOT alone in the intent to treat population (ITT) and where PFS/DFS is defined as the time from randomization to disease progression or relapse after surgery or death from any cause.', 'timeFrame': 'from randomization up to 5 years'}\n\nPlease estimate the sample size based on the assumption: \nType I error is 5% and one-sided Log rank test is used. Statistical power is 80%. Dropouts prior to randomization are set at 35%. Dropouts after randomization are set at 5%. Accrual time is 42 months followed by 2 years follow up period.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary efficacy analysis will compare randomized surgical resection combined with HIPEC to randomized surgical resection only on the time to the primary efficacy endpoint using the intent-to-treat population. The hypothesis test will use the log rank test to compare the investigational arms. The study assumes a Hazard ratio of 0.65 favoring the HIPEC group. The PFS/DFS in the reference arm is set as 20.19\u00e2\u0080\u0089months (calculation on complete data from study FLOT4) for signet ring cell containing gastric cancers. Accrual time is 42\u00e2\u0080\u0089months followed by 2\u00e2\u0080\u0089years follow up period. Dropouts prior to randomization are set at 35%. Dropouts after randomization are set 5%. Type I error is 5% and one-sided Log rank test is used. Two hundred patients are to be randomized to provide a statistical power of 80%. These 200 patients will be recruited in 20 German sites with already proven experience in conducting HIPEC procedure.", "id": 804, "split": "val"} +{"trial_id": "NCT04448366", "pmid": "34880026", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Behavioral Therapy to Improve Quality of Life After Surgical Treatment of Women With Endometriosis\n\nIncluded conditions:\n- Endometriosis\n- Quality of Life\n- Pain\n\nStudy Armgroups:\n- {'label': 'Cognitive behavioral therapy group', 'type': 'EXPERIMENTAL', 'description': 'Patients in this group will undergo a total of 7 sessions of CBT in 5 months in addition to usual care.', 'interventionNames': ['Behavioral: Cognitive behavioral therapy']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Patients in this group will undergo usual care only.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive behavioral therapy', 'description': 'Patients in the CBT group will receive usual care. In addition, they will undergo one pre-surgery and six post-surgery face-to-face sessions of CBT. In the pre-surgery session, management of expectations towards surgery will be addressed. In the six post-surgery sessions, attention will be paid to psycho-education concerning the biological link between endometriosis-related pain and stress, relaxation training, cognitive stress management, and management of anxiety, catastrophizing and hypervigilance. The CBT sessions will be coordinated by a registered psychotherapist who is experienced in CBT and has knowledge about endometriosis. All CBT will be individual sessions.', 'armGroupLabels': ['Cognitive behavioral therapy group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30', 'description': 'The Endometriosis Health Profile 30 (EHP-30) is a disease-specific QoL questionnaire which is validated for use in endometriosis patients and measures the impact of the disease on physical, mental and social aspects of life.\\n\\nThe EHP-30 is not a numerical scale.', 'timeFrame': '7,5 months'}\n- {'measure': 'Change in general Quality of Life assessed by the Short Form 36', 'description': 'The Short Form 36 (SF-36) is a multipurpose, general health survey which is applied to measure QoL on nine different domains: physical functioning, social functioning, role limitations due to physical health, role limitations due to emotional problems, emotional well-being, vitality, pain, general health, and health change.\\n\\nThe SF-36 is not a numerical scale.', 'timeFrame': '7,5 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, power (1-\u03b2) = 0.85, and a dropout rate of 19%.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The calculation for the required sample size was performed for the primary endpoint QoL. There was no study available describing the effect size of CBT on QoL after endometriosis surgery which could be used in the sample size calculation. Therefore, we used a study in which the authors examine a cognitive behavioural intervention to improve QoL in patients undergoing surgery due to chronic back pain.13 Based on this article we expect to find medium to large effect sizes (Cohen\u00e2\u0080\u0099s d) of 0.75 and 1.35 (measured with the physical and mental component scales of the 12-Item Short-Form Health Survey) of postoperative CBT compared with usual care-only on QoL regarding physical and mental health, respectively. Based on literature we expect the dropout rate to be 15%\u00e2\u0080\u009316%.14 15 However, due to the intensity of the intended intervention combined with surgery we anticipating patient dropout to be higher: 19%. Therefore, a total of 100 patients should be included to detect significant effects (\u00ce\u00b1=0.05, power (1-\u00ce\u00b2)=0.85).", "id": 805, "split": "val"} +{"trial_id": "NCT04448808", "pmid": "37147642", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Treating Nightmares in Posttraumatic Stress Disorder with Dronabinol: a Randomized Controlled Study (THC PTSD-trial)\n\nIncluded conditions:\n- Posttraumatic Stress Disorder\n\nStudy Armgroups:\n- {'label': 'BX-1 (dronabinol)', 'type': 'EXPERIMENTAL', 'description': 'BX-1', 'interventionNames': ['Drug: BX-1']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo of BX-1', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'BX-1', 'description': 'BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.', 'armGroupLabels': ['BX-1 (dronabinol)']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo of BX-1, oral solution', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Frequency and intensity of nightmares', 'description': 'Frequency and intensity of nightmares, measured with the Clinician-Administered PTSD Scale-IV (CAPS-IV) B2 score for the last week, range 0-8. A lower score indicates less frequent and/or intense nightmares.', 'timeFrame': '10 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a two-sided, two-sample t-test with a power of 0.8. An adjustment for baseline scores in an ANCOVA model is applied. A 10% dropout rate is assumed.", "answer": 176, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on the primary endpoint \u00e2\u0080\u009cClinician-Administered PTSD Scale-IV (CAPS-IV) B2 score at 10\u00c2\u00a0weeks\u00e2\u0080\u009d in the full analysis set including all randomized patients who received the study medication at least once. The aim is to show a lower average score at 10\u00c2\u00a0weeks in the intervention group (I) than in the control group (C). Sample size calculation will be based on a two-sided, two-sample t-test. Adjustment for baseline scores in an ANCOVA model which is applied for the primary efficacy analysis will increase the power compared with a two-sample t-test, which ignores the influence of different baseline values. Therefore, this strategy for sample size calculation is a conservative procedure. In a random-effects meta-analysis of four RCTs investigating the effect of prazosin on PTSD nightmares, a combined standardized mean difference (Cohen\u00e2\u0080\u0099s d) of 0.5 (95% CI\u00e2\u0080\u0089=\u00e2\u0080\u00890.03\u00e2\u0080\u00930.96) was observed [1]. We conservatively assume a standardized effect which is a little smaller and given by 0.45. This assumed effect can be considered as clinically relevant because distressing nightmares are an independent risk factor for comorbidity and severity in PTSD patients. Nightmares also contribute to alcohol and substance abuse, suicidal ideation, and even completed suicide [17]. As studies assessing minimal clinically important difference (MCID) for reduction of nightmares in PTSD are currently missing, clinical significance cannot be used to calculate sample size.\n The required sample size to detect this effect of 0.45 with a power of 0.8 is 158 (79 per group) calculated with nQuery Version 8.2.1.0. We conservatively assume that there will be no more than 10% of patients who are randomized but never get the study medication. Therefore, the total number of patients to be recruited is 176 (158/176\u00e2\u0080\u0089=\u00e2\u0080\u00890.9) or 88 per group.", "id": 806, "split": "val"} +{"trial_id": "NCT04452864", "pmid": "35962371", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Can a Serious Game-based Cognitive Training Attenuate Cognitive Decline Related to Alzheimer's Disease\n\nIncluded conditions:\n- Alzheimer Disease\n- Dementia\n- Mild Cognitive Impairment\n\nStudy Armgroups:\n- {'label': 'Study Intervention', 'type': 'EXPERIMENTAL', 'description': 'The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months this group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site.', 'interventionNames': ['Device: Computerized Cognitive Training']}\n- {'label': 'Active Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'This control study arm will watch documentaries at home for three months (each day for 20 minutes) , instead of performing the CCT and serve as active control group. This group will also train with the CCT tasks after these three months.', 'interventionNames': ['Device: Documentaries with delayed Computerized Cognitive Training']}\n- {'label': 'Wait-List Control', 'type': 'OTHER', 'description': 'This control study arm will start with the CCT with a delay of three months and serve as wait-list control group.', 'interventionNames': ['Device: Computerized Cognitive Training']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Computerized Cognitive Training', 'description': 'The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.', 'armGroupLabels': ['Study Intervention', 'Wait-List Control']}\n- {'type': 'DEVICE', 'name': 'Documentaries with delayed Computerized Cognitive Training', 'description': 'The active control group watches documentaries for three months before starting with the CCT.', 'armGroupLabels': ['Active Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in AD specific component score', 'description': 'The outcome is quantified by an AD component score including measures of EM (auditory verbal learning), SM (verbal fluency, naming task) and spatial abilities (Rey-Osterrieth complex figure test). These scores will be assessed four times, before the training as well as after three, six and nine months by tablet-based cognitive tests. A short follow-up assessment will be performed after a total of 12 months which does not include primary outcome measure.', 'timeFrame': 'The primary endpoint will be assessed four times, with breaks of three months in between. Primary outcome will be assessed up to 9 months.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 5%, Power = 80%, Non-sphericity correction factor = 0.75", "answer": 162, "answer_type": "ACTUAL", "explanation": "Sample size\n For our primary analysis (\u00e2\u0080\u009cDoes change in performance on the three typical AD domains 3 months after the start of the training differ between groups?\u00e2\u0080\u009d), a repeated- measures ANOVA is planned (3 groups with 2 time points). We computed the necessary sample size using G*Power [66] to ensure a power of 80% to detect an assumed moderate effect (i.e. effect size: \u00ce\u00b72\u00e2\u0080\u0089=\u00e2\u0080\u00890.06, f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25) with \u00ce\u00b1 of 5%. The power analysis revealed a total sample size of 162 (54 participants per group). Moreover, we performed a power analysis for testing the interaction between the groups and all four time points within a repeated-measures ANOVA using the same parameters as before (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00895%, power\u00e2\u0080\u0089=\u00e2\u0080\u008980%, \u00ce\u00b72\u00e2\u0080\u0089=\u00e2\u0080\u00890.06) as well as a non-sphericity correction factor of 0.75. According to this power analysis a total sample size of 96 (32 participants per group) is needed.", "id": 807, "split": "val"} +{"trial_id": "NCT04455360", "pmid": "33203440", "question": "Here is the design of a clinical trial:\n\nOfficial Title: EMERALD: Can a Virtual Eye Movement Desensitisation and Reprocessing Intervention Improve Psychological Outcome Following Covid-19 Related Critical Illness: A Feasibility Trial\n\nIncluded conditions:\n- Post Traumatic Stress Disorder\n- Intensive Care Psychiatric Disorder\n- Anxiety Disorders\n- Depression\n- Critical Care\n- COVID\n\nStudy Armgroups:\n- {'label': 'EMDR R-TEP intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive a minimum of 2 and a maximum of 8 online EMDR R-TEP sessions, starting within 3-months of hospital discharge. Sessions will be delivered online by experienced, suitably trained and registered psychological practitioners.', 'interventionNames': ['Other: Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol']}\n- {'label': 'Standard care', 'type': 'NO_INTERVENTION', 'description': 'Patients will receive standard post-hospital discharge care.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol', 'description': 'EMDR is a form of psychotherapy treatment whereby the client verbally relates a narrative of a traumatic episode or emotionally disturbing material in brief sequential doses while simultaneously focusing on an external stimulus. The EMDR Recent-Traumatic Events protocol (R-TEP) aims to enable an individual to process memories of the event in order to reduce psychological morbidity. EMDR R-TEP should be delivered within 3-months of the onset of a traumatic event.', 'armGroupLabels': ['EMDR R-TEP intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of recruitment, intervention adherence, incidence of treatment related adverse events and trial completion to final assessment timepoints', 'description': 'Feasibility will be determined by the following measures:\\n\\n1. Able to recruit \\\\>30% of eligible patients approached\\n2. Complete early EMDR intervention programme in 75% or more of trial participants randomised to intervention.\\n3. Protocol adherence\\n4. Assignment of causality of serious events will be assessed by the chief investigator. Events attributable to trial procedures will be reviewed by trial management board, study sponsor and the research ethics committee, in order to determine ongoing feasibility.\\n5. Outcome measures completed in 75% or more of trial participants', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \n25% mortality/loss to follow-up.", "answer": 26, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n This is a feasibility study, the results of which will be used to power a definitive study if appropriate. We anticipate a 25% mortality /loss to follow-up. A total of 26 patients will be recruited to this study, 13 patients in each arm.", "id": 808, "split": "val"} +{"trial_id": "NCT04456348", "pmid": "35773649", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Association Between Gait Features Assessed by Artificial Intelligent System and Cognitive Function Decline in the Patients of Silent Cerebrovascular Disease: A Multicenter Prospective Cohort Study\n\nIncluded conditions:\n- Silent Stroke\n\nStudy Armgroups:\n- {'label': 'positive', 'description': 'Subjects have gait disorder according to intelligent gait assessment at baseline.', 'interventionNames': ['Other: there is no intervention']}\n- {'label': 'negative', 'description': \"Subjects don't have gait disorder according to intelligent gait assessment at baseline.\", 'interventionNames': ['Other: there is no intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'there is no intervention', 'description': 'There is no intervention', 'armGroupLabels': ['negative', 'positive']}\n\nPrimary Outcomes:\n- {'measure': 'Change in cognitive assessment scale score(MMSE)', 'description': 'It will be assessed by the Mini-Mental state examination (MMSE), which is scored 0-30.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nTest efficiency (1-beta) is 90%, test level (alpha) is 0.05, and an estimated 20% shedding rate.", "answer": 1600, "answer_type": "ESTIMATED", "explanation": "Sample size\n Referring to previous studies of cognitive decline among patients with SCD [19\u00e2\u0080\u009323], we assume that the MMSE score will decrease by 0.5\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00890.5 points in the normal gait group and 0.7\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891.2 points in the abnormal gait group within 1\u00e2\u0080\u0089year; the ratio of abnormal gait to normal gait among outpatients with SCD is 1:2. Test efficiency 1-beta is set at 90%, while test level alpha is set at 0.05. An estimated 20% shedding rate, sample size of 1050 patients with a normal gait and 550 patients with an abnormal gait will be required. Therefore, a total of 1600 patients will be included.", "id": 809, "split": "val"} +{"trial_id": "NCT04457895", "pmid": "38191246", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Open-labelled, Controlled Trial Evaluating the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Experimental arm', 'type': 'EXPERIMENTAL', 'description': 'For experimental arm patients, there will be a 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yoga (the first on site and by videoconference for the others).\\n\\nStarting the first day of the yoga practice there will be one daily 15 min session at home with \"My Yoga Guide\" and the audio guide during 12 weeks.', 'interventionNames': ['Behavioral: educational yoga program']}\n- {'label': 'control arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'The control arm patients will have standard care. They will be proposed to participate in the physical therapy - yoga - educational program after the end of the study.', 'interventionNames': ['Other: no intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'educational yoga program', 'description': 'Daily 15-min yoga sessions at home with the \"Le guide du yoga\" and the audio-guide, during 12 weeks.\\n\\nOne 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yog (the first on site and by videoconference for the others)', 'armGroupLabels': ['Experimental arm']}\n- {'type': 'OTHER', 'name': 'no intervention', 'description': 'no yoga session at home and no yoga -therapeutic educatuion session', 'armGroupLabels': ['control arm']}\n\nPrimary Outcomes:\n- {'measure': 'the efficacy of a combined intervention of physical therapy and yoga, including patient education with a control group for confirmed osteoarticular and/or musculoskeletal pain (\u22654) due to hormone therapy in patients treated for breast cancer.', 'description': 'Rate of patients with a 2-point reduction on the Numeric Pain Rating Scale (NPRS) of osteoarticular and/or musculoskeletal pain due to hormonal therapy treatment between T0 (inclusion) and T2 (end of treatment).', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a bilateral alpha risk of 5%, a power of 80%, and an allowance for 10% potentially non-evaluable patients.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on the comparison of the proportion of patients who will report a reduction of at least two units of their osteoarticular and/or musculoskeletal pain due to HT between T0 and T2 in each group, assessed on the NPRS from 0 to 10. Indeed, a reduction of two units measured on the NPRS is considered as the minimal clinically important difference in chronic musculoskeletal pain intensity.38 To detect a difference of 25% between the control and the experimental groups (15% vs 40%) and based on a bilateral alpha risk of 5%, with a power of 80%, 98 patients, 49 per group, would be required. Accounting for 10% of potentially non-evaluable patients, 108 patients are to be included in the study, with 54 patients per group.", "id": 810, "split": "val"} +{"trial_id": "NCT04457908", "pmid": "35332042", "question": "Here is the design of a clinical trial:\n\nOfficial Title: the Effectiveness and Cost Effectiveness in Screening Gait Disorder of Silent Cerebrovascular Disease Assisted by Artificial Intelligent System and Clinical Doctors - A Randomized Parallel-controlled Study\n\nIncluded conditions:\n- Silent Stroke\n\nStudy Armgroups:\n- {'label': 'intelligent', 'type': 'OTHER', 'description': 'receive the neurological function assessment by artificial intelligence', 'interventionNames': ['Diagnostic Test: intelligent assessment']}\n- {'label': 'manual', 'type': 'NO_INTERVENTION', 'description': 'receive the neurological function assessment by doctor'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'intelligent assessment', 'description': 'intelligent neurological function assessment', 'armGroupLabels': ['intelligent']}\n\nPrimary Outcomes:\n- {'measure': 'Sensitivity', 'description': 'Compared with the gold standard panel of neurology, the sensitivity of the intelligent system and clinicians to screen for gait disorders', 'timeFrame': 'baseline'}\n\nPlease estimate the sample size based on the assumption: \nThe power is 80% (1-\u03b2=0.80) and the significance level is \u03b1=0.05. The expected shedding (dropout) rate is 6%.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Sample size\n This study is a 1:1 superiority trial. Referring to the preliminary study of gait disorder in SCD and our group, we expect that the sensitivity of doctors and intelligent assistants will be 85%, while the sensitivity of the doctor group will be 68%. The power is 1\u00e2\u0088\u0092\u00ce\u00b2=80%, with a significance level of \u00ce\u00b1=0.05. According to our calculations, there should be 94 positive cases evaluated by the gold standard in each group. The expected shedding rate is 6%; therefore, each group required 100 positive cases. Considering that the positive rate of gait disorder in the population is approximately 20%, a total of 1000 subjects should be included. NCSS Statistical Software 2021 was used to calculate sample size. (https://www.ncss.com/)\n There are 14 subcentres for the two regions in our study, including three secondary and three tertiary hospitals in Shanghai, and four secondary and four tertiary hospitals in Guizhou. The expected ratio of patients in secondary and tertiary hospitals is 1:2; in principle, no less than 30 subjects should be enrolled in each centre and 400 subjects for each region.", "id": 811, "split": "val"} +{"trial_id": "NCT04458207", "pmid": "34107933", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Older Adults - an Intervention Study\n\nIncluded conditions:\n- Chewing Problem\n- Cognitive Decline\n- Magnetic Resonance Imaging\n- Degenerative; Dementia\n- Mastication Disorder\n- Neurocognitive Dysfunction\n\nStudy Armgroups:\n- {'label': 'Experimental group (EG), the immediate rehabilitation group', 'type': 'EXPERIMENTAL', 'description': 'The experimental group will begin with the rehabilitation immediately after the first measurement of cognitive tests (pre-test). Three months after complete rehabilitation the first post-test (post-test 1) will be conducted on all participants. Participants will be recalled after about a year for a long-term follow up (post-test 2). The OHIP-14, chewing function test, saliva samples, neuropsychological assessments together with MRI assessments will also be recorded at different time points (i.e., pre-test, post-test 1 and post-test 2).', 'interventionNames': ['Procedure: Oral prosthetic rehabilitation']}\n- {'label': 'Control group (CG), the test-retest group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control group will be tested with the cognitive tests two times (pre-test + post-test 1) at an interval of about three months or more inbetween tests and before the onset of the prosthodontic rehabilitation. Three months after complete rehabilitation the post-test (post-test 2) will be conducted on all participants. Further, participants will be recalled after about a year for a long-term follow up (post-test 3). The OHIP-14, chewing function test, saliva samples, neuropsychological assessments together with MRI assessments will also be recorded at these time points (i.e., pre-test, post-test 1, post-test 2 and post-test 3).', 'interventionNames': ['Procedure: Oral prosthetic rehabilitation']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Oral prosthetic rehabilitation', 'description': 'Individual treatment options will be discussed with the participants individually and rehabilitation will be provided as agreed by the dentist and the participant. The rehabilitation will include fixed prosthodontics. The procedures will involve a control phase involving scaling, root planing oral hygiene instructions etc., extractions and bone augmentation when needed and temporary removable dentures. Restoration of the lost vertical dimension (if needed) with occlusal splints, tooth preparations, placement of dental implants (if needed) and finally cementation of dental crowns. The rehabilitation phase is estimated to take approximately 3-18 months, or more.', 'armGroupLabels': ['Control group (CG), the test-retest group', 'Experimental group (EG), the immediate rehabilitation group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Brief Visuospatial Memory Test Revised (BVMT-R)', 'description': 'Measuring non-verbal episodic memory. Measured in correct answers. Score: 0-36. A high score indicates a better performance.', 'timeFrame': '1: Baseline pre-test. 2: Change pre-test/post-test1, CG 3months after baseline, EG 3months after intervention (Int). 3: Change post-test1/post-test2, CG 3months after Int, EG 1year after Int. 4: Change post-test1/post-test2, CG 1year after Int.'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u00ce\u00b1) set to 0.05, power at 0.80, and a moderate dropout rate of 20-25%.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n No studies are currently available that directly compare rehabilitation of chewing function with a control condition on neurocognitive measures. We, therefore, designed our RCT as a superiority trial with enough statistical power to detect a difference in outcome between treatments (if present) with a medium effect size (partial eta square, eta2). For the longitudinal analysis that assesses rehabilitation differences, we expect an effect size (partial eta square, eta2) on the NA of at least 0.06. With \u00ce\u00b1 set to 0.05 and power at 0.80, a sample of 30 participants in each group is required. The power calculation of the repeated measures analysis is estimated with within-participant factors, which also controls for the between-participant variance. However, due to the moderate rate of dropouts (20\u00e2\u0080\u009325%) observed across different ongoing studies, optional non-participation of MRI screening, and technical difficulties (e.g., movement artifacts) during brain imaging, we estimate that inclusion of 40 participants in each group is required to meet the demands for statistical power. However, only the first 20 participants willing and eligible to participate in the MRI procedures in each group will undergo brain imaging due to practical and logistical reasons. The MRI acquisitions are optional since there are more contraindications medically and patients are more reluctant to participate. By making MRI optional participants can still be included in the study when MRI acquisitions are not feasible.", "id": 812, "split": "val"} +{"trial_id": "NCT04461301", "pmid": "36596634", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial).\n\nIncluded conditions:\n- Frail Elderly Syndrome\n- Major Surgery\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Patients that meet the inclusion criteria will be randomised and scheduled for surgery at least 2 weeks after the diagnosis/decision to proceed to surgery. This timeframe allows the implementation of a minimal 2 weeks (up to 4 weeks) multidisciplinary prehabilitation program. Prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. An individual treatment strategy will be proposed to the patient by a multidisciplinary team consisting of surgeon, anesthesiologist, dietitian and physiotherapist.', 'interventionNames': ['Procedure: Multimodal Prehabilitation']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Perioperative care of the control group will be based on standardized, multi-element, ERAS recommendations as already implemented in the different participating clinics.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Multimodal Prehabilitation', 'description': 'A multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Comprehensive Complication Index (CCI)', 'description': 'The comprehensive complication index (value from 0 = no complication to 100 = death) is a valuable, validated index for the assessment of multiple postoperative complications. It has been developed based on Swiss hospital data and has been validated internationally.', 'timeFrame': '30 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level alpha of 0.05, power of 0.80, and a dropout rate of 20%.", "answer": 466, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on internal data (Bern University Hospital), median CCI is expected to be 30 (IQR 21\u00e2\u0080\u009337). Assuming an average clinically relevant improvement of 15% in the intervention group compared with the control group, the sample size calculation for a non-parametric Wilcoxon-Mann-Whitney test resulted in a total patient sample of 388 (assuming a significance level alpha of 0.05 and power of 0.80). We expect a dropout rate of 20%. We, therefore, need 466 patients: 233 in each arm. We aim to complete the inclusion within 3 years.", "id": 813, "split": "val"} +{"trial_id": "NCT04462666", "pmid": "35365187", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oral Huzhang Granules for Acute Gouty Arthritis: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial\n\nIncluded conditions:\n- Gouty Arthritis\n\nStudy Armgroups:\n- {'label': 'HZG intervention', 'type': 'EXPERIMENTAL', 'description': 'During the 5-day treatment period, participants in the Experimental group will receive 10 sacks of experimental granules. They will be instructed to take two sacks per day, one in the morning and one in the evening, in approximately 30 minutes after the meal.. The placebo etoricoxib will also be taken daily in the morning for 5 days.', 'interventionNames': ['Drug: Huzhang granule', 'Drug: Etoricoxib Placebo']}\n- {'label': 'Etoricoxib intervention', 'type': 'ACTIVE_COMPARATOR', 'description': 'During the 5-day treatment period, participants in the Etoricoxib group will receive 5 Etoricoxib capsules. They will be instructed to take one capsule per day in the morning, at approximately 30 minutes after the meal. The placebo HZKL will also be taken daily in the morning for 5 days.', 'interventionNames': ['Drug: Etoricoxib', 'Drug: Huzhang granule Placebo']}\n- {'label': 'Placebo intervention', 'type': 'PLACEBO_COMPARATOR', 'description': 'During the 5-day treatment period, participants in the Placebo group will receive 10 sacks of placebo HZG. They will be instructed to take two sacks per day, one sack in the morning and one in the evening, at approximately 30 minutes after the meal. And the placebo etoricoxib also be taken daily in the morning for 5 days.', 'interventionNames': ['Drug: Huzhang granule Placebo', 'Drug: Etoricoxib Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Huzhang granule', 'description': 'Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.', 'armGroupLabels': ['HZG intervention'], 'otherNames': ['Chinese Herbal Medicine']}\n- {'type': 'DRUG', 'name': 'Etoricoxib', 'description': 'take one capsule per day in the morning, at approximately 30 minutes after the meal.', 'armGroupLabels': ['Etoricoxib intervention'], 'otherNames': ['Chemical drug']}\n- {'type': 'DRUG', 'name': 'Huzhang granule Placebo', 'description': 'Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.', 'armGroupLabels': ['Etoricoxib intervention', 'Placebo intervention'], 'otherNames': ['Chinese Herbal Medicine']}\n- {'type': 'DRUG', 'name': 'Etoricoxib Placebo', 'description': 'take one capsule per day in the morning, at approximately 30 minutes after the meal.', 'armGroupLabels': ['HZG intervention', 'Placebo intervention'], 'otherNames': ['Chemical drug']}\n\nPrimary Outcomes:\n- {'measure': 'Visual Analogue Score (VAS)', 'description': 'Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack\uff0cit can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain)', 'timeFrame': 'Up to 5 days after treatment'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided significance level (\u00ce\u00b1) is set at 0.05, statistical power is set at 0.8, and a 20% loss to follow-up is considered.", "answer": 267, "answer_type": "ESTIMATED", "explanation": "Sample size\n The required sample size was calculated using an estimation formula based on the differences among the three sample rates [14, 17, 18]. A previous clinical study [19] reported that the response rates of the etoricoxib treatment, TCM treatment group, and placebo treatment groups were 63.89%, 42.5%, and 15.5%, respectively. Setting the two-sided significance level (\u00ce\u00b1) at 0.05 and statistical power at 0.8, a minimum sample size of 74 participants per group (222 participants in total) was estimated to provide sufficient statistical power to detect a between-group difference of approximately 20% in treatment efficiency, defined as the change in analgesic effectiveness. Considering a 20% loss to follow-up, we aim to enroll 89 patients in each arm, that is, a total of 267 patients.", "id": 814, "split": "val"} +{"trial_id": "NCT04463160", "pmid": "36410808", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island. Impact of the \"Say No to Diabetes\" Intervention.\n\nIncluded conditions:\n- Diabetes\n\nStudy Armgroups:\n- {'label': 'prevention program for prediabetes \"Say No to Diabetes\"', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: prevention program for prediabetes \"Say No to Diabetes\"']}\n- {'label': 'No prevention program', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'prevention program for prediabetes \"Say No to Diabetes\"', 'description': '10 therapeutic education sessions', 'armGroupLabels': ['prevention program for prediabetes \"Say No to Diabetes\"']}\n\nPrimary Outcomes:\n- {'measure': 'The impact of the \"Say No to Diabetes\" intervention on the incidence of type 2 diabetes', 'description': 'Diabetes : fasting blood glucose \u2265 1.26 g / l (7 mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO \u22652 g / l (11.1 mmol / l)', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a homogeneous distribution of prediabetic individuals among 1200 GPs, with each GP following between 30 and 60 subjects with prediabetes. The required number of investigating physicians is estimated between 100 and 150 GPs.", "answer": 2000, "answer_type": "ESTIMATED", "explanation": "Sample size\n To perform sufficiently detailed and powerful analyses, we chose to include 2000 subjects. The results of the CONSTANCES study presented at the 2018 French Society of Diabetology congress estimated that 7.5% of the population aged 18\u00e2\u0080\u009370 years in Mainland France is prediabetic, a prevalence 1.5 times higher than that of treated diabetics.18 These results allow us to estimate the number of Reunionese individuals with pre-diabetes of the same age group to between 37\u00e2\u0080\u0089600 (7.5% of the age group as in Mainland France) and 75\u00e2\u0080\u0089300 (15% of the age group due to the twice-higher proportion of subjects with diabetes), based on the estimation of the Reunionese population age groups by the French National Institute for Statistical and Economic Studies in 2018.19 Considering a homogeneous distribution of these individuals between 1200 GPs (Regional health agency 2017 data),20 each physician would follow between 30 and 60 subjects with pre-diabetes. As recruitment for clinical studies is not routine in primary care, the required number of investigating physicians was estimated between 100 GPs and 150 GPs.", "id": 815, "split": "val"} +{"trial_id": "NCT04463654", "pmid": "38341590", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Zero Self-Harm - a Mobile Phone Application to Reduce Non-suicidal Self-injury: A Randomized Clinical Superiority Trial\n\nIncluded conditions:\n- Self-Injurious Behavior\n\nStudy Armgroups:\n- {'label': 'Zero Self-Harm', 'type': 'EXPERIMENTAL', 'description': 'When randomized to the Zero Self-Harm app the participants will receive an introduction to the app through videos in the app, which explains, amongst others, how to review previous crisis situations and possible strategies for future crisis. This will ensure the navigation and knowledge of the technicalities of the app, in addition to ensure the app can be used privately without personal guidance from e.g a therapist.', 'interventionNames': ['Device: Zero Self-Harm app']}\n- {'label': 'Treatment as usual', 'type': 'NO_INTERVENTION', 'description': 'The control group will continue their present course of treatment and/or counseling at non-profit organizations, service centers in the municipalities, at outpatient treatment services for psychiatric disorders and/or care, attention at emergency departments. They will receive no treatment on the nature of NSSI. Participants in the control group will be offered a possibility to download the Zero Self-Harm app after they have completed the last questionnaire at six months, which will be stressed at the initial appointment as well as after collection of all data.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Zero Self-Harm app', 'description': 'Safety plan app for smartphones', 'armGroupLabels': ['Zero Self-Harm']}\n\nPrimary Outcomes:\n- {'measure': 'Deliberate Self Harm Inventory', 'description': '17-item self-report questionnaire that assesses various aspects of self harm (defined as the deliberate, direct self-destruction of body tissue without suicidal intent) over specified time periods, including frequency (continuous range) and type of self-harm behavior (e.g. cutting, burning etc.). The DSHI demonstrates adequate test-retest reliability and construct, discriminant validity among non-clinical and patient samples', 'timeFrame': '6 month'}\n\nPlease estimate the sample size based on the assumption: \nPower of 90%, type I error probability of 0.05.", "answer": 280, "answer_type": "ACTUAL", "explanation": "Sample size\n Based on previous estimates, a reduction of 3.5 NSSI episodes is expected in the intervention group after the 6-month follow-up compared to participants in the waitlist control group at follow-up after 6 months [28, 43, 44]. A post-intervention standard deviation of 9 is assumed based on previous findings [43, 44]. If the true difference between the intervention and control groups is 3.5, a total of 140 participants should be included in each group in order to reject the null hypothesis with a power of 90% and a type I error probability of 0.05, implying a total of 280 participants.", "id": 816, "split": "val"} +{"trial_id": "NCT04468126", "pmid": "39448217", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.\n\nIncluded conditions:\n- Acute Respiratory Failure\n- Hypoxemic Respiratory Failure\n\nStudy Armgroups:\n- {'label': 'standard oxygen group', 'type': 'ACTIVE_COMPARATOR', 'description': 'In order to maintain SpO2 between 92 and 96%', 'interventionNames': ['Other: Standard oxygen']}\n- {'label': 'high-flow nasal cannula oxygen group', 'type': 'EXPERIMENTAL', 'description': 'At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 %', 'interventionNames': ['Other: High-flow nasal oxygen therapy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Standard oxygen', 'description': 'Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.', 'armGroupLabels': ['standard oxygen group']}\n- {'type': 'OTHER', 'name': 'High-flow nasal oxygen therapy', 'description': 'Humidified and heated oxygen with a gas flow at least 50 l/min through nasal cannula and inspired fraction of oxygen adjusted in order to maintain a SpO2 between 92 and 96%', 'armGroupLabels': ['high-flow nasal cannula oxygen group']}\n\nPrimary Outcomes:\n- {'measure': 'Mortality at 28 days after randomization', 'description': 'Death between randomization and 28 days after randomization', 'timeFrame': 'Day 28'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80% (beta risk of 0.2) and a two-sided alpha level of 0.05.", "answer": 1110, "answer_type": "ESTIMATED", "explanation": "Sample size\n In accordance with the literature and our previous study,1 18 we determined that randomisation of 1110 patients would provide a power of 80% (beta risk of 0.2) to show an absolute difference of 6% in rate of mortality at day 28, between the control groups using standard oxygen (mortality rate estimated at 18%) and the experimental group using high-flow nasal oxygen (mortality rate estimated at 12%), at two-sided alpha level of 0.05.", "id": 817, "split": "val"} +{"trial_id": "NCT04472585", "pmid": "34488858", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients\n\nIncluded conditions:\n- Coronavirus Infection\n- COVID\n- Sars-CoV2\n\nStudy Armgroups:\n- {'label': 'Ivermectin alone', 'type': 'ACTIVE_COMPARATOR', 'description': 'Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care', 'interventionNames': ['Drug: Ivermectin Injectable Solution', 'Drug: Placebo empty capsule']}\n- {'label': 'Ivermectin with Zinc', 'type': 'ACTIVE_COMPARATOR', 'description': 'Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care', 'interventionNames': ['Drug: Ivermectin Injectable Solution', 'Drug: Zinc', 'Drug: Placebo empty capsule']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo drug plus standard care', 'interventionNames': ['Other: Injectable Placebo', 'Drug: Placebo empty capsule']}\n- {'label': 'Ivermectin (oral) alone', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral ivermectin 0.2mg/kg/day', 'interventionNames': ['Drug: Placebo empty capsule', 'Drug: Oral Ivermectin']}\n- {'label': 'Ivermectin (oral) with Zinc', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care', 'interventionNames': ['Drug: Zinc', 'Drug: Placebo empty capsule', 'Drug: Oral Ivermectin']}\n- {'label': 'Zinc Alone', 'type': 'ACTIVE_COMPARATOR', 'description': '20mg Zinc Sulphate 8 hourly plus standard care', 'interventionNames': ['Drug: Zinc', 'Drug: Placebo empty capsule']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ivermectin Injectable Solution', 'description': 'Subcutaneous Ivermectin 200ug/kg body weight 48 hourly', 'armGroupLabels': ['Ivermectin alone', 'Ivermectin with Zinc'], 'otherNames': ['Montpellier']}\n- {'type': 'OTHER', 'name': 'Injectable Placebo', 'description': '0.9% normal saline', 'armGroupLabels': ['Placebo'], 'otherNames': ['0.9% normal saline']}\n- {'type': 'DRUG', 'name': 'Zinc', 'description': 'Zinc Sulphate 20mg 3 times a day', 'armGroupLabels': ['Ivermectin (oral) with Zinc', 'Ivermectin with Zinc', 'Zinc Alone']}\n- {'type': 'DRUG', 'name': 'Placebo empty capsule', 'description': 'Placebo empty capsule', 'armGroupLabels': ['Ivermectin (oral) alone', 'Ivermectin (oral) with Zinc', 'Ivermectin alone', 'Ivermectin with Zinc', 'Placebo', 'Zinc Alone']}\n- {'type': 'DRUG', 'name': 'Oral Ivermectin', 'description': '0.2mg/kg/day', 'armGroupLabels': ['Ivermectin (oral) alone', 'Ivermectin (oral) with Zinc']}\n\nPrimary Outcomes:\n- {'measure': 'qRT-PCR', 'description': 'time needed to turn positive COVID-19 PCR to negative', 'timeFrame': '14 days'}\n- {'measure': 'Time taken for alleviation of symptoms', 'description': 'time needed to turn off symptoms', 'timeFrame': 'upto 14 days'}\n- {'measure': 'Severity of symptoms', 'description': 'time needed of symptom serverity', 'timeFrame': 'upto 14 days'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomised (sample size)\n 180 participants will be randomized into six arms with five investigational and one placebo group.", "id": 818, "split": "val"} +{"trial_id": "NCT04473261", "pmid": "33568226", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients\n\nIncluded conditions:\n- Covid19\n- SARS-CoV-2\n- Corona Virus Infection\n\nStudy Armgroups:\n- {'label': 'Iodine Complex (Capsule form)', 'type': 'EXPERIMENTAL', 'description': 'Iodine Complex) capsule (200mg) will be given three times a day', 'interventionNames': ['Drug: Iodine Complex']}\n- {'label': 'Iodine Complex (Syrup form)', 'type': 'EXPERIMENTAL', 'description': 'Iodine Complex syrup form (40ml) will be given three times a day', 'interventionNames': ['Drug: Iodine Complex']}\n- {'label': 'Standard Care Alone', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting.', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Iodine Complex (Nasal Spray)', 'type': 'EXPERIMENTAL', 'description': 'Iodine complex throat spray of 2 puffs three times a day.', 'interventionNames': ['Drug: Idoine Complex']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Iodine Complex', 'description': 'Iodine Complex capsule (200mg) will be given three times a day', 'armGroupLabels': ['Iodine Complex (Capsule form)']}\n- {'type': 'DRUG', 'name': 'Iodine Complex', 'description': 'Iodine Complex syrup form (40ml) will be given three times a day', 'armGroupLabels': ['Iodine Complex (Syrup form)']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Empty capsule will be given as placebo', 'armGroupLabels': ['Standard Care Alone'], 'otherNames': ['capsule']}\n- {'type': 'DRUG', 'name': 'Idoine Complex', 'description': 'Iodine Complex spray form 2 puffs will be given three times a day', 'armGroupLabels': ['Iodine Complex (Nasal Spray)']}\n\nPrimary Outcomes:\n- {'measure': 'qRT-PCR', 'description': 'Time taken for viral load clearance', 'timeFrame': '14 days'}\n- {'measure': 'HRCT chest', 'description': 'Time taken for radiological improvement', 'timeFrame': '14 days'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomised (sample size)\n 200 patients will be randomized into four groups with three experimental and one placebo arm.", "id": 819, "split": "val"} +{"trial_id": "NCT04473326", "pmid": "34862289", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimizing Message Framing for Healthy Habits for Patients With Type 2 Diabetes - Phase II (Pragmatic Trial)\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n- Medication Adherence\n\nStudy Armgroups:\n- {'label': 'Reinforcement Learning Intervention Arm', 'type': 'EXPERIMENTAL', 'description': 'Up to daily, tailored text messages.', 'interventionNames': ['Behavioral: Reinforcement Learning']}\n- {'label': 'Control Arm', 'type': 'NO_INTERVENTION', 'description': 'Up to daily, untailored text messages.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Reinforcement Learning', 'description': \"Participants in the intervention arm will receive up to daily, tailored text messages based on their electronic pill bottle-measured adherence. Given the participants' baseline characteristics and time-varying responses to the messages, a reinforcement learning algorithm will deliver different text messages and adapt over time to determine which type of messaging works best for each individual participant.\", 'armGroupLabels': ['Reinforcement Learning Intervention Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Medication Adherence', 'description': 'Medication adherence to type 2 diabetes oral medications (averaged) as measured by the number of dates and times of pillbottle openings in the electronic pill bottles', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a standard deviation (SD) of 12.5% for adherence, SD of 1.3 for HbA1c, a power of 0.8, and a significance level (\u03b1) of 0.05. It also considers up to 25% missingness for the glycaemic control outcome and uses multiple imputation if >10% of participants have missing HbA1c data.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Analytic plan and sample size\n We will report means and frequencies of prerandomisation variables separately by intervention and control arm, comparing these values using absolute standardised differences. The outcomes will be evaluated using intention-to-treat principles among all randomised participants.\n In the primary analysis, we will evaluate adherence and glycaemic control using generalised estimating equations with an identity link function and normally distributed errors. We will also adjust for the block randomised design. We do not expect any missing data for the primary outcome, but may have up to 25% missingness for the glycaemic control outcome.46 54 If >10% of participants have missing HbA1c data, we will repeat our analyses using multiple imputation.54 55 A similar approach will be taken for self-reported adherence, except using a log link function and Poisson distributed errors to generate relative risks of the proportion of adherent patients in the intervention versus control arms.56 In secondary analyses, we will control for any differences in baseline variables between the arms despite randomisation.\n As a sensitivity analysis, we will censor patients in the analysis when they have stopped using the electronic pill bottle for >30\u00e2\u0080\u0089days. We will also evaluate the change in HbA1c from baseline until the end of follow-up and differences in self-reported adherence separately for the three items that make up the self-reported scale we are using. For glycaemic control (HbA1c) and self-reported adherence, we will also conduct complete case analyses. Similarly, subgroup analyses will include stratification by age, sex, race/ethnicity, baseline HbA1c, baseline self-reported adherence and number of study medications.\n Our study should be sufficiently powered to detect clinically meaningful differences in the primary outcome. With 60 subjects, we estimated that we would have the power to detect a 10% difference in average adherence over the 6-month follow-up period between the two arms, assuming an SD=12.5%, power=0.8 and \u00ce\u00b1=0.05. With this sample size, we would also be able to detect an HbA1c difference of 1.0% between arms (assuming SD=1.3) and 50% relative difference in self-reported adherence.54\n On trial completion, we will cluster intervention patients by their response to different text message factors and evaluate the ability to predict these cluster phenotypes using baseline information before randomization. Based on prior work and the general 1:10 rule of thumb for predictor parameters, we expect to elucidate at least two unique patient characteristics for the clusters.25 57 We have further classified each text message as quantitative (ie, containing numbers), social reinforcement with specific reference to their doctor, or containing lifestyle information, which we will also incorporate as post-hoc prediction factors to evaluate responsiveness to individual texts; in total, there will be at least 5000 individual text messages sent. This exploratory prediction modelling on trial completion could provide a more accurate \u00e2\u0080\u0098starting point\u00e2\u0080\u0099 on which future programmes could begin to adapt to further personalise message content.", "id": 820, "split": "val"} +{"trial_id": "NCT04473989", "pmid": "33795297", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Weekly Injection of Teriparatide on the Healing of Distal Radius Fracture in a Double-blind, Randomized Controlled Clinical Trial\n\nIncluded conditions:\n- Colles' Fracture\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Injection product without active teriparatide', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'PTH 40ug/w', 'type': 'EXPERIMENTAL', 'description': 'Injection product with active teriparatide', 'interventionNames': ['Drug: recombinant teriparatide for injection']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'recombinant teriparatide for injection', 'description': 'weekly subcutaneous administration of 40 ug', 'armGroupLabels': ['PTH 40ug/w'], 'otherNames': ['Xinfutai']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'weekly subcutaneous administration of 40 ug', 'armGroupLabels': ['Placebo'], 'otherNames': ['Xinfutai placebo']}\n\nPrimary Outcomes:\n- {'measure': 'The median time of radiographic healing', 'description': 'A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union', 'timeFrame': '0-14 weeks'}\n\nPlease estimate the sample size based on the assumption: \nLoss to follow-up rate of 20%, power of 80%, significance level (\u00ce\u00b1) of 5%, and standard deviation (SD) of 2.2.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the results of a similar clinical study,18 we predicted a difference in fracture healing time between groups of approximately 1.5 weeks. Assuming a loss to follow-up rate of 20%, each group will need to contain 40 patients to achieve a power of 80%, with an \u00ce\u00b1 value of 5% and SD of 2.2.", "id": 821, "split": "val"} +{"trial_id": "NCT04474106", "pmid": "35365190", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Extracorporeal Shock Wave Therapy (ESWT) in Acute Traumatic Complete (AIS A) and Incomplete (AIS B-D) Cross-sectional Lesions on Motor and Sensory Function Within Six Months After Injury: A Two-arm Three-stage Adaptive, Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial\n\nIncluded conditions:\n- Acute Traumatic Spinal Cord Injury\n\nStudy Armgroups:\n- {'label': 'ESWT', 'type': 'EXPERIMENTAL', 'description': 'The extracorporeal shockwave therapy is applied once at the level of lesion and 5 segments above and below; or below the occiput (in lesions higher than C6) and above the sacrum (in lesions lower than T12). In addition, the ESWT is applied to the soles of both feet on the medial side of the plantar surface. The ESWT is applied as soon as possible within 48 hours post-injury.', 'interventionNames': ['Device: Shock waves']}\n- {'label': 'Control', 'type': 'SHAM_COMPARATOR', 'description': 'In the control group, the same procedure is performed, but without the device emitting extracorporeal shock waves using a dummy head.', 'interventionNames': ['Device: dummy head']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Shock waves', 'description': 'The shockwave generator orthogold 100\u00ae generates high-energy acoustic waves that behave much like other sound waves except that they have much greater pressure and energy. As with sound waves, Spark Waves\u00ae can easily travel great distance as long as the acoustic impedance stays the same.', 'armGroupLabels': ['ESWT']}\n- {'type': 'DEVICE', 'name': 'dummy head', 'description': 'The shockwave generator orthogold 100\u00ae will be used in combination with a dummy head, to Refrain shock waves', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'changes in total motor scores (TMSC) = TMSC after 6 month minus TMSC at baseline', 'description': 'greater improvement in motor and sensory function (the AIS grade) can be achieved in patients after spinal trauma (AIS A-D) by applying a single extracorporeal shockwave therapy compared to the control group.', 'timeFrame': 'day 0 to 6 month'}\n\nPlease estimate the sample size based on the assumption: \nA one-sided error rate of 5% and a planned power of 80% are used. The triangle test is selected for upper and lower limits. Interim evaluations are conducted at stages 1 and 2 to determine early termination based on success or lack of efficacy.", "answer": 246, "answer_type": "ESTIMATED", "explanation": "Study sample size\n Sample size calculation is usually based on an effect size expected from a given treatment. Due to a lack of knowledge about the effects of EWST on sensory (SF) and motor functions (MF), such an estimation is limited. For this reason, a so-called adaptive design was chosen, corresponding to the \u00e2\u0080\u009cmulti-arm multi-level approach\u00e2\u0080\u009d (MAMS approach) proposed by Jaki et al. [65]. The advantage of this design is that the effect size needed to calculate the sample size is not based on specific values, but on probabilities (p and p0) that can be used to identify the desired or the uninteresting effect. The probability p = 0.6 chosen for the study for the desired effect means that a randomly selected person in the treatment group has a 60% probability of achieving a better result than a randomly selected person in the control group. The uninteresting effect is assumed with a probability of p0 = 0.5. This value means that both the novel treatment and the placebo treatment perform equally well (Jaki et al., 2019). Another advantage of MAMS is that this form of sampling does not require any knowledge of the variance of the endpoint variables. All the calculations required for this are implemented in an R package and published accordingly (Jaki et al., 2019).\n A two-armed, three-stage adaptive study design is envisaged at Neurowave. In stage 1 and stage 2, interim evaluations are carried out to determine whether the study can already be terminated. This will be the case if either the intended and thus desired result can already be sufficiently confirmed, or it becomes apparent that the study will not be a success. These interim evaluations offer the opportunity to shorten the study. If none of these two cases occur, the study will continue up to stage 3. The overarching advantage of this design is that the smallest possible number of patients can be found to demonstrate a medically relevant effect.\n With a one-sided error rate of 5% and a planned power of 80%, the following design parameters could be calculated. For the upper and lower limits, the triangle test is selected [65].\nStage 1Stage 2Stage 3Cumulative sample size (control):4182123Cumulative sample size (treatment):4182123Maximum total sample size: 246Upper bound2.131.891.85Lower bound0.001.131.85p-value for H1 ((stopping for) success)0.0180.0310.033p-value for H0 (stopping for a lack of efficacy)0.5000.130Continue as planned at stage 1: 0.500 > p >\u00e2\u0080\u0089 0.018Continue as planned at stage 2: 0.130 > p >\u00e2\u0080\u0089 0.031The calculation was done with the R package MAMS", "id": 822, "split": "val"} +{"trial_id": "NCT04475783", "pmid": "34583746", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery\n\nIncluded conditions:\n- Peripheral Artery Disease\n\nStudy Armgroups:\n- {'label': 'Sirolomus DCB group', 'type': 'EXPERIMENTAL', 'description': 'Intervention with Sirolimus-coated balloon catheter', 'interventionNames': ['Combination Product: Percutaneous Transluminal Angioplasty (PTA)']}\n- {'label': 'Paclitaxel DCB group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention with Paclitaxel-coated balloon catheter', 'interventionNames': ['Combination Product: Percutaneous Transluminal Angioplasty (PTA)']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Percutaneous Transluminal Angioplasty (PTA)', 'description': 'PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery', 'armGroupLabels': ['Paclitaxel DCB group', 'Sirolomus DCB group']}\n\nPrimary Outcomes:\n- {'measure': 'Patency rate (Absence of clinically driven target lesion revascularization)', 'description': 'patency rate after one year defined as absence of clinically driven target lesion revascularization (TLR) due to symptoms and drop of ABI of \u2265 20% or \\\\> 0.15 when compared to post-procedure or restenosis with PVR \\\\> 2.4 evaluated by duplex ultrasound', 'timeFrame': 'one year after study procedure (PTA with medical product under investigation or comparator)'}\n- {'measure': 'Safety outcome', 'description': 'Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel vessel revasculariza-tion', 'timeFrame': 'through 12 months post-procedure'}\n\nPlease estimate the sample size based on the assumption: \nPower of 89% for each test and 80% for both primary outcomes. One-sided Farrington-Manning test will be applied. A dropout rate of 10% is assumed.", "answer": 478, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n In the randomized controlled pilot COMPARE trial, 1-year primary patency after paclitaxel-coated balloon angioplasty (IN.PACT DCB) was 89.0% [14]. In addition, the IN.PACT global study revealed 94% freedom from the primary composite safety endpoint in the long-lesion imaging cohort [15].\n From this, we calculated that 430 participants (215 in each group) need to be analysed regarding the primary efficacy outcome, and 280 (140 in each group) regarding the primary safety outcome to show noninferiority of the Magic Touch sirolimus DCB over paclitaxel-coated balloon angioplasty with a power of 89% for every single test and of 80% for both primary outcomes. Noninferiority margin is set at 10% for both outcomes.\n As heterogeneity regarding 12-month primary patency and need for TLR (the main driver of the primary composite safety endpoint in terms of quantity) is substantial even across different types of paclitaxel-coated balloons (65 to 86% [I2 = 54%] and 71 to 93% [I2 = 66%], respectively [16]); a deviation from the average by 10% with sirolimus-coated balloon angioplasty would still be within the range that can be considered noninferior.\n One-sided Farrington-Manning test will be applied for the primary outcomes. Finally, assuming a dropout rate of 10%, 478 patients (239 per group) should be recruited.", "id": 823, "split": "val"} +{"trial_id": "NCT04478201", "pmid": "33827851", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparing the Effectiveness of Side-lying Sleep Positioning to Back-lying at Reducing Oxygen Desaturation Resulting From Obstructive Sleep Apnoea in Infants With Cleft Palate\n\nIncluded conditions:\n- Obstructive Sleep Apnea\n- Cleft Palate\n\nStudy Armgroups:\n- {'label': 'Back lying sleep position', 'type': 'EXPERIMENTAL', 'description': 'sleep on the back', 'interventionNames': ['Other: back sleep positioning']}\n- {'label': 'Side lying sleep position', 'type': 'EXPERIMENTAL', 'description': 'sleep on the side', 'interventionNames': ['Other: side sleep positioning']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'back sleep positioning', 'description': 'sleeping on the back.', 'armGroupLabels': ['Back lying sleep position']}\n- {'type': 'OTHER', 'name': 'side sleep positioning', 'description': 'sleeping on the side', 'armGroupLabels': ['Side lying sleep position']}\n\nPrimary Outcomes:\n- {'measure': 'Oxygen saturation during sleep at 1 month of age', 'description': 'Oxygen saturation during sleep at 1 month of age (expressed as 4% oxygen desaturation index, ODI-4). Oximetry is considered the mainstay of assessment of oxygenation in infants and will be the primary outcome measurement instrument. The ODI-4 represents the average number of times that oxygen saturation falls by at least 4% from baseline every hour.', 'timeFrame': '1 month of age'}\n\nPlease estimate the sample size based on the assumption: \nTo detect a difference of 0.5 SDS with 80% power and alpha equal to 0.05, and to account for potential unequal variances with a variance ratio of 2. The sample size is inflated to allow for a potential attrition rate of 21%.", "answer": 244, "answer_type": "ESTIMATED", "explanation": "Sample size\n Data from the feasibility study21 and published studies22 have reported estimates of the SD of the primary outcome ODI-4 in the side-lying infants at 4 weeks to range from 8 to 11 units, with a higher SD observed in the back-lying group. The observed difference in mean ODI-4 between the side-lying and back-lying infant cohorts was 15 units (a standardised effect size of 0.91).21 It was considered a smaller but more realistic difference in means of five units to be a clinically important difference (SD 10), a standardised effect size of 0.5. The sample size calculation comparing two means with unequal variances for the primary outcome was, therefore, based on a standardised effect size of 0.5. To account for potential unequal variances in each group a variance ratio of 2 was used in the calculations. To detect a difference of 0.5 SDS with 80% power and alpha equal to 0.05 would require 96 infants to be monitored in each arm of the trial (a total of 192 participants). Informed by the multicentre feasibility and oximetry studies the sample size will be inflated to 244 participants in the RCT, to allow for potential attrition of 21%.", "id": 824, "split": "val"} +{"trial_id": "NCT04478331", "pmid": "34330855", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery: a Three-arm Randomized Control Study\n\nIncluded conditions:\n- Bariatric Surgery Candidate\n\nStudy Armgroups:\n- {'label': 'CONTROL', 'type': 'NO_INTERVENTION', 'description': 'The Control group will receive the usual care. In the physical activity (PA) field, this includes two individual motivational interviews with a PA professional, and a group workshop during the first year after BS. PA recommendations will be explained to each participant, and their achievement will be encouraged and supported during these sessions. No face-to-face PA sessions will be offered as part of the usual care.'}\n- {'label': 'ACTI-VISIO', 'type': 'EXPERIMENTAL', 'description': 'The two PA sessions per week will be delivered via videoconferencing (developed by Mooven\u2122). The PA program consists in tailored adapted PA sessions led by a professional specialized in adapted PA. These sessions were specifically designed to be appropriate for the population and were developed in collaboration with the authors to ensure standardization of the recommended volume of PA. The PA sessions will be given live, individually at the beginning and then in groups of four women. During sessions, the professional and the participants will interact simultaneously, and the execution of the exercises will be monitored and adapted live by the professional. To ensure the safety of the PA, a rating of perceived exertion will be requested after each session on a 10-point scale. If the RPE exceed 7, the professional specialized in adapted PA will adjust the training load. In addition to the exercises, the sessions will also include advice and tips for reaching the recommended PA level.', 'interventionNames': ['Behavioral: Technology-based physical activity interventions']}\n- {'label': 'ACTI-MOBIL', 'type': 'EXPERIMENTAL', 'description': 'The PA sessions will be delivered by an eHealth platform (developed by BePatient\u2122) associated with an activity bracelet. The researchers enrich PA content on the platform and ensure standardization of the recommended volume of PA. The platform consists of tips for reaching the PA level, PA questionnaires, PA feedback measured by the activity bracelet, and a video demonstration of PA sessions performed by a peer. The PA sessions are automatically broadcasted twice a week for 12 weeks. To ensure the safety of the PA, the sessions were designed to be appropriate for this population and the RPE will be measured after each session on a 10-point scale. If the RPE exceeds 7 for 3 consecutive sessions, the training load will be adjusted. The platform will also include a variety of content, including dietary tips, obesity-related facts, information about surgery, and frequently asked questions.', 'interventionNames': ['Behavioral: Technology-based physical activity interventions']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Technology-based physical activity interventions', 'description': 'The technology groups will receive a PA program for 12 weeks. These PA programs will be given twice a week and include: 5-10 minutes of warm-up, 20-40 minutes of aerobic exercise and muscle strengthening via circuit training composed of 8-10 exercises with 8-12 repetitions per exercise for 2-3 series, and 5-10 minutes of stretching. In addition, advice and counseling will be given about walking activities to achieve the recommendations.', 'armGroupLabels': ['ACTI-MOBIL', 'ACTI-VISIO']}\n\nPrimary Outcomes:\n- {'measure': \"Change of functional capacity calculated by the percentage achievement of the theoretical distance calculated by the Capodaglio's (2013) formula\", 'description': 'We will aggregate the following primary outcome measures into the Capodaglio (2013) formula: 894.2177 - (2.0700 x age(years)) - (51.4489 x 1) - 5.1663 x BMI (kg/m\u00b2) to obtain the theoretical distance, and we will calculate the percentage achievement of this theoretical distance: ((distance traveled(meters) - theoretical distance(meters)) / theoretical distance(meters))x100.\\n\\nHigher percentage of achievement reflecting higher functional capacity.', 'timeFrame': 'Baseline (T0), 3 months (T3), and 6 months (T6)'}\n- {'measure': 'Change of distance traveled during a six-minute walk test (6MWT)', 'description': 'Distance traveled during a six-minute walk test (6MWT) will be expressed in meters', 'timeFrame': 'Baseline (T0), 3 months (T3), and 6 months (T6)'}\n- {'measure': 'Change of body mass', 'description': 'Kilograms', 'timeFrame': 'Baseline (T0), 3 months (T3), and 6 months (T6)'}\n- {'measure': 'Height', 'description': 'Meters', 'timeFrame': 'Baseline (T0)'}\n- {'measure': 'Date of birth', 'description': 'The date of birth will be requested once (pre-bariatric surgery) and will be used to calculate the age in years at the different periods needed to calculate the theoretical 6MWT distance', 'timeFrame': 'Baseline (T0)'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for a power of 80% and an alpha of 5%, with an anticipated 10% dropout rate.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size for the study is based on the distance travelled during a 6MWT relativised with age, sex and body mass index.47 A recent meta-analysis showed an overall effect Z=2.52 (p=0.01) of change in walking distance after BS in an exercise group compared with a control group.62 An overall effect Z=2.52 corresponds to f=0.20.63 However, this effect size is probably minimised because it has not been relativised according to body mass index. Furthermore, eHealth PA programmes for obese or sedentary individuals have an effect size of d=0.37,64 corresponding to f=0.19.63 However, only 45% of eHealth interventions are based on theoretical models,65 which reduces their effectiveness. Given these limitations, a slightly larger effect size of f=0.25 is considered. A total of 108 participants will be necessary to keep a power of 80% and alpha of 5%.66 We anticipate that 10% of the participants will be lost to follow-up, drop out of testing, withdraw informed consent or be excluded from the study. Thus, with 120\u00e2\u0080\u0089women, 40 in each group, we consider our study to be sufficiently powered.", "id": 825, "split": "val"} +{"trial_id": "NCT04478721", "pmid": "34580096", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomised Controlled Trial of Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Due to Enterobacteriaceae Showing Resistance to Third Generation Cephalosporins\n\nIncluded conditions:\n- Bacteremia\n\nStudy Armgroups:\n- {'label': 'Temocillin', 'type': 'EXPERIMENTAL', 'description': 'Patients enrolled in this arm, will receive 2g each 8 hours of intravenous temocillin.', 'interventionNames': ['Drug: Temocillin']}\n- {'label': 'Meropenem', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients enrolled in this arm, will receive 1g each 8 hours of intravenous meropenem.', 'interventionNames': ['Drug: Meropenem']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Temocillin', 'description': 'The intervention of experimental arm will be Intravenous administration of temocillin.', 'armGroupLabels': ['Temocillin']}\n- {'type': 'DRUG', 'name': 'Meropenem', 'description': 'The intervention of comparator arm will be intravenous administration of meropenem.', 'armGroupLabels': ['Meropenem']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with a \"success\" at the test of cure (TOC)', 'description': 'A success at the test of cure is the resolution of infection symptoms', 'timeFrame': 'Up to 7-10 days after the last day of antibiotic therapy'}\n- {'measure': 'Survival at day 28', 'description': 'Number of patients who are alive', 'timeFrame': 'At day 28.'}\n- {'measure': 'Number of patients who do not need to stop or change the assigned drug', 'description': 'Reasons for not change can be no adverse event, no perceived failure during treatment or no occurrence of a superimposed infection.\\n\\nParticipants who stop or change the assigned drug will not meet the primary outcome.', 'timeFrame': 'Up to 7-14 days after the last day of antibiotic therapy'}\n- {'measure': 'Number of patients who do not need to prolong therapy beyond 14 days', 'description': 'Assigned treatment to be administered for less than 14 days', 'timeFrame': 'Up to 7-14 days after the last day of antibiotic therapy'}\n- {'measure': 'Not recurrence until day 28', 'description': 'Recurrence is reappearance of symptoms with positive blood culture for the same microorganism.\\n\\nParticipants with recurrence will not meet the primary outcome.', 'timeFrame': 'At day 28.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% one-sided significance level, 5% missing patients, 1:1 assignment", "answer": 334, "answer_type": "ESTIMATED", "explanation": "Sample size\n We estimated an 85% success rate with meropenem and with temocillin. In order to reject the null hypothesis with 80% power and a 5% one-sided significance level for a 10% non-inferiority margin with a 1:1 assignment, with 5% of missing patients, a total of 167 patients in each study arm are needed (total, 334 patients).", "id": 826, "split": "val"} +{"trial_id": "NCT04479683", "pmid": "37817147", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"COTIDEA COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment (Partial Hospitalization) After Short Inpatient Care in Early Onset Anorexia Nervosa: a Non-inferiority Trial A Non-inferiority Study\"\n\nIncluded conditions:\n- Early Onset Anorexia Nervosa\n\nStudy Armgroups:\n- {'label': 'standard care', 'type': 'OTHER', 'description': 'continuation of full-time hospitalization until the minimum healthy weight is reached, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals.', 'interventionNames': ['Other: standard care']}\n- {'label': 'FTH (full-time hospitalisation) then day hospitalization)', 'type': 'EXPERIMENTAL', 'description': 'FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals.\\n\\nDuring this phase, all children are evaluated once a week on a somatic level.', 'interventionNames': ['Other: FTH then DH support']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'FTH then DH support', 'description': 'FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals.\\n\\nDuring this phase, all children are evaluated once a week on a somatic level.', 'armGroupLabels': ['FTH (full-time hospitalisation) then day hospitalization)']}\n- {'type': 'OTHER', 'name': 'standard care', 'description': 'continuation of full-time hospitalization until the minimum healthy weight is reached, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals.', 'armGroupLabels': ['standard care']}\n\nPrimary Outcomes:\n- {'measure': 'BMI BMI', 'description': 'body mass index (BMI) at 1 year after admission into FTH', 'timeFrame': 'one year'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided Student's t test, significance level of 2.5%, power of 90%, dropout rate of 10%", "answer": 88, "answer_type": "ESTIMATED", "explanation": "Sample size\n We calculated the sample size for a one-sided Student\u00e2\u0080\u0099s t test with a significance level of 2.5% and a power of 90% based on the clinically determined non-inferiority margin for a difference in BMI of 1\u00c2\u00a0kg/m2, assuming a distribution of the BMI of 16,6\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u00891,35\u00c2\u00a0kg/m2. This procedure led to a required sample size of 80 patients (40 per group). Assuming a dropout rate of 10% [8], we calculated a sample size of 88 patients. We aim to include 88 children with EOAN (44 per group).", "id": 827, "split": "val"} +{"trial_id": "NCT04483219", "pmid": "35379611", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Tyrosine Kinase Inhibitor (TKI) in Combination With Anti-PD-1 Antibody in TKI-responded Microsatellite Stability/Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Adenocarcinoma.\n\nIncluded conditions:\n- MSS\n- pMMR\n- Metastatic Colorectal Adenocarcinoma\n\nStudy Armgroups:\n- {'label': 'TKI \u00b1 anti-PD-1 antibody', 'type': 'EXPERIMENTAL', 'description': 'According to response to TKI, the combination of anti-PD-1 treatment would be determined.', 'interventionNames': ['Drug: TKI \u00b1 anti-PD-1 antibody']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'TKI \u00b1 anti-PD-1 antibody', 'description': 'After one cycle of TKI, evaluations would be performed according to RECIST v 1.1. (1) obvious response (A): CR, PR or shrunken SD, or cavitation in metastatic lung lesions, or decrease in the density of liver metastatic targets \u226515%; (2) general response (B): enlarged SD; (3) poor response (C): PD. TKI \uff0b anti-PD-1 antibody will be administered in group A. The subjects in group C will exit the study. The subjects in group B will continue TKI for another one cycle, the obvious response subjects will entered group A, the general response subjects will keep in arm B and continue the TKI monotherapy, and the poor response subjects will exit the study.\\n\\n1. Fruquintinib 5mg or regorafenib 120mg, qd po, 3 weeks, Q4w. (The investigators decide to choose fruquintinib or regorafenib)\\n2. Toripalimab injection 240mg, Q3w, until the disease progresses or lasts for two years.', 'armGroupLabels': ['TKI \u00b1 anti-PD-1 antibody']}\n\nPrimary Outcomes:\n- {'measure': '9-month progression-free survival (PFS) rate (in subjects receiving TKI followed by TKI in combination with anti-PD-1 antibody)', 'description': 'From the date of first dose of treatment to the first of either disease progression, relapse or death from any cause, evaluate patient PFS rate at 9 months', 'timeFrame': '9 months'}\n\nPlease estimate the sample size based on the assumption: \nType 1 error rate is 0.05, power is 0.90, and a 10% dropout rate is considered.", "answer": 53, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This is a single-arm phase II clinical trial, with 9-month PFS rate as the primary endpoint. A Simon\u00e2\u0080\u0099s two-staged design is used to calculate the sample size.\n The null hypothesis is that the true 9-month PFS rate is 27.1%, which was reported by the FRESCO trial. The 9-month PFS rate of the TKI+anti-PD-1 antibody (arm A) group is supposed to be 55%, yielding a type 1 error rate of 0.05 and power of 0.90. The simon2stage package of STATA software (version 15.0) is used to obtain the sample size. The sample size of arm A is 25 cases. Sixteen evaluable patients are recruited in the first stage. If more than four patients can reach 9\u00e2\u0080\u0089months according to iRECIST 1.1 criteria, nine additional patients will be added to the second stage (for a total of 25 patients). The null hypothesis will be rejected if more than 10 patients achieve 9-month PFS in 25 patients.\n According to the FRESCO study, the proportion of patients with CR+PR+shrunken SD in the fruquintinib group was 52.9% after 8-week treatment. Hence, to ensure that there are 25 patients in arm A, 48 patients should be selected at the initial stage. Considering a 10% dropout rate, we need to recruit 53 patients in this trial.", "id": 828, "split": "val"} +{"trial_id": "NCT04483635", "pmid": "37230524", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PROTECT RCT (PRevention of COVID-19 With Oral Vitamin D Supplemental Therapy in Essential healthCare Teams\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '10 placebo tablets taken orally at baseline, followed by 1 placebo tablet once a week for 16 weeks\\n\\nNote that the study may be prolonged according to the overall infection rate monitored monthly.', 'interventionNames': ['Dietary Supplement: Placebo']}\n- {'label': 'Vitamin D3', 'type': 'EXPERIMENTAL', 'description': '10 tablets containing 10,000 IU (total : 100,000 IU) of Vitamin D3 taken orally at baseline, followed by 10,000 IU once a week for 16 weeks.\\n\\nNote that the study may be prolonged according to the overall infection rate monitored monthly.', 'interventionNames': ['Dietary Supplement: Vitamin D']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo', 'description': 'Weekly oral dose of placebo', 'armGroupLabels': ['Placebo']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Vitamin D', 'description': 'Weekly oral dose of Vitamin D', 'armGroupLabels': ['Vitamin D3'], 'otherNames': ['cholecalciferol']}\n\nPrimary Outcomes:\n- {'measure': 'Change in incidence of laboratory-confirmed COVID-19 infection', 'description': 'documented by salivary or NP samples obtained clinically for screening or diagnostic purposes throughout the study period, self-obtained salivary samples at endpoint, analysed by RT-qPCR or COVID-19 seroconversion at endpoints', 'timeFrame': '16 weeks'}\n\nPlease estimate the sample size based on the assumption: \n1:1 treatment allocation, 80% power, 15% dropout rate, interim analysis at 75% participant completion of 12 weeks, trial termination for efficacy if P(OR<1)>0.95, and potential extension to 24 weeks based on infection rate progress.", "answer": 34, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Given uncertainties in infection progression, a Bayesian adaptive design was used where the posterior probability of effectiveness, that is, P(OR<1|data) was the basis of inference and decision making.34 Assuming an expected OR of 0.80 and 1:1 treatment allocation, a total net sample size of 2100 was required to identify a 20% reduction in the risk of COVID-19 in the vitamin D versus control group, with 80% power with the design described above. Considering a dropout rate of 15%, 2414 participants were targeted. An interim analysis was planned when 75% of participants would have reached week 12, at which time the following assessments were to be made: the progression over time in the incidence of infection (slope of the curve of infection) was to be updated and if the probability of effectiveness exceeded 0.95 (p(OR<1)>0.95), the trial would have been terminated for efficacy at the interim point (12 weeks); otherwise, the study would have continued to 16-week follow-up. Simulation results showed that, with the net sample size of 2100 (assuming an expected OR of 0.80 and 1:1 treatment allocation), there was about a 55% chance that the trial would be terminated for efficacy at the interim analysis.35 The overall infection rate was monitored on a monthly basis: note that the study could have been extended to 24 weeks based on the progress of the infection rate, if required.", "id": 829, "split": "val"} +{"trial_id": "NCT04484246", "pmid": "35042460", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Incidence and Prevalence of Sarcopenia in Patients 70 Year and Older With Localized and Locally Advanced Porstate Cancer, Treated by Radiotherapy and Androgen Deprivation Therapy. a Monocentric Cohort Trial\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Prevalence of sarcopenia in older patient with prostate cancer', 'description': 'All patients are screened for sarcopenia with the SAR-F questionnaire test score \u22654/10 suspected of sarcopenia will undergo a dual-X-ray exam to dertemine their skeletal muscle mass and the prevalence of sarcopenia before oncological treatment.'}\n\nPrimary Outcomes:\n- {'measure': 'Prevalence of sarcopenia in older patient with prostate cancer', 'description': 'All patients are screened for sarcopenia with the SAR-F questionnaire test', 'timeFrame': '36 months'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided 95% confidence interval with a width between 0.115 to 0.131.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size, power, and statistical methods\n Under the assumption that the prevalence of sarcopenia in older patients with prostate cancer before initiation of treatment with ADT is between 20 to 30%, according to one of the rare studies published on the subject [21], a sample size of 200 subjects allows an estimation with a width of two-sided 95% confidence interval between 0,115 to 0.131. Previous feasibility analysis showed current collaboration between urologist, radiotherapist and geriatrician should allow enrollment of the adequate number of patients during the trial period.", "id": 830, "split": "val"} +{"trial_id": "NCT04484922", "pmid": "35395776", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial\n\nIncluded conditions:\n- Congenital Heart Disease\n\nStudy Armgroups:\n- {'label': 'Dexmedetomidine', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Normal saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'continuous infusion of dexmedetomidine during the surgery', 'armGroupLabels': ['Dexmedetomidine']}\n- {'type': 'DRUG', 'name': 'Normal saline', 'description': 'continuous infusion of normal saline during the surgery', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Bayley scales of Infant development', 'description': 'Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as \"average\" if they were within 1 SD of the mean or higher (scores .85), \"at risk\" if they were 1 to 2 SD below the mean (scores 70-84), and \"delayed\" if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor)', 'timeFrame': '1 year after the surgery'}\n\nPlease estimate the sample size based on the assumption: \nAlpha error of 5%, power of 80%, and a dropout ratio of 20%.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n In a previous study, 75% of patients who underwent surgery with cardiopulmonary bypass during infancy or cardiac surgery during the neonatal period were marked below 85 at BSID within 3\u00e2\u0080\u0089years [42]. We assumed that dexmedetomidine infusion could reduce the proportion of patients with low BSID from 75 to 50%. With an alpha error of 5% and power of 80%, 132 patients with a 1:1 allocation to the study group and the control group will be required. Considering the relatively long time span between enrollment and follow-up, we set the dropout ratio to be close to 20%. Finally, we plan to enroll 160 patients with a 1:1 allocation ratio to each group.", "id": 831, "split": "val"} +{"trial_id": "NCT04486131", "pmid": "39414276", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Lateral Nodal Recurrence in Rectal Cancer\n\nIncluded conditions:\n- Rectal Cancer\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Lateral local recurrence', 'description': 'Lateral local recurrence diagnosed during the follow up', 'timeFrame': '3 years'}\n\nPlease estimate the sample size based on the assumption: \nA one-group \u03c72 test with a 5% two-sided significance level and 90% power is used. A drop-out rate of 5% is considered. An interim analysis will be conducted after the inclusion of the first 75 participants to evaluate early indicators of effectiveness and safety.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is based on a historical control group with an average 3-year LLR rate of 13% (11% Snapshot and 16% Consortium) in low LARC with LLNs \u00e2\u0089\u00a57.0\u00e2\u0080\u0089mm after (C)RT+TME (without LLND), which is the current standard treatment in Europe.5 6 14 It is hypothesised that (C)RT+TME+LLND can reduce this rate to 6%, as found by the Consortium study. A one-group \u00cf\u00872 test with a 5% two-sided significance level will have 90% power to detect the difference between the null hypothesis proportion of 0.13 and the alternative proportion of 0.06 when the sample size is 190. If correcting for a drop-out rate of 5%, 200 patients are needed. Included patients in need of more extensive surgery (ie, pelvic exenteration or presumed inability to spare the hypogastric nerves on MRI) will be registered and analysed as a separate cohort since these more extensive tumours have higher LLR rates and cannot undergo nerve-sparing LLND.\n Annually, approximately 882 patients present with low LARC and are treated with neoadjuvant therapy in the Netherlands.14 Considering 122 (14%) of these patients have LLNs \u00e2\u0089\u00a57.0\u00e2\u0080\u0089mm, a minimum 2.5-year inclusion period is needed to achieve the estimated sample size (expecting 60% of eligible patients to be enrolled).14 As some of the eligible patients will undergo open surgery, it is expected that the inclusion period may require an extension. An interim analysis will be carried out after the inclusion of the first 75 participants. The goal of this interim analysis is to evaluate early indicators of effectiveness concerning oncological outcomes, particularly LLR rate, and to evaluate safety by examining short-term surgical complications (within 90 days) and early functional outcomes (urogenital dysfunction within 3 months). The results will help improve the preoperative information provided to patients. If the interim analysis reveals a high LLR rate that suggests that the hypothesis may not be achievable or significant morbidity within 3\u00e2\u0080\u0089months of surgery, the study team will consider to prompt the study ahead of time.\n Additionally, patients with rectal cancer and an LLN of 5.0\u00e2\u0080\u00936.9\u00e2\u0080\u0089mm SA with at least one malignant feature will be investigated. For this analysis, a sample size calculation is impossible due to limited data. Therefore, all eligible patients in this group will be collected during the study period.", "id": 832, "split": "val"} +{"trial_id": "NCT04488458", "pmid": "36109038", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Treatment of Periprosthetic Joint Infections Guided by Minimum Biofilm Eradication Concentration (MBEC) in Addition to Minimum Inhibitory Concentration (MIC); a Prospective Randomized Clinical Trial\n\nIncluded conditions:\n- Prosthetic Joint Infection\n- Prosthetic Infection\n- Hip Prosthesis Infection\n- Knee Prosthesis Infection\n\nStudy Armgroups:\n- {'label': 'MBEC and MIC susceptibility testing', 'type': 'EXPERIMENTAL', 'description': 'For all administered antimicrobials staphylococcal strains must be susceptible in disc diffusion tests/MIC, regardless of MBEC-level. Antibiotic combinations will be selected from 5 already recommended non-cell wall active anti-staphylococcal antibiotics with high per-oral bio-availabilities and acceptable bone penetration used in the treatment of PJIs: rifampicin, fusidic acid, ciprofloxacin/levofloxacin and clindamycin.\\n\\nMBEC cut-off for replacement with 2nd or 3rd line antibiotic: RIF MBEC/MIC \\\\> 8; LEV MBEC/MIC \\\\> 5; FUS MBEC/MIC \\\\> 3; CLI MBEC/MIC \\\\> 4; LIN MBEC/MIC \\\\> 2; T/S MBEC \\\\> MIC\\n\\nSecond line of treatment:\\n\\nRIF and Fusidic acid 500 mg TID (ter in die) RIF and Clindamycin 450 - 600 mg TID LEV and Fusidic acid 500 mg TID LEV and Clindamycin 450 mg TID\\n\\nThird line of treatment:\\n\\nLinezolid 600 mg BID (bis in die) Sulfamethoxazole/Trimethoprim 800/160 mg TID Clindamycin 450 mg TID and Fusidic acid 500 mg TID', 'interventionNames': ['Diagnostic Test: MIC or MBEC+MIC based treatment algorithm']}\n- {'label': 'MIC susceptibility testing', 'type': 'ACTIVE_COMPARATOR', 'description': 'If the causative bacterium is susceptible according to MIC diagnostics, the patient will follow the first line of treatment: Rifampicin 750-900 mg/day + Levofloxacin 750 mg BID', 'interventionNames': ['Diagnostic Test: MIC or MBEC+MIC based treatment algorithm']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'MIC or MBEC+MIC based treatment algorithm', 'description': 'i) Non cell wall active standard of care antibiotic combination (MIC-guided) for 6 weeks.\\n\\nii) Non cell wall active antibiotic combination according to a MBEC-based decision algorithm for 6 weeks.', 'armGroupLabels': ['MBEC and MIC susceptibility testing', 'MIC susceptibility testing']}\n\nPrimary Outcomes:\n- {'measure': 'Number of changes in antimicrobial regimen other than standard of care', 'description': 'Proportions of antimicrobial regimens other than standard of care through application of proposed MBEC-algorithm.', 'timeFrame': '6 weeks'}\n\nPlease estimate the sample size based on the assumption: \n1:1 randomisation allocation, power 80%, alpha set to 5%, intention to treat analysis.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We consider the diagnostic tool clinically useful if it guides treatment differently than standard scheme in more than 25% of the decisions, according to the MBEC cut-off for replacement. Change of treatment decision other than first-line treatment is considered as an event. Sample size calculation is based on two independent study groups comparing proportions of events. Based on our previous work,41 we anticipate that MIC alone will guide to other than first-line treatment in 40% of the staphylococci PJI. We anticipate that the MIC and MBEC in combination will guide to other than first-line treatment in at least 75% of cases. With 1:1 randomisation allocation, power 80% and alpha set to 5%, the study requires 60 patients, 30 in each group. We will include 64 patients to account for dropouts. Analyses will be undertaken according to intention to treat.", "id": 833, "split": "val"} +{"trial_id": "NCT04488874", "pmid": "36221362", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Effectiveness of Hypertonic Sodium Lactate Infusion for Intraoperative Brain Relaxation in Patients Undergoing Scheduled Craniotomy for Supratentorial Brain Tumor Resection: Study Protocol of a Single Center Double-blind Randomized Controlled Phase II Pilot Trial\n\nIncluded conditions:\n- Sodium Lactate\n- Intracranial Hypertension\n- Brain Relaxation\n\nStudy Armgroups:\n- {'label': 'Sodium Lactate', 'type': 'EXPERIMENTAL', 'description': 'Intravenous Molar Sodium Lactate is administered during the first surgical incision. The dose is 2.5mL/kg.', 'interventionNames': ['Drug: Sodium Lactate']}\n- {'label': 'Mannitol 20%', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intravenous mannitol 20% is administered during the first surgical incision. The dose is 5mL/kg (1g/kg).', 'interventionNames': ['Drug: Mannitol 20% Infusion']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sodium Lactate', 'description': 'Sodium lactate is administered at 2.5mL/kg during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory.\\n\\nSodium Lactate and Mannitol 20% are used at an equimolar dose', 'armGroupLabels': ['Sodium Lactate']}\n- {'type': 'DRUG', 'name': 'Mannitol 20% Infusion', 'description': 'Mannitol 20% is administered intravenously at a dose of 5mL/kg, so 1g/kg, during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory.', 'armGroupLabels': ['Mannitol 20%']}\n\nPrimary Outcomes:\n- {'measure': 'Quality of brain relaxation', 'description': 'An adequate brain relaxation is evaluated by the neurosurgeon with a stage 1 (perfectly relaxed) or 2 (acceptably relaxed) of the brain swelling score validated by Todd et al. The brain swelling score is a four-point-scale: 1 (normal brain; no swelling); 2 (minimal swelling, but acceptable); 3 (serious swelling but no specific change in management required); or 4 (severe brain swelling requiring some intervention). Todd et al. reported a significant Relationship between intracranial pressure and the brain swelling score. The brain swelling score is the consensual tool used in clinical trials to assess the clinical effectiveness of brain relaxative therapy.', 'timeFrame': 'intraoperative'}\n\nPlease estimate the sample size based on the assumption: \nMeasurement accuracy of the primary outcome is set at 20% for the interventional group.", "answer": 50, "answer_type": "ACTUAL", "explanation": "3.11. Sample size calculation\n No previous study has assessed the clinical effectiveness of hypertonic sodium lactate infusion for intraoperative brain relaxation in patients undergoing scheduled craniotomy for supratentorial brain tumor resection. Thus, no assumption can be made on the expected difference in primary outcome between groups. The sample size calculation was based on the expected measurement accuracy of the primary outcome in the interventional group.\n Seo et al reported a satisfactory brain relaxation (primary outcome) in 65% of patients who received the same dose of 20% mannitol as in the conventional group.[8] We hypothesized that the primary outcome will be at least 55% in the interventional group to consider that hypertonic lactate sodium infusion provides a clinically relevant brain relaxation for supratentorial brain tumor resection.\n A sample size of 25 patients was calculated to achieve a measurement accuracy of the primary outcome of 20% in the interventional group. In this phase II pilot study, 2 groups of patients are included to check whether the expected rate of the primary outcome is the same in the conventional group as in the study from Seo et al[8] and to provide reliable data for further studies. Thus, the inclusion of a total sample size of 50 patients (25 patients per group) is planned.", "id": 834, "split": "val"} +{"trial_id": "NCT04489160", "pmid": "34863258", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Trial on the Safety and Efficacy of C1 Inhibitor for the Acute Management of Severe Traumatic Brain Injury\n\nIncluded conditions:\n- Traumatic Brain Injury\n- Trauma, Head\n\nStudy Armgroups:\n- {'label': 'C1-inhibitor', 'type': 'EXPERIMENTAL', 'description': 'One dose 6000 IU C1-inhibitor intravenously', 'interventionNames': ['Drug: C1 Inhibitor, Human']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '0.9% saline', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'C1 Inhibitor, Human', 'description': '6000 IU C1-INH', 'armGroupLabels': ['C1-inhibitor'], 'otherNames': ['Cinryze']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': '0.9% saline', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Therapy Intensity Level (TIL) Scale', 'description': 'TIL differentiated for various treatment modalities aimed at prevention or control of raised Intracranial Pressure (ICP) and/or for CPP management (0 to 38 points)', 'timeFrame': 'First four ICU days'}\n- {'measure': 'Glasgow Outcome Scale Extended (GOSE)', 'description': 'Functional outcome (minimum score = 1, maximum score = 8)', 'timeFrame': 'At 6 months after trauma'}\n- {'measure': 'Complication rate', 'description': 'Adverse and serious adverse events related possibly related to study medication', 'timeFrame': 'Up to 1 year'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 0.05 (two-sided) significance level, and approximately 10% withdrawal and loss to follow-up rate.", "answer": 106, "answer_type": "ESTIMATED", "explanation": "Sample size\n To detect a between-group difference in the TIL Scale of 2.2, with 90% power and 0.05 (two-sided) significance level, a total of 106 patients are required. Calculations were based on the anticipated mean of 8.2 and standard deviation 3.2 of the novel TIL in TBI patients admitted to the ICU [38]. The patient group treated with C1-INH is estimated to have an average TIL of 6 [39, 51]. Both treatment groups will include 53 patients to power the trial and to account for withdrawal and loss to follow-up (approximately 10%). With this sample size, a difference of 2.2 on the TIL scale can be detected, which is clinically relevant as it corresponds to one medium level of intervention (such as CSF drainage or mannitol treatment) less to control ICP indicating a significant treatment effect. As no minimal clinically important difference (MCID) for the TIL scale is defined in the literature, we will adhere to this shift of 2.2 points on the right-skewed scale.", "id": 835, "split": "val"} +{"trial_id": "NCT04491526", "pmid": "34876420", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Quadruple Blinded, Placebo Controlled, Multi-centered Trial Investigating Prophylactic Tamsulosin in Prevention of Postoperative Urinary Retention in Men After Endoscopic Total Extraperitoneal Inguinal Hernia Repair\n\nIncluded conditions:\n- Urinary Retention\n- Inguinal Hernia\n\nStudy Armgroups:\n- {'label': 'Tamsulosin Arm', 'type': 'EXPERIMENTAL', 'description': 'p.o.', 'interventionNames': ['Drug: TAMSULOSIN Mepha Ret Depocaps 0.4 mg']}\n- {'label': 'Placebo Arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'p.o.', 'interventionNames': ['Drug: Control Intervention']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'TAMSULOSIN Mepha Ret Depocaps 0.4 mg', 'description': '0.4mg/day Tamsulosin hydrochloride (\"TAMSULOSIN Mepha Ret Depocaps 0.4 mg\") from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)', 'armGroupLabels': ['Tamsulosin Arm'], 'otherNames': ['Verum']}\n- {'type': 'DRUG', 'name': 'Control Intervention', 'description': 'One placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)', 'armGroupLabels': ['Placebo Arm'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Post operative urinary retention (Need for any catheterization postoperatively)', 'description': 'Need for any catheterization postoperatively (Yes/No)', 'timeFrame': 'up to 3 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \n80% study power, 5% significance level, 2% dropout rate", "answer": 634, "answer_type": "ESTIMATED", "explanation": "Sample size\n We anticipate the detection of a 65% relative risk reduction of POUR in the experimental group in comparison with the placebo group, based on conservative assumptions from previous publications.5\u00e2\u0080\u00937 To detect a 65% reduction of POUR in the experimental group (2.9% anticipated) in comparison with the placebo group (8.3% anticipated) and to assure a study power of 80% with a Fisher\u00e2\u0080\u0099s exact test and a significance level of 5% and adjusting for a dropout rate of 2% we need 634 patients in total; 317 in each group.", "id": 836, "split": "val"} +{"trial_id": "NCT04494074", "pmid": "38286691", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Int\u00e9r\u00eat du Traitement de la fi\u00e8vre Par Refroidissement Externe Pour la Survie Des Patients ventil\u00e9s en Choc Septique\n\nIncluded conditions:\n- Septic Shock\n\nStudy Armgroups:\n- {'label': 'Fever Control by external cooling', 'type': 'EXPERIMENTAL', 'description': 'External cooling during 48 hours to obtain normothermia', 'interventionNames': ['Other: External Cooling']}\n- {'label': 'Fever respected, no cooling', 'type': 'NO_INTERVENTION', 'description': 'Fever respect without any antipyretic therapy'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'External Cooling', 'description': 'External Cooling', 'armGroupLabels': ['Fever Control by external cooling']}\n\nPrimary Outcomes:\n- {'measure': 'Mortality', 'description': 'All causes mortality', 'timeFrame': 'Day 60 from randomization'}\n\nPlease estimate the sample size based on the assumption: \nFor a two-sided alpha of 5%, a power of 80%, and a cooling-to-no cooling ratio of 1:1, the sample size calculation was performed using the nQuery V.8 software.", "answer": 820, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n \n Justification of estimations\n The Sepsis-3 definition of septic shock will select patients with a higher mortality risk than those reported in older studies.35 39 The expected mortality has been extracted from the results of the pilot study and from the databases of two RCTs performed in France (ie, \u00e2\u0080\u0098HYPER2S\u00e2\u0080\u0099 and \u00e2\u0080\u0098SEPSISPAM\u00e2\u0080\u0099) among patients meeting the Sepsis-3 criteria (n=698 patients).15 40 41 Half of the patients had ARDS and the observed mortality was 54%; mortality was similar among patient with and without ARDS.\n In a meta-analysis of personal data, the RR of death using fever control among patients requiring mechanical ventilation and vasopressors was 22% (OR 0.72, 95%\u00e2\u0080\u0089CI 0.50 to 1.04).23 The RR difference estimation in large RCTs comparing two treatments for sepsis was 22% in the \u00e2\u0080\u0098HYEPR2S\u00e2\u0080\u0099, \u00e2\u0080\u0098SEPSISPAM\u00e2\u0080\u0099, \u00e2\u0080\u0098CASS\u00e2\u0080\u0099 and \u00e2\u0080\u0098APROACCHSS\u00e2\u0080\u0099 studies. The RR difference estimations in large RCTs comparing treatments for ARDS were 19% in the \u00e2\u0080\u0098PETAL\u00e2\u0080\u0099 study and 33% in \u00e2\u0080\u0098EPVent-2\u00e2\u0080\u0099 study.13 40\u00e2\u0080\u009344\n \n \n Hypotheses\n An expected mortality of 52% with an expected RR of death of 19% is assumed. The hypothesis is to reduce mortality at day 60 from 52% to 42%. For a two-sided alpha of 5%, a power of 80% and a cooling-to-no cooling ratio of 1:1, 780 evaluable patients are needed. Due to lost to follow-up or other reasons, the final sample size of 820 patients is planned. The calculation was performed using the nQuery V.8 software (PTT0).\n \n \n Randomisation\n ICU medical investigators complete the process of informed consent and randomise the patients during their ICU stay. The treatment arm allocation will be provided by an interactive web response system (IWRS). After randomisation, cooling will be initiated immediately in patients allocated to the experimental group (figure 1). Allocation will be performed by stratification based on ARDS and by covariate-adaptive procedures. The ARDS criteria and the following patient characteristics\u00e2\u0080\u0094known to be strong predictors of mortality\u00e2\u0080\u0094will be recorded and added to the IWRS at randomisation to power the algorithm and ensure to the groups are balanced:\n \n \n Immunosuppression (ie, cancer chemotherapy, HIV, corticosteroids >1\u00e2\u0080\u0089mg/kg and/or >1\u00e2\u0080\u0089month, solid organ transplant, bone marrow transplant, immunosuppressant drugs for autoimmune disease).\n \n \n Arterial oxygen partial pressure to fractional inspired oxygen PaO2/FiO2 ratio (\u00e2\u0089\u00a44\u00e2\u0080\u0089hours before randomisation).\n \n \n Lactate level (\u00e2\u0089\u00a44\u00e2\u0080\u0089hours before randomisation).\n \n \n Age.\n \n \n Vasopressors (epinephrine+norepinephrine).\n \n \n Clinical centre of randomisation.\n \n \n \n Figure 1\n \n SEPSISCOOL-II trial design. ARDS, acute respiratory distress syndrome.\n \n \n \n The aforementioned characteristics are routinely monitored: their real-time availability guarantees the feasibility and the robustness of the real-time successful randomisation. These variables will be monitored and recorded in the study database. Hence, the distribution of covariates will be continually updated as the trial progresses.\n Dynamic hierarchical randomisation will be used to tackle the challenges of balancing a large number of stratification variables.45 The minimal sufficient balance randomisation method developed by Zhao et al46 will be implemented. As recommended by regulators, a random component will be incorporated to reduce the predictability of the allocation.47 48 The imbalance control limit will be set to p\u00e2\u0089\u00a50.3 for all covariates, and the covariate-adaptive allocation procedure will start after 20 patients have been randomised in each ARDS stratum.46 For each covariate (either continuous or categorical), a vote is conducted to decide whether this covariate should be selected for the randomisation and how to reach balance. The algorithm then allocate the definitive arm, with a predefined probability, according to the results of the votes for the selected covariates. This process is performed for each new participant.\n \n \n Development and test of the algorithm\n The proposed algorithm for randomisation has been tested internally and widely on simulated data (>10 000 datasets simulated). Nineteen scenarios were computed and included worst-case and best-case schemes. Once we will have fully implemented the randomisation in this study, a separate research paper will provide a comprehensive overview of all relevant developments (ie, simulations and real-world data) used for assessing and validating the performances of the proposed algorithm.", "id": 837, "split": "val"} +{"trial_id": "NCT04494087", "pmid": "33500291", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Potential Benefit in Information Providing and Influence on Patient Anxiety and Satisfaction by Means of Preoperative Explanatory Videos in Total Extraperitoneal Inguinal Hernioplasty: a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Inguinal Hernia\n\nStudy Armgroups:\n- {'label': 'Hernia video', 'type': 'ACTIVE_COMPARATOR', 'description': 'The video of the intervention group will provide a short (\\\\< 5 min) summary explaining the basic principles of endoscopic extraperitoneal hernia repair, its possible complications and the postoperative course. After carefully watching the video, participants should be able to correctly answer to a multiple-choice test consisting of 12 questions related to the aforementioned topics.', 'interventionNames': ['Other: Explanatory video']}\n- {'label': 'Mock video', 'type': 'PLACEBO_COMPARATOR', 'description': 'This video is a general documentation of the \"typical\" day of surgery in the day clinic. The information is essentially limited to the pictorial representation of the individual wards which the patient will pass through during the operation (arrival at the clinic, admission, transport to the operating theatre, recovery room, discharge).\\n\\nThe video explicitly does not transport any information that could be helpful for answering the quiz questions or for medical understanding of the operation itself.', 'interventionNames': ['Other: Explanatory video']}\n- {'label': 'Control group', 'type': 'SHAM_COMPARATOR', 'description': 'The link of the third group leads to a digital version of the information sheet, which has already been discussed with all patients during the informed consent discussion. The digital version of the informed consent form allows the patient to read the information again. The third group thus corresponds to the standard of care.', 'interventionNames': ['Other: Informed consent form']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Explanatory video', 'description': 'Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving', 'armGroupLabels': ['Hernia video', 'Mock video']}\n- {'type': 'OTHER', 'name': 'Informed consent form', 'description': 'Links to a digital version of the informed consent form already discussed during the process of informed consent giving.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Score in multiple-choice-test', 'description': 'Quiz with questions regarding background, indication, implementation, complications and postoperative course of the total extraperitoneal inguinal h ernioplasty (TEP) procedure. The questions asked check relevant aspects for the patient with regard to the planned operation. The structure of the multiple-choice quiz takes the \"single best option\" out of 12 questions. Maximum value of the test is 12 (12/12, highest score-best outcome), the lowest 0 (0/12, lowest score-worst outcome).\\n\\nThe questions are clearly posed and the correct answer is based on current guidelines for the management of inguinal hernia, which have been published by the European Hernia Society (EHS), American Hernia Society (AHS), International Endo Hernia Society (IEHS) and the European Association for Endoscopic Surgery and Other Interventional Techniques (EAES) as a consensus document by \"HerniaSurge\".', 'timeFrame': 'assessed 1-2 days after group allocation/exposure'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level (\u03b1)=0.05, power=0.8, dropout rate=15%", "answer": 183, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on a previous study,17 we calculated, a priori for the investigation of the primary outcome, a total number of 183 patients. This number was calculated for the primary outcome. According to this case number estimation 61 patients per group should be included. Using g-power,18 an analysis of variance analysis was performed and a drop-out rate of 15% was postulated (power=0.8; \u00e2\u008d\u00ba=0.05; f=0.25; N(min)=159).", "id": 838, "split": "val"} +{"trial_id": "NCT04497025", "pmid": "34810187", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility and Safety of an Immersive Virtual Reality-based Vestibular Rehabilitation Program for Dizziness, Balance and Fatigue Improvement in People With Multiple Sclerosis: Protocol for a Pilot Randomised Controlled Study\n\nIncluded conditions:\n- Multiple Sclerosis\n- Vestibular Disease\n- Dizziness\n- Balance Disorders\n- Fatigue\n- Quality of Life\n- Usability\n- Cybersickness\n\nStudy Armgroups:\n- {'label': 'Immersive virtual reality-based vestibular training.', 'type': 'EXPERIMENTAL', 'description': 'Subjects in this group will receive the same intervention than the other group of study, but they will wear a 3D head mounted display (Oculus Quest glasses) and will receive real-time gaming feedback in terms of visual and audio output while using the training system.\\n\\nParticipants will receive a total of 20 sessions (3 sessions of 50 minutes per week, 7 weeks). These sessions will be divided in 10 initial sessions (based on the three first blocks of Cawthorne-Cooksey protocol) and 10 advanced sessions in which vestibular exercises are gradually get more complicated by modifiying the following exercise parameters: base of support width, standing on unstable surface, alternatives single leg support, tandem position, increased velocity of head movements, higher head range motion and coordinated movements with arms and trunk.\\n\\nSame location, tailoring parameters and physical therapist supervision than conventional vestibular training.', 'interventionNames': ['Other: Immersive Virtual-based vestibular rehabilitation']}\n- {'label': 'Conventional vestibular training.', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subjects in the control group will receive a total of 20 sessions of 50 minutes (3 sessions per week, 7 weeks). They will receive traditional \"Cawthorne-Cooksey\" vestibular rehabilitation exercises. This program improves vestibular compensation through a mechanism of neuroplasticity known as adaptation, habituation and substitution. Just like the virtual reality intervention it will be divided in 10 initial sessions and 10 advanced sessions. For the advanced phase of intervention exercises parameters were the same described for the virtual vestibular rehabilitation intervention.\\n\\nA physical therapy with at least two years of expertise in vestibular rehabilitation will adjust the difficulty level. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).', 'interventionNames': ['Other: Conventional vestibular rehabilitation protocol']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Immersive Virtual-based vestibular rehabilitation', 'description': 'Vestibular rehabilitation based on virtual environment using a head mounted display', 'armGroupLabels': ['Immersive virtual reality-based vestibular training.']}\n- {'type': 'OTHER', 'name': 'Conventional vestibular rehabilitation protocol', 'description': '\"Cawthorne-Cooksey\" vestibular rehabilitation exercises.', 'armGroupLabels': ['Conventional vestibular training.']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of virtual reality-based vestibular rehabilitation', 'description': 'Usability of virtual reality device: System Usability Scale (0-100%). Higher Scores means higher usability\\n\\nParticipation rate\\n\\nRetention rate\\n\\nAdherence to treatment rate', 'timeFrame': '7 weeks of intervention'}\n- {'measure': 'Safety of virtual reality-based vestibular rehabilitation', 'description': 'Cybersickness: Scores ranging between 10 and 15 mean significant symptoms and above 20 indicates a simulator problem\\n\\nFalls registry\\n\\nAdverse events registry', 'timeFrame': '7 weeks of intervention'}\n\nPlease estimate the sample size based on the assumption: \nFormal sample size calculation is not carried out; recommendations for good practice in feasibility and pilot studies are followed.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A major reason for conducting a pilot study is to determine the initial data to perform a sample size calculation for a larger trial.76 For this reason, the formal sample size will not be carried out. However, following the recommendations of good practice for the design and analysis of feasibility and pilot studies in preparation for RCT,76 77 we aimed to recruit at least 30 subjects (15 per group).", "id": 839, "split": "val"} +{"trial_id": "NCT04497324", "pmid": "34001174", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.', 'interventionNames': ['Biological: Convalescent plasma']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Standard of care'}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Convalescent plasma', 'description': 'Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.', 'armGroupLabels': ['Experimental group']}\n\nPrimary Outcomes:\n- {'measure': 'Transfusion-related Serious Adverse Events', 'description': 'Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2', 'timeFrame': '14 days after randomization'}\n\nPlease estimate the sample size based on the assumption: \nconfidence level of 95%, power of 80%, drop-out rate of 10%", "answer": 100, "answer_type": "ACTUAL", "explanation": "Numbers to be randomized (sample size)\n The sample size was calculated using the Fleiss formula with continuity correction to detect a mortality reduction from 50 to 20% between the two treatment arms with a confidence level of 95% and a power of 80%. Based on this information, a total of 45 patients per arm would be needed. After adjustment for a drop-out rate of 10% after enrolment, a total of 50 patients per arm (100 patients in total) will be enrolled.", "id": 840, "split": "val"} +{"trial_id": "NCT04497974", "pmid": "36627602", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Role of Long-term Dietary Sweetness Exposure on Sweetness Preferences\n\nIncluded conditions:\n- Food Preferences\n\nStudy Armgroups:\n- {'label': 'Regular dietary sweetness exposure - Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Regular dietary sweetness exposure (RSE) - The RSE group consumes a diet with 25 - 30 % energy from sweet tasting foods, for 6 months.', 'interventionNames': ['Other: Dietary intervention']}\n- {'label': 'Low dietary sweetness exposure - Experimental', 'type': 'EXPERIMENTAL', 'description': 'Low dietary sweetness exposure (LSE) - The LSE group consumes a diet with 10 - 15 % energy from sweet tasting foods, for 6 months.', 'interventionNames': ['Other: Dietary intervention']}\n- {'label': 'High dietary sweetness exposure - Experimental', 'type': 'EXPERIMENTAL', 'description': 'High dietary sweetness exposure (HSE) - The HSE group consumes a diet with 40 - 45 % energy from sweet tasting foods, for 6 months.', 'interventionNames': ['Other: Dietary intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Dietary intervention', 'description': 'Varying the exposure to sweetness via diet manipulation.', 'armGroupLabels': ['High dietary sweetness exposure - Experimental', 'Low dietary sweetness exposure - Experimental', 'Regular dietary sweetness exposure - Control']}\n\nPrimary Outcomes:\n- {'measure': 'Change in preference score.', 'description': 'Measured during preference testing, using Ranking on a scale methodology (scale anchored at 0: Dislike extremely; 50: Neither dislike or like; 100: Like extremely) in a series of test foods.', 'timeFrame': 'from month 0 to month 6.'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a parallel design with 3 groups, two repeated measures (baseline vs 6-month) with a correlation of 0.7, a power of 80%, a significance level of 0.05, and a potential dropout rate of 20%.", "answer": 180, "answer_type": "ACTUAL", "explanation": "Sample size estimation\n The sample size calculation is based on our primary outcome: change in most preferred sweet taste concentration from 0\u00e2\u0080\u00936\u00c2\u00a0months. Previous studies have established that it is possible to detect shifts in preferred concentration from preference tests [36, 52]. For example, looking at the study of Liem and de Graaf [52] and the change in most preferred concentration, we can observe that mean ranking score for the sweet exposure group changed by around 0.4 and by around 0.6 for the sour exposure group from baseline to after exposure, which is around 10%. Therefore, the effect size of 0.1 was considered to be a relevant and meaningful effect size for our study, and was used to estimate the sample size. We estimate that 147 participants are needed to detect an effect size of 0.1, assuming a parallel study with 3 groups, with two repeated measures (baseline vs 6-month, correlation between measures of 0.7), and a power of 80% at a significance level of 0.05. To account for a potential dropout of 20%, 180 individuals will be enrolled in the study.", "id": 841, "split": "val"} +{"trial_id": "NCT04499677", "pmid": "33685502", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Favipiravir, Lopinavir/Ritonavir or Combination Therapy: a Randomised, Double Blind, 2x2 Factorial Placebo-controlled Trial of Early Antiviral Therapy in COVID-19\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Favipiravir + Lopinavir/ritonavir (LPV/r)', 'type': 'EXPERIMENTAL', 'description': 'Oral favipiravir at 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Lopinavir/ritonavir (LPV/r) at 400mg/100 mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7', 'interventionNames': ['Drug: Favipiravir', 'Drug: Lopinavir/ Ritonavir']}\n- {'label': 'Favipiravir + Lopinavir/ritonavir (LPV/r) placebo', 'type': 'EXPERIMENTAL', 'description': 'Oral favipiravir at 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Lopinavir/ritonavir (LPV/r) matched placebo at 400mg/100mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7.', 'interventionNames': ['Drug: Favipiravir', 'Other: Lopinavir/ Ritonavir Placebo']}\n- {'label': 'Favipiravir placebo + Lopinavir/ritonavir (LPV/r)', 'type': 'EXPERIMENTAL', 'description': 'Oral favipiravir matched placebo at 1800 mg twice daily on Day 1, by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Lopinavir/ritonavir (LPV/r) at 400mg/100mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7.', 'interventionNames': ['Drug: Lopinavir/ Ritonavir', 'Other: Favipiravir Placebo']}\n- {'label': 'Favipiravir placebo + Lopinavir/ritonavir (LPV/r) placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Oral favipiravir matched placebo at 1800 mg twice daily on Day 1, by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Lopinavir/ritonavir (LPV/r) matched placebo at 400mg/100mg twice daily on Day 1, followed by 200mg/50mg four (4) times daily from Day 2 to Day 7.', 'interventionNames': ['Other: Favipiravir Placebo', 'Other: Lopinavir/ Ritonavir Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Favipiravir', 'description': 'Dosage and method of administration: Day 1: 1800 mg twice daily; Day 2 to Day 7: 400 mg four (4) times daily.', 'armGroupLabels': ['Favipiravir + Lopinavir/ritonavir (LPV/r)', 'Favipiravir + Lopinavir/ritonavir (LPV/r) placebo'], 'otherNames': ['Avigan']}\n- {'type': 'DRUG', 'name': 'Lopinavir/ Ritonavir', 'description': 'Dosage and method of administration: Day 1: 400mg/100 mg twice daily; Day 2 to Day 7: 200mg/50mg four (4) times daily', 'armGroupLabels': ['Favipiravir + Lopinavir/ritonavir (LPV/r)', 'Favipiravir placebo + Lopinavir/ritonavir (LPV/r)'], 'otherNames': ['Kaletra']}\n- {'type': 'OTHER', 'name': 'Favipiravir Placebo', 'description': 'Dosage and method of administration: Day 1: 1800 mg twice daily; Day 2 to Day 7: 400 mg four (4) times daily.', 'armGroupLabels': ['Favipiravir placebo + Lopinavir/ritonavir (LPV/r)', 'Favipiravir placebo + Lopinavir/ritonavir (LPV/r) placebo']}\n- {'type': 'OTHER', 'name': 'Lopinavir/ Ritonavir Placebo', 'description': 'Dosage and method of administration: Day 1: 1800 mg twice daily; Day 2 to Day 7: 400 mg four (4) times daily.', 'armGroupLabels': ['Favipiravir + Lopinavir/ritonavir (LPV/r) placebo', 'Favipiravir placebo + Lopinavir/ritonavir (LPV/r) placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Upper respiratory tract viral load at Day 5', 'description': 'Quantitative polymerase chain reaction (PCR) performed on saliva samples at Day 5 of therapy', 'timeFrame': 'Day 5 from randomisation'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 240, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n 240 participants, 60 in each arm.", "id": 842, "split": "val"} +{"trial_id": "NCT04500080", "pmid": "35292485", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility and Safety of Physical Exercise Program in Men With Prostate Cancer Receiving Androgen Deprivation Therapy and Radiotherapy\n\nIncluded conditions:\n- Prostate Cancer\n- Androgen Deprivation Therapy\n- Radiotherapy\n\nStudy Armgroups:\n- {'label': 'PE intervention', 'type': 'EXPERIMENTAL', 'description': 'Aerobic, resistance, and neuromotor exercise', 'interventionNames': ['Behavioral: PE Intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'PE Intervention', 'description': 'Each single exercise session will last for one hour and will consist of a combination of the following elements:\\n\\n* Aerobic Exercise (AE): 20-30 minutes at moderate-high intensity, from 60 to 80% of the maximum heart rate (% HRmax).\\n* Resistance Exercise (RE): 30 minutes of strength activity of the major muscle groups.\\n* Neuromotor Exercise (NE): will be integrated with strength exercises and will consist of jumping, balance and coordination activities', 'armGroupLabels': ['PE intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility - Recruitment rate', 'description': 'Percentage ratio between patients included in the study and number of participants screened for recruitment.', 'timeFrame': 'At baseline (T0)'}\n- {'measure': 'Feasibility - Adherence rate to the exercise program', 'description': 'Determine the percentage of patients adhering to the program and the weekly exercise sessions.', 'timeFrame': 'Throughout the 20 week study period'}\n- {'measure': 'Feasibility - Dropout rate', 'description': 'Percentage of patients that withdraw from the study and the reason to withdraw', 'timeFrame': 'Throughout the 20 week study period'}\n- {'measure': 'Feasibility - Safety/Adverse events', 'description': 'Any adverse events, related or not related to the exercise program, will be documented', 'timeFrame': 'Throughout the 20 week study period'}\n- {'measure': \"Feasibility - Compliance and patients' experience\", 'description': 'Determined by qualitative evaluation, using interviews, to assess experiences, accessibility and acceptability of the exercise intervention.', 'timeFrame': 'Following the study conclusion at 20 weeks.'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated.", "answer": 5, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n No formal sample size requirement is needed for this single-group, pilot, feasibility study. At the Santa Maria Nuova Hospital of Reggio Emilia, nearly 30 patients/year undergo ADT and RT, and we aim to recruit 25 patients during the 12-month recruitment period.", "id": 843, "split": "val"} +{"trial_id": "NCT04501198", "pmid": "33120822", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Moxibustion Combined With Characteristic Lifestyle Intervention of Traditional Chinese Medicine in the Treatment of Abdominal Obesity: A Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Obesity\n\nStudy Armgroups:\n- {'label': 'Moxibustion with characteristic lifestyle intervention of TCM', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine.In this study, xiusheng decoction, traditional exercises, and modern lifestyle intervention will be combined as the characteristic lifestyle intervention method of TCM to help participants establish healthy living habits. Participants will receive the treatment of moxibustion 6 times a week to fulfill a 8-session treatment course, and the intervention of Xiusheng Decoction and Traditional exercises will last for 8 weeks.While the intervention of modern lifestyle intervention will be conducted for 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks.', 'interventionNames': ['Device: moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine']}\n- {'label': 'moxibustion with lifestyle intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive moxibustion combined with lifestyle intervention. Participants will receive the treatment of moxibustion 6 times a week to fulfill a 8-session treatment course,while the intervention of modern lifestyle intervention will be conducted for 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks.', 'interventionNames': ['Device: Moxibustion combined with lifestyle intervention.']}\n- {'label': 'lifestyle intervention', 'type': 'OTHER', 'description': 'Participants will receive lifestyle intervention which includes modern dietary exercise modifications. Participants will receive this treatment for a 8-session treatment course and 4-session follow-up course.', 'interventionNames': ['Device: lifestyle intervention']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine', 'description': '1. The moxibustion acupoints will be selected as\u2460zhongwan, guanyuan, shenque, and zusanli;\u2461pishu,shenshu. Acupoints group\u2460will be selected on Monday, Wednesday, and Friday, Acupoints group\u2461will be selected on Tuesday, Thursday, Saturday.Moxibustion treatment will be applied once every day, 6 times per week, for 8 consecutive weeks.\\n2. Xiusheng decoction, traditional exercises, and modern lifestyle intervention will be combined as the characteristic lifestyle intervention method of TCM to help participants establish healthy living habits. The Xiusheng Decoction should be taken twice a day. Traditional exercises will be taken for 35\\\\~40 minutes everyday, 7 times a week. The intervention of Xiusheng Decoction and traditional exercises will be conducted for 8 weeks. All patients will be instructed to follow a good living habits which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks.', 'armGroupLabels': ['Moxibustion with characteristic lifestyle intervention of TCM']}\n- {'type': 'DEVICE', 'name': 'Moxibustion combined with lifestyle intervention.', 'description': '1. The moxibustion acupoints will be selected as\u2460zhongwan, guanyuan, shenque, and zusanli;\u2461pishu,shenshu. Acupoints group\u2460will be selected on Monday, Wednesday, and Friday, Acupoints group\u2461will be selected on Tuesday, Thursday, Saturday.Moxibustion treatment will be applied once every day, 6 times per week, for 8 consecutive weeks.\\n2. All patients will be instructed to follow a good living habits including diet and exercise intervention which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks.', 'armGroupLabels': ['moxibustion with lifestyle intervention']}\n- {'type': 'DEVICE', 'name': 'lifestyle intervention', 'description': 'All patients will be instructed to follow a good living habits including diet and exercise intervention which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks.', 'armGroupLabels': ['lifestyle intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in waistline', 'description': 'Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).', 'timeFrame': 'week 0,week 2,week 4,week 6,week 8,week 12'}\n\nPlease estimate the sample size based on the assumption: \n1-sided \u03b1 level of 0.025, ensuring adequate power, and anticipating a 10% dropout rate.", "answer": 150, "answer_type": "ESTIMATED", "explanation": "2.7\n Sample size calculation\n The participants will be randomly divided into moxibustion combined with characteristic lifestyle intervention of TCM (intervention group), moxibustion combined with lifestyle intervention (intervention group), the lifestyle intervention (control group) in a 2:2:1 allocation ratio. The sample size was calculated based on the primary outcome, which is proposed to be the WC. Statistical Analysis System software (version 9.3)(SAS 9.3 Institute Inc., Cary, NC) was used to calculate the required sample size.\n Based on the results of previous studies and related literature reports, sample size required for each individual hypothesis testing was estimated at the 1-sided \u00ce\u00b1 level 0.025. With other assumptions, the basis of estimated sample sizes was listed in Table 2. To ensure adequate power for each individual hypothesis testing, a sample size of 135 was required, which consists of 54 subjects in the moxibustion combined with characteristic lifestyle intervention of TCM (intervention group), 54 subjects in the moxibustion combined with lifestyle intervention (intervention group), and 27 subjects in the lifestyle intervention (control group). Anticipating a 10% dropout rate, a total of 150 participants were recruited.\n \n Table 2\n \n Sample sizes required for each individual hypothesis testing.", "id": 844, "split": "val"} +{"trial_id": "NCT04507542", "pmid": "33435919", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Playing and Singing for the Recovering Brain: Efficacy of Enriched Social-Motivational Musical Interventions in Stroke Rehabilitation\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Enriched Music-Supported Therapy group', 'type': 'EXPERIMENTAL', 'description': 'Participants in the eMST-group will follow a 10-week program of Enriched Music-Supported Therapy. The program comprises 3 individual self-training sessions and 1 group session per week (total program duration: 40 hours).', 'interventionNames': ['Behavioral: Enriched Music-Supported Therapy']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the control intervention group will follow the Graded Repetitive Arm Supplementary Program (GRASP, Harris et al., 2009). They will be asked to complete 4 weekly one-hour session for 10 weeks (total program duration: 40 hours).', 'interventionNames': ['Behavioral: Graded Repetitive Arm Supplementary Program']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Enriched Music-Supported Therapy', 'description': 'Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program is based on musical training, combining self-training sessions of music playing using an app for electronic tablets and music therapy group sessions.', 'armGroupLabels': ['Enriched Music-Supported Therapy group'], 'otherNames': ['Music-Supported Therapy']}\n- {'type': 'BEHAVIORAL', 'name': 'Graded Repetitive Arm Supplementary Program', 'description': 'Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program comprises self-training sessions of mass repetition of movements and task-specific exercises for the upper extremity.', 'armGroupLabels': ['Control group'], 'otherNames': ['GRASP']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Action Research Arm Test', 'description': 'Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.', 'timeFrame': 'immediately after the intervention'}\n- {'measure': 'Change in Action Research Arm Test', 'description': 'Upper extremity function measure. The measure is a 19-item test divided into four subtests (grasp, grip, pinch and gross movement). For each item, the patient is asked to perform a simple task that involves a functional movement of the affected upper limb. Each task is rated using a 4-point ordinal scale. The maximum possible score is 57 and the minimal clinically important difference is 5.7 points.', 'timeFrame': '3 months after completing the intervention'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, and a dropout rate of 15%.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on a clinically relevant difference between treatment groups with 80% power and a 5% significance level. Considering that the minimal detectable change of the ARAT (primary outcome) is 5.7 points and that an acceptable difference between groups of 15% is defined to be clinically meaningful [84, 85], a sample size of 26 participants will be required in each group. From experience gathered in previous studies [32, 77], the dropout rate in this type of interventions is relatively low (15%). Taking this rate into consideration, a final estimation of 60 participants is needed in the study, 30 per group.", "id": 845, "split": "val"} +{"trial_id": "NCT04513418", "pmid": "35698100", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy\n\nIncluded conditions:\n- Esophageal Neoplasms\n\nStudy Armgroups:\n- {'label': 'Interventional group', 'type': 'EXPERIMENTAL', 'description': 'Patients receive omega-3 fatty-acid enriched enteral nutritional emulsion during the neoadjuvant chemoradiotherapy. Patients are meanwhile encouraged to intake 25-30kcal/kg through regular food.', 'interventionNames': ['Dietary Supplement: Preoperative immunonutrition']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Patients are encouraged to intake 25-30kcal/kg through regular food without supplemental nutritional support before esophagectomy.'}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Preoperative immunonutrition', 'description': 'Preoperative immunonutrition includes an omega-3 fatty-acid enriched enteral nutritional emulsion given by oral intake, nasogastric feeding tube or jejunostomy 600ml per day, lasting for the whole period of neoadjuvant chemoradiation. Meanwhile, oral intake is encouraged to reach 25-30kcal/kg through regular food.', 'armGroupLabels': ['Interventional group']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of postoperative nutrition and immune-related complications', 'description': 'Rate of gastrointestinal complications (anastomotic leakage, gastrointestinal dysfunction), metabolic complications (electrolyte disturbances, liver or renal dysfunction) and infectious complications(wound infection, catheter-related infection, pneumonia, sepsis, or other infections requiring antibiotics).', 'timeFrame': 'Up to 30 days after surgery'}\n\nPlease estimate the sample size based on the assumption: \nA bilateral significance level (\u03b1) of 0.05, a power of test (1-\u03b2) of 0.80, and an estimated drop rate of 15%.", "answer": 244, "answer_type": "ESTIMATED", "explanation": "Power and sample size calculation\n The power and sample size calculation was based on the hypothesis that pre-operative immunonutrition during the neoadjuvant therapy can reduce postoperative nutrition and immune-related complications after esophagectomy. According to the previously published articles [22] and our own experience, the related complication rates were estimated at 50% in the control group and 30% in the interventional group. The required sample size of interventional and control arm (ratio\u00e2\u0080\u0089=\u00e2\u0080\u00892:1) was therefore calculated as 137 cases and 69 cases to detect the reduction in related complications from 50 to 30% based on a bilateral significance level (\u00ce\u00b1) of 0.05 and a power of test (1-\u00ce\u00b2) of 0.80. Considering an estimated drop rate of 15%, the minimum sample size of this study is 244 patients, 162 cases in the interventional group and 82 in the control group.\n All the esophageal cancer patients in the outpatient and inpatient service are screened for eligibility. Recruiting announcements are also published on the website of the participating center to promote recruitment.", "id": 846, "split": "val"} +{"trial_id": "NCT04514224", "pmid": "32958031", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementation of a Health Information Technology System for Young African American Women Into Community-Based Clinical Sites\n\nIncluded conditions:\n- Preconception Care\n\nStudy Armgroups:\n- {'label': 'Healthy Start Program 1', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n- {'label': 'Community Health Center 1', 'description': 'Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n- {'label': 'Healthy Start Program 2', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n- {'label': 'Community Health Center 2', 'description': 'Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n- {'label': 'Healthy Start Program 3', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n- {'label': 'Community Health Center 3', 'description': 'Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n- {'label': 'Healthy Start Program 4', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n- {'label': 'Community Health Center 4', 'description': 'Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n- {'label': 'Healthy Start Program 5', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n- {'label': 'Healthy Start Program 6', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Gabby implementation', 'description': 'Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings', 'armGroupLabels': ['Community Health Center 1', 'Community Health Center 2', 'Community Health Center 3', 'Community Health Center 4', 'Healthy Start Program 1', 'Healthy Start Program 2', 'Healthy Start Program 3', 'Healthy Start Program 4', 'Healthy Start Program 5', 'Healthy Start Program 6']}\n- {'type': 'OTHER', 'name': 'Evaluate the Gabby implementation', 'description': 'Assess implementation outcomes using the Proctor Implementation Outcomes Framework', 'armGroupLabels': ['Community Health Center 1', 'Community Health Center 2', 'Community Health Center 3', 'Community Health Center 4', 'Healthy Start Program 1', 'Healthy Start Program 2', 'Healthy Start Program 3', 'Healthy Start Program 4', 'Healthy Start Program 5', 'Healthy Start Program 6']}\n\nPrimary Outcomes:\n- {'measure': 'Acceptability of Gabby system by staff', 'description': 'Information about the acceptability of the Gabby system will be gleaned form qualitative and quantitative data. Virtual interviewers of key staff will be done informed by an interview guide to collect the qualitative data. The quantitative data will be assessed using an investigator developed 33-question Likert scale-based survey. Responses along the 5-point Likert scale will consist of Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), Strongly Agree (5). Higher score from acceptability related questions indicate greater acceptability.', 'timeFrame': '6 months'}\n- {'measure': 'Feasibility of Gabby system by staff', 'description': 'Information about the feasibility of the Gabby system will be gleaned form qualitative and quantitative data. Virtual interviewers of key staff will be done informed by an interview guide to collect the qualitative data. The quantitative data will be assessed using an investigator developed 33-question Likert scale-based survey. Responses along the 5-point Likert scale will consist of Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), Strongly Agree (5). Higher score from feasibility related questions indicate greater feasibility.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nPaired two-sided tests, power of 0.80, significance level of 0.05, intra-class correlation coefficient (ICC) of 0.012, design effect of 1.3, and an anticipated 2/3 of end-users providing outcome data.", "answer": 125, "answer_type": "ACTUAL", "explanation": "Sample size and power calculation\n To assess implementation based on usage and uptake, we will treat the sample size calculated for effectiveness as a convenience sample. Because usage and uptake are being analyzed descriptively with no baseline data and no over-time comparison, it is not appropriate to calculate power for these outcomes.\n To assess effectiveness based on per-end-user stage of change outcomes, our target sample size calculation is based on 12 available sites. Based on our previous RCT of 528 African American/Black women recruited nationally, [19] we expect to see an approximately 7.3% difference in the rate of risks behaviors achieving action or maintenance from 0 to 5.5\u00e2\u0080\u0089months, with a common error variance of approximately 28.7%. With paired two-sided tests, at a power of 0.80 and a significance level of 0.05, we would require at least 125 subjects to detect an effect of at least this magnitude. Because end-users are nested within sites, we also must account for within-site clustering. Based on published intra-class correlation coefficient (ICC) data from 61 clinical practices in 8 practice based research networks on risks such as smoking, diet, and exercise, we anticipate an ICC of 0.012 and a design effect of 1.3 [33]. Based on this design effect, we require at least 160 end-users, or 13 end-users per site. If we anticipate only about 2/3 of end-users to provide outcome data (consistent with our previous study), then we must enroll approximately 240 users, or 20 end-users per site, to detect a change in our outcome from 0 to 5.5\u00e2\u0080\u0089months.", "id": 847, "split": "val"} +{"trial_id": "NCT04515719", "pmid": "35105722", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity\n\nIncluded conditions:\n- Systemic Lupus Erythematosus\n\nStudy Armgroups:\n- {'label': 'Belimumab 2mg/kg', 'type': 'EXPERIMENTAL', 'description': 'Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Belimumab 2mg/kg is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.', 'interventionNames': ['Biological: Belimumab']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Eligible patients were randomized in a 1:1 ratio to belimumab/placebo on the background of standard therapy. Placebo (normal saline) is administered intravenously at week 0, week 2, week 4 and then every 4 weeks until 48 weeks.', 'interventionNames': ['Biological: Placebo']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Belimumab', 'description': 'Belimumab 2mg/kg intravenously', 'armGroupLabels': ['Belimumab 2mg/kg'], 'otherNames': ['BENLYSTA\u2122']}\n- {'type': 'BIOLOGICAL', 'name': 'Placebo', 'description': 'Placebo intravenously', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Percentage of patients with disease flares', 'description': 'Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).', 'timeFrame': '52 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe trial assumes an 80% power at a two-sided alpha error of 0.05, with an estimated 10% drop-out rate.", "answer": 334, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The NEA study showed that 10\u00e2\u0080\u0089mg/kg belimumab reduced the severe flare rates in patients with active SLE significantly better than placebo (22% vs 12%, p=0.0004). Besides, according to the BLISS-52, BLISS-76 and the post hoc analysis, 1\u00e2\u0080\u0089mg/kg belimumab helped patients achieve comparable endpoints with 10\u00e2\u0080\u0089mg/kg group. Therefore, low-dose belimumab (120\u00e2\u0080\u0089mg per infusion, about 2\u00e2\u0080\u0089mg/kg) is chosen for the trial to prevent lupus flares among patients with low-grade SLE.\n The sample size estimation was thus carried out with the reference to the flare rate of the placebo arm in our previous \u00e2\u0080\u0098Met Lupus\u00e2\u0080\u0099 trial enrolling similar population12 and the reduction magnitude of flare rate borrowed from the NEA trial.\n A sample size of 167 participants per group including an estimated 10% drop-out would provide the trial with 80% power at a two-sided alpha error of 0.05, yielding a minimum required enrolment of 334 participants.", "id": 848, "split": "val"} +{"trial_id": "NCT04516616", "pmid": "37253491", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study of Pd-1 Antibody in Combination with Neoadjuvant Chemotherapy for Locally Advanced Cervical Cancer\n\nIncluded conditions:\n- Uterine Cervical Neoplasm\n- Uterine Cervical Cancer\n- Cervical Cancer\n\nStudy Armgroups:\n- {'label': 'Study group', 'type': 'EXPERIMENTAL', 'description': 'Patients receive 1 cycle of cisplatin and albumin-bound paclitaxel combined neoadjuvant chemotherapy and subsequent 2 cycles of PD-1 antibody combined neoadjuvant chemotherapy.', 'interventionNames': ['Drug: Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles)', 'description': 'PD-1 monoclonal antibody \uff08SHR-1210)\uff1a200mg\uff0cIV infusion\uff0cQ3W Cisplatin\uff1a75-80 mg/m2, IV infusion, Q3W Albumin-bound paclitaxel: 260 mg/m2\uff0c30min\uff0cIV infusion, Q3W', 'armGroupLabels': ['Study group']}\n\nPrimary Outcomes:\n- {'measure': 'Objective Response Rate (ORR)', 'description': 'ORR is defined as the percentage of the participants in the ITT population who have a Complete Response or Partial Response. The ORR will be assessed by a blind independent central reviewer per RECIST 1.1', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided binomial test, type I error rate of 0.05, power of 91.4%, estimated dropout rate of 15%.", "answer": 85, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The clinical response rate in patients with LACC after NACT is approximately 70%.20 21 With a one-sided binomial test at an overall type I error rate of a=0.05, a sample size of 69 patients is needed to maintain 91.4% power under the hypothesis that the overall response rate of neoadjuvant immunotherapy is expected to increase to 85%. Eighty-two patients are included in the study, with an estimated dropout rate of 15%.", "id": 849, "split": "val"} +{"trial_id": "NCT04517266", "pmid": "36575421", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer Patients According to Clinical-genomic Model: an Open Label, Non-inferior Randomized Controlled Trial\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'experimental group', 'type': 'EXPERIMENTAL', 'description': 'whole breast/chest wall irradiation + SVC irradiation', 'interventionNames': ['Radiation: omit of IMI group']}\n- {'label': 'controlled group', 'type': 'ACTIVE_COMPARATOR', 'description': 'whole breast/chest wall irradiation + IMI+SVC irradiation', 'interventionNames': ['Radiation: IMI group']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'omit of IMI group', 'description': 'clincial high risk breast \uff08\u22652 risk factors\uff09patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.', 'armGroupLabels': ['experimental group']}\n- {'type': 'RADIATION', 'name': 'IMI group', 'description': 'clincial high risk breast \uff08\u22652 risk factors\uff09patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.', 'armGroupLabels': ['controlled group']}\n\nPrimary Outcomes:\n- {'measure': '2-year event-free survival', 'description': 'any recurrence,distant metastasis or death in 2 years', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, an alpha level of 0.025 (one-sided), and an anticipated enrolment period of 24 months.", "answer": 214, "answer_type": "ESTIMATED", "explanation": "Power and sample size calculation\n The power and sample size are calculated according to the hypothesis that the 5-year event-free survival of omitting IMNI group is non-inferior to those patients treated with comprehensive RNI with IMNI. According to survival outcome of pN1 breast cancer in our institute, the 5-year event free survival (EFS) is estimated to be 91% for the control and 81% for experimental groups, respectively. The permissible limit for HR is 2.30, with statistical power of 80%, an alpha level of 0.025 (one-sided). With an anticipated enrolment period of 24\u00c2\u00a0months, a total sample size of 208 patients is estimated to be needed. To compensate for eligible patients, the targeted number of patients is set at 214.", "id": 850, "split": "val"} +{"trial_id": "NCT04519242", "pmid": "34384419", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The BFF Study- The Better to Fix or Fuse Study 'Retaining or Removing the Joint in the Foot: A Randomized Controlled Multicenter Trial of Primary Arthrodesis Versus Joint Stabilisation in Lisfranc Fracture Dislocation Midfoot Injuries\n\nIncluded conditions:\n- Lisfranc Fracture\n- Arthrodesis\n- Internal Fixation\n- Quality of Life\n\nStudy Armgroups:\n- {'label': 'Patients enrolled in the ORIF group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Open reduction and internal fixation (ORIF), ORIF will be done by using bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS). For fixation, TMT4 and/or TMT5 K-wires (1.6 or 2.0mm) can be used instead.', 'interventionNames': ['Procedure: Surgery']}\n- {'label': 'Patients enrolled in the PA group', 'type': 'ACTIVE_COMPARATOR', 'description': 'PA will be done by removal of the articular surface and subsequent stabilization with bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS).', 'interventionNames': ['Procedure: Surgery']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Surgery', 'description': 'ORIF will be done by using bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS). For fixation TMT4 and/or TMT5 K-wires (1.6 or 2.0mm) can be used instead.\\n\\nPA will be done by removal of articular surface and subsequent stabilization with bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS).\\n\\nType and sequence of fixation of the involved rays as needed, partial or complete fixation as needed, judgement by treating surgeon.', 'armGroupLabels': ['Patients enrolled in the ORIF group', 'Patients enrolled in the PA group']}\n\nPrimary Outcomes:\n- {'measure': 'The 5 level EQ-5D version (EQ-5d-5L) questionnaire', 'description': 'This validated questionnaire (as defined by the EQ-5D-5L questionnaire) is a descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \\\\& discomfort, Anxiety \\\\& depression), each of which has five severity levels that are described by statements appropriate to that dimension. When the patients has no problems at the dimension, f.e. mobility, this is coded as \"1\".\\n\\nLEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems', 'timeFrame': '2-year follow up period'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated, power of 80%, and consideration of near-perfect correlation in longitudinal analysis.", "answer": 112, "answer_type": "ESTIMATED", "explanation": "Sample size and feasibility\n The primary outcome is quality of life over the follow up period, quantified using the EQ-5D-5L score. The longitudinal analysis will include multiple observations per patient, but it is unclear how strong consecutive measurements are correlated. For that reason, we performed a sample size calculation for a cross-sectional contrast between the two groups, so that even with near-perfect correlation, we would have sufficient power to detect a clinically meaningful difference.\n The estimated standard deviation (SD) of the EQ-5D-5L scores is 0.15. To be able to have sufficient statistical power (i.e., 80%) to detect a clinically meaningful difference in QoL of 0.08 points, we need to include 56 patients per group, or 112 in total. We estimate, based on previous experience, that we would need to screen approximately 190 patients to find 112 patients eligible and willing to participate.", "id": 851, "split": "val"} +{"trial_id": "NCT04520802", "pmid": "33980522", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Neuroinflammation in Cognitive Decline Post-cardiac Surgery: The FOCUS Study\n\nIncluded conditions:\n- Postoperative Cognitive Dysfunction\n- Coronary Artery Disease\n- Pathophysiology\n\nStudy Armgroups:\n- {'label': 'POCD', 'description': 'Patients with postoperative cognitive decline (POCD) after coronary artery bypass grafting (CABG) surgery', 'interventionNames': ['Diagnostic Test: 18F-DPA-714 PET/CT neuroimaging']}\n- {'label': 'no POCD', 'description': 'Patients without postoperative cognitive decline (POCD) after coronary artery bypass grafting (CABG) surgery', 'interventionNames': ['Diagnostic Test: 18F-DPA-714 PET/CT neuroimaging']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': '18F-DPA-714 PET/CT neuroimaging', 'description': '* Pre- and postoperative neuroimaging using 18F-DPA-714 PET/CT and brain MRI.\\n* Longitudinal neuropsychological examinations (up to 6 months postoperatively)\\n* Blood samples are drawn to assess the severity of the systemic inflammatory response', 'armGroupLabels': ['POCD', 'no POCD']}\n\nPrimary Outcomes:\n- {'measure': 'Change in TSPO PET tracer uptake at 3-7 days post-surgery', 'description': '18F-DPA-714', 'timeFrame': '3-7 days post-surgery minus preoperative (= day before surgery)'}\n\nPlease estimate the sample size based on the assumption: \nAn unpaired two-sample t-test with a power of 80% and a one-sided alpha of 0.05. To account for lower increments, 15 patients per group will result in a power of 85% with an alpha of 0.05.", "answer": 15, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n No data on the degree of glial activation after systemic inflammatory responses in post-cardiac surgery patients are available. Research on cognitive dysfunction after cardiac surgery estimates a prevalence of approximately 50% at hospital discharge.1 5 48 Therefore, we will define two groups based on the presence or absence of cognitive dysfunction at hospital discharge.\n Previous studies in dementia patients observed a 15%\u00e2\u0080\u009335%\u00e2\u0080\u0089higher PET tracer uptake in patients with cognitive impairment compared with healthy controls, with an SD of 30%.55 56 Therefore, we assume that patients with cognitive dysfunction at hospital discharge after cardiac surgery will have a 30% higher delta tracer uptake compared with patients without cognitive decline. To assess a 30% higher delta tracer uptake in patients with cognitive dysfunction, an unpaired two-sample t-test results in 13 patients per group with a power of 80% and a one-sided alpha of 0.05. In order to account for lower increments we will include 15 patients per group resulting in a power of 85% with an alpha of 0.05 to differentiate an increase of 30% in delta tracer uptake. Consequently, we will include a total of 30 patients, assuming that 50% will have cognitive decline at hospital discharge. The investigator can decide to withdraw a subject from the study for (1) urgent medical reasons or (2) if a protocol violation occurs or (3) if the subject is lost to follow-up. Replacement of individuals will not be necessary in this observational cohort once both PET scans are performed (ie, primary objective has been met).\n Sample size calculations were conducted for the primary objective solely, considering cognitive decline at hospital discharge. Assessment of long-term cognitive outcomes (up to 6 months) together with assessment of our secondary outcomes has been set up in an exploratory setting. The data of this study will be important to calculate the power and feasibility of a subsequent prospective project focused on long-term outcomes.", "id": 852, "split": "val"} +{"trial_id": "NCT04521309", "pmid": "33138867", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Antibodies Based Intravenous Immunoglobulin (IVIG) Therapy for Severe and Critically Ill COVID-19 Patients\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Standard care only n = 10 patients.'}\n- {'label': 'IVIG dose: 0.15 g/kg', 'type': 'EXPERIMENTAL', 'description': 'Standard Care + Single dose of 0.20 g/Kg anti-COVID-19 IVIG (experimental drug prepared at DUHS) n= 10 patients', 'interventionNames': ['Biological: SARS-CoV-2 antibody based IVIG therapy']}\n- {'label': 'IVIG dose: 0.20 g/kg', 'type': 'EXPERIMENTAL', 'description': 'Standard Care + Single dose of 0.25 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients', 'interventionNames': ['Biological: SARS-CoV-2 antibody based IVIG therapy']}\n- {'label': 'IVIG dose: 0.25 g/kg', 'type': 'EXPERIMENTAL', 'description': 'Standard Care + Single dose of 0.30 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients', 'interventionNames': ['Biological: SARS-CoV-2 antibody based IVIG therapy']}\n- {'label': 'IVIG dose: 0.30 g/kg', 'type': 'EXPERIMENTAL', 'description': 'Standard Care + Single dose of 0.35 g/Kg anti-COVID19 IVIG (experimental drug prepared at DUHS) n= 10 patients', 'interventionNames': ['Biological: SARS-CoV-2 antibody based IVIG therapy']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'SARS-CoV-2 antibody based IVIG therapy', 'description': 'Patient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include:\\n\\nAirway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics', 'armGroupLabels': ['IVIG dose: 0.15 g/kg', 'IVIG dose: 0.20 g/kg', 'IVIG dose: 0.25 g/kg', 'IVIG dose: 0.30 g/kg']}\n\nPrimary Outcomes:\n- {'measure': '28 Days mortality', 'description': 'All cause mortality of participants will be monitored for 28 days to assess the safety and efficacy of IVIG treatment.', 'timeFrame': '28 days'}\n- {'measure': 'Requirement of supplemental oxygen support', 'description': 'Number of days required for invasive or non-invasive oxygen supply during hospital stay as per oxygen saturation status of patient', 'timeFrame': '28 days'}\n- {'measure': 'Number of days on assisted ventilation', 'description': 'Number of days a participant will be requiring assisted ventilation both invasive and noninvasive', 'timeFrame': '28 days'}\n- {'measure': 'Days to step down', 'description': 'Shifting from ICU to ward', 'timeFrame': '28 days'}\n- {'measure': 'Days to Hospital Discharge', 'description': 'Duration from day of enrollment in study to Day of hospital discharge', 'timeFrame': '28 days'}\n- {'measure': 'Adverse events during hospital stay', 'description': 'Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)', 'timeFrame': '28 days'}\n- {'measure': 'Change in C-Reactive Protein (CRP) levels', 'description': 'Change in C-Reactive Protein (CRP) levels from baseline will be used to monitor inflammation', 'timeFrame': '28 days'}\n- {'measure': 'Change in neutrophil lymphocyte ratio', 'description': 'change in neutrophil lymphocyte ratio from baseline will be used to monitor inflammation', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Numbers to be randomised (sample size)\n Total 50 patients are randomised. The intervention arms consist of 40 participants divided in four groups of 10 participants while the comparator group consists of 10 patients.", "id": 853, "split": "val"} +{"trial_id": "NCT04522791", "pmid": "34425878", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Breathing, Relaxation, Attention Training, & Health in Older Adults\n\nIncluded conditions:\n- Mild Cognitive Impairment\n- Healthy Aging\n\nStudy Armgroups:\n- {'label': 'RFB+VSOP (MCI)', 'type': 'EXPERIMENTAL', 'description': 'For home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.\\n\\nA total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.', 'interventionNames': ['Behavioral: RFB', 'Behavioral: VSOP']}\n- {'label': 'IR+VSOP (MCI)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The control IR strategy will be used, set-up of which will be the same as the RFB + VSOP intervention group with IR replacing RFB. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.', 'interventionNames': ['Behavioral: VSOP', 'Behavioral: IR']}\n- {'label': 'IR only (MCI)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants randomized to this condition will receive weekly in-person check-in visits, and perform daily 10-minute IR, so that the number of treatment contacts (though not duration) will be equivalent. A total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.', 'interventionNames': ['Behavioral: IR']}\n- {'label': 'RFB+VSOP (HC)', 'type': 'OTHER', 'description': 'this is a new healthy control intervention arm used for testing adherence related items.\\n\\nFor home-based RFB+VSOP: The investigators will instruct subjects to do 10-minutes of app- guided paced breathing at RF daily; for select days, there will be VSOP training immediately following RFB.\\n\\nA total of 8 weeks intervention. The investigators will extend the intervention for additional two weeks for make-up sessions.', 'interventionNames': ['Behavioral: RFB', 'Behavioral: VSOP']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'RFB', 'description': 'The RFB protocol entails a combination of 8 weekly, in-lab training sessions using HRV biofeedback software (Physiocom, Seattle, WA) and daily paced breathing homework using a mobile-based HRV biofeedback app (Inner Balance, HeartMath, LLC, CA).', 'armGroupLabels': ['RFB+VSOP (HC)', 'RFB+VSOP (MCI)']}\n- {'type': 'BEHAVIORAL', 'name': 'VSOP', 'description': 'The investigators will use the INSIGHT online program (Posit Science). The platform will be built for our study, including 5 tasks (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice different cognitive processes with PS/A as the shared domain.', 'armGroupLabels': ['IR+VSOP (MCI)', 'RFB+VSOP (HC)', 'RFB+VSOP (MCI)']}\n- {'type': 'BEHAVIORAL', 'name': 'IR', 'description': 'Guided imagery relaxation, equal in dose and frequency to RF practice, will be used to control for relaxation effects that may occur via RFB (which could provide an alternative explanation for outcomes). IR activities will be facilitated using the Insight Timer mobile-based app, which emphasizes the use of visualization and imagery strategies to help the body relax.', 'armGroupLabels': ['IR only (MCI)', 'IR+VSOP (MCI)']}\n\nPrimary Outcomes:\n- {'measure': 'change of ANS flexibility at 2 months from baseline', 'description': 'A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.', 'timeFrame': '2 months post-baseline'}\n- {'measure': 'change of ANS flexibility at 8 months from baseline', 'description': 'A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.', 'timeFrame': '8 months post-baseline'}\n- {'measure': 'change of ANS flexibility at 14 months from baseline', 'description': 'A composite score developed via central autonomic networks and heart rate variability at rest and in response to a challenging cognitive stressor. Higher indicates better ANS flexibility. No max/min.', 'timeFrame': '14 months post-baseline'}\n- {'measure': 'change of cognition at 2 months from baseline', 'description': 'A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated.\\n\\nVisual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated.\\n\\nA composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.', 'timeFrame': '2 months post-baseline'}\n- {'measure': 'change of cognition at 8 months from baseline', 'description': 'A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated.\\n\\nVisual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated.\\n\\nA composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.', 'timeFrame': '8 months post-baseline'}\n- {'measure': 'change of cognition at 14 months from baseline', 'description': 'A composite score in executive function computed from Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). No min/max; higher score indicates higher executive function. Z-transformation will be calculated.\\n\\nVisual episodic memory computed from Brief Visuospatial Memory Test-Revised (BVMT-R). Age normative percentile scores range from 0-100, higher indicating better memory. Z-transformation will be calculated.\\n\\nA composite score will be a mean Z-score of composite score of EXAMINER and percentile score of BVMT-R.', 'timeFrame': '14 months post-baseline'}\n\nPlease estimate the sample size based on the assumption: \nAlpha = 0.025, 3 measurement time points (baseline, post-intervention, 12-month follow-up), 20% attrition rate.", "answer": 114, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample estimation is based on the effect of RFB+VSOP combined intervention on two primary outcomes (ANS flexibility and cognition/IADL) by comparing to other groups (IR+VSOP control and IR control only). Literature indicates the following information related to deciding the effect size: (1) a moderate to large effect (using Hedges\u00e2\u0080\u0099 g = 0.83) of HRVB (including RFB) on stress regulation measures [17], (2) a small to moderate effect of VSOP on cognition, (3) correlation between ANS measures (\u00cf\u00872 = 11.70, r = 0.44) [7, 64], and (4) correlations between ANS measures and cognition (pooled r = 0.16) [65]. We estimate alpha = 0.025 (correct for two comparisons: combined intervention group with VSOP+IR control, as well as with the IR control group), and 3 measurement time points: baseline, post-intervention assessment, and 12-month follow-up. A sample size of 96 will be able to detect a small effect (d = 0.20). We further estimate a 20% attrition rate at the 12-month follow-up (in another local longitudinal study of cognitively healthy older adults Dr. Lin conducted [66], the attrition rate was less than 20% for up to a 5-year follow-up), and we will use a sample size of 114 (n = 38 per group).", "id": 854, "split": "val"} +{"trial_id": "NCT04523116", "pmid": "39448911", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Validation of Tie2 as the First Tumour Vascular Response Biomarker for VEGF Inhibitors: Optimising the Design of a Subsequent Randomised Discontinuation Trial: VALTIVE1\n\nIncluded conditions:\n- Ovary Cancer\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Progression free survival (PFS)', 'description': 'To establish the validity of the Tie2 test as measured by progression free survival by showing the difference in terms of PFS between Tie2 vascular responders and Tie2 vascular non- responders.', 'timeFrame': \"Up to 12 months after completion of the last Participant's follow up visit\"}\n\nPlease estimate the sample size based on the assumption: \nFor the bevacizumab only arm, a significance level of 0.05 and a statistical power of 80% are assumed. For the bevacizumab + PARPi arm, a significance level of 0.05 and a power of 90% are assumed. Additionally, a one-sided time dependent Cox-regression analysis is used for the bevacizumab only arm, and a two one-sided t-test (TOST) for equivalence is used for the bevacizumab + PARPi arm. Missing/dropout rates are 10% for the bevacizumab only arm and 10% early progressive disease and 15% loss to follow up for the bevacizumab + PARPi arm.", "answer": 176, "answer_type": "ESTIMATED", "explanation": "Sample size\n \n Arm: bevacizumab only\n For the purposes of sample size calculation, survival data were simulated from the survival rate published in the ICON7 trial. Given a group of N simulated patients, with 75% vascular responders and 25% non-responders, the significance of survival difference between vascular responders and non-responders was estimated using a one-sided time dependent Cox-regression analysis, at a significance level of 0.05. The simulation was repeated 1000 times for each different value of N. We sought the minimum N value that would allow detection of significance in 800 simulation runs or more. We intend to recruit 176 patients (160\u00e2\u0080\u0089+\u00e2\u0080\u008910% to allow for loss to follow up), of which 132 will have a Tie2-defined vascular response and 44 will be non-responders, to allow a statistical power of 80% and a significance level of 0.05 for the detection of an HR of 0.55. As the control arm of the ICON8b trial is the standard of care, we have agreement that up to 50 ICON8b control patients\u00e2\u0080\u0099 translational research samples and accompanying data would be available for this application. Therefore, in total we need to recruit at least 126 patients.\n \n \n Arm: bevacizumab\u00e2\u0080\u0089+\u00e2\u0080\u0089PARPi\n In this arm, we will test the hypothesis that olaparib has no impact on the expression level of Tie2 and, therefore, it does not compromise the decision-making utility of Tie2 as a vascular response biomarker for bevacizumab. Accordingly, the null hypothesis for the power calculation is that Tie2 trajectory will not be altered through the addition of olaparib. Based on our ICON7 data, we anticipate that Tie2 has a mean reduction of 0.04 and standard deviation of 0.19 (both on log2 scale) from 9 to 18\u00c2\u00a0weeks (the estimated period during which olaparib would be added) in patients already receiving bevacizumab. Defining one standard deviation as the acceptance criteria for equivalence, we estimate that a minimum number of 23 participants will be needed to achieve a 90% power at a significance level of 0.05 based on a two one-sided t-test (TOST) for equivalence. We plan to recruit a total of 29 participants for this arm and the control cohort, allowing for 10% of patients who may develop early progressive disease and 15% of patients who may be lost to follow up during the study.", "id": 855, "split": "val"} +{"trial_id": "NCT04523649", "pmid": "35840293", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protocol for Rationale and Design of Home-Based SolUtion for Remote Atrial Fibrillation Screening to PrevenT RecUrrence StrOke (HUA-TUO AF Trial): A Randomized Open-label Study\n\nIncluded conditions:\n- Stroke, Cardiovascular\n\nStudy Armgroups:\n- {'label': 'Home-based atrial fibrillation screening group', 'type': 'EXPERIMENTAL', 'description': 'Patients in this group will be given a handheld single lead ECG recorder (Comfit Healthcare Devices Limited, Hong Kong SAR, China) and a patient-facing smartphone application specially designed for the study, and they will be requested to record daily ECG and certain vital measurement.', 'interventionNames': ['Device: Remote atrial fibrillation screening with handheld single lead ECG recorder']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Conventional medical care'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Remote atrial fibrillation screening with handheld single lead ECG recorder', 'description': 'Patients in this group will be given a handheld single lead ECG recorder (Comfit Healthcare Devices Limited, Hong Kong SAR, China) and a patient-facing smartphone application specially designed for the study, and they will be requested to record daily ECG and certain vital measurement.', 'armGroupLabels': ['Home-based atrial fibrillation screening group']}\n\nPrimary Outcomes:\n- {'measure': 'First detection of AF', 'description': 'First detection of AF by the handheld ECG, defined as an episode of irregular heart rhythm, without detectable P waves, lasting more than 30 seconds', 'timeFrame': '2 years'}\n\nPlease estimate the sample size based on the assumption: \n90% power, significance level of p<0.05, and an attrition rate of 15%.", "answer": 1740, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary analysis is to test whether home-based AF screening is superior to conventional care to detect new-onset AF. A total sample size of 1740 patients who had stroke is expected to achieve 90% power to detect a statistically significant difference (p<0.05) in time to first documented AF episode at 24 months. The sample size calculation is based on cumulative AF detection of 4% (2% per year) in the control group and 8% (4% per year) in the home-based AF screening group at 2 years. An attrition rate of 15% is accounted for in this sample size.", "id": 856, "split": "val"} +{"trial_id": "NCT04523701", "pmid": "34326053", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Diagnostic Role of the \"White Test\" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection- A Randomized Controlled Multicentric Superiority Trial- The BiLe-Trial (Bile Leakage Trial)\n\nIncluded conditions:\n- Bile Leakage\n\nStudy Armgroups:\n- {'label': 'Experimental Intervention (treatment)', 'type': 'EXPERIMENTAL', 'description': 'Open bile ducts are identified by visual control of the liver resection surface combined with the direct injection in the cystic stump of 20-40ml of SMOFlipid 20% Fresenius Kabi Canada Ltd.; authorization number: 57231 (Swissmedic).\\n\\nSMOFlipid is a white oily emulsion containing soya oil and medium chain triglycerides as main active components, normally used as parenteral nutrition as complement for essential fat acids supplementation. In this study the \"white\" test (= the administration of SMOFlipid retrograde through the cystic duct) is made by injection of one or two 20cc syringes full of lipidic solution (SMOFlipid 20%) in the cystic stump, directing the flow to the intrahepatic ducts. Residual fat emulsion is washed out from the biliary tract by a low pressure infusion of 20 to 50 ml of saline solution.', 'interventionNames': ['Drug: \"white\" test\" (= the administration of SMOFlipid retrograde through the cystic duct)']}\n- {'label': 'Control Intervention', 'type': 'NO_INTERVENTION', 'description': 'Open bile ducts are identified in the control group by visual control of the liver resection surface combined with the use of white gauzes (standard procedure)'}\n\nInterventions:\n- {'type': 'DRUG', 'name': '\"white\" test\" (= the administration of SMOFlipid retrograde through the cystic duct)', 'description': '\"white\" test\" (= the administration of SMOFlipid retrograde through the cystic duct)', 'armGroupLabels': ['Experimental Intervention (treatment)']}\n\nPrimary Outcomes:\n- {'measure': 'rate of postoperative bile leakage', 'description': 'Comparison of the rate of postoperative bile leakage in the control and in the intervention group. This is a binary endpoint defined by the presence or absence of the bile leakage (yes or no). Bile leakage is defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3.', 'timeFrame': 'within 30 days postoperative'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, significance level of 0.05, no interim analysis planned.", "answer": 210, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The BiLe-Trial is designed as a superiority trial, hypothesising that the intraoperative performance of the white test with lipidic solution reduces the rate of postoperative bile leakage compared with the use of a white gauze applied on the resected liver surface.\n The sample size was determined via simulations of the primary analysis. The simulations were based on the assumption that the intraoperative use of the white test with SMOFlipid 5% will lead to a postoperative reduction of the bile leakage rate from 21% in the control group (Nadalin et al and our retrospective data) to 7% in the intervention group. To detect this difference with a statistical power of 80% using Pearson\u00e2\u0080\u0099s \u00cf\u00872 test (with continuity correction) at a two-sided 0.05 significance level a sample size of 105 patients was required for each group, which means that 210 patients should be included in the study. No interim analysis is planned. The assumptions about the bile leakage rates were derived from evidence in the literature in conjunction with experience at hospitals participating in the study and currently using one of the studied treatments. The Cantonal Hospital Aarau is currently using the control treatment and saw a bile leakage rate of 19% among patients undergoing liver resection of two or three segments during the past years. A prospective cohort study of patients undergoing major (ie, at least three segments) liver resection found a bile leakage rate of 22.9% for the control group.8 The same cohort study found a bile leakage of 5.3% for the treatment group and also another observational study found a similar bile leakage rate of 5.1% among patients undergoing major liver resection surgery with lipidic solution.7 By contrast, the Cantonal Hospital of St. Gallen is routinely using lipidic solution in addition to standard methods and estimated their bile leakage rate at 10%. Hence, for both study groups, we assume a bile leakage rate that lies in between those observed.", "id": 857, "split": "val"} +{"trial_id": "NCT04525820", "pmid": "35120577", "question": "Here is the design of a clinical trial:\n\nOfficial Title: High Dose Vitamin-D Substitution in Patients With COVID-19: a Randomized Controlled, Multi Center Study\n\nIncluded conditions:\n- Covid19\n- Vitamin D Deficiency\n- Corona Virus Infection\n- ARDS\n- Coronavirus\n- SARS-CoV Infection\n\nStudy Armgroups:\n- {'label': 'High Dose Vitamin D', 'type': 'EXPERIMENTAL', 'description': \"Patient will receive a single high dose of vitamin D (140'000) in addition to daily 800 IU of vitamin D.\\n\\nThe medication be administered orally\", 'interventionNames': ['Drug: Single high dose vitamin D', 'Drug: Treatment as usual vitamin D']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patient will receive a single dose of placebo, orally administered and then treatment as usual (daily 800 IU of vitamin D, orally administered)', 'interventionNames': ['Drug: Placebo', 'Drug: Treatment as usual vitamin D']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Single high dose vitamin D', 'description': \"Patient receives either one dose orally of 140'000 IU (7 ml) of this drug once as an intervention treatment additionally to TAU or the patient receives 7 ml of the placebo Solution (7 ml) in addition to TAU\", 'armGroupLabels': ['High Dose Vitamin D'], 'otherNames': ['VITAMIN D3 oil 500 IU/drop']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Patient receives a single dose of a placebo solution', 'armGroupLabels': ['Placebo'], 'otherNames': ['Oily placebo solution']}\n- {'type': 'DRUG', 'name': 'Treatment as usual vitamin D', 'description': 'Both groups receive the treatment as usual after the single high dose or the placebo which will be 800 IU per day', 'armGroupLabels': ['High Dose Vitamin D', 'Placebo'], 'otherNames': ['Vitamin D3 solution 4000 IU/ml']}\n\nPrimary Outcomes:\n- {'measure': 'Length of hospitalization', 'description': 'Overall duration of the hospitalization from day of admission until the day of discharge or fatality', 'timeFrame': 'Administration to Discharge from hospital care (mean duration is between 14 and 22 days for Patients with COVID 19)'}\n\nPlease estimate the sample size based on the assumption: \nAlpha = 0.05, power = 0.80, sigma = 2.96, delta = 2, alternative hypothesis = two-sided, and a 10% dropout rate.", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n To calculate the sample size, we looked at an interventional study of vitamin D, which examined the length of hospital stay as an outcome and what is known about the median length of hospital stay in patients hospitalized with COVID-19. A randomized, double-blind, placebo-controlled trial examined the effects of adjunctive vitamin D in adults hospitalized with community-acquired pneumonia (CAP) on time to recovery [28]. The primary outcome was the complete resolution of chest radiograph infiltrates at 6 weeks post-study treatment. Secondary outcomes included length of hospital stay, intensive care admission, and return to regular activity. At the same time, adjunctive vitamin D did not affect the primary outcome (OR 0.78, 95% CI 0.31 to 1.86, p = 0.548). There was evidence it increased the complete resolution of pneumonia in participants with baseline vitamin D levels <\u00e2\u0080\u008925\u00e2\u0080\u0089nmol/L (OR 17.0, 95% CI 1.40\u00e2\u0080\u0093549.45, p = 0.043). Although not significant, the results indicated that patients in the intervention group had shorter length of hospital stay (mean = 3.8, SD = \u00c2\u00b1 3.1, n = 60) when compared with patients in the placebo group (mean = 4.8, SD = \u00c2\u00b1 6.5, n = 57), which indicates a small effect size (Cohen\u00e2\u0080\u0099s d) of 0.1980. The study indicated a 20% reduction in length of hospital stay.\n Considering the above results in the light of COVID-19, more extended hospital stays in COVID-19 patients are expected. In smaller observational studies describing the clinical course of hospitalized COVID-19 patients in China, a median hospital stay of 12\u00e2\u0080\u0089days (IQR 9\u00e2\u0080\u009315) (n = 137) [1] or of 10\u00e2\u0080\u0089days (IQR, 7.0\u00e2\u0080\u009314.0) among those discharged alive (n = 47) [29] were observed. Guan et al. presented the clinical characteristics of 1099 patients with laboratory-confirmed COVID-19, and the median length of hospital stay was reported to be 12\u00e2\u0080\u0089days (IQR = 10\u00e2\u0080\u009314) [30], which we will take as a basis for our sample size calculation.\n Sample size calculation was performed using the function \u00e2\u0080\u009cpower.t.test\u00e2\u0080\u009d from the R package \u00e2\u0080\u009cstats\u00e2\u0080\u009d with the following parameters [31]: alpha = 0.05, power = 0.80, sigma = 2.96, delta (difference in the primary outcome between intervention and control group) = 2, and alternative hypothesis = two-sided, which resulted in a minimum of 35 patients per group, therefore a total of 70 patients. With a conservatively estimated 10% dropout rate, including the loss to follow-up, and a block size randomization of four, we decided to include 80 patients.", "id": 858, "split": "val"} +{"trial_id": "NCT04527861", "pmid": "35799145", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oncologic Outcomes of Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial\n\nIncluded conditions:\n- Colorectal Cancer\n- Colon Cancer\n- Rectal Cancer\n\nStudy Armgroups:\n- {'label': 'Single-incision Laparoscopic Surgery', 'type': 'EXPERIMENTAL', 'description': 'Patients with colorectal cancer undergo single-incision laparoscopic surgery.', 'interventionNames': ['Procedure: Single-incision Laparoscopic Surgery']}\n- {'label': 'Conventional Laparoscopic Surgery', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients with colorectal cancer undergo conventional laparoscopic surgery\uff083\\\\~5 ports\uff09.', 'interventionNames': ['Procedure: Conventional Laparoscopic Surgery']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Single-incision Laparoscopic Surgery', 'description': 'In this group\uff0cthe surgery is performed through a single incision. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides\uff0chand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.', 'armGroupLabels': ['Single-incision Laparoscopic Surgery'], 'otherNames': ['SILS']}\n- {'type': 'PROCEDURE', 'name': 'Conventional Laparoscopic Surgery', 'description': 'In this group\uff0cthe surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.', 'armGroupLabels': ['Conventional Laparoscopic Surgery'], 'otherNames': ['CLS']}\n\nPrimary Outcomes:\n- {'measure': '3-year disease free survival rate', 'description': '3-year disease free survival rate', 'timeFrame': '36 months after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe unilateral statistical significance level is 0.025, the power is 80%, and the study group and the control group will be allocated in a 1:1 ratio. The largest dropout rate is approximately 20%.", "answer": 710, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In this study, the 3-year DFS is the main effectiveness evaluation index for noninferiority evaluation. According to previous studies [27\u00e2\u0080\u009329], the 3-year DFS of the CLS group was approximately 75%. This study assumes that the 3-year DFS of the study group is the same as that of the control group. The expected enrolment time is 3\u00c2\u00a0years, and the follow-up time to reach the primary endpoint is 3\u00c2\u00a0years. If the acceptable noninferiority limit of DFS in the three years of this study is 10%, when DFS is exponentially distributed, the corresponding HR limit is 1.49. This number will be combined with \"Log-Rank Tests for Noninferiority\" in the professional sample size estimation software NCSS-PASS (14th edition, NCSS, LLC, Utah, USA). When the unilateral statistical significance level is 0.025, the inspection efficiency is 80%, and the study group and the control group will be allocated in the ratio of 1:1, the required sample size of each group will be 284. Considering that the largest abscission rate in this clinical study is approximately 20%, it was finally determined that the sample size of each group will be 355 cases, and the total number of cases required will be 710.", "id": 859, "split": "val"} +{"trial_id": "NCT04529148", "pmid": "37164472", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized, Double-masking, Placebo-controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Ginkgo Biloba Dropping Pills in the Treatment of Coronary Heart Disease With Stable Angina Pectoris and Depression\n\nIncluded conditions:\n- Stable Angina Pectoris Associated With Depression\n\nStudy Armgroups:\n- {'label': 'The treatment group', 'type': 'EXPERIMENTAL', 'description': 'Ginkgo biloba dropping pills (63mg / pill), oral, 5 pills each time, three times a day,12 weeks totally. ( Continued to receive the best western medicine treatment for stable angina pectoris of coronary heart disease during the observation period.)', 'interventionNames': ['Drug: Ginkgo biloba dropping pills\uff0cbest western medicine treatment']}\n- {'label': 'The control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Mimetic drug of ginkgo biloba dropping pills (63mg / pill),oral, 5 pills each time, three times a day,12 weeks totally.( Continued to receive the best western medicine treatment for stable angina pectoris of coronary heart disease during the observation period.)', 'interventionNames': ['Drug: Mimetic drug of ginkgo biloba dropping pills\uff0cbest western medicine treatment']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ginkgo biloba dropping pills\uff0cbest western medicine treatment', 'description': 'oral', 'armGroupLabels': ['The treatment group']}\n- {'type': 'DRUG', 'name': 'Mimetic drug of ginkgo biloba dropping pills\uff0cbest western medicine treatment', 'description': 'oral', 'armGroupLabels': ['The control group']}\n\nPrimary Outcomes:\n- {'measure': 'Score of Seattle Angina Questionnaire\uff08SAQ \uff09', 'description': 'Score 19 items of the 5 items of the scale, and calculate the total scores of the 5 items respectively, then convert them into standard points according to the formula: standard score = (actual score of the dimension - lowest score of the dimension) / (highest score of the dimension - lowest score of the dimension) \u00d7 100. The higher the score, the better the quality of life and body function.', 'timeFrame': 'at the 0-week'}\n- {'measure': 'Score of Seattle Angina Questionnaire\uff08SAQ \uff09', 'description': 'Score 19 items of the 5 items of the scale, and calculate the total scores of the 5 items respectively, then convert them into standard points according to the formula: standard score = (actual score of the dimension - lowest score of the dimension) / (highest score of the dimension - lowest score of the dimension) \u00d7 100. The higher the score, the better the quality of life and body function.', 'timeFrame': 'at the 4-week'}\n- {'measure': 'Score of Seattle Angina Questionnaire\uff08SAQ \uff09', 'description': 'Score 19 items of the 5 items of the scale, and calculate the total scores of the 5 items respectively, then convert them into standard points according to the formula: standard score = (actual score of the dimension - lowest score of the dimension) / (highest score of the dimension - lowest score of the dimension) \u00d7 100. The higher the score, the better the quality of life and body function.', 'timeFrame': 'at the 8-week'}\n- {'measure': 'Score of Seattle Angina Questionnaire\uff08SAQ \uff09', 'description': 'Score 19 items of the 5 items of the scale, and calculate the total scores of the 5 items respectively, then convert them into standard points according to the formula: standard score = (actual score of the dimension - lowest score of the dimension) / (highest score of the dimension - lowest score of the dimension) \u00d7 100. The higher the score, the better the quality of life and body function.', 'timeFrame': 'at the 12-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 0-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 1-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 2-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 3-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 4-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 5-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 6-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 7-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 8-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 9-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 10-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 11-week'}\n- {'measure': 'Frequency of angina pectoris related symptoms every week', 'description': 'With the help of questionnaire survey\uff0cwe can judge whether there is angina pectoris\uff0crecord the frequency of angina pectoris symptoms, and the frequency before treatment, during follow-up and after treatment will be compared within and between groups.', 'timeFrame': 'at the 12-week'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 0.05, power (\u03b2) of 0.8, and a potential dropout rate of 10%", "answer": 72, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n To the best of our knowledge, there are no previous studies on treating SAP with depressive symptoms in CHD with GBDPs. As suggested in previous studies on GBDPs and similar proprietary Chinese medicines for CHD,20\u00e2\u0080\u009322 the sample size was estimated, and the improvement of weekly angina attack frequency was taken as the main effect index according to the statistical requirements. We assumed the mean difference of 2.7, with a pooled SD of 3.8 for each group, \u00ce\u00b1=0.05 (the significant level), and \u00ce\u00b2=0.2 (power of 0.8), the sample size in the test and control groups will be estimated to be 32 (1:1 sample size ratio) for 64 cases. In addition, a potential dropout rate of 10% will be considered, requiring a sample of 72 cases.", "id": 860, "split": "val"} +{"trial_id": "NCT04532788", "pmid": "37208674", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Customized Corneal Cross-linking Versus Standard Corneal Cross-linking in Patients With Progressive Keratoconus\n\nIncluded conditions:\n- Keratoconus\n\nStudy Armgroups:\n- {'label': 'Customized crosslinking', 'type': 'ACTIVE_COMPARATOR', 'description': \"In the customized corneal cross-linking protocol (cCXL) a patient-specific treatment pattern, based on the patient's Pentacam images, will be used to treat the cornea. The CXL pattern exists out of 3 concentric circles and is centered on the cone. To estimate the cone location a combination of the thinnest corneal point, maximum anterior elevation and maximum posterior elevation is used. The epithelium is debrided with alcohol within the marked zone. After the application of riboflavin each circle receives a different amount of energy, which gradually decreases with increasing circle size.\\n\\nThe procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States).\", 'interventionNames': ['Procedure: Customized crosslinking']}\n- {'label': 'Standard crosslinking', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the standard corneal cross-linking protocol (sCXL) the epithelium is debrided with alcohol over a region with a diameter of 9.0 mm. After the application of riboflavin the cornea is irradiated with UVA with a fluence of 10 mW/cm2 during 9 minutes with a diameter of 9.0 mm, resulting in a total energy of 5.4 J/cm2.\\n\\nThe procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States).', 'interventionNames': ['Procedure: Standard crosslinking']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Customized crosslinking', 'description': \"In the customized corneal cross-linking protocol (cCXL) a patient-specific treatment pattern, based on the patient's Pentacam images, will be used to treat the cornea. The CXL pattern exists out of 3 concentric circles and is centered on the cone. To estimate the cone location a combination of the thinnest corneal point, maximum anterior elevation and maximum posterior elevation is used. The epithelium is debrided with alcohol within the marked zone. After the application of riboflavin each circle receives a different amount of energy, which gradually decreases with increasing circle size.\\n\\nThe procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States).\", 'armGroupLabels': ['Customized crosslinking']}\n- {'type': 'PROCEDURE', 'name': 'Standard crosslinking', 'description': 'In the standard corneal cross-linking protocol (sCXL) the epithelium is debrided with alcohol over a region with a diameter of 9.0 mm. After the application of riboflavin the cornea is irradiated with UVA with a fluence of 10 mW/cm2 during 9 minutes with a diameter of 9.0 mm, resulting in a total energy of 5.4 J/cm2.\\n\\nThe procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States).', 'armGroupLabels': ['Standard crosslinking']}\n\nPrimary Outcomes:\n- {'measure': 'Change in maximum keratometry (Kmax)', 'description': 'Kmax is measured with Scheimpflug photography (Pentacam\u00ae HR, OCULUS Optikgeraete GmbH, Wetzlar, Germany)', 'timeFrame': '12 months postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nWithin-group standard deviation (SD) of 1.72 D, 90% power, one-sided significance level alpha of 0.025, and 10% loss-to-follow-up.", "answer": 124, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n For non-inferiority, we assume that the intervention group should have an average decrease in Kmax of 1.0 D, based on clinical experience and recent evidence. The non-inferiority margin is equal to -0.3 D (i.e., the mean difference between cCXL and sCXL should be greater than -0.3 to achieve statistical significance). Assuming this non-inferiority margin and a within-group standard deviation (SD) of 1.72 D, we need to include 55 patients per group to detect non-inferiority with 90% power and a one-sided significance level alpha of 0.025. The sample size was calculated using an online calculator for the comparison of two means (www.powerandsamplesize.com). Accounting for 10% loss-to-follow-up, we need to include 62 patients per group, i.e., 124 patients in total.", "id": 861, "split": "val"} +{"trial_id": "NCT04534751", "pmid": "34479938", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective, Multi-center, Randomized, Parallel-control, Superiority Study Comparing Administration of Clotting Factor Concentrates With a Standard Massive Hemorrhage Protocol in Severely Bleeding Trauma Patients.\n\nIncluded conditions:\n- Traumatic Hemorrhage\n- Coagulopathy\n- Massive Hemorrhage\n\nStudy Armgroups:\n- {'label': 'Intervention Group- Clotting Factor Concentrates', 'type': 'EXPERIMENTAL', 'description': 'Fibryga + Octaplex (Fibrinogen + PCC)\\n\\nFibrinogen Concentrate 4g (Fibryga) + Prothrombin Complex Concentrate 2000 IU (Octaplex) in the first and second massive hemorrhage protocol (MHP) packs.', 'interventionNames': ['Biological: Fibrinogen + PCC']}\n- {'label': 'Control Group: Standard FP transfusion', 'type': 'ACTIVE_COMPARATOR', 'description': 'Frozen Plasma (FP)', 'interventionNames': ['Biological: Frozen Plasma']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Fibrinogen + PCC', 'description': 'Patients randomized to the intervention group will receive 4g of Fibryga and 2000 IU Octaplex will be released as part of the first and second MHP packs, if requested.\\n\\nIf a third MHP pack is required, and thereafter, FC will be administered if the fibrinogen level drops below 1.5-2.0 g/L at the discretion of the clinical team or based on conventional laboratory test results or viscoelastic methods.\\n\\nPatients in both groups will otherwise receive identical MHP treatment packs (4 units of red blood cells \\\\[RBC\\\\] in pack 1 and 4 units of RBC and 1 pool of platelets in pack 2 (equivalent to 4 units).', 'armGroupLabels': ['Intervention Group- Clotting Factor Concentrates'], 'otherNames': ['Fibryga + Octaplex']}\n- {'type': 'BIOLOGICAL', 'name': 'Frozen Plasma', 'description': '4U FP will be released as part of the first and second MHP packs.\\n\\nPatients in both groups will otherwise receive identical MHP treatment packs (4 units of red blood cells \\\\[RBC\\\\] in pack 1 and 4 units of RBC and 1 pool of platelets in pack 2 (equivalent to 4 units).\\n\\nPatients randomized to the control group may receive FC if the fibrinogen level drops below 1.5-2.0 g/L at the discretion of the clinical team or based on conventional laboratory test results or viscoelastic methods. FC dosing in MHP packs 3 and above will be site-specific and at the discretion of the treating clinician.', 'armGroupLabels': ['Control Group: Standard FP transfusion']}\n\nPrimary Outcomes:\n- {'measure': 'Composite of total number of Allogeneic Blood Products (ABPs)', 'description': 'The primary endpoint is to demonstrate superiority with respect to the composite number of all ABP units (RBCs, FP and platelets) transfused', 'timeFrame': 'within 24 hours'}\n\nPlease estimate the sample size based on the assumption: \nA type I error probability of \u03b1=0.025 will be used, with inferences based on the one-sided 97.5% CI from a negative binomial regression model. The power is set at 80%, and a 15% dropout rate is assumed.", "answer": 350, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was based on demonstrating superiority in efficacy of the intervention (FC+PCC) compared with the active control (FP), with respect to the primary outcome. To demonstrate that the early administration of FC\u00e2\u0080\u0093PCC is clinically superior to the usual component therapy, with respect to the primary outcome (mean number of ABP units within 24 hours post admission), a type I error probability of \u00ce\u00b1=0.025\u00e2\u0080\u0089will be used. Inferences will be based on the one-sided 97.5% CI derived from the estimated least square means of a negative binomial regression model. Superiority will be concluded if the upper limit of this CI is less than 1.0 (ie, the mean number of ABPs is larger in the control group).\n The superiority design of the FiiRST 2 trial was chosen due to the impact on clinical practice and logistical benefits that FC\u00e2\u0080\u0093PCC may offer. Empirical estimates of the mean number of ABP units within the first 24 hours and its dispersion were based on results of the FIIRST 1 Study.11 In FiiRST 1, the mean (\u00c2\u00b1SD) composite number of ABPs was 1.50 (\u00c2\u00b12.51) in the intervention group and 3.06 (\u00c2\u00b15.06) in the control group. A mean difference in 5 units of the composite outcome (eg, mean 15 units in the control group and mean 10 units in the intervention group) is considered as a clinically meaningful difference that should be detected with at least 80% power. This approach was used for power determination, which was calculated as 80% with a sample size of 297, which would suffice to demonstrate the superiority of the investigational treatment under the stated assumptions. The FIIRST 1 study had a 10% patient drop off (exclusions post randomisation for subjects where informed consent could not be obtained and for patients randomised and not treated with any coagulation products in pack 1). In addition, FiiRST 1 had 10% death rate. Hence, we inflated the sample size to account for a drop-out percentage by 15% for a final sample estimate of 350 patients.", "id": 862, "split": "val"} +{"trial_id": "NCT04536272", "pmid": "40087802", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Reduced Anticoagulation Targets in ECLS (RATE)\n\nIncluded conditions:\n- Heart Failure\n- Respiratory Failure\n- Extracorporeal Membrane Oxygenation\n- Bleeding\n- Thrombosis\n\nStudy Armgroups:\n- {'label': 'Target of 2-2.5 times baseline aPTT (usual care, about 60-75)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Administration of heparin during ECLS with an aPTT target of 2-2.5 times baseline.', 'interventionNames': ['Drug: Heparin']}\n- {'label': 'Target of 1.5-2.0 times baseline aPTT (45-60 sec.)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Administration of heparin during ECLS with an aPTT target of 1.5-2.0 times baseline.', 'interventionNames': ['Drug: Heparin']}\n- {'label': 'LMWH guided by weight and renal function.', 'type': 'ACTIVE_COMPARATOR', 'description': 'Administration of LMWH guided by weight and renal function during ECLS.', 'interventionNames': ['Drug: LMWH']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Heparin', 'description': 'Administration of heparin with a target of 2-2.5 or 1.5-2.0 times baseline aPTT during ECLS.', 'armGroupLabels': ['Target of 1.5-2.0 times baseline aPTT (45-60 sec.)', 'Target of 2-2.5 times baseline aPTT (usual care, about 60-75)'], 'otherNames': ['Unfractionated heparin']}\n- {'type': 'DRUG', 'name': 'LMWH', 'description': 'Administration of LMWH guided by weight and renal function during ECLS.', 'armGroupLabels': ['LMWH guided by weight and renal function.'], 'otherNames': ['Dalteparine', 'Enoxaparine', 'Nadroparine', 'Tinzaparine']}\n\nPrimary Outcomes:\n- {'measure': 'Hemorrhagic complications', 'description': 'Severe hemorrhagic complications will be registered according to the Extracorporeal Life Support Organization (ELSO) definitions for major bleeding and is defined as clinically overt bleeding with a decrease in hemoglobin of at least 1,24 mmol/L (2 g/dl)/24 hours, or a transfusion requirement of \u2265 3 EH RBC over that same time period. Bleeding that is retroperitoneal, pulmonary or involves the central nervous system, or bleeding that requires surgical intervention is also considered major bleeding.', 'timeFrame': 'Through ECLS completion, an average of 14 days'}\n- {'measure': 'Severe thromboembolic complications', 'description': 'Severe thromboembolic complication defined as ischemic stroke, limb ischemia, or acute pump failure', 'timeFrame': 'Through ECLS completion, an average of 14 days'}\n- {'measure': 'Mortality', 'description': 'Mortality at 6 months', 'timeFrame': '6 months after ECLS'}\n\nPlease estimate the sample size based on the assumption: \nNon-inferiority with a significance level (alpha) of 5%, power of 80%, and a non-inferiority limit (delta) of 7.5%.", "answer": 330, "answer_type": "ESTIMATED", "explanation": "Sample size\n The RATE trial is powered for the primary composite endpoint: (1) severe hemorrhagic complications according to the ELSO definitions; (2) severe thromboembolic complication defined as ischemic stroke, limb ischemia, or acute pump failure; and (3) mortality at 6\u00c2\u00a0months. We estimate that cases reaching the composite endpoint decrease from 70% in the control arm to 60% in each intervention arm. This sample size calculation is made to show non-inferiority with a significance level (alpha) of 5%, power of 80%, and a non-inferiority limit (delta) of 7.5%. The corresponding sample size is 91 patients per arm. To compensate for a lower effect and potential drop-outs, 330 patients will be enrolled.", "id": 863, "split": "val"} +{"trial_id": "NCT04539002", "pmid": "36596632", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Aerobic Exercise to Improve Mobility in Multiple Sclerosis: Optimizing Design and Execution for a Full-scale Multimodal Remyelination Clinical Trial\n\nIncluded conditions:\n- Multiple Sclerosis\n- Sclerosis\n- Demyelinating Diseases\n- Autoimmune Diseases of the Nervous System\n- Nervous System Diseases\n- Demyelinating Autoimmune Diseases, CNS\n- Exercise\n\nStudy Armgroups:\n- {'label': 'MS: Cycle', 'type': 'EXPERIMENTAL', 'description': 'Twenty-two participants in the clinical trial arm will be randomized to MS:Cycle: an aerobic exercise intervention on a stationary ergometer. Participants will exercise thrice weekly for 30 minutes with graded supervision for 24 weeks.', 'interventionNames': ['Behavioral: Aerobic exercise']}\n- {'label': 'MS: Take Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Twenty-two participants in the clinical trial arm will be randomized to MS: Take Control (MSTC): a monthly, hour-long MS education control group led by a trained facilitator.', 'interventionNames': ['Behavioral: Education Group Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Aerobic exercise', 'description': 'Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks.', 'armGroupLabels': ['MS: Cycle']}\n- {'type': 'BEHAVIORAL', 'name': 'Education Group Control', 'description': 'A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator.', 'armGroupLabels': ['MS: Take Control']}\n\nPrimary Outcomes:\n- {'measure': 'Somatosensory Evoked Potentials (SSEPs)', 'description': 'Measure of functional myelination of the somatosensory tracts of the spinal cord', 'timeFrame': 'From baseline to week 24'}\n\nPlease estimate the sample size based on the assumption: \nFor part 1, the significance level (\u00ce\u00b1) is 0.05, power is 88%. For part 2, the significance level (\u00ce\u00b1) is 0.05, power is >80%, and a 20% dropout rate is assumed.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Part 1 of the study will explore the relationship of demyelination with mobility in pwMS. Based on prior studies associating transformed SSEP z-scores and the expanded disability status scale (rho=0.81, p<0.001) in pwMS, n=60 participants would have 88% power to detect a correlation rho=0.40 (\u00ce\u00b1=0.05). All power analyses were computed using Power And Sample Size (PASS) software (V.15). For part 2 of the study (to explore if aerobic exercise improves mobility and promotes remyelination), we assume the effect size of z-transformed evoked potential values between baseline and 24\u00e2\u0080\u0089weeks is 0.54 in pwMS based on prior studies.27 Assuming a 20% drop out rate, enrolling 44 participants in the clinical trial would achieve the necessary final sample size of 36 participants, or 18 per group. This will give us >80% power to detect a 50% effect size (\u00ce\u00b1=0.05). Our sample size is similar to prior remyelination clinical trials of the pharmacotherapies clemastine and bexarotene in MS using visual evoked potentials, a similar functional myelination biomarker of the visual system.28 29 As this is the first clinical trial of exercise to use SSEP to assess for remyelination, it is unknown if the study intervention, different evoked potential modality or other factors may impact the required sample size.\n To our knowledge, this study is the first clinical trial in MS to use quantitative T1 MWF as a biomarker of structural remyelination and therefore a well-informed power analysis cannot be performed. However, 11 per group is similar to other studies that have demonstrated changes in white matter integrity in pwMS after rehabilitative interventions.30 31 If additional funding is obtained, the sample size of the MRI subset may be increased.", "id": 864, "split": "val"} +{"trial_id": "NCT04542785", "pmid": "33789853", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Lenient Rate Control Versus Strict Rate Control for Atrial Fibrillation. The Danish Atrial Fibrillation (DanAF) Randomised Clinical Trial\n\nIncluded conditions:\n- Atrial Fibrillation, Persistent\n- Atrial Fibrillation Chronic\n- Atrial Fibrillation\n\nStudy Armgroups:\n- {'label': 'Lenient rate control', 'type': 'EXPERIMENTAL', 'description': 'Treating physicians will target a resting heart rate between 80 and 110 beats per minute on a 12-lead resting ECG measured over 1 minute after 5 minutes of rest.', 'interventionNames': ['Other: Rate control']}\n- {'label': 'Strict rate control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treating physicians will target a resting heart rate a mean resting heart rate \\\\< 80 bpm on a 12-lead resting ECG measured over 1 minute after 5 minutes of rest.', 'interventionNames': ['Other: Rate control']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Rate control', 'description': 'Treatment will be provided according to current guidelines and as such the algorithm for treatment will be differentiated based on the status of left ventricular ejection fraction. For participants with reduced left ventricular ejection fraction, beta-blockers (metoprolol and bisoprolol) will be the primary therapy. Secondary therapies may include digoxin or amiodarone. For participants with preserved left ventricular ejection fraction, the primary therapy will be beta-blockers (metoprolol and bisoprolol) or non-dihydropyridine calcium-channel blockers (verapamil) with secondary therapy consisting of digoxin or amiodarone. Pacing therapies, alone or with atrioventricular node ablation, are utilised as indicated in the view of the treating physician.', 'armGroupLabels': ['Lenient rate control', 'Strict rate control']}\n\nPrimary Outcomes:\n- {'measure': 'Short Form-36 (SF-36) physical component score', 'timeFrame': 'After 1 year'}\n\nPlease estimate the sample size based on the assumption: \npower of 80%, significance level of 5%", "answer": 350, "answer_type": "ESTIMATED", "explanation": "Sample size: quality of life using the SF-36 questionnaire (physical component score)\n Using a minimal important difference of 3 points on the physical component score, an SD of 10, power of 80% and a significance level of 5% and a total of 350 participants will be needed.17 39 40 Based on this sample size, we have estimated the power of all remaining outcomes (see online supplemental file 5).\n \n 10.1136/bmjopen-2020-044744.supp5\n Supplementary data", "id": 865, "split": "val"} +{"trial_id": "NCT04544046", "pmid": "35397575", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Trial of a Supportive Oncology Care at Home Intervention for Patients With Cancer Receiving Definitive Treatment\n\nIncluded conditions:\n- Pancreatic Cancer\n- GastroEsophageal Cancer\n- Rectal Cancer\n- Head and Neck Cancer\n- Lymphoma\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants assigned to the standard care arm will receive standard oncology care and attend regular clinic visits. Participants on the standard care arm will complete questionnaires from baseline up to 6 months following enrollment.', 'interventionNames': ['Other: Usual Care']}\n- {'label': 'Supportive Oncology Care at Home', 'type': 'EXPERIMENTAL', 'description': 'The research study procedures include:\\n\\n* Remote monitoring of symptoms, vitals, and body weight\\n* Questionnaires asking about demographic information (e.g. gender, ethnicity, income) and experience with cancer (e.g. quality of life, symptoms)\\n* Data collection from medical record', 'interventionNames': ['Other: Supportive Oncology Care at Home']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Supportive Oncology Care at Home', 'description': 'Remote monitoring of symptoms, vital signs, and body weight with home-based care to address any concerning issues identified.', 'armGroupLabels': ['Supportive Oncology Care at Home']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Standard care arm will receive standard oncology care and attend regular clinic visits.', 'armGroupLabels': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of participants requiring a hospital admission or emergency department visit', 'description': \"Compare the difference between study arms using Fisher's exact tests, and logistic regression, adjusted for any potential confounders that are imbalanced between the two groups at baseline (e.g. age, gender).\", 'timeFrame': 'baseline to 6 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% two-sided type 1 error, no missing data, intention-to-treat principle", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary endpoint of the proposed study is a comparison of the proportion of patients requiring a hospital admission or ED visit during the study period between the study groups. Enrolling 300 patients, or 150 per arm, will provide\u00e2\u0080\u0089>\u00e2\u0080\u008980% power to detect a 15% difference between arms, assuming the rate in the control arm is 55% (based on our experience in the pilot study and prior published literature), with a 5% two-sided type 1 error. A 15% difference in the proportion of patients requiring a hospital admission or ED visit represents a clinically important difference, consistent with other practice-changing supportive care interventions in oncology [32, 39\u00e2\u0080\u009341]. We had no missing data on healthcare utilization in our pilot work as these patients are receiving care at our institution, and we will use the intention-to-treat principle with all randomized subjects.", "id": 866, "split": "val"} +{"trial_id": "NCT04546451", "pmid": "36747142", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Musical and Psychomotor Interventions for Cognitive, Sensorimotor, and Cerebral Decline in Patients With Mild Cognitive Impairment (COPE): a Study Protocol for a Multicentric Randomized Controlled Study\n\nIncluded conditions:\n- Mild Cognitive Impairment\n\nStudy Armgroups:\n- {'label': 'Music practice', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive Music Practice interventions of 45 minutes twice a week over 6 months, provided by a professional musician', 'interventionNames': ['Behavioral: Music practice']}\n- {'label': 'Psychomotor therapy', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive Psychomotor interventions of 45 minutes twice a week over 6 months, provided by a professional psychomotor therapist', 'interventionNames': ['Behavioral: Psychomotor therapy']}\n- {'label': 'Passive control group', 'type': 'NO_INTERVENTION', 'description': 'Healthy passive controls will pass all measurements without any intervention. The control group participants must adhere to the same inclusion and exclusion criteria as the experimental groups, except for an MCI diagnosis. Control participants will be matched to the experimental groups for age, gender and education level.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Music practice', 'description': 'Patients will be trained to play a simple instrument (tongue-drum) in a group setting using different musical styles.', 'armGroupLabels': ['Music practice']}\n- {'type': 'BEHAVIORAL', 'name': 'Psychomotor therapy', 'description': 'Patients will be trained in body awareness and a wide range of of movement activities.', 'armGroupLabels': ['Psychomotor therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Cognitive Telephone Screening Instrument (COGTEL)', 'description': 'This test can be applied by telephone or face-to-face (in this study we will apply the face-to-face method). The outcome consists of increase or less decrease (experimental group 1 or 2 vs. the control group) of the total weighted score at the COGTEL test directly after the 6 months interventions as compared to directly before the interventions.\\n\\nThe COGTEL test provides a main weighted score of core cognitive function, it comprises 6 subtests covering prospective memory, short- and long-term verbal memory, working memory (digit span), verbal fluency and inductive reasoning.\\n\\nCOGTEL main weighted score: COGTEL Total score = 7.2 x Prospective Memory score + 1.0 x Verbal Short-Term Memory score + 0.9 x Verbal Long-Term Memory score + 0.8 x Working Memory score + 0.2 x Verbal Fluency score + 1.7 x Inductive Reasoning score\\n\\n(Kliegel, Martin, \\\\& Jager, 2007, doi:10.3200/JRLP.141.2.147-172) (lhle et al., 2017, doi:10.1159/000479680)', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe statistical power analysis assumes an alpha of 0.05 and a power of 0.80. The MMSE score is highly correlated with the COGTEL score (r = 0.93). An attrition rate of 20% is considered.", "answer": 48, "answer_type": "ACTUAL", "explanation": "Statistical analysis plan and sample size calculation\n \n Basic statistical analyses\n First we will use linear mixed model equations (lme) using the open-source software R [144] to evaluate the longitudinal effects for all variables separately comparing both experimental groups to the control group and to each other. These lme are flexible and powerful statistical models that consider several levels of clustering, continuous, ordinal and categorical explanatory variables. They support unbalanced data and allow to integrate demographic data into the models. Our 2 patient groups may turn out unbalanced due to attrition. Moreover, because we are interested in development, we will incorporate the baseline scores in the models. This will allow correcting for differences between the groups at baseline.\n We will also compare those results with more traditional multivariate analyses of covariance.\n If the data are not normally distributed, and if data transformation cannot cope with this non-normality, we will either use robust analyses (weighting outliers or other influential observations) or use non-parametric approaches.\n In testing multiple contrasts, adjustments of the alpha criterion for multiple comparisons will be applied.\n Concerning the primary objective, the analysis will consist in evaluating increase or less decrease (experimental group 1 or 2 vs. the control group) of the total weighted score at the COGTEL test [79, 80] at t1 and t2 compared to baseline and to the passive control group, by means of lme and MANCOVA analyses, using a two-sided alpha criterion of 0.05.\n \n \n Advanced multivariate statistical analyses\n Finally, we will perform an exploratory analysis of the data using a multivariate data-driven approach. Analyzing separately behavioral data and several kinds of brain imaging data, cross-sectionally or over time, provides valuable information on these specific data. Additionally, combining diverse behavioral and different kinds of brain data within data-driven multivariate analyses may unravel hidden \"covert\" relationships [145, 146]. Specifically, we will perform multivariate data-driven analyses using multimodal Independent Component Analysis (ICA) [145, 146] and Partial Least of Squares (PLS) [147, 148] which have both been used successfully on multimodal brain imaging data.\n Two methods will be used:\n 1) Joint, fusion, and linked ICA [149, 150] represent several blends of multimodal extensions of ICA that allow combining different types of data such as functional and structural neuroimaging data. The results of these analyses should reveal interactions between different types of information and consequently allow us to investigate differences between our groups / experimental conditions (interventions) [145, 149]. In addition, we will also decompose the fMRI data into functional brain networks using innovation-driven co-activation patterns (iCAPs), a recent approach of dynamic functional connectivity [151] that that can quantify temporal interactions between different networks.\n 2) PLS is another powerful technique that can identify components of multivariate relationships between imaging and behavioral data [148, 152], notably unified PLS correlation models [148]. This PLS technique allows revealing hidden relationships between all battery tests and MRI measurements over time and potentially show whether these relationships differ between the groups (machine-learning). We will also use PLS regression models to fit the best interventional neurobehavioral model for predicting the rehabilitation of elderly on a specific behavioral outcome i.e. evolution of the working memory performance. Implementations of these approaches are publicly available in addition to several in-house extensions that allow using them in the most flexible way, including machine-learning approaches [153, 154].\n These advanced analyses will be performed in close collaboration with Prof. D. Van de Ville (computer scientist), professor of bioengineering at the EPFL (\u00c3\u0089cole polytechnique f\u00c3\u00a9d\u00c3\u00a9rale de Lausanne) and the University of Geneva and internationally recognized for his expertise in advanced techniques of MRI-analysis, specifically of resting-state and morphometric changes. Prof. Van De Ville and Prof. James worked together for many years.\n \n \n Statistical power of the study\n We performed a statistical power analysis for sample size estimation, based on the main outcome of this project, a significant group improvement at the COGTEL test. Data used for this analysis stem from a study on MCI patients by Biasutti et Mangiacotti (2018 [62], comparing musical instrumental practice (n\u00e2\u0080\u0089=\u00e2\u0080\u008915) to soft gymnastic activities (n\u00e2\u0080\u0089=\u00e2\u0080\u008914). In this study, the main outcome was a change over time in the MMSE score. Between baseline and the end of their twice weekly 3-month interventions, similar to the interventions in the current study, the MMSE performance did not change in the soft gymnastics group whereas it improved significantly in the musical instrumental practice group (F(1,33)\u00e2\u0080\u0089=\u00e2\u0080\u008913.906; p\u00e2\u0080\u0089<\u00e2\u0080\u00890.001; p\u00ce\u00b72\u00e2\u0080\u0089=\u00e2\u0080\u00890.296). Such a partial \u00ce\u00b72 value corresponds to Cohen's effect size f of 0.65 which is considered large [155]. With an alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80, projected sample size required for this effect size is n\u00e2\u0080\u0089=\u00e2\u0080\u008912 (GPower 3.1) [156].\n The MMSE being highly correlated to the COGTEL (r\u00e2\u0080\u0089=\u00e2\u0080\u00890.93) [80], our proposed sample size of n\u00e2\u0080\u0089=\u00e2\u0080\u008916 per group (or n\u00e2\u0080\u0089=\u00e2\u0080\u008912 considering an attrition rate of 20%) seems reasonable for observing a significant COGTEL effect.\n We recruit in two university hospital memory clinics; sample size was in the COVID context also determined according to their databases and recommendations, to ensure feasibility, but we will respect our power calculation above.\n In general, it is difficult to recruit older adults for interventional neuroimaging studies. MRI measurements represent an impediment for older adults, even if they are mentally fit. Those studies therefore suffer from under recruitment. Even with fewer healthy older individuals than the number of patients suggested in the current protocol, many authors could still publish significant findings [157\u00e2\u0080\u0093163].\n \n \n Attrition / Drop-outs\n A total of 16 volunteers will be recruited for each of the experimental patient groups and the control group. Thus, the intended total number of participants will be 48. Given the unclear future of the covid pandemic and the natural attrition in our patient population, our minimum aim is a total of at least 12 participants in each group at the completion of the six-month interventions and measurements, which corresponds to our power analyses (see section Statistical power of the study). We maintain the 16-person target for the control group. Thus, we predict a 20% attrition rate among the patients and will over-recruit 32 participants. We will not be able to compensate for dropouts because the interventions are ongoing.", "id": 867, "split": "val"} +{"trial_id": "NCT04547621", "pmid": "35906549", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Combination of Hypofractionated Stereotactic Radiotherapy and Chemoradiotherapy Using Intensity-Modulated Radiotherapy for Newly Diagnosed Glioblastoma Multiforme: A Prospective, Single-Center, Single-Arm Phase II Clinical Trial\n\nIncluded conditions:\n- Glioma, Malignant\n\nStudy Armgroups:\n- {'label': 'HSRT+IMRT+Temozolomide', 'type': 'EXPERIMENTAL', 'description': '* Intensity-modulated radiotherapy 20Gy/10fx, 5 days a week for 2 weeks.\\n* Hypofractionated stereotactic radiotherapy 30Gy/5fx, 5 days a week for 1 week.\\n* Temozolomide once daily (75mg/m2/d) orally administered concurrently with radiotherapy.', 'interventionNames': ['Device: Radiation', 'Drug: Temozolomide']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Radiation', 'description': 'Intensity-modulated radiotherapy 20Gy/10fx', 'armGroupLabels': ['HSRT+IMRT+Temozolomide']}\n- {'type': 'DEVICE', 'name': 'Radiation', 'description': 'Hypofractionated Stereotactic Radiotherapy 30Gy/5fx', 'armGroupLabels': ['HSRT+IMRT+Temozolomide']}\n- {'type': 'DRUG', 'name': 'Temozolomide', 'description': 'Temozolomide 75 mg/m2 concurrently administered with RT.', 'armGroupLabels': ['HSRT+IMRT+Temozolomide']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival (OS)', 'description': 'Estimated using the Kaplan-Meier method', 'timeFrame': 'From the start of treatment to the date of death or the last follow-up, up to approximately 24 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 0.050 significance level, 10% loss to follow-up", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size and power justification\n The design will be a prospective single-arm phase II trial to determine the effectiveness and safety of HSRT plus chemoradiotherapy after surgery for GBM. A two-sided, one-sample log-rank test calculated from a sample of 45 subjects achieves 80% power at a 0.050 significance level to detect a hazard ratio of 0.580 when the median survival time of the historic control group is 14\u00c2\u00a0months. Subjects are accrued for 12\u00c2\u00a0months. Follow-up continues for 24\u00c2\u00a0months after the last subject is added. Assuming a 10% loss to follow-up, the actual sample size will be 50.", "id": 868, "split": "val"} +{"trial_id": "NCT04547985", "pmid": "33522931", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Naltrexone Treatment for Prolonged Grief Disorder: A Pilot Study\n\nIncluded conditions:\n- Prolonged Grief Disorder\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '24 randomized patients will take placebo daily for 8 weeks.', 'interventionNames': ['Drug: Placebo']}\n- {'label': 'Naltrexone', 'type': 'ACTIVE_COMPARATOR', 'description': '24 randomized patients will take naltrexone daily for 8 weeks', 'interventionNames': ['Drug: Naltrexone HCl 50 MG Oral Tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Naltrexone HCl 50 MG Oral Tablet', 'description': 'Generic, oral tablet.', 'armGroupLabels': ['Naltrexone']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Composed of filler material and encapsulated to appear identical to naltrexone.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13 (PG-13)', 'description': 'Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies.\\n\\nMinimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of \u226530 is the threshold for \"syndromal\" level PGD.\\n\\nProlonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.', 'timeFrame': 'Baseline and 8 Weeks'}\n- {'measure': 'Change in Prolonged Grief Disorder Symptom Severity as Assessed by Prolonged Grief-13', 'description': 'Prolonged Grief Disorder (PGD) is a newly defined syndrome that is a specific reaction to the loss of a loved one. Change in PGD symptom severity will be measured by using Prolonged Grief-13-R (PG-13-R), a self-rated scale consisting of 11 items. The validity and reliability of the scale were tested and validated in previous studies.\\n\\nMinimum Score: 11 - reflecting the lowest level of PGD symptom severity (distress) Maximum Score: 55 - reflecting the highest level of PGD symptom severity (distress) Diagnostic Criteria PGD symptom severity of \u226530 is the threshold for \"syndromal\" level PGD.\\n\\nProlonged Grief (PG-13-R) is a diagnostic tool. If a respondent meets the diagnostic criteria for PGD, this suggests that they should seek more thorough evaluation from a mental health professional. Only an in-person assessment by a mental health professional can determine for certain the clinical significance of the reported symptoms, and provide recommendations or referrals for treatment.', 'timeFrame': 'Baseline and 12 weeks'}\n- {'measure': 'Change in Number of Participants With Prolonged Grief Disorder as Assessed by Structured Clinical Interview for PGD (SCIP)', 'description': 'Eligibility for the study and change in symptom severity will be measured by SCIP. This structured clinical interview is adapted to the DSM-5-TR criteria for PGD. Interviewers will be trained to standard which will be a \u03ba \\\\> 0.8 agreement between trainee and trainer.', 'timeFrame': 'Every 4 weeks for 8 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power (Type II error < 0.2) to detect a significant difference (Type I error < 0.05); interim analysis at 50% information fraction; accrual rate of 6 participants per month over 9-12 months.", "answer": 9, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n According to previous studies tracking grief intensity changes across time among the bereaved sample [5, 26], we estimate a natural decline of 1.0 in PG-13-R scores during a period of 2\u00e2\u0080\u0089months with a standard deviation of 6.0, for patients 12 to 18\u00e2\u0080\u0089months post bereavement. Meanwhile, we propose a 20% decline from baseline PG-13-R for the treatment group. The effect size (Cohen\u00e2\u0080\u0099s d) was then assumed to be 0.83. The null hypothesis is that comparing to the placebo-controlled group, naltrexone treatment at 50\u00e2\u0080\u0089mg mitigates grief intensity among patients with prolonged grief disorder in a 2-month period. With 48 participants (n\u00e2\u0080\u0089=\u00e2\u0080\u008924 naltrexone arm; n\u00e2\u0080\u0089=\u00e2\u0080\u008924 placebo arm) and an interim analysis at 50% information fraction, we expect to have 80% power (Type II error\u00e2\u0080\u0089<\u00e2\u0080\u00890.2) to detect a significant difference (Type I error\u00e2\u0080\u0089<\u00e2\u0080\u00890.05) in PG-13-R baseline-to-2-month scores comparing the intervention and control groups. The accrual rate is expected to be 6 participants per month with the recruitment period spanning over 9\u00e2\u0080\u009312\u00e2\u0080\u0089months.", "id": 869, "split": "val"} +{"trial_id": "NCT04551404", "pmid": "35590399", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transcranial Electrical and Acoustic Stimulation for Tinnitus: A Randomized Double Blind Clinical Trial\n\nIncluded conditions:\n- Tinnitus\n- Tinnitus, Subjective\n\nStudy Armgroups:\n- {'label': 'Study Intervention(s) A', 'type': 'EXPERIMENTAL', 'description': 'TRNS bilateral temporal regions combined with AS for 20 minutes\\n\\nSham-tRNS bilateral temporal regions combined with Sham-AS for 20 minutes', 'interventionNames': ['Other: transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS)']}\n- {'label': 'Study Intervention(s) B = Control Intervention', 'type': 'EXPERIMENTAL', 'description': 'TRNS bilateral temporal regions for 20 minutes\\n\\nSham-tRNS bilateral temporal regions for 20 minutes', 'interventionNames': ['Other: transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS)', 'description': 'The study intervention consists of a bilateral tRNS application over temporal regions, parallel to the application of AS with WN 15 dB above the individual MML in one study arm. TRNS will be applied using two electrodes (35 qcm, 0,9% saline -soaked). Stimulus intensity will be below individual sensation threshold, but max. 2 mA. AS will never surpass 85 dB SPL at the ears.', 'armGroupLabels': ['Study Intervention(s) A']}\n- {'type': 'OTHER', 'name': 'transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)', 'description': 'The study intervention consists of a bilateral tRNS application over temporal regions', 'armGroupLabels': ['Study Intervention(s) B = Control Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change of self-report Visual Analogue Scale (VAS) ratings on tinnitus severity (loudness, distress)', 'description': 'Minmum value = 1, maximum value =10. The higher scores means a worse outcome.', 'timeFrame': 'up to 6 months'}\n- {'measure': 'Change of minimum masking level (MML)', 'timeFrame': 'up to 6 months'}\n\nPlease estimate the sample size based on the assumption: \nsignificance level (alpha) = 0.05, power (beta) = 0.95, groups = 2, measurements = 5, dropout rate = 25%", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size calculations were conducted in G*Power 3.1.9 for the repeated measures, within-between interaction (ANOVA). The total sample size needed to detect a high assessment-by-treatment interaction effect (f\u00e2\u0080\u0089=\u00e2\u0080\u00890.25, beta\u00e2\u0080\u0089=\u00e2\u0080\u00890.95, alpha\u00e2\u0080\u0089=\u00e2\u0080\u0089.05, groups\u00e2\u0080\u0089=\u00e2\u0080\u00892, measurements\u00e2\u0080\u0089=\u00e2\u0080\u00895) is 32 participants. However, to compensate for a high estimated dropout rate of up to 25% during treatment, the aim is to recruit 40 participants leading to 20 participants per group.", "id": 870, "split": "val"} +{"trial_id": "NCT04555278", "pmid": "33762244", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Repetitive Transcranial Magnetic Stimulation Alone and in Combination with Motor Control Exercise for the Treatment of Patients with Chronic Non-specific Low Back Pain (ExTraStim Trial): Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Chronic Low-back Pain\n\nStudy Armgroups:\n- {'label': 'Active rTMS + Motor control exercises', 'type': 'EXPERIMENTAL', 'description': 'Active (real) repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes).', 'interventionNames': ['Device: Active rTMS', 'Other: Motor Control Exercises']}\n- {'label': 'Sham rTMS + Motor control exercises', 'type': 'SHAM_COMPARATOR', 'description': 'Sham repetitive transcranial magnetic stimulation (20 minutes), immediately followed by a session of motor control exercises taught and supervised by a physiotherapist (30 minutes).', 'interventionNames': ['Device: Sham rTMS', 'Other: Motor Control Exercises']}\n- {'label': 'Active rTMS', 'type': 'EXPERIMENTAL', 'description': 'Active (real) repetitive transcranial magnetic stimulation (20 minutes).', 'interventionNames': ['Device: Active rTMS']}\n- {'label': 'Sham rTMS', 'type': 'SHAM_COMPARATOR', 'description': 'Sham repetitive transcranial magnetic stimulation (20 minutes).', 'interventionNames': ['Device: Sham rTMS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Active rTMS', 'description': 'A figure-of-8 coil connected to a biphasic Magstim Rapid 2 stimulator (The MagstimCo, Whitland, UK) will be used. Coil orientation and position will be guided throughout the experiment by a neuronavigation system (Brainsight, Rogue research, Montreal, QC, Canada). The intensity of rTMS will be set at 95 % of the first dorsal interosseous (FDI) resting motor threshold (RMT).\\n\\nActive rTMS will consist of 40 trains of 5 seconds each at 10 Hz (25-s intertrain interval) applied over M1 (on FDI cortical representation), for a total of 2000 stimulations lasting 20 minutes.', 'armGroupLabels': ['Active rTMS', 'Active rTMS + Motor control exercises'], 'otherNames': ['Repetitive Transcranial Magnetic Stimulation']}\n- {'type': 'DEVICE', 'name': 'Sham rTMS', 'description': 'A sham coil will be use (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS (30 min).', 'armGroupLabels': ['Sham rTMS', 'Sham rTMS + Motor control exercises'], 'otherNames': ['Sham Repetitive Transcranial Magnetic Stimulation']}\n- {'type': 'OTHER', 'name': 'Motor Control Exercises', 'description': \"The rehabilitation program will consist of a 30-minute session of motor control exercises following the rTMS (Active or Sham) intervention. This approach aims to improve spine health through the optimization of spine loading. The first session will be preceded by an individualized evaluation of the participant's abilities and deficiencies to tailor the training program to each participant.\", 'armGroupLabels': ['Active rTMS + Motor control exercises', 'Sham rTMS + Motor control exercises']}\n\nPrimary Outcomes:\n- {'measure': 'Pain intensity (average pain over the last week)', 'description': 'Pain score on a 11-point pain numerical rating scale (PNRS) ranging from 0 to 10, with 0 meaning no pain and 10 the worst pain imaginable.', 'timeFrame': 'Change from baseline to 4 weeks, 8 weeks, 12 weeks and 24 weeks'}\n\nPlease estimate the sample size based on the assumption: \nalpha of 0.05, beta of 0.20, and 20% dropout rate", "answer": 140, "answer_type": "ACTUAL", "explanation": "Sample size\n Our sample was estimated using the CID for pain intensity (2 points)30 and the standard deviation reported from a study that used a combination of transcranial direct current stimulation and exercise (3.0).58 Considering an alpha of 0.05, a beta of 0.20 and 20% of dropout, a sample size of 140 participants (35 per group) was calculated using G*Power V.3.1.9 software.", "id": 871, "split": "val"} +{"trial_id": "NCT04555785", "pmid": "36670471", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor\n\nIncluded conditions:\n- Bleeding\n\nStudy Armgroups:\n- {'label': 'Platelet transfusion with Wilate \u00ae', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Wilate']}\n- {'label': 'Platelet transfusion with Placebo', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Wilate', 'description': \"Wilate \u00ae will be given with platelets in cases of severe bleeding. Wilate \u00ae is a 1:1 balanced mixture of von Willebrand Factor (2'000 IU) and Coagulation factor VIII (2'000 IU) and as such has anti-haemorrhagic potential. It is extracted from plasma, freeze-dried and virus-inactivated.\", 'armGroupLabels': ['Platelet transfusion with Wilate \u00ae']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Empty placebo will be given with platelets in cases of severe bleeding.', 'armGroupLabels': ['Platelet transfusion with Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Number of blood products', 'description': 'Number of blood products (fresh frozen plasma (FFP), red blood cells (RBC)) according to groups.', 'timeFrame': '48 hours'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level of 5%, negative binomial regression, covariates included: blood loss, number of blood products transfused within 12 h before administration, anticoagulants administered 7 days before, site of bleeding, level of thrombocytes at baseline", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Determination of sample size\n A total of 120 (each group 60) patients are needed to detect a 50% reduction of the number of blood products subsequently transfused within two days in patients with Wilate\u00c2\u00ae compared to placebo. The sample size is calculated for a power of 80 % and a significance level of 5% for an estimate of the treatment effect evaluated with a negative binomial regression. To improve the precision of the treatment effect, the following covariates will be included: blood loss, number of blood products transfused within 12 h before administration of the study drug, anticoagulants administered 7 days before, the site of bleeding and the level of thrombocytes at baseline. The sample size calculation is based on a simulation applying resampling techniques on historical clinical data of 150 USB patients that meet the inclusion criteria.", "id": 872, "split": "val"} +{"trial_id": "NCT04557618", "pmid": "39178291", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage\n\nIncluded conditions:\n- Subarachnoid Hemorrhage\n\nStudy Armgroups:\n- {'label': 'Auricular VNS Stimulation', 'type': 'EXPERIMENTAL', 'description': 'Participants receive twice daily auricular vagal nerve stimulation', 'interventionNames': ['Device: Auricular Vagus Nerve Stimulation']}\n- {'label': 'Sham Auricular VNS Stimulation', 'type': 'SHAM_COMPARATOR', 'description': 'Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied', 'interventionNames': ['Device: Sham Auricular Vagus nerve Stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Auricular Vagus Nerve Stimulation', 'description': 'Transcutaneous auricular vagal nerve stimulation', 'armGroupLabels': ['Auricular VNS Stimulation']}\n- {'type': 'DEVICE', 'name': 'Sham Auricular Vagus nerve Stimulation', 'description': 'Transcutaneous auricular vagal nerve ear clip applied without current', 'armGroupLabels': ['Sham Auricular VNS Stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'Inflammatory markers in the serum on admission', 'description': 'TNF alpha from blood draw', 'timeFrame': 'On hospital day 1'}\n- {'measure': 'Change in inflammatory markers in the serum', 'description': 'TNF alpha from blood draws', 'timeFrame': 'Through hospital admission, average of 4 weeks'}\n- {'measure': 'Inflammatory markers in the CSF on admission', 'description': 'TNF alpha from cerebrospinal fluid', 'timeFrame': 'On hospital day 1'}\n- {'measure': 'Change in inflammatory markers in the CSF', 'description': 'TNF alpha from cerebrospinal fluid', 'timeFrame': 'Through hospital admission, average of 4 weeks'}\n- {'measure': 'Cerebral vasospasm', 'description': 'Presence of moderate/severe radiographic vasospasm', 'timeFrame': 'Through hospital admission, average of 4 weeks'}\n- {'measure': 'Hydrocephalus', 'description': 'Need for permanent CSF diversion via a ventricular shunt', 'timeFrame': 'Through hospital admission, average of 4 weeks'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided, two-sample t-test; equal variance at both time points; weak correlation (0.15) between measurement pairs; compound symmetry covariance structure with Rho of 0.2; significance level (alpha) of 0.05; power of 80%.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size\n Goal enrollment for the pilot NAVSaH trial is 50 patients, based on power calculations to detect significant differences in inflammatory cytokines, radiographic vasospasm, and chronic hydrocephalus.\n Under a 2-by-2 repeated measures design consisting of two groups of patients, each measured at two time points, our goal is to compare the change across time in the taVNS group to the change across time in the Sham group. Based upon previous work from Koopman et al. [67], we assume our study will observe 1.1 standardized inflammatory cytokines mean change difference between the two groups. Using a two-sided, two-sample t-test, assuming both time points have equal variance and there is a weak correlation (i.e., 0.15) between measurement pairs, a sample size of 25 in each group achieves at least 80% power to detect a standardized difference of 1.1 in mean changes, with a significance level (alpha) of 0.05 [68].\n Based upon our preliminary data, we assume this study will observe 25% and 55% severe vasospasm in the taVNS and Sham groups, respectively. Under a design with 2 repeated measurements (i.e., 2 raters), assuming a compound symmetry covariance structure with a Rho of 0.2, at a significance level (alpha) of 0.05, a sample size of 25 in each group achieves at least 80% power when the null proportion is 0.55, and the alternative proportion is 0.25 [69\u00e2\u0080\u009371].\n As previously described, LV et al. [8] studied the relationship between cytokine levels and clinical endpoints in SAH, including hydrocephalus. From their outcomes, we predict a needed enrollment of approximately 50 to detect these endpoints. From our own preliminary data, with an incidence of chronic hydrocephalus 0% in treated patients and 28.6% in control (despite grade of hemorrhage), alpha = 0.05 and power = 0.80, the projected sample size to capture that change is approximately 44 patients.", "id": 873, "split": "val"} +{"trial_id": "NCT04560140", "pmid": "33397316", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Promoting Community Reintegration Using Narratives and Skills Building for Young Adults With Stroke\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Eligible participants will be randomly assigned to receive usual care with the novel 24-week Narrative and Skills-building Intervention.', 'interventionNames': ['Behavioral: Narrative and Skills-building Intervention']}\n- {'label': 'Usual care group', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive usual stroke care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Narrative and Skills-building Intervention', 'description': \"The intervention is grounded in Narrative Theory and Bandura's principles of Self-efficacy and Outcome Expectation. It will consist of eight individual sessions over six months delivered by a facilitator. Participants will be facilitated to narrate their survival experiences and rebuild core life skills.\", 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': \"Change in the participants' level of community reintegration\", 'description': \"The Chinese version of the Reintegration to Normal Living Index (RNIL-C) will be used to assess the participants' level of community reintegration. It consists of 11 items in eight domains: mobility, self-care, daily work and school activity, recreational and social activities, family roles, personal relationships, presentation of self to others and general coping skills. Participants are asked to rate the extent to which each item describes their situation on a scale from 1 - 'a small extent' to 5 - 'a great extent'. The total score is calculated by summation and normalised to give 100 with a total score range of 25 to 100. A higher score indicates better community reintegration. The RNIL-C has high internal consistency (Cronbach's alpha=0.92) and good convergent validity.\", 'timeFrame': 'Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an 80% power at a two-sided 5% level of significance and allows for a potential attrition rate of up to 20%.", "answer": 208, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n The sample size is estimated based on the outcomes of community reintegration, self-efficacy and outcome expectation. In our previous interventional study [23], the effect sizes of a stroke self-management programme on community reintegration, self-efficacy and outcome expectation of performing self-management behaviours were 0.44, 0.55 and 0.53, respectively. Using the power analysis software PASS 16 (NCSS, LLC. Kaysville, Utah, USA), a sample size of 83 participants per study arm is estimated to give this two-arm RCT 80% power at a two-sided 5% level of significance to detect an effect size as small as 0.44 on the primary outcome between the control and intervention groups at a post-intervention time point. Further allowing for a potential attrition rate of up to 20%, 208 participants, with 104 per group, will be recruited.", "id": 874, "split": "val"} +{"trial_id": "NCT04560387", "pmid": "33710588", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation\n\nIncluded conditions:\n- Atrial Fibrillation\n- Obesity\n\nStudy Armgroups:\n- {'label': 'Interventional', 'type': 'EXPERIMENTAL', 'description': 'Physician-lead complex program of weight-reducing interventions including education, diet counselling and regular physical activity aimed at achieving and maintaining a 10% reduction of baseline body weight.\\n\\nBariatric surgery - sleeve gastrectomy in a subgroup of subjects with BMI \\\\> 35 kg/m2, i.e. standard indication of bariatric surgery (patients with BMI \\\\> 35 kg/m2 and a presence of metabolic or other complications).', 'interventionNames': ['Behavioral: Physician-lead complex program of weight-reducing interventions', 'Procedure: Bariatric surgery - sleeve gastrectomy']}\n- {'label': 'Conservative', 'type': 'NO_INTERVENTION', 'description': 'Routine treatment of obesity'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Physician-lead complex program of weight-reducing interventions', 'description': 'A structured motivational and goal directed program will be used for weight reduction involving physicians, nutritionists, educators and physiotherapists. Initially, based on the input data provided by the patient an individual nutritional plan will be designed with the aim of reducing caloric intake by 10%. Low-intensity aerobic exercise for 30 min will be prescribed 3-times a week with the aim of increasing the frequency to 5-times a week and participants will be offered the possibility to participate in regular physiotherapist-lead group exercises. Patients will be required to maintain a diet and physical activity diary. Regular reviews will be scheduled every 3-6 months according to the actual weight loss.', 'armGroupLabels': ['Interventional']}\n- {'type': 'PROCEDURE', 'name': 'Bariatric surgery - sleeve gastrectomy', 'description': \"Bariatric surgery will be performed based on actual medical indication and independently of patient's participation in the study. Sleeve gastrectomy was selected as the currently most frequent restrictive type of bariatric surgery with a proven efficacy on weight reduction, metabolic status and low-grade inflammation\", 'armGroupLabels': ['Interventional']}\n\nPrimary Outcomes:\n- {'measure': 'Atrial fibrillation burden', 'description': 'Atrial fibrillation burden expressed as % of total monitoring time at final visit', 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% two-sided significance level, 20% dropout rate, statistical analysis using SigmaStat software, results expressed as mean \u00b1 SEM, t tests or rank sum tests for two-group comparisons, one-way ANOVA or Kruskal-Wallis test for multiple group comparisons, P value < 0.05 considered significant.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample Size Calculation and Statistical Analysis\n Sample size calculation is based on the study by Abed et al. in which weight-reducing lifestyle interventions were associated with a 68.2% (1055\u00c2\u00a0min) difference of AF burden in comparison to non-interventional controls [12]. Given these data, a sample size of 68 individuals in each group will give 80% power of detecting a difference in AF burden as statistically significant at the 5% two-sided significance level. Assuming a dropout rate of approximately 20%, we plan to enrol 160 (80\u00e2\u0080\u0089+\u00e2\u0080\u008980) participants in total. Statistical analysis will be performed using SigmaStat software (Systat Software Inc., San Jose, CA, USA). Results will be expressed as mean\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u0089SEM. We will use t tests or rank sum tests for two-group comparisons and one-way ANOVA or Kruskal\u00e2\u0080\u0093Wallis test for multiple group comparisons as appropriate according to the normality of data distribution. A P value less than 0.05 will be considered statistically significant.", "id": 875, "split": "val"} +{"trial_id": "NCT04560907", "pmid": "33941632", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Aquablation vs. Holmium Laser Enucleation of the Prostate in the Treatment of Benign Prostatic Hyperplasia in Medium to Large Size Prostates: A Prospective Randomized Trial\n\nIncluded conditions:\n- Benign Prostatic Hyperplasia (BPH)\n\nStudy Armgroups:\n- {'label': 'Aquablation', 'type': 'EXPERIMENTAL', 'interventionNames': ['Procedure: Aquablation']}\n- {'label': 'HoLEP', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Procedure: HoLEP']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Aquablation', 'description': 'By means of a high-pressure saline stream, parenchymal tissue of the prostate is removed endoscopically through a heat-free mechanism called hydrodissection. The intervention is supported by live ultrasound guidance and the required depth as well as the angle of the resection is planned out prior to the resection. The bladder is accessed using a 24-Fr hand-piece, which accommodates the scope. The handpiece is supported by an articulating arm attached to the operation table. Once placed in the optimal position, the system automatically adjusts the alignment as necessary.\\n\\nHemostasis is consecutively achieved through diathermy and post procedure, a threeway catheter is inserted and bladder irrigation is initiated.', 'armGroupLabels': ['Aquablation']}\n- {'type': 'PROCEDURE', 'name': 'HoLEP', 'description': 'This is done endoscopically under general anesthesia the three lobes of the prostate that are cored out intact with the laser are pushed into the bladder before being morcellated by a special instrument inserted through the telescopic camera. A catheter is placed into the bladder to drain the urine while the raw surface heals, then left in place for around 24 hours before being removed on the day of discharge from hospital. Sterile saline fluid is also irrigated into the bladder through the catheter to dilute any blood in the urine and prevent clots from forming.', 'armGroupLabels': ['HoLEP']}\n\nPrimary Outcomes:\n- {'measure': 'International Prostate Symptoms Score (IPSS)', 'description': 'The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \n90% power, one-sided significance level of 5%, 10% dropout rate", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size\n Assuming a non-inferiority margin of 4 points, a true difference of 0 points, an SD of 6 points at each assessment and a correlation of 0.35 between assessments, 51 evaluable patients per group will provide 90% power to reject the null hypothesis in a t-test for non-inferiority at a one-sided significance level of 5%. To allow for 10% of dropouts, 114 patients need to be recruited. We aim to recruit 120 patients to allow for some uncertainty about the above assumptions.", "id": 876, "split": "val"} +{"trial_id": "NCT04562389", "pmid": "39911057", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase 1/3 Study to Evaluate Efficacy and Safety of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination with Ruxolitinib in Treatment-na\u00efve Patients with Myelofibrosis\n\nIncluded conditions:\n- Myelofibrosis\n\nStudy Armgroups:\n- {'label': 'Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID', 'type': 'EXPERIMENTAL', 'description': 'Participants with MF will receive a dose of 40 milligrams (mg) selinexor oral tablets once weekly (QW) on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib twice a day (BID) based on the participants baseline platelet count.', 'interventionNames': ['Drug: Selinexor', 'Drug: Ruxolitinib']}\n- {'label': 'Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID', 'type': 'EXPERIMENTAL', 'description': 'Participants with MF will receive a dose of 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.', 'interventionNames': ['Drug: Selinexor', 'Drug: Ruxolitinib']}\n- {'label': 'Phase 1b: Selinexor and Ruxolitinib BID', 'type': 'EXPERIMENTAL', 'description': 'Participants with MF will receive a dose of 40 or 60 mg selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.', 'interventionNames': ['Drug: Selinexor', 'Drug: Ruxolitinib']}\n- {'label': 'Phase 3: Selinexor 60 mg + Ruxolitinib BID', 'type': 'EXPERIMENTAL', 'description': 'Participants with MF will receive a fixed starting dose of 60 mg selinexor (RD) oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.', 'interventionNames': ['Drug: Selinexor', 'Drug: Ruxolitinib']}\n- {'label': 'Phase 3: Placebo + Ruxolitinib BID', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants with MF will receive a matching placebo of selinexor oral tablets QW on Days 1, 8, 15, and 22 of each 28-day cycle in combination with a starting dose of 15 or 20 mg ruxolitinib BID based on the participants baseline platelet count.', 'interventionNames': ['Other: Placebo', 'Drug: Ruxolitinib']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Selinexor', 'description': 'Participants will receive a dose of 40 or 60 mg selinexor oral tablets QW.', 'armGroupLabels': ['Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID', 'Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID', 'Phase 1b: Selinexor and Ruxolitinib BID'], 'otherNames': ['KPT-330']}\n- {'type': 'DRUG', 'name': 'Selinexor', 'description': 'Participants will receive a dose of 60 mg selinexor oral tablets QW.', 'armGroupLabels': ['Phase 3: Selinexor 60 mg + Ruxolitinib BID'], 'otherNames': ['KPT-330']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Participants will receive a matching placebo of selinexor oral tablets QW', 'armGroupLabels': ['Phase 3: Placebo + Ruxolitinib BID']}\n- {'type': 'DRUG', 'name': 'Ruxolitinib', 'description': 'Participants will receive a dose of 15 or 20 mg ruxolitinib oral tablets BID.', 'armGroupLabels': ['Phase 1a: Cohort 1: Selinexor 40 mg + Ruxolitinib BID', 'Phase 1a: Cohort 2: Selinexor 60 mg + Ruxolitinib BID', 'Phase 1b: Selinexor and Ruxolitinib BID', 'Phase 3: Placebo + Ruxolitinib BID', 'Phase 3: Selinexor 60 mg + Ruxolitinib BID']}\n\nPrimary Outcomes:\n- {'measure': 'Phase 3: Proportion of Participants with Spleen Volume Reduction (SVR) of Greater than or Equal to (>=) 35 Percent (%) (SVR35) at Week 24 Measured by the Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan', 'timeFrame': 'At Week 24'}\n- {'measure': 'Phase 3: Absolute mean change in TSS (Abs-TSS) from baseline to Week 24 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0', 'timeFrame': 'At Week 24'}\n- {'measure': 'Phase 1: Maximum Tolerated Dose (MTD)', 'timeFrame': 'Approximately within the first cycle (28 days) of therapy'}\n- {'measure': 'Phase 1: Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'Approximately within the first cycle (28 days) of therapy'}\n- {'measure': 'Phase 1: Number of Participants With Adverse Events (AEs) by Occurrence, Nature, and Severity', 'timeFrame': 'From start of drug administration up to 30 days after last dose of study treatment (approximately 48 months)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 1-sided type 1 error of 0.025", "answer": 350, "answer_type": "ESTIMATED", "explanation": "2.4.\n Sample size\n To provide 80% power for statistical significance of the co-primary endpoints at the overall 1-sided type 1 error of 0.025 level, approximately 350 patients will be enrolled.", "id": 877, "split": "val"} +{"trial_id": "NCT04562558", "pmid": "37612621", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective\uff0cMulticenter\uff0cRandomized Trial of Biweekly Single-dose Actinomycin-D Versus Multi-day Methotrexate Protocol for the Treatment of Low-risk Gestational Trophoblastic Neoplasia\n\nIncluded conditions:\n- Gestational Trophoblastic Tumor\n- Gestational Trophoblastic Neoplasia\n- Stage I Gestational Trophoblastic Tumor\n- Stage II Gestational Trophoblastic Tumor\n- Stage III Gestational Trophoblastic Tumor\n- Invasive Mole\n- Choriocarcinoma\n\nStudy Armgroups:\n- {'label': 'Arm1-Methotrexate', 'type': 'EXPERIMENTAL', 'description': 'Patients receive methotrexate intramuscularly\uff0850mg\uff09 on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment. If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Leucovorin']}\n- {'label': 'Arm 2-Dactinomycin', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive IV pulse actinomycin-D (1.25mg/m2\uff0c2mg max dos) every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment.If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.', 'interventionNames': ['Drug: Dactinomycin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Methotrexate', 'description': '50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days', 'armGroupLabels': ['Arm1-Methotrexate'], 'otherNames': ['MTX']}\n- {'type': 'DRUG', 'name': 'Leucovorin', 'description': '15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days', 'armGroupLabels': ['Arm1-Methotrexate'], 'otherNames': ['Calcium folinate']}\n- {'type': 'DRUG', 'name': 'Dactinomycin', 'description': '1.25mg/m2 (2mg max dose)intravenous every 14 days.', 'armGroupLabels': ['Arm 2-Dactinomycin'], 'otherNames': ['dactinomycin D']}\n\nPrimary Outcomes:\n- {'measure': 'Completely remission (CR) rate by single-agent', 'description': 'Percentage of participants with complete response by single-agent chemotherapy. A complete response was defined as a normal hCG sustained over 3 weekly measurements.', 'timeFrame': 'from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy\uff0cassessed up to 8 months'}\n- {'measure': 'Overall completely remission rate', 'description': 'Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure', 'timeFrame': 'from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy or multi-agent chemotherapy\uff0cassessed up to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nAllocation ratio of 1:1, significance level (\u03b1) = 0.05, power = 0.8, and 10% drop-out rate.", "answer": 228, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to the efficacy of the two chemotherapy regimens reported in previous literature, we estimated that the CR rates of biweekly single-dose Act-D and multiday MTX therapy are 78% and 60%, respectively. Conducting a randomized controlled study with an allocation ratio of 1:1 and considering \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.8, 103 patients per group are needed. Considering the 10% drop-out rate, each group requires 114 patients (228 patients in total).", "id": 878, "split": "val"} +{"trial_id": "NCT04562649", "pmid": "37226141", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Community Health Worker And MHealth to ImProve Viral Suppression\n\nIncluded conditions:\n- HIV/AIDS\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Wise App that delivers medication adherence reminders and community health worker sessions', 'interventionNames': ['Device: Wise App with medication adherence reminders', 'Behavioral: CHW Sessions']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Standard of care'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Wise App with medication adherence reminders', 'description': 'The Intervention group will receive the Wise App that delivers medication adherence reminders.', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'CHW Sessions', 'description': 'The Intervention group will complete sessions with a community health worker (CHW).', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Number of Virally Suppressed Participants', 'description': 'The number of virally suppressed participants. Viral suppression defined as viral load of \\\\<200 copies/mL.', 'timeFrame': '6 month follow up, 12 month follow up'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level (\u03b1) of 0.05, 2-sided tests, 80% retention rate at each follow-up, correlation of 0.6 for outcome measures at different time points, intra-cluster correlation (ICC) of 0.2, and 75% baseline viral suppression rate.", "answer": 300, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The statistical power was calculated based on the primary outcome of viral suppression (viral load\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u0089200 copies/mL). 300 participants will be enrolled (n\u00e2\u0080\u0089=\u00e2\u0080\u0089150 in each site) with a 1:1 random assignment to the intervention arm and the control arm (i.e., 75 in each arm per site). All power estimates are based on \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and 2-sided tests and the following assumptions: (1) an 80% retention rate at each follow-up assessment for each study arm; (2) a correlation of 0.6 of outcome measure for participants at different time points of assessment; (3) an intra-cluster correlation (ICC) of 0.2 of participants of same study sites; and (4) 75% baseline viral suppression rate (based on preliminary data of the BA2C study). For the total sample (n\u00e2\u0080\u0089=\u00e2\u0080\u0089300), we calculated power of at least 80% in order to detect a difference of 12% or greater in viral suppression. The 12% difference in viral suppression is equivalent to a small effect size (Cohen\u00e2\u0080\u0099s D of 0.31).", "id": 879, "split": "val"} +{"trial_id": "NCT04562753", "pmid": "38532422", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Clinical Trial to Estimate the Efficacy, Safety and Cost-utility of the Trapezium-Metacarpal (TMC) Prosthesis Compared to Suspensionplasty.\n\nIncluded conditions:\n- First CarpoMetacarpal Osteoartrithis\n- Basal Thumb Osteoartrithis\n\nStudy Armgroups:\n- {'label': 'Ma\u00efa\u00ae TMC Prosthesis (L\u00e9pine Groupe)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients undergoing thumb basal joint arthroplasty using Ma\u00efa\u00ae TMC prosthesis as treatment of osteoarthritis.', 'interventionNames': ['Procedure: Ma\u00efa\u00ae TMC Prosthesis (L\u00e9pine Groupe)']}\n- {'label': 'APL Suspensionplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.', 'interventionNames': ['Procedure: APL Suspensionplasty']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Ma\u00efa\u00ae TMC Prosthesis (L\u00e9pine Groupe)', 'description': 'Patients undergoing thumb basal joint arthroplasty using Ma\u00efa\u00ae TMC prosthesis as treatment of osteoarthritis.', 'armGroupLabels': ['Ma\u00efa\u00ae TMC Prosthesis (L\u00e9pine Groupe)']}\n- {'type': 'PROCEDURE', 'name': 'APL Suspensionplasty', 'description': 'Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.', 'armGroupLabels': ['APL Suspensionplasty']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Pain, pre- to post-operatively, as measured by a standard visual analogue score (VAS) diagram to grade perceived pain', 'description': 'The standard VAS diagram is a scale from 0 to 10 where 0 indicates No Pain (smiling face), and 10 indicates Worst possible, unbearable, excruciating pain (crying face).', 'timeFrame': 'Baseline, 3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months, 1 year after surgery, 2 years after surgery'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, beta risk of 0.1, bilateral contrast, common standard deviation of 1.5, and 10% dropout rate.", "answer": 106, "answer_type": "ESTIMATED", "explanation": "Sample size\n A total of 106 participants will be necessary (53 subjects for each treatment group) to detect differences equal to or greater than 30% in the visual analog scale (VAS) on the baseline status of the patient [33]. Accepted values will be for an alpha risk of 0.05 and a beta risk of 0.1, in a bilateral contrast. The common standard deviation is assumed to be 1.5. It is assumed that 10% of the trial patients will be lost.", "id": 880, "split": "val"} +{"trial_id": "NCT04563325", "pmid": "37263683", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oral-only Antibiotics for Bone and Joint Infections in Children - A Nationwide Randomized Controlled Trial\n\nIncluded conditions:\n- Osteomyelitis\n- Septic Arthritis\n- Bone Infection\n- Joint Infection\n- Bone and Joint Infection\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'ACTIVE_COMPARATOR', 'description': '\\\\< 5 years: High-dose oral co-amoxiclav (1:8) 33 mg amoxicillin/kg/dose (max. 1 g) three-times daily (TDS) until clinical and paraclinical improvement (min. 3 days) followed by oral co-amoxiclav (1:4) 17 mg amoxicillin/kg/dose (max. 500 mg) TDS for 7 days (arthritis) or 21 days (osteomyelitis).\\n\\n=/\\\\> 5 years: High-dose oral dicloxacillin 50 mg/kg/dose (max. 2 g) four-times daily (QID) until clinical and paraclinical improvement (min. 3 days) followed by oral dicloxacillin 25 mg/kg/dose (max. 1 g) QID for 7 days (arthritis) or 21 days (osteomyelitis).\\n\\nTreatment will be adjusted according to microbiological findings.', 'interventionNames': ['Drug: Oral co-amoxiclav or oral dicloxacillin only']}\n- {'label': 'Standard', 'type': 'ACTIVE_COMPARATOR', 'description': 'IV ceftriaxon 100 mg/kg/dose (max. 4 g) once daily (QD) (all ages) until clinical and paraclinical improvement (min. 3 days) followed by:\\n\\n\\\\< 5 years: Oral co-amoxiclav (1:4) 17 mg amoxicillin/kg/dose (max. 500 mg) TDS for 7 days (arthritis) or 21 days (osteomyelitis).\\n\\n\\\\>/= 5 years: Oral dicloxacillin 25 mg/kg/dose (max. 1 g) QID for 7 days (arthritis) or 21 days (osteomyelitis).\\n\\nTreatment will be adjusted according to microbiological findings.', 'interventionNames': ['Drug: IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Oral co-amoxiclav or oral dicloxacillin only', 'description': 'High dose oral treatment followed by standard dose oral treatment', 'armGroupLabels': ['Experimental']}\n- {'type': 'DRUG', 'name': 'IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin', 'description': 'IV treatment followed by standard dose oral treatment', 'armGroupLabels': ['Standard']}\n\nPrimary Outcomes:\n- {'measure': 'Sequelae at 6 months', 'description': 'Proportion of children with sequelae 6 months after initiation of treatment defined as abnormal mobility or function of the affected joint/bone. Evaluated by blinded clinical examination by a qualified pediatrician and/or pediatric orthopedic surgeon.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided significance level (alpha) of 2.5%, power of 90%, and a 10% rate of drop-out", "answer": 180, "answer_type": "ACTUAL", "explanation": "Sample size and power calculation\n Outcomes will be compared by a non-inferiority assumption with an inferiority margin of 5% and an expected treatment success of 99% in both groups. With a one-sided significance level (alpha) of 2.5% and accounting for a 10% rate of drop-out, a sample size of 180 children in the principal stratum, 90 children in each group, will provide a power of 90% to detect non-inferiority.", "id": 881, "split": "val"} +{"trial_id": "NCT04563390", "pmid": "37208132", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Projection-based Augmented Reality Exposure System in Treating Cockroach Phobia. A Randomized Controlled Trial\n\nIncluded conditions:\n- Specific Phobia\n\nStudy Armgroups:\n- {'label': 'Projection-based augmented reality exposure therapy', 'type': 'EXPERIMENTAL', 'description': 'Intervention group that receives the projection-based augmented reality to carry out the exposure therapy for cockroach phobia.', 'interventionNames': ['Behavioral: Projection-based augmented reality exposure therapy (P-ARET).']}\n- {'label': 'In vivo exposure', 'type': 'EXPERIMENTAL', 'description': 'Intervention group that receives traditional in vivo exposure therapy for cockroach phobia.', 'interventionNames': ['Behavioral: In vivo exposure therapy']}\n- {'label': 'WL Control', 'type': 'NO_INTERVENTION', 'description': 'Waiting list control group.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Projection-based augmented reality exposure therapy (P-ARET).', 'description': 'The intervention will be based on exposure therapy to cockroaches using P-ARET. The treatment will follow the guidelines of the \"one-session treatment\" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention.', 'armGroupLabels': ['Projection-based augmented reality exposure therapy']}\n- {'type': 'BEHAVIORAL', 'name': 'In vivo exposure therapy', 'description': 'The intervention will be based on traditional in vivo exposure therapy to real cockroaches. The treatment will follow the guidelines of the \"one-session treatment\" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention.', 'armGroupLabels': ['In vivo exposure']}\n\nPrimary Outcomes:\n- {'measure': \"Change in Behavioral Avoidance Test (BAT; adapted from \u00d6st, Salkovskis, & Hellstr\u00f6m's, 1991)\", 'description': 'Patients will be confronted to a real cockroach and they will be encouraged to get closer and interact with the stimulus as much as they can. The anxiety level (0-10), distance and level of interaction with the animal will be registered and evaluated on a scale ranging from 0 (the participant does not enter the room) to 12 (the participant interacts with the cockroach).', 'timeFrame': 'Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).'}\n\nPlease estimate the sample size based on the assumption: \npower of 0.80, alpha of 0.05, and an additional 20% for expected follow-up attrition", "answer": 96, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Power calculations were performed using Epidat V.4.2 statistical software to estimate the sample size necessary to detect a large standardised mean difference between groups (Cohen\u00e2\u0080\u0099s d=0.80) with a power of 0.80 and an alpha of 0.05, based on previous studies using AR systems.15 21 These calculations were conducted based on the primary outcome: the Behavioral Avoidance Test (BAT), specifically on the \u00e2\u0080\u0098performance\u00e2\u0080\u0099 variable of this test, which is explained below. The minimum sample size for each group was identified as 26 (78 in total), but at least an additional 20% will be recruited to take into account expected follow-up attrition; thus, a minimum total sample of 96 participants (32 per group) is estimated.15 34", "id": 882, "split": "val"} +{"trial_id": "NCT04563403", "pmid": "37208142", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improving the Efficacy of Exposure Therapy Using Projection-Based Augmented Reality for the Treatment of Cockroach Phobia: A Randomized Clinical Trial\n\nIncluded conditions:\n- Specific Phobia, Animal\n\nStudy Armgroups:\n- {'label': 'Treatment with Multiple Stimuli', 'type': 'EXPERIMENTAL', 'description': 'Projection-based augmented reality therapy (P-ARET) with Multiple Stimuli (MS) (P-ARET MS). Intervention group that receives P-ARET treatment varying the stimuli available in the system (different cockroaches in colour, size, etc).', 'interventionNames': ['Behavioral: Projection-based augmented reality therapy (P-ARET)']}\n- {'label': 'Treatment with Single Stimuli', 'type': 'EXPERIMENTAL', 'description': 'Projection-based augmented reality therapy (P-ARET) with Single Stimuli (SS) (P-ARET SS). Intervention group that receives P-ARET treatment using a single stimulus (one cockroach).', 'interventionNames': ['Behavioral: Projection-based augmented reality therapy (P-ARET)']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Projection-based augmented reality therapy (P-ARET)', 'description': 'The intervention will be based on exposure therapy to cockroaches using P-ARET. The treatment will follow the guidelines of the \"one-session treatment\" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention.', 'armGroupLabels': ['Treatment with Multiple Stimuli', 'Treatment with Single Stimuli']}\n\nPrimary Outcomes:\n- {'measure': \"Change in Behavioral Avoidance Test (BAT; adapted from \u00d6st, Salkovskis, & Hellstr\u00f6m's, 1991).\", 'description': 'Patients will be confronted to a real cockroach and they will be encouraged to get closer and interact with the stimulus as much as they can. The anxiety level (0-10), distance and level of interaction with the animal will be registered and evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (the participant interacts with the cockroach).', 'timeFrame': 'Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80, alpha set at 0.05, and an additional 20% for expected follow-up attrition", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Power calculations were carried out using the statistical software Epidat V.4.2. to estimate the necessary sample size to detect a moderate between-group standardised mean difference (Cohen\u00e2\u0080\u0099s d=0.70) with a power of 0.80 and an alpha set at 0.05, based on a similar study comparing MS and SS exposure.24 This size calculation is based on the main result, which is the \u00e2\u0080\u0098performance\u00e2\u0080\u0099 variable of the behavioural avoidance test (BAT) with a real cockroach.\n The minimum sample size for each group was identified as 33 (66 in all), but at least an additional 20% will be recruited to allow for expected follow-up attrition, with an estimated minimum total sample of 80 participants (40 per group).17", "id": 883, "split": "val"} +{"trial_id": "NCT04565613", "pmid": "34983751", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protein Supplementation Versus Standard Feeds in Underweight Critically Ill Children: A Dual-Centre Randomized Controlled Pilot Trial\n\nIncluded conditions:\n- Critically Ill\n\nStudy Armgroups:\n- {'label': 'Standard care group', 'type': 'NO_INTERVENTION', 'description': 'The participants will receive feeding as per standard of care (without protein or any other supplementations).'}\n- {'label': 'Study interventional group', 'type': 'EXPERIMENTAL', 'description': 'The participants will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds.', 'interventionNames': ['Dietary Supplement: Enteral protein supplementation']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Enteral protein supplementation', 'description': \"The participants in the study interventional group will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds. This will be via 100% whey protein isolate (Nestle Beneprotein). Doses will be calculated on the patient's admission weight and rounded up to the nearest 1g. Doses will not be adjusted to account for weight changes in the PICU.\\n\\nProtein supplementation will continue for a total of 7 days from the start of enrolment into the study or until PICU discharge, whichever is earlier. If the patient is able to take solid feeds during the study intervention period, the intervention will be stopped. However, if the device required for feeding is removed but the patient takes milk/liquid feeds fully, protein supplementation will continue.\", 'armGroupLabels': ['Study interventional group'], 'otherNames': ['Protein isolate (Nestle Beneprotein)']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of eligible patients approached for consent', 'description': 'Number of eligible patients who are approached for consent', 'timeFrame': 'Throughout study period, over 36 months'}\n- {'measure': 'Proportion of participants receiving their first protein supplementation within 72 hours of enrolment', 'description': 'Number of patients who received protein supplementation within 72 hours of enrolment', 'timeFrame': 'Throughout the study, over 24 months'}\n- {'measure': 'Participant accrual rate', 'description': 'Average monthly enrolment at each centre', 'timeFrame': 'Throughout the study, over 24 months'}\n- {'measure': 'Protocol adherence', 'description': '\\\\>80% of protein target administered according to the protocol in the intervention arm', 'timeFrame': 'Throughout study period, over 24 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for a power \u226590% to detect the effect size, with a one-sided significance level (\u03b1) set at 50%. The dropout rate is assumed to be 10%-12%.", "answer": 70, "answer_type": "ESTIMATED", "explanation": "Sample size and interim analysis\n The purpose of this pilot study is to investigate whether protein supplementation has promising efficacy and is worth further investigation. A large randomised study with usual care as the active control would be inappropriate as insufficient evidence of benefit of protein supplementation exists to justify such a study. In circumstances involving uncertainty of benefit and need for parsimony in resource expenditures, a small randomised study invoking the \u00e2\u0080\u0098selection theory\u00e2\u0080\u0099 approach proposed by Simon et al22 23 can provide an initial assessment of benefit. In the selection theory approach, the objective is to rank multiple potential treatments and then select those with the best responses for further study. However, our study involves only two treatments\u00e2\u0080\u0094protein supplementation versus standard feeds\u00e2\u0080\u0094which simplifies the approach in a determination of whether protein supplementation is better than standard feeds.\n In the absence of any prior rates of clinical outcomes or effect size, our study will allow a response assessment and the potential for demonstrating greater efficacy of protein supplementation versus standard feeds in underweight critically ill children, with high statistical power, using a procedure that circumvents a formal hypothesis test.\n Effect size is defined as \u00ce\u00b4=(\u00ce\u00bc1\u00e2\u0080\u0093\u00ce\u00bc2)/\u00cf\u0083, where \u00ce\u00bc1 and \u00ce\u00bc2 represent clinical endpoint population means for the protein supplementation and standard feeds arms, respectively. In calculating sample size in the context of selection theory, we postulate the conventional underlying null and alternative hypotheses of H0: \u00ce\u00b4\u00e2\u0089\u00a40 versus H1: \u00ce\u00b4>0, respectively. In our pilot study, we will target an effect size of \u00ce\u00b4=0.33, which is considered a small-to-moderate effect size and often viewed as representing a clinically important difference.24 If protein supplementation is superior to standard feeds by \u00ce\u00b4\u00e2\u0089\u00a50.33, we desire to detect this difference with power \u00e2\u0089\u00a590%. However, under a true null hypothesis, we will choose to ignore the type I error rate, and so set \u00ce\u00b1=50%\u00e2\u0080\u0094equivalent to random chance. Performing the sample size calculation based on a one-sided hypothesis test of two independent means using a two-sample t-test with one-sided \u00ce\u00b1=0.50, a sample size of n=35 per group achieves power=0.92 to detect an effect size of \u00ce\u00b4=0.33. (PASS commercial software was used to perform the sample size calculation.)\n From our preliminary data, we expect to have approximately 48 patients per year meet eligibility criteria for our pilot study. Our projection is that we will see 144 eligible patients over the 3-year recruitment period (3\u00c3\u009748). Assuming a conservative consent rate of 55%, we anticipate at least 80 patients with BMI z-score \u00e2\u0089\u00a4\u00e2\u0088\u00922 which will provide 40 patients in each study arm. Accounting for a dropout rate of 10%\u00e2\u0080\u009312% due to mortality and other causes, we would anticipate n=35 patients per arm completing the study (total N=70), which for \u00ce\u00b4\u00e2\u0089\u00a50.33 achieves >90% probability for demonstrating superiority of protein supplementation to standard feeds. To ensure we are able to assess feasibility and test study procedures and infrastructure at each site, we aim to enrol 26 or 27 patients per centre per year (13 or 14 per arm).\n It is emphasised that under the selection theory paradigm, the best treatment for further consideration in a subsequent larger trial is selected on the basis of descriptive statistics\u00e2\u0080\u0094in this case, higher mean value. Hence, given an effect size of \u00ce\u00b4\u00e2\u0089\u00a50.33, the proposed procedure and sample size will ensure a >90% probability of protein supplementation as the better treatment, demonstrated by a higher mean value, without a formal hypothesis test. A 95% CI will be calculated on the protein supplementation versus standard feeds mean difference for the clinical efficacy variables.\n Should recruitment be slow and challenging, the study team will meet and decide on the best method in increasing enrolment. Some a priori strategies that we will consider include (but not limited to) changing the criteria to include:\n \n \n Children on non-invasive ventilation or respiratory distress, and requiring any form of tube feeding\n \n \n Children with BMI \u00e2\u0089\u00a4\u00e2\u0088\u00921 on PICU admission", "id": 884, "split": "val"} +{"trial_id": "NCT04566250", "pmid": "34022863", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin): a Randomized Controlled Trial\n\nIncluded conditions:\n- Knee Arthroscopy\n- Shoulder Arthroscopy\n\nStudy Armgroups:\n- {'label': 'Non-Opioid Prescription and Infographic', 'type': 'ACTIVE_COMPARATOR', 'description': 'The study intervention will involve 3 components:\\n\\n1. A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 20mg PO daily x 30 tabs (to be taken only while utilizing Naproxen). In the case of a Naproxen intolerance, a prescription for Meloxicam 15mg PO BID PRN x 60 tabs will be given.\\n2. A limited opioid \"rescue prescription\": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription.\\n3. Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control.', 'interventionNames': ['Combination Product: Non-Opioid Prescription and Infographic']}\n- {'label': 'Standard of Care', 'type': 'OTHER', 'description': 'The control group is standard of care, which typically includes a prescription for an opioid.', 'interventionNames': ['Combination Product: Non-Opioid Prescription and Infographic']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Non-Opioid Prescription and Infographic', 'description': 'The study intervention will involve 3 components:\\n\\n1. A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 40mg PO daily x 30 tabs (to be taken only while utilizing Naproxen).\\n2. A limited opioid \"rescue prescription\": A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription.\\n3. Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control.', 'armGroupLabels': ['Non-Opioid Prescription and Infographic', 'Standard of Care']}\n\nPrimary Outcomes:\n- {'measure': 'Total oral morphine equivalents (OMEs)', 'description': 'The primary outcome is the number of total OMEs consumed as determined by a patient-reported medication diary.', 'timeFrame': '6 weeks postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nAlpha-value of 0.05, power of 80%, and a standard deviation of 155 OMEs. Sample sizes should be increased by 10-40% to account for loss to follow-up and unforeseen circumstances.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Based on prior literature, patients undergoing knee and shoulder arthroscopy can be expected to consume a median of about 100 OMEs post-surgery without intervention [4]. We are prescribing 75 OMEs in the intervention group with a rescue opioid prescription. Patients have been shown to consume 25\u00e2\u0080\u009350% of their prescription depending on whether they are undergoing knee or shoulder arthroscopy, respectively. Given this, we expect that the overall prescription consumption will be 33% of the prescribed amount (i.e. 25 OMEs). Using an alpha-value of 0.05, power of 80%, and a standard deviation of 155 OMEs [4], the required sample size is 68 patients per group, for a total sample size of 136. According to Thoma et al., estimated sample sizes should be increased by 10\u00e2\u0080\u009340% to allow for loss to follow-up and unforeseen circumstances [27]. Thus, based on the most conservative estimate of this guidance, we will increase our sample size by 40% for a total of 190 patients, rounded to 200 (100 per group). Allowing for patients who need to be excluded, those who choose not to participate, and loss to follow-up, we estimate we will need to screen approximately 300 patients for eligibility for a 66% inclusion rate [28].", "id": 885, "split": "val"} +{"trial_id": "NCT04568668", "pmid": "33546752", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Implementing and Evaluating ActionADE to Transform Medication Safety Among Patients With Adverse Drug Reactions\n\nIncluded conditions:\n- Adverse Drug Event\n- Adverse Drug Reaction\n\nStudy Armgroups:\n- {'label': 'ADE information transmitted to PharmaNet', 'type': 'EXPERIMENTAL', 'description': \"Patients in the experimental arm will have standardized adverse drug event information documented in ActionADE transmitted to and stored in PharmaNet, British Columbia's medication dispensing database. The adverse drug event information will become visible to any subsequent healthcare provider who accesses the patient's PharmaNet profile. Community pharmacy software will import the adverse drug event information such that community pharmacists can view the adverse drug event information prior to dispensing medications.\", 'interventionNames': ['Device: ActionADE']}\n- {'label': 'Standard care (ADE information retained locally)', 'type': 'NO_INTERVENTION', 'description': 'Patients in the control group will have their adverse drug event information recorded in ActionADE, and their information will be retained locally, as is the current standard of care. This means that their adverse drug event information will not be visible to other providers via PharmaNet.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'ActionADE', 'description': \"ActionADE is a software application that allows healthcare providers to document standardized adverse drug event information in a user-friendly and standardized manner. We integrated ActionADE uni-directionally with PharmaNet, a secure province-wide network that links all pharmacies in British Columbia to a central data system. This allows care providers to pull in demographic information and visualize their patient's medication dispensing history.\\n\\nIn 2020, we enabled bi-directional integration with PharmaNet allowing clinicians to transmit standardized adverse drug event information back to the PharmaNet database. The three dominant community pharmacy systems in the geographic area of the trial will display the adverse drug event information in their systems, and generate patient-specific medication-level alerts when pharmacists attempt to re-dispense a culprit medication.\", 'armGroupLabels': ['ADE information transmitted to PharmaNet']}\n\nPrimary Outcomes:\n- {'measure': 'Culprit or same-class medication re-dispensing during follow-up', 'description': 'The summary measure will be the proportion of patients with a culprit medication re-dispensation within 12 months. The effect measure will be the between-group difference in the proportion with a 12 month re-dispensation.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nWe will have >95% power to detect the effect size with \u03b1=0.05 (2-sided) using a Z-test with no continuity correction. We anticipate less than 1% loss to follow-up within 12 months. For the secondary trial, we will have at least 80% power to detect risk ratios of 0.70 to 0.85 over a range of non-adherence proportions (0.2 to 0.5).", "answer": 3600, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on our pilot work and the emergency department volumes of participating sites, we anticipate recruiting at least 200 patients per month, yielding a minimum of 3600 patients over an 18\u00e2\u0080\u0089month recruitment period. A previous study found that 26.6% (95% CI 17.3% to 38.5%) of seniors were re-prescribed a culprit medication within 6\u00e2\u0080\u0089months after an adverse drug reaction-related hospitalization [30]. An Ontario database study estimated that 54% of elderly patients were re-exposed to a high-risk medication within 6\u00e2\u0080\u0089months of a presentation related to an adverse drug reaction [31]. From our prior work, we anticipate that over one third of our patients will be seniors \u00e2\u0089\u00a5\u00e2\u0080\u008980\u00e2\u0080\u0089years of age [13]. Assuming a re-exposure proportion of 30% in patients \u00e2\u0089\u00a5\u00e2\u0080\u008980, and 15% in younger patients, we anticipate 20% of patients being re-exposed to culprit medications over a 12-month period in the control arm. With 3600 patients, we will have >\u00e2\u0080\u008995% power to detect a 5% absolute reduction (from 20 to 15%) in culprit medication re-dispensing assuming \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (2-sided) and approximating the analysis with a test of two proportions (Z-test) with no continuity correction. Through discussion with other clinicians, we believe that an absolute difference of 5% would be the minimal clinically important difference to change practice. Based on a prior study, we anticipate less than 1% loss to follow-up within 12\u00e2\u0080\u0089months due to unresolved linkages between Medical Service Plan and PharmaNet data. Although a total sample size of ~\u00e2\u0080\u00892000 would be adequate (>\u00e2\u0080\u008980% power) for the primary analysis, we chose to recruit additional patients to allow for exploration of potential treatment effect modification due to the absence of alert overrides in one of the three community pharmacy systems.\n Based on prior estimates of the proportion patients with adverse drug events who are categorized as being due to non-adherence, we anticipate approximately 2000 patients with an index event of non-adherence to accumulate over that time for our secondary trial [4, 32\u00e2\u0080\u009334]. We will have at least 80% power to detect risk ratios of 0.70 to 0.85 over a range of non-adherence proportions (0.2 to 0.5).", "id": 886, "split": "val"} +{"trial_id": "NCT04570202", "pmid": "37052108", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Symptoms of Depression, Stress and Burnout, and Long-term Psychological Impact in Health Care Professionals Exposed to the Novel Coronavirus Disease 2019 Outbreak (HARD-COVID-19 - Health cAre woRkers exposeD to covID-19)\n\nIncluded conditions:\n- Depression\n- Burnout, Professional\n- Post Traumatic Stress Disorder\n\nStudy Armgroups:\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'Subject from this group are screened positive for psychological distress but they will only receive standard of care.'}\n- {'label': 'Eye Movement Desensitization & Reprocessing Group', 'type': 'EXPERIMENTAL', 'description': 'Subject from this group are screened positive for psychological distress. They will receive 12 sessions of Eye Movement Desensitization \\\\& Reprocessing therapy by a trained therapist over three months in addition to standard of care.', 'interventionNames': ['Behavioral: EMDR']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'EMDR', 'description': 'The EMDR therapy is organized in eight different phases, requiring attending multiple sessions, usually 12 separate sessions.', 'armGroupLabels': ['Eye Movement Desensitization & Reprocessing Group']}\n\nPrimary Outcomes:\n- {'measure': 'Efficacy on symptoms of Post-Traumatic Stress Disorder', 'description': 'This study is investigating three different conditions (PTSD, Depression and Burnout) each assessed with its own primary endpoint. Thus, the trial will have three primary endpoints.\\n\\nChange over a 6 months period in symptoms of PTSD measured by the Post-Traumatic Stress Disorder Checklist Scale for Diagnostic and Statistical Manual of mental disorders fifth edition ((DSM-5), PCL-5). The PCL-5 score is on a scale from 0 to 80. The higher the score, the higher the level of PTSD symptoms are.', 'timeFrame': 'From inclusion to 6 months after inclusion'}\n- {'measure': 'Efficacy on symptoms of Burnout', 'description': 'Change over a 6 months period in symptoms of Burnout measured by the Professional Quality Of Life questionnaire (ProQOL). The ProQOL score is on a scale from 30 to 150. The higher the score, the higher the level of Burnout symptoms are.', 'timeFrame': 'From inclusion to 6 months after inclusion'}\n- {'measure': 'Efficacy on symptoms of Depression', 'description': 'Change over a 6 months period in symptoms of depression measured by the Patient Health Questionnaire (PHQ-9). The PHQ-9 score is on a scale from 0 to 27. The higher the score, the higher the level of depression symptoms are.', 'timeFrame': 'From inclusion to 6 months after inclusion'}\n\nPlease estimate the sample size based on the assumption: \n90% power with \u03b1 = 0.05 (two-sided), Family Wise Type I Error Rate controlled using Holm's procedure for three primary endpoints", "answer": 900, "answer_type": "ACTUAL", "explanation": "3.10.\n Sample size\n To reach 90% power with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (two-sided) for a 0.245 relevant effect size maximum on each of the primary endpoints, we need, among the eligible participants, a maximum of 450 participants per trial group. This means that a maximum of 450 participants will be included in the EMDR + usual care group, and 450 participants will be allocated to the usual care group (control group). The Family Wise Type I Error Rate will be controlled using Holm's procedure to account for the presence of three primary endpoints (Holm, 1979). Therefore, it is expected that 900 participants will be recruited from the cohort for the trial. If the sample size of 900 participants included in the randomized trial is not achieved after the baseline assessment (M0), we will expand randomization at the 3-month (M3) and 6-month (M6) follow-up visits.\n The sample size of the study was primarily defined for assessing the efficacy on primary outcomes for the trial, and no formal calculations were made to determine the sample size for the cohort study. However, if 3000 participants are recruited within the cohort as expected, cohort analysis will plausibly be performed with a sufficient level of precision and power.", "id": 887, "split": "val"} +{"trial_id": "NCT04571801", "pmid": "34663439", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimization of Sepsis Therapy Based on Patient-specific Digital Precision Diagnostics\n\nIncluded conditions:\n- Sepsis\n- Septic Shock\n\nStudy Armgroups:\n- {'label': '1', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard diagnostics', 'interventionNames': ['Diagnostic Test: Standard diagnostics']}\n- {'label': '2', 'type': 'EXPERIMENTAL', 'description': 'Standard diagnostics + NGS', 'interventionNames': ['Diagnostic Test: Next Generation Sequencing (NGS)']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Standard diagnostics', 'description': 'Standard diagnostics (Microbial diagnostics by means of standard culture methods + optional consultation of experts in the field of infectious diseases) within the first 72 h after diagnosis of sepsis / septic shock', 'armGroupLabels': ['1']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Next Generation Sequencing (NGS)', 'description': 'Standard diagnostics + NGS (Microbial diagnostics using standard culture methods + Next Generation Sequencing + optional consultation of experts in the field of infectious diseases) within the first 72 h after diagnosis of sepsis / septic shock', 'armGroupLabels': ['2']}\n\nPrimary Outcomes:\n- {'measure': 'Desirability of Outcome Ranking / Response Adjusted for Duration of Antibiotic Risk-Score', 'description': 'DOOR/RADAR-score \\\\[points\\\\], (min. 1, max. 5), a lower score indicates a better outcome', 'timeFrame': '28 days'}\n\nPlease estimate the sample size based on the assumption: \nA power of 90% with a relative effect of p = 0.6 and a drop-out rate of 12.5%.", "answer": 410, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n For sample size calculation, a sophisticated secondary outcome analysis of the following four large sepsis studies of the SepNet Study Group (VISEP [15], MAXSEP [16], HYPRESS [17], and SISPCT [18]) was performed, in which the above described OCO-groups were represented as follows: OCO 1: 33%, OCO 2: 3%, OCO 3: 22%, OCO 4: 14%, and OCO 5: 28%. It is assumed that the anti-infective treatment period in OCO 1 and OCO 2 is 7\u00e2\u0080\u0089days in average, whereas it is prolonged up to 15\u00e2\u0080\u0089days (with a standard deviation of 10\u00e2\u0080\u0089days) in average in OCO 3 and OCO 4. Based on the assumption that the OCO group can be improved by at least 2 stages in 42% of IG patients in parallel to a shortening of the anti-infective treatment by 2\u00e2\u0080\u0089days, this would result in a power of 90% with 180 patients in each of the two study groups (CG, IG), provided that an IG patient has a lower DOOR/RADAR score as compared to a CG patient with a relative effect of p = 0.6. Including an additional drop-out rate of 12.5% (and considering these patients as OCO 5) would finally result in an overall sample size of 410 patients (CG: n = 205/IG: n = 205).", "id": 888, "split": "val"} +{"trial_id": "NCT04574232", "pmid": "34108168", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods\n\nIncluded conditions:\n- Doping in Sport\n- Glucocorticoids\n\nStudy Armgroups:\n- {'label': 'athletic subjects', 'type': 'OTHER', 'description': 'athletic subjects who may need intra-articular knee infiltration', 'interventionNames': ['Drug: knee intra-articular infiltration with Triamcinolone acetonide']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'knee intra-articular infiltration with Triamcinolone acetonide', 'description': 'knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide', 'armGroupLabels': ['athletic subjects']}\n\nPrimary Outcomes:\n- {'measure': 'Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection', 'description': 'For subjects with a glucocorticoids urinary value below the 15 ng/ml threshold at D0 (before injection), identification of the date (up to 35 days) following the intra-articular ultrasound-guided injection which will correspond in the standards of the World Agency (under 15 ng/ml)', 'timeFrame': 'Change from baseline, pre-injection (day 0) to date (up to 35 days) where glucocorticoids urinary value below the 15 ng/ml'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated; focuses on recruitment potential and inclusion criteria.", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Sample size\n It is a pilot study. The inclusion of 20 patients is envisaged to be in accordance with the potential for recruitment. We are considering the possibility of at least two subjects with a value above WADA standards (<30 ng/mL) at baseline which will not be included for the primary or secondary endpoints. However, they will be integrated into the kinetics analysis and will be identifiable there.", "id": 889, "split": "val"} +{"trial_id": "NCT04576169", "pmid": "39663172", "question": "Here is the design of a clinical trial:\n\nOfficial Title: TREatment of Triangular FibrOcaRtilage ComplEx Ruptures (REINFORCER): Protocol for Randomized, Controlled, Blinded, Efficacy Trial of Triangular Fibrocartilage Complex Tears\n\nIncluded conditions:\n- Triangular Fibrocartilage Complex Injury\n\nStudy Armgroups:\n- {'label': 'Central or Radial Tear: Arthroscopic debridement', 'type': 'EXPERIMENTAL', 'description': 'Arthroscopic debridement', 'interventionNames': ['Procedure: Arthroscopic Debridement']}\n- {'label': 'Central or Radial Tear: Sham surgery', 'type': 'PLACEBO_COMPARATOR', 'description': 'Diagnostic arthroscopy only (placebo surgery).', 'interventionNames': ['Procedure: Placebo surgery']}\n- {'label': 'Ulnar Tear: Arthroscopic or open repair', 'type': 'EXPERIMENTAL', 'description': 'Arthroscopic or open repair', 'interventionNames': ['Procedure: Arthroscopic or Open Repair']}\n- {'label': 'Ulnar Tear: Physiotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Diagnostic arthroscopy and physiotherapy', 'interventionNames': ['Procedure: Physiotherapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Arthroscopic Debridement', 'description': 'Wrist arthroscopy can be performed with or without irrigation. In the debridement arm, a central or radial TFCC tear found during arthroscopy is debrided with a shaver. Portals are closed either with sutures or with medical tape. Immediate mobilization of the wrist is allowed after the operation. Participants are provided with instructions for home exercises, and they are advised to commence the exercises two weeks post-operation.', 'armGroupLabels': ['Central or Radial Tear: Arthroscopic debridement']}\n- {'type': 'PROCEDURE', 'name': 'Placebo surgery', 'description': 'Diagnostic wrist arthroscopy can be performed with or without irrigation. A central or radial TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed either with sutures or with medical tape. The procedure is performed in general or regional anesthesia in operating room. Participants are not able to see to the operation area or monitor. They will listen to music with noise-cancelling headphones throughout the operation. The operative time will be matched, with the surgeon simulating a debridement procedure. Immediate mobilization of the wrist is allowed after the operation. Participants are provided with instructions for home exercises, and they are advised to commence the exercises two weeks post-operation.', 'armGroupLabels': ['Central or Radial Tear: Sham surgery']}\n- {'type': 'PROCEDURE', 'name': 'Arthroscopic or Open Repair', 'description': 'An ulnar TFCC tear found during wrist arthroscopy is sutured to the capsule or fovea with one of the separately defined methods choosed by the treating hand surgeon. The procedure is performed in general or regional anesthesia in operating room. Wounds are closed and standardized post-operative treatment is started after six weeks.', 'armGroupLabels': ['Ulnar Tear: Arthroscopic or open repair']}\n- {'type': 'PROCEDURE', 'name': 'Physiotherapy', 'description': 'An ulnar TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed with sutures or medical tape. The procedure is performed in general or regional anesthesia in operating room. Physiotherapy exercises of wrist and DRUJ stabilizers is started after two weeks.', 'armGroupLabels': ['Ulnar Tear: Physiotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Patient-Rated Wrist Evaluation (PRWE)', 'description': 'The PRWE questionnaire is a wrist-specific instrument comprising a 15-item questionnaire assessing pain and disability in daily living. PRWE provides a score ranging from 0 (best) to 100 (worst). This wrist-specific tool demonstrates good reliability, validity, and responsiveness. Translation and validation have been conducted for Danish, Finnish, and Swedish languages. In interpreting the results, we will employ the Minimally Important Difference (MID) value of 14. PRWE as secondary outcome will be measured at all the other time points (6 months, 2, 5 and 10 years) than primary outcome.', 'timeFrame': '10 year follow-up, primary time point at 1 year'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate (significance level) is 0.05, power is 80%, and attrition rate is 15%.", "answer": 204, "answer_type": "ESTIMATED", "explanation": "Sample size\n This trial is designed as a superiority trial, aiming to detect a mean difference of 14 points. With type I error rate of 0.05 and a power of 80%, we need 44 participants per arm to detect a difference of >14 points in PRWE assuming SD of 20. Considering attrition rate of 15%, the final number of participants per randomisation cohort arm is 51, totalling 204 participants for the whole trial.", "id": 890, "split": "val"} +{"trial_id": "NCT04577846", "pmid": "34244280", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Surgical Site Infection (SSI) Rates in Patients Undergoing Mastectomy Without Reconstruction, a Comparison Among Those Receiving Preoperative Prophylactic Antibiotics Alone Versus Continued Prophylactic Antibiotics Postoperatively-A Multicenter, Double-blinded Randomized Control Trial.\n\nIncluded conditions:\n- Surgical Site Infection\n\nStudy Armgroups:\n- {'label': 'Intervention Arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'The intervention arm will be administered, either Cefazolin iv every 8 hours while NPO or cefalexin 500 mg q8 hours per oral if tolerating a diet.', 'interventionNames': ['Drug: Cephalexin 500 MG']}\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'Controls will be provided with initially IV placebo while NPO and then with a placebo capsule filled with inert material for the duration of the drains which usually is about 14 days.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Cephalexin 500 MG', 'description': 'Cefalexin 500 mg PO q8 hours will be continued for the duration of the indwelling drains which usually is about 14 days.', 'armGroupLabels': ['Intervention Arm']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'A placebo capsule filled with inert material for the duration of the drains which usually is about 14 days.', 'armGroupLabels': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'Surgical Site Infection (SSI)', 'description': 'Standard CDC criteria:\\n\\n1. purulent drainage from the incision or drain site;\\n2. organisms isolated from an aseptically obtained culture of fluid or tissue;\\n3. deliberate opening of the incision by a surgeon in patients having either tenderness, localized swelling, redness, or warmth; or\\n4. diagnosis of SSI by the surgeon or study wound assessor or\\n5. prescription of therapeutic antibiotics;\\n6. Patients clinically diagnosed and documented to have cellulitis.', 'timeFrame': 'up to 30 days.'}\n\nPlease estimate the sample size based on the assumption: \nA 5% level of significance, 80% power, and a 10% inflation for non-response rate.", "answer": 384, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated in OpenEpi software V.3.01. The minimum sample size that will be required is 384 patients who have undergone mastectomy with indwelling drains. Of these, 192 patients will be those with a single dose of prophylactic preoperative antibiotic and prolonged use of prophylactic postoperative oral antibiotics (intervention arm), and 192 participants will be those with a single dose of prophylactic preoperative antibiotic with placebo (control arm), with inflation of 10% in both the groups for non-response rate. An anticipated incidence of surgical site infection (SSI) of 3.4% in the intervention arm and 9.2%\u00e2\u0080\u009314% in the control arm,4 24 with a 5% level of significance and power of 80% to detect a 9% reduction of infection in intervention arm versus the control. Since we will be recruiting participants from three study sites, we applied proportionate sampling to estimate the sample size for each group. In this technique, the sample size of each site is proportionate to the total population size, which was 565. We calculated the per cent (weight) for each group by taking a ratio of the number of individuals in each group and the total population. Hence, we will require a minimum sample of 66 women in the intervention arm and 66 women in the control arm from AKU, 85 women in the intervention arm and 85 women in the control arm from LNH, and 41 women in the intervention arm and 41 women in control arm from DUHS campus.", "id": 891, "split": "val"} +{"trial_id": "NCT04578262", "pmid": "33737443", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Epley Manoeuvre for Posterior Semi-circular Canal Benign Paroxysmal Positional Vertigo in People With Multiple Sclerosis: Protocol of a Randomized Controlled Trial\n\nIncluded conditions:\n- Benign Paroxysmal Positional Vertigo\n- Multiple Sclerosis\n\nStudy Armgroups:\n- {'label': 'Epley Manoeuvre', 'type': 'EXPERIMENTAL', 'description': 'Epley manoeuvre in participants with Multiple Sclerosis who suffer from benign paroxysmal positional vertigo. Only one administration.', 'interventionNames': ['Procedure: Epley Manoeuvre']}\n- {'label': 'Sham Manoeuvre', 'type': 'SHAM_COMPARATOR', 'description': 'The second group will received a sham manoeuvre. However after the experimental intervention ends, this groups will also receive Epley manoeuvre.', 'interventionNames': ['Procedure: Sham Manoeuvre']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Epley Manoeuvre', 'description': 'This manoeuvre is constituted by five steps. In the first step, while the patient is in supine posture the head will be positioned 45 degrees turned towards the unaffected ear and the head slightly overhang on the edge of the couch. In this second step maintaining the previous position of the head, physiotherapist will turn head 45 degrees turned towards the affected ear. Next, in the third step, the whole body will turn until is located 135 degrees from the baseline supine position. In the fourth step, while the head keeps turned to the affected ear the subject will be incorporated until he is sitting. In the fifth step, while the subject is seated with the head in neutral position the chin will be bended 20 degrees. Each procedure will be held among 30 seconds or two minutes, while the dizziness or the nystagmus vanish. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).', 'armGroupLabels': ['Epley Manoeuvre'], 'otherNames': ['canalith repositioning procedure for posterior semi-circular canal']}\n- {'type': 'PROCEDURE', 'name': 'Sham Manoeuvre', 'description': 'The sham manoeuvre consist is going to star with the participant in a neutral seated position. Sum to it, head is rotated 45 degrees towards the unaffected vestibule. After that, the participant will be guided by the physiotherapist to a lateral decubitus position towards the affected side on which his nose will be pointing above. To conclude, the seated position will be reached again without head rotation. Each position of the sham manoeuvre will be maintained along one minute. During all the process the videonystagmography glasses will be dressed by participants and they will be indicated not to close eyes in the intervention. After the execution of the manoeuvre, also this group will be evaluated 48 hours after. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).', 'armGroupLabels': ['Sham Manoeuvre']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in the conversion of a positive to a negative Dix Hallpike Test', 'description': 'The performance of Dix Hallpike Test consists on a participant sit on a table and the head is turn 45 degrees towards the tested side. Once this position is stablished, the evaluator is going to laid back the participant in a quick movement sum to a neck extension of 20 degrees with the affected ear down. Throughout the process subject will be indicated to keep eyes open to allow the search of nystagmus. If torsional nystagmus or vertigo appears while the head is down it is indicative of posterior canal benign paroxysmal positional vertigo.', 'timeFrame': 'Baseline, immediately after intervention and 48 hours after intervention.'}\n\nPlease estimate the sample size based on the assumption: \none-tailed hypothesis, \u00ce\u00b1 error of 0.05, statistical power of 80%, estimated dropout rate of 15%", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated using the G*Power software (V.3.1.7; Kiel University, Kiel, Germany).50 The sample size has been calculated as 80 participants for a one-tailed hypothesis, with an \u00ce\u00b1 error of 0.05, size effect of d=0.8, statistical power of 80% and an estimated dropout rate of 15%.51 52", "id": 892, "split": "val"} +{"trial_id": "NCT04578990", "pmid": "35477870", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.\n\nIncluded conditions:\n- Peripheral Arterial Disease\n- Arteriosclerosis\n\nStudy Armgroups:\n- {'label': 'Walking intervention group', 'type': 'EXPERIMENTAL', 'description': 'It will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly.', 'interventionNames': ['Other: Walking intervention']}\n- {'label': 'Strength intervention group', 'type': 'EXPERIMENTAL', 'description': 'The training program consists of performing a training program with resistance exercises for 36-72 weeks.', 'interventionNames': ['Other: Strength intervention']}\n- {'label': 'Concurrent intervention group', 'type': 'EXPERIMENTAL', 'description': 'The training program consists of alternating strength and resistance stimuli in the same session for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied for 35 minutes and to complete the 60 minutes, the same guidelines will be followed as in the walking exercise, applying resistance stimuli.', 'interventionNames': ['Other: Concurrent intervention']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'It will receive standard advice consisting of the recommendation to perform aerobic exercise at the lower limbs level.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Walking intervention', 'description': 'It will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly.\\n\\nDepending on the data obtained in Visit 1, the speed will be determined for each patient and the degree of the initial slope that is comfortable when walking until it induces symptoms of moderate intermittent claudication. The progression of the intensity of the speed and incline of the slope will be increased progressively and individually for each patient.', 'armGroupLabels': ['Walking intervention group']}\n- {'type': 'OTHER', 'name': 'Strength intervention', 'description': \"The training program consists of performing a training program with resistance exercises for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied. The same guidelines will be followed as in the walking exercise, but in this case, applying force stimuli. If symptoms of moderate intermittent claudication occur (3-4) based on the Claudication Symptom Rating Scale in 5-10 minutes, a period of rest (sitting or standing) will be performed until the pain disappears at the level of the lower limb. This sequence will be repeated until the strength training session is completed. The progression of force stimuli will be increased weekly depending on the subjective perception of the patient's effort and according to the guidelines set by our group of investigation.\", 'armGroupLabels': ['Strength intervention group']}\n- {'type': 'OTHER', 'name': 'Concurrent intervention', 'description': 'The training program consists of alternating strength and resistance stimuli in the same session for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied for 35 minutes and to complete the 60 minutes, the same guidelines will be followed as in the walking exercise, applying resistance stimuli. If claudication symptoms occur moderate intermittent (3-4) based on the Claudication Symptom Rating Scale in 5-10 minutes, a period of rest (sitting or standing) will be performed until the pain in the lower extremity disappears. This sequence will be repeated until the 20 minutes established to end the session are completed concurrent training. The progression of the strength and resistance stimuli will be increased weekly depending on the perception subjective effort of the patient and according to the guidelines established by our research group.', 'armGroupLabels': ['Concurrent intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Pain-free walking distance', 'description': 'Pain-free walking distance using Treadmill based walking', 'timeFrame': '3 months from the start of the study'}\n- {'measure': 'Pain-free walking distance', 'description': 'Pain-free walking distance using Treadmill based walking', 'timeFrame': '6 months from the start of the study'}\n- {'measure': 'Pain-free walking distance', 'description': 'Pain-free walking distance using the 6-minute walk test distance', 'timeFrame': '3 months from the start of the study'}\n- {'measure': 'Pain-free walking distance', 'description': 'Pain-free walking distance using the 6-minute walk test distance', 'timeFrame': '6 months from the start of the study'}\n- {'measure': 'General functional state', 'description': 'General functional state using the Barthel questionnaire.', 'timeFrame': '3 months from the start of the study'}\n- {'measure': 'General functional state', 'description': 'General functional state using the Barthel questionnaire.', 'timeFrame': '6 months from the start of the study'}\n- {'measure': 'Perceived quality of life level', 'description': 'Perceived quality of life level', 'timeFrame': '3 months from the start of the study'}\n- {'measure': 'Perceived quality of life level', 'description': 'Perceived quality of life level', 'timeFrame': '6 months from the start of the study'}\n- {'measure': 'Ankle-Brachial Index (ABI)', 'description': 'To know if the proposed training programs improve the ankle-brachial index.', 'timeFrame': '3 months from the start of the study'}\n- {'measure': 'Ankle-Brachial Index (ABI)', 'description': 'To know if the proposed training programs improve the ankle-brachial index.', 'timeFrame': '6 months from the start of the study'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk of 0.05, power of 80%, 20% rate of lost to follow-up, bilateral contrasts, and a correlation of 0.5 between baseline and final measurements.", "answer": 124, "answer_type": "ESTIMATED", "explanation": "Calculation of sample size\n A sample of 124 patients, 31 per group, is needed to detect a 155 m improvement in pain-free walking distance after the intervention, assuming that the SD of the improvement is also 155 m (primary outcome 1). This is similar to an increase of 159\u00e2\u0080\u0089s walking without pain, for an average speed of 3.5\u00e2\u0080\u0089km/hour, as has been described previsouly.33 This calculation is comparable to any improvement as long as the SD is equal to or less than this improvement, and to comparisons between the control group and any of the other groups (correction for three comparisons using Bonferroni). This calculation is analogous for the rest of the result variables (Barthel, SF-12, VascQOL-6, ABI) as long as the difference observed between groups is equal to or greater than the common SD (primary outcome 2). The correlation between baseline and final measurement has been assumed to be 0.5. For comparisons between the treatment and control groups using the proportional version (proportion of patients improving in one group vs the other) the differences should be 50% improvement vs 15% or, equivalently, 35% vs 5%. In all calculations, a 20% rate of lost to follow-up, an alpha risk of 0.05, power of 80% and bilateral contrasts have been assumed.", "id": 893, "split": "val"} +{"trial_id": "NCT04579315", "pmid": "34462278", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Long-term Effects of the New Nordic Renal Diet on Phosphorus and Lipid Homeostasis in Patients With Chronic Kidney Disease, Stages 3 and 4 - A Randomized Controlled Trial\n\nIncluded conditions:\n- Chronic Kidney Disease(CKD)\n- Hyperphosphatemia\n- Blood Pressure\n\nStudy Armgroups:\n- {'label': 'Intervention group, NNRD group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Main principles of the interventional whole food approach are:\\n\\n* Maximum of 850 mg phosphorous/day\\n* Protein: 0.8 g/kg/day\\n* 80% vegetable products; 20% animal products\\n* Maximum of 5-7 g NaCl/day (table salt)\\n* Fresh raw products\\n* Seasonal oriented\\n* Fish: At least once a week\\n* Vegetarian: At least once a week\\n* Wide range of fruit and vegetables\\n* Easy to follow in daily practice\\n* Rich in flavors\\n* Sufficient content of micro- and macronutrients', 'interventionNames': ['Other: Intervention group; NNRD group']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'There is no intervention, patients are following their habitual diet'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Intervention group; NNRD group', 'description': 'The intervention is a whole food approach, meaning that the participants in the intervention group receives all daily food elements that they should consume', 'armGroupLabels': ['Intervention group, NNRD group']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in change in 24-hour urine phosphorus excretion from baseline to week 26 between the two study groups', 'description': '24-hour urine sample', 'timeFrame': 'Baseline, day: 14, 30, 60, 90, 120, 150, 180 and three months after study completion'}\n\nPlease estimate the sample size based on the assumption: \nType-1 error risk of 0.05 (alpha, two-tailed), power of 80% (beta), SD of 24-hour urine phosphorus excretion of 200 mg, and a minimum clinically relevant difference of 300 mg.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size calculation and statistical analysis\n The sample size calculation is based on results from previous studies performed by this study group. Within 6 months of participating in this study, we expect a decrease in eGFR to be about 1\u00e2\u0080\u0089mL/min/1.73 m2. This will have no influence on the total amount of 24-hour urine phosphorus excretion (primary endpoint), as CKD progresses and normophosphatemia is maintained by increasing the per nephron urinary phosphorus excretion stimulated by an increase in FGF23 and PTH leading to progressively increasing plasma levels of FGF23 and secondary hyperparathyroidism (SHP).\n In a randomised controlled study with a type-1 error risk of 0.05 (alpha, two tailed) and a power of 80% (beta) with an SD of 24-hour urine phosphorus excretion of 200\u00e2\u0080\u0089mg and a minimum clinical relevant difference of 300\u00e2\u0080\u0089mg, the study population is estimated at 21 in each group. There will be dropouts so we will include 30 participants in each group. The total number of participants to be included in this study is 60.", "id": 894, "split": "val"} +{"trial_id": "NCT04582734", "pmid": "34862302", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease: The Heart & Mind Trial\n\nIncluded conditions:\n- Cognitive Therapy\n- Anxiety Disorders\n- Heart Diseases\n\nStudy Armgroups:\n- {'label': 'Intervention group - cognitive behavioral therapy', 'type': 'EXPERIMENTAL', 'description': 'The intervention consists of three parts: 1) screening of hospitalised and outpatient cardiac patients at four university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores \u22658 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a cardiac nurse with CBT training, plus usual care or usual care alone.The intervention is considered finalized if the patient has a HADS-A score under 8 two times in a row. The intervention group will receive usual care as well.', 'interventionNames': ['Behavioral: Cognitive-behavioural therapy']}\n- {'label': 'Usual Care group', 'type': 'NO_INTERVENTION', 'description': 'The usual care group (control group) will receive usual care which consists cardiac disease control and treatment.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive-behavioural therapy', 'description': 'Cognitive-behavioural therapy intervention', 'armGroupLabels': ['Intervention group - cognitive behavioral therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Hospital Anxiety and Depression Scale (HADS) Anxiety', 'description': 'Primary outcome is anxiety measured by HADS-A. HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards.\\n\\nScores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.', 'timeFrame': '5 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (type 1 error) set at 0.05 and 0.01, power set at 90%, and assumptions for secondary outcomes with SDs of 0.46 and 17.3, and power >0.999 and 0.914 respectively.", "answer": 336, "answer_type": "ACTUAL", "explanation": "Sample size and power estimations\n \n Sample size\n It has previously been found that among cardiac patients the minimal clinically important difference on the HADS is 1.7 points.44 In a trial investigating the effect of CBT on patients with implantable cardioverter defibrillator (ICD) and anxiety,45 a difference between groups of four points was found; intervention group 4.95 (SD 3.30) versus usual care group 8.98 (SD 4.03), p<0.0001, Cohen\u00e2\u0080\u0099s d \u00e2\u0088\u00920.86. Therefore, an expected difference of 2 points seems reasonable. The SD is found to be 2.7 in a group of 3250 patients with heart disease and HADS-A above 8 (unpublished data from the DenHeart dataset).\n With a power of 90% and a type 1 error set at 0.05, a total of 39 patients should be entered into each group. If the risk of type I error is reduced to 0.01 and the expected minimal difference is still two points then 56 patients should be entered into each group. To allow for sub-analyses on each of the main groups, arrhythmia, heart failure and ischaemic heart disease, we include a total of 336 patients (168 intervention patients and 168 control patients) equally distributed among the three main diagnostic groups to have sufficient statistical power.\n \n \n Power estimations for secondary outcomes\n BAI: In a previous study, the response within each subject group was normally distributed with an SD of.46 If the true difference between the intervention and control group means is 5.245 we will be able to reject the null hypothesis that the population means of the intervention and control groups are equal with a probability (power) >0.999.\n HRV (SDNNi): In a previous study the response within each subject group was normally distributed with a SD of 17.3 (6). If the true difference in the intervention and control group means is 6.32, we will be able to reject the null hypothesis that the population means of the intervention and control groups are equal with a probability (power) of 0.914.", "id": 895, "split": "val"} +{"trial_id": "NCT04582734", "pmid": "34862302", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease: The Heart & Mind Trial\n\nIncluded conditions:\n- Cognitive Therapy\n- Anxiety Disorders\n- Heart Diseases\n\nStudy Armgroups:\n- {'label': 'Intervention group - cognitive behavioral therapy', 'type': 'EXPERIMENTAL', 'description': 'The intervention consists of three parts: 1) screening of hospitalised and outpatient cardiac patients at four university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores \u22658 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a cardiac nurse with CBT training, plus usual care or usual care alone.The intervention is considered finalized if the patient has a HADS-A score under 8 two times in a row. The intervention group will receive usual care as well.', 'interventionNames': ['Behavioral: Cognitive-behavioural therapy']}\n- {'label': 'Usual Care group', 'type': 'NO_INTERVENTION', 'description': 'The usual care group (control group) will receive usual care which consists cardiac disease control and treatment.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive-behavioural therapy', 'description': 'Cognitive-behavioural therapy intervention', 'armGroupLabels': ['Intervention group - cognitive behavioral therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Hospital Anxiety and Depression Scale (HADS) Anxiety', 'description': 'Primary outcome is anxiety measured by HADS-A. HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards.\\n\\nScores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.', 'timeFrame': '5 months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (type 1 error) set at 0.05 and 0.01, power set at 90%, and assumptions for secondary outcomes with SDs of 0.46 and 17.3, and power >0.999 and 0.914 respectively.", "answer": 336, "answer_type": "ACTUAL", "explanation": "Sample size\n It has previously been found that among cardiac patients the minimal clinically important difference on the HADS is 1.7 points.44 In a trial investigating the effect of CBT on patients with implantable cardioverter defibrillator (ICD) and anxiety,45 a difference between groups of four points was found; intervention group 4.95 (SD 3.30) versus usual care group 8.98 (SD 4.03), p<0.0001, Cohen\u00e2\u0080\u0099s d \u00e2\u0088\u00920.86. Therefore, an expected difference of 2 points seems reasonable. The SD is found to be 2.7 in a group of 3250 patients with heart disease and HADS-A above 8 (unpublished data from the DenHeart dataset).\n With a power of 90% and a type 1 error set at 0.05, a total of 39 patients should be entered into each group. If the risk of type I error is reduced to 0.01 and the expected minimal difference is still two points then 56 patients should be entered into each group. To allow for sub-analyses on each of the main groups, arrhythmia, heart failure and ischaemic heart disease, we include a total of 336 patients (168 intervention patients and 168 control patients) equally distributed among the three main diagnostic groups to have sufficient statistical power.", "id": 896, "split": "val"} +{"trial_id": "NCT04582799", "pmid": "34666820", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Extra-Corporeal Carbon Dioxide Removal for Acute Decompensation of Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial (The ORION Study)\n\nIncluded conditions:\n- Pulmonary Disease, Chronic Obstructive\n\nStudy Armgroups:\n- {'label': 'Standard of Care (NIV)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients in the control group will be treated with non-invasive ventilation only.', 'interventionNames': ['Device: NIV']}\n- {'label': 'Extracorporeal CO2 Removal (NIV+ECCO2R)', 'type': 'EXPERIMENTAL', 'description': 'Patients in the treatment group will be treated with non-invasive ventilation combined with Extracorporeal CO2 Removal.', 'interventionNames': ['Device: ECCO2R', 'Device: NIV']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'ECCO2R', 'description': 'Extracorporeal CO2 Removal', 'armGroupLabels': ['Extracorporeal CO2 Removal (NIV+ECCO2R)']}\n- {'type': 'DEVICE', 'name': 'NIV', 'description': 'Non-invasive ventilation', 'armGroupLabels': ['Extracorporeal CO2 Removal (NIV+ECCO2R)', 'Standard of Care (NIV)']}\n\nPrimary Outcomes:\n- {'measure': 'Combined 28-day mortality or surrogate events', 'description': 'Incidence of death, prolonged mechanical ventilation, development of septic shock, development of severe hypoxemia, second episode of COPD exacerbation', 'timeFrame': '28 days after enrollment'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a two-sided log-rank test with a 0.05 significance level and 90% power. The study duration is 25 months, with 24 months for accrual and 1 month for follow-up. No dropouts or crossovers are assumed.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size\n A two-sided log-rank test with an overall sample size of 284 subjects (142 in the control group and 142 in the treatment group) achieves 90% power at a 0.05 significance level to detect a hazard ratio of 0.67 when the proportion surviving without events in the control group is 40% (we estimated a combined proportion of death, prolonged mechanical ventilation, septic shock, severe hypoxemia and second episode of COPD exacerbation of 60% [23\u00e2\u0080\u009333]). The study will last 25 months of which 24 months to accrual and 1 month of follow up. No subject will drop out of the control/treatment group. We assume no cases of switch (crossing-over) between the arms: the proportion of the control group that switches to a group with a risk rate equal to the treatment group is equal to zero (and vice versa).\n This study has been designed to demonstrate a relative increase of 35% in the event free survival (from 40% to 54%), assuming the above-mentioned parameters.", "id": 897, "split": "val"} +{"trial_id": "NCT04585581", "pmid": "37793933", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Before the Beginning: Preconception Lifestyle Interventions to Improve Future Metabolic Health\n\nIncluded conditions:\n- Gestational Diabetes\n\nStudy Armgroups:\n- {'label': 'diet + training', 'type': 'EXPERIMENTAL', 'interventionNames': ['Behavioral: time-restricted eating', 'Behavioral: high intensity exercise', 'Other: Standard Care']}\n- {'label': 'controls', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Standard Care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'time-restricted eating', 'description': 'Participants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours.', 'armGroupLabels': ['diet + training']}\n- {'type': 'BEHAVIORAL', 'name': 'high intensity exercise', 'description': 'Participants will be encouraged to exercise with high intensity 2-3 times per week', 'armGroupLabels': ['diet + training']}\n- {'type': 'OTHER', 'name': 'Standard Care', 'description': 'Standard clinical care', 'armGroupLabels': ['controls', 'diet + training']}\n\nPrimary Outcomes:\n- {'measure': 'Plasma glucose concentration', 'description': 'Plasma glucose concentration after 2 h oral glucose tolerance testing (75 g glucose)', 'timeFrame': 'Gestational week 28'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a two-sided t-test with a power of 0.90, a significance level of 0.05, and an expected dropout rate of 10-20%.", "answer": 167, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The primary outcome of this study is glucose tolerance (after a 2-hour OGTT) in gestational week 28. The HAPO study results63 indicate strong, continuous associations of maternal glucose levels, even below the diagnostic level of GDM with adverse maternal and offspring outcomes. Based on the increasing risk of adverse maternal and offspring outcomes across 2-hour plasma glucose categories with a change of~1\u00e2\u0080\u0089mmol/L, we consider a difference of 1\u00e2\u0080\u0089mmol/L in 2-hour plasma glucose after OGTT between the intervention and control group as clinically relevant. We also used the observed standard deviation (1 SD = 1.3\u00e2\u0080\u0089mmol/L) in 2-hour plasma glucose after OGTT in the HAPO study for the sample size calculations. Calculation of the sample size for a two-sided t-test to detect a difference of 1\u00e2\u0080\u0089mmol/L between the groups, using an SD of 1.3\u00e2\u0080\u0089mmol/L, a power of 0.90 and a significance level of 0.05, yields 37 participants in each group in gestational week 28. To allow for an expected exclusion from the study due to not conceiving within the study period (~50%)64 yielding 74 per group, further drop-out during the study period (10\u00e2\u0080\u009320%), yielding 93 per group, and to increase statistical power for secondary analyses, we initially wanted to include 260 participants in the trial.\n However, we terminated the inclusion of new participants at 167 participants since we had reached 47 participants in each group who were pregnant in gestational week 12. With this number of participants, we foresee that we will have at least 37 participants in each group in gestational week 28, allowing for up to 20% dropout during pregnancy. We expect more participants who are already included to become pregnant in the upcoming period, which will increase the number of pregnant participants.", "id": 898, "split": "val"} +{"trial_id": "NCT04586517", "pmid": "33725859", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Heavy-load Resistance Training During (Neo-)Adjuvant Chemotherapy on Muscle Cellular Outcomes in Women With Breast Cancer\n\nIncluded conditions:\n- Breast Cancer Female\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive supervised heavy-load resistance training twice a week during treatment with chemotherapy (approximately 16-weeks). After end of chemotherapy, participants will be encouraged to continue the training program and are provided with 12-month membership at a local gym.', 'interventionNames': ['Other: Heavy-load resistance training']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will be encouraged to continue with their usual activities during chemotherapy and not start resistance training (approximately 16-weeks). After end of chemotherapy participants will be offered to attend a 2-week introduction to the strength-training program and provided with a 12-month membership at a local gym.', 'interventionNames': ['Other: Control']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Heavy-load resistance training', 'description': 'Supervised heavy-load resistance training during chemotherapy treatment', 'armGroupLabels': ['Intervention group'], 'otherNames': ['Physical exercise', 'Physical training']}\n- {'type': 'OTHER', 'name': 'Control', 'description': 'Activity as usual during chemotherapy', 'armGroupLabels': ['Control group'], 'otherNames': ['usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Assessment of changes in muscle fiber cross-sectional area', 'description': 'Change from baseline in muscle fiber cross-sectional area at 16 weeks. Through immunohistochemical staining of muscle fiber cross-sections will muscle fiber area be assessed for type 1 and type 2 muscle fibers', 'timeFrame': 'From baseline to the 16 week time-point'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80% requires 10 participants per group; to achieve 95% power, 16 participants per group are needed. The sample size accounts for potential drop-outs.", "answer": 40, "answer_type": "ACTUAL", "explanation": "2.3\n Sample size\n The power calculation is based on results from strength training effects in prostate cancer patients on androgen deprivation therapy, the Physical Exercise and Prostate Cancer trial (PEPC trial).[10] With a similar effect on muscle fiber size (+898\u00e2\u0080\u008a\u00c2\u00b1\u00e2\u0080\u008a840\u00e2\u0080\u008a\u00ce\u00bcm2), we need 10 participants in each group to get a statistical power of 80% in the present study, to further enhance the power up to 95%, we need 16 participants in each group. Consequently, 50 participants (25 in each arm) will be recruited to account for drop-outs during the intervention. The power calculation is based on the PEPC trial[10] but findings from the study by Mijwel and colleagues[13] strongly support similar expectations in breast cancer patients on chemotherapy.", "id": 899, "split": "val"} +{"trial_id": "NCT04587999", "pmid": "34531206", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Quick-Wee Versus Bladder Stimulation to Collect Midstream Urine From Pre-continent Infants: a Randomized Controlled Trial\n\nIncluded conditions:\n- Urinary Tract Infections\n\nStudy Armgroups:\n- {'label': 'bladder stimulation', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: bladder stimulation']}\n- {'label': 'Quick wee', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Quick wee']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'bladder stimulation', 'description': 'The bladder stimulation technique requires the presence of 2 people:\\n\\n* The child must be held by an adult (caregiver or parent) under the armpits, legs dangling.\\n* the first person (the investigator), performs the stimulation technique consisting of: rapid tapping (frequency of about 100 / min), over the pubic area, at the level of the bladder, alternated with external rotational movements of the pits lumbar, in the kidneys. Alternate these 2 maneuvers every 30 seconds.\\n* The second person starts the stopwatch at the start of the stimulation, and is about to collect the urine, 2nd jet in a sterile pot\\n* The maneuver ends as soon as urine is obtained, and will be stopped after 5 minutes in case of failure.', 'armGroupLabels': ['bladder stimulation']}\n- {'type': 'OTHER', 'name': 'Quick wee', 'description': 'The Quick wee technique requires the presence of only one person:\\n\\nStimulation of the suprapubic area by circular movements, with a cold and wet compress held by sterile forceps.\\n\\nCollection of urine in a sterile container.', 'armGroupLabels': ['Quick wee']}\n\nPrimary Outcomes:\n- {'measure': 'volume of urine collection to measure the effectiveness of two techniques', 'description': 'measure of success of the urine collection technique is determined by collecting at least 2 millimeters of urine in less than 5 minutes', 'timeFrame': 'at the end of intervention completion, an average 30 minutes'}\n\nPlease estimate the sample size based on the assumption: \nA bilateral hypothesis with an alpha risk of 5%, power of 80%, and an additional 10% to account for data loss.", "answer": 230, "answer_type": "ACTUAL", "explanation": "Sample size\n Based on the literature data,24 the success rate for midstream urine collection by Quick-Wee is 31% in infants under 1 year of age. The success rate for midstream urine collection by bladder stimulation is 56%.22 Therefore, we plan to have a success rate of 50% in the Bladder Stimulation group.\n Thus, the number of subjects per arm required to demonstrate this difference between the groups with a \u00cf\u0087\u00c2\u00b2 test would be 104 according to a bilateral hypothesis, at the alpha risk of 5% and with a power of 80% (nQuery Advisor, V.7.0). We consider an additional 10% of patients to account for data loss. Therefore, a sample size of 230 infants under the age of 1 year will be included in the study (115 in each group).\n According to our estimates, 250 patients per year who meet the inclusion criteria consult in the emergency departments of the investigating centres. Considering a participation rate of around 60%, 150 infants are eligible per year. It seems reasonable to consider a study period of 18 months.", "id": 900, "split": "val"} +{"trial_id": "NCT04588857", "pmid": "34725072", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Double-blind Placebo-controlled Trial on the Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia\n\nIncluded conditions:\n- Prostatic Hyperplasia\n\nStudy Armgroups:\n- {'label': 'Active drug', 'type': 'EXPERIMENTAL', 'description': 'dexamethasone 24 mg i.v., single dose', 'interventionNames': ['Drug: Dexamethasone']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'saline i.v., single dose', 'interventionNames': ['Drug: Saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'The participants in the experimental group will receive a single 24 mg intravenous dose of dexamethasone immediately prior to PAE.', 'armGroupLabels': ['Active drug']}\n- {'type': 'DRUG', 'name': 'Saline', 'description': 'The participants in the placebo group will receive 6 ml of saline i.v. immediately prior to PAE.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Body temperature', 'description': 'Mean rectal body temperature, measured in degrees Celsius', 'timeFrame': 'Measured by participant on Day 2 following PAE,'}\n- {'measure': 'Postprocedural pain', 'description': 'Mean postprocedural pain measured on Brief Pain Inventory Short Form (BPI-SF), score on a 0-10 scale, higher score indicates higher level of pain', 'timeFrame': 'During the first 5 days following PAE'}\n- {'measure': 'Postprocedural quality of life', 'description': 'Mean postprocedural quality of life measured on BPI-SF, score on a 0-10 scale, higher score indicates lower quality of life', 'timeFrame': 'During the first 5 days following PAE'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided two-sample t-test, 80% power, significance level of 0.05, compensation for dropouts.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size\n A pilot study conducted at the Department of Urology, Rigshospitalet on four patients undergoing PAE (without DEXA administration) showed a mean postprocedural rectal temperature of 37.8\u00c2\u00b0C (SD 0.38) 2\u00e2\u0080\u0089days post-PAE. Day 2 is chosen as study target as it had the highest mean temperature of the 5\u00e2\u0080\u0089days in which the temperature was measured. The goal reduction is from mean temperature on day 2 (subfebrile) to a mean of 37.4\u00c2\u00b0C (afebrile). A one-sided two-sample t-test power calculation with 80% power and a significance of 0.05 gives a required sample size of 28 patients in each group or 56 patients in total.\n In the literature, a 3-point decrease (SD 2) on the BPI-SF questionnaire is considered clinically relevant.23 24 With that in mind, a one-sided two-sample t-test power calculation with 80% power and a significance of 0.05 gives a required sample size of 7 patients in each group or 14 patients in total.\n In conclusion, this study will include 30 patients in each group (60 in total) to compensate for eventual dropouts. Dropouts are defined as patients who, after inclusion, either do not receive the allocated trial medication or are lost to follow-up for the primary outcomes.\n The study has not been powered for the secondary outcome measures.", "id": 901, "split": "val"} +{"trial_id": "NCT04589715", "pmid": "35667733", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Electroacupuncture on Symptoms of Female Pelvic Organ Prolapse(Level II - III )\n\nIncluded conditions:\n- Pelvic Organ Prolapse\n\nStudy Armgroups:\n- {'label': 'electroacupuncture group', 'type': 'EXPERIMENTAL', 'description': 'patients will receive electroacupuncture at 3 acupoints(Bladder meridian of foot-taiyang 33 and 35#BL33 and BL35), and Spleen meridian of foot-taiyin 33(SP6)) 3 times/week for 4 weeks, then 3 times/week for 4 weeks, and then once/week for 4 weeks(24 times in total in 3 months), and be followed up for 6 months after treatment. Disposable acupuncture needles with size of 0.30 \u00d7 75 mm will be used at BL 33 and BL 35, and needles with size of 0.30 \u00d740 mm at SP 6. Standardized electroacupuncture apparatuses will be used, and the stimulation will last for 30 minutes with a continuous wave of 20 Hz, and a current intensity of 2 to 6.5 mA at BL33 and BL 35, and 1 to 3.5 mA at SP6.', 'interventionNames': ['Other: electroacupuncture']}\n- {'label': 'sham electroacupuncture group', 'type': 'SHAM_COMPARATOR', 'description': 'patient will receive sham electroacupuncture with the same frequency and amount as applied in the electroacupuncture group, as well as the follow-up period. Disposable acupuncture needles with size of 0.30 \u00d7 40 mm will be applied and penetrate the skin of patients for 2 to 3mm at sham acupoints to the 3 acupoints mentioned above. The stimulation will only last for 30-second with a very weak currency intensity and a continuous wave of 20 Hz.', 'interventionNames': ['Other: sham electroacupuncture']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'electroacupuncture', 'description': 'the same as described in experimental arm.', 'armGroupLabels': ['electroacupuncture group']}\n- {'type': 'OTHER', 'name': 'sham electroacupuncture', 'description': 'the same as described in sham comparator.', 'armGroupLabels': ['sham electroacupuncture group']}\n\nPrimary Outcomes:\n- {'measure': 'the change from baseline on the score of the Pelvic Floor Distress Inventory-short form 20 (PFDI-20)', 'description': 'Data will be collected via the the Pelvic Floor Distress Inventory-short form 20 (PFDI-20) . The questionnaire consists of three sections, pelvic organ prolapse distress inventory 6 (POPDI-6), colorectal-anal distress inventory 8 (CRADI-8), and urinary distress inventory 6 (UDI-6). Each section has 6-8 questions with 5 answers rated from 0-4 in each, and mean score of each section is the total score of this section divided by number of questions in this session. Then the sum of the mean scores of the three section timing 25 will come to the total score of the questionnaire(0-300). The higher the total score is, the severer the symptoms are.', 'timeFrame': 'at baseline, and 3 months when the treatment is completed.'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level (two-tailed), and 10% loss of follow-up rate.", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In this study change of PFDI-20 score from baseline will be used as the basis for primary sample size estimation. As there is no consensus on the minimal clinically important difference (MCID) of PFDI-20 score,27 and few RCT on acupuncture was identified, the study decided to use 15 points as MCID based on previous studies on conservative therapies for POP.9\u00e2\u0080\u009328 Assuming a PDFI-20 baseline score of 60 points, it is estimated that 160 patients (80 per group) are needed to provide 80% power for detection of a difference of 15 points between groups at 12 weeks since randomisation, using a SD of 27 points,9 22 29 a two-tailed 5% level of significance and 10% loss of follow-up rate. PASS V.15 software was used for sample size calculation.", "id": 902, "split": "val"} +{"trial_id": "NCT04590989", "pmid": "35351696", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PREVENTOMICS: Empowering Consumers to 'PREVENT' Diet-related Diseases Through 'OMICS' Sciences - Danish Intervention Study\n\nIncluded conditions:\n- Overweight\n- Obesity\n- Metabolic Syndrome\n\nStudy Armgroups:\n- {'label': 'Personalized Plan (PP)', 'type': 'EXPERIMENTAL', 'description': 'Each subject in the PP group will be allocated to one of five clusters based on their metabolic and genetic health biomarkers from samples of urine, plasma, serum, and saliva. 58 biomarkers will be included to characterize the 5 metabolic clusters/processes in the PREVENTOMICS platform: 1) oxidative stress; 2) inflammation; 3) carbohydrate metabolism; 4) lipid metabolism; 5) microbiota-generated metabolites. Eurecat Nutrition Team has prepared a list of recommended food items to increase and food to exclude/limit from the diet for each cluster. The list will be adopted by Simple Feast in creating five different menus that will encompass the 12 meals/week of breakfasts and dinners for the five different metabolic clusters. Additionally, subjects will receive personalized actionable \"Do\\'s\" push notifications by ONMI. The messages are personalized based on user reports from the behavioral questionnaire at V2 in addition to inputs from the nutritional recommendations of food to increase.', 'interventionNames': ['Other: Personalized Nutrition Plan']}\n- {'label': 'Control Group', 'type': 'PLACEBO_COMPARATOR', 'description': \"Dietary intervention:\\n\\nThe second group of 50 subjects will receive meals from Simple Feast, after integrating their metabolic profile and other blood biomarkers by PREVENTOMICS, which are based on the national dietary guidelines.\\n\\nBehavioral intervention:\\n\\nSubjects will also receive nudges, after filling out ONMI's behavioral questionnaire at V2, but that will not be personalized (i.e. basic information that is available online from NHS and WHO).\", 'interventionNames': ['Other: Non-Personalized Nutrition Plan']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Personalized Nutrition Plan', 'description': \"* Personalized breakfasts and dinners designed and cooked by Simplefeast, delivered twice a week (eaten 6 days per week) + access to Simplefeast's App for recipes of other meals not provided (i.e. lunches and Saturdays) which are designed to match the individual nutritional recommendations.\\n* Personalized behavioral change program via electronic push notifications by ONMI\", 'armGroupLabels': ['Personalized Plan (PP)']}\n- {'type': 'OTHER', 'name': 'Non-Personalized Nutrition Plan', 'description': \"* Standard meals of breakfasts and dinners designed and cooked by Simple feast, based on general dietary recommendations, and delivered to participants twice a week. In addition, they will also have access to Simple feast's recipe App for other meals not provided. The recipes presented are generic, not personalized.\\n* Subjects in the control group will also be enrolled in the behavioral program by ONMI, but the program will not be personalized nor based on the same behavior change methodology as in the PP group. In other words, the control group will get information more than is triggered to take actual action (i.e. general guidelines that is available from the National Health Service and World Health Organization).\", 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in body fat mass from baseline to week 10 will be analyzed by means of linear mixed models including sex, age and BMI at baseline as fixed effects as well as the stratification variable (cluster).', 'description': 'Fat mass is evaluated by use of Dual X-ray absorptiometry (DXA) scans. The DXA-scan (iDXA, Lunar Radiation Co., Madison, Wisconsin, USA) is performed at V2 and V3 to calculate the difference between the two measurements.', 'timeFrame': 'Baseline (V2) and week 10 (V3).'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-tailed significance level of 0.05, and an anticipated 18% dropout rate.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Power and sample size calculation\n To detect a difference in body fat mass change of 1.25 kg between the two intervention groups with 80% power at a two-tailed level of significance of 0.05, assuming a SD of 2.0 kg, a sample size of 41 per group (ie, personalised vs control) is needed, that is, a total sample size of 82 completers. To allow for an anticipated 18% dropout rate, 50 subjects per group would need to be recruited (total n=100). The expected difference in fat mass between groups (1.25 kg) and the associated SD (2.0 kg) were based on values calculated from the raw data of the SHOPUS study.47 In that study, we reported on body weight and fat mass during a 6-month dietary intervention in subjects with BMI of 22.6\u00e2\u0080\u009347.3 kg/m2. To conduct power calculations for this study, we extracted raw data from the SHOPUS study that were most representative of the current subjects and intervention duration. Accordingly, we selected those SHOPUS participants with BMI \u00e2\u0089\u00a527 kg/m2 and elevated waist circumference (males >94 cm; females>80 cm) which represented more than 67% of the total study population (n=145) and assessed their body weight and fat mass at 12 weeks; this was an interim time point of the SHOPUS study (not published in the original paper),47 which was the closest to the 10-week time frame of the current intervention.", "id": 903, "split": "val"} +{"trial_id": "NCT04591496", "pmid": "34922616", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The SmartFeeding4Kids, a Web-based Food Parenting Intervention to Promote Positive Feeding Practices and Healthy Diet in Preschool Children, Through Self-regulation and Behavior Change Techniques: a Randomized Control Trial\n\nIncluded conditions:\n- Parental Feeding Practices and Children's Healthy Diet\n\nStudy Armgroups:\n- {'label': 'SmartFeeding4Kids', 'type': 'EXPERIMENTAL', 'description': \"SmartFeeding4Kids: information about children's healthy diet and effective parental feeding practices, with a behavioral intervention (5 sessions plus 2 brief booster sessions online intervention)\", 'interventionNames': ['Behavioral: Behavioral change intervention;', 'Behavioral: Health Education']}\n- {'label': 'SmartFeeding4Kids Health', 'type': 'ACTIVE_COMPARATOR', 'description': \"Psychoeducational condition: information about children's healthy diet and effective parental feeding practices (5 sessions plus 2 brief booster sessions online intervention)\", 'interventionNames': ['Behavioral: Health Education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Behavioral change intervention;', 'description': \"Behavioral change intervention: goal setting, regarding child's diet and parental feeding practices; self-monitoring, with observation and recording of the child's food intake and parental feeding practices; individualized feedback, based on preceding week monitoring and according to the defined objectives, regarding child's and parent's behaviors; modeling and direct suggestions by tailored parent figures; positive reinforcement associated to parents' accomplishment of the objectives; prompts, to remember the defined objectives and the main messages of the intervention.\", 'armGroupLabels': ['SmartFeeding4Kids']}\n- {'type': 'BEHAVIORAL', 'name': 'Health Education', 'description': \"Health education: provision of information about preschool children's nutrition guidelines, effective parental feeding practices, strategies to overcome food and feeding-related barriers, and steps to form healthy habits.\", 'armGroupLabels': ['SmartFeeding4Kids', 'SmartFeeding4Kids Health']}\n\nPrimary Outcomes:\n- {'measure': \"Changes from baseline in the child's dietary intake reported by parents\", 'description': \"Child's dietary intake reported by parents: Child's dietary intake is evaluated through a 24h food recall, completed during 3 days (two weekdays and one weekend day). Data regarding the mean number of portions of vegetables, fruit, and sugar-sweetened foods and beverages registered on three days will be extracted from the database and analyzed separately as primary outcomes.\", 'timeFrame': 'Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention'}\n- {'measure': 'Changes from baseline in parental feeding practices', 'description': \"Parental feeding practices: Parental feeding practices are evaluated through a self-reported questionnaire, Food Parenting Practices Questionnaire, with three subscales (Child's Intake Self-regulation Practices, Food Availability and Accessibility Practices, and Ineffective Control Practices) developed and adapted to the Portuguese population within this study. Parents answer to 40 items on a 5-point Likert scale (from Totally false to Totally true). Higher values on each subscale indicate a more frequent use of this type of parental feeding practices. The total mean score of each subscale ranged from 1 to 5.\", 'timeFrame': 'Baseline, immediately after the intervention, 3 months after the intervention, 6 months after the intervention'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha level of 0.05, power of 0.80, a moderate correlation pattern between time measurements of 0.35, and a dropout rate of 50% were assumed.", "answer": 260, "answer_type": "ESTIMATED", "explanation": "Power and sample size\n Statistical power analysis was performed for sample size estimation based on published data regarding this topic using G*Power 3.1.9.2. For our repeated measures within-between group comparison study, we used Cohen\u00e2\u0080\u0099s f criteria and considered a small effect size of 0.15 [8, 31], an alpha equal to 0.05, and power of 0.80 for a two-group with four repeated measures design (with a moderate correlation pattern between time measurements of 0.35). The sample size needed is approximately 130 participants (i.e., 65 parents in each of the two-arm groups), but the total sample size was adjusted to account for a dropout rate of 50% [32, 33]. Therefore, the sample will be collected until 130 participants in each group (N = 260) enroll in the study. Our proposed sample size will also be adequate for multilevel modeling with level 1 repeated measures nested within level 2 individuals, by assuring a minimum of 50 individuals required for level 2 [34].", "id": 904, "split": "val"} +{"trial_id": "NCT04593810", "pmid": "35461264", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Automated Closed-Loop Ventilation Versus Conventional Ventilation on Duration and Quality of Ventilation ('ACTiVE') - a Randomized Clinical Trial in Intensive Care Unit Patients\n\nIncluded conditions:\n- Ventilator-free Days\n- Quality of Breathing\n\nStudy Armgroups:\n- {'label': 'INTELLiVENT-ASV', 'type': 'EXPERIMENTAL', 'description': 'Use of INTELLIVENT-ASV after intubation and during all mechanical ventilation in the ICU.', 'interventionNames': ['Procedure: INTELLiVENT-ASV']}\n- {'label': 'Conventional ventilation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Use of conventional ventilation after intubation and during all mechanical ventilation in the ICU.', 'interventionNames': ['Procedure: CONVENTIONAL VENTILATION']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'INTELLiVENT-ASV', 'description': \"INTELLiVENT-ASV is activated as soon possible. The sensors for ETCO2 and SpO2 are connected and activated. Patient's gender and height are set on the ventilator and patient condition is chosen if applicable.\", 'armGroupLabels': ['INTELLiVENT-ASV']}\n- {'type': 'PROCEDURE', 'name': 'CONVENTIONAL VENTILATION', 'description': \"Conventional ventilation consists of VCV or PCV and PSV, depending on patient's activity. None of the semi or fully automated modes of ventilation is allowed at any time.\", 'armGroupLabels': ['Conventional ventilation']}\n\nPrimary Outcomes:\n- {'measure': 'Ventilator-free days and alive at day 28', 'description': 'The number of days from day 1 to day 28 the patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours', 'timeFrame': 'first 28 days after start of ventilation'}\n\nPlease estimate the sample size based on the assumption: \nBeta of 80% power, two-tailed alpha of 0.05, and a dropout rate of 5%.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We will include a total of 1200 patients. The sample size is based on the hypothesis that INTELLiVENT\u00e2\u0080\u0093ASV will shorten ventilation duration by 1.5\u00e2\u0080\u0089days with no changes in mortality rate. Based on previously performed studies in which the mean number of VFD\u00e2\u0080\u009328 was 20 \u00c2\u00b1 9\u00e2\u0080\u0089days [26, 27], a sample of 1200 patients (600 in each treatment group) is needed to have beta of 80% power and a two-tailed alpha of 0.05, to detect a mean between-group difference of 1.5 VFD\u00e2\u0080\u009328, allowing a dropout rate of 5%.", "id": 905, "split": "val"} +{"trial_id": "NCT04594980", "pmid": "33674366", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Open-Label Randomized Controlled Study of the Efficacy of Surgical Treatment in Patients With Single Level Lumbar Spinal Stenosis Using Minimally Invasive Decompression and Fusion and Traditional Open\n\nIncluded conditions:\n- Lumbar Spinal Stenosis\n- Intervertebral Disc Degeneration\n\nStudy Armgroups:\n- {'label': 'Minimally invasive TLIF', 'type': 'OTHER', 'description': 'Patients will undergo a single level decompression and fusion using a minimally invasive technique. Followed posterior screw fixation is mandatory.', 'interventionNames': ['Procedure: lumbar fusion']}\n- {'label': 'Open TLIF', 'type': 'OTHER', 'description': 'Patients will undergo a single level decompression and fusion using an open traditional technique. Followed posterior screw fixation is mandatory.', 'interventionNames': ['Procedure: lumbar fusion']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'lumbar fusion', 'description': 'Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.', 'armGroupLabels': ['Minimally invasive TLIF', 'Open TLIF']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in Oswestry Disability Index (ODI)', 'description': 'To observe the change of ODI as compared to baseline through follow-up terms. min - 0, - the best result, patient is active; max - 50 - the worst result, patient is not physically active', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided Mann-Whitney U test, significance level p=0.05, power 80%, 20% dropout rate", "answer": 96, "answer_type": "ACTUAL", "explanation": "Sample size\n Under non-inferiority design, the sample size was calculated for ODI difference between the values before intervention and 3 months after. Assuming mean of ODI difference is 39 and SD of ODI difference is 19.3 in both groups (based on our own published data (18.8 at 1-year follow-up,27 19.3 at 3-month follow-up28), the non-inferiority margin \u00ce\u00b4=12, for a one-sided Mann-Whitney U test with a critical significance p=0.05\u00e2\u0080\u0089and test power is 80%, it is enough to allocate 38 patients. Considering the 20% loss, the total sample size will be 96 patients, 48 in each group.\n The exact number of patients might be adjusted based on actual dropout rate achieved by the time of interim analysis.", "id": 906, "split": "val"} +{"trial_id": "NCT04595097", "pmid": "34551948", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Adjunctive Inspiratory Muscle Training for Patients With COVID-19\n\nIncluded conditions:\n- Covid19\n- Exercise\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': \"The training volume will be 24 sessions. Training frequency will be 3 sessions per week. Duration of training sessions will be around 60min. Patients will perform endurance training or interval training at moderate to high intensities. IMT in both groups will be performed using the PowerBreathe KHP2 device (POWERbreatheKHP2, HaB, International, Southam, UK). Training intensity in the intervention group will be set initially at a load of 50% of patients' maximal inspiratory mouth pressure (MIP). This initial load will be continuously and gradually increased to the highest tolerable intensity during each of the supervised sessions.\", 'interventionNames': ['Device: inspiratory muscle traiing']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The training volume will be 24 sessions. Training frequency will be 3 sessions per week. Duration of training sessions will be around 60min. Patients will perform endurance training or interval training at moderate to high intensities. Sham IMT will be performed using the PowerBreathe KHP2 device (POWERbreatheKHP2, HaB, International, Southam, UK). Training intensity in the control group will be set at 10% baseline PImax and will be not modified throughout the intervention period.', 'interventionNames': ['Device: inspiratory muscle traiing']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'inspiratory muscle traiing', 'description': 'The patients are encouraged to inhale against a load to increase the inspiratory muscle strength and endurance', 'armGroupLabels': ['Control group', 'Intervention Group'], 'otherNames': ['tapered flow resistive loading']}\n\nPrimary Outcomes:\n- {'measure': 'Cardiopulmonary Exercise Testing Measurements', 'description': 'Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.The ventilatory anaerobic threshold (VAT) will be determined by the V-slope method.', 'timeFrame': 'change from baseline in Peak VO2, VE/VCO2 slope and VAT at 8 weeks and 6 months'}\n\nPlease estimate the sample size based on the assumption: \nAn \u03b1 error probability of 0.05, power (1-\u03b2 error probability) of 0.80, and a dropout rate of 15%.", "answer": 138, "answer_type": "ACTUAL", "explanation": "Sample size\n Due to the lack of data on the effect of supervised IMT in a PR in patients with post-COVID-19, we performed a power analysis based on a previous meta-analysis of peak VO2 (in mL/kg/min) in patients with idiopathic pulmonary fibrosis.18 We used the software GPower to calculate sample size with a priori analysis with an intergroup difference of 1.46\u00e2\u0080\u0089mL/kg/min, an SD of 3.5\u00e2\u0080\u0089mL/kg/min, an \u00ce\u00b1 error probability of 0.05 and power (1-\u00ce\u00b2 error probability) of 0.80. Based on the results, it was decided that 138 patients will be divided into two groups, with a dropout rate of 15%.", "id": 907, "split": "val"} +{"trial_id": "NCT04596566", "pmid": "35046093", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Can Personalized Diet Therapy Favourably Impact Disease Severity in Patients With Crohn's Disease\n\nIncluded conditions:\n- Crohn Disease\n\nStudy Armgroups:\n- {'label': 'CD-TDI', 'type': 'OTHER', 'description': 'Therapeutic diet Intervention ( CD-TDI )Group : Patients receiving CD-TDI will be offered patient-centered counseling for 12 weeks by a Registered Dietitian (RD) trained in the CD-TDI protocol with the goals of (a) identification and treatment of malnutrition if present, (b) targeted treatment of macro- and micronutrient deficiencies using whole foods;(c) increasing adherence to CD-TDI (d) multivitamin adherence and (e) reduced exposure to dietary antigens (e.g., maltodextrin, carrageenan, other food additives). They will receive a5 face-to-face appointment every 3 weeks with the study RD, and all other weekly appointments, which are 8 in number will be completed by phone.', 'interventionNames': ['Other: Therapeutic diet Intervention']}\n- {'label': 'Conventional management', 'type': 'NO_INTERVENTION', 'description': 'Conventional Management (Control) Group: CM patients will meet with the RD at baseline, week 7 and week 13 to complete their 24HR food recall twice on different days of the week, followed by a phone few days after the visit to complete the second part of the recall. They will be advised to follow their habitual diet and will be offered the dietary intervention at 14 weeks if they are still experiencing a disease flare'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Therapeutic diet Intervention', 'description': 'The CD-TDI will incorporate global principles of the Mediterranean Diet (MD) refined to inform specific food choices based on our pilot data results and published literature reported mechanisms of mitigating inflammation in IBD. Patient compliance will be measured in three ways: 1) Mediterranean diet score checklists completed every 3 weeks at the face-to-face visits; 2) goal attainment scores captured weekly to identify the goals set, and the goals attained 47; and 3) fatty acids profiled from red blood cells to identify if fat intake reflects CD-TDI fat recommendations: 35% total calories from fat, 15% from MUFA, 13% from SFA and 6% from PUFA with a 8 n6:n:3 ratio of 8:1', 'armGroupLabels': ['CD-TDI']}\n\nPrimary Outcomes:\n- {'measure': 'Fecal calprotectin: Change is being assessed.', 'description': '\\\\<250 ug/mg with at least 100ug/g decline from baseline. FCP is a test used to detect inflammation in the colon and is associated with disease activity and severity.', 'timeFrame': 'baseline, 7 and 13 weeks.'}\n- {'measure': 'Harvey Bradshaw Index (HBI): Change is being assessed', 'description': 'HBI is a validated, non-invasive measure of disease activity captured through a symptom questionnaire and is a surrogate to endoscopic assessment to determine disease severity. HBI minimum value is \"0\" and maximum no limit. HBI \\\\< 5 is used in this study to indicate clinical remission. HBI\\\\> 16 means severe disease activity. Higher scores means worse outcomes. Based on experience with past recruitment for clinical trials, endoscopic assessment is not feasible due to access and patient acceptance.', 'timeFrame': 'baseline, 7 and 13 weeks.'}\n- {'measure': 'Bowel wall thickness on sonographic findings and Fecal calprotectin: Change is being assessed.', 'description': 'For asymptomatic patients with active disease at the time of recruitment (HBI \\\\<5 ) a combined primary endpoint using both FCP \\\\<250 ug/mg with at least 100ug/g decline from baseline and ultrasound findings of bowel wall thickening will be used.( \u2264 3mm).', 'timeFrame': 'baseline, 7 and 13 weeks for fecal calprotectin and baseline and week 13 for sonographic findings'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level of 0.05, power of 0.80, 2:1 allocation ratio (CD-TDI to CM), 10% dropout rate", "answer": 102, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on the primary outcome of symptomatic (clinical) and objective (biochemical) remission. We estimated the effect size estimates in the control group based on corticosteroid-free remission rates in the phase III CALM trial, wherein 23.8% (29/122) of patients in the conventional therapy arm achieved remission at week 11.39 Assuming a control group remission rate of 25%, an alpha level of 0.05, power of 0.80 and 2:1 allocation ratio (CD-TDI to CM), a sample size of 93 patients (62 and 31 patients randomised to CD-TDI and CM, respectively) would be sufficient to detect a remission rate 55% in the intervention arm. Estimates of the remission rate in the CD-TDI arm are based on a previous prospective trial of a similar dietary intervention in paediatric patients with mild-to-moderate CD.15 In this trial, 76% (28/37) of patients achieved clinical remission at week 12. Given that adding biochemical measures is likely to reduce the remission rate compared with symptoms alone and because paediatric patients may be more responsive to dietary interventions compared with adults, we used a more conservative estimate of remission in the CD-TDI arm of 55% for the power calculations. Assuming a 10% drop out rate, an estimated 102 patients must be randomised.", "id": 908, "split": "val"} +{"trial_id": "NCT04597840", "pmid": "36008058", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Multicenter, Prospective, Longitudinal and Randomized Comparison of Both the Clinical and Economic Impact of Biosynthetic Absorbable Mesh to the Surgical Standard of Care in Contaminated Incisional Hernia Repair\n\nIncluded conditions:\n- Ventral Hernia Repair\n\nStudy Armgroups:\n- {'label': 'biosynthetic mesh group', 'type': 'EXPERIMENTAL', 'description': 'Patient will undergo incisional hernia repair with biosynthetic mesh reinforcement. Based on the discretion of the surgeon, two types of biosynthetic mesh from different brand can be used: the Phasix mesh from BARD or the BioA mesh from GORE. These two biosynthetic meshes are resorbable, which means they are gradually absorbed by the body.', 'interventionNames': ['Procedure: Incisional hernia repair with reinforcement of biosynthetic mesh']}\n- {'label': 'standard of repair group', 'type': 'OTHER', 'description': 'Patient will undergo incisional hernia repair according to the standard of repair, which is simple suture or mesh reinforcement (using synthetic or biological meshes).', 'interventionNames': ['Procedure: Incisional hernia repair with simple suture or synthetic mesh reinforcement.']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Incisional hernia repair with reinforcement of biosynthetic mesh', 'description': 'The biosynthetic mesh (Phasix or Bio-A meshes) will be placed as a sublay in the retromuscular position to reinforce midline fascial closure. All the surgical procedure (including placement and fixation of the mesh) will be performed according to a standardized protocol.', 'armGroupLabels': ['biosynthetic mesh group']}\n- {'type': 'PROCEDURE', 'name': 'Incisional hernia repair with simple suture or synthetic mesh reinforcement.', 'description': 'Based on the discretion of the surgeon, the incisional hernia repair will be done by simple suture or by synthetic mesh reinforcement. All the surgical procedure (including placement and fixation of the mesh if applicable) will be performed according to a standardized protocol.', 'armGroupLabels': ['standard of repair group']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of incisional hernia recurrence', 'description': 'The rate of incisional hernia recurrence will be evaluated by radiologic imaging.', 'timeFrame': '3 years after surgery'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-sided alpha risk of 5%, and an increase of 15% to account for possible patients lost to follow-up and premature withdrawal.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to studies, the proportion of recurrent hernias at 3 years after being masked in a contaminated environment (grade III of the VHWG) treated according to the recommended technique reaches 75%.26\n The COBRA study reported a clinical recurrence rate at 2 years of 17% with the use of slowly absorbable mesh in a contaminated environment.27 This study was not comparative, and the relatively low rate of recurrence was possibly underestimated by the clinical definition of recurrence. Indeed, asymptomatic recurrences were not diagnosed.\n It was considered that 75% of patients would present with recurrent IH at 3 years in the control group. An absolute difference of 30% between the experimental group and the control group was expected. Under these assumptions, the inclusion of 47 patients in each group, for a total of 94 patients, would reveal a statistically significant difference between the two groups with a power of 80%. Numbers were calculated using Fisher\u00e2\u0080\u0099s exact test and a two-sided alpha risk of 5%.28 To take into account possible patients lost to follow-up and premature withdrawal, the number of patients needed would be increased by 15% to reach a total of 108 patients included (54 patients per group).", "id": 909, "split": "val"} +{"trial_id": "NCT04598633", "pmid": "35477563", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Influence of Probiotics on Clinical Parameters, the Oral Microbiome and the Immune System During an Orthodontic Treatment: a Prospective, Double-blind, Randomized, Clinical Study\n\nIncluded conditions:\n- Gingivitis\n- Orthodontic Appliance Complication\n\nStudy Armgroups:\n- {'label': 'Lactobacillus reuteri Prodentis\u00ae-lozenges', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Dietary Supplement: Lactobacillus reuteri Prodentis\u00ae-lozenges (DSM 17938, ATCC PTA 5289)']}\n- {'label': 'Placebo-lozenges (BioGaia)', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Dietary Supplement: Placebo-lozenges (BioGaia)']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Lactobacillus reuteri Prodentis\u00ae-lozenges (DSM 17938, ATCC PTA 5289)', 'description': 'Supplementary intake of Lactobacillus reuteri Prodentis\u00ae-lozenges (DSM 17938, ATCC PTA 5289) 2 times per day for 12 weeks', 'armGroupLabels': ['Lactobacillus reuteri Prodentis\u00ae-lozenges']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo-lozenges (BioGaia)', 'description': 'Placebo-lozenges (BioGaia) 2 times per day for 12 weeks', 'armGroupLabels': ['Placebo-lozenges (BioGaia)']}\n\nPrimary Outcomes:\n- {'measure': 'Gingival Index (GI)', 'description': 'Primary endpoint is the change of the Gingival Index (GI) from baseline to week 4. The measurement of GI is described by L\u00f6e et al, which scores the gingival condition according to the defined criteria. The scores will be measured at four sites per tooth, added and divided by four to obtain the \"GI for the tooth\"-Index. We will use the \\'GI for the tooth\\' described there, but only for those teeth with fixed ortodontic brackets. The \\'GI for the patient\\' is then the mean of the GIs for the teeth.\\n\\nCRITERIA FOR THE GINGIVAL INDEX SYSTEM\\n\\n0 = Absence of inflammation.\\n\\n1. = Mild inflammation - slight cliange in color and little change in texture.\\n2. = Moderate inflammation - modcrate glazing, redness,oedema, hypertrophy, bleeding on pressure.\\n3. = Severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration.', 'timeFrame': 'Baseline to week 4 of intake'}\n\nPlease estimate the sample size based on the assumption: \nTwo sample t-test, alpha = 0.05, Power = 0.85, one-sided test (superiority), H0: no difference between treatment and control, H1: difference in means between treatment and control is at least one SD (effect size > 1). The Wilcoxon rank-sum test (WRT) is used for significance, with an estimated power of at least 80%. A low dropout rate of 5% is assumed.", "answer": 34, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary endpoint is the change of the Gingival Index from baseline to week four. The selected studies [45, 46, 86\u00e2\u0080\u009388] were designed as randomized controlled trials (RCTs) and compared L. reuteri lozenges with control in various populations (Table 5). Effect size was calculated as follows: the change of the GI at a follow up visit and baseline was calculated. Then, the difference of this change in treatment and the control group was calculated and divided by the pooled standard deviation. Effect size varies across the studies. Notably, Iniesta et al. [88] reported no effect of lozenges compared to control. The other studies reported a significant effect [45, 46, 86, 87]. The smallest effect size of 1.00 was reported by Schlagenhauf et al. 2016 [45]. We use this worst case for the sample size estimation.Table 5Effect size of L. reuteri lozenges versus control lozenges on Gingival Index (GI)PaperEffect sizeNumber of study participantsSchlagenhauf et al. [45]1,0055Schlagenhauf et al. [46]1,3372Vivekananda et al. [86]2,7930Tekce et al. [87]1,5240Iniesta et al. [88]0,0040\n It cannot be assumed that the change in GI is normally distributed. Hence a Wilcoxon rank-sum test (WRT) is used to decide for significance. As the WRT is non-parametric, a sample size estimation for this test is not possible. Blair et al. 1980 [89] compared WRT with the t-test. The comparison showed that the power of the WRT is comparable to the power of t-test for various distributions. In the worst case, the WRT showed a power that was 5 percentage points lower than the power of the t-test. Thus, we will perform a power calculation for the t-test with 85% power and get the power of WRT of at least 80%.\n Sample size estimation is performed with the following parameters: Two sample t-test, alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, Power\u00e2\u0080\u0089=\u00e2\u0080\u00890.85, one-sided test (superiority), H0: no difference between treatment and control and H1: difference in means between treatment and control is at least one SD (effect size\u00e2\u0080\u0089>\u00e2\u0080\u00891). The sample size calculation yielded as a result 16 study participants per arm, i.e. 32 participants in total. A greater effect size will yield smaller sample sizes. Sample size was calculated with Software R [90] using the function\u00e2\u0080\u0099power.t.test\u00e2\u0080\u0099 by the CCS (A.S.). The formula for this sample size estimation is n\u00e2\u0080\u0089=\u00e2\u0080\u0089(\u00cf\u0083/\u00ce\u00b4)2 * (z1\u00e2\u0088\u0092\u00ce\u00b1\u00e2\u0080\u0089+\u00e2\u0080\u0089z1\u00e2\u0088\u0092\u00ce\u00b2)2 where \u00ce\u00b4/\u00cf\u0083 is the effect size and z1\u00e2\u0088\u0092\u00ce\u00b1 is the 1-\u00ce\u00b1-quantile of the t-distribution. We estimate that two study participants will drop out till week four. This corresponds to a low drop-out rate of 5%, in line with the selected studies [45, 46, 86\u00e2\u0080\u009388]. Therefore, 34 patients have to be recruited. The analysis of the primary endpoint is applied to the per-protocol population. Therefore, the number of cases will be 17 study participants for each study and each control group: 34 adolescents (17 study participants for the study group, 17 study participants for the control group) and 34 adults (17 study participants for the study group, 17 study participants for the control group).", "id": 910, "split": "val"} +{"trial_id": "NCT04600063", "pmid": "34530885", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Phase II Study of Isolation Procedure Versus Conventional Procedure in Distal Pancreatosplenectomy for Pancreatic Cancer\n\nIncluded conditions:\n- Resectable Pancreatic Body/Tail Carcinoma\n\nStudy Armgroups:\n- {'label': 'Conventional procedure', 'type': 'OTHER', 'description': 'In the conventional procedure group, first, the pancreatic body and tail and spleen are mobilized (mandatory procedure), and the regional lymph nodes of the body and tail of the pancreas, such as the hepatoduodenal mesentery (No12 lymph node) and the common hepatic artery perimeter (No8), are removed. (Recommended procedure) and dissection of lymph nodes (No14p) around SMA (Recommended procedure), and after dissection of the gastro-splenic ligament and pancreas, transection of the splenic vein at the end of the resection procedure (required procedure) . However, in order to prevent bleeding and secure a safe field of view, early pancreatotomy is allowed.', 'interventionNames': ['Procedure: Isolation procedure (RAMPS procedure)', 'Procedure: Conventional procedure']}\n- {'label': 'Isolation procedure (RAMPS procedure)', 'type': 'EXPERIMENTAL', 'description': 'In the Isolation procedure group, the transection of the root of the splenic artery and the pancreatic transection are performed first, followed by the transection of the splenic vein (mandatory procedure). At that time, the branch from the splenic artery (dorsal pancreatic artery), the branch to the splenic vein (left gastric vein, inferior mesenteric vein), and short gastric arteriovenous are also disconnected as soon as possible (recommended procedure). An operation to lift up the pancreatic neck from the dorsal portal vein or superior mesenteric artery to expose the splenic vein (so-called tunneling) is allowed. After that, lymph node dissection such as hepatoduodenal mesentery (No12), common hepatic artery perimeter (No8), lymph node dissection around SMA (No14p) was performed (recommended procedure), and at the end of the resection operation, the pancreas body/tail and spleen are mobilized and removed (required procedure).', 'interventionNames': ['Procedure: Isolation procedure (RAMPS procedure)', 'Procedure: Conventional procedure']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Isolation procedure (RAMPS procedure)', 'description': 'In the Isolation procedure group, the transection of the root of the splenic artery and the pancreatic transection are performed first, followed by the transection of the splenic vein (mandatory procedure). At that time, the branch from the splenic artery (dorsal pancreatic artery), the branch to the splenic vein (left gastric vein, inferior mesenteric vein), and short gastric arteriovenous are also disconnected as soon as possible (recommended procedure). An operation to lift up the pancreatic neck from the dorsal portal vein or superior mesenteric artery to expose the splenic vein (so-called tunneling) is allowed. After that, lymph node dissection such as hepatoduodenal mesentery (No12), common hepatic artery perimeter (No8), lymph node dissection around SMA (No14p) was performed (recommended procedure), and at the end of the resection operation, the pancreas body/tail and spleen are mobilized and removed (required procedure).', 'armGroupLabels': ['Conventional procedure', 'Isolation procedure (RAMPS procedure)']}\n- {'type': 'PROCEDURE', 'name': 'Conventional procedure', 'description': 'In the conventional procedure group, first, the pancreatic body and tail and spleen are mobilized (mandatory procedure), and the regional lymph nodes of the body and tail of the pancreas, such as the hepatoduodenal mesentery (No12 lymph node) and the common hepatic artery perimeter (No8), are removed. (Recommended procedure) and dissection of lymph nodes (No14p) around SMA (Recommended procedure), and after dissection of the gastro-splenic ligament and pancreas, transection of the splenic vein at the end of the resection procedure (required procedure) . However, in order to prevent bleeding and secure a safe field of view, early pancreatotomy is allowed.', 'armGroupLabels': ['Conventional procedure', 'Isolation procedure (RAMPS procedure)']}\n\nPrimary Outcomes:\n- {'measure': '2-year recurrence-free survival', 'description': 'Until 2 years after last entry case undergo surgery', 'timeFrame': 'Up to 24 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, approximately 10% ineligible cases.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size\n Clinical trials of isolation and conventional procedures during distal pancreatectomy for pancreatic body/tail cancer have not been widely reported. A two parallel multicenter randomized selection phase II trial compared the conventional procedure with isolation procedure as a basis for a future phase III trial [18]. Its principal aim was to evaluate whether the isolation procedure has a better 2-year recurrence-free survival rate than the conventional procedure in DPS for PDAC. In an observational study, Abe et al. reported that the recurrence rate during the approximately 2-year follow-up period of the conventional procedure was 75%, whereas that of the isolation procedure was 67% [7]. In the current study, we also assume that each group will have a similar 2-year progression-free survival rate. We therefore calculated the number of patients required on the basis of a selection design so that the conventional procedure arm would select a regimen with a 2-year recurrence-free survival rate 8% higher than the expected value with 80% probability. The minimum required number of cases is 46 cases per group. Assuming that approximately 10% of ineligible cases will occur, the target number of registered cases is set to 50 per group (100 cases in total).", "id": 911, "split": "val"} +{"trial_id": "NCT04600492", "pmid": "37407055", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in CTEPH Patients After Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty\n\nIncluded conditions:\n- Hypertension, Pulmonary\n\nStudy Armgroups:\n- {'label': 'Active Comparator: Active drug group Riociguat', 'type': 'ACTIVE_COMPARATOR', 'description': 'Riociguat 0.5mg\u30011.0mg\u30012.5mg', 'interventionNames': ['Drug: Riociguat Oral Tablet']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo 0.5mg\u30011.0mg\u30012.5mg', 'interventionNames': ['Drug: Riociguat Oral Tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Riociguat Oral Tablet', 'description': 'Take any dose of Riociguat from 0.5mg to 2.5mg, or placebo', 'armGroupLabels': ['Active Comparator: Active drug group Riociguat', 'Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'Peak CI change', 'description': 'Change in Peak CI during the cardiopulmonary exercise test (CPET)', 'timeFrame': 'from baseline to 16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, two-sided significance level of 5%, and a drop-out rate of 10%.", "answer": 72, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Preliminary clinical data indicated that discontinuation of riociguat decreased resting CI, estimated by the Fick method, by 0.24\u00e2\u0080\u0089L/min/m2 in 27 inoperable CTEPH patients treated with BPA. The mean change of peak CI during CPET was \u00e2\u0088\u00920.27\u00e2\u0080\u0089L/min/m2 (SD 0.39) when estimated from the resting CI based on polynomial regression analysis. We assume that the peak CI would remain unchanged in the riociguat continuing group and is the same SD as in the riociguat discontinuing group. With a power of 80% and two-sided significance level of 5%, we calculated that 33\u00e2\u0080\u0089patients would be necessary for each group, and the total number of participants needed was 66. Assuming a drop-out rate of 10%, the expected number of cases was 36 for each group, for a total of 72 participants.", "id": 912, "split": "val"} +{"trial_id": "NCT04601311", "pmid": "39523352", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Digitally Supported Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics - a Randomised Clinical Trial\n\nIncluded conditions:\n- Type 2 Diabetes\n\nStudy Armgroups:\n- {'label': 'Guided self-determination', 'type': 'EXPERIMENTAL', 'description': '3 to 5 one-hour digital or analogue guided self-determination sessions', 'interventionNames': ['Behavioral: Guided self-determination']}\n- {'label': 'Personal support in goal-pursuing', 'type': 'ACTIVE_COMPARATOR', 'description': 'Up to five personal goal pursuing support sessions', 'interventionNames': ['Behavioral: Personal support in goal-pursuing']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Guided self-determination', 'description': \"Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'....\\n\\nThe goal is registered.\\n\\nPatients go through a guided self-determination intervention preparing themselves by completing reflection sheets, analogue or digital by patient's choice, and individually facilitated by a guided self-determination-certified nurse, face-to-face, over video or over telephone. Sessions scheduled every second week. Number of sessions 3-5 is decided at session 2.\\n\\nA relative may take part in one session completing an analogue reflection sheet as preparation.\\n\\nParticipants continue usual care.\", 'armGroupLabels': ['Guided self-determination']}\n- {'type': 'BEHAVIORAL', 'name': 'Personal support in goal-pursuing', 'description': \"Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'....\\n\\nThe goal is registered.\\n\\nPatients receive personal goal pursuing support up to five sessions, lasting up to one hour with a communication trained healthcare professional following up on the goal, face-to-face, digitally, or over telephone. The sessions are scheduled every second week. A relative may take part in one session.\\n\\nParticipants continue usual care.\", 'armGroupLabels': ['Personal support in goal-pursuing']}\n\nPrimary Outcomes:\n- {'measure': 'diabetes distress', 'description': 'Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID)', 'timeFrame': 'The Problem area in diabetes (PAID) will be measured at 12-months follow-up. A higher score on the scale (0-100) indicate higher diabetes distress'}\n\nPlease estimate the sample size based on the assumption: \nThe trial assumes a power of 80% (beta at 20%) and a significance level (alpha) of 5%, two-tailed.", "answer": 224, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This randomised clinical trial is designed to evaluate superiority when comparing the intervention group and the attention control group. The sample size calculation was based on our primary outcome and an estimated minimal clinical important difference from the mean of six points and standard deviation (SD) of 16 points from our systematic review conducted prior to initiating this OVERCOME trial [7, 18].\n With a power of 80% (a beta at 20%) and an alpha at 5%, two-tailed, a sample size of 112 participants is needed in each intervention group corresponding to a total of 224 participants included in the trial.", "id": 913, "split": "val"} +{"trial_id": "NCT04601311", "pmid": "34949603", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Digitally Supported Guided Self-determination Intervention Versus Attention Control for People With Type 2 Diabetes in Outpatient Clinics - a Randomised Clinical Trial\n\nIncluded conditions:\n- Type 2 Diabetes\n\nStudy Armgroups:\n- {'label': 'Guided self-determination', 'type': 'EXPERIMENTAL', 'description': '3 to 5 one-hour digital or analogue guided self-determination sessions', 'interventionNames': ['Behavioral: Guided self-determination']}\n- {'label': 'Personal support in goal-pursuing', 'type': 'ACTIVE_COMPARATOR', 'description': 'Up to five personal goal pursuing support sessions', 'interventionNames': ['Behavioral: Personal support in goal-pursuing']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Guided self-determination', 'description': \"Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'....\\n\\nThe goal is registered.\\n\\nPatients go through a guided self-determination intervention preparing themselves by completing reflection sheets, analogue or digital by patient's choice, and individually facilitated by a guided self-determination-certified nurse, face-to-face, over video or over telephone. Sessions scheduled every second week. Number of sessions 3-5 is decided at session 2.\\n\\nA relative may take part in one session completing an analogue reflection sheet as preparation.\\n\\nParticipants continue usual care.\", 'armGroupLabels': ['Guided self-determination']}\n- {'type': 'BEHAVIORAL', 'name': 'Personal support in goal-pursuing', 'description': \"Before randomisation, the participants are supported in formulating one personal value-clarifying goal: 'One thing I want to achieve in my life with diabetes within a year is'....\\n\\nThe goal is registered.\\n\\nPatients receive personal goal pursuing support up to five sessions, lasting up to one hour with a communication trained healthcare professional following up on the goal, face-to-face, digitally, or over telephone. The sessions are scheduled every second week. A relative may take part in one session.\\n\\nParticipants continue usual care.\", 'armGroupLabels': ['Personal support in goal-pursuing']}\n\nPrimary Outcomes:\n- {'measure': 'diabetes distress', 'description': 'Assessed by the validated 20-item scale of diabetes-related distress burden, Problem Areas in Diabetes (PAID)', 'timeFrame': 'The Problem area in diabetes (PAID) will be measured at 12-months follow-up. A higher score on the scale (0-100) indicate higher diabetes distress'}\n\nPlease estimate the sample size based on the assumption: \nEstimated mean and SD from trials, SD of 16, power of 80% (beta at 20%), significance level (alpha) at 5%, two-tailed.", "answer": 224, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was determined by a predicted difference in the primary outcome measure, PAID, between the experimental and control group. We could not identify any previous studies quantising the minimal important difference of PAID. Informed by the estimated mean and SD from the trials included in our systematic review25 (results not yet published), we pragmatically chose six PAID points as the minimal important difference. It must be noted that the minimal important difference should preferably be based on low risk of bias trials, as high risk of bias trials may overestimate the effect.26 Unfortunately, it was only possible to identify trials at high risk of bias in our systematic review.25 In another review conducted by our research group,22 we did, however, identify trials at low risk of bias investigating the effect of psychosocial interventions (not GSD). We found that estimates from these trials at low risk of bias47 roughly corresponded to the minimal important difference and SDs chosen for our sample size calculation. Consistent with these trials that used PAID as an outcome measure, we expect a SD of 16. With a power of 80% (a beta at 20%) and an \u00ce\u00b1 at 5%, two-tailed, a sample size of 112 participants is needed in each intervention group corresponding to a total of 224 participants included in the trial.", "id": 914, "split": "val"} +{"trial_id": "NCT04602585", "pmid": "35905117", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Psycho-education on Clinical Outcomes Among Patients With a First Episode Psychosis in Central Uganda - A Pilot Randomized Control Trial\n\nIncluded conditions:\n- Psychosis\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': \"After discharge, the program manager will link the participants with a VHT nearest to them. The participants (randomized to the intervention arm) will be informed during the consent procedure that they will undergo 6 psycho-education sessions (1 per month) together with a family member at the participant's residence. The VHTs and participants will meet and schedule appointments for the next engagements. This shall be done on a case by case basis. Some psycho-education sessions could take place in the patient's residence, others in the nearest public space (school or church or mosque compounds). The investigators will document where the majority of these sessions happen. This will help the investigators document feasibility. The PI and RAs will sit in some of the sessions during the pilot phase of data collection to ensure fidelity to the manual.\", 'interventionNames': ['Behavioral: Psycho-education']}\n- {'label': 'Usual care arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will receive usual care', 'interventionNames': ['Behavioral: Psycho-education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Psycho-education', 'description': 'Participants will receive 6 psycho-education sessions as adjunct therapy to the use of antipsychotics', 'armGroupLabels': ['Experimental', 'Usual care arm']}\n\nPrimary Outcomes:\n- {'measure': 'Reduction in symptom severity', 'description': 'The investigators will measure a reduction in symptom severity as measured by the PANSS or YMRS', 'timeFrame': '6 Months'}\n\nPlease estimate the sample size based on the assumption: \nNo formal sample size and power calculation conducted; recruitment feasibility assessed by recruiting 70% of potentially eligible participants over 20 weeks and retaining 80% of recruited participants.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Being a study assessing feasibility of recruitment as a primary outcome, we have not conduced a formal sample size and power calculation. Rather, we have considered that recruiting 70% of potentially eligible participants over a 20-week period and retaining 80% of recruited participants will provide us with adequate data that will be needed in recruiting participants for a powered RCT.\n In 2018 [41], a total of 43,870 individuals accessed care at the hospital, 60% (26,322) of them were diagnosed with psychotic disorders, approximately 20% (5,264) of the 26,322 patients with psychosis presented for the first time (potential cases of FEP). Thus, the number of participants who are eligible for recruitment is approximate 440 per month. Close to 20% of the Ugandan population lives within the central districts from where we intend to recruit participants\u00e2\u0080\u0094we anticipate having 88 patients (with psychosis) eligible for recruitment per week. However, a significant proportion of patients present with a psychosis resulting from substance use. We anticipate that approximately 40% of the 88 patients would be eligible as per criteria described below. Thus, we will have approximately 32 participants eligible for recruitment per week with a recruitment target of 24 of the 32 participants per week. We will document what proportion of this figure is attained.\n With a sample size of 80 participants, we will be able to conduct preliminary analyses to detect modest significant differences (5% increase in mean scores) in illness self-management and adherence as well as a 5% reduction in mean stigma and symptom severity. We will use this data to generate an effect size that can be used in a sample size estimation of a powered RCT.", "id": 915, "split": "val"} +{"trial_id": "NCT04603859", "pmid": "35470194", "question": "Here is the design of a clinical trial:\n\nOfficial Title: When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)\n\nIncluded conditions:\n- Pregnancy\n- Obesity\n- Parturition\n\nStudy Armgroups:\n- {'label': 'Elective induction of labour', 'type': 'EXPERIMENTAL', 'description': 'Elective induction of labour at 39 gestational weeks and 0 to 3 days.', 'interventionNames': ['Procedure: Elective induction of labor at 39 gestational weeks and 0 to 3 days']}\n- {'label': 'Expectant management', 'type': 'NO_INTERVENTION', 'description': 'Awaiting spontaneous labor.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Elective induction of labor at 39 gestational weeks and 0 to 3 days', 'description': 'Elective induction of labor (eIOL) according to local policies', 'armGroupLabels': ['Elective induction of labour'], 'otherNames': ['eIOL']}\n\nPrimary Outcomes:\n- {'measure': 'Caesarean section', 'description': 'number (no.)', 'timeFrame': 'At delivery'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 0.05, power of at least 85%, and consideration of dropout and crossover.", "answer": 1900, "answer_type": "ESTIMATED", "explanation": "Sample size\n The power calculation was based on the assumption of a caesarean section rate in the expectant management group of 25% and in the induction of labour group of 19%. These data were based on the caesarean section rate among women with a prepregnancy BMI \u00e2\u0089\u00a530\u00e2\u0080\u0089kg/m2 who delivered at Aarhus University Hospital in 2018. On the basis of these numbers and with an alpha of 0.05, a total sample size of 854 per group would provide a power of at least 85% to detect a difference of 6% in the caesarean section rate between the two groups. Anticipating dropout and allowing crossover the sample size was increased to 950 participants in each group (1900 in total).", "id": 916, "split": "val"} +{"trial_id": "NCT04605458", "pmid": "34187835", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Contingency Management to Promote Smoking Abstinence in Cancer Patients\n\nIncluded conditions:\n- Smoking Cessation\n\nStudy Armgroups:\n- {'label': 'Contingency Management', 'type': 'EXPERIMENTAL', 'interventionNames': ['Combination Product: Contingency Management']}\n- {'label': 'Standard Care', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Combination Product: Standard Care']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Contingency Management', 'description': 'Participants will receive 3-6 counseling sessions, nicotine patches \\\\& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.', 'armGroupLabels': ['Contingency Management']}\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Standard Care', 'description': 'Participants will receive 3-6 counseling sessions, nicotine patches \\\\& lozenges, and CO breath test monitoring.', 'armGroupLabels': ['Standard Care']}\n\nPrimary Outcomes:\n- {'measure': 'Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing', 'description': 'Abstinence will be defined by 7 days by self-report of no tobacco products, confirmed by CO breath test less than or equal to 4ppm and/or urine anabasine levels less than or equal to 2 ng/ml', 'timeFrame': 'Changes between the study intake appointment to day of surgery, up to five weeks apart'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an 80% power with a type 1 error rate of 5% to detect the difference between the groups. It also accounts for a between-visit, within-participant correlation of \u03c1=0.95 and an attrition rate of 20% between surgery and follow-up visits. No correction for multiple comparisons is applied.", "answer": 282, "answer_type": "ESTIMATED", "explanation": "Power and sample size\n We will test the primary hypothesis that rates of smoking abstinence will be significantly higher at the time of surgery in the CM group as compared with the MO group. In our previous pilot trial (n=40), 52% (11/21) of those who received CM were abstinent on the day of surgery compared with 16% (3/19) of the patients in MO (\u00ce\u0094=36.6%; s\u00ce\u0094=13.3%; adjusted RR (95% CI) 3.3 (1.1 to 9.7)). It has been noted that parameter estimates from pilot trials tend to provide overly optimistic CIs around resulting estimates.60 61 Thus, we will assume a more conservative biologically confirmed 7-day PPA rate at the time of surgery of 20% in the MO group and an abstinence rate of 40% in the CM group (\u00ce\u0094=20%). Based on these estimates, we will have 80% power with a type 1 error rate of 5% to detect the difference between those receiving CM (40%) and those receiving MO (20%) with 82 participants randomised to each of the two treatment groups (total n=164). Randomisation will be done at the participant level and stratified by site and treatment length, thus we expect very modest between site variation as compared with the total variance (~ \u00cf\u0081=0.01); however, due to sampling of participants across two distinct sites, we will inflate the necessary sample size to n=141 participants per group to account for this possible loss of power. This results in a total of N=282 randomised participants across both sites to maintain adequate power to detect the clinically meaningful difference stated.\n This proposed study size will also provide sufficient power to detect important difference in abstinence rates at the 3-month and 6-month follow-up visits between groups. In the pilot study, those who received the preoperative CM intervention for smoking abstinence, 43% (9/21) were abstinent at the 3-month follow-up visit compared with 5% (1/19) of the patients in the MO group (\u00ce\u0094=37.6%; s\u00ce\u0094=12.0%; adjusted RR (95% CI) 8.6 (1.5 to 49.4)). Similar to hypothesis 1, we assume a conservative biologically confirmed 7-day PPA rate at the 3-month and 6-month follow-up visit of 10% based on pilot response data and U.S. Public Health Service guidelines for the participants randomised to receive MO and an abstinence rate of 30% in the CM group. Accounting for a between-visit (two follow-up visits), within-participant correlation of \u00cf\u0081=0.95 and an attrition rate between surgery and the follow-up visits of 20%, the randomised sample of 282 participants will provide greater than 80% power to detect the stated difference in abstinence rates at the 3-month and 6 month follow-ups. All comparisons are powered using a two-sided type 1 error rate of 5% and no correction for multiple comparisons is applied to sample size estimates.", "id": 917, "split": "val"} +{"trial_id": "NCT04606680", "pmid": "33545941", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparative Effectiveness of Herb-partitioned Moxibustion Plus Lifestyle Modification Treatment for Patients With Simple Obesity: A Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Obesity\n\nStudy Armgroups:\n- {'label': 'Heat application group', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive heat application at acupoints plus lifestyle modification. Participants will receive heat application treatment once every other day, 3 times per week, for 4 consecutive weeks.', 'interventionNames': ['Device: Heat application at acupoints']}\n- {'label': 'Medicated plaster group', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive medicated plaster at acupoints plus lifestyle modification. Participants will receive medicated plaster at acupoints and lifestyle modification every once every other day, 3 times per week, for 4 consecutive weeks.', 'interventionNames': ['Device: Medicated plaster at acupoints']}\n- {'label': 'Herb-partitioned moxibustion group', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive herb-partitioned moxibustion at acupoints plus lifestyle modification. Participants will receive herb-partitioned moxibustion at acupoints and lifestyle modification every once every other day, 3 times per week, for 4 consecutive weeks.', 'interventionNames': ['Device: Herb-partitioned moxibustion at acupoints']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Heat application at acupoints', 'description': \"1. The acupoints will be selected as Tianshu, Pishu, shenshu, zhongwan, and zusanli. The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard. The hot sticker will be placed on the patient's acupoints for about 2 hours. This treatment will be applied once every other day, 3 times per week, for 4 consecutive weeks. The treatment will be delayed during the menstrual period.\\n2. The following lifestyle modification are recommended to help to establish healthy habits:\\n\\nThe proportion of three nutrients in total calories comprises of 55%-65% from carbohydrates, 20%-30% from oils and 15% from protein, and the energy of the whole day distributed to three meals will follow the proportion of 30% for breakfast, 40% for lunch and 30% for dinner. Meanwhile, low-to-moderate intensity physical activities will be instructed to them for at least 5 days per week continually, 30%-50% of the maximum heart rate reserve value will be required.\", 'armGroupLabels': ['Heat application group']}\n- {'type': 'DEVICE', 'name': 'Medicated plaster at acupoints', 'description': \"1. The acupoints will be selected as Tianshu, Pishu, shenshu, zhongwan, and zusanli. The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard.The chinese traditional medicine(aconite root, dried ginger, evodia rutaecarpa, clove, cinnamon, etc)in moderation will be grinded into powder\uff0cand the powder will be added with a certain amount of flour, and finally they will be blended with ginger juice to the appearance of mud. Next, 10g of the kneaded medicine mud will be taked and applied to the bottom of the ordinary sticker. They will be placed on the patient's acupoints for about 2 hours. The sticker has the same shape as the hot sticker, but it does not have the effect of thermal stimulation and infrared radiation. This treatment will be applied once every other day, 3 times per week, for 4 consecutive weeks. The treatment will be delayed during the menstrual period.\\n2. Lifestyle modification:It will be performed as the same as the heat application group.\", 'armGroupLabels': ['Medicated plaster group']}\n- {'type': 'DEVICE', 'name': 'Herb-partitioned moxibustion at acupoints', 'description': \"1. The acupoints will be selected as Tianshu, Pishu, shenshu, zhongwan, and zusanli. The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard\\\\[18\\\\]. The chinese traditional medicine(aconite root, dried ginger, evodia rutaecarpa, clove, cinnamon, etc)in moderation will be grinded into powder\uff0cand the powder will be added with a certain amount of flour, and finally they will be blended with ginger juice to the appearance of mud. Next, 10g of the kneaded medicine mud will be taked and applied to the bottom of the hot sticker. They will be placed on the patient's acupoints for about 2 hours. This treatment will be applied once every other day, 3 times per week, for 4 consecutive weeks. The treatment will be delayed during the menstrual period.\\n2. Lifestyle modification:It will be performed as the same as the heat application group.\", 'armGroupLabels': ['Herb-partitioned moxibustion group']}\n\nPrimary Outcomes:\n- {'measure': 'the clinical effectiveness', 'description': 'The clinical effectiveness of 4 weeks of (A)Heat application group, (B)Medicated plaster group, and (C)Herb-partitioned moxibustion group for the improvement of simple obesity will be assessed and determined by the clinical evaluation of nimodipine:\\n\\n1. Healing: The clinical symptoms disappear or almost disappear, and the syndrome score is reduced by \u226585 percent;\\n2. Significant effect: The clinical symptoms are obviously improved, and the syndrome score is reduced by \\\\<85 percent, but \u226550 percent;\\n3. Effective: The clinical symptoms have improved, syndrome scores decreased by\\\\<50 percent, but \u226530 percent;\\n4. Invalid: The clinical symptoms were not improved, even worse, and the syndrome score was reduced by\\\\<30 percent.\\n\\nIntegral variation formula(Nimodipine method: \\\\[(pre-treatment score-post-treatment score)/pre-treatment score\\\\]X100 percent.', 'timeFrame': 'week 4.'}\n\nPlease estimate the sample size based on the assumption: \n80% power to detect a significant difference with a significance level of 0.025 (1 sided) and a 10% withdrawal rate.", "answer": 108, "answer_type": "ESTIMATED", "explanation": "2.11\n Sample size calculation\n In a previous study, the effective rate of simple obesity in the herb-partitioned moxibustion group was P1\u00e2\u0080\u008a=\u00e2\u0080\u008a.80. The effective rate of the heat application group was P2\u00e2\u0080\u008a=\u00e2\u0080\u008a.65, and the effective rate of the medicated plaster group was P3\u00e2\u0080\u008a=\u00e2\u0080\u008a.6. PASS V.11 software (NCSS, Kaysville, UT) was used to calculate that, based on 80% power to detect a significant difference(\u00ce\u00b1\u00e2\u0080\u008a=\u00e2\u0080\u008a0.025, 1 sided), 33 participants will be required for each group. Allowing for a 10% withdrawal rate, we plan to include a total of 108 participants with 36 participants in each group.", "id": 918, "split": "val"} +{"trial_id": "NCT04607993", "pmid": "34922610", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Study on the Effectiveness and Feasibility of Prone Position Ventilation Technique for Postoperative Acute Lung Injury in Infants With Congenital Heart Disease\n\nIncluded conditions:\n- Investigative Techniques\n\nStudy Armgroups:\n- {'label': 'Prone position ventilation technique', 'type': 'EXPERIMENTAL', 'description': 'Prone position ventilation for children with congenital heart disease after surgery', 'interventionNames': ['Behavioral: Prone position ventilation technique']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'conventional postoperative position, no prone position ventilation'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Prone position ventilation technique', 'description': '1. Inform the children\\'s family members of the purpose and method of prone position ventilation\\n2. Assess the fixation of various catheters\\n3. Suspend feeding before placing prone position\\n4. Confirm the time to start prone position ventilation under the joint assessment of medical staff\\n5. Place the child in a prone position with the participation of researchers, doctors and nursing staff, with the child\\'s head tilted to one side to avoid damage to the eyes and nose due to compression, and the arms are bent upward to form a \"W\" . Bend both lower limbs downward to form an \"M\" shape, and use a soft pillow cushion to measure the knee joints to avoid compression\\n6. The whole process ensures the smooth fixation of tracheal intubation and various catheters\\n7. Proper sedation during prone position ventilation to achieve good human-machine synchronization\\n8. At least 6-8 hours in prone position every day', 'armGroupLabels': ['Prone position ventilation technique']}\n\nPrimary Outcomes:\n- {'measure': 'Oxygenation index', 'description': 'Oxygenation index refers to a goal in respiratory therapy,OI(mmHg)=PaO2/FiO2 It is a continuous variable.', 'timeFrame': 'at 6th hours after enrollment'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) is 0.05, power (\u03b2) is 0.2, and an attrition rate of 10% is considered.", "answer": 68, "answer_type": "ACTUAL", "explanation": "Sample size/power calculation\n According to pre-experimental investigations, the average oxygenation index required by the experimental group of children is 276, with a standard deviation of 68, and the control group has an average oxygenation index of 228, with a standard deviation of 67. Comparing the two independent sample means, \u00ce\u00b1 = 0.05, \u00ce\u00b2 = 0.2, the Gpower sample calculation software showed an effect size of 0.71. The ratio of the test group and the control group is 1:1. An attrition rate of 10% has been factored in the sample size calculation. The calculated sample size is 34 patients per group and total sample size is 68 patients.", "id": 919, "split": "val"} +{"trial_id": "NCT04610034", "pmid": "34772747", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"Resilient Caregivers\" - A Randomized Controlled Trial of a Resilience-based Intervention for Distressed Partner Caregivers of Cancer Patients\n\nIncluded conditions:\n- Distress, Emotional\n\nStudy Armgroups:\n- {'label': '\"Resilient Caregivers\"', 'type': 'EXPERIMENTAL', 'description': 'Intervention program', 'interventionNames': ['Behavioral: \"Resilient Caregivers\"']}\n- {'label': 'Control group', 'type': 'OTHER', 'description': 'Care as usual', 'interventionNames': ['Other: Care as usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': '\"Resilient Caregivers\"', 'description': '\"Resilient Caregivers\" is a 7-session group program developed for partner caregivers of patients with cancer (6 weekly sessions and 1 booster session). Each session takes place in groups of approximately 8 participants and lasts for two-and-a-half hours. Sessions 1 to 3 focuses on the caregiver and introduces the resilience components of coping strategies, meta-reflective skill and clarification of values. Sessions 4 and 5 focuses on these components in the relationship between the caregiver and the cancer patient and social support networks respectively, while Session 6 focuses on resilience in relation to self-care and care for the partner. A booster session will be scheduled one month after the end of Session 6 in order to follow-up on the intervention and allow participants to reflect on the benefits and challenges of the program.', 'armGroupLabels': ['\"Resilient Caregivers\"']}\n- {'type': 'OTHER', 'name': 'Care as usual', 'description': 'The control arm will receive usual care, which implies no systematic support.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in symptoms of anxiety', 'description': 'Measured by Generalized Anxiety Disorder-7 (GAD-7); range 0-21; higher scores = more symptoms', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nLinear mixed model with a random subject effect, four measurements, two groups, 80% power (95% certainty between 75% and 85%), significance level of 0.05.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size and power calculations\n We calculated power simulated from a linear mixed model with a random subject effect, in a set up with four measurements (baseline and three follow-up measurements), and two groups (intervention, control) with no difference at baseline on the primary outcome of anxiety (online supplemental material 1). We plan to include 80 participants to obtain at least 80% power (95% certainty between 75% and 85%) for detecting a minimum difference of \u00e2\u0088\u00923 points between intervention and control groups at 6-month and 12-month follow-up as measured by the Generalised Anxiety Disorder scale (online supplemental material 1).37 The calculations were carried out using R package simr with an assumed significance level of 0.05.38", "id": 920, "split": "val"} +{"trial_id": "NCT04615429", "pmid": "33407777", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Double-blind, Randomized, Controlled, Clinical Trial to Assess the Efficacy of Allogenic Mesenchymal Stromal Cells in Patients With Acute Respiratory Distress Syndrome Due to COVID-19\n\nIncluded conditions:\n- Acute Respiratory Distress Syndrome\n- COVID-19 Pneumonia\n\nStudy Armgroups:\n- {'label': 'Mesenchymal Stromal cells', 'type': 'EXPERIMENTAL', 'description': 'Approximately 1x10E6 MSC/kg', 'interventionNames': ['Biological: Mesenchymal stromal cells']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Solution identical to experimental treatment, without the MSC', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Mesenchymal stromal cells', 'description': 'Administration of one single dose of allogenic Mesenchymal stromal cells', 'armGroupLabels': ['Mesenchymal Stromal cells']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Administration of placebo (solution identical to experimental treatment, without the MSC)', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration', 'description': 'Primary endpoint', 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 20, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomised (sample size)\n A total of 20 participants are planned to be randomized, 10 to each treatment group.", "id": 921, "split": "val"} +{"trial_id": "NCT04617457", "pmid": "34794396", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Open-label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy With Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas\n\nIncluded conditions:\n- Pancreatic Cancer\n- Metastasis\n- Surgery\n- Oligometastatic Disease\n\nStudy Armgroups:\n- {'label': 'NAPOX chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'NAPOX chemotherapy in 14-day cycles with the four IMPs given intravenously in the following order: nal-irinotecan, oxaliplatin, folinic acid and 5-fluouracil.', 'interventionNames': ['Drug: nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)', 'description': 'preoperative chemotherapy', 'armGroupLabels': ['NAPOX chemotherapy'], 'otherNames': ['nal-irinotecan (nal-iri)', 'oxaliplatin (ox)', '5-fluouracil (5-FU)', 'folinic acid (FA)', 'ONIVYDE TM']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival after R0/R1 resection (OS-res)', 'description': 'OS for patient after macroscopic tumor resection', 'timeFrame': 'max 24 months follow-up'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided log-rank test, power of 80%, one-sided significance level of 0.1, accrual period of 14 months, minimum follow-up of 24 months, R0/R1 resection rate of 35%", "answer": 150, "answer_type": "ESTIMATED", "explanation": "Statistical hypotheses and sample size determination\n OS after R0/R1 resection (OS-res) will be used as the primary endpoint to assess the efficacy of NAPOX in patients with oligometastatic adenocarcinoma of the pancreas.\n Hence, the hypotheses to be tested are:\nH0: median OS-res \u00e2\u0089\u00a410\u00e2\u0080\u0089monthsH1: median OS-res \u00e2\u0089\u00a514\u00e2\u0080\u0089months\n The hypothesis will be tested with a one-sided log-rank test.\n Since median OS-res of \u00e2\u0089\u00a514\u00e2\u0080\u0089months is expected, 53 patients and 42 OS-res events are required to test the null hypothesis with a power of 80% at a one-sided significance level of 0.1 (one-sample testing using log-rank test) if an accrual period of 14\u00e2\u0080\u0089months (period from FPI to resection approx. 4\u00e2\u0080\u0089months) and a minimum follow-up of 24\u00e2\u0080\u0089months after resection is assumed. The longer the follow-up duration, the higher is the power to detect a specific alternative effect size. Assuming a R0/R1 resection rate of 35%, 150 patients will be included in this clinical trial.", "id": 922, "split": "val"} +{"trial_id": "NCT04617977", "pmid": "35296490", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Interdependent Quality of Life in Parent-Child Dyads Adjusting to Eczema: Effects of a Randomized Controlled Trial of the Integrative Body-Mind-Spirit Group Intervention\n\nIncluded conditions:\n- Eczema\n- Dermatitis, Atopic\n\nStudy Armgroups:\n- {'label': 'Parent-child I-BMS intervention group', 'type': 'EXPERIMENTAL', 'description': 'Children with eczema and their parent caregivers will attend the six sessions simultaneously in a parallel group format. Parent caregivers will attend the parents group in the first 2.5 hours; while children will attend the children group in the first 2.5 hours. Both parents and children will later reunite in the joint group in the final 0.5 hours.', 'interventionNames': ['Behavioral: I-BMS for families with children suffering from eczema']}\n- {'label': 'Parent only I-BMS intervention group', 'type': 'EXPERIMENTAL', 'description': 'Only parent caregivers of children with eczema will attend the six sessions. The content of the 2.5-hour parents group will be the same as the one in Arm 1 (Parent-child I-BMS intervention group), with an additional 0.5 hour of reflective discussion among group members. The children group will simultaneously attend a group activity class in a separate room for 3 hours.', 'interventionNames': ['Behavioral: I-BMS for families with children suffering from eczema']}\n- {'label': 'Parent only health education active control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Only parent caregivers of children with eczema will attend the six sessions. Each session consists of teaching in the first 2.5 hours and Q\\\\&A in the final 0.5 hour. The children group will simultaneously attend a group activity class in a separate room for 3 hours.', 'interventionNames': ['Behavioral: Health education for parents whose children have eczema']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'I-BMS for families with children suffering from eczema', 'description': 'It is a strength-based, family system approach to aid empowerment of individuals. It focuses on the interplay between physical and emotional well-being, the spiritual transformation of adverse life experiences, and the acceptance of adversity through reflection on the philosophical concepts of forgiveness and letting go. It integrates Western therapeutic techniques and Eastern philosophies to develop spiritual transformation through suffering and pain under a meaning-oriented framework. It consists of six three-hour consecutive weekly sessions: (1) awareness of body-mind connection; (2) regulation of emotion; (3) acknowledgement of the gains and losses in the caregiving or illness experience; (4) appreciation of self and others; (5) cultivation of acceptance; and (6) meaning reconstruction of caregiving or illness experience.', 'armGroupLabels': ['Parent only I-BMS intervention group', 'Parent-child I-BMS intervention group']}\n- {'type': 'BEHAVIORAL', 'name': 'Health education for parents whose children have eczema', 'description': 'It focuses on practical eczema management. It serves as a control for group effect between conditions. It consists of six three-hour sessions: (1) information about the physiology of eczema and its health impact; (2) recognition and avoidance of trigger factors and daily skin care; (3) dealing with itching and scratching; (4) stage-related treatment of symptoms and unconventional therapies; (5) general child nutrition, food allergies in eczema, and different forms of diets; and (6) self-management plan and problems in integrating into daily routine.', 'armGroupLabels': ['Parent only health education active control group']}\n\nPrimary Outcomes:\n- {'measure': 'Changes over the measurement points in the Family Dermatology Life Quality Index', 'description': 'It has 10 items. It measures how much a child with atopic dermatitis affects the quality of life of their parent caregivers. Scores range from 0 to 30, where a high score represents a greater effect on the life of the parent caregiver.', 'timeFrame': 'Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up'}\n- {'measure': \"Changes over the measurement points in the Children's Dermatology Life Quality Index\", 'description': \"It has 10 items. It measures the impact of atopic dermatitis on the lives of children. Scores range from 0 to 30, where a higher score represents a greater impact on the child's life.\", 'timeFrame': 'Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up'}\n- {'measure': 'Changes over the measurement points in the Cognitive Emotion Regulation Questionnaire - Short Version', 'description': 'It has 18 items. It measures the specific cognitive emotion regulation strategies parent caregivers have used when caring for their children. It has nine subscales, namely, self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive appraisal, acceptance and planning. Subscale scores range from 2 to 10, where a higher score represents more usage of a specific cognitive emotion strategy.', 'timeFrame': 'Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up'}\n- {'measure': 'Changes over the measurement points in the Short Version of the Cognitive Emotion Regulation Questionnaire for Spanish Kids', 'description': 'It has 18 items. It measures the specific cognitive emotion regulation strategies children have used to cope with their illness experience. It has nine subscales, namely, self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive appraisal, acceptance and planning. Subscale scores range from 2 to 10, where a higher score represents more usage of a specific cognitive emotion strategy.', 'timeFrame': 'Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up'}\n\nPlease estimate the sample size based on the assumption: \nAlpha value set to 0.05, correlation among repeated measures set at 0.5, 80% power, and 25% attrition at each assessment point.", "answer": 192, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation for each parent\u00e2\u0080\u0099s primary outcome (ie, QoL and emotional regulation) is conducted using G*Power V.3.1.9.4 \u00e2\u0080\u0098ANOVA: Repeated measures, between factors\u00e2\u0080\u0099. The alpha value is set to 0.05. Correlation among repeated measures is set at 0.5. A minimum of 108 parents will be required to detect a small effect of 0.25 among the three arms across three assessment points with 80% power. Considering 25% attrition at each assessment point, a total sample of 192 parents is needed.\n Sample size calculation for each child\u00e2\u0080\u0099s primary outcome (ie, QoL and emotional regulation) is the same as that of the parents. A minimum of 108 children will be required to detect a small effect of 0.25 among the three arms across three assessment points with 80% power. Considering 25% attrition at each assessment point, a total sample of 192 children is needed. Taken together, the final target sample consists of 192 parent\u00e2\u0080\u0093child dyads (64 dyads per arm).", "id": 923, "split": "val"} +{"trial_id": "NCT04618198", "pmid": "35667721", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Clinical Trial of Early Empiric Anti-Mycobacterium Tuberculosis Therapy for Sepsis in Sub-Saharan Africa\n\nIncluded conditions:\n- Tuberculosis\n- HIV I Infection\n- Sepsis\n\nStudy Armgroups:\n- {'label': 'Diagnosis dependent / conventional dose anti-TB therapy', 'type': 'NO_INTERVENTION', 'description': 'Standard care per admitting team including ceftriaxone x 7 days\\n\\nIf subsequent TB test positive, then WHO recommended weight-based anti-TB therapy x 28 days'}\n- {'label': 'Immediate anti-TB therapy/conventional dose anti-TB therapy', 'type': 'EXPERIMENTAL', 'description': 'Standard care per admitting team including ceftriaxone x 7 days plus immediate empiric WHO recommended weight-based dose anti-TB therapy x 28 days', 'interventionNames': ['Other: Immediate anti-TB therapy']}\n- {'label': 'Diagnosis dependent/sepsis specific dose anti-TB therapy', 'type': 'EXPERIMENTAL', 'description': 'Standard care per admitting team including ceftriaxone x 7 days\\n\\nIf subsequent TB test positive, then sepsis specific dose anti-TB therapy x 28 days', 'interventionNames': ['Other: Sepsis-specific dose anti-TB therapy']}\n- {'label': 'Immediate anti-TB therapy/sepsis specific dose anti-TB therapy', 'type': 'EXPERIMENTAL', 'description': 'Standard care per admitting team including ceftriaxone x 7 days plus immediate empiric sepsis specific dose anti-TB therapy x 28 days', 'interventionNames': ['Other: Immediate anti-TB therapy', 'Other: Sepsis-specific dose anti-TB therapy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Immediate anti-TB therapy', 'description': 'Study participants will receive immediate empiric anti-TB therapy', 'armGroupLabels': ['Immediate anti-TB therapy/conventional dose anti-TB therapy', 'Immediate anti-TB therapy/sepsis specific dose anti-TB therapy']}\n- {'type': 'OTHER', 'name': 'Sepsis-specific dose anti-TB therapy', 'description': 'Study participants will receive conventional WHO weight-based dose anti-TB therapy', 'armGroupLabels': ['Diagnosis dependent/sepsis specific dose anti-TB therapy', 'Immediate anti-TB therapy/sepsis specific dose anti-TB therapy']}\n\nPrimary Outcomes:\n- {'measure': '28-day mortality', 'description': 'number of participants with mortality', 'timeFrame': '28 days from enrollment'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size was calculated to give 80% power, with a two-sided significance level of 5%, allowing for a 20% loss to follow-up.", "answer": 436, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size calculations indicate that enrolling 109 participants per group (a total of 436 participants) yields sufficient power to meet the primary objectives of the trial, to examine the main effects of the timing of anti-TB therapy and the use of sepsis-specific dosing on 28-day mortality. To reach this goal, each of two regional sites in Moshi, Tanzania and Mbarara, Uganda will enrol 218 participants over a 3-year period, a requirement of 72\u00e2\u0080\u009373 participants per country per year. This calculation allows for 20% of participants to be discharged (alive) prior to day 28. Kaplan-Meier curves will be used to estimate the survival distribution for each of the four groups, estimating and comparing 28-day mortality based on the complementary log-log transformation.23\n The sample size was calculated to give 80% power, with a two-sided significance level of 5%, for testing each of the main effects of timing and dose on 28-day mortality, assuming a 28-day mortality of 45% in the diagnosis-dependent timing/conventional dose group (upper left cell \u00e2\u0080\u0098a\u00e2\u0080\u0099 in figure 2), 32% in each of the diagnosis-dependent timing/sepsis-specific dosing and immediate timing/conventional dose groups (off-diagonal cells \u00e2\u0080\u0098b\u00e2\u0080\u0099 and \u00e2\u0080\u0098c\u00e2\u0080\u0099 in the figure 2), and 19% in the immediate timing, sepsis-specific dose group (lower right cell \u00e2\u0080\u0098d\u00e2\u0080\u0099 in the figure 2). The calculations allow for a 20% loss to follow-up. An interaction plot for these assumed proportions is shown in figure 4.\n \n Figure 4\n \n Interaction plot of estimated effects of immediate and sepsis-specific dosing strategies in the ATLAS trial. ATLAS, A randomised clinical TriaL of early empiric Anti-Mycobacterium tuberculosis therapy for Sepsis in sub-Saharan Africa.", "id": 924, "split": "val"} +{"trial_id": "NCT04620031", "pmid": "34417990", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-Center, Randomized, Single-Blind, Propofol-Controlled Phase III Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation\n\nIncluded conditions:\n- Sedation in Intensive Care\n\nStudy Armgroups:\n- {'label': 'HSK3486', 'type': 'EXPERIMENTAL', 'description': 'HSK3486 for Sedation', 'interventionNames': ['Drug: HSK3486']}\n- {'label': 'Propofol', 'type': 'ACTIVE_COMPARATOR', 'description': 'Propofol for Sedation', 'interventionNames': ['Drug: Propofol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'HSK3486', 'description': 'Loading Dose\uff1a0.1 mg/kg, infused with 4 min \u00b1 30 s\uff1b Maintenance Dose\uff1aMaintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h. Range of maintenance dose: 0.06-0.8 mg/kg/h', 'armGroupLabels': ['HSK3486']}\n- {'type': 'DRUG', 'name': 'Propofol', 'description': 'Loading Dose\uff1a0.5 mg/kg, infused with 4 min \u00b1 30 s\\n\\nMaintenance Dose\uff1aMaintenance is started at 1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5 mg/kg/h. Range of maintenance dose:\\n\\n0.3-4 mg/kg/h', 'armGroupLabels': ['Propofol']}\n\nPrimary Outcomes:\n- {'measure': 'Success rate of sedation', 'description': '1) The time period during which the RASS is in the range of +1 to -2 accounts for \u2265 70% of the total duration of study administration and 2) Remedial treatment is not used.', 'timeFrame': 'Within 24 hours of administration'}\n\nPlease estimate the sample size based on the assumption: \nType I error (false positive) set at 0.025 (unilateral), power at 80%, and a 10% dropout rate", "answer": 135, "answer_type": "ACTUAL", "explanation": "Sample Size\n This trial is designed as a non-inferiority objective study for MV sedation within 24\u00c2\u00a0h. Assuming the ciprofol study drug and propofol (the positive control drug) will have an ICU sedation success rate of 99%, the type I error (false positive) will be set at 0.025 (unilateral) and the power at 80%. The non-inferiority margin considered to be clinically acceptable will be set at 8%, with a required sample size of 120 patients, allowing for a 10% dropout rate. Thus, a total of 135 patients who will receive mechanical ventilation will be included from July 2020 to July 2022 in our ICU, based on random assignment at a ratio of 2:1 to the ciprofol (n\u00e2\u0080\u0089=\u00e2\u0080\u008990) or propofol control (n\u00e2\u0080\u0089=\u00e2\u0080\u008945) groups.", "id": 925, "split": "val"} +{"trial_id": "NCT04621136", "pmid": "34315793", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity\n\nIncluded conditions:\n- Retinopathy of Prematurity\n\nStudy Armgroups:\n- {'label': 'Ripasudil eye drops', 'type': 'EXPERIMENTAL', 'description': 'Ripasudil eye drops', 'interventionNames': ['Drug: Ripasudil ophthalmic solution 0.4%']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ripasudil ophthalmic solution 0.4%', 'description': 'Phase1 A total of three infants will receive ripasudil eye drops(0.4%) once daily for one week, followed by twice-daily drug administration for two weeks. The three infants who participate in Phase1 can continue to receive the eye drop treatment for additional 9 weeks(12 weeks in total)if the investigators determine that there are no safety issues with ripasudil. In addition, a data and safety monitoring board(DSMB)will be held two times to decide whether the new patients can be enrolled into phase1, and also if phase2 can begin.\\n\\nPhase2:A total of 21 patients will receive ripasudil eye drops(0.4%)twice daily for 12 weeks.', 'armGroupLabels': ['Ripasudil eye drops'], 'otherNames': ['GLANATEC ophthalmic solution 0.4%']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patients with Adverse Events(AEs) and Adverse Drug Reactions(ADRs)', 'description': 'Safety Assessment', 'timeFrame': 'throughout the study duration(up to week16)'}\n\nPlease estimate the sample size based on the assumption: \nDropout rate of about 10% for medical record screening, consent acquisition rate of approximately 35%, and a dropout rate of about 15% after inclusion.", "answer": 24, "answer_type": "ACTUAL", "explanation": "Sample size\n A total of 24 patients (3 in phase I and 21 in phase II) will be enrolled in this trial. Based on the past medical records, the number of new subjects per month who were considered to be eligible for this clinical trial was eight. Assuming a dropout rate of about 10% for medical record screening, a consent acquisition rate of approximately 35% and a dropout rate of about 15% after inclusion, approximately five cases were expected to be included during the planned registration period of phase I. In phase II, the number of newly eligible patients is expected to be approximately 95 and a total of approximately 25 cases can be expected to be included during the registration period.", "id": 926, "split": "val"} +{"trial_id": "NCT04621266", "pmid": "39043588", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of a Home-based Peer Support Program for Chinese Mothers With Low Breastfeeding Self-efficacy to Increase the Exclusivity and Duration of Breastfeeding: a Randomized Controlled Trial\n\nIncluded conditions:\n- Breastfeeding\n\nStudy Armgroups:\n- {'label': 'Online Home-based peer support intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive intervention on top of standard usual care.', 'interventionNames': ['Behavioral: Online Home-based peer support']}\n- {'label': 'Standard usual care', 'type': 'NO_INTERVENTION', 'description': 'Participants will receive standard usual care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Online Home-based peer support', 'description': \"Online Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes.\", 'armGroupLabels': ['Online Home-based peer support intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Infant Feeding Status: Exclusive Breastfeeding', 'description': 'Number/ proportion of participants who practice exclusive breastfeeding at 1 months postpartum.', 'timeFrame': 'At 1 month postpartum'}\n- {'measure': 'Infant Feeding Status: Exclusive Breastfeeding', 'description': 'Number/ proportion of participants who practiced exclusive breastfeeding at 2 month postpartum.', 'timeFrame': 'At 2 months postpartum'}\n- {'measure': 'Infant Feeding Status: Exclusive Breastfeeding', 'description': 'Number/ proportion of participants that practice exclusive breastfeeding at 4 months postpartum.', 'timeFrame': 'At 4 months postpartum'}\n- {'measure': 'Infant Feeding Status: Exclusive Breastfeeding', 'description': 'Number/ proportion of participants that practice exclusive breastfeeding at 6 months postpartum.', 'timeFrame': 'At 6 months postpartum'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a significance level of 5%, and an attrition rate of 30% were used.", "answer": 442, "answer_type": "ACTUAL", "explanation": "Sample size\n The exclusive breastfeeding rate in Hong Kong was 26.3% at 6 months by the time of project initiation.24 To calculate the sample size, a power of 80% and a significant level of 5% were used. Assuming a conservative participation rate of 25% based on our pilot study.23 It is estimated that a sample size of at least 442 participants would be required (n=221 per group), allowing for an attrition rate of 30%.", "id": 927, "split": "val"} +{"trial_id": "NCT04621877", "pmid": "35998966", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Lay-Delivered Behavioral Activation in Senior Centers\n\nIncluded conditions:\n- Depression\n\nStudy Armgroups:\n- {'label': 'Volunteer-delivered Behavioral Activation - \"Do More, Feel Better\"', 'type': 'EXPERIMENTAL', 'description': '\"Do More, Feel Better\" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients.', 'interventionNames': ['Behavioral: Volunteer-delivered Behavioral Activation']}\n- {'label': \"Master's Level Clinician-delivered Behavioral Activation\", 'type': 'ACTIVE_COMPARATOR', 'description': \"Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians\", 'interventionNames': [\"Behavioral: Master's level clinician-delivered Behavioral Activation\"]}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Volunteer-delivered Behavioral Activation', 'description': 'Behavioral Activation as delivered by trained volunteers', 'armGroupLabels': ['Volunteer-delivered Behavioral Activation - \"Do More, Feel Better\"']}\n- {'type': 'BEHAVIORAL', 'name': \"Master's level clinician-delivered Behavioral Activation\", 'description': \"Behavioral Activation as delivered by trained master's level clinicians\", 'armGroupLabels': [\"Master's Level Clinician-delivered Behavioral Activation\"]}\n\nPrimary Outcomes:\n- {'measure': 'Hamilton Rating Scale for Depression (HAM-D)', 'description': 'The HAM-D will be used as measure of depressive symptom severity. The HAM-D is a clinically administered measure and has been validated in a variety of psychiatric populations.', 'timeFrame': 'Change from Baseline HAM-D at 3, 6, 9, 24, and 36 weeks after treatment starts'}\n- {'measure': 'Behavioral Activation Scale (BADS)', 'description': 'The BADS will be used as the primary target measure, and yields a total score reflecting level of engagement in reinforcing activities. The BADS has shown good psychometric properties; studies have validated the BADS as a mechanism by which behavioral activation interventions reduces depression.', 'timeFrame': 'Change from Baseline BADS at 3, 6, 9, 24, and 36 weeks after treatment starts'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions included an ICC of 5%, intercept variance of 0.80, residual variance of 0.2, a 20% attrition rate, a Type 1 one-sided error rate of 0.05, and equal numbers of clients within providers and across conditions.", "answer": 288, "answer_type": "ESTIMATED", "explanation": "Power and sample size\n \n H1 and H2\n We used Monte Carlo simulation studies to determine power and sample size.53 Data were simulated from a two-level structural equation model (repeated measures and growth factors at level 1, provider at level 2). The test statistic was the effect of intervention condition on the slopes of activity level and depression. The model was parameterised such that the slope represented the total amount of change from baseline to 9 weeks. We powered the trial to detect a non-inferiority margin for Cohen\u00e2\u0080\u0099s d effect size >0.2. We set the ICC to 5%, consistent with meta-analyses that suggest therapist effects explain 5% of the variability in psychotherapy outcomes.54 55 We set the intercept variance to 0.80 and residual variance of the repeated measures to 0.2, implying a reliability for HAM-D of 0.80, consistent with meta-analysis.56 Growth factor variances were set to levels typically observed, with the within-cluster slope variance set to 10% of the intercept variance.56 We also conservatively assumed a 20% attrition rate over the course of the study. We used a Type 1 one-sided error rate of 0.05, and equal numbers of clients within providers and across conditions. To determine sample size, we simulated 2000 data sets each across a range of possible sample sizes. Results indicated that to achieve 80% power, we would need a total sample size of 288 clients, 144 in each condition.\n \n \n H3\n Data were simulated from a parallel process growth curve model.57 To reduce model complexity (ie, keep the number of model parameters < the number of clusters), we ignored clustering at the provider level, but otherwise kept the sample size fixed at 288 and used the same parameters described for the aim 1 simulations. We varied the size of the effect across simulations to determine the minimum possible effect identifiable with 80% power. We found that we have 81% power to detect effects as small as b=0.4.", "id": 928, "split": "val"} +{"trial_id": "NCT04624477", "pmid": "34194396", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Active Surveillance or Surgery for Primary Management of Very Low Risk Papillary Thyroid Cancer: How Often Are the Long-term Disease Management Goals Achieved?\n\nIncluded conditions:\n- Papillary Thyroid Cancer\n- Papillary Thyroid Carcinoma\n- Papillary Microcarcinoma of the Thyroid\n\nStudy Armgroups:\n- {'label': 'Active Surveillance', 'description': 'Patients under active surveillance choose to not have immediate thyroid surgery. Patients are closely monitored with respect to clinical status, ultrasound imaging, biochemical indices (thyroid function, thyroglobulin, and thyroglobulin antibodies) and any thyroid cancer-related treatments (if received). Active surveillance is conducted at a participating study site. Criteria defining disease progression are established, and if such criteria are met, thyroid surgery is recommended to the patient. However, patients are free to choose to have thyroid surgery at any time, in the absence of disease progression. Thyroid cancer clinical and treatment outcomes are tracked by the study team.'}\n- {'label': 'Immediate Thyroid Surgery (total or partial thyroidectomy)', 'description': \"Patients who choose surgery, undergo thyroidectomy, as per current standards of care, by a surgeon of their choice in an institution of their choice. The treating surgeon, in discussion with the patient, will choose the extent of thyroid surgery that may be appropriate for the individual case. Post-surgical follow-up is per the discretion of the treating surgeon, endocrinologist, or other healthcare providers involved in the patient's thyroid cancer care. Thyroid cancer clinical and treatment outcomes are tracked by the study team.\"}\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': \"Number of Participants in the Active Surveillance Group who Experience 'Failure' of Active Surveillance Disease Management\", 'description': \"'Failure' of Active Surveillance Disease Management is defined as: surgery for the indication of thyroid cancer that has progressed during study monitoring. Thyroid cancer disease progression under active surveillance includes: a) thyroid cancer enlargement \\\\> 3mm in largest dimension, b) thyroid cancer growth in a location that is concerning (e.g. extension outside of the thyroid, concerning proximity to critical structures such as the trachea or recurrent laryngeal nerve), or c) development of metastatic disease (in lymph nodes or distant organs). The specific type of disease progression will be reported.\", 'timeFrame': 'Through study completion, an estimated average of 3 years'}\n- {'measure': \"Number of Participants in the Surgical Group who Experience 'Failure' of Surgical Disease Management\", 'description': \"For patients who choose immediate surgery for management of thyroid cancer, the intent of surgery is curative. Thus, 'failure' of surgical disease management is defined by receiving additional treatment for structural thyroid cancer detected at follow-up (i.e. treatment of thyroid cancer detected on imaging or biopsy during follow-up). Additional thyroid cancer treatment may include additional surgery, radioactive iodine, ethanol ablation of lymph nodes, or external beam radiation treatment. The specific treatment used for recurrent or persistent thyroid cancer and the indication for the treatment will be reported.\", 'timeFrame': 'Through study completion, an estimated average of 3 years'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size is calculated to achieve a 95% confidence interval half-width of 2% around the estimate of 3% disease management 'failure' in the AS arm, with an 80% chance that the CI half-width will be narrower than 2.1%.", "answer": 450, "answer_type": "ESTIMATED", "explanation": "Sample Size Calculation\n Statistical assumptions justifying our proposed total sample size of 450 patients (in total, including consenting patients from the original Toronto study as well as patients from all participating sites recruited in the multi-center study) are as follows, as they relate to the primary outcome analysis: i) Based on our current preliminary data from Toronto (September, 2020), the ratio of those choosing AS to those choosing surgery will be 3:1. ii) Based on published data from a prior published retrospective study of Toronto patients under the care of a primary investigator (AMS), it is expected that within an approximately 5-year time frame, approximately 3.4% of low risk papillary thyroid cancer patients in the surgical arm will receive treatment for recurrent disease (17). For purpose of sample size calculations this number is rounded down to 3%, in the time frame of about 2 to 3 years. Based on published data on active surveillance of VL-PTC, which is largely based on papillary microcarcinomas (7), we estimate that after about 2 - 3 years of follow-up, the cumulative incidence of disease progression requiring surgery in the AS arm will be approximately 3% (including both tumor growth and incident nodal metastatic disease). The sample size is guided by estimation of disease management \u00e2\u0080\u0098failure\u00e2\u0080\u0099 (absence of success) in the AS arm, as outcomes with surgery are better established. To estimate the risk of \u00e2\u0080\u0098failure\u00e2\u0080\u0099 of disease management in the AS group with an expected 95% confidence interval half-width of 2% (e.g., a confidence interval of 2% around the estimate of 3%), the required sample size is 328; there is an 80% chance the CI half-width will be narrower than 2.1%. Under the 3:1 ratio assumption above, approximately 110 surgical patients need to be recruited to obtain 328 AS patients. In order to accommodate some attrition in both groups, we plan to recruit a total of 450 patients (including patients consenting to long-term follow-up from the original Toronto study) and expect approximately 330 in AS group and 120 in the surgical group). Recruitment of surgical arm patients will enable controlled comparisons for the secondary outcomes. The sample size will be re-evaluated on a yearly basis, and the total sample size may be adjusted accordingly to maintain the desired precision in the AS arm.", "id": 929, "split": "val"} +{"trial_id": "NCT04624854", "pmid": "39587825", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD): A Prospective, Multicenter, Randomized, Controlled Trial\n\nIncluded conditions:\n- Coronary Artery Disease\n- Myocardial Ischemia\n- Acute Coronary Syndrome\n- Heart Diseases\n- Syndrome Heart Disease\n- Cardiovascular Diseases\n- Arteriosclerosis\n- Arterial Occlusive Diseases\n- Coronary Disease\n- Vascular Diseases\n\nStudy Armgroups:\n- {'label': 'Aspirin monotherapy', 'type': 'PLACEBO_COMPARATOR', 'description': 'Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.', 'interventionNames': ['Drug: Aspirin monotherapy']}\n- {'label': 'Clopidogrel and Aspirin dual-antiplatelet therapy', 'type': 'EXPERIMENTAL', 'description': 'Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.', 'interventionNames': ['Drug: Clopidogrel and Aspirin dual-antiplatelet therapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Clopidogrel and Aspirin dual-antiplatelet therapy', 'description': 'Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.', 'armGroupLabels': ['Clopidogrel and Aspirin dual-antiplatelet therapy']}\n- {'type': 'DRUG', 'name': 'Aspirin monotherapy', 'description': 'Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.', 'armGroupLabels': ['Aspirin monotherapy']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of MACCE(cardiovascular death, nonfatal myocardial infarction or nonfatal stroke).', 'description': 'To evaluate the effect of Clopidogrel and Aspirin dual-antiplatelet therapy on the incidence of MACCE in patients with MVD', 'timeFrame': 'Through study completion, an average of 2 years.'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided test at the 5% significance level, 80% power, 5% dropout rate, and 3% noncompliance rate. The enrollment duration is 24 months with a follow-up time of at least 12 months (median follow-up time of 24 months). Randomization is 1:1.", "answer": 8250, "answer_type": "ACTUAL", "explanation": "2.6\n Sample Size Calculation\n Based on data extracted from the PEGASUS\u00e2\u0080\u0090TIMI 54 study, the expected annual rate of MACCEs is estimated to be 5% in the control arm [19]. It is anticipated that prolonged DAPT treatment in patients with MVD will reduce the target relative risk by 20% (i.e., the hazard ratio [treatment/control] is equal to 0.8) and the per\u00e2\u0080\u0090year event rate by approximately 4% for the primary endpoint in those populations [20, 21]. Moreover, a two\u00e2\u0080\u0090sided test is set at the 5% significance level, and 80% power is designed to reject the null hypothesis. The enrollment duration is estimated to be 24 months, and the follow\u00e2\u0080\u0090up time is at least 12 months (with an expected median follow\u00e2\u0080\u0090up time of 24 months). The enrollment progress in both groups was consistent, and eligible patients will be randomized on a 1:1 basis according to the protocol. Considering a 5% dropout rate and an expected noncompliance (switching groups) rate in those groups will be 3%. Therefore, the DAPT\u00e2\u0080\u0090MVD trial is required to enroll at least 8250 subjects (4125 in each arm).", "id": 930, "split": "val"} +{"trial_id": "NCT04629599", "pmid": "35440458", "question": "Here is the design of a clinical trial:\n\nOfficial Title: IPT for Major Depression Following Perinatal Loss: Healing After Loss (HeAL)\n\nIncluded conditions:\n- Major Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'Interpersonal psychotherapy for major depression following perinatal loss', 'type': 'EXPERIMENTAL', 'description': \"Participants in the IPT condition will receive 12 group sessions and 2 individual (pre-group and 1-month booster) sessions as outlined in the manual The individual sessions prepare patients to use the group effectively, to keep group members focused on their treatment goals, and to maintain treatment gains. In addition, 3 of the 12 group sessions will invite women to include their partners or other support people to bolster the woman's social support system and to reduce conflicts over how to react to the loss. These sessions are important because relationship distress is common following perinatal loss. Our IPT intervention allows new women to enter the group every 4 weeks of the 12-week group. Group sessions are semi-structured, and each woman will cover the four group topics three times, approaching each topic from a different stage in the mourning process.\", 'interventionNames': ['Behavioral: Interpersonal psychotherapy for major depression following perinatal loss']}\n- {'label': 'Coping with Depression', 'type': 'ACTIVE_COMPARATOR', 'description': 'The Coping with Depression (CWD) course is a structured, manualized psycho-educational group treatment for MDD. The CWD course is based on social learning theory which posits that depression is associated with a decrease in pleasant and an increase in unpleasant person-environment interactions. The problems shown by depressed individuals are viewed as behavioral, with cognitive patterns that can be unlearned or relearned. Its effectiveness is comparable to other forms of psychotherapy in depression. The course content is cognitive-behavioral in nature and is designed to train skills that can be used in the alleviation of depression. The skill modules focus on relaxation, cognitive skills, and behavioral activation. As in the pilot trial, CWD will consist of an individual pregroup session, 12 group therapy sessions (allowing new women to enter every 4th session) and a 1-month individual booster session to provide an identical treatment dose as the experimental condition.', 'interventionNames': ['Behavioral: Coping with Depression']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Interpersonal psychotherapy for major depression following perinatal loss', 'description': \"Participants in the IPT condition will receive 12 group sessions and 2 individual (pre-group and 1-month booster) sessions as outlined in the manual The individual sessions prepare patients to use the group effectively, to keep group members focused on their treatment goals, and to maintain treatment gains. In addition, 3 of the 12 group sessions will invite women to include their partners or other support people to bolster the woman's social support system and to reduce conflicts over how to react to the loss. These sessions are important because relationship distress is common following perinatal loss. Our IPT intervention allows new women to enter the group every 4 weeks of the 12-week group. Group sessions are semi-structured, and each woman will cover the four group topics three times, approaching each topic from a different stage in the mourning process.\", 'armGroupLabels': ['Interpersonal psychotherapy for major depression following perinatal loss'], 'otherNames': ['IPT']}\n- {'type': 'BEHAVIORAL', 'name': 'Coping with Depression', 'description': 'The Coping with Depression (CWD) course is a structured, manualized psycho-educational group treatment for MDD. The CWD course is based on social learning theory which posits that depression is associated with a decrease in pleasant and an increase in unpleasant person-environment interactions. The problems shown by depressed individuals are viewed as behavioral, with cognitive patterns that can be unlearned or relearned. Its effectiveness is comparable to other forms of psychotherapy in depression. The course content is cognitive-behavioral in nature and is designed to train skills that can be used in the alleviation of depression. The skill modules focus on relaxation, cognitive skills, and behavioral activation. As in the pilot trial, CWD will consist of an individual pregroup session, 12 group therapy sessions (allowing new women to enter every 4th session) and a 1-month individual booster session to provide an identical treatment dose as the experimental condition.', 'armGroupLabels': ['Coping with Depression'], 'otherNames': ['CWD']}\n\nPrimary Outcomes:\n- {'measure': 'Time to Major Depressive Disorder recovery', 'description': 'Assessed via the Longitudinal Interview Follow-up Evaluation (LIFE; lower is better)', 'timeFrame': 'censored at 28 weeks, the proposed study duration'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a 1:1 allocation, power of 0.80, two-sided tests at p=0.05, and a missing/dropout rate of up to 25%.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size\n \n Recovery outcomes\n For the primary outcome of time to MDD recovery (censored at 28 weeks), assuming 1:1 allocation, power 0.80, two-sided tests at p=0.05, and observed estimated HR=1.79, the required number of events is 94 (number of MDEs resolved). By week 28, there were 17 events in the preliminary data (17\u00e2\u0080\u0089women had MDD resolved, 11 in the IPT condition and 6 in the CWD condition) out of 45 participants, so the rate of events was 0.38. Thus to have 94 events, total N=246 is required. Given that 90% of pilot trial participants completed at least one follow-up assessment,31 we increased the sample size to 274. Given the observed HR of 5.85 for PTSD in the pilot trial, power for PTSD recovery should be greater than 80%. Tests of mediation in aim 3 will have greater power than the primary outcome because of reduction in error variance when controlling for the mediator.\n \n \n Continuous (secondary) outcomes\n Assuming an unadjusted d=0.32\u00e2\u0080\u0089and a correlation of 0.6 between follow-up measures and 0.3 with baseline (as observed in the preliminary data), the adjusted effect size would be 0.40, and only n=200 participants would be needed before attrition. If study attrition is higher, the study still has >80% power for secondary outcomes (table 3).\n \n Table 3\n \n Power for n=274 for secondary outcomes\n \n \n \n \n \n d=0.29\n d=0.32\n d=0.35\n \n \n \n \n 10% attrition\n 0.81\n \n0.88\n\n 0.93\n \n \n 15% attrition\n 0.74\n 0.83\n 0.88\n \n \n 20% attrition\n 0.72\n 0.80\n 0.86\n \n \n 25% attrition\n 0.69\n 0.78\n 0.84", "id": 931, "split": "val"} +{"trial_id": "NCT04631770", "pmid": "37898488", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Mediastinal Lymph Node Dissection Versus Spared Mediastinal Lymph Node Dissection in Stage IA Non-small Cell Lung Cancer Presented as Ground-glass Nodules: Study Protocol of a Phase III, Randomized, Multi-center Trial (MELDSIG) in China\n\nIncluded conditions:\n- Lung Neoplasms\n- Lymph Node Excision\n\nStudy Armgroups:\n- {'label': 'Mediastinal lymph node dissection group', 'type': 'EXPERIMENTAL', 'description': 'A', 'interventionNames': ['Procedure: Systemic mediastinal lymph node dissection']}\n- {'label': 'Spared mediastinal lymph node dissection group', 'type': 'ACTIVE_COMPARATOR', 'description': 'B', 'interventionNames': ['Procedure: Spared mediastinal lymph node dissection']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Systemic mediastinal lymph node dissection', 'description': 'Systematic hilar and mediastinal lymph node dissection.', 'armGroupLabels': ['Mediastinal lymph node dissection group']}\n- {'type': 'PROCEDURE', 'name': 'Spared mediastinal lymph node dissection', 'description': 'Mediastinal lymph node is spared in this group.', 'armGroupLabels': ['Spared mediastinal lymph node dissection group']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival', 'description': 'Overall survival is defined as days from randomization to death from any cause, and it was censored at the last day when the patient was alive.', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided significance level of 5%, power of 80%, drop-out rate of 5%, accrual time of 2 years, follow-up time of 5 years", "answer": 1362, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to previous studies on stage IA subsolid and pure GGNs, the 5-year survival rate is 87.6%\u00e2\u0080\u0093100%.10 11 We assumed an expected 5-year OS rate of 90% in the mediastinal LND group and an anticipated accrual time of 2 years and a follow-up time of 5 years. Based on a one-sided significance level of 5%, a power of 80%, a non-inferiority margin of 5% for 5-year OS rate and a drop-out rate of 5%, the total sample size was set at 1362 patients (681 per arm) by PASS V.11.0 software.", "id": 932, "split": "val"} +{"trial_id": "NCT04633421", "pmid": "37337234", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Impact of High Versus Standard Enteral Protein Provision on Functional Recovery Following Intensive Care Admission: a Randomized Controlled, Multicenter, Parallel Group Trial in Mechanically Ventilated, Critically Ill Patients\n\nIncluded conditions:\n- Critical Illness\n- Intensive Care Unit Acquired Weakness\n\nStudy Armgroups:\n- {'label': 'PRECISe protocol EN (8g protein/100kcal)', 'type': 'EXPERIMENTAL', 'description': 'Enteral (EN) feed with 8 grams protein per 100 kcal (2.0 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission.', 'interventionNames': ['Dietary Supplement: PRECISe protocol EN 8g protein/100kcal']}\n- {'label': 'PRECISe protocol EN (5g protein/100kcal)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Enteral (EN) feed with 5 grams protein per 100 kcal (1.3 g/kg/day protein when on target). The caloric goal is 25 kcal/kg/day to be reached on day 4 of ICU admission.', 'interventionNames': ['Dietary Supplement: PRECISe protocol EN 5g protein/100kcal']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'PRECISe protocol EN 8g protein/100kcal', 'description': 'Enteral feed containing 8g protein/100kcal', 'armGroupLabels': ['PRECISe protocol EN (8g protein/100kcal)']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'PRECISe protocol EN 5g protein/100kcal', 'description': 'Enteral feed containing 5g protein/100kcal', 'armGroupLabels': ['PRECISe protocol EN (5g protein/100kcal)']}\n\nPrimary Outcomes:\n- {'measure': 'Health Related Quality of Life (HRQL)', 'description': 'Overall difference in EQ-5D single summary index between intervention and control group over the three time-points combined, corrected for baseline. A higher summary index indicates better Health related Quality of Life.', 'timeFrame': 'Day 0, Day 30, 90 and 180 after index ICU admission.'}\n\nPlease estimate the sample size based on the assumption: \nEstimated standard deviation of 0.3, type I error rate \u03b1 = 0.05, type II error rate \u03b2 = 0.20 (80% power), and an estimated 5% loss to follow-up. Adjusted for observed standard deviation of 0.38 and 9.4% loss to follow-up.", "answer": 935, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Trial data of health-related quality of life scores repeated at multiple time points after ICU discharge are not readily available. For this reason, the power calculation was based on a published point-measurement of the EQ-5D-5L health utility score at 180\u00c2\u00a0days following ICU admission [46]. Reported instrument-defined minimally important difference estimates for the EQ-5D-5L utility scores are between 0.037 and 0.069 for Canada, China, Spain, Japan, England, and Uruguay scoring algorithms [47, 48]. We chose a minimum difference of 0.06 points on the EQ-5D-5L health utility score as representing the minimum clinically important difference to be detected [47].\n Based on these data, the sample size for the PRECISe trial was calculated as follows: with an estimated standard deviation (SD) of health utility scores of 0.3 at 180\u00c2\u00a0days [46], considering a type I error rate \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and a type II error rate \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.20 (yielding a statistical power of 80%), 392 participants per intervention group will be required to detect the minimum clinically important difference of 0.06 in EQ-5D-5L health utility score. In line with other critical care trials, the sample size has been adjusted upwards for an estimated 5% loss to follow-up for the primary endpoint [19]. After this adjustment, the final sample size for the PRECISe trial was set at 824 participants.\n During the preplanned interim safety analysis, it became apparent that mortality was higher than anticipated, resulting in a standard deviation of the EQ-5D-5L HUS that was larger than expected (0.38 vs 0.30). Since this potentially could reduce the power of the study, the DSMB advised to review the statistical analysis plan to account for this and agreed on increasing sample size. By running a computer simulation of the primary outcome analysis using actual pooled data of the actual study population at that time (n\u00e2\u0080\u0089=\u00e2\u0080\u0089709), it was calculated that with the observed standard deviation, a sample size of 935 patients would be required to retain 80% power to detect the minimally important difference of 0.06, while correcting for the actually observed loss-to-follow-up of 9.4%.", "id": 933, "split": "val"} +{"trial_id": "NCT04635943", "pmid": "33836826", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Phase IIA Clinical Trial to Evaluate the Efficacy of Ivermectin to Obtain Negative PCR Results in Patients With Early Phase COVID-19\n\nIncluded conditions:\n- Covid19\n- Coronavirus Infection\n- SARS-CoV Infection\n\nStudy Armgroups:\n- {'label': 'Ivermectin', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants on this arm will receive orally one (1) daily dose of ivermectin 300 mcg/kg for three (3) consecutive days, starting at the enrolment visit.', 'interventionNames': ['Drug: Ivermectin']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants on this arm will receive orally one (1) daily dose of placebo for three (3) consecutive days, starting at the enrolment visit.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ivermectin', 'description': 'One daily dose of NOXAL-Ivermectin Oral Solution (6 mg/mL) at 300mcg/kg for three (3) consecutive days. A weight-equivalence table will be used to determine each participant\u00b4s dose (number of oral drops/day).', 'armGroupLabels': ['Ivermectin'], 'otherNames': ['Noxal']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'The placebo presentation will be an oral drop solution undistinguishable from ivermectin, but without this device pharmaceutical ingredient.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patients with a positive SARS-CoV-2 PCR.', 'description': 'Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment', 'timeFrame': '7 days post-treatment'}\n\nPlease estimate the sample size based on the assumption: \nNot provided", "answer": 186, "answer_type": "ACTUAL", "explanation": "Numbers to be randomized (sample size)\n The planned sample size is 186 SARS-CoV-2 PCR positive patients: 93 patients to treatment and 93 to the placebo group.", "id": 934, "split": "val"} +{"trial_id": "NCT04642027", "pmid": "35428210", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer\n\nIncluded conditions:\n- Prostate Cancer\n- Cancer Recurrence\n\nStudy Armgroups:\n- {'label': 'Conventional', 'type': 'ACTIVE_COMPARATOR', 'description': 'Conventional sEBRT', 'interventionNames': ['Radiation: Conventional sEBRT']}\n- {'label': 'Hypofractionation', 'type': 'EXPERIMENTAL', 'description': 'Hypofractionated sEBRT', 'interventionNames': ['Radiation: Hypofractionated sEBRT']}\n\nInterventions:\n- {'type': 'RADIATION', 'name': 'Conventional sEBRT', 'description': 'A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks', 'armGroupLabels': ['Conventional'], 'otherNames': ['Conventional salvage external beam radiation therapy']}\n- {'type': 'RADIATION', 'name': 'Hypofractionated sEBRT', 'description': 'A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks', 'armGroupLabels': ['Hypofractionation'], 'otherNames': ['Hypofractionated salvage external beam radiation therapy']}\n\nPrimary Outcomes:\n- {'measure': '5-year progression-free survival', 'description': 'Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first', 'timeFrame': '5 years'}\n\nPlease estimate the sample size based on the assumption: \nAlpha of 5%, study power of 81%, and a dropout rate of 12%.", "answer": 538, "answer_type": "ESTIMATED", "explanation": "Sample size considerations\n A systematic review and meta-analysis reported that each additional Gy in the conventional sEBRT-arm is possibly associated with a 2% higher bPFS, independent of other factors. These results imply that our biological dose escalated effect with hypofractionation will result in 16% higher bPFS (8\u00e2\u0080\u0089Gy\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u00892% per Gy). However, this meta-analysis did not include series using a radiotherapy dose above 70\u00e2\u0080\u0089Gy. In higher dose series as proposed in this study, the relative benefit may be lower and consequently an expected benefit of 16% may be too optimistic. Therefore, a conservative 12% higher 5-year bPFS in the experimental arm of 20 fractions of 3\u00e2\u0080\u0089Gy compared to the conventional sEBRT schedule of 35 fractions of 2\u00e2\u0080\u0089Gy (70\u00e2\u0080\u0089Gy) has been chosen. This estimated benefit of 12% is also supported by a meta-analysis including conventional and hypofractionated regimens addressing the influence of fraction size and the total dose effect on bPFS and toxicity [28].\n The results of the GETUG-AFU 16 trial showed a 5-year bPFS of 62% with the conventional fractionated radiotherapy protocol [26]. We used this percentage (62%) for the 5-year bPFS in our conventional sEBRT treatment arm. Following the above mentioned literature, we hypothesize that with the experimental regimen the bPFS can be improved from 62 to 74%. Using an alpha of 5% and a study power of 81%, the required sample size is 235 participants per treatment arm. Assuming a dropout of 12%, we need to recruit 269 participants per treatment arm: 538 in total.", "id": 935, "split": "val"} +{"trial_id": "NCT04647136", "pmid": "34980614", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Fertility Health Awareness Strategies on Fertility Knowledge and Childbearing in Young Married Couples (FertStart)\n\nIncluded conditions:\n- Fertility Awareness\n- Childbearing Intentions\n\nStudy Armgroups:\n- {'label': 'Fertility Health Screening', 'type': 'ACTIVE_COMPARATOR', 'description': 'Clinic-based fertility health screening and counselling', 'interventionNames': ['Diagnostic Test: Fertility Health Screening']}\n- {'label': 'Fertility Awareness Tools', 'type': 'ACTIVE_COMPARATOR', 'description': 'Online intervention to provide fertility education and behavioural nudge for optimal reproductive timing.', 'interventionNames': ['Behavioral: Fertility Awareness Tools']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'No intervention but exposed to usual information from the media on fertility and family benefits (no different from general population).'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Fertility Health Screening', 'description': \"Basic fertility health screening comprising an anti-Mullerian hormone (AMH) test and semen analysis, a doctor's consultation to explain the results, and standardised reproductive counselling by a trained nurse comprising a discussion of reproductive plans (including addressing barriers the couple face), education on age-related fertility decline and limitations of artificial reproductive technologies, advice on the optimal reproductive timing and when to seek further help. An educational brochure will be handed to the couple during the counselling session.\", 'armGroupLabels': ['Fertility Health Screening']}\n- {'type': 'BEHAVIORAL', 'name': 'Fertility Awareness Tools', 'description': 'Online intervention consisting of 1) video targeting fertility education and specific attitudes, social norms and perceived control for having children, 2) a fertility awareness tool (FERTISTAT) and 3) an educational brochure on fertility. This intervention can be self-administered and is therefore easily scalable.', 'armGroupLabels': ['Fertility Awareness Tools']}\n\nPrimary Outcomes:\n- {'measure': 'Change in parenthood intentions', 'description': \"The difference in the female partner's intended age at first birth at 6 months post-randomization compared to baseline, elicited by a direct question in pre and post-questionnaires.\", 'timeFrame': 'Baseline (before intervention) and 6 months later'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5% (two-sided), power of 80%, and a 30% dropout rate.", "answer": 1200, "answer_type": "ESTIMATED", "explanation": "Sample size\n Comparative trials of fertility knowledge interventions demonstrated no or modest (\u00e2\u0088\u00920.8 years) decreases in womens\u00e2\u0080\u0099 intended age at first birth.19\u00e2\u0080\u009323 Based on a three-arm trial with several comparisons with the control, to detect a hypothesised difference of 0.5 years in the wife\u00e2\u0080\u0099s intended age at first birth between the treatment arms at 6-month follow-up, with a hypothesised SD of 2\u00e2\u0080\u0089years, at a significance level of 5% (two-sided) and a power of 80%, we need to randomise 216 couples in each of the two intervention arms and 305 couples in the control arm. To account for a 30% dropout rate, 310 couples in each intervention arms and 440 in the control arm (total 1060) are needed. We target to recruit 1200 couples, 352 in each intervention arm and 496 in the control arm, stratified by the wife\u00e2\u0080\u0099s age group (25\u00e2\u0080\u009329 and 30\u00e2\u0080\u009334 years old). This represents about 2.6% and 1.7% of eligible females in the two age groups.49 The first 140 couples will be part of the pilot phase and may not be included in the final analysis if significant changes to the protocol are made thereafter.", "id": 936, "split": "val"} +{"trial_id": "NCT04647162", "pmid": "35998952", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety of Surgical Treatment In Severe Primary Pontine Hemorrhage Evacuation (STIPE): a Multicentric, Randomized, Controlled, Open-label Trial\n\nIncluded conditions:\n- Cerebrovascular Disorders\n- Pontine Hemorrhage\n- Primary\n- Surgery\n\nStudy Armgroups:\n- {'label': 'medical group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive only medical treatment including active life support, nutritional support, homeostasis maintenance of the internal environment, and other symptomatic treatment.', 'interventionNames': ['Other: life support']}\n- {'label': 'surgical group', 'type': 'EXPERIMENTAL', 'description': 'Patients receive intervention such as the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.', 'interventionNames': ['Procedure: hematoma evacuation by craniotomy', 'Procedure: hematoma evacuation by stereotactic puncture', 'Procedure: hematoma evacuation by neuroendoscopy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'hematoma evacuation by craniotomy', 'description': 'The intervention method of hematoma evacuation is under craniotomy.', 'armGroupLabels': ['surgical group']}\n- {'type': 'PROCEDURE', 'name': 'hematoma evacuation by stereotactic puncture', 'description': 'The intervention method of hematoma evacuation is under stereotactic puncture.', 'armGroupLabels': ['surgical group']}\n- {'type': 'PROCEDURE', 'name': 'hematoma evacuation by neuroendoscopy', 'description': 'The intervention method of hematoma evacuation is under neuroendoscopy.', 'armGroupLabels': ['surgical group']}\n- {'type': 'OTHER', 'name': 'life support', 'description': 'The treatments in medical group includes life support, nutrition support, and rehabilitation therapy\u3002', 'armGroupLabels': ['medical group']}\n\nPrimary Outcomes:\n- {'measure': 'Safety Outcome Number 1: Rate of Mortality', 'description': 'Percentage of participants who died during the first 30 days after randomization.', 'timeFrame': '30 days from randomization'}\n- {'measure': 'Safety Outcome Number 2: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis', 'description': 'Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.', 'timeFrame': '30 days from randomization'}\n- {'measure': 'Safety Outcome Number 3: Rate of Symptomatic Rebleeding', 'description': 'The difference in the rate of symptomatic rebleeding 72 hours post surgery.', 'timeFrame': '72 hours post surgery'}\n\nPlease estimate the sample size based on the assumption: \n5% significance level (two-sided), 80% power, 6% missing rate during follow-up", "answer": 64, "answer_type": "ESTIMATED", "explanation": "Sample size\n The calculation of sample size depends on the outcome distribution from our previous work.11 It was reported that 70.4% patients died with MT while only 30.4% died undergoing surgical HE after sPPH. A sample size of 60 would be required to demonstrate a significant level of 5% (two-sided) with 80% power. Considering the 6% missing rate during follow-up, the total sample size was 64 cases with 16 and 48 cases in MT and HE group, respectively.", "id": 937, "split": "val"} +{"trial_id": "NCT04647474", "pmid": "37093833", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective and Longitudinal Cohort Study Assessing Mental wellbeIng and Quality of Life in Prostate Cancer - the MIND-P Study\n\nIncluded conditions:\n- Prostate Cancer\n\nStudy Armgroups:\n- {'label': 'Radical Prostatectomy', 'description': 'Participants undergoing any curative surgical treatment option for prostate cancer irregardless of approach (open, laparoscopic or robotic)'}\n- {'label': 'Active Surveillance', 'description': 'Participants undergoing active surveillance as the management option for prostate cancer as defined by regular surveillance attendance at the primary treating site.'}\n- {'label': 'Hormone Monotherapy', 'description': 'Participants undergoing medical hormone therapy (Antiandrogens and Gonadotropin-releasing hormone (GnRH) agonists or antagonists) or surgical castration (e.g. orchidectomy) options as the primary treatment for prostate cancer.'}\n- {'label': 'Radical Radiotherapy', 'description': 'Participants undergoing primary radiotherapy treatment for prostate cancer irregardless of delivery methods (e.g. External beam radiation therapy or brachytherapy).'}\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Mean difference of mental wellbeing measures between four management groups', 'description': 'Mental wellbeing validated tools scores including Patient Health Questionnaire-9 (PHQ-9), Generalised Anxiety Disorder-7 (GAD-7), Body Image Scale, Fear of Recurrence Scale and Masculine Self-Esteem Prostate Cancer-Related Quality of Life (PC-QOL) Subset Scale', 'timeFrame': 'Baseline, 3, 6, 9 and 12 months post diagnosis'}\n\nPlease estimate the sample size based on the assumption: \nOne-way ANOVA, power of 0.8, alpha value of 0.05, dropout rate of 25%.", "answer": 300, "answer_type": "ACTUAL", "explanation": "Sample size\n Target sample size calculations are based on the primary aim and outcome of the study evaluating mean differences between different treatment cohorts. This was conducted for hypothesis testing against minimal clinically significant difference (MCSD) of the five mental wellbeing measures of interest, as previously reported in the literature. This was calculated utilising a one-way ANOVA across the four cohorts. Common standard deviation (SD) derived from the literature, or previous pilot data from a small cross-sectional sample were also used to subsequently calculate the effect size f value, with a power of 0.8 and an alpha value of 0.05 utilised. G*Power Software V3.1 [30] was used to calculate the required sample sizes. The largest required sample size across the five mental wellbeing measures was used as the required minimal sample size.\n \n \n PHQ-9 \u00e2\u0080\u0093MCSD of 5 [31], SD of 3.49 (pilot data)\n \n \n GAD 7 \u00e2\u0080\u0093MCSD of 5 [32], SD of 3.49 (pilot data)\n \n \n FCR7 \u00e2\u0080\u0093MCSD of 10, SD 7.01 [24]\n \n \n BIS\u00e2\u0080\u0093No clear MCSD published in literature [33], use of 10 as cut off for significant symptoms [25], SD of 3.93 (pilot data)\n \n \n Masculine Self-Esteem MCSD of 9.8 [34], SD of 15.79 [35]\n \n \n Sample size calculations utilising the above values revealed a maximum requirement of 232 participants (58 per cohort) using the PC-QOL Masculine Self-Esteem Scale. Assuming a reasonable dropout rate of 25%, a requirement of 75 participants per cohort was set to give an overall target sample of 300 participants. During recruitment, individual treatment cohorts of these sizes will be targeted, with a gradual stop in recruitment across these different cohorts to gain sizes of groups as close to equal as possible. However, due to likely unequal dropout rates and some crossover to different treatment arms during follow up (e.g. those undergoing surveillance subsequently undergoing radical treatment) it is likely some disparity in cohort sizes will exist. These would subsequently require consideration within analysis and conclusions drawn from study results if any individual cohort contains fewer than the minimum sample size described above.", "id": 938, "split": "val"} +{"trial_id": "NCT04648436", "pmid": "35351178", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Survival and Quality of Life After Early Surgical Intervention Versus Wait-and-see in Elderly Patients With a Traumatic Acute Subdural Hematoma (ASDH): a Pragmatic Randomized Controlled Trial With Multicenter Parallel Group Design\n\nIncluded conditions:\n- Intracranial Hemorrhages\n- Surgery\n\nStudy Armgroups:\n- {'label': 'Early surgery', 'type': 'OTHER', 'interventionNames': ['Other: Early neurosurgical hematoma evacuation']}\n- {'label': 'Initial conservative treatment', 'type': 'OTHER', 'interventionNames': ['Other: Conservative treatment (best medical management)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Early neurosurgical hematoma evacuation', 'description': 'Early neurosurgical hematoma evacuation (preferably within 2 hours)', 'armGroupLabels': ['Early surgery']}\n- {'type': 'OTHER', 'name': 'Conservative treatment (best medical management)', 'description': 'Conservative treatment (best medical management) on the ICU or ward', 'armGroupLabels': ['Initial conservative treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Glasgow Outcome Scale Extended (GOS-E)', 'description': 'scale of functional outcome ranging from 1-8 in which a higher score reflects a better recovery', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation achieves a 90% power to detect a change in the log odds ratio of 0.69 with a 0.05 (two-sided) significance level, allowing for a loss of follow-up of 8%.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The sample size of 300 patients was based on an ordinal analysis method of the primary outcome. It was calculated analytically using PASS software version 11 and achieves a 90% power to detect a change in the log odds ratio of 0.69 with a 0.05 (two-sided) significance level, allowing for a loss of follow-up of 8%. Calculations were based on the expected percentage distribution of conservatively treated patients over the GOS-E categories 1\u00e2\u0080\u00938 (15, 10, 10, 10, 10, 10, 15, 20) with category 1 and 2 combined and an estimated (adjusted) proportional odds ratio of 2.0 representing the targeted treatment effect that is considered clinically relevant in the management of elderly with a traumatic ASDH. Table 4 shows the corresponding distribution of patients over the GOS-E outcome categories. The rationale for combining GOS-E categories 1 and 2 in the statistical analysis is the opinion of the researchers that a potentially large shift of patients from category 1 (death) to category 2 (vegetative state) should not result in a positive trial as this cannot be considered a beneficial or positive effect of surgery.\nTable 4Estimated shift over GOS-E outcome categoriesGOS-E1&2345678Patient\u00e2\u0080\u0099s conditionDead and vegetative stateLower severe disabilityUpper severe disabilityLower moderate disabilityUpper moderate disabilityLower good recoveryUpper good recoveryInitial conservative treatment (%)25101010101520Early surgery (%)14789101933", "id": 939, "split": "val"} +{"trial_id": "NCT04649450", "pmid": "34598983", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MusiC to Prevent deliriUm During neuroSurgerY: A Single Centered Prospective Randomized Controlled Trial\n\nIncluded conditions:\n- Delirium\n\nStudy Armgroups:\n- {'label': 'Music', 'type': 'EXPERIMENTAL', 'description': 'Participants in the music group will receive headphones with music 30 minutes before surgery. Patients will be able to choose music from a preselected list composed by a team consisting of researchers and dedicated music therapists. The headphones will be removed before entering the operating room. Once in the operating room they will receive earphones after intubation, compatible with the Mayfield and site of operation. The intraoperative music intervention will be continued during the surgical procedure and discontinued just before detubation. The duration of the intraoperative music intervention depends on the duration of surgery and will be documented. After surgery, during recovery at the post-operative care unit (PACU) another 30 minutes of music through headphones will be given. The following 3 days (post-operative day 1, 2 and 3) at the neurosurgical ward they will receive music twice a day for 30 minutes. All participants will further receive standard of clinical care.', 'interventionNames': ['Other: Music']}\n- {'label': 'Standard of clinical care', 'type': 'NO_INTERVENTION', 'description': 'Standard of clinical care.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Music', 'description': 'Participants in the music group will receive headphones with music 30 minutes before surgery. Patients will be able to choose music from a preselected list composed by a team consisting of researchers and dedicated music therapists. The headphones will be removed just before entering the operating room. Once in the operating room they will receive earphones after intubation, compatible with the Mayfield and site of operation. The intraoperative music intervention will be continued during the surgical procedure and discontinued just before detubation. The duration of the intraoperative music intervention depends on the duration of surgery and will be documented. After surgery, during recovery at the post-operative care unit (PACU) another 30 minutes of music through headphones will be given. The following 3 days at the neurosurgical ward they will receive music twice a day for 30 minutes.', 'armGroupLabels': ['Music']}\n\nPrimary Outcomes:\n- {'measure': 'Delirium', 'description': 'All participating patients on the ward will be screened using the Delirium Observation Screening (DOS) scale. The DOS is a score of 1 until 13, in which a score of 3 or higher is suspicious for delirium. Screening is conducted 3 times per day (i.e. during each shift) and maintained until day 5. In case of raised suspicion of delirium by DOS, a psychiatrist is consulted to confirm or reject clinical diagnosis of delirium based on the DSM-V criteria. Presence of delirium is confirmed by the psychiatrist after positive DOS screening, all other patients will be considered as absence of delirium. In case of discharge towards another hospital within 5 days, onset of delirium is evaluated in that hospital. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.', 'timeFrame': 'First five post-operative days. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.'}\n\nPlease estimate the sample size based on the assumption: \nAssuming a power of 80%, a two-sided p value of 0.05, and 1:1 randomisation. We expect a lost to follow-up of 5%.", "answer": 189, "answer_type": "ESTIMATED", "explanation": "Sample size\n We expect an incidence of delirium in our control group of 30%. This is based on literature documenting incidence of delirium in neurosurgical patients in a northern European population of 29%\u00e2\u0080\u009333%.4\u00e2\u0080\u00936 8\u00e2\u0080\u009313 62 The expected effect cannot be based on previous literature since no adequate trials exist on the effect of music on delirium. Other non-pharmacological interventions mention a relative reduction of 36%\u00e2\u0080\u009377%.19 22 We will, therefore, consider the intervention clinically relevant if a relative reduction of 60%, corresponding to an absolute reduction of 18%, is achieved. Assuming a power of 80%, a two-sided p value of 0.05, and 1:1 randomisation, a sample size of 90 patients per arm would be required. We expect a lost to follow-up of 5% and will, therefore, include 189 patients.\n \n Inclusion period\n We expect 50% of the craniotomy patients not to be eligible due to inclusion or exclusion criteria given above. This leaves 240 eligible patients each year, taking into account that approximately 480 craniotomies are conducted at the Erasmus MC in Rotterdam each year. In 30% of these cases, it concerns emergency operations and we do not expect to be able to include many of these patients. Considering this, we would in theory therefore need 14 months for inclusion. Hence, we would plan 24 months of inclusion time taking into account all the logistic challenges. In practice, this comes down to one or two inclusions each week.", "id": 940, "split": "val"} +{"trial_id": "NCT04650880", "pmid": "38684265", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Double-blind Controlled Trial on the Effect of Vitamin D on Ovulation Rate of Women With Polycystic Ovary Syndrome\n\nIncluded conditions:\n- Polycystic Ovary Syndrome\n- Anovulation\n\nStudy Armgroups:\n- {'label': 'Vitamin D', 'type': 'ACTIVE_COMPARATOR', 'description': 'Vitamin D 50,000 IU/ week for 4 weeks, followed by 50,000 IU once every 2 weeks for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.', 'interventionNames': ['Dietary Supplement: Vitamin D']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo tablets with same external appearance for 52 weeks Those who remain anovulatory after 6 months will be treated with a 6-month course of letrozole (2.5mg to 7.5mg for 5 days per cycle titrated according to response) for ovulation induction.', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Vitamin D', 'description': 'Vitamin D supplementation', 'armGroupLabels': ['Vitamin D']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo tablets with the same external appearance', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Ovulation rate', 'description': 'Serum progesterone', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nAt least 80% power to detect the difference of 20% between the groups with type I error of 0.05. Accounting for 20% dropouts.", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The ovulation rate in Chinese women after taking letrozole is about 60%.26 Assuming the ovulation rate is increased to 80% after taking vitamin D, 91\u00e2\u0080\u0089women in each group will achieve at least 80% power to detect the difference of 20% between the groups with type I error of 0.05. Accounting for 20% dropouts, then 110\u00e2\u0080\u0089women per arm and 220\u00e2\u0080\u0089women are needed in total.", "id": 941, "split": "val"} +{"trial_id": "NCT04652544", "pmid": "34921084", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study\n\nIncluded conditions:\n- Spinal Cord Injuries\n- Vitamin D Deficiency\n\nStudy Armgroups:\n- {'label': '\"Low\" dose', 'type': 'EXPERIMENTAL', 'description': \"One vial with 600 \u00b5g cholecalciferol (corresponding to a total of 24'000 IU vitamin D) and one vial with placebo every month.\", 'interventionNames': ['Drug: Cholecalciferol (Vitamin D3)', 'Other: Placebo']}\n- {'label': '\"High\" dose', 'type': 'EXPERIMENTAL', 'description': \"Two vials with 600 \u00b5g cholecalciferol each (corresponding to a total of 48'000 IU vitamin D) every month.\", 'interventionNames': ['Drug: Cholecalciferol (Vitamin D3)']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Two vials with a placebo every month.', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Cholecalciferol (Vitamin D3)', 'description': 'Vi-De 3\u00ae Monthly Dose from Dr. Wild \\\\& Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.', 'armGroupLabels': ['\"High\" dose', '\"Low\" dose'], 'otherNames': ['Vi-De 3\u00ae Monthly Dose']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'A placebo will be produced, consisting of the same ethanol solution as Vi-De 3\u00ae Monthly Dose, but without cholecalciferol.', 'armGroupLabels': ['\"Low\" dose', 'Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Vitamin D status', 'description': 'Serum levels of 25(OH)D in nmol/L', 'timeFrame': '0 to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nAssuming a significance level of 5% and a power of 0.80, with between-group variances ranging from 1000 to 3500 and correlations between repeated measures ranging from 0.1 to 0.9.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Sample size\n We defined the minimal sample size as the sample size needed to detect a statistically meaningful difference in the time course of the primary outcome vitamin D status across the three intervention groups. For this, we estimated the sample size needed to detect an interaction between treatment and time across the three intervention groups using the power analysis package for repeated measures in Stata software, V.16.0 (StataCorp, 2019). The expected mean vitamin D status at each time point was calculated for each intervention group using the generalised pharmacokinetic curve equation of Heaney, et al35 which we parametrised for the purpose of this study using the available data for vitamin D supplementation in chronic SCI.23 36\n Assuming a significance level of 5% and a power of 0.80, minimal sample sizes were calculated for a range of between-group variances (ie, 1000\u00e2\u0080\u00933500, with 500 incremental steps) and correlations between repeated measures (ie, 0.1\u00e2\u0080\u00930.9, with 0.1 incremental steps; online supplemental file 3). Based on this power analysis for sample size, we conservatively plan for 45 participants with a full data set, implying 15 participants in each of the three intervention groups. In the case of dropouts or a large amount of missing data for a given participant, recruitment will be continued until the minimal sample size of 15 participants per intervention groups is effectively achieved. Sample size calculation did not take secondary outcome parameters into account. Since long-term studies among the chronic SCI population are rare, this study may inform the minimal sample size needed for future studies targeting the dynamics of secondary outcome parameters in response to vitamin D supplementation.\n \n 10.1136/bmjopen-2021-053951.supp3\n Supplementary data", "id": 942, "split": "val"} +{"trial_id": "NCT04654533", "pmid": "35717243", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SEnsitive Care: Understanding and REsponding - Promoting Sensitivity in Center-based Childcare of 0-2 Year Old Children (the SECURE Project)\n\nIncluded conditions:\n- Caregiver Interactive Skills\n\nStudy Armgroups:\n- {'label': 'COSC', 'type': 'EXPERIMENTAL', 'description': 'Eight weekly manualized sessions of Circle of Security Classroom (COSC), delivered in groups, two hours per session, 5-10 childcare providers per group.\\n\\nCOSC is facilitated by a psychologist who is a registered COSP facilitator and who has completed the an additional COSC online training.', 'interventionNames': ['Other: COSC']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Usual care control condition, i.e., standard practice in the participating childcare centers.\\n\\nTeams of childcare providers are allocated to either COSC or waitlist in clusters, and baseline and follow-up measures are collected parallel in both groups. Childcare providers allocated to the waitlist will receive COSC after the follow-up data have been collected.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'COSC', 'description': \"COSC is professional development program for early childcare providers adapted from the Circle of Security-Parenting (COSP) model. It is a manualized intervention that leverages research on attachment relationships combining psycho-education with a mentalization-based approach. The model uses pre-produced video vignettes of secure and problematic caregiver-child interactions to illustrate how caregivers' may struggle in meeting children's' attachment needs.\\n\\nParticipants are invited to reflect on how they meet and perhaps still not meet the needs of the children in their care with a particular focus on the challenging or 'difficult' children.\\n\\nThe COSP manual has been translated into Danish (Cooper, Hoffman and Powel, 2020, translated by Pedersen, Kronendorf von Wowern, Lier, \\\\& Smith-Nielsen), and the additional COSC material has been translated into Danish for the purpose of this study.\", 'armGroupLabels': ['COSC']}\n\nPrimary Outcomes:\n- {'measure': 'Caregiver Interactive Profile (CIP-scales), Sensitive responsiveness scale.', 'description': 'Coding of sensitive responsiveness is based on video-recorded caregiver-child interactions and sensitivity is rated on a 7-point scale with higher ratings reflecting higher levels of sensitivity', 'timeFrame': '12-16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha of 0.05, 80% power, correlation between baseline and post-intervention of 0.5, ICC of 0.1.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n The primary outcome for the study is the childcare providers\u00e2\u0080\u0099 sensitive responsiveness using the CIP-Scales [52]. Therefore, sample size was determined as the number of participants required to achieve min. 80% power for detecting a change in this measure with a two-sided alpha of 0.05. Two previous RCTs have examined interventions aiming at increasing professional caregivers\u00e2\u0080\u0099 sensitive responsiveness using the CIP-Scales. These studies find medium (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.55) to large (d\u00e2\u0080\u0089=\u00e2\u0080\u00890.72) effects of the interventions on caregivers\u00e2\u0080\u0099 sensitive responsiveness post intervention. For normally distributed outcomes, a sample of 29\u00c2\u00a0day care centers (15 intervention, 14 control corresponding to 110 caregivers) with each 3.4 caregivers yields a statistical power of 81% to detect an effect size of d\u00e2\u0080\u0089=\u00e2\u0080\u00890.55 using a two-sided alpha of 0.05, a correlation between baseline and post-intervention of 0.5 and an ICC of 0.1. This is the conservative estimate using the lowest effect size. If the effect size is 0.72 the statistical power rises to 96%.", "id": 943, "split": "val"} +{"trial_id": "NCT04656483", "pmid": "34907057", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)\n\nIncluded conditions:\n- Neurodevelopmental Disorders\n\nStudy Armgroups:\n- {'label': 'Telemedicine Video Feedback Arm', 'type': 'EXPERIMENTAL', 'description': \"Mother-child dyads will take part into a 6 video-conference sessions of Video Feedback (vVF). The vVF will be standardized according to previously published RCTs. Specifically, the 6 vVFI sessions will be organized in two subsequent phases: 4 sessions based on sharing the focus on different relational themes, and 2 sessions of interactive integration. In more specific terms, during the first set of 4 sessions the psychologist will review with mothers' segments of the videotapes obtained during the baseline assessment and will focus on four different relational themes: responsiveness, physical stimulation, teaching, and parenting experience. During the interactive integration session, the insights developed from the first 4 videoconferences will be applied to the real-time interaction between the parent and his/her infant under the guidance of the psychologist.\", 'interventionNames': ['Other: Telemedicine Video Feedback Intervention']}\n- {'label': 'Psychoeducational booklet arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Mothers assigned to condition B will receive an informative booklet addressing the same themes discussed in the experimental intervention (i.e., responsiveness, physical stimulation, teaching, and parenting experience), but not tailored on their own infant or specific parenting challenges.', 'interventionNames': ['Other: Psychoeducational Booklet Intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Telemedicine Video Feedback Intervention', 'description': \"Mother-child dyads will take part into a 6 video-conference sessions of Video Feedback (vVF). The vVF will be standardized according to previously published RCTs. Specifically, the 6 vVFI sessions will be organized in two subsequent phases: 4 sessions based on sharing the focus on different relational themes, and 2 sessions of interactive integration. In more specific terms, during the first set of 4 sessions the psychologist will review with mothers' segments of the videotapes obtained during the baseline assessment and will focus on four different relational themes: responsiveness, physical stimulation, teaching, and parenting experience. During the interactive integration session, the insights developed from the first 4 videoconferences will be applied to the real-time interaction between the parent and his/her infant under the guidance of the psychologist.\", 'armGroupLabels': ['Telemedicine Video Feedback Arm']}\n- {'type': 'OTHER', 'name': 'Psychoeducational Booklet Intervention', 'description': 'Mothers of this condition will receive an informative booklet addressing the same themes included in the experimental intervention (responsiveness, physical stimulation, teaching, and parenting experience), but not tailored on their own infant status.', 'armGroupLabels': ['Psychoeducational booklet arm']}\n\nPrimary Outcomes:\n- {'measure': 'Maternal sensitivity', 'description': 'The maternal sensitivity will be coded through the Global Rating Scales (Murray, Fiori-Cowley, Hooper, \\\\& Cooper, 1996). The score will range from 1 (low) to 5 (high).', 'timeFrame': 'Immediate post-intervention (6 weeks after the intervention started)'}\n\nPlease estimate the sample size based on the assumption: \nalpha=0.05, beta=0.05, power=0.95, attrition rate of 20% for each phase", "answer": 168, "answer_type": "ESTIMATED", "explanation": "Statistical power and sample size estimation\n The sample size was estimated for what pertains the first specific aim, that is, the effect of an early VFI intervention on maternal sensitivity. A minimum sample size of 59 subjects per group (alpha=0.05, beta=0.05, power=0.95, effect size, d=0.67) was estimated using G*Power software on the basis of meta-analytical evidence of online interventions focused on parenting.37 Moreover, due to the longitudinal nature of the study, attrition rate of 20% for each phase was considered, therefore a starting sample size of 84 infants for each group (total sample size=168) has been estimated.", "id": 944, "split": "val"} +{"trial_id": "NCT04659499", "pmid": "35287613", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter, Open-label, Single-arm, Phase II Clinical Trial of Nab-paclitaxel in Combination With Pyrotinib in Adjuvant Therapy for Lymph Node-negative and Small Tumor HER2-positive Breast Cancer\n\nIncluded conditions:\n- Early Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Nab-paclitaxel in combination with pyrotinib treatment group', 'type': 'EXPERIMENTAL', 'description': 'Nab-paclitaxel 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib 240mg daily for one year', 'interventionNames': ['Drug: Nab-paclitaxel in combination with pyrotinib']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Nab-paclitaxel in combination with pyrotinib', 'description': 'Nab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year', 'armGroupLabels': ['Nab-paclitaxel in combination with pyrotinib treatment group']}\n\nPrimary Outcomes:\n- {'measure': '3-year-DFS', 'description': '3-years-disease free survival rate', 'timeFrame': 'From the start of treatment to 3 years'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided significance level of 5%, power of 80%, and a dropout rate of 10%.", "answer": 261, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The group-sequential Poisson test based on the number of events of invasive disease or any-cause death was used for sample size calculation. In designing the trial, a 3-year event rate of\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u008912.4% was considered to be unacceptable in this population, and\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00897.2% would be considered as a success [20, 21]. Assuming that the one-sided significance level is 5% and the power is 80%, the sample size should be 253. Considering a dropout rate of 10%, the target number of patients was determined as 261.", "id": 945, "split": "val"} +{"trial_id": "NCT04660318", "pmid": "34389569", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System\n\nIncluded conditions:\n- Plethysmography\n- Remote Photoplethysmography Imaging\n- Physiological Parameters\n\nStudy Armgroups:\n- {'label': 'Experimental: remote photoplethysmography for physiological parameters Monitor Readings', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Remote photoplethysmography for physiological parameters']}\n- {'label': 'Control: rstandard acquisition system for physiological parameters Monitor Readings', 'type': 'OTHER', 'interventionNames': ['Device: standard acquisition system for physiological parameters']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Remote photoplethysmography for physiological parameters', 'description': 'physiological parameters will be acquired using the Remote photoplethysmography software simultaneously for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)', 'armGroupLabels': ['Experimental: remote photoplethysmography for physiological parameters Monitor Readings']}\n- {'type': 'DEVICE', 'name': 'standard acquisition system for physiological parameters', 'description': 'physiological parameters will be acquired using the standard acquisition system for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)', 'armGroupLabels': ['Control: rstandard acquisition system for physiological parameters Monitor Readings']}\n\nPrimary Outcomes:\n- {'measure': 'Concordance of rPPG heart rate readings', 'description': 'Heart rateconcordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG', 'timeFrame': '30-120 seconds.'}\n- {'measure': 'Concordance of rPPG respiratory rate readings', 'description': 'respiratory rate concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG', 'timeFrame': '30-120 seconds.'}\n- {'measure': 'Concordance of rPPG oxygen saturation readings', 'description': 'oxygen saturation concordance analysis by standard acquisition system (photoplethysmography of the finger) compared rPPG', 'timeFrame': '30-120 seconds.'}\n\nPlease estimate the sample size based on the assumption: \nAdjustment according to age, sex, and skin phototype, and considering 10% of bad quality signals", "answer": 1045, "answer_type": "ESTIMATED", "explanation": "Sample size\n With a given ICC of \u00cf\u0081=0.85 between the two groups of measures with a 95% CI of 0.05 width (two sided), the adjustment according to age, sex and skin phototype, and considering 10% of bad quality signals, the workforce is 1045 subjects. This number and the subjects recruited will allow a sufficiently wide distribution of values (in terms of different observed values and variety of subjects) for a good distribution of the results on the axes and thus a good estimation of the ICC.", "id": 946, "split": "val"} +{"trial_id": "NCT04660383", "pmid": "36707111", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Intradialytic Inspiratory Muscle Training at Different Intensities on Diaphragm Hypertrophy and Functional Capacity in Patients Undergoing Hemodialysis: a Randomized Clinical Trial.\n\nIncluded conditions:\n- Kidney Failure, Chronic\n\nStudy Armgroups:\n- {'label': 'IMT 50', 'type': 'EXPERIMENTAL', 'description': 'IMT intervention: IMT50 - 50% of the maximum inspiratory pressure (MIP), using equipment \"Threshold IMT\u00ae\" or \"Power Breathe\u00ae\", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs.', 'interventionNames': ['Device: Inspiratory Muscle Training']}\n- {'label': 'IMT 30', 'type': 'EXPERIMENTAL', 'description': 'IMT intervention: IMT30 - 30% of the maximum inspiratory pressure, using equipment \"Threshold IMT\u00ae\" or \"Power Breathe\u00ae\", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs.', 'interventionNames': ['Device: Inspiratory Muscle Training']}\n- {'label': 'IMT 10', 'type': 'SHAM_COMPARATOR', 'description': 'IMT intervention: IMT10 - 10% of the maximum inspiratory pressure, using equipment \"Threshold IMT\u00ae\" or \"Power Breathe\u00ae\", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs.', 'interventionNames': ['Device: Inspiratory Muscle Training']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Inspiratory Muscle Training', 'description': 'Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.', 'armGroupLabels': ['IMT 10', 'IMT 30', 'IMT 50']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Functional Capacity (6MWT)', 'description': 'The 6MWT is a useful, validated, and well-tolerated tool that requires no specialized equipment, used to determine the functional capacity of individuals with chronic kidney disease. 19 In addition, the 6MWT is able to represent the submaximal level of functional capacity (e.g., daily physical activity). The results will be defined as the difference in meters in distance covered at weeks 0 and 12. Participants will be instructed to walk on a flat, straight corridor, and will be told that the objective of the test is to walk as far as possible for six minutes at a self-selected speed.', 'timeFrame': 'Baseline, 3 months'}\n- {'measure': 'Change in Functional Capacity (CPET)', 'description': 'Patients will be submitted to CPET on an exercise bike, using an incremental loading protocol according to the guidelines published by the American Thoracic Society / American College of Chest Physicians.', 'timeFrame': 'Baseline, 3 months'}\n- {'measure': 'Change in diaphragm hypertrophy', 'description': 'Mode B ultrasound (EnVisor C, Philips, Bothell, Washington) with a 12.0 MHz ultrasound probe (L12-3, Philips) will be used for the image of the diaphragm in the apposition zone, the vertical section that rests against the lateral portion of the right rib cage, with the method described by Wait et al.', 'timeFrame': 'Baseline, 3 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, and a 20% increase to control for possible losses in follow-up.", "answer": 36, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The results obtained in the study by Campos et al17 were inserted using the WINPEPI software. They found a difference of 50% in the increase in functional capacity measured by the 6MWT in the training group with 50% of MIP, with 20% SD. Based on these data, the minimum need for a sample with 30 individuals was identified using 80% power and 5% significance, that is, 10 for each group. The sample size will be increased by 20% to control possible losses in the follow-up, thus finalising a sample of 36 individuals, 12 for each group.", "id": 947, "split": "val"} +{"trial_id": "NCT04663750", "pmid": "35101110", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vitrectomy, Subretinal Tissue Plasminogen Activator and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative Age-Related Macular Degeneration (TIGER): a Phase 3, Pan-European, Two-group, Observer-masked, Superiority, Randomised Controlled Surgical Trial.\n\nIncluded conditions:\n- Eye Diseases\n- Macular Degeneration, Wet\n- Sub-Macular Hemorrhage\n\nStudy Armgroups:\n- {'label': 'Arm A - Surgery with aflibercept', 'type': 'EXPERIMENTAL', 'description': 'Surgery with aflibercept at the end of surgery, with post-operative review day 1 and week 1 (day 7)', 'interventionNames': ['Procedure: Pars plana vitrectomy', 'Drug: Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12', 'Drug: subretinal injection of recombinant TPA (Alteplase) up to a maximum of 25 micrograms in 0.2 mls', 'Drug: Intravitreal 20% sulfahexafluoride (SF6) gas tamponade']}\n- {'label': 'Arm B - Aflibercept monotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Aflibercept monotherapy commencing at baseline.', 'interventionNames': ['Drug: Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Pars plana vitrectomy', 'description': 'Pars plana vitrectomy', 'armGroupLabels': ['Arm A - Surgery with aflibercept']}\n- {'type': 'DRUG', 'name': 'Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12', 'description': 'Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12.', 'armGroupLabels': ['Arm A - Surgery with aflibercept', 'Arm B - Aflibercept monotherapy'], 'otherNames': ['Aflibercept (Eylea, Bayer)']}\n- {'type': 'DRUG', 'name': 'subretinal injection of recombinant TPA (Alteplase) up to a maximum of 25 micrograms in 0.2 mls', 'description': 'Subretinal injection of recombinant TPA (Alteplase, Actilyse, Boehringer Ingelheim) up to a maximum of 25 micrograms in 0.2 mls.', 'armGroupLabels': ['Arm A - Surgery with aflibercept'], 'otherNames': ['Actilyse (Boehringer Ingelheim)']}\n- {'type': 'DRUG', 'name': 'Intravitreal 20% sulfahexafluoride (SF6) gas tamponade', 'description': 'Intravitreal 20% sulfahexafluoride (SF6) gas tamponade.', 'armGroupLabels': ['Arm A - Surgery with aflibercept']}\n\nPrimary Outcomes:\n- {'measure': 'assessment of Early Treat of Diabetic Retinopathy Study (ETDRS) letters of best-corrected visual acuity (BCVA) in the study eye.', 'description': 'The primary outcome is the proportion of participants with a BCVA gain \u226510 ETDRS letters in the study eye at the 12 month visit.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-group \u03c72 test with a 5% two-sided significance level and 90.62% power. An attrition rate of approximately 12% is assumed.", "answer": 210, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n To calculate our sample size, we undertook a bracketing exercise with our patient focus group as detailed below in the Public and Patient Involvement section. We asked them what improvement in \u00e2\u0080\u0098treatment success\u00e2\u0080\u0099, defined as meaningful gain in vision, they would require to undergo eye surgery, with the attendant downsides such as discomfort, head positioning, complications, recovery and possible cataract surgery, and assuming a 1 in 4 chance of success with anti-VEGF injections alone [7]. We defined treatment success as a 10\u00c2\u00a0letter gain in the ETDRS letter score (for justification see the section \u00e2\u0080\u0098Primary efficacy outcome\u00e2\u0080\u0099).\n The findings ranged from one patient who would not want surgery \u00e2\u0080\u0098at my age\u00e2\u0080\u0099, regardless of outcome, to another who would have surgery even if it improved his success from only 25 to 26%. The most common response was that patients wanted at least a 50% chance of success to consider vitrectomy.\n What also emerged in this elderly patient focus group was a consensus that they wanted the doctor to make the best decision on their behalf. Paradoxically then, our patient focus group exercise led us to ask 10 ophthalmologists, from junior to senior, across a range of subspecialities, what they would do, \u00e2\u0080\u0098if it was their eye\u00e2\u0080\u0099. We asked them to assume they were older adults with \u00e2\u0089\u008825% success with anti-VEGF therapy. The median \u00e2\u0080\u0098success rate\u00e2\u0080\u0099 needed to consider surgery differed if it was their potentially better or worse seeing eye (47.5% vs 55% respectively), but overall the average, median, and mode were 49%, 50% and 50% respectively. Thus, we used 50% as the minimum success rate needed to justify surgery.\n Our synthesis of the literature [7] found that 27% of patients receiving anti-VEGF monotherapy for AMD-related SMH gained 2 Snellen lines (\u00e2\u0089\u008810 letters).\n A two-group \u00cf\u00872 test with a 5% two-sided significance level has 90.62% power to detect a difference between a Group 1 proportion, \u00cf\u00801, of 0.27 and a Group 2 proportion, \u00cf\u00802 of 0.5 (odds ratio 2.704) when the sample size in each group is 94 (NQuery Advanced software v 8.2.1). With \u00e2\u0089\u008812% attrition, the sample size inflates to 210 participants.", "id": 948, "split": "val"} +{"trial_id": "NCT04664673", "pmid": "37055214", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of the Intensive Intervention \"Hand-Arm Bimanual Intensive Therapy Including Lower Extremities\" (HABIT-ILE) in Chronic (> 6 Months) Adults With Acquired Brain Damage (Stroke)\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'HABIT-ILE', 'type': 'EXPERIMENTAL', 'description': 'HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks adapted for adults stroke survivors', 'interventionNames': ['Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)']}\n- {'label': 'Regular care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Usual customary treatment for adults stroke survivors during two weeks', 'interventionNames': ['Behavioral: Regular care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)', 'description': 'motor learning-based, intensive therapy originally developed for hemiplegic children.', 'armGroupLabels': ['HABIT-ILE'], 'otherNames': ['HABIT-ILE Stroke']}\n- {'type': 'BEHAVIORAL', 'name': 'Regular care', 'description': 'customary or usual treatment given to any adult stroke survivor', 'armGroupLabels': ['Regular care'], 'otherNames': ['Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)', 'description': 'This assessment is an observation-based instrument assessing the effectiveness of the spontaneous use of the affected hand when performing bimanual activities in adults post stroke scored in a logit based 0-100 AHA-unit scale (higher score indicate higher ability)', 'timeFrame': 'baseline, 3 weeks and 13 weeks after baseline'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (1-\u03b2) = 0.9, and considerations for potential dropouts and data loss.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size\n Since this is the first time HABIT-ILE will be proposed to adults with stroke, the sample size was calculated regarding motor changes observed in a previous study of HABIT-ILE in school-aged children with congenital brain lesions.21 Based on the results of the Assisting Hand Assessment changes, a similar effect size is expected here. Thus, we hypothesise an incremental improvement of 1 SD between the intervention group and the control group (between-group difference=6, SD=5). With an \u00ce\u00b1=0.05\u00e2\u0080\u0089and a 1\u00e2\u0088\u0092\u00ce\u00b2=0.9, a sample size of 16 participants should be included in each group (32 total). Considering potential dropouts and data loss in assessments, 24 participants per group (48 in total) will be included.", "id": 949, "split": "val"} +{"trial_id": "NCT04665297", "pmid": "34604546", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Individualized Approach to Promote Nurturing Care in Low and Middle Income Countries: a Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development\n\nIncluded conditions:\n- Child Development\n\nStudy Armgroups:\n- {'label': 'Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'Subjects from intervention clusters will receive the GMCD intervention, delivered in monthly visits to the home by frontline health workers, for 24 months. 0-12 months represents the primary effectiveness study, and 12-24 months a secondary maintenance study.', 'interventionNames': ['Behavioral: International Guide for Monitoring Child Development']}\n- {'label': 'Control Arm', 'type': 'NO_INTERVENTION', 'description': 'Subjects in control clusters will continue to receive usual care from their frontline health workers. After 12 months (primary effectiveness study) control will cross into the intervention for months 12-24.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'International Guide for Monitoring Child Development', 'description': 'Monthly GMCD visits includes assessment of risk factors, open-ended exploration of caregiver concerns about development, assessment of functioning in seven developmental domains, and using mutual problem solving strategies to develop a nurturing care plan with the caregiver.', 'armGroupLabels': ['Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Composite Language Score at 12 months', 'description': 'Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153', 'timeFrame': 'Change from 0 to 12 months'}\n- {'measure': 'Change in Composite Motor Score at 12 months', 'description': 'Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154', 'timeFrame': 'Change from 0 to 12 months'}\n- {'measure': 'Change in Composite Cognitive Score at 12 months', 'description': 'Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145', 'timeFrame': 'Change from 0 to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an intracluster correlation coefficient of 0.2 and refusals and attrition of 25%, the sample size will have 80% power to detect an overall difference of 0.3 SD on the BSID3 language composite score. The sample size is also powered to allow independent analysis of each site at a difference of 0.4 SD with 80% power.", "answer": 624, "answer_type": "ESTIMATED", "explanation": "Sample size and recruitment\n Our total sample size is 624 children in 52 clusters, n=312 (26 clusters) in India and n=312 (26 clusters) in Guatemala. Our primary effectiveness outcome is to compare the difference in mean BSID3 Scores at 12 months. Cohen\u00e2\u0080\u0099s d effect sizes of recent community-based integrated parenting interventions on children\u00e2\u0080\u0099s development including studies in India and Guatemala have ranged from 0.3 to 0.4 SDs.11 14\u00e2\u0080\u009317 Assuming an intracluster correlation coefficient of 0.2 and refusals and attrition of 25%, our sample size will have 80% power to detect an overall difference of 0.3 SD on the BSID3 language composite score. The sample size is also powered to allow independent analysis of each site at a difference of 0.4 SD with 80% power.\n Research staff will obtain lists of eligible children from participating frontline workers. Study nurses will join the frontline health worker at enrollment home visits, confirm eligibility and solicit informed consent. These recruitment activities will be supplemented with phone calls or additional home visits as needed.", "id": 950, "split": "val"} +{"trial_id": "NCT04670198", "pmid": "35680254", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Waiting-list Feasibility Study and Process Evaluation of a Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)\n\nIncluded conditions:\n- Diabetes Mellitus, Type 1\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'The intervention arm will receive the Youth Empowerment Skills (YES) programme.', 'interventionNames': ['Behavioral: Youth Empowerment Skills']}\n- {'label': 'Waiting-list control', 'type': 'OTHER', 'description': 'The waiting-list control arm will receive usual care for six months before receiving the Youth Empowerment Skills (YES) programme.', 'interventionNames': ['Behavioral: Waiting-list control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Youth Empowerment Skills', 'description': 'The Youth Empowerment Skills (YES) programme is a novel psychoeducational intervention with simulation-based experiential learning tailored to the needs of young people. It is based on a social-cognitive learning model, and comprises attendance at 3 all-day YES sessions in non-healthcare settings (groups of 10); and then post-programme networking through social media and follow-up events facilitated by the youth worker. Sessions are led by a peer-educator and a health professional', 'armGroupLabels': ['Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Waiting-list control', 'description': 'Usual care for 6 months, followed by the YES programme.', 'armGroupLabels': ['Waiting-list control']}\n\nPrimary Outcomes:\n- {'measure': 'Glycated haemoglobin (HbA1c)', 'description': 'HbA1c will be used to measure:\\n\\n1. the number of participants achieving clinically significant reductions of 5.5mmol/mol or more and mean differences between groups over time\\n2. the standard deviation (SD) of the mean difference between the intervention and control group in HbA1c at 6 months; for the control group the SD of the mean difference between HbA1c at 12 months and pre-exposure (phase 2) and for the phase 1 intervention group the SD of the mean HbA1c difference between post (6 and 12 months) and pre-exposure.', 'timeFrame': 'Baseline, 6 months, 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study is not statistically powered to estimate a clinical effect. An estimated 20% drop-out rate is considered.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Participants and sample size\n We aim to recruit 50 young people and randomise half to the phase 1 programme exposure, and half to the phase 2 exposure. The inclusion criteria will involve:\n \n \n Age 14\u00e2\u0080\u009319 years.\n \n \n Diagnosis of T1DM.\n \n \n Suboptimal glycaemic control (HbA1c>69\u00e2\u0080\u0089mmol/mol or 8.5%).3\n \n \n No current or planned attendance of other structured education programmes.\n \n \n Participants will be excluded if they: have a severe physical or mental illness, unstable retinopathy, significant learning difficulties; are unable to communicate in English; or are pregnant. Participants meeting the inclusion criteria will be recruited opportunistically at the participating centres through clinical referrals and patient database searches. Based on recruitment to the pilot study, we estimate that we will be able to recruit >30% of eligible patients. To increase engagement, we will run the full study, including programme occurrences and follow-up sessions, during school holidays as this was identified by young people as the optimal period for running the YES programme.\n As a feasibility evaluation, the study is not statistically powered to estimate a clinical effect. Instead, we aim to estimate the effect-size/SD of outcomes to formulate a power calculation for a definitive trial. National Institute for Health Research guidance indicates that samples of 24\u00e2\u0080\u009350 are adequate for this purpose.33\u00e2\u0080\u009335 We have inflated our sample to allow for an estimated 20% drop-out rate.", "id": 951, "split": "val"} +{"trial_id": "NCT04673578", "pmid": "35105633", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Celecoxib Versus Placebo as an Adjunct to Treatment-as-usual in Children and Youth With Obsessive-compulsive Disorder: A Single-site Randomized Quadruple-blind Phase II Study\n\nIncluded conditions:\n- Obsessive-Compulsive Disorder\n- Pediatric Psychiatric Disorder\n\nStudy Armgroups:\n- {'label': 'Celecoxib', 'type': 'EXPERIMENTAL', 'description': 'Celecoxib 50 mg orally twice daily (if weight 10-25 kg) or 100 mg orally twice daily (if weight \\\\> 25 kg) for 12 weeks. Used as adjunct to treatment-as-usual.', 'interventionNames': ['Drug: Celecoxib']}\n- {'label': 'Placebo (microcrystalline cellulose)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo capsules identical to celecoxib. One capsule orally twice daily for 12 weeks. Used as adjunct to treatment-as-usual.', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Celecoxib', 'description': 'Selective COX-2 inhibitor; nonsteroidal anti-inflammatory drug (NSAID)', 'armGroupLabels': ['Celecoxib'], 'otherNames': ['MINT-CELECOXIB', 'NDC Code: 0025-1525', 'ATC Code: M01AH01', 'Canadian DIN: 02412497']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Microcrystalline cellulose', 'armGroupLabels': ['Placebo (microcrystalline cellulose)']}\n\nPrimary Outcomes:\n- {'measure': \"Children's Yale-Brown Obsessive-Compulsive Scale, 1st Edition (CY-BOCS-I)\", 'description': 'The CY-BOCS is a well-validated clinician-rated measure to assess obsessive-compulsive symptom severity. This results in two subscale total scores, Obsessions and Compulsions, each ranging from 0-20, with a higher score indicating greater symptom severity. These subscale scores are summed to provide a total score, ranging from 0 to 40, that is used to measure overall OCD symptom severity.', 'timeFrame': '12 weeks (adjusted for baseline severity)'}\n\nPlease estimate the sample size based on the assumption: \nA correlation of 0.5 between baseline and final CY-BOCS score, 80% power, directional one-tailed alpha, and imputation for missing follow-up data due to attrition.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size of 80 participants (40 per arm) was estimated on the basis of the primary hypothesis. If we assume a power to detect a minimally clinically significant between-group difference in CY-BOCS scores of 2.5 with an SD of 5 (equivalent to a Cohen\u00e2\u0080\u0099s d effect size of 0.5 and roughly based on two existing studies of adjunctive celecoxib in adults23 24) a correlation of 0.5 between baseline and final CY-BOCS score, and a sample size of 40 participants per arm, we will have power of 80% to detect a between-group difference using a directional, one-tailed alpha (celecoxib10 mmol/l) on the Freestyle Libre\u00ae flash glucose monitoring system over 12 weeks.', 'timeFrame': '14 week duration of study'}\n- {'measure': 'Number of episodes of Diabetic Ketoacidosis (DKA) and blood ketone \u03b2-hydroxybutyrate levels above 1.0mmol/l.', 'timeFrame': '14 week duration of study'}\n- {'measure': 'Occurrence of Serious Adverse Events (SAEs) deemed potentially related to the dietary programmes.', 'timeFrame': '14 week duration of study'}\n\nPlease estimate the sample size based on the assumption: \nThis study will not undertake significance tests. Descriptive, graphical and/or basic inferential statistics of endpoints will be presented. Levels of missing data will be investigated and used to inform future studies. No imputation will be used. There will be no interim analysis or stopping guidelines.", "answer": 12, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n The target sample size is 12 participants. This was chosen pragmatically to obtain sufficient data on the safety and feasibility of an ILED and CLED in people with T1D and overweight and obesity, while balancing cost and time. With this sample size there is a high probability of seeing at least one episode of severe hypoglycaemia or DKA.\n This study will not undertake significance tests. Descriptive, graphical and/or basic inferential statistics of endpoints will be presented, for example, frequencies and percentages, mean and SD or median and quartiles, as appropriate. Levels of missing data will be investigated and used to inform future studies. No imputation will be used. There will be no interim analysis or stopping guidelines. A full statistical analysis plan will be prepared prior to data analysis.", "id": 954, "split": "val"} +{"trial_id": "NCT04675593", "pmid": "35768875", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Using MHealth to Improve Adherence and Reduce Blood Pressure in Individuals with Hypertension and Mood Disorders.\n\nIncluded conditions:\n- Bipolar Disorder\n- Non-Adherence, Medication\n- Hypertension\n- Major Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'iTAB-CV + Self Monitoring', 'type': 'EXPERIMENTAL', 'description': 'Receives iTAB-CV intervention plus self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating', 'interventionNames': ['Behavioral: iTAB-CV']}\n- {'label': 'Self Monitoring', 'type': 'ACTIVE_COMPARATOR', 'description': 'Receives self-monitoring (SM), blood pressure home monitoring, eCAP, and weekly mood rating', 'interventionNames': ['Behavioral: Self-Monitoring']}\n- {'label': 'iTAB-CV + Self Monitoring - High Intensity Booster', 'type': 'EXPERIMENTAL', 'description': 'Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the high intensity booster group will start off receiving 1 reminder per day and taper down to 1 reminder per week over 2 months, in addition to self monitoring.', 'interventionNames': ['Behavioral: iTAB-CV']}\n- {'label': 'iTAB-CV + Self Monitoring - Low Intensity Booster', 'type': 'EXPERIMENTAL', 'description': 'Following the 4-month assessment, subjects in the iTAB-CV group will be re-randomized to receive either a high intensity booster or low intensity booster. Those in the low intensity booster group will receive 1 reminder per week for 2 months, in addition to self monitoring.', 'interventionNames': ['Behavioral: iTAB-CV']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'iTAB-CV', 'description': 'Individualized Texting for Adherence Building - Cardiovascular (iTAB-CV): a personalized patient-centered text message-based adherence intervention', 'armGroupLabels': ['iTAB-CV + Self Monitoring', 'iTAB-CV + Self Monitoring - High Intensity Booster', 'iTAB-CV + Self Monitoring - Low Intensity Booster']}\n- {'type': 'BEHAVIORAL', 'name': 'Self-Monitoring', 'description': 'The Self-Monitoring (control) group will monitor their medication adherence, take their blood pressure weekly with a home blood pressure monitor provided by the study after being trained by the study staff, and rate their mood weekly in response to a text reminder.', 'armGroupLabels': ['Self Monitoring']}\n\nPrimary Outcomes:\n- {'measure': 'Change in the Tablet Routine Questionnaire (TRQ)', 'description': 'The TRQ item is a subject report of the percentage of prescribed medications not taken within the past month.', 'timeFrame': 'Baseline and Month 4'}\n- {'measure': 'Change in systolic blood pressure (SBP)', 'description': 'Systolic blood pressure indicates how much pressure your blood is exerting against your artery walls when the heart beats. Higher reading implies more pressure', 'timeFrame': 'Baseline and Month 4'}\n- {'measure': 'Change in Adherence based on the Electronic Monitoring Device (eCAP)', 'description': 'Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as \"taken\" if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.', 'timeFrame': 'Baseline and Month 4'}\n\nPlease estimate the sample size based on the assumption: \nType I error levels of 0.025 for each of the two primary analyses using Bonferroni correction, 25% attrition rate, power of 0.80, autoregressive (AR(1)) model covariance structure with correlation coefficient of 0.44 and error variance of 308 for adherence, and compound symmetry correlation parameter value of 0.36 for SBP.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Power analyses are based on computations from the Repeated Measures and Sample Size (RMASS) [72] with inputs estimated from prior study data. Our projected sample size is n\u00e2\u0080\u0089=\u00e2\u0080\u0089200, with 100 participants per arm. In this power analysis, the research team will assume type I error levels of 0.025 for each of the two primary analyses, using Bonferroni correction to account for multiple comparisons. Conservatively, for this study, the researchers will assume 25% attrition based on a previous 12\u00e2\u0080\u0089month trial conducted by members of the study team with individuals with comorbid serious mental illness and diabetes [73]. For sample size requirement for aim 1, the investigators used past-month TRQ as an approximation of expected and longer-term maintenance adherence status and considered primary outcomes to be at 3\u00e2\u0080\u0089months. The investigators expect similar or even greater effect sizes at 4\u00e2\u0080\u0089months given the longer treatment duration. In the pilot study, there was 23.10% improvement in TRQ observed for iTAB-CV. The control comparator for the efficacy trial will be SM of adherence, BP, and mood. Based on the literature, no improvement in self-reported adherence was reported in a similar control arm [74]. The study staff thus assume no change in adherence. In a BD adherence RCT, 7% improvement was observed in the control arm. Hence, the investigators conservatively project a 7% mean improvement in adherence among controls. Thus, (1) there is a mean difference of 16.1% in adherence after 4\u00e2\u0080\u0089months between arms and (2) suppose autoregressive (AR(1)) model covariance structure with correlation coefficient of 0.44 and an error variance of 308, as estimated value from the data. With assumed attrition of 25%, for a 2-sided test of the treatment by time interaction effect being equal to zero, and with alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.025 and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80, the required total sample size is approximately 78.\n From the pilot data, mean screen SBP was 144.81 (SD 15.46). Change from screen to 3\u00e2\u0080\u0089months with the iTAB-CV intervention saw a mean reduction in SBP of 8.78. Reductions in BP of at least 2\u00e2\u0080\u0089mmHg can significantly reduce the incidence of cardiovascular disease and its complications in both hypertensive and normotensive individuals, and reductions of the magnitude seen in this team\u00e2\u0080\u0099s pilot work is well above thresholds that are considered clinically meaningful [75]. Based on our preliminary mixed model, the researchers also observed compound symmetry correlation parameter value of 0.36. This covariance model had similar model fit as with an AR(1) model in terms of AIC/BIC criteria and parameter estimate values. The researchers will assume no SBP pressure change is observed in the SM arm and estimated error standard deviation of 15.46, as observed [38]. Finally, in a linear mixed model with participant-level random effects, with two-sided type I error of 0.025, power\u00e2\u0080\u0089=\u00e2\u0080\u00890.80 for the projected sample size of 182 participants. The study staff will target a sample of 200 for the study to allow for some deviation from assumptions. Thus, the researchers should have sufficient statistical power for the first 2 primary aims.", "id": 955, "split": "val"} +{"trial_id": "NCT04676828", "pmid": "34418994", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial\n\nIncluded conditions:\n- Lung Cancer\n- Radiation-Induced Disorder\n- Radiation Pneumonitis\n- Pulmonary Disease\n- Lung Function Decreased\n\nStudy Armgroups:\n- {'label': 'SPECT functional avoidance treatment', 'type': 'EXPERIMENTAL', 'description': 'SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.', 'interventionNames': ['Diagnostic Test: Single-photon-emission CT scan']}\n- {'label': 'Standard treatment', 'type': 'NO_INTERVENTION', 'description': 'CT-based radiation therapy given over 5- 6.5 weeks.'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Single-photon-emission CT scan', 'description': 'SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung', 'armGroupLabels': ['SPECT functional avoidance treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Radiation-induced lung toxicity', 'description': 'crude rate of symptomatic radiation-induced lung toxicity of grade 2 and higher. According to the Common Toxicity Criteria for Adverse Events version 5.0 for radiation pneumonitis, dyspnea, cough, or any other radiation-induced respiratory, thoracic and mediastinal disorder.', 'timeFrame': 'Measured serially from 1 to 12 months after treatment completion'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for at least 80% power to have 95% confidence in ruling out a freedom from RILT rate of 75% in favor of 84%. A randomised phase II design with a 2:1 randomisation of SPECT to standard treatment is proposed. A modest attrition rate is accounted for.", "answer": 195, "answer_type": "ESTIMATED", "explanation": "Sample size\n Bases on the Quantitative Analyses of Normal Tissue Effects in the Clinic lung report and previously reported prospective trial rates [6], a freedom from RILT rate of 75% would be expected to be observed in patients receiving standard therapy. For the SPECT to be considered worthwhile for further investigation a freedom from RILT rate of at least 84% would suggest a clinically worthwhile signal in SPECT. Based on Ahern\u00e2\u0080\u0099s single arm design, a sample size of 130 patients receiving SPECT would have at least 80% power to have 95% confidence in ruling out an uninteresting freedom from RILT rate of 75% in favour of a clinically more interesting rate of 84%. In order to reduce selection bias, a randomised phase II design is proposed with a 2:1 randomisation of SPECT to standard treatment. The sample size of 195 is required and a total of 200 patients will be enrolled to offset a modest attrition rate. All patients will be followed for at least 6\u00e2\u0080\u0089months. The primary endpoint will be described by the proportion of patients in the SPECT arm are free of symptomatic RILT of at least grade 2 together with the associated 95% confidence interval. The corresponding proportion will be calculated in the control arm to provide contemporary free of symptomatic RILT of at least grade 2 rates in the standard treatment group.\n It is expected that 5\u00e2\u0080\u00936 patients per month can be accrued between the two participating countries (Denmark and Australia), thus, it is expected that accrual to this study could be completed in 3\u00e2\u0080\u0089years.", "id": 956, "split": "val"} +{"trial_id": "NCT04676958", "pmid": "36539791", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Vitamin K2 on Recovery From Muscle Damaging Exercise in Young and Older Adults\n\nIncluded conditions:\n- Inflammation\n- Oxidative Stress\n- Vitamin K\n- Exercise\n- Strength\n- Recovery\n\nStudy Armgroups:\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': '380 mg capsule/day micro-crystalline cellulose', 'interventionNames': ['Dietary Supplement: Micro-crystalline cellulose']}\n- {'label': 'Vitamin K2', 'type': 'ACTIVE_COMPARATOR', 'description': '380 mg capsule/day micro-crystalline cellulose including 240ug/day Vitamin K2', 'interventionNames': ['Dietary Supplement: Vitamin K2']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Vitamin K2', 'description': 'Vitamin K2', 'armGroupLabels': ['Vitamin K2']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Micro-crystalline cellulose', 'description': 'Micro-crystalline cellulose', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Change in post exercise recovery of muscle strength', 'description': 'Muscle strength (MVC) of the knee extensor muscles will be measured before and after (3h, 24h, 48h, 72h) an acute bout of resistance exercise', 'timeFrame': 'Change from baseline to 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \npower of 80% and alpha level of 0.05, accounting for dropout", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n We have based our sample size on being able to (within age groups) detect a physiologically relevant difference in muscle strength of 10% with an SD of 10%, based on data from within our laboratory, with a power of 80% and alpha level of 0.05. This would require a sample size of 17 in each group and so we will aim to recruit 20 participants to each group (within age groups) to account for dropout.", "id": 957, "split": "val"} +{"trial_id": "NCT04678609", "pmid": "35428274", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Open and Closed Kinetic Chain Exercise on Functional Outcomes and Lower Limb Biomechanics in Mild Knee Osteoarthritis Patients\n\nIncluded conditions:\n- Osteoarthritis, Knee\n- Aging Problems\n\nStudy Armgroups:\n- {'label': 'Open kinetic chain exercise', 'type': 'EXPERIMENTAL', 'description': 'In the OKC exercise group, participants will be taught by a physiotherapist about open kinetic chain exercises. Then, they will do the exercises at their home for eight weeks, with three session per week. The physiotherapist will contact the participants to monitor their adherence to the intervention. A diary is also provided to monitor their progress, pain level and any adverse events related to the intervention.', 'interventionNames': ['Other: Exercise']}\n- {'label': 'Closed kinetic chain exercise', 'type': 'EXPERIMENTAL', 'description': 'In the OKC exercise group, participants will be taught by a physiotherapist about open kinetic chain exercises. Then, they will do the exercises at their home for eight weeks, with three session per week. The physiotherapist will contact the participants to monitor their adherence to the intervention. A diary is also provided to monitor their progress, pain level and any adverse events related to the intervention.', 'interventionNames': ['Other: Exercise']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': \"The untreated control group will receive patient's usual care of local government hospital which includes information about clinical manifestations, risk factors, diagnosis, treatment and nursing care for knee OA. Control group did not receive any home exercises guidance.\"}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Exercise', 'description': 'CKC: exercise with joints fixed on the ground OKC: exercise with joints not fixed on the ground', 'armGroupLabels': ['Closed kinetic chain exercise', 'Open kinetic chain exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline of pain intensity score at post-intervention', 'description': 'pain intensity will be assessed using a visual analogue scale. It consists of a bidirectional 10-cm straight line, where 0 cm is \"no pain\" and 10 cm is \"worst imaginable pain,\" located at either end of the line. Patients will be instructed to draw a vertical mark on the line indicating their pain level.', 'timeFrame': '8 weeks'}\n- {'measure': 'Change from baseline of disability score at post-intervention', 'description': 'Western Ontario and McMaster Universities Arthritis Index consists of a number of questions designed to assess the clinical severity of the disease (5 questions for pain, 2 questions for stiffness and 17 questions for physical function). It includes 24 questions, each question scored using a five-point scale (0-4) with higher scores representing greater levels of pain, stiffness and severity of the disease. The overall score (index) is determined by summing the scores across the three dimensions and the score ranges between 0-96 (derived from a 0-4 Likert scale).', 'timeFrame': '8 weeks'}\n- {'measure': 'Change from baseline of quality of life score at post-intervention', 'description': 'The Osteoarthritis Knee and Hip Quality of Life in Malay Version consists of 43 items divided into five dimensions: physical activity, mental health, pain, social support, and social functioning Each item in the five dimensions is measured on a numerical rating scale from 0 to 10. Each item is scored on a scale from 0 to 10, and the normalized scores were obtained by computing the sum of item scores for each domain and calculated to a scale from 0 (worst) to 100 (best) possible quality of life.', 'timeFrame': '8 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (alpha) is set at 0.05, the statistical power is 0.8, and a dropout rate of 20% is anticipated.", "answer": 66, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was determined using G*Power statistical software version 3.1.9.2 (Universit\u00c3\u00a4t D\u00c3\u00bcsseldorf, Germany) based on the primary outcome variables of pain and function based on the visual analog scale (VAS) scores as well as the Western Ontario and McMaster Universities Arthritis (WOMAC) Index respectively. The sample size for this study was determined to detect an effect size of 0.5, based on a previous study [21] with an alpha value of 0.05. Eighteen participants per group will be sufficient to achieve a statistical power of 0.8. By anticipating a dropout rate of 20%, a total of 22 participants per group (total N = 66) will be recruited.", "id": 958, "split": "val"} +{"trial_id": "NCT04681534", "pmid": "34980610", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered Through AlphaDBS System in Patients With Parkinson's Disease\n\nIncluded conditions:\n- Parkinson Disease\n\nStudy Armgroups:\n- {'label': 'conventional DBS', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Device: AlphaDBS System']}\n- {'label': 'adaptive DBS', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: AlphaDBS System']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'AlphaDBS System', 'description': 'AlphaDBS can be programmed with two different types of stimulation: conventional DBS and adaptive DBS, that automatically adjusts the energy delivered to patient using a biosignal, local field potential (LFP), in a close loop configuration.', 'armGroupLabels': ['adaptive DBS', 'conventional DBS']}\n\nPrimary Outcomes:\n- {'measure': 'Safety and tolerability of the \"AlphaDBS\" System, when used in cDBS and aDBS mode', 'description': 'Occurrence of device related adverse events', 'timeFrame': '1 month'}\n\nPlease estimate the sample size based on the assumption: \nType I error probability of 0.05, power of 99%, TEED=44.6 in aDBS, TEED=158.7 in cDBS, SD=100, and a higher SD observed multiplied by 4.5. The study will also observe adverse events occurring in 5%-10% of the patients, but not rare events in the range of 1%-2%.", "answer": 15, "answer_type": "ESTIMATED", "explanation": "Sample size\n The objective of the study is to collect data, such as the degree of correlation between GOT in aDBS and cDBS, that will allow calculation of the sample size needed for a pivotal study if this study confirms the results obtained in a previous trial. This study will randomise at least 15\u00e2\u0080\u0089patients.\n Based on the figures obtained in the clinical trial with patients in the \u00e2\u0080\u0098acute\u00e2\u0080\u0099 phase,25 and without considering corrections for multiple testing, this sample will allow using exploratory statistics to demonstrate a difference in TEED during cDBS and aDBS sessions through a non-parametric test for an effect size of 1.14, assuming the following parameters, using type I error probability equal to 0.05 and power of 99%: TEED=44.6 in aDBS, TEED=158.7 in cDBS, SD=100, multiplying by 4.5 the higher SD observed. Also, 15 patients will allow to observe AEs occurring in 5%\u00e2\u0080\u009310% of the patients, but not rare events in the range 1%\u00e2\u0080\u00932%. However, at this stage, rare hardware-related AEs (1%\u00e2\u0080\u00932%) are not considered since they were already described by other DBS devices manufacturers and thus expected. Also, rare hardware related are usually observable in studies with longer observation periods than that included in this study (1\u00e2\u0080\u0089month) which is thus not ideal to assess this type of information, which in any case will be collected.", "id": 959, "split": "val"} +{"trial_id": "NCT04682899", "pmid": "34353802", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Procalcitonin-guided Initiation of Antibiotics in AECOPD Inpatients: a Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Procalcitonin\n- Chronic Obstructive Pulmonary Disease\n\nStudy Armgroups:\n- {'label': 'PCT-guided antibiotic therapy (PCT group)', 'type': 'EXPERIMENTAL', 'description': 'Participants in the PCT group will complete a PCT test within 2 hours after randomization and the results will be sent back to the clinician by laboratory through the internal network of the hospital. The prescribing clinician will use the results of the PCT to help guide their antibiotic prescription decision. The detailed recommendations are as follows: if PCT\\\\<0.1ng/ml\uff0cstrongly discouraged\uff1bif PCT (0.1-0.25ng/ml) and no sputum purulence, discouraged; if PCT (0.1-0.25ng/ml) and sputum purulence, Recommended; PCT\\\\>0.25 ng/ml, Strongly recommended.', 'interventionNames': ['Drug: procalcitonin-guided antibiotic therapy']}\n- {'label': 'Guideline-guided antibiotic therapy (guideline group)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the guideline group will also need to complete a PCT test within 2 hours after randomization, however, the laboratory will save the results and do not sent back to the clinician. The clinician will make an antibiotic prescribing decision on the basis of the recommendations of GOLD guideline. The guideline recommend the following patients to receive antibiotic therapy. Patients with exacerbations of COPD who have three cardinal symptoms: increase in dyspnea, sputum volume, and sputum purulence; have two of the cardinal symptoms, if increased purulence of sputum is one of the two symptoms; or require mechanical ventilation (invasive or noninvasive).', 'interventionNames': ['Drug: guideline-guided antibiotic therapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'procalcitonin-guided antibiotic therapy', 'description': 'In procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin.', 'armGroupLabels': ['PCT-guided antibiotic therapy (PCT group)']}\n- {'type': 'DRUG', 'name': 'guideline-guided antibiotic therapy', 'description': 'In guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline.', 'armGroupLabels': ['Guideline-guided antibiotic therapy (guideline group)']}\n\nPrimary Outcomes:\n- {'measure': 'Antibiotic prescription rate', 'description': 'proportion of patients receiving antibiotics for AECOPD', 'timeFrame': 'within 30 days post randomization'}\n- {'measure': 'Treatment success rate', 'description': 'Treatment success is defined as cure (a complete resolution of signs and symptoms associated with the exacerbation) or improvement (a resolution or reduction of the symptoms and signs associated with the exacerbation, without new symptoms or signs).', 'timeFrame': 'day 30 post randomization'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a 5% significance level and 90% power for detecting the difference in antibiotic consumption. For demonstrating non-inferiority, it uses a one-sided significance level of 0.05% and 80% power. A drop-out rate of 20% is assumed for both endpoints.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Sample size\n This study is designed to have sufficient power to detect a 20% reduction from an estimated 70% that consume antibiotics for the AECOPD during the 30 days following randomisation. In the Schuetz\u00e2\u0080\u0099s RCT to compare PCT guide antibiotic prescription with guideline therapy, subgroup analysis in patients with AECOPD shown that the 30-day prescription rate of guideline group and PCT group was 69.9% and 48.7%, respectively.15 Detecting a difference in proportions between 0.70 and 0.50 at the 5% significance level with 90% power requires a total of 242 participants. Assuming a drop-out rate of 20%, we will need to enrol 302 participants. In addition, we aim to have sufficient power to demonstrate that participants managed with PCT-guided strategy are non-inferior, compared with those managed with guideline recommendations, in terms of treatment success rate at day 30 post randomisation. A limited number of studies have reported the success rate at day 30 after randomisation in patients with AECOPD.16 23 According to prior trials in terms of hospitalised patients with AECOPD, Stolz et al16 reported the short-term treatment success rate as 83.9% (from 14 to 21 days post randomisation) and Prins et al23 determined the treatment failure rate at day 30 after randomisation as 20.3%. Based on these data and assuming a treatment success rate of 0.8 at day 30 following randomisation, a non-inferior margin of 0.1,24 based on a one-sided significance level of 0.05% and 80% power, would require 396 participants. Again, with a drop-out rate of 20%, 495 participants will need to be included. Finally, considering these two primary endpoints, we will aim to recruit 500 participants in total to the study.", "id": 960, "split": "val"} +{"trial_id": "NCT04683068", "pmid": "35395021", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial Comparing Self-referred Message to Family-referred Message Promoting Men's Adherence to Evidence-based Guidelines on BRCA1/2 Germline Genetic Testing: a Study Protocol\n\nIncluded conditions:\n- BRCA1 Mutation\n- BRCA2 Mutation\n- Psychosocial Factors\n\nStudy Armgroups:\n- {'label': 'First-person gain-framed self-referred messages', 'type': 'ACTIVE_COMPARATOR', 'description': 'This group receives a message in which the main character is a man who speaks in first-person. The character is a man with a sister with a BRCA germline mutation. After this common introduction, the content of the messages becomes different.\\n\\nGroup 1 receives a self-referred narrative message in which the protagonist explains that he has decided to have a genetic test to discover BRCA germline mutation. He then explains the reasons why this decision is important to himself (e.g., implementing preventive behaviors) and what are the possible benefits for the individual.', 'interventionNames': ['Behavioral: Message comparison']}\n- {'label': 'First-person gain-framed family-referred messages', 'type': 'EXPERIMENTAL', 'description': 'This group receives a message in which the main character is a man who speaks in first-person. The character is a man with a sister with a BRCA germline mutation. After this common introduction, the content of the messages becomes different.\\n\\nGroup 2 receives a family-referred narrative message in which the frame is similar to the previous message, but the character this time explains what are that the benefits for his family and why his decision to have a genetic test is important to them.', 'interventionNames': ['Behavioral: Message comparison']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Message comparison', 'description': 'Message comparison', 'armGroupLabels': ['First-person gain-framed family-referred messages', 'First-person gain-framed self-referred messages']}\n\nPrimary Outcomes:\n- {'measure': 'Intention to undergo genetic testing', 'description': 'The intention of undergoing genetic testing is measured through three items evaluating the urge to engage the behavior. Example of item is: \"In the next few months, do you have the intention of planning a genetic screening?\". Response options are on a 5-point Likert scale.', 'timeFrame': '2-3 weeks after the intervention exposure'}\n\nPlease estimate the sample size based on the assumption: \nalpha lower than .05, power (1-B) = .70, 7 covariates", "answer": 264, "answer_type": "ACTUAL", "explanation": "Sample size and power calculation\n Participants will be 264 males, relatives of women with BRCA1 and/or BRCA2 germline mutations who are patients of the Division of Cancer Prevention and Genetics at the European Institute of Oncology (IEO) in Milan. The IEO is a specialized Hospital and an internationally recognized Cancer Center located in Italy working on research, prevention, diagnosis, and treatment of cancer.\n The sample size is determined through an a priori power analysis using GPower 4.0 [51]. Among the imputed parameters it was chosen to include partial \u00ce\u00b72 = .05, alpha lower than .05, power d (1-B) = .70. Considering that Luszczynska et al. [52] found a \u00ce\u00b72 = .01, \u00ce\u00b72 = .05 is a prudential choice. Two groups, corresponding to the two experimental conditions of the study, and 7 covariates were included. The final estimated number of participants is 132, 66 in each group. It should be noted that changing the number of covariates does not change the total number of participants. As of the date of submission of this research plan for preregistration, the data have not yet been collected, created, or realized.", "id": 961, "split": "val"} +{"trial_id": "NCT04688684", "pmid": "37036843", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Emirates Heart Health Project: A Stepped-wedge Cluster Randomized-controlled Trial of a Family-based Health Coach Guided Dietary and Exercise Intervention for Reducing Weight and Cardiovascular Risk in Overweight and Obese Adult Nationals of the United Arab Emirates.\n\nIncluded conditions:\n- Overweight and Obesity\n- Cardiovascular Risk Factor\n\nStudy Armgroups:\n- {'label': 'Family-based intervention', 'type': 'EXPERIMENTAL', 'description': 'These participants will undergo the health coach based intervention with fitness tracker and diet changes, which will be delivered to all family members who meet the inclusion criteria and are enrolled in the study.', 'interventionNames': ['Behavioral: Family-based diet and exercise intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Family-based diet and exercise intervention', 'description': 'The participants will meet together weekly as a family unit to receive education and planning to implement diet and lifestyle changes under the supervision of a health coach. This coach will also be available during the week by telephone or messaging for additional individualized support if needed.', 'armGroupLabels': ['Family-based intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Weight', 'description': 'Weight (change from enrollment to end of intervention)', 'timeFrame': '16 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study will use an unpaired t-test for comparison. The design aims for a power of 80% and a one-sided significance level of 5%. An interim analysis will be performed after four clusters have completed the intervention to re-calculate the required sample size.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n In order to calculate an appropriate sample size without reliable information on the intracluster correlation we will calculate our sample size in terms of the number of clusters required. This also takes into account the cluster design of the study. The sample size in terms of individuals will then be the required number of clusters times the average cluster size.\n For this purpose, we assume that the natural fluctuation in cluster mean weight change (i.e., the standard deviation in mean weight change among clusters) is 3.5%, i.e., half the target weight reduction of 7%. This assumption is based on (or rather inspired by) variation in BMI between successive waves (approximately 5 years apart: much longer than our follow-up period) observed in the Framingham Study [29] where the standard deviation in individual weight differences was between 6% and 7%.\n We will assume that we compare the two groups using an unpaired t-test.\n For a two-armed parallel cluster randomized design to achieve a power of 80% and a one-sided significance level of 5%, we would need four clusters in each trial arm, i.e., a total of eight clusters [32] Since the stepped-wedge cluster design that we have selected is more efficient than a parallel design [33], this sample size should be adequate given our assumption. However, to accommodate for unduly optimistic assumptions about the standard deviation in weight changes we will increase our total sample size to 10 clusters.\n An interim analysis will be performed once four clusters have completed the intervention and the required sample size will be re-calculated on the basis of observed fluctuations in parameters; if this leads to the conclusion that more than 10 clusters are required to detect a statistical significance in the primary outcome, the team will meet to discuss how and if the sample of clusters can be extended.", "id": 962, "split": "val"} +{"trial_id": "NCT04692467", "pmid": "34351939", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Treatment of Early Hypertension Among Persons Living With HIV in Haiti\n\nIncluded conditions:\n- HIV/AIDS\n- Pre Hypertension\n\nStudy Armgroups:\n- {'label': 'Intervention (Early hypertension)', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \\\\>130 mmHg after 1 month.', 'interventionNames': ['Drug: Amlodipine 5mg']}\n- {'label': 'Standard of Care', 'type': 'NO_INTERVENTION', 'description': 'Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP \u2265140 or DBP \u226590 mm Hg).'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Amlodipine 5mg', 'description': \"Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.\", 'armGroupLabels': ['Intervention (Early hypertension)'], 'otherNames': ['Norvasc']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Mean Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, 12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power with alpha 0.05, conservative correlation among measurement of 0.95, standard deviation of BP at each time point = 25 mmHg", "answer": 250, "answer_type": "ACTUAL", "explanation": "Power and sample size calculations\n With a sample of 250 participants across both arms and 8 time points for BP measurements for each participant, we have 80% power with alpha 0.05 to detect a difference in change in SBP of 4 mmHg or more between the study arms at 12 months (assuming consistent difference across time and a conservative correlation among measurement of 0.95, standard deviation of BP at each time point = 25 mmHg) [30]. We will present summary statistics (e.g., mean and SD of pre, post, and difference within and between arms).", "id": 963, "split": "val"} +{"trial_id": "NCT04692974", "pmid": "38394113", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cognitive Frailty in Older Adults: Protocol of a Pilot RCT of the Role of Technology in Physical Activity Enhancement\n\nIncluded conditions:\n- Mild Cognitive Impairment\n- Frailty\n\nStudy Armgroups:\n- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention group will be given the wearables which they will use together with the accompanying mobile application for the period of the study (6 months). During the period of intervention, the wearable will track the physical activity of the older adults via the number of steps taken and number of hours of moderate physical work (based on heart rate). Heart rate and steps will be tracked whenever participants are wearing the watch, which is when they are awake. The watch is to be charged every night when they are sleeping. Participants will have to log down their physical activity by activating the physical activity tracker either on the watch or on the mobile application. If they did not hit the required level of physical activity, they will be sent a notification prompt through the mobile application with details of nearby workout locations as recommendation.', 'interventionNames': ['Device: Mobile phone application and smart watch']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'For the control group, they will wear the wearables as a tracking device for the period of the study (6 months). No prompts will be given and the mobile application will only be installed but not used for this group.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Mobile phone application and smart watch', 'description': 'Mobile phone application prompts', 'armGroupLabels': ['Intervention Group']}\n\nPrimary Outcomes:\n- {'measure': 'Mean Change from Baseline in frailty screening scores on the FRAIL questionnaire at 3 and 6 months', 'description': '5 questions on fatigue, resistance, ambulation, illness and loss of weight. It is a simple screening test for frailty. Scores of 0 (non-frail), 1-2 (pre-frail) and 3-5 (frail).', 'timeFrame': 'At 3 months and 6 months'}\n- {'measure': 'Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months', 'description': 'Hand grip strength in kilograms', 'timeFrame': 'At 3 months and 6 months'}\n- {'measure': 'Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months', 'description': 'Gait speed, time taken to walk a specified distance as fast as possible, in seconds', 'timeFrame': 'At 3 months and 6 months'}\n- {'measure': 'Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months', 'description': 'Timed Up and Go (TUG), time taken to stand up from a chair, walk 3 meters, turn around and sit back down, in seconds', 'timeFrame': 'At 3 months and 6 months'}\n- {'measure': 'Mean Change from Baseline in physical frailty as measured by physical performance tests at 3 months and 6 months', 'description': 'Chair Stand Test, time taken to stand up fully 5 times from a chair in seconds', 'timeFrame': 'At 3 months and 6 months'}\n- {'measure': 'Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months', 'description': 'Rey Auditory Verbal Learning Test (RAVLT) assesses verbal learning and memory', 'timeFrame': 'At 3 months and 6 months'}\n- {'measure': 'Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months', 'description': 'Digit Span Forward and Backward (DS) assesses working memory capacity', 'timeFrame': 'At 3 months and 6 months'}\n- {'measure': 'Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months', 'description': 'Colour Trails Test (CTT) assesses visual-spatial skills and attention', 'timeFrame': 'At 3 months and 6 months'}\n- {'measure': 'Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months', 'description': \"Wechsler's Block Design (WBS) assesses visuospatial ability\", 'timeFrame': 'At 3 months and 6 months'}\n- {'measure': 'Mean Change from Baseline in cognitive scores as measured on the Neurocognitive Assessment test battery at 3 and 6 months', 'description': 'Semantic Fluency - animals (SFA) assesses semantic memory', 'timeFrame': 'At 3 months and 6 months'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80, significance level (\u00ce\u00b1) of 0.05, correlation between repeated measures of 0.50, nonsphericity correction of 1, and a potential drop-out rate of 20%.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n Given a hypothesized treatment effect size of 0.4, according to the meta-analysis of physical activity intervention on cognitive outcomes [30] and physical outcomes [31], it was estimated using G*Power [32] that a total sample size of 42 was required to detect a significant within-between interaction with a power of .80, assuming \u00ce\u00b1 = .05; the correlation between repeated measures = .50 and nonsphericity correction = 1. After considering potential drop-out rates of 20% and publication value, a total sample size of 60 was reached. This will be adequate to detect an effect size of 0.4 or larger, at a power of .80 if such an effect exists. In order to assess the feasibility of this RCT, recruitment and retention rates will be examined as secondary outcome measures.", "id": 964, "split": "val"} +{"trial_id": "NCT04694417", "pmid": "34844641", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prevention of Leg Cramps Using Compression Stockings or Magnesium Supplements in the Age Group of 50 to 84: a Study Protocol for a Randomised Controlled Trial\n\nIncluded conditions:\n- Muscle Cramp\n- Stockings, Compression\n- Magnesium\n\nStudy Armgroups:\n- {'label': 'Compression stocking', 'type': 'EXPERIMENTAL', 'description': \"Compression stockings are mainly used for the prevention and reduction of lower limb oedema or venous thrombosis. There are three compression classes used in health care. The compression stocking group of the study will receive CE-marked stockings within the compression class of 1 (25-40 mmHg compression). The correct size for the compression stockings will be defined by the reported circumference of the participant's ankle and calf. The participants will be given instructions to put the stockings on immediately after getting out of bed in the morning and to take them off before going to bed in the evening for the last four weeks of the study. Stockings within the mild compression class have no harmful effects on individuals when the exclusion criteria are considered. The participants will be instructed to communicate with a dedicated research assistant via e-mail or phone in case of any problems or questions.\", 'interventionNames': ['Other: Compression stocking']}\n- {'label': 'Magnesium', 'type': 'ACTIVE_COMPARATOR', 'description': 'Magnesium is a mineral substance which regulates many biochemical reactions in the body, for example protein synthesis and the function of the muscles and nerves. It has a significant role in controlling blood sugar, blood pressure, energy generation and the formation of the bones. The recommended dietary allowance for magnesium is 420 mg for males and 320 mg for females over 50 years old. Dark green vegetables, leguminous plants, nuts, seeds and wholegrains are good sources of magnesium (11,12).\\n\\nIn the average Finnish diet, the recommendation is usually exceeded, and excessive amounts of magnesium in the body are extremely rare. The magnesium arm of the study will take oral tablets containing 620 mg of magnesium hydrochloride daily for the last four weeks of the study, which is equivalent to 250 mg of pure magnesium per day. The magnesium tablets for this study were manufactured and analysed by the Pharmia pharmaceutical company in Finland.', 'interventionNames': ['Dietary Supplement: Magnesium tablet']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo tablets will consist of microcrystalline cellulose, magnesium stearate (anti-caking agent) and silicon dioxide. The placebo tablets were manufactured and analysed by the Pharmia pharmaceutical company in Finland. The placebo arm will receive placebo tablets to be taken daily for the last four weeks of the study. The participants will not know whether they are randomised into the magnesium arm or the placebo arm. The packaging and the appearance of the placebo and magnesium tablets are identical.', 'interventionNames': ['Other: Placebo tablet']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Compression stocking', 'description': 'Please see the description of the intervention in another section', 'armGroupLabels': ['Compression stocking']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Magnesium tablet', 'description': 'Please see the description of the intervention in another section', 'armGroupLabels': ['Magnesium']}\n- {'type': 'OTHER', 'name': 'Placebo tablet', 'description': 'Please see the description of the intervention in another section', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'The change in quantity of leg cramps', 'description': \"The change in quantity of leg cramps from the four-week follow-up period (prior to the intervention) to the four-week intervention period will be assessed on the basis of the participants' responses to the survey. The number of cramps will be recoded on a weekly online survey during four weeks before intervention and during the four-week intervention period. The change in the number of cramps from the four-week period prior the intervention to the intervention period will be calculated. The difference between groups will be analyzed by one-way analysis of variance of repeated measurements.\", 'timeFrame': '8 weeks'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level of 0.05, and a drop-out rate of 30%", "answer": 225, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The projected number of participants is based on sample size calculations, in which a power of 80% and significance level of 0.05 will show a difference between the intervention groups in the reduction of the quantity of leg cramps when variance analysis is used in statistical testing. The calculations for the minimum sample size are based on three of Cohen\u00e2\u0080\u0099s (1988) suggested effect sizes for f variance analysis. When the effect size of 0.25 and a drop-out rate of 30% are used, the number of applicable participants should be a minimum of 225 persons.", "id": 965, "split": "val"} +{"trial_id": "NCT04694443", "pmid": "34932580", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility and Cost-effectiveness of a Multidisciplinary Home-based Telehealth Intervention Program to Reduce Falls in Parkinson\u00b4s Disease (TeleFall).\n\nIncluded conditions:\n- Parkinson Disease\n\nStudy Armgroups:\n- {'label': 'Study group', 'type': 'ACTIVE_COMPARATOR', 'description': 'The study group will receive the multidisciplinary tele-health intervention plus standard medical care', 'interventionNames': ['Procedure: Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'The control group will receive the best standard medical care', 'interventionNames': ['Other: Standard in-office medical care']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)', 'description': 'Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits', 'armGroupLabels': ['Study group'], 'otherNames': ['Education']}\n- {'type': 'OTHER', 'name': 'Standard in-office medical care', 'description': 'Non-pharmacological and pharmacological treatment provided in-office visits', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of falls reduction', 'description': 'Comparison of incidence of falls between the study and control groups by using diaries and wearable sensors', 'timeFrame': '8 months'}\n- {'measure': 'Feasibility', 'description': 'Number of virtual videoconferences completed', 'timeFrame': '8 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% probability of type 1 error, 95% confidence level, 9% dropout rate", "answer": 50, "answer_type": "ACTUAL", "explanation": "Sample size\n We calculated the sample size using the Epidat\u00c2\u00ae 4.1 statistical software. Considering that a 50% fall reduction in the number of falls compared to baseline will be obtained in 24% of the participants in the intervention group and 2% in the control group, we estimated that 70 patients (35 per group) would provide 80% power (5% probability of type 1 error) with a confidence level of 95%. By assuming a 9% dropout rate, a total sample of 76 patients will be then included in this study.", "id": 966, "split": "val"} +{"trial_id": "NCT04698330", "pmid": "35784546", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Berberine Plus Inulin on Diabetes Care in Patients With Latent Autoimmune Diabetes in Adults: A Randomized Controlled Trial\n\nIncluded conditions:\n- Type 1 Diabetes Mellitus\n- Autoimmune Diabetes\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'EXPERIMENTAL', 'description': 'LADA patients are assigned to receive berberine and inulin for 3-month.', 'interventionNames': ['Drug: Berberine', 'Drug: Inulin']}\n- {'label': 'Group B', 'type': 'EXPERIMENTAL', 'description': 'LADA patients are assigned to receive berberine and placebo(for inulin) for 3-month.', 'interventionNames': ['Drug: Berberine', 'Drug: Inulin placebo tablets']}\n- {'label': 'Group C', 'type': 'EXPERIMENTAL', 'description': 'LADA patients are assigned to receive placebo(for berberine) and inulin for 3-month.', 'interventionNames': ['Drug: Inulin', 'Drug: Berberine placebo tablets']}\n- {'label': 'Group D', 'type': 'PLACEBO_COMPARATOR', 'description': 'LADA patients are assigned to receive placebo(for berberine) and placebo(for inulin) for 3-month.', 'interventionNames': ['Drug: Berberine placebo tablets', 'Drug: Inulin placebo tablets']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Berberine', 'description': '0.6g (6 pills) of Berberine tablets administered twice a day orally before meal for 3 months', 'armGroupLabels': ['Group A', 'Group B']}\n- {'type': 'DRUG', 'name': 'Inulin', 'description': '0.6g (6 pills) of Inulin tablets administered twice a day orally before meal for 3 months', 'armGroupLabels': ['Group A', 'Group C']}\n- {'type': 'DRUG', 'name': 'Berberine placebo tablets', 'description': '0.6g (6 pills) of Berberine placebo tablets administered twice a day orally before meal for 3 months', 'armGroupLabels': ['Group C', 'Group D']}\n- {'type': 'DRUG', 'name': 'Inulin placebo tablets', 'description': '0.6g (6 pills) of Inulin placebo tablets administered twice a day orally before meal for 3 months', 'armGroupLabels': ['Group B', 'Group D']}\n\nPrimary Outcomes:\n- {'measure': 'Change in HbA1c', 'description': 'The primary outcome measure is the change in mean HbA1c level, reflecting the blood glucose management status of the patients.', 'timeFrame': '1 year after start of trial'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided alpha level of 0.05, 80% power, and consideration of reasonable attrition.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "2.1.2 Sample Size Determination\n Sample size was determined using published data from a 12-week clinical trial with BBR and probiotics, in which the drugs decreased HbA1c by 0.44% in people with T2D (Zhang, Gu et\u00c2\u00a0al., 2020), assuming a common within-group standard deviation (SD) of 0.80% and a two-sided \u00ce\u00b1 level of 0.05. With these assumptions, a sample size of 53 evaluable subjects per arm provided 80% power to detect a difference from placebo. Considering the reasonable attrition during the study, we planned to enroll 60 patients per group (i.e., a total of 240 patients).", "id": 967, "split": "val"} +{"trial_id": "NCT04698395", "pmid": "38367973", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of HABIT-ILE in Secondary Brain Damage Outcomes of Infants and Toddlers With Signs of Cerebral Palsy\n\nIncluded conditions:\n- Cerebral Palsy\n\nStudy Armgroups:\n- {'label': 'HABIT-ILE', 'type': 'EXPERIMENTAL', 'description': 'Baby HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks', 'interventionNames': ['Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)']}\n- {'label': 'Regular care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Usual customary care intervention during two weeks', 'interventionNames': ['Behavioral: Regular care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)', 'description': 'motor learning-based, intensive therapy for children with cerebral palsy', 'armGroupLabels': ['HABIT-ILE'], 'otherNames': ['Baby HABIT-ILE']}\n- {'type': 'BEHAVIORAL', 'name': 'Regular care', 'description': 'customary or usual care given to any infant/toddler with cerebral palsy', 'armGroupLabels': ['Regular care'], 'otherNames': ['Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Changes on the Mini-Assisting Hand Assessment (Mini-AHA)', 'description': 'Measures how well infants (8-18 months) with signs of unilateral or hemiplegic cerebral palsy use their more affected hand, when using both hands together to play (scored in percentage).', 'timeFrame': 'baseline, 3 weeks, 13 weeks and 26 weeks after baseline'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) = 0.05, Power (1\u2212\u03b2) = 0.9, and consideration of potential dropouts and data loss in MRI.", "answer": 48, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation was performed based on the Assisting Hand Assessment (AHA36) score of a HABIT-ILE pilot study performed in 10 infants with unilateral CP.34 In this pilot study, toddlers with unilateral CP (1\u00e2\u0080\u00934 years old) encountered an intensive intervention of 50 hours over 2 weeks, as in the present study. A mean improvement of 8.2 AHA units (SD=5.9\u00e2\u0080\u0089AHA units) after the intensive therapy was reported. Thus, our hypothesis is an incremental improvement of 1 SD between the immediate group and the delayed group at second and third assessments (between group difference=7.2, SD=5.9). With \u00ce\u00b1=0.05\u00e2\u0080\u0089and a 1\u00e2\u0088\u0092\u00ce\u00b2=0.9, a sample size of 15 participants per group is required. Considering potential dropouts and data loss in MRI, 24 participants will be included in each group (48 in total).", "id": 968, "split": "val"} +{"trial_id": "NCT04700345", "pmid": "37710274", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Managing Non-acute Subdural Hematoma Using Liquid Materials\uff1aa Chinese Randomized Trial of MMA Treatment\n\nIncluded conditions:\n- Subdural Hematoma, Non-acute\n\nStudy Armgroups:\n- {'label': 'Embolization', 'type': 'EXPERIMENTAL', 'description': 'Middle meningeal artery(MMA) embolization', 'interventionNames': ['Device: Onyx', 'Procedure: Burr-hole', 'Other: Medical Management']}\n- {'label': 'No embolization', 'type': 'ACTIVE_COMPARATOR', 'description': 'Traditional treatment group', 'interventionNames': ['Procedure: Burr-hole', 'Other: Medical Management']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Onyx', 'description': 'Embolization of the Middle Meningeal Artery using the liquid embolic material', 'armGroupLabels': ['Embolization']}\n- {'type': 'PROCEDURE', 'name': 'Burr-hole', 'description': 'Burr-hole drainage of subdural hematoma', 'armGroupLabels': ['Embolization', 'No embolization']}\n- {'type': 'OTHER', 'name': 'Medical Management', 'description': 'best medical management', 'armGroupLabels': ['Embolization', 'No embolization']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure', 'description': 'SDH recurrence (\\\\>10 mm max. thickness) or receiving re-operation in patients who underwent surgery/ symptomatic SDH progression (\\\\>3 mm increase in max thickness or receiving surgical rescue in patients who did not undergo sugery) at 90 days\\n\\n\"Symptomatic\" is hereby defined as one or more of the following features which are attributed to the progression/recurrence: headache, short-term cognitive decline, speech difficulty or aphasia, gait impairment, focal weakness, sensory deficits, seizures', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \nThe trial is powered to assess superiority with a power of 90%, a two-sided alpha of 0.05, and an 8% drop-out rate.", "answer": 722, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Our estimates are based on the hematoma recurrence or progression rate of conventional treatment from the literature. The hematoma recurrence or progression rate of conventional treatment ranged from 14 to 27.5% [14\u00e2\u0080\u009318], and the hematoma progression rate of atorvastatin treatment is 11.2% as reported [9], so we assume the event rate of the control group is 12%. The hematoma recurrence of MMA embolization ranged from 1.4 to 8.9% as reported [14\u00e2\u0080\u009318], and a systematic review reported that the recurrence rate for patients treated with MMA embolization for primary cSDH was 4.1% [19], so we assume the event rate of the intervention group is 5%. The trial is powered to assess superiority. When assuming the event rate of 5% in intervention group and 12% event rate in the control group, with a power of 90% and two-sided alpha of 0.05, allowing for 8% drop-outs, the estimated sample size is 722 patients in total.", "id": 969, "split": "val"} +{"trial_id": "NCT04701034", "pmid": "36137638", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intravenous Immunoglobulin and Prednisolone to Women With Unexplained Recurrent Pregnancy Loss After Assisted Reproductive Technology Treatment: a Randomised, Double-blind, Placebo-controlled Trial\n\nIncluded conditions:\n- Habitual Abortion\n- Recurrent Pregnancy Loss\n- Fertility Disorders\n- Miscarriage\n\nStudy Armgroups:\n- {'label': 'Active treatment group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intravenous immunoglobulin(IVIg) and prednisolone. IVIG is administered at the time of embryo/blastocyst transfer (ET) (5 days before to 2 days after ET) and if the participant becomes pregnant, the infusion (same dose) is repeated in gestational week 5, 6, and 7.\\n\\nParticipants with pre-pregnancy weight \u226470 kg will receive 25 g immunoglobulin (250 ml), participants with weight 70-85 kg will receive 30 g immunoglobulin (300 ml), and participants with weight \u226585 kg will receive 35 g immunoglobulin (350 ml) at each infusion, which will approximate 0.4 g IVIg per kg body weight.\\n\\nPrednisolone, tablets, 5mg. 1 tablet daily started within first 3 days of menstrual cycle and until ET. On the day of ET, the participant will double her dose to 2 tablets daily until a negative pregnancy test, the time of biochemical loss/miscarriage, or pregnancy week 8+0, whichever comes first. Gradual discontinuation four days with one tablet before completing cessation.', 'interventionNames': ['Drug: Human Intravenous Immunoglobulins, (Privigen (R), CLS Behring)', 'Drug: Prednisolone Tablets']}\n- {'label': 'Passive treatment group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Human albumin infusion and placebo tablets.\\n\\nHuman albumin, 5%, (CLS Behring). Participants with pre-pregnancy weight \u226470 kg will receive 250 ml, participants with weight 70-85 kg will receive 300 ml, and participants with weight \u226585 kg will receive 350 ml at each infusion. Administration is planned at the time of ET (5 days before to 2 days after ET) and if the participant becomes pregnant, the infusion is repeated in the same volume in gestational week 5, 6, and 7.\\n\\nPlacebo tablets: contain 85 mg of lactose monohydrate, 86 mg potato starch, 8.1 mg talc, 3 mg gelatine, and 0.9 mg magnesium stearate. 1 tablet daily started within first 3 days of menstrual cycle and until ET. On the day of ET, the participant will double her dose to 2 tablets daily until a negative pregnancy test, the time of biochemical loss/miscarriage, or pregnancy week 8+0, whichever comes first. Gradual discontinuation four days with one tablet before completing cessation.', 'interventionNames': ['Drug: Human Albumin Solution', 'Drug: Placebo tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Human Intravenous Immunoglobulins, (Privigen (R), CLS Behring)', 'description': 'infusion: Initial infusion rate of 0.3 ml/kg BW/hr in about 30 min. If well-tolerated, the infusion rate may gradually be increased to 4.8 ml/kg BW/hr. During the infusion, health care personnel are present to secure immediate action in case of serious AR. Blood pressure and pulse is monitored before, during and after the treatment. In case of anaphylaxis, the treatment is discontinued and the participant is excluded. The hospital ward possess adrenaline 0.1 % solutions ready in case of anaphylaxis.', 'armGroupLabels': ['Active treatment group'], 'otherNames': ['IVIg']}\n- {'type': 'DRUG', 'name': 'Prednisolone Tablets', 'description': '5 mg before ET and 10 mg after ET until gestational week 8+0', 'armGroupLabels': ['Active treatment group']}\n- {'type': 'DRUG', 'name': 'Human Albumin Solution', 'description': 'Infusion: Initial infusion rate of 0.3 ml/kg BW/hr in about 30 min. If well-tolerated, the infusion rate may gradually be increased to 4.8 ml/kg BW/hr. During the infusion, health care personnel are present to secure immediate action in case of serious AR. Blood pressure and pulse is monitored before, during and after the treatment. In case of anaphylaxis, the treatment is discontinued and the participant is excluded. The hospital ward possess adrenaline 0.1 % solutions ready in case of anaphylaxis.', 'armGroupLabels': ['Passive treatment group'], 'otherNames': ['Albumin infusion']}\n- {'type': 'DRUG', 'name': 'Placebo tablet', 'description': '1 tablet before ET and 2 tablets after ET until gestational week 8+0', 'armGroupLabels': ['Passive treatment group']}\n\nPrimary Outcomes:\n- {'measure': 'A normal live fetus at nuchal scan in ITT population', 'description': 'The frequency of participants with minimum one apparently normal fetus alive at the time of nuchal scan (approx. week 12) in patients receiving active and placebo treatment, respectively.\\n\\nHere, the primary analyses will be undertaken as an intention-to-treat (ITT) analysis, including all participants who were allocated to either active or placebo treatment at the start of the ART cycle, even if they did not receive infusion with IVIg or albumin due to cancellation of embryo/blastocyst transfer.', 'timeFrame': '12 week after embryo transfer'}\n- {'measure': 'A normal live fetus at nuchal scan in PP population', 'description': 'The frequency of participants with minimum one apparently normal fetus alive at the time of nuchal scan (approx. week 12) in patients receiving active and placebo treatment, respectively.\\n\\nHere, the primary analyses will be undertaken as a per-protocol (PP) analysis, including patients who were randomized and received the allocated infusion of study medicine at the time of embryo/blastocyst transfer and had this transfer performed.', 'timeFrame': '12 week after embryo transfer'}\n- {'measure': 'Live birth rate in ITT population', 'description': 'The frequency of participants with a liveborn (sign of life immediately af delivery \\\\>24 weeks) among all randomized participants', 'timeFrame': 'At delivery'}\n- {'measure': 'Live birth rate in the PP population', 'description': 'The frequency of participants with a liveborn (sign of life immediately af delivery \\\\>24 weeks) among all participants who fulfill criteria for PP-analysis', 'timeFrame': 'At delivery'}\n- {'measure': 'A normal live fetus at nuchal scan among participants who become pregnant after embryo transfer in the ITT population', 'description': 'The frequency of participants in the ITT population with minimum one apparently normal fetus alive at the time of nuchal scan (approx. week 12) in patients receiving active and placebo treatment, respectively, and who become pregnant after embryo transfer.', 'timeFrame': '12 week after embryo transfer'}\n- {'measure': 'A normal live fetus at nuchal scan among participants who become pregnant after embryo transfer in the PP population', 'description': 'The frequency of participants in the PP population with minimum one apparently normal fetus alive at the time of nuchal scan (approx. week 12) in patients receiving active and placebo treatment, respectively, and who become pregnant after embryo transfer.', 'timeFrame': '12 week after embryo transfer'}\n\nPlease estimate the sample size based on the assumption: \nA type I error of 0.05, a type II error of 0.20, <2% dropouts, and <10% protocol deviations are expected.", "answer": 74, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on previous studies of similar patients4 5 reporting an live birth rate (LBR) of 36.5% and 34.2% after IVIg and prednisolone treatment, respectively, and an expectation of similar treatment effects in women with 2 and \u00e2\u0089\u00a53\u00e2\u0080\u0089PLs, a minimum LBR of 40% in the active treatment group is anticipated. In the RCT by Stephenson and Fluker,28 an LBR of 12% in IVF/ICSI patients with a mean of 3.2 previous failed ETs receiving placebo treatment was reported. The patients admitted to the RPL Clinic within the last 3 years, who would have been eligible for the study, have had a mean of 6.4 previous failed ETs, and we therefore think that a reasonable estimate of the LBR in those of our patients allocated to placebo will be similar to the observed 12%. Based on these expectations, a type I error of 0.05, and a type II error of 0.20, the study will need a sample of 74 participants. Based on experience from previous trials, <2% dropouts and <10% protocol deviations (see figure 2) are expected.\n \n Figure 2\n \n Diagram over the criteria for major protocol deviations. ET, embryo transfer; IV, intravenous.", "id": 970, "split": "val"} +{"trial_id": "NCT04701840", "pmid": "37053246", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder\n\nIncluded conditions:\n- Suicidal Ideation\n- Major Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'Sequential bilateral accelerated theta burst stimulation', 'type': 'ACTIVE_COMPARATOR', 'description': 'Three sessions of Sequential bilateral accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).', 'interventionNames': ['Device: MagVenture TMS Therapy System w/Theta Burst Stimulation']}\n- {'label': 'Sham seqential billateral accelerated theta burst stimulation', 'type': 'SHAM_COMPARATOR', 'description': 'Three sessions of Sequential bilateral sham accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).', 'interventionNames': ['Device: Sham MagVenture TMS Therapy System w/Theta Burst Stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'MagVenture TMS Therapy System w/Theta Burst Stimulation', 'description': 'During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field properties on the active site are identical to that of the standard Cool-B70 coil, cleared for iTBS treatment.', 'armGroupLabels': ['Sequential bilateral accelerated theta burst stimulation'], 'otherNames': ['The MagVenture TMS Therapy System w/Theta Burst Stimulation']}\n- {'type': 'DEVICE', 'name': 'Sham MagVenture TMS Therapy System w/Theta Burst Stimulation', 'description': 'During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field on the sham site is significantly reduced, and is less than 5% of that of the active site.', 'armGroupLabels': ['Sham seqential billateral accelerated theta burst stimulation']}\n\nPrimary Outcomes:\n- {'measure': 'Suicidal Ideation', 'description': 'Suicidal Ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). This is a validated, clinician-rated tool collected to assess lifetime and ongoing suicidal ideation and behavior. The severity of ideation subscale is a 5-point ordinal scale 1-5 . 1 = Wish to be dead - 5 = Active Suicidal Ideation with Specific Plan and Intent. Assessed at baseline, 10 days and 12 months.', 'timeFrame': 'up to 12 months'}\n- {'measure': 'Hospitalizations', 'description': 'The total number of hospitalizations related to suicide idealization', 'timeFrame': 'up to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size estimation and power analysis suggested that a sample size of 35 participants per group (N = 70) would achieve 80% power at a .05 significance level (2-tailed). The dropout rate is estimated to be 10%, based on previous repetitive TMS studies.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on prior experience, it is anticipated that 200 patients will be screened and 100 will be enrolled to reach the target sample size of 80 needed to complete this pilot study. The sample size for the primary outcome (suicidal ideation over 10 days of sequential bilateral aTBS treatment) was estimated by incorporating a repeated-measures design with assumptions about potential participants (eg, effect size, odds ratio [OR]). These assumptions were based on a 2018 study of the effect of bilateral repetitive TMS vs sham stimulation on suicidal ideation in adult patients with treatment-resistant MDD [31]. The results from the a priori sample size estimation and power analysis suggested that a sample size of 35 participants per group (N = 70) would achieve 80% power at a .05 \u00ce\u00b1 level (2-tailed) [31]. The aim is to detect an overall OR of 2.85 for the primary outcome of less suicidal ideation with sequential bilateral aTBS vs sham stimulation in a 2-group (between-participants) randomized design. The posited OR is based on 10 (within-participants) repeated measurements of severity of suicidal ideation on the CSSR-S subscale, when the proportion (incident rate) of suicidal ideation from the sham group at the end of the 10-day trial meets or exceeds 0.50 and the assumed within-participant correlation between observations (suicide ideation) for the same participant is 0.50 or less. (A correlation of 0.50 was based on guidance from our preliminary study of TMS [14].) The posited OR of 2.85 for the current application is slightly more conservative than what was reported in a study by Weissman et al [31] of effects of bilateral TMS vs sham stimulation on suicidal ideation in adult patients with treatment-resistant MDD (OR = 3.03).\n The dropout rate is estimated to be 10%, an approximation based on treatment discontinuation results from our previous repetitive TMS studies [14,80,81]. Thus, 80 participants will be enrolled to allow for this expected rate of attrition with the intent of capturing evaluable data for 70 participants. PASS (Power Analysis and Sample Size) 2019 software version 14.0.15 (NCSS) was used to perform the sample size and power analysis.\n To definitively evaluate the effect of sequential bilateral aTBS treatment on suicidal ideation in adolescents, we may require a sample size larger than 70. The treatment effect of sequential bilateral aTBS has not been previously studied in adolescents with suicidal depression, and we have no previous findings from an adolescent population to guide effect size selection for the present effort. The selection of 70 participants was, in part, resource driven. The sample size is designed to detect a moderate effect and to establish a proof of concept so that the research can expand to a subsequent, larger-scale multicenter study. Nevertheless, the current pilot study permits an evaluation of whether receiving sequential bilateral aTBS shows initial evidence of improving suicidal ideation in depressed adolescents.", "id": 971, "split": "val"} +{"trial_id": "NCT04704076", "pmid": "35120150", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Preventing Infant Malnutrition With Early Supplementation, Aim 3\n\nIncluded conditions:\n- Underweight\n- Wasting\n- Stunting\n- Breastfeeding\n- Microbial Colonization\n\nStudy Armgroups:\n- {'label': 'Early, Small-Volume Supplementation (ESVS)', 'type': 'EXPERIMENTAL', 'description': 'Breastfeeding with up to 59 mL formula daily until 30 days of age, followed by recommendation to breastfeed exclusively through 6 months of age', 'interventionNames': ['Other: ESVS']}\n- {'label': 'Exclusive Breastfeeding', 'type': 'ACTIVE_COMPARATOR', 'description': 'Recommendation to breastfeed exclusively for 6 months without any other food or fluid except vitamins, minerals and medications', 'interventionNames': ['Other: Exclusive breastfeeding']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ESVS', 'description': 'Breastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age', 'armGroupLabels': ['Early, Small-Volume Supplementation (ESVS)']}\n- {'type': 'OTHER', 'name': 'Exclusive breastfeeding', 'description': 'Breastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age', 'armGroupLabels': ['Exclusive Breastfeeding']}\n\nPrimary Outcomes:\n- {'measure': 'Weight-for-age z-score (WAZ) at 30 days of age', 'description': 'WAZ calculated according to WHO Child Growth Standards', 'timeFrame': '30 days of age'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an 80% or greater power, a significance level that is not explicitly stated, and accounts for up to 20% loss to follow-up.", "answer": 324, "answer_type": "ACTUAL", "explanation": "Sample size\n In each country, trained study staff will weigh up to 1,064 infants to identify and randomize 72 with birth weight \u00e2\u0089\u00a42500g and 90 who weigh <2600g on day 4. With respect to the primary aim, determining the impact of formula on WAZ at 30 days of infant age, the anticipated sample size of 324 dyads (144 LBW infants and 180 infants with low weight on day 4 under equal randomization) will provide 80% or greater power per weight stratum for intervention group comparison to detect a difference of 0.20 with respect to the outcome of WAZ at day 30 for the entire study cohort after accounting for up to 20% loss to follow-up. This sample size will also allow the estimation of the mean difference between WAZ at day 30 and WAZ at birth with 0.17 and 0.15 standard errors by intervention group, respectively, for the entire study cohort. Including both mothers and infants, the total sample size for the randomized trial is anticipated to be 324 mothers and 324 infants, or 648 individual participants in total.", "id": 972, "split": "val"} +{"trial_id": "NCT04704453", "pmid": "36471253", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With Head and Neck Cancer in Remission and With Sequelae Neuropathic Pain.\n\nIncluded conditions:\n- Head and Neck Cancer\n\nStudy Armgroups:\n- {'label': 'Experimental arm (A): capsaicin patch', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Capsa\u00efcin patch (Qutenza\u00ae)']}\n- {'label': 'Standard arm (B): amitriptyline', 'type': 'OTHER', 'interventionNames': ['Drug: Amitriptyline (Laroxyl\u00ae)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Capsa\u00efcin patch (Qutenza\u00ae)', 'description': 'Treatment by application of capsaicin 8% (Qutenza\u00ae) patches 3 months apart (Month 1, Month 4 and Month 7).', 'armGroupLabels': ['Experimental arm (A): capsaicin patch']}\n- {'type': 'DRUG', 'name': 'Amitriptyline (Laroxyl\u00ae)', 'description': 'Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily.', 'armGroupLabels': ['Standard arm (B): amitriptyline']}\n\nPrimary Outcomes:\n- {'measure': 'The rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.', 'description': 'Pain will be assessed using a numerical scale from 0 to 10.', 'timeFrame': '9 months for each patient'}\n\nPlease estimate the sample size based on the assumption: \none-sided chi-square test, alpha of 0.05%, 90% power, 5% lost to follow-up, randomization ratio 1:1", "answer": 130, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on the literature, we expect 25% of patients to present with a pain decrease of at least two points [6]. To detect a 25% improvement (i.e., standard: 25%, experimental: 50%), using a one-sided chi-square test with an alpha of 0.05%, will require the enrollment of 125 patients, for 90% power. Assuming that 5% of patients will be lost to follow-up, we will need to randomize 130 patients (Randomization ratio1:1). According to the recommendations for comparative phase II trials, the target differences and type I error rates are relaxed.", "id": 973, "split": "val"} +{"trial_id": "NCT04705259", "pmid": "35597993", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study): Protocol for a Stepped Wedge Cluster Randomised Trial\n\nIncluded conditions:\n- Antimicrobial Stewardship\n- Antibiotics Causing Adverse Effects in Therapeutic Use\n\nStudy Armgroups:\n- {'label': 'ENGAGEMENT bundle', 'type': 'ACTIVE_COMPARATOR', 'description': 'A multimodal bundle of interventions to optimise antibiotic prescribing in residential aged care facilities. The bundle includes education for nurses and general practitioners caring for residents, telehealth support and implementation of state-wide guidelines.', 'interventionNames': ['Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle']}\n- {'label': 'Usual care', 'type': 'PLACEBO_COMPARATOR', 'description': 'Usual facility practices with regards to antibiotic prescribing and review', 'interventionNames': ['Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Antimicrobial Stewardship ENGAGEMENT bundle', 'description': 'Given that a single intervention is unlikely to be effective in stewardship programs, nor in care improvement processes at RACFs \\\\[7\\\\], this trial will deliver a set of multimodal, multidisciplinary interventions to optimise antibiotic use in RACFs. This RACF AMS ENGAGEMENT bundle will comprise the following key interventions:\\n\\n* Education and engagement of prescribers, nurses, pharmacists and residents and family members\\n* Nursing initiatives to improve UTI diagnosis and reduce inappropriate urine testing\\n* Guideline development specific to antibiotic use in RACF residents\\n* Antimicrobial stewardship team creation in RACF with GP involvement\\n* EMergency department liaison and use of clinical pathways to ensure consistency of practice across the care continuum\\n* ElectroNic decision support to guide RACF urine testing and GP antibiotic prescribing\\n* Telehealth support for key intervention components', 'armGroupLabels': ['ENGAGEMENT bundle', 'Usual care']}\n\nPrimary Outcomes:\n- {'measure': 'Defined Daily Doses (DDDs) of Antibiotics', 'description': 'The primary outcome measure for this trial is antibiotic use as measured by DDDs of antibiotics per 1000 resident bed days.', 'timeFrame': '18 months'}\n\nPlease estimate the sample size based on the assumption: \n82% power, intra class correlation coefficient (ICC) of 0.012, coefficient of variation of 0.3", "answer": 18, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size was calculated based on the outcome of antibiotic consumption as measured by DDDs. For a trial to run over 20 months with a mean cluster size of 50 residents and a control event rate of 120 DDDs per 1000 resident days [22, 42], 18 RACFs will provide 82% power to detect a 20% reduction in DDDs, which has been demonstrated as feasible by other studies [28, 43] (although these studies have utilised other metrics to quantify antibiotic consumption). The power calculation is based on a conservative intra class correlation coefficient (ICC) of 0.012 and coefficient of variation of 0.3 [44].", "id": 974, "split": "val"} +{"trial_id": "NCT04707846", "pmid": "36283748", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Re-engineering Precision Therapeutics Through N-of-1 Trials: Feasibility Study of Personalized Trials of Light Therapy for Fatigue\n\nIncluded conditions:\n- Fatigue\n\nStudy Armgroups:\n- {'label': 'Bright Light Therapy', 'type': 'EXPERIMENTAL', 'description': 'Individuals will receive bright blue light therapy using glasses developed by AYO. During treatment blocks for bright blue light therapy, participants will receive a text message within an hour of their self-reported wake time instructing them to use their designated light therapy device for 30 minutes. Bright blue light therapy will be administered in 2 treatment periods each 2 weeks in length (4 weeks total). Bright blue light treatment has been previously identified as an efficacious treatment for fatigue. It has also been shown in a number of studies that the blue wavelength of light is a key component to the shift of fatigue measures in patient reported outcomes.', 'interventionNames': ['Device: Bright Blue Light Commercial AYO Light Therapy Device']}\n- {'label': 'Dim Light Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Individuals will receive dim blue light therapy using glasses developed by AYO. During treatment blocks for bright blue light therapy, participants will receive a text message within an hour of their self-reported wake time instructing them to use their designated light therapy device for 30 minutes. Dim blue light therapy will be administered in 2 treatment periods each 2 weeks in length (4 weeks total).', 'interventionNames': ['Device: Dim Blue Light Commercial AYO Light Therapy Device']}\n- {'label': 'Usual Care', 'type': 'NO_INTERVENTION', 'description': 'During usual care periods, participants will be instructed to abstain from use of AYO light therapy devices, and instructed to treat their fatigue as they normally would. Usual care will be presented in 2 periods each 2 weeks in length (4 weeks total).'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Bright Blue Light Commercial AYO Light Therapy Device', 'description': 'AYO light therapy glasses are a commercially available device which have 4 Light-emitting diodes (LEDs) with a dominant wavelength of approximately 470nm \u00b1 2nm and typical irradiance (100% intensity) of approximately 250 \u00b5W/cm\u00b2. AYO bright light glasses are classified as \"exempt\" for photo-biological risk based on the international standard and conformity assessment for photo-biological safety of lamps (IEC 62471).', 'armGroupLabels': ['Bright Light Therapy']}\n- {'type': 'DEVICE', 'name': 'Dim Blue Light Commercial AYO Light Therapy Device', 'description': 'AYO light therapy glasses were made available to the research team by the vendor. The device has 4 Light-emitting diodes (LEDs) with a dominant wavelength of approximately 470nm \u00b1 2nm and reduced irradiance (1% intensity) of approximately 250 \u00b5W/cm\u00b2. AYO dim light glasses are classified as \"exempt\" for photo-biological risk based on the international standard and conformity assessment for photo-biological safety of lamps (IEC 62471).', 'armGroupLabels': ['Dim Light Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Mean System Usability Score (SUS).', 'description': 'The SUS is a validated 10-item questionnaire that asks users to score each item on a Likert scale from Strongly Disagree (rating of 1) to Strongly Agree (rating of 5). The SUS will be presented to the participant as addressing the ease of use, complexity, consistency of the Personalized Trials system as a whole, from recruitment to receipt of the report. Individual results are calculated to arrive at a composite measure out of 100. Participant SUS scores will be averaged together and an overall mean will be reported with standard deviation. Higher scored values correlate to a more usable system, and therefore a better outcome.', 'timeFrame': 'Assessed once after the results report has been sent to the participant, within 4 months of intervention completion.'}\n\nPlease estimate the sample size based on the assumption: \nA 1-sample binomial test at a 2.5% significance level (1-sided) with approximately 90% power. The standard error (SE) is expected to be no greater than 8% in estimating the rate of SUS \u226585.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size of 60 participants was chosen to ensure a sufficient number of participants to obtain a preliminary assessment of the feasibility of this series of N-of-1 trials of BL and DL therapy for fatigue. In the current study, feasibility is determined by participant scores on the SUS. The numbers of assessment measures and treatment repetitions per trial were based on expert recommendations by a statistician and their estimations about the maximal duration of the trial to maintain patient engagement. The primary endpoint is trial completion in the first 3 months. We aim to demonstrate a trial completion rate greater than 50% in randomised participants. With n=60\u00e2\u0080\u0089and use of a 1-sample binomial test at 2.5% significance 1-sided, we will have approximately 90% power if the true completion rate is 70%. With 60 randomised participants, expecting a trial completion rate of 70%, we anticipate SUS data are available in about 42 participants, thus giving an SE no greater than 8% in estimating the rate of SUS \u00e2\u0089\u00a585, an exceptional level of usability.46 The SE will be the largest when the trial completion rate is at 50%. Data will be reported transparently so that individual-level heterogeneity can be assessed.47", "id": 975, "split": "val"} +{"trial_id": "NCT04707859", "pmid": "37487656", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 3\n\nIncluded conditions:\n- Angina Pectoris\n- Atherosclerosis\n- Coronary Artery Disease\n- Myocardial Ischemia\n\nStudy Armgroups:\n- {'label': 'Cohort', 'description': 'Participants consenting to the study will undergo:\\n\\na1) An interview a2) Blood samples withdrawals a3) ECG a4) Non-enhanced CT a5) CCTA a6) Follow-up for \\\\> 10 years\\n\\nPatients with suspicion of coronary stenosis detected by CCTA will after undergo:\\n\\nb1) Rb PET b2) 15O-water PET b3) Invasive coronary angiography with 3 vessel measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR)', 'interventionNames': ['Diagnostic Test: Head to head comparison: Rubidium vs 15O-water PET']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Head to head comparison: Rubidium vs 15O-water PET', 'description': 'Head to head comparison with invasive FFR as reference. Adjustment for abnormal microcirculation', 'armGroupLabels': ['Cohort']}\n\nPrimary Outcomes:\n- {'measure': 'Diagnostic accuracy of Rb PET and 15-O PET', 'description': 'Head-to-head comparison using ICA-FFR as reference standard stratified for CFR', 'timeFrame': 'ICA: 4 weeks after inclusion'}\n\nPlease estimate the sample size based on the assumption: \nMinimum of 8% absolute precision on both sides for the expected sensitivity and specificity.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the Dan-NICAD 1 and 2 trials, we expect that approximately 1000 patients are needed to be included and undergo coronary CTA. Following coronary CTA, we expect that 250 (25%) patients in whom coronary stenosis cannot be ruled out are eligible for continuing to the perfusion examinations and ICA part of the study. We expect 80% to complete both 82Rb-PET and 15O-water-PET and undergo ICA examination. By including 1000 patients, we are able to evaluate the predictive validity parameters (sensitivity, specificity, positive and negative predictive values) with a minimum of 8% absolute precision on both sides for the expected sensitivity (80%) and specificity (80%) for both 82Rb-PET and 15O-water-PET at a disease prevalence of 50% at ICA-FFR.", "id": 976, "split": "val"} +{"trial_id": "NCT04711525", "pmid": "36315523", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL) Intervention for Preschool's Child-parent Dyads to Prevent Childhood Obesity: A Cluster-randomized Controlled Trial\n\nIncluded conditions:\n- Childhood Obesity Prevention\n\nStudy Armgroups:\n- {'label': 'Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)', 'type': 'EXPERIMENTAL', 'description': 'The preschool children in the experimental group will be exposed to interactive classroom instruction, and their parents will be exposed to the Web-based program. In the experimental group, apart from the standard preschool health education curriculum, the preschool children will also be exposed to the interactive activities and quizzes using Web 2.0 tools, educational videos of a healthy lifestyle, sensory-based food education activities, cooking demonstrations, fun, and active games, and exercises. Whereas the parents will be exposed to Web-based healthy lifestyle educational materials, videos, and pictures sharing, quizzes, and communication through the WhatsApp and closed Facebook groups. Besides, a total of 3 messages per week will be delivered to the parents in the experimental group. The messages will be included announcing the release of a new topic, a reminder to log in to the website and read the health information, and a reminder to participate in the online activities.', 'interventionNames': ['Behavioral: Experimental Group: Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)']}\n- {'label': 'Standard health education', 'type': 'ACTIVE_COMPARATOR', 'description': 'The children in the control group do not have exposed to the i-MaCHeL interactive classroom instruction, and their parents do not have access to the i-MaCHeL website materials. Thus, the children will be continued with standard health education only in the preschool setting, and their parents will be received Web-based health newsletters. The Web-based newsletters consist of general health information that are relevant to the preschool life stage. In ensuring that the experimental and control groups appear the same, the topics in the Web-based newsletters will have a look and feel similar nature to the experimental group condition. But still, the topics will not be included the interactive components such as videos and pictures sharing activities, quizzes, individualized feedback, and communication through WhatsApp and closed Facebook groups. Only one message (announcement of the release of a new topic) per week will be delivered to parents of the control group.', 'interventionNames': ['Behavioral: Control Group: Standard health education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Experimental Group: Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)', 'description': 'The preschool children in the experimental group will be received the i-MaCHeL program delivers through interactive classroom instruction, and their parents will have access to the i-MaCHeL Web-based program.', 'armGroupLabels': ['Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)']}\n- {'type': 'BEHAVIORAL', 'name': 'Control Group: Standard health education', 'description': 'The children in the control group will be continued with standard health education only in the preschool setting, and their parents will be received general Web-based health newsletters.', 'armGroupLabels': ['Standard health education']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in child BMI-for-age z-score', 'description': 'Anthropometric measurements such as body weight and height will be assessed according to the standard procedures of the World Health Organization (1995). BMI will be calculated using the standard formula (kg/m2). BMI-for-age Z-score curve, according to the WHO references will be used to classify weight status. The child weight status will be categorized into four categories which are overweight (\\\\> +1SD of BMI-for-age z-score), obese (\\\\> +2SD of BMI-for-age z-score), thinness/wasting (\\\\< -2SD of BMI-for-age z score) and normal weight (+1SD to -2SD of BMI-for-age z-score).', 'timeFrame': '3-month and 9-month after baseline'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an 80% power to detect a small to medium effect size at a 5% significance level. The design effect due to cluster sampling is 1.37, and a 20% loss to follow-up is anticipated.", "answer": 460, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size is calculated for the primary outcome, BMI z-score. The sample size for individual randomisation of the present study is based on Formula 1 [29]. The values used in the sample size calculation are based on the BMI z-score data from Ahmad et al. (2018) [30] study, which is 1.95\u00c2\u00b10.45 and 2.09\u00c2\u00b10.35 for the treatment and control groups, respectively. Based on Formula 1, a calculated sample size required for each group arm is 131 child-parent dyads. It is calculated that, with at least 80% power to identify a small to medium effect size [31] at the 5% significance level, the present study needs a total of 262 child-parent dyads for the two-group arm.\n\nnIndividual_Binary=(z1\u00e2\u0088\u0092\u00ce\u00b12+z1\u00e2\u0088\u0092\u00ce\u00b2)2[\u00cf\u0083trt2+\u00cf\u0083con2r]\u00ce\u00942\n(1)\n\nwhere, r=ncon\u00cf\u0083con,\u00ce\u0094=\u00ce\u00bctrt\u00e2\u0088\u0092\u00ce\u00bccon\n \u00ce\u00bctrt = Mean in treatment group = 1.95\n \u00ce\u00bccon = Mean in control group = 2.09\n \u00cf\u0083trt = SD. in treatment group = 0.45\n \u00cf\u0083con = SD. in control group = 0.35\n z = Critical z value for a given Alpa (\u00ce\u00b1) = 0.05 (two \u00e2\u0088\u0092 sided) and Beta (\u00ce\u00b2) = 0.2 with the value of z1\u00e2\u0088\u0092\u00ce\u00b12 = 1.96 and z1\u00e2\u0088\u0092\u00ce\u00b2 = 0.84\n r = Ratio of the two sample sizes = 1/1\n An adjustment using the design effect (DE) is made for the calculated sample size to allow for the design structure (due to the cluster sampling method), which results in larger sample sizes [32]. Taking into account unequal cluster size [10], assume the mean cluster size of 38 child-parent dyads will be recruited per preschool. Based on the Formula 2 [32, 33], given that the number of individuals per cluster (n) in the present study is 38 child-parent dyads and the Intra-cluster correlation coefficient (\u00cf\u0081) from the previous studies is 0.01 [18, 34], the calculated design effect of the present study is 1.37.\n \nDesigneffect(DE)=1+(n\u00e2\u0080\u00931)\u00cf\u0081\n(2)\n\n By considering the design effect is 1.37 and the sample size required for each group arm (nIndividual_Binary) is 131 (see Formula 3), the total sample size of the individual randomisation is further increased from 262 to 360 child-parent dyads.\n \n(nIndividual_Binary)\u00c3\u0097Designeffect\u00c3\u00972\n(3)\n\n After estimating a loss to follow-up of 20% for this trial, the final sample size is increased to a total of 460 child-parent dyads (230 per group arm). Thus, based on the total number of participants in the two groups is 460 and the number of individuals per cluster is 38 child-parent dyads (see Formula 4), a calculated number of preschool clusters in the present study is 12 preschools. Therefore, 6 preschool clusters will be randomised to each experimental and control group.\n \nn_cluster=Totalnumberofparticipantsinthetwogroupsnumberofindividualspercluster\n(4)", "id": 977, "split": "val"} +{"trial_id": "NCT04713124", "pmid": "36991490", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Ready2Change-Methamphetmine (R2C-M): A Randomised Controlled Trial of a Telephone-delivered Intervention to Reduce Methamphetamine Use\n\nIncluded conditions:\n- Methamphetamine Use Disorder\n\nStudy Armgroups:\n- {'label': 'R2C-M intervention', 'type': 'EXPERIMENTAL', 'description': 'R2C-M telephone intervention - Six approximately weekly sessions of R2C-M telephone-delivered intervention (50 minutes in duration), delivered by the same R2C-M Counsellor each session (a qualified clinical psychologist trained in the R2C protocol by the developer, Dr Kate Hall). Call duration will be recorded. Sessions will be digitally recorded, and an independent researcher will randomly select and rate fidelity of intervention sessions for 20% of participants.\\n\\nR2C-M workbooks - Two workbooks to facilitate counsellor-delivered exercises within sessions, and between-session practice, will be mailed/emailed to participants.\\n\\nSelf-help booklet - (as in control group) R2C-M participants will also receive a booklet of information and self-help strategies for methamphetamine use problems.', 'interventionNames': ['Behavioral: R2C-M', 'Other: Self-help booklet']}\n- {'label': 'Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'Self-help booklet - Control participants will receive (by mail/email) a booklet of information and self-help strategies for methamphetamine use problems.\\n\\nTelephone check-ins + information on further support - (to control for frequency of contact across treatment arms) Participants in this group will receive 6 telephone calls from the research team (lasting maximum 5 minutes, call duration will be recorded). During these calls, participants will be asked about their use of the booklet. Whenever required, the researcher will provide participants with information on further support (e.g. DirectLine or other state/territory AOD helpline for advice or referral).', 'interventionNames': ['Other: Self-help booklet']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'R2C-M', 'description': 'R2C-M comprises 12 modules addressing core practice elements and skills from evidence-based cognitive and behavioural interventions. Modules include: (i) self-monitoring, goal setting and behaviour change skills; (ii) identification of strengths and motivational enhancement; (iii) relapse prevention; (iv) psychoeducation and harm reduction; (v) emotion regulation skills; (vi) anger management skills; (vii) urges and cravings management skills; (viii) sleep hygiene skills; (ix) mindfulness skills; (x) interpersonal skills; (xi) anxiety management skills; (xii) depressed mood management skills. The R2C-M workbooks contain psychoeducation and intervention exercises, to facilitate counsellor-delivered exercises within sessions, and between-session practice.', 'armGroupLabels': ['R2C-M intervention']}\n- {'type': 'OTHER', 'name': 'Self-help booklet', 'description': 'A booklet of information and self-help strategies for methamphetamine use problems.', 'armGroupLabels': ['Control', 'R2C-M intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Methamphetamine problem severity', 'description': 'Change in methamphetamine problem severity (Drug Use Disorders Identification Test; DUDIT)', 'timeFrame': '3-months post-randomisation'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 5% significance level, 90% power, and a 20% dropout rate. The between-subject variance component is 21, and the within-subject variance component is 63. The study also considers potential deterioration of effects by 50% at 6 months and return to baseline by 12 months.", "answer": 204, "answer_type": "ACTUAL", "explanation": "Sample size estimates\n We aim to randomise between 188 and 204 participants to this study (i.e. total N = 196 \u00c2\u00b1 8, subjects per study arm = 98 \u00c2\u00b1 4). This was calculated using the Genstat [66] power procedure. The primary outcome measure (DUDIT score 3 months post-baseline) can range from 0 to 40 and will be analysed via a linear mixed model. Using data from our pilot work\u00c2\u00a0[20], we found that the between-subject variance component in DUDIT score was 21, the within-subject variance component was 63 and the estimated improvement (decline) in DUDIT score was 17 (SE = 1.6). We estimate that by 3 months there will be an improvement of at least 16 in the R2C-M arm and that the control arm could exhibit an improvement of up to 10. With 75 evaluable subjects in each treatment arm, the study will have 90% power to detect this difference in improvement using an F-test conducted at the 5% significance level. If these conjectured improvements by 3 months are not durable and, for example, deteriorate by 50% at 6 months, and return, on average, to baseline values by 12 months, then this treatment-by-time interaction scenario will be detected with at least 90% power. The initial target sample size of 188 comprises 75 per arm, inflated to 94 per arm to allow for approximately 20% drop-out, which is based on the attrition rates reported in other treatment [67] and helpline [68] research with AOD cohorts using 12\u00c2\u00a0month endpoints. Provision has been made to increase the recruitment target, based on the 3\u00c2\u00a0and 6\u00c2\u00a0month attrition rates observed after recruitment and data collection commenced (after 12 months of data collection with this complex cohort, 3 and 6\u00c2\u00a0month attrition rates were higher than anticipated). As such, the target sample size was increased from 188 subjects, to up to 204 participants (i.e. an additional 8 subjects based on the 3\u00c2\u00a0month attrition rate; or an additional 16 subjects based on the 6\u00c2\u00a0month attrition rate). Based on our experience with social media advertising for alcohol and other drug treatment trials, it is estimated that 10\u00e2\u0080\u009312 participants will be recruited per month over 18 months.", "id": 978, "split": "val"} +{"trial_id": "NCT04713514", "pmid": "39155847", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Phase II Study Comparing Neo-epitope Based Vaccine OSE2101 (TEDOPI\u00ae) With or Without Anti-PD1 (Pembrolizumab) Versus Best Supportive Care as Maintenance Treatment in Platinum-sensitive Recurrent Ovarian Cancer Patient With Controlled Disease After Platinum-based Chemotherapy\n\nIncluded conditions:\n- Platinum-sensitive Ovarian Cancer\n- Relapsed Ovarian Cancer\n\nStudy Armgroups:\n- {'label': 'Arm A : Best Supportive Care', 'type': 'NO_INTERVENTION', 'description': 'Observational arm (Standard of care)'}\n- {'label': 'Arm B : OSE2101', 'type': 'EXPERIMENTAL', 'description': 'OSE2101 monotherapy - subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years.\\n\\nOSE2101 vaccine is an emulsion of peptides suspension in in Montanide\u00ae ISA 51 adjuvant and containing 0.5 mg/mL of each 10 synthetically manufactured peptides (5.0 mg/mL total peptide) in 1.5 mL of emulsion.', 'interventionNames': ['Drug: OSE2101']}\n- {'label': 'Arm C : OSE2101 + Pembrolizumab', 'type': 'EXPERIMENTAL', 'description': 'OSE2101 (subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years) + pembrolizumab (400 mg IV infusion on day 1 every 6 weeks until intolerance, disease progression, or up to 2 years.', 'interventionNames': ['Drug: OSE2101', 'Drug: Pembrolizumab 25 MG/ML [Keytruda]']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'OSE2101', 'description': 'subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years.', 'armGroupLabels': ['Arm B : OSE2101', 'Arm C : OSE2101 + Pembrolizumab'], 'otherNames': ['TEDOPI\u00ae']}\n- {'type': 'DRUG', 'name': 'Pembrolizumab 25 MG/ML [Keytruda]', 'description': '400 mg IV infusion on day 1 every 6 weeks until intolerance, disease progression, or up to 2 years.', 'armGroupLabels': ['Arm C : OSE2101 + Pembrolizumab'], 'otherNames': ['KEYTRUDA\u00ae', 'MK-3475']}\n\nPrimary Outcomes:\n- {'measure': 'Progression free survival (PFS)', 'description': 'Progression-free survival (PFS) is the time from randomization to progression measured radiologically using RECIST v1.1 guidelines as reported by the investigator or death, whatever the cause, whichever comes first. Patients alive and free of progression at the cut-off date will be censored at the last tumor assessment date', 'timeFrame': 'from date to randomization to date of event, assessed up to 4 years'}\n\nPlease estimate the sample size based on the assumption: \nThe trial is designed with a type I error rate (\u03b1) of 5% and a type II error rate (\u03b2) of 10%, with one-sided tests. The sample size calculation ensures 90% power to detect the improvement in PFS. Hierarchical testing will be employed using one-sided log-rank tests with a nominal \u03b1 value of 0.05. The trial assumes a 2-year accrual period and a minimum 1-year follow-up per patient.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "3.7.\n Statistical methods & sample size determination\n This proof-of-concept trial aims to assess the efficacy of two investigational treatments (Arms B and C) compared with best supportive care (Arm A) as the control group. The primary end point is\u00c2\u00a0PFS, measured from randomization to disease progression. Sample size calculations were conducted using SAS 9.4 power analysis software.\n The trial is designed with a type I error rate (\u00ce\u00b1) of 5% and a type II error rate (\u00ce\u00b2) of 10%, with one-sided tests. Previous trials have shown short median PFS in patients with platinum-sensitive relapse who responded to re-challenge with platinum doublet: 5.5\u00c2\u00a0months for BRCA-mutated patients and less than 4\u00c2\u00a0months for non-BRCA-mutated patients. We anticipate a slightly shorter PFS (<4\u00c2\u00a0months) in our population, as most patients will have received a PARP inhibitor and are required to have non-progression on platinum chemotherapy rather than an objective response per RECIST criteria. The combination of OSE2101 and pembrolizumab is hypothesized to outperform both OSE2101 alone and best supportive care (BSC). If the combination does not outperform BSC, no difference is expected between OSE2101 alone and BSC.\n Hierarchical testing (fixed sequence procedure) will be employed to compare the treatment arms, using three one-sided log-rank tests in a predefined order:1.**H1**: Arm C (OSE2101\u00c2\u00a0+\u00c2\u00a0pembrolizumab) vs\u00c2\u00a0Arm A (BSC)- If H1 is statistically significant, proceed to:2.**H2**: Arm C (OSE2101\u00c2\u00a0+\u00c2\u00a0pembrolizumab) vs\u00c2\u00a0Arm B (OSE2101)- If both H1 and H2 are statistically significant, proceed to:3.**H3**: Arm B (OSE2101) vs\u00c2\u00a0Arm A (BSC)\n\n All one-sided tests in this sequence will use a nominal \u00ce\u00b1 value of 0.05. If H1 is not rejected, further tests will be exploratory.\n The sample size is calculated to ensure 90% power to detect an improvement in PFS for the combination therapy compared with BSC, with a hazard ratio (HR) of 0.57 (assuming median PFS increases from 4 to 7\u00c2\u00a0months under the exponential distribution of PFS), and an imbalanced randomization of 2:1. This design requires 121 events (progression or deaths) to test H1. Assuming a 2-year accrual period and a minimum 1-year follow-up per patient, 180 patients need to be randomized across Arm A (n\u00c2\u00a0=\u00c2\u00a045), Arm B (n\u00c2\u00a0=\u00c2\u00a045)\u00c2\u00a0and Arm C (n\u00c2\u00a0=\u00c2\u00a090) to observe the required events.\n With 45 patients in the OSE2101 monotherapy arm, the trial will have 78% power to detect an HR of 0.57 compared with the BSC arm.", "id": 979, "split": "val"} +{"trial_id": "NCT04714047", "pmid": "36109033", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Progressive Resistance Training Compared to Neuromuscular Exercise in Patients With Hip Osteoarthritis, and the Additive Effect of Booster Sessions: A Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Hip Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'Group 1:', 'type': 'EXPERIMENTAL', 'description': 'PRT', 'interventionNames': ['Other: Progressive Resistance Training and no booster sessions']}\n- {'label': 'Group 2:', 'type': 'EXPERIMENTAL', 'description': 'PRT + Booster sessions', 'interventionNames': ['Other: Progressive Resistance Training and booster sessions']}\n- {'label': 'Group 3:', 'type': 'ACTIVE_COMPARATOR', 'description': 'NEMEX', 'interventionNames': ['Other: Neuromuscular exercise and no booster sessions']}\n- {'label': 'Group 4:', 'type': 'EXPERIMENTAL', 'description': 'NEMEX + Booster sessions', 'interventionNames': ['Other: Neuromuscular exercise and booster sessions']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Progressive Resistance Training and no booster sessions', 'description': 'An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week.\\n\\nThe sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of PRT with exercises targeting the muscles of the hip and knee joints; leg press, hip extension, hip abduction, hip flexion and knee extension. The progression will be in line with guidelines provided by the American College of Sports Medicine. The intensity will follow repetition maximum (RM) targets, from 12 RM for the first week towards 8 RM for the last weeks.\\n\\nAfter the 12 weeks, this group consists of patients who are randomized to receive no further treatment. For the following 9 months, these patients are given a membership to a fitness center where they are encouraged to continue the same exercise regime.', 'armGroupLabels': ['Group 1:']}\n- {'type': 'OTHER', 'name': 'Progressive Resistance Training and booster sessions', 'description': 'An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week.\\n\\nThe sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of PRT with exercises targeting the muscles of the hip and knee joints; leg press, hip extension, hip abduction, hip flexion and knee extension. The progression will be in line with guidelines provided by the American College of Sports Medicine. The intensity will follow repetition maximum (RM) targets, from 12 RM for the first week towards 8 RM for the last weeks.\\n\\nAfter the 12 weeks, this group consists of patients who are randomized to receive 4 booster sessions (at 1, 3, 5 and 7 months after termination of the initial 12 week intervention). Additionally, for the following 9 months, these patients are given a membership to a fitness center where they are encouraged to continue the same exercise regime without supervision.', 'armGroupLabels': ['Group 2:']}\n- {'type': 'OTHER', 'name': 'Neuromuscular exercise and no booster sessions', 'description': 'An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week.\\n\\nThe sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of NEMEX training with exercises focused on stability, postural function, postural orientation, lower extremity muscle strength, and functional exercises. Progression is made when an exercise is performed with good sensorimotor control and good quality of the performance and with minimal exertion and adequate control of the movement.\\n\\nAfter the 12 weeks, this group consists of patients who are randomized to receive no further treatment. For the following 9 months, these patients are given equipment and encouraged to continue the same exercise regime at home without supervision.', 'armGroupLabels': ['Group 3:']}\n- {'type': 'OTHER', 'name': 'Neuromuscular exercise and booster sessions', 'description': 'An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week.\\n\\nThe sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of NEMEX training with exercises focused on stability, postural function, postural orientation, lower extremity muscle strength, and functional exercises. Progression is made when an exercise is performed with good sensorimotor control and good quality of the performance and with minimal exertion and adequate control of the movement.\\n\\nAfter the 12 weeks, this group consists of patients who are randomized to receive 4 booster sessions (at 1, 3, 5 and 7 months after termination of the initial 12 week intervention). Additionally, for the following 9 months, these patients are given equipment and encouraged to continue the same exercise regime at home.', 'armGroupLabels': ['Group 4:']}\n\nPrimary Outcomes:\n- {'measure': 'Change in functional performance measured by the 30-seconds chair stand test', 'description': 'The 30-second chair stand test is a valid and responsive measure of lower-extremity muscle strength evaluating sit-to-stand function, which is limited in people with lower extremity OA.', 'timeFrame': 'Measured at baseline, 12 week and 12 month follow-up.'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a power of 0.90, a two-sided significance level of \u03b1=0.05, and an anticipated dropout rate of 30%.", "answer": 160, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size calculation is based on the expected between-group difference in the 30 s CST from baseline to 3-month follow-up. Due to lack of hip OA specific data, the sample size calculation relies on data from knee OA. A mean change of 2.5 chair stands was found by Skoffer et al59 in knee OA patients after 4 weeks of PRT and a mean change of 1.0 chairs stands was found by Bennell et al60 after 12 weeks of NEMEX also in knee OA patients, resulting in a difference between treatments of 1.5 chair stands. An SD of 2.52 for the 30 s CST is calculated from the 95%\u00e2\u0080\u0089CI of the change in the intervention group of the study by Skoffer et al.59 Given a power of 0.90 and two-sided significance level \u00ce\u00b1=0.05, the estimated sample size for a two-sample means test comparing PRT to NEMEX yields 122 participants. With an anticipated dropout rate of 30%, a total of 160 participants is the estimated sample size. For the primary 12-month comparison, the difference between groups receiving booster sessions and groups not receiving booster sessions is expected to be larger than for the comparison of PRT and NEMEX. Hence, we expect this study to be adequately powered for both comparisons.", "id": 980, "split": "val"} +{"trial_id": "NCT04714762", "pmid": "36344008", "question": "Here is the design of a clinical trial:\n\nOfficial Title: eHealth in Treatment of Gestational Diabetes - eMOM GDM -Study (Phase 2)\n\nIncluded conditions:\n- Gestational Diabetes\n- Mobile Application\n\nStudy Armgroups:\n- {'label': 'Intervention (eMOM GDM application)', 'type': 'EXPERIMENTAL', 'description': 'Participants in the intervention group will use the eMOM GDM -application one week/month. The participants will also receive regular antenatal care in maternity clinics and hospitals. In addition they will meet a study nurse three times during study period (at GW 24-28, at GW 35-37 and 3 mo postpartum).', 'interventionNames': ['Device: eMOM GDM application']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will meet a study nurse 3 times during study period (at GW 24-28, at GW 35-37 and 3 mo postpartum). They also receive regular antenatal care in maternity clinics and hospitals.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'eMOM GDM application', 'description': 'Participants in the intervention group will use the eMOM GDM -application one week/month.\\n\\neMOM GDM application includes:\\n\\n* continuous glucose monitor (CGM, Medtronic)\\n* diet (digital food tracker) (min 3 days during one application week)\\n* heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3)\\n* weight measured once a week\\n\\nThe sensors can be worn and the application used during the whole pregnancy (if a mother is interested in)', 'armGroupLabels': ['Intervention (eMOM GDM application)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in fasting glucose', 'description': 'change in fasting glucose measured by Huslab (laboratory measurement)', 'timeFrame': 'from gestational weeks 24-28 to gestational weeks 35-37'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) < 0.05, power = 95%, assumed drop-out rate = 40%.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size\n To detect at least a 0.32\u00e2\u0080\u0089mmol/L between-group mean difference in the fP-glucose (primary outcome) response to the intervention (\u00ce\u00b1<0.05, power=95%, an assumed drop-out rate of 40%), a sample of 200\u00e2\u0080\u0089women (100 in each intervention arm) is needed for the intervention study. This anticipated difference of 0.32\u00e2\u0080\u0089mmol/L between the intervention group and control group corresponds to 0.7 SD of variation in fP-glucose change observed previously in similar women and stage of pregnancy (SD needed for power calculation has been calculated from the Finnish Gestational Diabetes Prevention Study-population; SD for change in fP-glucose value between II and III trimesters in women who got GDM diagnoses at II trimester).51", "id": 981, "split": "val"} +{"trial_id": "NCT04719468", "pmid": "38233784", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of Ballet Dancing on Motor and Non-motor Symptoms of Parkinson's Disease: a Hybrid Type 2 Effectiveness-implementation Trial\n\nIncluded conditions:\n- Parkinson Disease\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Dance with ballet elements']}\n- {'label': 'Usual Treatment', 'type': 'NO_INTERVENTION', 'description': \"usual treatment with the addition of joining 'Tea and Biscuit' sessions remotely\"}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Dance with ballet elements', 'description': 'Ballet-based dance sessions will be delivered by trained artists within the English National Ballet group in a professional dance space/ delivered remotely, COVID-19 permitting.', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in total score of the Movement Disorders Society Sponsored Non-Motor Rating Scale', 'description': 'Clinical Effectiveness Primary Outcome Measure, higher score indicate worse non-motor symptomatology, the maximum score is 1008.', 'timeFrame': 'Baseline (week -4 to 0), end of intervention (week 12-14) and up to 24 weeks post intervention depending on participant availability'}\n- {'measure': 'Acceptability of Intervention Measure', 'description': 'Implementation Effectiveness Primary Outcome Measure - a 4 item, 5-point likert scale', 'timeFrame': 'post intervention (week 12)'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, 10% attrition rate, superiority study at immediate follow-up", "answer": 160, "answer_type": "ESTIMATED", "explanation": "Sample size\n Given that no previous studies explored the effect of ballet dancing on the symptoms of PD, sample size calculation is based on detecting a significant difference between intervention and the control group in the mean changes from baseline to follow-up in the primary outcome (MDS-NMS). To date, no clinical trials have yet utilised MDS-NMS as an outcome measure due to its novelty. As such, our estimation of the sample size is based on detecting a medium effect size (Cohen\u00e2\u0080\u0099s d 0.5) with 80% power and 5% significance, resulting in the total of 144 participants. Given that the randomisation ratio is 2:1, the intervention group is expected to include 96 participants and the control group 48 participants. Allowing a 10% attrition rate for the final analysis, the total number of participants in the study will be 160. The study is powered as a superiority study at immediate follow-up.", "id": 982, "split": "val"} +{"trial_id": "NCT04719481", "pmid": "35831045", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Reduction Effect of Oral Pravastatin on Acute Phase Response of Intravenous Zoledronic Acid: a Real-world Study\n\nIncluded conditions:\n- Postmenopausal Osteoporosis\n\nStudy Armgroups:\n- {'label': 'pravastatin 80mg/d', 'type': 'EXPERIMENTAL', 'description': 'Oral administration of pravastatin at 1 h before zoledronic acid infusion, 24 h and 48 h after zoledronic acid infusion', 'interventionNames': ['Drug: Pravastatin Sodium 80 MG']}\n- {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Oral administration of placebo at 1 h before zoledronic acid infusion, 24 h and 48 h after zoledronic acid infusion', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Pravastatin Sodium 80 MG', 'description': 'daily oral administration of 80mg', 'armGroupLabels': ['pravastatin 80mg/d'], 'otherNames': ['Meibailezhen']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'daily oral administration', 'armGroupLabels': ['placebo'], 'otherNames': ['Meibailezhen placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Incidence of acute phase response', 'description': 'Effect of oral pravastatin on the incidence of acute phase response within 72 hours after zoledronic acid infusion', 'timeFrame': '0-72 hours'}\n\nPlease estimate the sample size based on the assumption: \nThe number of events per variable is selected to be 10. A 10% loss to follow-up is considered.", "answer": 110, "answer_type": "ESTIMATED", "explanation": "Sample size\n This study adopts a real-world prospective non-randomised controlled clinical trial design method. Considering that there may be 4\u00e2\u0080\u00936 factors associated with baseline variables (including intervention), the number of events per variable was selected to be 10.16\u00e2\u0080\u009318 After the adjustment of five factors, such as age, body weight, height, BMD and intervention, approximately (10\u00c3\u00975=) 50 participants in each arm were deemed necessary. In addition, considering a 10% loss to follow-up, 55 participants will be needed for each arm for a total of 110 participants.", "id": 983, "split": "val"} +{"trial_id": "NCT04723719", "pmid": "37055205", "question": "Here is the design of a clinical trial:\n\nOfficial Title: SIESTA Sleep IntervEntion as Symptom Treatment for ADHD - Blended CBT Sleep Intervention to Improve Sleep, ADHD Symptoms and Related Problems in Adolescents With ADHD\n\nIncluded conditions:\n- ADHD\n- Sleep\n- Adolescents\n- CBT\n\nStudy Armgroups:\n- {'label': 'SIESTA training + treatment as usual for ADHD', 'type': 'EXPERIMENTAL', 'description': 'We developed a cognitive behavioral therapy for sleep problems in adolescents with ADHD. This includes seven individual sessions with the adolescent and two individual sessions with the parent(s)/guardian(s). Participants receive this CBT training called SIESTA next to their treatment as usual for ADHD symptomatology (mostly ADHD-medication).', 'interventionNames': ['Behavioral: SIESTA', 'Other: Treatment as usual for ADHD']}\n- {'label': 'Treatment as usual for ADHD only', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants continue their treatment as usual for ADHD (mostly ADHD-medication).', 'interventionNames': ['Other: Treatment as usual for ADHD']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'SIESTA', 'description': 'SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization.', 'armGroupLabels': ['SIESTA training + treatment as usual for ADHD'], 'otherNames': ['Sleep IntervEntion as Symptom Treatment for ADHD']}\n- {'type': 'OTHER', 'name': 'Treatment as usual for ADHD', 'description': 'Participants continue their treatment as usual for ADHD.', 'armGroupLabels': ['SIESTA training + treatment as usual for ADHD', 'Treatment as usual for ADHD only'], 'otherNames': ['TAU']}\n\nPrimary Outcomes:\n- {'measure': 'Sleep architecture objective TST pre-test to post-test', 'description': 'objective (actigraphy) sleep architecture (specified as TST in hours and minutes)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep architecture objective SOL pre-test to post-test', 'description': 'objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep architecture objective SE pre-test to post-test', 'description': 'objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep architecture objective NoA pre-test to post-test', 'description': 'objective (actigraphy) sleep architecture (specified as NoA)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep architecture subjective TST pre-test to post-test', 'description': 'subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep architecture subjective SOL pre-test to post-test', 'description': 'subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep architecture subjective SE pre-test to post-test', 'description': 'subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep architecture subjective NoA pre-test to post-test', 'description': 'subjective (sleep logs) sleep architecture (specified as NoA)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep architecture objective TST pre-test to follow-up', 'description': 'objective (actigraphy) sleep architecture (specified as TST in hours and minutes)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep architecture objective SOL pre-test to follow-up', 'description': 'objective (actigraphy) sleep architecture (specified as SOL in hours and minutes)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep architecture objective SE pre-test to follow-up', 'description': 'objective (actigraphy) sleep architecture (specified as SE = TST/time in bed in percentage)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep architecture objective NoA pre-test to follow-up', 'description': 'objective (actigraphy) sleep architecture (specified as NoA)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep architecture subjective TST pre-test to follow-up', 'description': 'subjective (sleep logs) sleep architecture (specified as TST in hours and minutes)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep architecture subjective SOL pre-test to follow-up', 'description': 'subjective (sleep logs) sleep architecture (specified as SOL in hours and minutes)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep architecture subjective SE pre-test to follow-up', 'description': 'subjective (sleep logs) sleep architecture (specified as SE = TST/time in bed in percentage)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep architecture subjective NoA pre-test to follow-up', 'description': 'subjective (sleep logs) sleep architecture (specified as NoA)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep problems SSHS pre-test to post-test', 'description': 'subjective sleep problems assessed by questionnaires (SSHS)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep problems CSRQ pre-test to post-test', 'description': 'subjective sleep problems assessed by questionnaires (CSRQ)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep problems CSHQ pre-test to post-test', 'description': 'subjective sleep problems assessed by questionnaires (CSHQ)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep problems SSHS pre-test to follow-up', 'description': 'subjective sleep problems assessed by questionnaires (SSHS)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep problems CSRQ pre-test to follow-up', 'description': 'subjective sleep problems assessed by questionnaires (CSRQ)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep problems CSHQ pre-test to follow-up', 'description': 'subjective sleep problems assessed by questionnaires (CSHQ)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n- {'measure': 'Sleep hygiene pre-test to post-test', 'description': 'subjective sleep hygiene assessed by questionnaires (ASHSr)', 'timeFrame': 'From pre-test to post-test (+- 8 weeks)'}\n- {'measure': 'Sleep hygiene pre-test to follow-up', 'description': 'subjective sleep hygiene assessed by questionnaires (ASHSr)', 'timeFrame': 'From pre-test to follow-up (+-3 months after posttest)'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.8 and an \u00ce\u00b1 of 0.5 were used. An additional 15% was added to account for possible drop-out or lack of response on assessment.", "answer": 92, "answer_type": "ACTUAL", "explanation": "Sample size estimates\n A recent study in typically developing adolescents with sleep problems found large effects (\u00ce\u00b2=0.91) at post-test of a CBT sleep treatment as compared with waitlist controls on their primary sleep-related outcome measure (objectively measured) and a medium effect size for reduction of ADHD symptoms.13 14 Based on this research, moderate to large effect sizes can be expected for SIESTA in combination with TAU for ADHD on sleep outcomes as compared with TAU for ADHD only. Therefore, using G*power we calculated with this large effect size a power of 0.8 and an \u00ce\u00b1 of 0.5 for our desired sample size. There are at least 40 participants per condition needed for analysing the data implementing a linear mixed effects model. However, to anticipate for possible drop-out or lack of response on assessment (although expected to be minimal due to inclusion of motivational interviewing and the pilot study) and as the effect size of the ADHD outcome is medium and not large (d=0.55), an additional 15% will be recruited, resulting in a total of 92 participants, with 46 participants per condition.", "id": 984, "split": "val"} +{"trial_id": "NCT04723758", "pmid": "35680613", "question": "Here is the design of a clinical trial:\n\nOfficial Title: COLO-DETECT: A Randomised Controlled Trial of Lesion Detection at Colonoscopy Using the GI Genius Artificial Intelligence Platform\n\nIncluded conditions:\n- Colonic Polyp\n- Colorectal Polyp\n- Colorectal Adenoma\n- Colorectal Adenomatous Polyp\n- Colorectal SSA\n- Sessile Serrated Adenoma\n- Sessile Colonic Polyp\n\nStudy Armgroups:\n- {'label': 'GI Genius-assisted colonoscopy (GGC)', 'type': 'EXPERIMENTAL', 'description': 'In the GGC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure, except that at some point prior to commencing withdrawal of the colonoscope, a member of the endoscopy staff will turn on the GI Genius machine. This will remain operational from the time it is switched on until the end of the procedure.', 'interventionNames': ['Device: GI Genius-assisted diagnostic colonoscopy']}\n- {'label': 'Standard Colonoscopy (SC)', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the SC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure.', 'interventionNames': ['Diagnostic Test: Diagnostic Colonoscopy']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'GI Genius-assisted diagnostic colonoscopy', 'description': 'Participants will undergo diagnostic colonoscopy, which will be identical to the normal standard of care at the unit where they are undergoing their procedure, except that GI Genius will be turned on during the procedure.', 'armGroupLabels': ['GI Genius-assisted colonoscopy (GGC)']}\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Diagnostic Colonoscopy', 'description': 'Diagnostic colonoscopy will be performed as per the standard of care for the unit where the patient is having their procedure.', 'armGroupLabels': ['Standard Colonoscopy (SC)']}\n\nPrimary Outcomes:\n- {'measure': 'Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP)', 'description': 'The number of adenomas identified during each colonoscopy will be summed and divided by the total number of colonoscopies performed. MAP is usually expressed as a number to one decimal place (e.g. 1.2).', 'timeFrame': 'The number of adenomas detected in each procedure will be counted at 14 days post-procedure'}\n\nPlease estimate the sample size based on the assumption: \n90% power, two-sided test for difference in proportions, alpha value of 0.05, 10% attrition rate.", "answer": 2032, "answer_type": "ACTUAL", "explanation": "Sample size\n The primary outcome for COLO\u00e2\u0080\u0090DETECT is the difference in MAP between GGC and SC (for which a clinically meaningful mean difference has been considered to be 0.50 for screening patients and 0.30 for symptomatic patients) (based on communications between the senior author, the clinicians involved in the trial and taking opinion from other experts). Due to the importance of ADR in detection studies and its historical widespread use it is important that this study is also powered to demonstrate a difference in ADR.\n Exploratory\u00e2\u0080\u0094and, importantly, separate\u00e2\u0080\u0094sample size calculations for MAP and ADR indicate that a larger sample would be required to detect a significant difference in ADR than in MAP; COLO\u00e2\u0080\u0090DETECT has therefore been powered to detect a clinically meaningful and statistically significant difference in ADR, which exceeds that required to detect such a difference in MAP. This represents a difference of 7% in ADR (with a clinically meaningful difference deemed to be 10% for screening patients and 5% for symptomatic patients). Assuming a mixed sample of 40% screening (BCSP) patients and 60% symptomatic patients, with a baseline ADR of 27.6% across the sample (by aggregating BCSP and non\u00e2\u0080\u0090BCSP data), a superiority design including 2032 participants will be required to provide 90% power for a two\u00e2\u0080\u0090sided test for difference in proportions with an alpha value of 0.05. Allowing for 10% attrition due to incomplete colonoscopies, the target sample size will be 1828 participants having a complete colonoscopy. This sample size will more than enable detection of a pooled difference of 0.18 mean difference in MAP.", "id": 985, "split": "val"} +{"trial_id": "NCT04724902", "pmid": "36385041", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Elastic Bandage Compression on Pain and Function in Individuals With Knee Osteoarthritis - a Randomized Controlled Trial\n\nIncluded conditions:\n- Knee Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'Compression Group', 'type': 'EXPERIMENTAL', 'description': \"The volunteer must remain supine on a stretcher, with both legs extended and relaxed. The intervention will be performed with elastic bandages (Selecta\u00ae of 13cm x 160 cm, composed of 45% cotton, 20% elastodiene and 27% polyamide) involving the entire knee surface, positioned considering anatomical aspects: covering the femoral condyles and the anterior tibial tuberosity). The bandage will involve the knee from the distal to the proximal, respecting the blood flow of the venous return. The level of compression was defined according to recommendations in the literature on compression interventions in lymphedema and venous changes, and should be kept between 30 mmHg and 60 mmHg. Variations on stipulated values may be interfered according to the volunteer's self-report, which should indicate a level of moderate, comfortable and pain-free compression. The intervention will be carried out for 20 minutes, once a day, for 4 consecutive days.\", 'interventionNames': ['Other: Elastic bandage compression']}\n- {'label': 'Sham Group', 'type': 'SHAM_COMPARATOR', 'description': 'For Sham application, the volunteer must remain supine on a stretcher, with both lower limbs extended and relaxed. Elastic bandages will be used (Selecta\u00ae of 13cm x 160 cm, composed of 45% cotton, 20% elastodiene and 27% polyamide) involving the entire knee surface, positioned considering anatomical aspects: covering the femoral condyles and the anterior tibial tuberosity) . The bandage will involve the knee from the distal (tibial tuberosity) to the proximal (femoral condyles), respecting the blood flow of the venous return. However, in this group, no compression force will be performed, maintaining the pressure at 00 mmHg according to a previous reliability study. The procedure will be carried out for 20 minutes, once a day, for 4 consecutive days.', 'interventionNames': ['Other: Elastic bandage compression']}\n- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': \"The Control group will be composed of individuals with knee osteoarthritis, who make up the study's waiting list and will carry out evaluations at the same time intervals as the other groups, but will not receive any type of intervention and will be instructed not to start another treatment during their participation.\"}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Elastic bandage compression', 'description': \"The compression will be applied with the volunteer in the supine position on a stretcher, with both lower limbs extended and relaxed. The intervention in the Compression group will be with elastic bandages involving the entire surface of the knee, positioned considering anatomical aspects: femoral condyles and the anterior tibial tuberosity. The level of compression must be maintained between 30 mmHg and 60 mmHg, according to the researched literature. The variations within these values will be stipulated according to the volunteer's self-report (comfortable and painless compression). The Shan Group will have the bandage wrapped around the knee without any compression force being exerted. The intervention will be carried out for 20 minutes, once a day, for 4 consecutive days. The Control group will be composed of volunteers who make up a study waiting list and will carry out the evaluations at the same time intervals as the other groups, but will not receive any type of intervention.\", 'armGroupLabels': ['Compression Group', 'Sham Group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline - Visual Analog Scale (VAS)', 'description': 'The scale will be made available visually to the individual so that he can classify the intensity of the average pain relative to the last week, and also before and after the performance of each functional physical test. The scale will vary from 0 to 10 cm, with 0 being the complete absence of pain, and 10 being the maximum pain intensity reported by the individual. The 1.75cm reduction will be considered an MDCI.', 'timeFrame': 'Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.'}\n- {'measure': 'Change from baseline WOMAC (Western Ontario e o McMaster Universities Osteoarthritis Index) - Pain scale', 'description': 'Self-report questionnaire, designed to assess problems experienced by individuals with lower limb OA, in the last 72 hours. The volunteer will be asked to answer 24 questions, which comprise three domains: pain, stiffness and physical function. The scores for the items are expressed using the Likert scale, classified as: none = 0, low = 25, moderate = 50, severe = 75 and very severe = 100. Higher scores indicate higher levels of pain, stiffness and physical dysfunction . The reduction of 8.74 points in the pain domain, from the baseline, will be considered an MDCI.', 'timeFrame': 'Baseline, immediately after intervention and follow-up evaluations of 12 and 24 weeks.'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level was set at 5%, the power was 95%, and a possible dropout rate of 20% was considered.", "answer": 90, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was preliminarily calculated using the G*Power software (V.3.1.3; University of Trier, Germany).54 Two calculations were performed: pain (assessed using the VAS) and function (assessed using the WOMAC questionnaire). The calculation was based on the application of an F-test for the difference between the three independent means (three groups). The effect size considered for this calculation, based on a previous study,17 were d=0.45 for EVA and d=0.39 for WOMAC, which after conversion represented f=0.225 and f=0.195, respectively.55 The f effect sizes were between small and moderate and coincided with the range of classification for the values of d presented. The significance level was set at 5%, and the power was 95%. The calculations indicated a total of 54 participants using the VAS and 72 participants using the WOMAC questionnaire. The calculation to be considered will be based on the WOMAC questionnaire, with 24 individuals per group, making a total of 72 individuals. Considering a possible dropout rate of 20%,17 29 participants should be allocated to each group; however, to facilitate calculations and randomisation, 30 participants will be allocated to each group (n=90).", "id": 986, "split": "val"} +{"trial_id": "NCT04725721", "pmid": "37864269", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Testing FIRST in Youth Outpatient Psychotherapy\n\nIncluded conditions:\n- Anxiety\n- Depression\n- Trauma\n- Behavior Problem\n\nStudy Armgroups:\n- {'label': 'FIRST', 'type': 'EXPERIMENTAL', 'description': 'FIRST is built upon five empirically supported principles of change (ESPCs-i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, trying the opposite). Each principle can be applied to treatment of problems spanning depression, anxiety (including OCD and PTS), and conduct problems-thus encompassing a majority of the youths seen in outpatient care. Its design addresses breadth of problem coverage, youth comorbidity, and flux in youth treatment needs during episodes of care. It is used in conjunction with performance feedback via a web-based tracking system that gives clinicians weekly data on youth treatment response. FIRST has treatment and training efficiency, and efficient clinician skill-building is supported by group consultation.', 'interventionNames': ['Behavioral: FIRST']}\n- {'label': 'Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.', 'interventionNames': ['Behavioral: Usual Care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'FIRST', 'description': 'FIRST is built upon five empirically supported principles of change (ESPCs-i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, trying the opposite). Each principle can be applied to treatment of problems spanning depression, anxiety (including OCD and PTS), and conduct problems-thus encompassing a majority of the youths seen in outpatient care. Its design addresses breadth of problem coverage, youth comorbidity, and flux in youth treatment needs during episodes of care. It is used in conjunction with performance feedback via a web-based tracking system that gives clinicians weekly data on youth treatment response. FIRST has treatment and training efficiency, and efficient clinician skill-building is supported by group consultation.', 'armGroupLabels': ['FIRST']}\n- {'type': 'BEHAVIORAL', 'name': 'Usual Care', 'description': 'Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.', 'armGroupLabels': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001)', 'description': 'The CBCL is a parent-report checklist with 113 youth problem items, each rated on a 0-1-2 scale (0 = not true, 1 = somewhat/sometimes true, 2 = very often true). The YSR is a corresponding 112-item youth-report checklist measure. From both the CBCL and the YSR, T-scores, adjusted for age and gender, Internalizing, Externalizing, and Total Problems scales will be used for outcome assessment. Higher scores represent more severe problems, with borderline and clinical cutoffs at T = 60 and T = 63, respectively. Evidence of CBCL/YSR validity and reliability is strong and extensive.', 'timeFrame': 'Change from baseline to 18 months (quarterly at 0, 3, 6, 9, 12, and 18 months from 0 up to 78 weeks)'}\n- {'measure': 'Behavior and Feelings Survey (BFS; Weisz et al., 2020)', 'description': 'The 12-item BFS is a measure of internalizing (6 items), externalizing (6 items), and total problems, developed via four studies, three with samples of clinically referred youths aged 7-15 and their caregivers. Both youth and caregiver forms showed robust factor structure, internal consistency, test-retest reliability, convergent and discriminant validity in relation to three well-established symptom measures (including CBCL and YSR), and slopes of change indicating efficacy in monitoring treatment progress during therapy. Items are rated on a scale from 0 (not a problem) to 4 (a very big problem). Internalizing and externalizing scale scores range from 0 to 24 and total problems from 0 to 48 (with higher scores indicating greater problem severity).', 'timeFrame': 'Change from baseline through end of treatment (weekly from 0 up to 78 weeks)'}\n- {'measure': 'Functional Top Problems Assessment (TPA; Weisz et al., 2011)', 'description': 'The TPA assesses youth and caregiver severity ratings (from 0 = not a problem to 4 = a very big problem) for the functional top three problems the youth and caregiver independently identified as most important to them, in separate baseline interviews. Psychometric analyses have shown strong test-retest reliability, convergent and discriminant validity for the TPA in relation to standardized measures, and sensitivity to change during treatment.', 'timeFrame': 'Change from baseline through end of treatment (weekly from 0 up to 78 weeks)'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include an ICC of 0.02, 5 out of 6 repeated measures, a significance level (\u03b1) of 0.05, power (1-\u03b2) of 0.80, and a conservative attrition/data loss rate of 15%.", "answer": 212, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n The target sample size is N\u00e2\u0080\u0089=\u00e2\u0080\u0089212 youths. We used Optimal Design [59] to determine power for the main treatment effects, specifically comparing the rate of change for FIRST vs. UC. Assuming at least 24 providers, an ICC of 0.02 (based on prior RCETs), 5 of 6 repeated measures (quarterly schedule, anticipating some missing data), and standard thresholds for significance (\u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), we determined that a minimum sample of N\u00e2\u0080\u0089=\u00e2\u0080\u0089180 youth participants was required to achieve adequate power (1-\u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.80) to detect an effect size (ES) of 0.50 This ES of 0.50 or higher is anticipated for two specific primary outcomes measures\u00e2\u0080\u0094the CBCL [30] collected quarterly and the parent-rated TPA [33] collected weekly. As a transdiagnostic intervention trial covering multiple problem areas and a wide developmental range, broad composite measures are most appropriate as the basis for power estimation. Further, caregivers are considered the primary informants due to higher reliability and validity of caregiver report across all youth ages [30, 33, 60]. The selection of the ES magnitude (e.g., 0.50) was based on synthesizing evidence from three previous open trials of FIRST [8] which ranged from 0.45 to 0.98 and randomized trial research with MATCH [15, 16, 61] which ranged from 0.29 to 0.72. The data for MATCH showed an average ES reduction of 43%. When applied to the FIRST findings, the results predicted an ES of 0.51 for FIRST compared to usual care, thus our ES\u00e2\u0080\u0089=\u00e2\u0080\u00890.50 hypothesis. The estimation of an ES of 0.50 strikes an appropriate balance between Type I and Type II errors, and between cost-effectiveness and scientific assuredness. Further, we anticipate a conservative attrition/data loss rate of 15% will occur between allocation and analyses. Thus, a target sample size of N\u00e2\u0080\u0089=\u00e2\u0080\u0089212 youths will ensure adequate power for the primary analyses (Aim 1).\n Monte Carlo simulations were conducted in R using the simsem package [62] to estimate power for the Aim 2 mediation analyses. These simulations revealed that 180 participants will provide sufficient power to detect whether FIRST can produce a 0.36-SD change in the slope of the CBCL/YSR symptom improvement through the indirect effect of change in negative affect regulation.\n Analyses of variables that may be associated with EST implementation (Aim 3) are considered exploratory and therefore were not designed to be adequately powered. Further, available power will vary across models. Nonetheless, power for these models was simulated using the simr package in R [63] which found a sample size of 180 to be adequate to detect a standardized regression coefficient as low as 0.25 for clinician-level predictors/moderators of outcomes within the FIRST condition (anticipating\u00e2\u0080\u0089~\u00e2\u0080\u008990 youths across 12\u00e2\u0080\u009320 FIRST clinicians).", "id": 987, "split": "val"} +{"trial_id": "NCT04725864", "pmid": "35803628", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Vaginal Progesterone as Luteal Support for Improvement of Live Birth in Frozen/Thawed In-vitro Fertilization Natural Cycles; a Multicenter, Open, Randomized Trial\n\nIncluded conditions:\n- Infertility\n- Embryo Transfer\n\nStudy Armgroups:\n- {'label': 'No progesterone', 'type': 'NO_INTERVENTION', 'description': 'Patients will have FET in natural cycles with no extra intervention.'}\n- {'label': 'Progesterone for 3 weeks', 'type': 'EXPERIMENTAL', 'description': 'At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for three weeks.', 'interventionNames': ['Drug: Progesterone vaginal tablet']}\n- {'label': 'Progesterone for 7 weeks', 'type': 'EXPERIMENTAL', 'description': 'At day LH+3 patients will start treatment with vaginal progesterone tablet at 100mg three times daily for seven weeks.', 'interventionNames': ['Drug: Progesterone vaginal tablet']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Progesterone vaginal tablet', 'description': 'The study drug is progesterone 100 mg administrated as a vaginal tablet three times daily.', 'armGroupLabels': ['Progesterone for 3 weeks', 'Progesterone for 7 weeks'], 'otherNames': ['Lutinus, manufactured by Ferring GmbH. ATC code G03DA04']}\n\nPrimary Outcomes:\n- {'measure': 'Number of participants with live birth', 'description': 'A child born alive. Also, the outcome will be reported according to Core Outcome Measure for Infertility Trials (Duffy et al., 2020) in a separate appendix.', 'timeFrame': 'Up to 41 weeks after embryo transfer.'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.80, significance level of 0.05, and a two-sided Fisher\u2019s exact test.", "answer": 1800, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n In order to find an effect size of a 7% increase in LBR per randomised patient, measured as a difference in proportions between no progesterone (0.33) and any progesterone group (0.40), 1800 subjects are needed if allocated 1:2. In order to find a difference between no progesterone (0.33) and progesterone for 3 weeks (0.41) and 7 weeks (0.41), respectively, 1200 subjects are needed if allocated 1:1. Also, for the comparison between the progesterone groups, 1200 subjects are needed if allocated 1:1, to detect a difference of 8%, (0.38 for 3 weeks of progesterone vs 0.46 for 7 weeks). For all comparisons above, except for the primary analysis, a difference between groups of 8% is used. If 1800 women are allocated 1:1:1, 600 to no progesterone, 600 to progesterone 3 weeks and 600 to progesterone 7\u00e2\u0080\u0089weeks, all four sample size calculations are fulfilled under the condition of a power of 0.80, a significance level 0.05 and a two-sided Fisher\u00e2\u0080\u0099s exact test.\n We thus have two primary superiority analyses in this study. The first is the comparison of LBR between no progesterone and the combined group of any progesterone with Fisher\u00e2\u0080\u0099s exact test on significance level 0.05. If this test is significant the probability mass of 5% will be transferred to the second comparison of live birth between progesterone for 3 weeks compared with progesterone for 7 weeks. If the first test is significant, we have been able to show that any progesterone gives significantly higher LBR than in women without progesterone. If in the second comparison 7 weeks shows significantly higher LBR than 3 weeks, we have also confirmed superiority regarding 7 weeks over 3 weeks. If the first analysis is non-significant, we have not been able to show any confirmative results in this study. The comparisons between no progesterone and 3 weeks progesterone and between no progesterone and 7 weeks progesterone is performed to calculate mean difference with 95%\u00e2\u0080\u0089CI between these groups.", "id": 988, "split": "val"} +{"trial_id": "NCT04726124", "pmid": "35613801", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective, Multicenter, Randomized, Controlled Clinical Trial to Validate the Safety and Efficacy of Microwave Versus Laser Ablation of the Great Saphenous Vein in Patients With Varicose Veins\n\nIncluded conditions:\n- Varicose Veins of Lower Limb\n\nStudy Armgroups:\n- {'label': 'treatment group', 'type': 'EXPERIMENTAL', 'description': 'Microwave Ablation Therapeutic Apparatus. Patients with primary lower extremity varicose veins were treated with endovenous microwave therapy using Microwave Ablation Therapy Apparatus. Ultrasound examination and questionnaire survey\uff08AVVQ and VCSS) were performed at 1 week, 3 months, 6 months,12 months after treatment,drug use and adverse events were recorded to assess complications and target lesion closure rate.', 'interventionNames': ['Device: Microwave Ablation Therapeutic Apparatus']}\n- {'label': 'control group', 'type': 'EXPERIMENTAL', 'description': 'Semiconductor Laser Treatment Apparatus. Patients with primary lower extremity varicose veins were treated with endovenous laser treatment using Semiconductor Laser Treatment Apparatus. Ultrasound examination and questionnaire survey\uff08AVVQ and VCSS) were performed at 1 week, 3 months, 6 months, 12 months after treatment,drug use and adverse events were recorded to assess complications and target lesion closure rate.', 'interventionNames': ['Device: Microwave Ablation Therapeutic Apparatus']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Microwave Ablation Therapeutic Apparatus', 'description': 'The selected and qualified subjects with primary lower extremity varicose veins were randomly treated with microwave ablation equipment or laser treatment equipment. Subjects in the two groups were returned to the hospital for follow-up at 7 days, 3 months, 6 months, 12 months after surgery, respectively, for ultrasound examination and questionnaire evaluation, medication status and adverse events were recorded, and target lesion closure rate and subject satisfaction were evaluated.', 'armGroupLabels': ['control group', 'treatment group'], 'otherNames': ['Semiconductor Laser Treatment Apparatus']}\n\nPrimary Outcomes:\n- {'measure': 'the complete closure rate of great saphenous vein at 6 months after surgery', 'description': 'Complete closure: Doppler ultrasonography showed that the target vein segment of the entire treatment is closed, with no discontinuous unclosed segment more than 5 cm.\\n\\nCalculation method: Complete closure rate = number of subjects with complete closure of target vein in the group/total number of subjects in the same group \u00d7 100%.\\n\\nThe B-ultrasound check is performed on subjects 6 months after the surgery for whether the target vein is completely closed, the result is recorded. After the trial is completed, the number of subjects whose target vein is completely closed is counted, and the complete closure rate of great saphenous vein is calculated.', 'timeFrame': '6 months after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (\u03b1) is 0.025, the power is 80%, and the maximum dropout rate is 20%.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size will be calculated based on the occlusion rate of GSV at 6 months after the treatment. According to the data reported in relevant literature, the effective rate ranges from 92% to 98%.15 16 After comprehensive consideration, the effective rate in this trial is preset as 95%. The non-inferiority cut-off value recognised by clinical experts is \u00e2\u0088\u009210%. The \u00ce\u00b1 is 0.025, and the power is taken as 80%. The calculation formula for the sample size of the qualitative index non-inferiority design in the Guidelines for Clinical Trial Design of Medical Devices17 is adopted:\n \n\nnT=nC=(Z1-\u00ce\u00b1/2+Z1-\u00ce\u00b2)2[(PC1-PC+PT1-PT](D-\u00e2\u0088\u0086)2\n\n\n PT and PC are the expected occlusion rates of GSV in the EMA group and the EVLA group, respectively, and \u00ce\u0094 refers to the non-inferiority test cut-off value (negative here). Based on this calculation formula, 75 patients are needed in each group. Considering a possible maximum dropout rate of 20% in each group during the trial, the planned number of patients in each group is increased to 90. As a result, the total number of patients enrolled in the two groups is 180.", "id": 989, "split": "val"} +{"trial_id": "NCT04727450", "pmid": "35524188", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Multimodal Training of Combined Cognitive and Physical and Cognitive or Physical Training Only on Cognition and Physical Fitness of Older Adults: A Cluster Randomized Controlled Trial\n\nIncluded conditions:\n- Cognitive Decline\n- Cognitive Impairment, Mild\n\nStudy Armgroups:\n- {'label': '1. Integrated format', 'type': 'ACTIVE_COMPARATOR', 'description': 'Integrated or Combination of ABC of A: cognitive training. B: physical training and C: Combined Cognitive and Physical Training (CCPT).', 'interventionNames': ['Behavioral: Cognitive training', 'Behavioral: physical training', 'Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP']}\n- {'label': '2. Cognitive training + Physical Training (A+B)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention of A \\\\& B treatments.', 'interventionNames': ['Behavioral: Cognitive training', 'Behavioral: physical training']}\n- {'label': '3. Physical training + CCPT (B+C)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention of B \\\\& C treatments.', 'interventionNames': ['Behavioral: physical training', 'Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP']}\n- {'label': '4. CCPT + Cognitive training (C+A)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Intervention of C \\\\& A treatments.', 'interventionNames': ['Behavioral: Cognitive training', 'Behavioral: Combination of cognitive and physical training (CCPT)-BIGMAP']}\n- {'label': '5. Control group', 'type': 'NO_INTERVENTION', 'description': 'No intervention'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive training', 'description': 'Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.', 'armGroupLabels': ['1. Integrated format', '2. Cognitive training + Physical Training (A+B)', '4. CCPT + Cognitive training (C+A)']}\n- {'type': 'BEHAVIORAL', 'name': 'physical training', 'description': 'Involves learning of preselected routines of \"line dancing\" taught by a line dance instructor.', 'armGroupLabels': ['1. Integrated format', '2. Cognitive training + Physical Training (A+B)', '3. Physical training + CCPT (B+C)']}\n- {'type': 'BEHAVIORAL', 'name': 'Combination of cognitive and physical training (CCPT)-BIGMAP', 'description': 'BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu \\\\& Chow, 2019).', 'armGroupLabels': ['1. Integrated format', '3. Physical training + CCPT (B+C)', '4. CCPT + Cognitive training (C+A)'], 'otherNames': ['\"Brain Invigoration Gross Motor Activation Program\" (BIGMAP)']}\n\nPrimary Outcomes:\n- {'measure': 'Cognitive Tests: for executive function (pre-test)', 'description': 'Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': 'Pre-test (1st test): before intervention'}\n- {'measure': 'Cognitive Tests: for executive function (2nd test)', 'description': 'Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': '2nd test: after 2-month intervention'}\n- {'measure': 'Cognitive Tests: for executive function (3rd test)', 'description': 'Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': '3rd test: after 4-month intervention'}\n- {'measure': 'Cognitive Tests: for executive function (4th test)', 'description': 'Wisconsin Card Sorting Test (WCST) for the executive function will be conducted (20-30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': '4th test: after 2-month follow up'}\n- {'measure': 'Cognitive Tests: for attention (pre-test)', 'description': 'Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': 'Pre-test (1st test): before intervention'}\n- {'measure': 'Cognitive Tests: for attention (2nd test)', 'description': 'Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': '2nd test: after 2-month intervention'}\n- {'measure': 'Cognitive Tests: for attention (3rd test)', 'description': 'Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': '3rd test: after 4-month intervention'}\n- {'measure': 'Cognitive Tests: for attention (4th test)', 'description': 'Color Trail Making test (CTMT) for attention will be conducted (5-8 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': '4th test: after 2-month follow up'}\n- {'measure': 'Cognitive Tests: for everyday memory (pre-test)', 'description': 'Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': 'Pre-test (1st test): before intervention'}\n- {'measure': 'Cognitive Tests: for everyday memory (2nd test)', 'description': 'Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': '2nd test: after 2-month intervention'}\n- {'measure': 'Cognitive Tests: for everyday memory (3rd test)', 'description': 'Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': '3rd test: after 4-month intervention'}\n- {'measure': 'Cognitive Tests: for everyday memory (4th test)', 'description': 'Rivermead Behavioral Memory Test (RBMT) for everyday memory will be conducted (30 min, unit on a scale) in four evaluation time frames, respectively. The evaluators at all sessions will be blind to the group membership of participants.', 'timeFrame': '4th test: after 2-month follow up'}\n\nPlease estimate the sample size based on the assumption: \nAlpha level of 0.05, power of 0.90, rho of 0.5, ICC of 0.1, 20% attrition rate", "answer": 228, "answer_type": "ESTIMATED", "explanation": "Sample size\n As suggested by Brown et al. (2015) [20], the first step of CRCT sample size estimation is to determine one for a non-clustered design. Based on the repeated measures of ANOVA analyses of 4 trials by 5 groupings (4 IGs\u00e2\u0080\u0089+\u00e2\u0080\u00891 CG) with parameters set to an effect size of 0.175 (small to medium), an alpha level of 0.05, power of 0.90, rho of 0.5, the sample size (nn) estimated is 95 (calculated by G*Power software). Next, the second step is to determine the design effect (De) for clustering estimation. It is calculated with a group size of 15 and ICC of 0.1 (from previous a study titled BIGMAP, to be published) [15] and yields 2.4. The required sample size for a CRCT is 228 (i.e., nn\u00c3\u0097De). By considering a 20% of attrition rate of the participants, the total sample size (N) of this study is set at 285, composed of 20 groups/centres of 14\u00e2\u0080\u009315 participants each.", "id": 990, "split": "val"} +{"trial_id": "NCT04727593", "pmid": "35123569", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Modulatory Role of Internet-supported Mindfulness-based Cognitive Therapy on Extracellular Vesicles and Psychological Distress in People Who Have Had Cancer: A Study Protocol for a Two-armed Randomized Controlled Trial\n\nIncluded conditions:\n- Cancer\n\nStudy Armgroups:\n- {'label': 'Mindfulness Based Cognitive Therapy (MBCT)', 'type': 'EXPERIMENTAL', 'description': 'Group intervention on Mindfulness-Based Cognitive Therapy classic program plus 4 monthly consolidation sessions of 90 minutes each.', 'interventionNames': ['Behavioral: Mindfulness Based Cognitive Therapy (MBCT)']}\n- {'label': 'Treatment as Usual (TAU)', 'type': 'OTHER', 'description': 'TAU will be the control condition.', 'interventionNames': ['Other: Treatment as Usual']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Mindfulness Based Cognitive Therapy (MBCT)', 'description': \"Experimental group: MBCT is program developed by Zindel Segal, Mark Williams, and John Teasdale , based on Jon Kabat-Zinn's Mindfulness-based Stress Reduction (MBSR) program. Participants learn to acknowledge their unhelpful thoughts and feelings, allowing the mind to move from an automatic and spiraling thought pattern to a more conscious emotional processing. Mindfulness practices include breath awareness, sitting and walking meditations, and mindful yoga. In this study, the following MBCT structure will be followed: group setting of 12 participants (maximum); 8 online weekly meetings of 2 hours via a videoconference platform (e.g., Cisco Webex), each one mediated by a trained mindfulness instructor(s); daily home practice of the learned skills; 2 hours of retreat after the fifth week; 6 months of home practice; 4 monthly consolidation sessions of 90 minutes each.\", 'armGroupLabels': ['Mindfulness Based Cognitive Therapy (MBCT)']}\n- {'type': 'OTHER', 'name': 'Treatment as Usual', 'description': 'In this case, participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral, and intervention for people with significant distress difficulties. Regarding pharmacological intervention, medication intake will be monitored during the study and changes will be registered. The engagement in non-pharmacological interventions such as psychological and psychosocial interventions will also be monitored.', 'armGroupLabels': ['Treatment as Usual (TAU)']}\n\nPrimary Outcomes:\n- {'measure': 'Change on Extracellular Vesicles', 'description': 'Isolated by ultracentrifugation with sucrose cushion. The collected EVs will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL).', 'timeFrame': 'T1 - before intervention; 8 weeks after T1; 24 weeks after T1'}\n- {'measure': 'Change on Distress', 'description': 'Measured with Depression Anxiety Stress Scales-21 - DASS-21, a self-report and public domain questionnaire that evaluates negative affective states. It is composed of 21 items, 7 focused on depression, 7 on anxiety, and 7 on stress. Each item is rated on a 4-point Likert-type scale, wherein in 0 represents \"did not apply to me at all\" and 3 represents \"applied to me very much or most of the time\". The score for each subscale ranges between 0 and 21. In the current study, a total score will be computed by summing all items, with higher scores being indicative of higher self-reported psychological distress.', 'timeFrame': 'T1- before intervention; T2 - 4 weeks after baseline; T3 - 8 weeks after baseline; T4 - 24 weeks after baseline; T5 - 52 weeks after baseline'}\n\nPlease estimate the sample size based on the assumption: \nAlpha significance level of 0.05, power of 0.80, and dropout rates ranging from 12.1% to 32% for the intervention group and 6% to 17.4% for the control group, with follow-up dropout rates of about 30.8% and 19.6% respectively.", "answer": 111, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Because no previous study has examined circulating EVs in relation to MBIs and cancer, we could not use a specific effect size in estimating the sample size. Nonetheless, a recent systematic review examining the effects of Internet-based MBIs on psychological distress (anxiety and depression) found a median Cohen\u00e2\u0080\u0099s d value between 0.38 and 0.42 for the other primary outcome, psychological distress [14]. By using G*Power-3.1 statistical software [82] and considering repeated-measures ANOVA related to within-between interaction (group \u00c3\u0097 time interaction), with an alpha significance level of 0.05 and an effect size of 0.38 (as calculated in [83]), a sample of 84 participants would allow for a power of 0.80. Additionally, previous studies showed dropout rates ranging from 12.1 to 32% for the intervention group and from 6 and 17.4% for the control group, when considering the period immediately following the intervention [23, 32, 40, 47, 49, 52, 84]. At follow-up, dropout rates were about 30.8% in the intervention group and 19.6% in the control group [52]. Considering the highest dropout rate (32%), 27 participants should be added to the estimated sample, resulting in a minimum of 111 participants to be included in the study.", "id": 991, "split": "val"} +{"trial_id": "NCT04729829", "pmid": "35802640", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomised Controlled Trial to Test the Effects of Fish Aggregating Devices and SBC Activities Promoting Fish Consumption in Timor-Leste\n\nIncluded conditions:\n- Dietary Deficiency\n\nStudy Armgroups:\n- {'label': 'FAD + SBC', 'type': 'ACTIVE_COMPARATOR', 'description': 'Community will be exposed to increased availability of fish from a fish aggregating device and will receive information and messaging as part of a social and behaviour change communication about consuming fish.', 'interventionNames': ['Behavioral: Social and behaviour change communication', 'Other: Fish aggregating device']}\n- {'label': 'FAD only', 'type': 'ACTIVE_COMPARATOR', 'description': 'Community will be exposed to increased availability of fish from a fish aggregating device only', 'interventionNames': ['Other: Fish aggregating device']}\n- {'label': 'SBC only', 'type': 'ACTIVE_COMPARATOR', 'description': 'Community will receive information and messaging as part of a social and behaviour change communication about consuming fish.', 'interventionNames': ['Behavioral: Social and behaviour change communication']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Control (No FAD or SBC)'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Social and behaviour change communication', 'description': 'Each SBC treatment community will receive nutrition content and learning through savings groups. The group members will participate in skill-building activities that promote five key behaviours about fish nutrition and household decision making on fish consumption as part of facilitated discussions, interactive learning sessions, and a video-based facilitated dialogue. Increased fish consumption through SBC mass attendance events through marketing of fish vendors, interactive learning, and edu-tainment competitions promoting fish consumption. SBC will raise awareness of the benefits of eating fish as part of a balanced diet, with a particular focus on pregnant and lactating mothers, and children under 5 years of age.', 'armGroupLabels': ['FAD + SBC', 'SBC only']}\n- {'type': 'OTHER', 'name': 'Fish aggregating device', 'description': 'This is a moored line attached to buoys in coastal waters that attracts oceanic fish to it, to make it easier for small-scale fishers to catch them using their existing gear and boats. This FAD will work to increase the catch rate and hence, the availability of fish for sale in upland community markets.', 'armGroupLabels': ['FAD + SBC', 'FAD only'], 'otherNames': ['FAD']}\n\nPrimary Outcomes:\n- {'measure': 'Per capita household fish consumption', 'description': 'measured as total quantity (g) of fish consumed by the household in the previous seven days divided by the number adult equivalents in the household.', 'timeFrame': '1 year'}\n- {'measure': 'Frequency of fish consumed at household level', 'description': 'measured as the number of days fish were consumed out of the previous seven days.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nAt least 80% statistical power and 25% attrition rate.", "answer": 720, "answer_type": "ACTUAL", "explanation": "Sample size and sampling procedure\n The sampling frame comprises rural, inland households in Timor Leste. We conducted a power calculation using the command clustersampsi in STATA based on secondary data, and a primary outcome of fish consumption per household. We assumed a minimum detectable effect of 15% and an intra-cluster correlation coefficient equal to 0.05. To achieve at least 80% statistical power, we require a sample size of 575 inland community households selected from 25 communities (that is, we sample 23 households in each community). Adjusting for 25% attrition, we estimate that a sample size of 720 is required\u00e2\u0080\u0094about 30 households per site.\n Sampling follows a multi-stage procedure. In the first stage, 6 coastal municipalities were purposively selected based on the coverage of Mercy Corps programming of VSLA groups. The second step involves compiling a list of rural coastal fishing villages with over 10 active fishing vessels and randomly selecting one village within each municipality. In the third step, a list of inland villages within a 30 km radius of each coastal villages and with active presence of a VSLA was compiled. Although we include only villages participating in VSLAs, the typical size of a VSLA (about 15 members) is less than the required number of households per village. In the fourth step, therefore, we generate a list of all households in the village, both VSLA members and non-members. To ensure the required sample size is satisfied (in accordance with the power analysis) we will randomly select additional households from the list of those not participating in VSLAs. The chosen households will be visited and asked if they would be willing to participate in the study. Where households are not willing, the closest neighbouring household will be asked, and so on.", "id": 992, "split": "val"} +{"trial_id": "NCT04730037", "pmid": "37070473", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Investigator-initiated, Multicenter, Phase 3, Randomized, Single-blind, Double-dummy, Parallel-group Study of Evaluate the Efficacy and Safety of Edoxaban Versus Warfarin (Vitamin K Antagonist) in Subjects With Chronic Thromboembolic Pulmonary Hypertension Taking Warfarin (Vitamin K Antagonist) at Baseline: KABUKI\n\nIncluded conditions:\n- CTEPH\n\nStudy Armgroups:\n- {'label': 'Edoxaban group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Edoxaban', 'Drug: Warfarin Potassium placebo']}\n- {'label': 'Warfarin group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Warfarin Potassium', 'Drug: Edoxaban placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Edoxaban', 'description': '- Edoxaban 30 mg/60 mg tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications', 'armGroupLabels': ['Edoxaban group']}\n- {'type': 'DRUG', 'name': 'Warfarin Potassium', 'description': '- Warfarin K 1 mg tablets once daily (Dose adjusted with target PT-INR of 1.5-2.5)', 'armGroupLabels': ['Warfarin group']}\n- {'type': 'DRUG', 'name': 'Warfarin Potassium placebo', 'description': '- Warfarin K 1 mg placebo tablets once daily', 'armGroupLabels': ['Edoxaban group']}\n- {'type': 'DRUG', 'name': 'Edoxaban placebo', 'description': '- Edoxaban 30 mg/60 mg placebo tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications', 'armGroupLabels': ['Warfarin group']}\n\nPrimary Outcomes:\n- {'measure': 'Ratio of 1-year resting PVR to baseline resting PVR', 'timeFrame': 'Week 48 of treatment'}\n\nPlease estimate the sample size based on the assumption: \nA non-inferiority test with a one-tailed significance level \u03b1=0.025 and statistical power \u03b2=0.9. A 20% dropout rate is also considered.", "answer": 74, "answer_type": "ACTUAL", "explanation": "Sample size\n Non-inferiority margin and sample size are determined according to the FDA Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry. The 1\u00e2\u0080\u0089year/baseline PVR ratio for a hypothetical placebo group (ie, CTEPH subjects without anticoagulation) is estimated to be 1.54 based on exhaustive literature review and expert opinions. The PVR ratio in the warfarin group is 1.09 (SD 1.22) based on our clinical database.27 Although the experience and available haemodynamic data for patients with CTEPH taking edoxaban are limited, data for all DOACs including edoxaban in our database shows that the change in PVR is comparable to that of warfarin. Hence, in this sample size calculation, the point estimate and SD of the PVR ratio for the edoxaban group was assumed to be same as that of warfarin.27The ratio of placebo PVR ratio/warfarin PVR ratio (M1) is 1.41. The non-inferiority margin (M2), which is 50% of M1, is calculated to be 1.19. A 20% increase in the PVR ratio is acceptable as a margin of measurement error. For a non-inferiority test with one-tailed significance level \u00ce\u00b1=0.025, the sample size required to ensure adequate statistical power \u00ce\u00b2=0.9 would be 30\u00e2\u0080\u0089cases per group (60\u00e2\u0080\u0089cases in two groups). Taking into account a 20% dropout rate, the sample size for this study is set at 74\u00e2\u0080\u0089patients (37 in the edoxaban group and 37 in the warfarin group).", "id": 993, "split": "val"} +{"trial_id": "NCT04730154", "pmid": "38233049", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Perceived Injustice Targeted Pain Neuroscience Education and Motivational Interviewing Compared to Biomedical Focused Education in Breast Cancer Survivors\n\nIncluded conditions:\n- Breast Neoplasms\n- Survivorship\n- Pain, Chronic\n\nStudy Armgroups:\n- {'label': 'Pain Neuroscience Education (PNE) + Motivational Interviewing (MI)', 'type': 'EXPERIMENTAL', 'description': \"Breast cancer survivors assigned to the experimental intervention will participate in 1 online PNE session followed by 3 PNE + MI sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format, allowing to individually tailor content to the patient's maladaptive beliefs and perceived injustice. After the first live session, breast cancer survivors will receive a perceived injustice-targeted PNE information leaflet that they need to read carefully at home.\", 'interventionNames': ['Behavioral: Pain Neuroscience Education (PNE)', 'Behavioral: Motivational Interviewing (MI)']}\n- {'label': 'Biomedically-focused Education', 'type': 'ACTIVE_COMPARATOR', 'description': \"Breast cancer survivors assigned to the experimental intervention will participate in 1 online biomedically-focused education session followed by 3 biomedically-focused education sessions spread over 4 weeks. Each session will last for approximately 45 minutes and all sessions will be held in one-on-one format in order to balance nonspecific treatment effects between treatment arms, the duration, format and number of sessions as well as the didactical approach will be identical in both treatment groups. After the first live session, breast cancer survivors will receive an information leaflet from 'Kom op tegen Kanker' regarding 'Pain in and after treatment' that they need to read carefully at home.\", 'interventionNames': ['Behavioral: Biomedically-focused education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Pain Neuroscience Education (PNE)', 'description': 'PNE is a cognitive behavioural intervention, including educating patients that pain is an output product of the brain resulting from input from multiple central and peripheral nervous system processes and leading to threat perception. Transferring that knowledge to patients, allows them to understand, accept and effectively cope with their pain. In order to obtain the targeted behavioural change, motivational interviewing is used as the communication process throughout PNE.', 'armGroupLabels': ['Pain Neuroscience Education (PNE) + Motivational Interviewing (MI)']}\n- {'type': 'BEHAVIORAL', 'name': 'Motivational Interviewing (MI)', 'description': 'Motivational interviewing is a directive, collaborative, patient-centered communication approach for eliciting and enhancing motivation for behaviour change by helping clients to resolve ambivalence and uncertainty.', 'armGroupLabels': ['Pain Neuroscience Education (PNE) + Motivational Interviewing (MI)']}\n- {'type': 'BEHAVIORAL', 'name': 'Biomedically-focused education', 'description': \"The traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective.\", 'armGroupLabels': ['Biomedically-focused Education']}\n\nPrimary Outcomes:\n- {'measure': 'Pain Outcome', 'description': \"The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\\\> 0.80).\", 'timeFrame': 'T0: within the week before the randomisation and the start of the intervention'}\n- {'measure': 'Pain Outcome', 'description': \"The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\\\> 0.80).\", 'timeFrame': 'T1: immediately after completing intervention'}\n- {'measure': 'Pain Outcome', 'description': \"The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\\\> 0.80).\", 'timeFrame': 'T2: 6 months after therapy completion'}\n- {'measure': 'Pain Outcome', 'description': \"The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\\\> 0.80).\", 'timeFrame': 'T3: 12 months after therapy completion'}\n- {'measure': 'Pain Outcome', 'description': \"The Brief Pain Inventory is a 14-item questionnaire assessing worst pain, pain severity, and pain interference in cancer patients over the past week, reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The Brief Pain Inventory is the most common, reliable and valid outcome measure to assess pain in cancer survivors (Cronbach's alfa and test-retest reliability score \\\\> 0.80).\", 'timeFrame': 'T4: 24 months after therapy completion'}\n\nPlease estimate the sample size based on the assumption: \nThe type I error was set to 0.05 and the type II error to 0.2. A risk of loss to follow-up of 20% was also considered.", "answer": 156, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size calculations were performed with G*Power 3.1.3 for between-group differences (t test) at 12 months of follow-up. The sample size calculation was based on an earlier trial regarding a conservative intervention for treating pain in BCS that had the same primary outcome (eg, BPI) and identical 12-month follow-up.46 Based on that earlier trial46 and calculation methods described by Lakens,82 the effect size was set to 0.44, based on an observed difference of 1.8 on BPI and a CI between 0.9 and 2.6 for 83 participants. The type I error was set to 0.05 and the type II error to 0.2. The resulting sample size for a one-sided test was 65 per treatment arm. Accounting for a risk of loss to follow-up of 20%, a total sample size of 156 participants is needed.", "id": 994, "split": "val"} +{"trial_id": "NCT04731025", "pmid": "36115667", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial (The BREAST-AB Trial)\n\nIncluded conditions:\n- Implant Complication\n- Implant Infection\n- Implant Site Infection\n- Implant Capsular Contracture\n- Implant Site Pocket Infection\n- Implant Expulsion\n- Antibiotic Side Effect\n\nStudy Armgroups:\n- {'label': 'Irrigation of implants with sterile isotonic saline', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.', 'interventionNames': ['Other: Placebo']}\n- {'label': 'Irrigation of implants with a triple antibiotic solution', 'type': 'EXPERIMENTAL', 'description': 'The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline', 'interventionNames': ['Drug: Gentamicin, Cefazolin and Vancomycin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Gentamicin, Cefazolin and Vancomycin', 'description': 'The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.', 'armGroupLabels': ['Irrigation of implants with a triple antibiotic solution'], 'otherNames': ['Hexamycin, Cefazolin \"MIP\" and Bactocin']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': '500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.', 'armGroupLabels': ['Irrigation of implants with sterile isotonic saline'], 'otherNames': ['Natriumklorid Fresenius Kabi 9 mg-ml']}\n\nPrimary Outcomes:\n- {'measure': 'All-cause explantation of the breast implant after the breast reconstruction surgery', 'description': 'All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation.', 'timeFrame': '180 days'}\n\nPlease estimate the sample size based on the assumption: \nThe independent sample unit is 'breast'. The trial has an alpha of 0.05 and a power of 0.90. A drop-out rate of up to 10% is accounted for.", "answer": 1003, "answer_type": "ESTIMATED", "explanation": "Sample size\n The trial is powered to find a 5% risk reduction in the primary outcome. Based on the literature, the assumed rate of implant loss in the control group is 10%.6 7 The independent sample unit is \u00e2\u0080\u0098breast\u00e2\u0080\u0099, because previous data do not suggest that implant loss is correlated between the two breasts of a patient.3 Therefore, the power of the trial is based on the number of breasts, so that the final number of included patients depends on the proportion of patients who undergo bilateral breast reconstruction. With an alpha of 0.05, the trial will have a power of 0.90 to detect an absolute risk reduction of 5% with 1158 breasts. To account for drop-out of up to 10%, we will include patients with a combined estimated number of 1274 breasts in the trial. We expect 27% of the patients to undergo bilateral breast reconstruction (based on unpublished data) and, therefore, 1003 patients will be included in the trial.", "id": 995, "split": "val"} +{"trial_id": "NCT04733053", "pmid": "35907828", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The POWER Study: Effects of a Physiotherapist-delivered Dietary Weight Loss Program in Addition to Exercise in People with Knee Osteoarthritis Who Have Overweight or Obesity - a Randomised Controlled Trial\n\nIncluded conditions:\n- Knee Osteoarthritis\n- Overweight and Obesity\n\nStudy Armgroups:\n- {'label': 'Diet plus exercise', 'type': 'EXPERIMENTAL', 'description': 'The initial physiotherapy consultation for participants in this group will last 75 minutes, with 30 minutes for the exercise component and 45 minutes for the diet component. Thereafter, consultations will last 50 minutes, with 20 minutes for the exercise component and 30 minutes for the diet component. The exercise component will be the same as that described for the exercise alone group.', 'interventionNames': ['Other: Diet plus exercise', 'Other: Exercise']}\n- {'label': 'Exercise', 'type': 'ACTIVE_COMPARATOR', 'description': 'Physiotherapy consultations for participants in this group will last 30 minutes initially and then 20 minutes thereafter, consistent with clinical practice. Physiotherapists will prescribe 5-6 strengthening exercises from a pre-determined list to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate and a personalised physical activity plan.', 'interventionNames': ['Other: Exercise']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Diet plus exercise', 'description': 'The diet program has two phases: 1) intensive weight loss through a ketogenic very low calorie diet VLCD, and 2) transition from ketogenic VLCD onto a healthy eating plan for weight maintenance. Meal replacements will be provided to participants free of charge from the start of the trial to a maximum of 14 weeks (12 weeks for the ketogenic diet and 2 weeks for transition). If a participant does not wish to transition off the ketogenic diet after 14 weeks but wants to continue or if they wish to recommence the ketogenic diet any time after week 14 they will need to purchase meal replacements themselves at their own cost.\\n\\nParticipants will be encouraged to aim to lose at least 10% body weight.', 'armGroupLabels': ['Diet plus exercise']}\n- {'type': 'OTHER', 'name': 'Exercise', 'description': 'The trial coordinator will have provided participants with educational material about OA, handouts of home exercises including photographs and descriptions, a logbook for recording home program completion and resistance exercise bands ahead of their first appointment. Physiotherapists will prescribe 5-6 strengthening exercises from a pre-determined list to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate. Review and modification will occur at each consultation to maintain moderate intensity (effort of \u22655 out of 10 (hard) on a modified Borg Rating of Perceived Exertion scale). The physiotherapist will also prescribe a personalised physical activity plan in collaboration with the participant that is supported and progressed over time.', 'armGroupLabels': ['Diet plus exercise', 'Exercise']}\n\nPrimary Outcomes:\n- {'measure': 'Body weight', 'description': 'Measured using calibrated digital laboratory platform scales (TCS-2 series) to 2 decimal places, the percentage of body weight change (baseline-follow up/baseline x100%) will be calculated as the primary outcome', 'timeFrame': 'Change between baseline and 6 months post randomization'}\n\nPlease estimate the sample size based on the assumption: \nA power of 0.8 and a two-tailed significance level of 0.05 are assumed. A 15% loss to follow-up is also considered. The sample size calculation does not adjust for clustering by physiotherapist and is conservative due to unknown correlations between percentage weight loss and baseline weight.", "answer": 88, "answer_type": "ACTUAL", "explanation": "Trial sample size\n Clinical practice guidelines for knee OA recommend patients who have overweight or obesity should lose at least 5\u00e2\u0080\u00937.5% of body weight [62]. We therefore powered the trial to detect a conservative between-group difference in weight loss of 5% of body weight assuming no change in weight in the exercise group based on previous research [13, 63]. While the between-participant standard deviation of percentage change in body weight was 5% in another study [63], we were more conservative and assumed a larger standard deviation of 7.5% given that our program has substantially less therapist contact (6 in ours compared with up to 12 individual sessions and 42 group sessions in the previous study [63]), which could result in more variation in response. For a power of 0.8 and a two-tailed significance level of 0.05, we required 37 participants per group. We increased this to 44 participants per group (88 in total) to allow for a 15% loss to follow up [34]. Since physiotherapists treat participants in both arms of the trial, we have not adjusted the sample size calculation for clustering by physiotherapist. Due to unknown correlations between percentage weight loss and baseline weight in this population, sample size calculations are conservative and do not account for the adjustment of baseline weight which will further increase the statistical power.", "id": 996, "split": "val"} +{"trial_id": "NCT04733742", "pmid": "39435713", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intravenous rhTNK-tPA Bridging With Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: A Multicenter, Randomized Controlled Trial\n\nIncluded conditions:\n- Stroke, Acute\n- Stroke, Ischemic\n\nStudy Armgroups:\n- {'label': 'Conbined treatment group', 'type': 'EXPERIMENTAL', 'description': 'intravenous tenecteplase bridging with endovascular treatment', 'interventionNames': ['Drug: rhTNK-tPA', 'Other: Endovascular treatment']}\n- {'label': 'Endovascular treatment alone group', 'type': 'ACTIVE_COMPARATOR', 'description': 'endovascular treatment alone', 'interventionNames': ['Other: Endovascular treatment']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'rhTNK-tPA', 'description': 'intravenous thrombolysis with rhTNK-tPA followed by endovascular treatment', 'armGroupLabels': ['Conbined treatment group'], 'otherNames': ['TNKase', 'TNK-tPA']}\n- {'type': 'OTHER', 'name': 'Endovascular treatment', 'description': 'endovascular treatment', 'armGroupLabels': ['Conbined treatment group', 'Endovascular treatment alone group'], 'otherNames': ['intra-arterial treatment', 'interventional therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patients functionally independent (mRS score 0 to 2) at 90 days', 'description': 'functional independence', 'timeFrame': '90 days'}\n\nPlease estimate the sample size based on the assumption: \n80% power at a 2-sided \u03b1=0.05 significance level, with an attrition rate of 15% for protocol violations, treatment failure, and loss to follow-up.", "answer": 544, "answer_type": "ESTIMATED", "explanation": "Sample Size Estimates\n Based on 2 Chinese randomized controlled trials of direct mechanical thrombectomy for acute large\u00e2\u0080\u0090vessel occlusive stroke,\n3\n, \n5\n it is assumed that the proportion of functional independence in the thrombectomy\u00e2\u0080\u0090alone group is 41%. Combining the results of 3 randomized controlled trials of intravenous tenecteplase followed by EVT in patients with stroke with LVO,\n12\n, \n16\n, \n17\n we hypothesize that the proportion of functional independence in the tenecteplase\u00e2\u0080\u0090plus\u00e2\u0080\u0090thrombectomy group will be 54%. Up to 462 (231 patients per arm) patients would provide 80% power at a 2\u00e2\u0080\u0090sided \u00ce\u00b1=0.05 significance level. The sample size will be inflated to 544 (272 patients per arm) to account for a possible attrition rate of 15% for protocol violations, treatment failure, and loss to follow\u00e2\u0080\u0090up. This calculation was conducted using PASS software version 15.0 (NCSS, LLC, Kaysville, UT).", "id": 997, "split": "val"} +{"trial_id": "NCT04735770", "pmid": "35042563", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Laparoscopically Inserted Transversus Abdominis Plane Block Versus Wound Local Anesthesia in Laparoscopic Endometriosis Surgery: a Prospective Randomized Controlled Double-blinded LTAP-trial\n\nIncluded conditions:\n- Endometriosis; Peritoneum\n- Postoperative Pain\n\nStudy Armgroups:\n- {'label': 'LTAP', 'type': 'EXPERIMENTAL', 'description': 'Patients receive laparoscopically inserted TAP block with levobupivacain and local wound anesthesia injections with saline.', 'interventionNames': ['Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine']}\n- {'label': 'Local wound analgesia', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients receive laparoscopically inserted TAP block with saline and local wound anesthesia injections with levobupivacaine.', 'interventionNames': ['Procedure: Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine', 'description': 'Postoperative pain management', 'armGroupLabels': ['LTAP', 'Local wound analgesia']}\n\nPrimary Outcomes:\n- {'measure': 'Postoperative opioid consumption', 'description': 'Oxicodone consumption measured via PCA-pump in Morphine equivalents', 'timeFrame': '24 hours'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 0.05 alpha error.", "answer": 46, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Sample size was calculated based on the assumption that LTAP would decrease the postoperative opioid consumption by 50%, which was thought to be a clinically relevant difference. The calculation was based on previous literature showing a 15.4\u00e2\u0080\u0089mg \u00c2\u00b1 9.2 postoperative opioid consumption after local wound analgesia [15]. With 80% power and 0.05 alpha error, the sample size of 46 (23 +\u00e2\u0080\u008923) was obtained to detect a decrease of 7.7\u00e2\u0080\u0089mg in opioid consumption from 15.4\u00e2\u0080\u0089mg in the control group to 7.7\u00e2\u0080\u0089mg in the intervention group, assuming a standard deviation of 9.2\u00e2\u0080\u0089mg. Sample size was calculated according to Chow et al. [16], and the calculation was performed with statistical program R.", "id": 998, "split": "val"} +{"trial_id": "NCT04735861", "pmid": "35613822", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sintilimab Plus Bevacizumab in Patients With Recurrent/Persistent Ovarian Clear Cell Carcinoma\n\nIncluded conditions:\n- Ovarian Clear Cell Carcinoma\n\nStudy Armgroups:\n- {'label': 'Combination Arm', 'type': 'EXPERIMENTAL', 'description': 'Sintilimab 200mg iv., q3w, up to 2 years; Bevacizumab 15mg/kg iv., q3w, up to 22 cycles. Treatment is given until confirmed progression, death, unacceptable toxicity, or any other protocol-specified criterion for withdrawal, whichever occurs first.', 'interventionNames': ['Drug: Sintilimab', 'Drug: Bevacizumab Biosimilar IBI305']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sintilimab', 'description': 'Sintilimab 200mg iv. q3w, up to 2 years.', 'armGroupLabels': ['Combination Arm'], 'otherNames': ['IBI308']}\n- {'type': 'DRUG', 'name': 'Bevacizumab Biosimilar IBI305', 'description': 'Bevacizumab 15mg/kg iv. q3w, up to 22 cycles', 'armGroupLabels': ['Combination Arm'], 'otherNames': ['IBI305']}\n\nPrimary Outcomes:\n- {'measure': 'Objective response rate (ORR)', 'description': 'ORR is defined as the proportion of patients with complete response(CR) and partial response(PR) assessed by the investigator in accordance with the RECIST 1.1 criteria.', 'timeFrame': 'Up to 3 years'}\n\nPlease estimate the sample size based on the assumption: \nUsing the Simon two-stage design with a significance level (\u03b1) of 0.05 and power (\u03b2) of 0.2. Considering a dropout rate of 10%.", "answer": 38, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size was estimated based on the primary endpoint of ORR. A retrospective study of recurrent or refractory OCCC reported a 6%\u00e2\u0080\u00938%\u00e2\u0080\u0089response rate for second-line treatment.8 Therefore, the null hypothesis is postulated of an ORR of 8% (P0), while 23% or more in the experimental in this study (P1). Using the Simon two-stage (Optimum) design with unilateral \u00ce\u00b1=0.05\u00e2\u0080\u0089and \u00ce\u00b2=0.2, totally 38 patients will be enrolled in this trial. In the first stage of accrual, 17 patients were enrolled. The response rate will be determined, if the total number of patients responding to sintilimab and bevacizumab is less than or equal to one patient, then the trial should terminate early and declare no worth of further investigation for the combination therapy. On the contrary, 17 patients will be recruited in the second stage, with a total of 34 patients. If the total number of patients achieving complete or PR is less than or equal to five cases, then the null hypothesis is true, and the trial does not reach the effective endpoint. Otherwise, it is determined that the combination regimen is effective and worthy of further large-scale clinical trials. Considering a dropout rate of 10%, a total of 38 patients will be included in this study.", "id": 999, "split": "val"} +{"trial_id": "NCT04735965", "pmid": "35149565", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft: Study Protocol of a Randomized Controlled Trial\n\nIncluded conditions:\n- Coronary Artery Disease\n- Postoperative Shivering\n\nStudy Armgroups:\n- {'label': 'Dexmedetomidine group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Dexmedetomidine']}\n- {'label': 'Meperidine group', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Meperidine']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Placeb']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine', 'description': 'Dexmedetomidine would be intravenously infused at a dose of 1\u03bcg/kg over 15 minutes 30 min before the end of surgery', 'armGroupLabels': ['Dexmedetomidine group']}\n- {'type': 'DRUG', 'name': 'Meperidine', 'description': 'Meperidine would be intravenously injected at a dose of 0.5mg/kg 30 min before the end of surgery', 'armGroupLabels': ['Meperidine group']}\n- {'type': 'DRUG', 'name': 'Placeb', 'description': 'Equal volume of normal saline to dexmedetomidine and meperidine group.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'The incidence of postoperative shivering', 'description': 'The incidence and severity of postoperative shivering and the rescue treatment', 'timeFrame': 'Within postoperative 24 hours'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power is set to 0.80 with a one-sided type I error of 0.05. An attrition rate of 5% is assumed.", "answer": 180, "answer_type": "ESTIMATED", "explanation": "Sample size\n Regarding the sample size, we calculated statistical power prior to the study. We set the statistical power to 0.80 with a one-sided type I error of 0.05. Patients will be randomly assigned into group Dex, group M and group P in 1:1:1 ratio. According to previous studies, we assumed that the incidence of shivering in group Dex and group M was 23% and 46.48%, respectively.20 21 Based on these parameters, we calculated the sample size of 55 patients per group. To compensate for potential drop-outs or inadequate procedures, we assumed an attrition rate of 5% and determined that 60 patients will be required in each group, to make a total of 180 patients.", "id": 1000, "split": "val"} +{"trial_id": "NCT04739592", "pmid": "35715774", "question": "Here is the design of a clinical trial:\n\nOfficial Title: The Effect of Alendronate Sodium Vitamin D3 Tablets on Knee Joint Structure and Knee Osteoarthritis Pain: A Multi-center, Randomized, Double-blind, Controlled Study.\n\nIncluded conditions:\n- Knee Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'alendronate sodium vitamin D3 tablets', 'type': 'EXPERIMENTAL', 'description': 'participants will receive alendronate sodium vitamin D3 tablets once per week for one year.', 'interventionNames': ['Drug: alendronate sodium vitamin D3 tablets']}\n- {'label': 'placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'participants will receive a placebo tablet once per week for one year.', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'alendronate sodium vitamin D3 tablets', 'description': 'once per week for one year', 'armGroupLabels': ['alendronate sodium vitamin D3 tablets']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'once per week for one year', 'armGroupLabels': ['placebo']}\n\nPrimary Outcomes:\n- {'measure': 'WORMS score of knee joint MRI', 'description': 'WORM score of participants at the sixth month after enrollment', 'timeFrame': 'The sixth month'}\n- {'measure': 'WORMS score of knee joint MRI', 'description': 'WORM score of participants at the 12th month after enrollment', 'timeFrame': 'The 12th month'}\n\nPlease estimate the sample size based on the assumption: \nPower level of 80%, alpha level of 0.05, and an anticipated 10% loss to follow-up each year.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on a previous observation, the mean annual loss of the medial tibial cartilage volumes in knee OA patients is 4.5% [25]. The monthly intake of vitamin D (50,000\u00c2\u00a0IU) would result in a serum vitamin D3 level\u00e2\u0080\u0089>\u00e2\u0080\u008960\u00c2\u00a0nmol/L [26], and this, in turn, has been reported to correlate with a 2.2% annual absolute reduction in cartilage loss [27]. This can be translated into a risk reduction of 22% for knee replacement over a period of 2\u00c2\u00a0years [28]. Our sample size calculation was conducted based on Cohen\u00e2\u0080\u0099s formula [29]. With a power level of 80% and alpha level of 0.05, 60 participants (30 in each group) were required to detect a 2.2% between-group difference in terms of medial tibial cartilage loss (WORMS scale) during the second assessment time-point (12\u00c2\u00a0months). Losses to follow-up were not considered in our initial sample size calculation (NCT04739592); however, given the fact that both interventions will be administered for a year and patients will be followed up for 2\u00c2\u00a0years after enrollment, we anticipate that around 10% will be lost to follow-up each year, so we increased our final sample size to 220 participants (110 in each group).", "id": 1001, "split": "val"} +{"trial_id": "NCT04739995", "pmid": "34992118", "question": "Here is the design of a clinical trial:\n\nOfficial Title: 12-month Randomized, Double-blind, Placebo-controlled, Pharmacological Clinical Trial to Evaluate the Effectiveness, Cost-utility and Neurobiological Effects of Low-dose Naltrexone in Patients With Fibromyalgia (INNOVA Project)\n\nIncluded conditions:\n- Randomized Controlled Trial\n\nStudy Armgroups:\n- {'label': 'Low-Dose-Naltrexone (LDN)', 'type': 'EXPERIMENTAL', 'description': 'The LDN treatment will consist of one 4.5 mg naltrexone tablet (lactose-free) taken daily for 12 months before going to sleep.', 'interventionNames': ['Drug: Low-dose naltrexone']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'The control group will take the placebo daily (a film-coated tablet, identical to the LDN, filled with a lactose-free excipient), for 12 months, following the same guidelines.', 'interventionNames': ['Drug: Low-dose naltrexone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Low-dose naltrexone', 'description': '4.5 mg LDN/day for 1 year', 'armGroupLabels': ['Low-Dose-Naltrexone (LDN)', 'Placebo'], 'otherNames': ['LDN']}\n\nPrimary Outcomes:\n- {'measure': 'Pain intensity', 'description': '-Numerical Rating Scale-NRS- from 0 (no pain) to 10 (worst possible pain)', 'timeFrame': 'Through study completion, an average of 1 year'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 5%, power of 80%, and a potential attrition rate of 20%.", "answer": 99, "answer_type": "ACTUAL", "explanation": "Sample size\n There are no previous RCTs about the efficacy of LDN for FMS; therefore, we estimated the sample size taking into account a previous LDN crossover study36 that had used self-reported pain as main outcome (the effect size was d=0.99). Thus, with a sample of 60 participants per arm, we aim to detect between-group differences with a significance level of 5% and a power of 80%. Allowing for a potential attrition rate of 20%, our final sample size is 60 participants per group. For the analysis of biomarkers (involving 50% of the sample), an initial sample size of 30 patients per arm is considered sufficient according to previous studies.37 41", "id": 1002, "split": "val"} +{"trial_id": "NCT04740346", "pmid": "34880028", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Multi-center Randomized Clinical Trial to Compare Survival Rates and Quality of Life According to Follow-up Period in Patients Who Underwent Radical Gastrectomy for Advanced Gastric Cancer (STOFOLUP Trial)\n\nIncluded conditions:\n- Gastric Cancer\n- Recurrence\n- Quality of Life\n\nStudy Armgroups:\n- {'label': '3 months follow-up', 'type': 'EXPERIMENTAL', 'description': 'Patients will be follow-up every 3 months after gastrectomy.', 'interventionNames': ['Diagnostic Test: Computed tomography, Chest X-ray, and blood test']}\n- {'label': '6 months follow-up', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients will be follow-up every 6 months after gastrectomy.', 'interventionNames': ['Diagnostic Test: Computed tomography, Chest X-ray, and blood test']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Computed tomography, Chest X-ray, and blood test', 'description': 'CT will be performed every 3 months after gastrectomy in the 3-months follow-up group. CT will be performed every 6 months after gastrectomy in the 6 months follow-up group.', 'armGroupLabels': ['3 months follow-up', '6 months follow-up']}\n\nPrimary Outcomes:\n- {'measure': '3-year overall survival', 'description': 'Death from any cause is defined as an event.', 'timeFrame': '3 years after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes an alpha error of 0.05, a statistical power of 0.80, and a drop-out rate of 10%.", "answer": 886, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The hypothesis of the poSTOperative FOLlow UP of gastric cancer patients for improved survival and quality of life (STOFOLUP) trial is that the 3-year OS will be different between the 3-month and 6-month groups. We assumed that the 3-year OS rate in the 6-month group will be 83% based on the results of the Capecitabine and Oxaliplatin Adjuvant Study in Stomach Cancer (CLASSIC) trial.10 Moreover, a survival difference of 6% has been considered between the two groups based on the COLOFOL trial.11 The sample size is planned for an accrual period of 24 months and a follow-up duration of 36 months. A total of 796 events are needed to detect this difference with an alpha error of 0.05 and a statistical power of 0.80. A drop-out rate of 10% has been considered and the final sample size is estimated to be 443 patients in each group (886 patients in total).", "id": 1003, "split": "val"} +{"trial_id": "NCT04741750", "pmid": "38238686", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Does a Simplified Algorithm and Integrated HCV Care Improve Linkage to Care, Retention, and Cure Among People Who Inject Drugs? A Pragmatic Quality Improvement Randomized Controlled Trial\n\nIncluded conditions:\n- Hepatitis C\n\nStudy Armgroups:\n- {'label': 'Usual Care within Community Clinics', 'type': 'NO_INTERVENTION', 'description': \"Complete blood count, comprehensive metabolic panel, international normalized ratio, HCV RNA, hepatitis B virus (HBV) serologies, point of care HIV test, and point of care liver fibrosis measurement. HCV genotype if required by patient's insurance for prior authorization. Care for opioid use disorder and skin infection is offered. Completion of the initial visit workup is sufficient to initiate a prior authorization request for DAAs from payers and an appointment for MAT follow-up in a community clinic if indicated. Patient coordination; authorization with insurance companies; scheduling appointments, follow-up, and ancillary support services will be conducted by a Patient Navigator. Patients are seen every 2-4 weeks for monitoring and adherence support. HCV treatment regimens are at the discretion of the treating provider in accordance with AASLD/IDSA guidelines and insurance requirements. Twelve weeks after HCV therapy completion, SVR12 HCV RNA and SVR12 CMP tests will be obtained.\"}\n- {'label': 'Simplified Care within a Mobile Medical Unit', 'type': 'EXPERIMENTAL', 'description': 'Simplified Care treatment is the same as for Usual Care with the exception that it is taking place within a mobile medical clinic that is scheduled to deliver treatment in alignment with regular syringe exchange services.', 'interventionNames': ['Other: Simplified HCV care within a mobile medical unit']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Simplified HCV care within a mobile medical unit', 'description': 'Delivers guideline-based care for HCV in a stream-lined manner on a mobile medical unit', 'armGroupLabels': ['Simplified Care within a Mobile Medical Unit']}\n\nPrimary Outcomes:\n- {'measure': 'Number of patients who initiate HCV treatment', 'description': 'Initiating treatment with a Direct-Acting Antiviral (DAA)', 'timeFrame': '6 months of follow-up'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided, two-sample proportion test with 80% power at a significance level of 5%.", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size justification\n To ensure that the proposed study has adequate power to determine the effectiveness of the simplified algorithm to determine the effectiveness of the simplified algorithm to improve HCV treatment initiation, i.e., the percentage of patients who are HCV RNA positivie and initiate treatment, the sample size was calculated based on a two-sided, two-sample proportion test with 80% power at a significance level of 5%. According to existing FHCSD data, between 20-25% of HCV infected patients (HCV RNA positive) initiate care [20]. Because the proposed treatment strategy addresses both barriers and facilitators of HCV treatment initiation, we believe that a greater than 15-20% improvement in care initiation is achievable. Thus, when the proportion of patients who initiate treatment in the control group is 20%, the target sample of approximately 200 patients (100 per study group) will provide sufficient power to detect a difference of approximately 17.5%. Furthermore, existing FHCSD data indicates that in the syringe exchange setting, approximately 15-20% of patients who take a rapid finger stick test are HCV Ab positive and of those, roughly 75% are HCV RNA positive [21]. Therefore, we will aim to administer approximately 1,350 tests during patient recruitment in order to identify approximately 200 patients who are HCV RNA positive and will be offered treatment.", "id": 1004, "split": "val"} +{"trial_id": "NCT04742764", "pmid": "34446497", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS): a Prospective, Randomized, Multicenter Clinical Trial\n\nIncluded conditions:\n- Septic Shock\n\nStudy Armgroups:\n- {'label': 'Group A', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to standard medical therapy.', 'interventionNames': ['Combination Product: Standard medical therapy']}\n- {'label': 'Group B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 12 hours.', 'interventionNames': ['Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours']}\n- {'label': 'Group C', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 24 hours.', 'interventionNames': ['Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Standard medical therapy', 'description': 'Standard medical therapy (according to the Surviving Sepsis Campaign) will include standard monitoring (pulseoximetry, 5-lead ECG, continuous invasive blood pressure monitoring, central venous cannulation and 24 with PiCCO-technology. Norepinephrine as a vasopressor and dobutamine - if needed - as an inotrope will be administered by the attending physician.', 'armGroupLabels': ['Group A']}\n- {'type': 'DEVICE', 'name': 'Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours', 'description': 'Standard medical therapy, as discussed above will be applied. Furthermore, Cytosorb will be administered as soon as it is possible after randomization but not later than 2 hour (start of the treatment, T0). In a blood pump circuit in pre-haemofilter position, using a kidney replacement device of Fresenius Multifiltrate as a solo therapy or in combination with renal replacement therapy. It will be run in CVVHD, CVVHDF or CVVH mode with a 150 and 200 ml/min blood flow. Anticoagulation will be applied intravenously with heparin, low molecular weight heparin or citrate. The aim of the pump flow rate will be 100-400 mL/min, and the flow rate will be recorded. Possible shock reversal will be assessed by the physician attending. Adsorber cartridges will be changed in every 12 hours. End of the study period (Te): 12 hours after shock reversal, death of the patient, or maximum of five days, whichever happens first.', 'armGroupLabels': ['Group B']}\n- {'type': 'DEVICE', 'name': 'Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours', 'description': 'The standard medical therapy and method of Cytosorb treatment as detailed above will be applied. Adsorber cartridges will be changed in every 24 hours.', 'armGroupLabels': ['Group C']}\n\nPrimary Outcomes:\n- {'measure': 'Shock reversal', 'description': 'Proportion of patients achieving shock reversal, defined as follows:\\n\\nno need (or minimal need, meaning max. the 10% of the maximum dose) of vasopressore for 3 hours, with haemodynamic measurements, and arterial, central venous blood gas analysis, arterial lactate level measurement, venous and arterial pCO2-gap and O2 saturation measurements to confirm cardiorespiratory stability', 'timeFrame': 'At the time of shock reversal assessed up to 5 days'}\n- {'measure': 'Time to shock reversal', 'description': 'The time from the start of the treatment (T0) until shock reversal', 'timeFrame': 'From the start of the treatment until shock reversal assessed up to 5 days'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a 20% dropout rate, 80% power, and a 95% significance level.", "answer": 135, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on the previous case series and the ACESS pilot data, the most apparent clinical benefit is expected to be the reduction in norepinephrine requirement; therefore, we chose shock reversal as the most important outcome.24\u00e2\u0080\u009326 In the ACESS trial, it was found that one single 24-hour treatment resulted in an almost 70% reduction in the required norepinephrine dose. A similar observation was made in a recent case series,24 in which a 50% reduction was found after a 24-hour treatment. Furthermore, in our pilot study, the most profound effect occurred within the first 12 hours of treatment, as far as norepinephrine requirement and PCT-level reduction are concerned.28 Based on these results, it is postulated that cytokine removal may be most effective in the first hours of treatment, therefore, shock reversal could occur faster in group B as compared with group C and faster in both groups as in group A (controls).\n The sample size calculation was based on patient data from the study of Kogelmann et al.25 The time of shock reversal was separately calculated for those in whom the first adsorber was changed after 12 hours (n=3), and for those who received therapy for 24-hours each time (n=17) (48\u00c2\u00b130 hours vs 68\u00c2\u00b121, respectively). In a recent prospective RCT on patients with sepsis and septic shock, vasopressors were weaned in 96\u00c2\u00b140 hours in the control group (n=50).36\n We considered these differences as clinically relevant and not to be overlooked between the three groups. Sample size calculation suggests that 135 patients (1:1:1) will need to be enrolled (45 in each study arm) to confirm or reject the hypothesis for the primary endpoint with a 20% drop-out, 80% power and 95% significance level. Non-responders will be handled as dropouts and will continue to receive SMT.", "id": 1005, "split": "val"} +{"trial_id": "NCT04744480", "pmid": "35078841", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Topical Anesthesia Combined With Intravenous Induction on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery: a Randomized Controlled Study\n\nIncluded conditions:\n- Coronary Artery Disease\n- Valvular Heart Disease\n- Arrhythmia\n- Myocardial Disease\n\nStudy Armgroups:\n- {'label': 'The combined topical anesthesia induction group', 'type': 'EXPERIMENTAL', 'description': 'The superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia\uff0c3-5ml 2% lidocaine would be used for supraglottic anesthesia, and 3ml 1% tetracaine would be used for subglottic anesthesia.', 'interventionNames': ['Procedure: The combined topical anesthesia induction group']}\n- {'label': 'The routine induction group', 'type': 'NO_INTERVENTION', 'description': 'The superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia.In the routine induction group\uff0call procedures will be the same as those of the topical anesthesia group, The drug will be replaced with constant volume saline.'}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'The combined topical anesthesia induction group', 'description': 'The superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia\uff0c3-5ml 2% lidocaine would be used for supraglottic anesthesia, and 3ml 1% tetracaine would be used for subglottic anesthesia.', 'armGroupLabels': ['The combined topical anesthesia induction group']}\n\nPrimary Outcomes:\n- {'measure': 'The area under the curve of baseline blood pressure', 'description': 'The area under the curve (AUC) of blood pressure below baseline from the beginning of general anesthesia induction to the surgery beginning.', 'timeFrame': 'From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours.'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level (alpha) is set at 0.025. The power is 80%. The potential dropout rate is estimated at 20%.", "answer": 96, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n This is a superiority, parallel-group, randomised controlled trial and the ratio of the participants in the two groups is 1:1. A one-sided, two-sample t-test with a sample size of 39 in each group achieves 80% power to detect a ratio of 0.700 when the ratio under the null hypothesis is 1.000. The coefficient of variation in the original scale is 0.6. The significance level (alpha) is set at 0.025. According to references, we identified a coefficient of variation of 60% for the AUC MAP of topical airway anaesthesia as clinically significant.14 We defined a clinically relevant effect as a between-group difference in the AUC (reduction from baseline MAP over 30 min after induction) of \u00e2\u0089\u00a533.3%. For this effect size, we estimated that 39 patients per study arm would be needed to demonstrate superiority (a<0.025, one-sided) with 80% power. It is estimated that the potential dropout due to various reasons is 20%, and 48 patients in each group would be calculated, resulting in a total of 96 patients.15", "id": 1006, "split": "val"} +{"trial_id": "NCT04744506", "pmid": "39402559", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Targeted Axillary Dissection Using Carbon Marking for Patients With Node-positive Breast Cancer Following Neoadjuvant Therapy (TADCOM): a Prospective, Multicenter, Randomized Controlled Trial\n\nIncluded conditions:\n- Breast Cancer\n- Surgery\n- Lymph Node Metastases\n\nStudy Armgroups:\n- {'label': 'Group 1: CG-TAD Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'US-guided clip insertion into suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and clipped LNs', 'interventionNames': ['Device: Tissue Marker Clip']}\n- {'label': 'Group 2: CN-LNM Group', 'type': 'EXPERIMENTAL', 'description': 'US-guided CNSI injection to tattoo suspicious ALNs pre-NAC Post-NAC, TAD removing SLNs and carbon-marked LNs', 'interventionNames': ['Drug: Carbon Nanoparticle Suspension Injection']}\n- {'label': 'Group 3: PCN-MAP Group', 'type': 'EXPERIMENTAL', 'description': 'US-guided CNSI injection around primary tumor pre-NAC, additional US-guided clip placement for metastatic LN Post-NAC, TAD removing SLNs, carbon-marked LNs, and clipped LNs', 'interventionNames': ['Drug: Carbon Nanoparticle Suspension Injection']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Tissue Marker Clip', 'description': 'Tissue Marker Clip to be Placed in Metastatic Axillary Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)', 'armGroupLabels': ['Group 1: CG-TAD Group']}\n- {'type': 'DRUG', 'name': 'Carbon Nanoparticle Suspension Injection', 'description': 'Carbon Nanoparticle Suspension Injection to be Placed in Metastatic Axillary Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)', 'armGroupLabels': ['Group 2: CN-LNM Group']}\n- {'type': 'DRUG', 'name': 'Carbon Nanoparticle Suspension Injection', 'description': 'Carbon Nanoparticle Suspension Injection to be Placed around Primary Tumor (Before Neoadjuvant Chemotherapy for Breast Cancer)', 'armGroupLabels': ['Group 3: PCN-MAP Group']}\n\nPrimary Outcomes:\n- {'measure': 'Lymph node retrieval rate marked', 'description': 'The proportion of successfully retrieved marked lymph nodes will be calculated and compared among the study groups to evaluate the effectiveness of each marking technique.', 'timeFrame': 'Up to 2 months'}\n- {'measure': 'Number of sentinel and marked lymph nodes', 'description': 'The mean, median, and range of the number of sentinel and marked lymph nodes harvested during surgery will be recorded and compared to assess the efficacy of the marking techniques in identifying lymph nodes of interest.', 'timeFrame': 'Up to 2 months'}\n- {'measure': 'Concordance between marked and sentinel lymph nodes', 'description': 'The consistency between marked lymph nodes and intraoperatively identified sentinel lymph nodes will be evaluated by calculating the percentage of marked nodes that are also sentinel nodes and vice versa.', 'timeFrame': 'Up to 2 months'}\n- {'measure': 'Complication rate', 'description': 'All surgery-related complications, including but not limited to hemorrhage, lymphedema, infection, pain, tissue damage, clip displacement, clip loss, absence of CNSI staining, and excessive CNSI staining, will be recorded and analyzed. The overall complication rate and rates for specific types of complications will be reported. The severity of complications will be assessed using the Clavien-Dindo classification to provide a standardized evaluation of complication severity.', 'timeFrame': 'Up to 60 months'}\n\nPlease estimate the sample size based on the assumption: \nCalculations were based on achieving a Type I error rate (\u00ce\u00b1) of 0.05 and a statistical power (1-\u00ce\u00b2) of 80%. An anticipated dropout rate of 10% was also considered.", "answer": 126, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n To ensure sufficient statistical power for detecting the predefined non-inferiority margin in this study, we performed sample size calculations. The non-inferiority margin was set at 10%, which represents the maximum allowable difference in effect size between the carbon marking and the conventional tissue marker clip methods. Calculations were based on achieving a Type I error rate (\u00ce\u00b1) of 0.05 and a statistical power (1-\u00ce\u00b2) of 80%. Initial calculations indicated a need for 112 participants to meet these criteria. Considering an anticipated dropout rate of 10%, we adjusted the sample size to 126 participants to maintain the necessary statistical power throughout the study. This adjustment results in approximately 42 participants per treatment arm. These calculations were conducted using Python (version 3.8.5) with the SciPy stats module (version 1.5.2).\n \n Neoadjuvant chemotherapy regimens\n NAC regimens for breast cancer will be customized based on the patient\u00e2\u0080\u0099s ECOG performance status, molecular subtype, and relevant biomarkers such as HER2 overexpression. Treatment durations range from 3 to 6 months, following the latest evidence-based guidelines. Anti-HER2 therapies are added for cases with HER2 overexpression to enhance efficacy. During NAC, patient response is closely monitored via ultrasound, mammography, and MRI before and after chemotherapy cycles, adjusting treatments based on individual tolerance and effectiveness. This personalized approach ensures optimal safety and outcomes, incorporating patient and clinical input in decision-making.", "id": 1007, "split": "val"} +{"trial_id": "NCT04748510", "pmid": "34372888", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment With Mechanical Axis Alignment on Outcomes After Total Knee Arthroplasty.\n\nIncluded conditions:\n- Osteoarthritis\n- Osteo Arthritis Knee\n\nStudy Armgroups:\n- {'label': 'Functionally aligned Total Knee Arthroplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'Knee arthroplasty performed using a functional alignment theory', 'interventionNames': ['Procedure: Functionally Aligned Total Knee Arthroplasty']}\n- {'label': 'Mechanical axis aligned Total Knee Arthroplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'Knee arthroplasty performed using a mechanical alignment theory', 'interventionNames': ['Procedure: Mechanically Aligned Total Knee Arthroplasty']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Functionally Aligned Total Knee Arthroplasty', 'description': \"Femoral + tibial osteotomy planned for equal resection of femoral condyles to replicate patient anatomy. In coronal plane, distal femoral resection of 6.5mm subchondral bone from medial + lateral condyles, adjusted 1-3mm for compensation of wear. Proximal tibia, 7mm resection from subchondral bone from medial + lateral tibial plateau. Sagittal plane, resection angle determined intraoperatively to closely match native femoral flexion + tibial slope. Axial plane: posterior femoral resection 6.5mm from the subchondral bone of medial and lateral posterior condyles. Tibial rotation aligned to Akagi's line. Adjustments will be made to bony alignment to balance soft tissues within boundaries of 6\u00b0 varus/3\u00b0 valgus HKA alignment. Femoral component alignment limited to 6\u00b0 valgus/3\u00b0 varus in coronal plane. Tibial alignment limited 6\u00b0 varus/3\u00b0 valgus in coronal plane. Combined flexion of components limited to 10\u00b0 flexion. Soft tissue release if balance within boundaries not achieved.\", 'armGroupLabels': ['Functionally aligned Total Knee Arthroplasty']}\n- {'type': 'PROCEDURE', 'name': 'Mechanically Aligned Total Knee Arthroplasty', 'description': \"Tibial and femoral osteotomies in the coronal plane will be planned perpendicular to the tibial and femoral mechanical axes respectively to achieve neutral overall alignment. Soft tissue balance will be assessed and minor adjustments to bony alignment made to balance the knees with a maximal adjustment of two degrees valgus and two degrees varus of coronal alignment from neutral. Femoral rotation will be planned to surgical epicondylar axis and adjustments to rotation made to allow equal flexion and extension balance (to within 1mm). If balance can not be achieved within these boundaries then soft tissue release will be undertaken. In the sagittal plane, 0-3\u00b0 degrees of posterior tibial slope and 0-5\u00b0 of femoral component flexion will be used to optimise implant sizing whilst preventing notching. In the axial plane, the tibial component aligned to Akagi's line, which connects the medial border of the patellar tendon attachment to the middle of the posterior cruciate ligament.\", 'armGroupLabels': ['Mechanical axis aligned Total Knee Arthroplasty']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in Forgotten Joint Score after 2 years', 'description': 'Difference in relative change in Forgotten joint score between FA and MA patients 2 years post-operatively compared to preoperatively. Scale 0-100 with higher scores being a better outcome', 'timeFrame': 'Preoperatively and 2 years postoperatively'}\n- {'measure': 'Difference in Oxford Knee Score after 2 years', 'description': 'Difference in relative change in Oxford Knee Score (OKS) between FA and MA patients 2 years post-operatively compared to preoperatively. Scale 0-48 with higher scores being a better outcome.', 'timeFrame': 'Preoperatively and 2 years postoperatively'}\n- {'measure': 'Relative change in range of motion between FA and MA patients post-operatively compared to preoperatively.', 'description': 'Difference in range of motion via goniometry preoperatively and postoperatively at 2 years', 'timeFrame': 'Preoperatively and 2 years postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to have at least 45 patients in each treatment group completing the study, implying considerations for dropout or missing data.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n In total, 100 patients will be enrolled in a 1:1 ratio between the two treatment groups. This will ensure that the minimum of 90 patients required to answer the study question are followed up for the duration of the study. The enrolment goal is to have at least 45 patients in each of the two treatment groups completing the study.", "id": 1008, "split": "val"} +{"trial_id": "NCT04748510", "pmid": "34372888", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Prospective Randomised Control Trial Comparing the Effect of Functional Alignment With Mechanical Axis Alignment on Outcomes After Total Knee Arthroplasty.\n\nIncluded conditions:\n- Osteoarthritis\n- Osteo Arthritis Knee\n\nStudy Armgroups:\n- {'label': 'Functionally aligned Total Knee Arthroplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'Knee arthroplasty performed using a functional alignment theory', 'interventionNames': ['Procedure: Functionally Aligned Total Knee Arthroplasty']}\n- {'label': 'Mechanical axis aligned Total Knee Arthroplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'Knee arthroplasty performed using a mechanical alignment theory', 'interventionNames': ['Procedure: Mechanically Aligned Total Knee Arthroplasty']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Functionally Aligned Total Knee Arthroplasty', 'description': \"Femoral + tibial osteotomy planned for equal resection of femoral condyles to replicate patient anatomy. In coronal plane, distal femoral resection of 6.5mm subchondral bone from medial + lateral condyles, adjusted 1-3mm for compensation of wear. Proximal tibia, 7mm resection from subchondral bone from medial + lateral tibial plateau. Sagittal plane, resection angle determined intraoperatively to closely match native femoral flexion + tibial slope. Axial plane: posterior femoral resection 6.5mm from the subchondral bone of medial and lateral posterior condyles. Tibial rotation aligned to Akagi's line. Adjustments will be made to bony alignment to balance soft tissues within boundaries of 6\u00b0 varus/3\u00b0 valgus HKA alignment. Femoral component alignment limited to 6\u00b0 valgus/3\u00b0 varus in coronal plane. Tibial alignment limited 6\u00b0 varus/3\u00b0 valgus in coronal plane. Combined flexion of components limited to 10\u00b0 flexion. Soft tissue release if balance within boundaries not achieved.\", 'armGroupLabels': ['Functionally aligned Total Knee Arthroplasty']}\n- {'type': 'PROCEDURE', 'name': 'Mechanically Aligned Total Knee Arthroplasty', 'description': \"Tibial and femoral osteotomies in the coronal plane will be planned perpendicular to the tibial and femoral mechanical axes respectively to achieve neutral overall alignment. Soft tissue balance will be assessed and minor adjustments to bony alignment made to balance the knees with a maximal adjustment of two degrees valgus and two degrees varus of coronal alignment from neutral. Femoral rotation will be planned to surgical epicondylar axis and adjustments to rotation made to allow equal flexion and extension balance (to within 1mm). If balance can not be achieved within these boundaries then soft tissue release will be undertaken. In the sagittal plane, 0-3\u00b0 degrees of posterior tibial slope and 0-5\u00b0 of femoral component flexion will be used to optimise implant sizing whilst preventing notching. In the axial plane, the tibial component aligned to Akagi's line, which connects the medial border of the patellar tendon attachment to the middle of the posterior cruciate ligament.\", 'armGroupLabels': ['Mechanical axis aligned Total Knee Arthroplasty']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in Forgotten Joint Score after 2 years', 'description': 'Difference in relative change in Forgotten joint score between FA and MA patients 2 years post-operatively compared to preoperatively. Scale 0-100 with higher scores being a better outcome', 'timeFrame': 'Preoperatively and 2 years postoperatively'}\n- {'measure': 'Difference in Oxford Knee Score after 2 years', 'description': 'Difference in relative change in Oxford Knee Score (OKS) between FA and MA patients 2 years post-operatively compared to preoperatively. Scale 0-48 with higher scores being a better outcome.', 'timeFrame': 'Preoperatively and 2 years postoperatively'}\n- {'measure': 'Relative change in range of motion between FA and MA patients post-operatively compared to preoperatively.', 'description': 'Difference in range of motion via goniometry preoperatively and postoperatively at 2 years', 'timeFrame': 'Preoperatively and 2 years postoperatively'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims to have at least 45 patients in each treatment group completing the study, implying considerations for dropout or missing data.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Power / sample size calculation\n For the primary outcome measure, functional outcome as assessed using the FJS score at 2 years following Mako arm-assisted TKA. Using data from our initial cohort recording functional outcomes, the mean FJS score at 1\u00e2\u0080\u0089year in the MA TKA was 59 (SD 6) and in the FA TKA was 75 (SD 8). It is assumed that MA results will be no better than FA results. The study was powered to demonstrate a 12-point difference in the Forgotten Joint Score. Whilst the minimal important difference (MID) has been reported with different values in the literature, Holtz et al. [37] calculated an MID at 2 years, most closely representing our study. A recent study published by Clement et al. [38] found the mean clinically important difference to be 13.7; this result was based on results at 6 months following surgery.\n Using a one tailed analysis (assuming superior results with the FA), an alpha value of 0.05 and power of 0.80, and accounting for expected dropout rate of 10%, this study will need 100 patients to answer the study question. Note that a more careful assessment of power and sample size for linear mixed effects model requires assumptions on the other covariates in the model and simulations. Such modelling is not expected to provide any reduction in power, so we have chosen to avoid this at the moment.", "id": 1009, "split": "val"} +{"trial_id": "NCT04748549", "pmid": "39695824", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty\n\nIncluded conditions:\n- Total Knee Arthroplasty\n\nStudy Armgroups:\n- {'label': 'Immersive VR group', 'type': 'EXPERIMENTAL', 'description': 'Patients in the Immersive VR group will don a VR headset connected to a software platform on a tablet, as well as noise cancelling headphones. Patients can choose their desired experience within the VR software from a selection of immersive environments and/or video content. Examples include sitting in a canoe on a river, on a peaceful meadow or in a forest. Patients also have the option to listen to guided meditation or select from a library of videos to watch on a web-based user interface.\\n\\nTo reduce the influence of the anesthesia provider on the determination of sedative requirements, patients will administer their own sedation according to their needs for relaxation and comfort using a patient controlled system.', 'interventionNames': ['Other: Virtual Reality Immersive Relaxation']}\n- {'label': 'Music group', 'type': 'ACTIVE_COMPARATOR', 'description': \"Patients randomized to the Music group will be equipped with VR headsets but won't view any content. They will also be equipped with noise cancelling headphones in the same fashion as the immersive VR group. A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient. Patients in the Sham VR group will also use patient controlled sedation.\", 'interventionNames': ['Other: Immersive Audio Experience']}\n- {'label': 'Sham VR + Usual Care Control Group', 'type': 'SHAM_COMPARATOR', 'description': 'Subjects in the control group will wear VR headsets and headphones but will not view any content or listen to any audible content. They will undergo Monitored Anesthesia Care (MAC) according to a prespecified protocol targeting light or moderate sedation with a propofol infusion.', 'interventionNames': ['Other: Sham Virtual Reality Experience']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Virtual Reality Immersive Relaxation', 'description': 'The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.', 'armGroupLabels': ['Immersive VR group']}\n- {'type': 'OTHER', 'name': 'Immersive Audio Experience', 'description': 'A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient.', 'armGroupLabels': ['Music group']}\n- {'type': 'OTHER', 'name': 'Sham Virtual Reality Experience', 'description': 'Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.', 'armGroupLabels': ['Sham VR + Usual Care Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Intraoperative Propofol Dose', 'description': 'Total propofol dose (mg/kg/min) administered intraoperatively', 'timeFrame': 'Duration of the procedure, on average 1 to 3 hours'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided t-test with a significance level of 0.025 and 90% power is used for the VR vs. control group comparison. For the VR vs. music group comparison, a two-sided t-test with a significance level of 0.025 and 67% power is used. The estimated mean propofol dose in the control group is 155 (\u00b145) mg h\u22121. To account for dropout and better estimate secondary outcomes, additional patients will be enrolled, increasing the power of the last hypothesis test to 76%.", "answer": 131, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The analysis involves two simultaneous comparisons: (1) comparing the VR group to the control group and (2) comparing the VR group to the music group. Data will be analyzed using the Bonferroni correction procedure for multiple comparisons. This is the first trial in the United States to use virtual reality for joint replacement, so no prior data exists to allow us to estimate the anticipated effect size. Therefore, we based our assumptions on clinical judgment. We believe a 33% reduction in propofol dose is clinically significant when comparing the VR to the control group. We will use G*Power 3.1.9.7. to calculate sample size, with a two-sided t-test with a significance level of 0.025, 90% power, and an estimated mean propofol dose of 155 (\u00c2\u00b1\u00e2\u0080\u008945) mg h\u00e2\u0088\u00921 in the control group for a sample size of 42 patients in the intervention group and 14 in the control group. Comparing the VR and music groups, a two-sided t-test with a significance level of 0.025, 42 participants per group, with an anticipated 12% decrease of propofol dose in the VR group, we will have 67% power to reject the null hypothesis. To compensate for anticipated dropout and to better estimate infrequent but important secondary outcomes including delirium, we will plan to enroll additional patients to bring the total planned enrollment in each group to 50:50:25, for a total of 125 patients. Accordingly, the power of our last hypothesis test will increase to 76%. Finally, during the pilot phase, six patients will be enrolled. Their data will not contribute to the primary outcome analysis. Thus, this study plans to enroll a total sample of 131 patients.", "id": 1010, "split": "val"} +{"trial_id": "NCT04749888", "pmid": "39122404", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of the Korea Early Childhood Home-visiting Intervention on Childhood Health and Development and Maternal Health: A Randomized Controlled Community Trial\n\nIncluded conditions:\n- Child Development\n- Parenting\n- Infant Development\n- Pregnancy Related\n- Maternal Distress\n\nStudy Armgroups:\n- {'label': 'Targeted nurse-led home visiting', 'type': 'EXPERIMENTAL', 'description': \"The intervention group will receive 25-29 home visits during pregnancy and the first 2 years of life conducted by child health nurses. The frequency of home visits will be determined by nurses based on the needs of the families. The content of each home visit is individually tailored to the mother's needs, skills, strengths, and capacity using parenting education materials.\", 'interventionNames': ['Behavioral: Targeted nurse-led home visiting']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'The control group will receive existing maternal and child health services (usual care) except for the targeted nurse-led home visits.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Targeted nurse-led home visiting', 'description': \"The KECHI encompasses 25-29 home visits, group activities, and community service linkage by social workers from the prenatal period until the child reaches the age of 2 years; as such, it is a complex intervention involving various domains to address a wide range of outcomes. Pregnant women with two or more risk factors who are deemed to have difficulties in raising children are eligible for the targeted multiple nurse home visits. Each home visit is implemented based on families' needs, and individualized interventions are provided to improve parenting and the home environment in order to promote the child's health and development and maternal health. The program includes educational materials for parents, such as a booklet covering issues on prenatal care, child development, postnatal child care, parent-child attachment, play, communication, safety, and goal-setting.\", 'armGroupLabels': ['Targeted nurse-led home visiting'], 'otherNames': ['KECHI (Korea Early Childhood Home-visiting Intervention)']}\n\nPrimary Outcomes:\n- {'measure': 'Home environment', 'description': 'Home environment as assessed using IT-HOME (Infant-Toddler Home Observation for Measurement of Environment) when the child is 6 months old. IT-HOME (Infant-Toddler Home Observation for Measurement of Environment), composed of 45 items, was developed by Caldwell \\\\& Bradley (1984). The minimum score is 0 and the maximum score is 45, and a higher score means a better outcome.', 'timeFrame': 'when the child is 6 months old.'}\n- {'measure': 'Home environment', 'description': 'Home environment as assessed using IT-HOME (Infant-Toddler Home Observation for Measurement of Environment) when the child is 12 months old. IT-HOME (Infant-Toddler Home Observation for Measurement of Environment), composed of 45 items, was developed by Caldwell \\\\& Bradley (1984). The minimum score is 0 and the maximum score is 45, and a higher score means a better outcome.', 'timeFrame': 'when the child is 12 months old.'}\n- {'measure': 'Home environment', 'description': 'Home environment as assessed using IT-HOME (Infant-Toddler Home Observation for Measurement of Environment) when the child is 24 months old. IT-HOME (Infant-Toddler Home Observation for Measurement of Environment), composed of 45 items, was developed by Caldwell \\\\& Bradley (1984). The minimum score is 0 and the maximum score is 45, and a higher score means a better outcome.', 'timeFrame': 'when the child is 24 months old.'}\n- {'measure': 'Emergency department visits due to injuries', 'description': 'Number of emergency department visits due to injuries when the child is 6 weeks old.', 'timeFrame': 'when the child is 6 weeks old.'}\n- {'measure': 'Emergency department visits due to injuries', 'description': 'Number of emergency department visits due to injuries when the child is 6 months old.', 'timeFrame': 'when the child is 6 months old.'}\n- {'measure': 'Emergency department visits due to injuries', 'description': 'Number of emergency department visits due to injuries when the child is 12 months old.', 'timeFrame': 'when the child is 12 months old.'}\n- {'measure': 'Emergency department visits due to injuries', 'description': 'Number of emergency department visits due to injuries when the child is 24 months old.', 'timeFrame': 'when the child is 24 months old.'}\n- {'measure': 'Child development (K-Bayley-III)', 'description': 'Child development as assessed using the K-Bayley-III (Korean Bayley Scales of Infant and Toddler Development-III) score when the child is 24 months old', 'timeFrame': 'when the child is 24 months old.'}\n- {'measure': 'Breastfeeding duration', 'description': 'Breastfeeding duration when the child is 6 weeks old.', 'timeFrame': 'when the child is 6 weeks old.'}\n- {'measure': 'Breastfeeding duration', 'description': 'Breastfeeding duration when the child is 6 months old.', 'timeFrame': 'when the child is 6 months old.'}\n- {'measure': 'Breastfeeding duration', 'description': 'Maternal self-rated health when the child is 12 months old.', 'timeFrame': 'when the child is 12 months old.'}\n- {'measure': 'Breastfeeding duration', 'description': 'Breastfeeding duration when the child is 24 months old.', 'timeFrame': 'when the child is 24 months old.'}\n- {'measure': 'Maternal self-rated health', 'description': 'Maternal self-rated health when the child is 6 weeks old.', 'timeFrame': 'when the child is 6 weeks old.'}\n- {'measure': 'Maternal self-rated health', 'description': 'Maternal self-rated health when the child is 6 months old.', 'timeFrame': 'when the child is 6 months old.'}\n- {'measure': 'Maternal self-rated health', 'description': 'Maternal self-rated health when the child is 12 months old.', 'timeFrame': 'when the child is 12 months old.'}\n- {'measure': 'Maternal self-rated health', 'description': 'Maternal self-rated health when the child is 18 months old.', 'timeFrame': 'when the child is 18 months old.'}\n- {'measure': 'Maternal self-rated health', 'description': 'Maternal self-rated health when the child is 24 months old.', 'timeFrame': 'when the child is 24 months old.'}\n- {'measure': 'Community service linkage', 'description': 'Community service linkage as measured by the number of community services a mother has received during the last year when the child is 12 months old.', 'timeFrame': 'when the child is 12 months old.'}\n- {'measure': 'Community service linkage', 'description': 'Community service linkage as measured by the number of community services a mother has received during the last year when the child is 24 months old.', 'timeFrame': 'when the child is 24 months old.'}\n\nPlease estimate the sample size based on the assumption: \nThe probability of type I error (alpha) was set at 0.05 (two-tailed) and type II error (beta) was set at 0.10 (power=90%). A 35% attrition rate was presumed for the primary outcome indicator at the 2-year follow-up.", "answer": 800, "answer_type": "ACTUAL", "explanation": "Sample size\n We considered IT-HOME as a main outcome measure for sample size calculation. In our prior study,53 the mean IT-HOME score for children at 6\u00e2\u0080\u009324 months post partum who received nurse home visitation services in Seoul was 32.5, and the SD was 5.0. Since we expect to recruit participants from more diverse backgrounds, we anticipated approximately 10% larger variations in IT-HOME scores. Effect sizes of 0.25\u00e2\u0080\u00930.3 SDs are considered meaningful and impactful at the population level,54 55 so we set the difference in IT-HOME scores between intervention and control groups to 1.50. The probability of type I error (alpha) was set at 0.05 (two-tailed) and type II error (beta) was set at 0.10 (power=90%). The presumption of 35% attrition for the primary outcome indicator at the 2-year follow-up, reflecting a rate slightly higher than that reported in other studies,54 resulted in a sample size of 400 per group (800 total).", "id": 1011, "split": "val"} +{"trial_id": "NCT04750070", "pmid": "37045565", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trial of Dopamine, Adrenaline, and Blood Transfusion for Treatment of Fluid Refractory Shock in Children With Severe Acute Malnutrition or Severe Underweight and Cholera or Other Dehydrating Diarrheas\n\nIncluded conditions:\n- Shock Hypovolemic\n- Shock, Septic\n- Blood Transfusion\n- Adrenaline\n- Dopamine\n\nStudy Armgroups:\n- {'label': 'Dopamine arm', 'type': 'EXPERIMENTAL', 'description': 'Children in the dopamine arm (Treatment plan A) will receive dopamine, 8 microgram/kg/min (increasing the dose after 15 minutes to 12 microgram/kg/min to a maximum of 15 microgram/kg/min)', 'interventionNames': ['Drug: Dopamine']}\n- {'label': 'Adrenaline arm', 'type': 'EXPERIMENTAL', 'description': 'Children in the adrenaline arm (Treatment plan B) will receive adrenaline, 0.1 microgram/kg/min (increasing the dose after 15 minutes to 0.2 microgram/kg.min to a maximum of 0.3 microgram/kg.min)', 'interventionNames': ['Drug: adrenaline']}\n- {'label': 'Blood transfusion arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Children in the blood transfusion arm (Treatment plan C) will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. While the blood transfusion is being arranged, IV fluid would be given @ of 3 ml per kg per hour', 'interventionNames': ['Drug: Blood Transfusion']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dopamine', 'description': 'Children will receive dopamine, 8 microgram/kg.min (increasing the dose after 15 minutes to 12 microgram/kg/min to a maximum of 15 microgram/kg/min)', 'armGroupLabels': ['Dopamine arm']}\n- {'type': 'DRUG', 'name': 'adrenaline', 'description': 'Children will receive adrenaline, 0.1 microgram/kg/min (increasing the dose after 15 minutes to 0.2 microgram/kg.min to a maximum of 0.3 microgram/kg.min)', 'armGroupLabels': ['Adrenaline arm'], 'otherNames': ['Epinephrine']}\n- {'type': 'DRUG', 'name': 'Blood Transfusion', 'description': 'Children will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. While the blood transfusion is being arranged, IV fluid would be given @ of 3 ml per kg per hour', 'armGroupLabels': ['Blood transfusion arm'], 'otherNames': ['Blood']}\n\nPrimary Outcomes:\n- {'measure': 'Case fatality rate', 'description': 'Number of mortalities among SAM or severe underweight children presenting with diarrhea and fluid refractory shock who would receive WHO standard fluid therapy followed by dopamine or adrenaline, compared to those receiving blood transfusion after WHO standard fluid therapy', 'timeFrame': '28 days (\u00b1 3 days)'}\n\nPlease estimate the sample size based on the assumption: \n80% power (20% type II error) and 0.05 type I error, with around 10% drop-outs after enrolment.", "answer": 135, "answer_type": "ESTIMATED", "explanation": "Sample size\n The 2010\u00e2\u0080\u00932011 data from the ICU of the Dhaka Hospital of the icddr, b (the proposed study site) revealed that among the 36 severely malnourished children with shock, 22 died, that is, mortality rate among SAM children with septic shock was 61% (22/36). We assumed that the proposed interventions would reduce the case fatality rate by 50%, that is, the rate will decrease from 61% to 31%.\n To detect this magnitude of difference in the death rate, with 80% power (20% type II error) and 0.05 type I error, the required sample size is 40 children in each of the three groups. Considering around 10% drop-outs after enrolment, the total sample size would be 45 children at least in each of the three groups, that is, a total of 135 children\u00e2\u0080\u0094the final sample size of our study.", "id": 1012, "split": "val"} +{"trial_id": "NCT04759573", "pmid": "33917889", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Early Vocal Contact (EVC) in the Neonatal Intensive Care Unit: A Multi-centre, Randomized Clinical Trial\n\nIncluded conditions:\n- Early Intervention\n- Prematurity\n\nStudy Armgroups:\n- {'label': 'Early Vocal Contact', 'type': 'EXPERIMENTAL', 'description': \"The EVC will take place in the hospital room while infants are in their individual incubators or open cribs. In the intervention group, mothers will be asked to speak and sing to their infants continuously over a 10-min period for each type of intervention (20 min in total). Mothers will be asked to talk in their native language and to sing familiar songs, while observing their infant's reactions. The order of the two vocalizations, speaking and singing, will be reversed in the next intervention.\\n\\nEarly Vocal Contact will be performed by mothers three times a week for 2 weeks, more than one hour after afternoon feeding. It will begin when the newborns are in an active sleep state, in calm awake state or in active awake state, but not in deep sleep or crying. Preterm infants will be enrolled from 25+0 to 32+6 weeks of GA, following the established inclusion criteria.\", 'interventionNames': ['Behavioral: Early Vocal Contact']}\n- {'label': 'Behavioral observation', 'type': 'ACTIVE_COMPARATOR', 'description': \"Mothers in the active control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviours through a standard cluster of indicators.\", 'interventionNames': ['Behavioral: Behavioral Observation']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Early Vocal Contact', 'description': \"Mothers will be asked to speak and sing to their infants continuously over a 10-min period for each type of intervention (20 min in total). Mothers will be asked to talk in their native language and to sing familiar songs, while observing their infant's reactions. The order of the two vocalizations, speaking and singing, will be reversed in the next intervention.\", 'armGroupLabels': ['Early Vocal Contact']}\n- {'type': 'BEHAVIORAL', 'name': 'Behavioral Observation', 'description': \"Mothers in the active control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviours through a standard cluster of indicators.\", 'armGroupLabels': ['Behavioral observation']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Heart Rate Variability', 'description': 'Heart rate is the number of heartbeats per minute.', 'timeFrame': 'Pre intervention (baseline), during the intervention and immediately after the intervention'}\n\nPlease estimate the sample size based on the assumption: \nAlpha setting at 0.025, beta setting at 0.80, and a 20% loss rate.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "3.7. Sample Size and Power Analysis\n The main outcome measures for the primary outcome will be the low-frequency (LF) and high-frequency (HF) power of the HRV measure. We expect the baseline measurement mean value (\u00c2\u00b1standard deviation) of LF and HF power for preterm infants to be 31 \u00c2\u00b1 4.9 Hz and 15 \u00c2\u00b1 2.6 Hz, respectively [58]. We assume that the treatment in the experimental population is effective if the mean values of LF and HF power reach 25 \u00c2\u00b1 4.9 and 17 \u00c2\u00b1 2.4 Hz, respectively. \n With an alpha setting at 0.025 and beta setting at 0.80, it is necessary to enroll 29 patients per group. Assuming a 20% loss, we aim to enroll at least 80 patients total (40 per group).", "id": 1013, "split": "val"} +{"trial_id": "NCT04760392", "pmid": "35551091", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Goal-directed Mobilization of Medical Inpatients (GoMob-in) - a Randomized, Controlled Trial\n\nIncluded conditions:\n- Immobility Syndrome\n- Fall\n- Delirium\n- Sarcopenia\n- Mobility Limitation\n- Hospital Acquired Condition\n\nStudy Armgroups:\n- {'label': 'GDM', 'type': 'EXPERIMENTAL', 'description': 'Goal-directed mobilization', 'interventionNames': ['Behavioral: Goal-directed mobilization']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Standard of care'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Goal-directed mobilization', 'description': '* A short educational intervention with handout of a leaflet on GDM.\\n* Definition of personal mobility goal level.\\n* Communication of the mobility goal level to involved stakeholders.\\n* Regular reassessment of the mobility goal level and \"booster sessions\" by physiotherapists.', 'armGroupLabels': ['GDM']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline of the DEMMI score', 'description': 'Change of the de Morton Mobility Index (DEMMI) score (range 0 to 100 with 0 indicating poor physical activity and 100 indicating a high level of independent physical activity) from baseline (at study inclusion), assessed by independent, blinded physiotherapist', 'timeFrame': 'Day 5\u00b12'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha level of 0.05, power of 0.8, and an estimated drop-out rate of 20%.", "answer": 160, "answer_type": "ACTUAL", "explanation": "Estimated sample size and power\n The sample size calculation was based on the primary outcome of a clinically meaningful change in the DEMMI score between baseline and 5\u00e2\u0080\u0089days of follow-up. The DEMMI score ranges from 0 to 100 points with 0 indicating no physical activity and 100 indicating maximal physical activity. Based on previous studies on changes in DEMMI scores during short-term hospitalisation of roughly 10 days,26 27 we expect a difference in change between the two groups of 5 score points. In an observational study of participants with low and high activity, SD for changes in the DEMMI score was 7.8 and 8.5 points, respectively (personal communication).26 In a study on older adult inpatients, the SD was between 12.5 and 15.4 points for absolute DEMMI scores at admission and discharge, respectively.27 The SD for changes is typically smaller than for absolute values; we therefore expect a rather conservative SD of about 10 points for the change in our study.\n To detect a difference in change of 5 score points with a SD of 10 points, at a two-sided alpha level of 0.05 with a power of 0.8, a sample size of 2\u00c3\u009764 participants is required. Based on an estimated drop-out rate of 20%, we aim to include 160\u00e2\u0080\u0089patients into the study (80 in each group).", "id": 1014, "split": "val"} +{"trial_id": "NCT04760444", "pmid": "33752609", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Michigan Men's Diabetes Project (MenD) - Peer Leader Intervention\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'Peer Leader Diabetes Self-Management Support (PLDSMS)', 'type': 'EXPERIMENTAL', 'description': 'Participants in the PLDSMS arm will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist. After the DSME group sessions, the group will complete 6 1-hour weekly diabetes self-management support (DSMS) session led by two peer leaders.', 'interventionNames': ['Behavioral: Peer Leader Diabetes Self-Management Support', 'Behavioral: Virtual Diabetes Self-Management Education']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants in the control group will receive 10 hours of group diabetes self-management education (DSME) with a certified diabetes care and education specialist.', 'interventionNames': ['Behavioral: Virtual Diabetes Self-Management Education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Peer Leader Diabetes Self-Management Support', 'description': 'While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.', 'armGroupLabels': ['Peer Leader Diabetes Self-Management Support (PLDSMS)']}\n- {'type': 'BEHAVIORAL', 'name': 'Virtual Diabetes Self-Management Education', 'description': 'Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.', 'armGroupLabels': ['Control Group', 'Peer Leader Diabetes Self-Management Support (PLDSMS)']}\n\nPrimary Outcomes:\n- {'measure': 'Hemoglobin A1C', 'description': 'This outcome measure is change in hemoglobin A1C measured using the DCA 2000 point-of-care testing instrument (value at 3 months minus value at baseline).', 'timeFrame': '3 months'}\n- {'measure': 'Self-Care Activities', 'description': 'This outcome measure is change in self-care activities as measured by the Summary of Diabetes Self-Care Activities (SDSCA) scale (value at 3 months minus value at baseline). The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. The range for the general diet, specific diet, exercise, blood-glucose testing, and foot care sub scales included below is 0 to 7. Higher scores are indicative of more frequent self-care activities compared to lower scores.', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \ncorrelations of 0.25 between successive measurements of A1C, power of 0.8, 20% attrition", "answer": 25, "answer_type": "ACTUAL", "explanation": "Sample size\n \n Power analysis\n Assuming 20% attrition, we expect a final sample size of 48 (excluding the four participants designated as peer leaders), approximately 12 per group (with 2 groups in the treatment arm). If we assume correlations of 0.25 between successive measurements of A1C, then this sample size will yield power of 0.8 to detect a difference of 0.6 standard deviation between average values of A1C in treatment and control groups.", "id": 1015, "split": "val"} +{"trial_id": "NCT04761042", "pmid": "35534081", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Controlled Pilot Study Assessing Feasibility and Impact of a Wilderness Program on Mental and Physical Health of Adolescent and Young Adult Cancer Survivors\n\nIncluded conditions:\n- Cancer\n\nStudy Armgroups:\n- {'label': 'Wilderness program', 'type': 'EXPERIMENTAL', 'description': 'A one-week (8 days) wilderness program, 3-month online support, and a follow-up visit for four days.', 'interventionNames': ['Other: WAYA-Wilderness']}\n- {'label': 'Holiday program (Attention control)', 'type': 'OTHER', 'description': 'A one-week (8 days) holiday program, 3-month online contact, and a follow-up visit for four days.', 'interventionNames': ['Other: WAYA-Holiday']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'WAYA-Wilderness', 'description': \"The wilderness intervention includes challenging tasks in order to help participants' overcome and master new physical and psychological challenges in an unknown environment, with the idea to support self-efficacy, self-esteem, and ability to recover from adversity. The program is designed to encourage participants to connect with nature as to experience gratitude for the richness of the natural world, a sense of calmness and trust upon spending time in nature, and to be more physically active in nature.\\n\\nElements previously described Participants will continue in a three-month program at home (on-line supported) after the initial 8-days in order to empower participants to incorporate elements of the onsite wilderness program into their daily life. An individualized a plan for activities will be developed together with the participant.\\n\\nAfter three months, there will be a re-visit with follow up on outcome measures and reconnection.\", 'armGroupLabels': ['Wilderness program']}\n- {'type': 'OTHER', 'name': 'WAYA-Holiday', 'description': 'An attention control group (information in \"Detailed description\")', 'armGroupLabels': ['Holiday program (Attention control)']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility - Participant Preferences', 'description': 'Participant Preferences (P-Pref) regarding intervention arms (no pref, slight pref, strong preference)', 'timeFrame': 'At prestudy screening - prior to inclusion'}\n- {'measure': 'Feasibility - Participant expectations', 'description': 'A textual description of what participants would expect to experience from participation in either intervention group.', 'timeFrame': 'At prestudy screening - prior to inclusion'}\n- {'measure': 'Feasibility - Participant willingness to be randomized', 'description': 'Willingness of participants to be randomized (Yes/No)', 'timeFrame': 'At prestudy screening - prior to inclusion'}\n- {'measure': 'Feasibility - Time to recruitment', 'description': 'A planned n of 40 is planned and documentation of time to reach the goal will be made until predetermined number of participants are reached or max up till 18 months', 'timeFrame': 'Until predetermined number of participants are reached or max up till 18 months'}\n- {'measure': 'Feasibility - Participant Adherence to Protocol', 'description': 'Adherence of the participants to the study protocol. A textual description of participant adherence based on observation and interviews documented in the participants study protocol', 'timeFrame': 'through study completion, an average of 1 1/2 year'}\n- {'measure': 'Feasibility - Logistics and Burden', 'description': 'Logistics and Burden (for participants) to perform physical performance/fitness tests. A textual description of participant Log-BurdenPhysbased on observation and interviews documented in the participants study protocol', 'timeFrame': 'Through study completion, an average of 1 1/2 year'}\n- {'measure': 'Feasibility - Logistics and willingness to complete all planned study-related questionnaires', 'description': 'Logistics and willingness to complete all planned study-related questionnaires. A textual description of participant Log-WillQuest based on observation and interviews documented in the participants study protocol', 'timeFrame': 'Through study completion, an average of 1 1/2 year'}\n- {'measure': 'Feasibility - Adherence to three month at home program', 'description': 'The adherence of the participants to the three months at home program and transference of activities in this period. A textual description of participant adherence based on observation and interviews documented in the participants study protocol', 'timeFrame': 'up to three months'}\n- {'measure': 'Feasibility - Occurrence of adverse events', 'description': 'Occurrence of adverse events during program execution. A textual description of occurence of AdvEvents based on observation and interviews documented in the participants study protocol.\\n\\nAdverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and analysed using preferred terms and allocation to system organ class. Safety of the interventions will be measured by analyzing number and type of adverse events reported.', 'timeFrame': 'up to three months'}\n\nPlease estimate the sample size based on the assumption: \nRecommendations of Whitehead et al", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size\n Based on the recommendations of Whitehead et al43 and an expected small to medium effect size for changes in quality of life, a sample size of 40 participants (n=20 per group) is chosen for this pilot study. A sample size of 20 participants in each group is also thought to generate sufficient interviews for the qualitative evaluation in the study.", "id": 1016, "split": "val"} +{"trial_id": "NCT04763135", "pmid": "35599320", "question": "Here is the design of a clinical trial:\n\nOfficial Title: What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol\n\nIncluded conditions:\n- Cancer\n- Neoplasms\n- Neoplasm Metastasis\n\nStudy Armgroups:\n- {'label': 'Oral mirtazapine', 'type': 'EXPERIMENTAL', 'description': 'Arm 1 patients will be treated using a daily mirtazapine treatment. Treatment will be taken on the evening. Treatment will be initiated at 15 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for old patients and those with liver failure.', 'interventionNames': ['Drug: Mirtazapine']}\n- {'label': 'Oral escitalopram', 'type': 'ACTIVE_COMPARATOR', 'description': 'Arm 2 patients will be treated using a daily escitalopram treatment. Treatment will be taken in the morning. Treatment will be initiated at 10 mg daily and gradually increased depending on symptom control and side effects. Treatment doses will be adapted for 5 mg for old patients.', 'interventionNames': ['Drug: Escitalopram']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Mirtazapine', 'description': 'Orally disintegrating tablets of mirtazapine introduced at the dose of 15 mg and increased up to 45 mg per day during 56 days.\\n\\nDoses escalation: based on symptom management and side effect assessment.', 'armGroupLabels': ['Oral mirtazapine']}\n- {'type': 'DRUG', 'name': 'Escitalopram', 'description': 'Orally disintegrating tablets of escitalopram introduced at the dose of 10 mg (or 5 mg for patients older than 65) and increased up to 20 mg per day during 56 days.\\n\\nDoses escalation: based on symptom management and side effect assessment.', 'armGroupLabels': ['Oral escitalopram']}\n\nPrimary Outcomes:\n- {'measure': 'Global health status score', 'description': 'The Global Health Status will be calculated from the specific subscale included in the EORTC-QLQ-C30 scale.\\n\\nThe difference between baseline and the end-point (day 56) will be the primary judgment criteria. A 4 to 8 points difference between baseline and endpoint will be considered as a mild difference, and a difference over 8 points will be considered as a moderate difference.', 'timeFrame': 'At baseline and day 56'}\n\nPlease estimate the sample size based on the assumption: \nBilateral test, alpha risk of 0.05, power of 0.8, and an attrition rate of 20%.", "answer": 1, "answer_type": "ACTUAL", "explanation": "Sample Size\n Based on an expected standard deviation of 26 in our primary outcome (The Global health Status), and considering a correlation of 0.5 between inclusion and day 56 (corresponding in a standard deviation of the variation of the GHS score of 26 between baseline and day 56), and expecting a moderately clinically significant difference of 8 points between groups, it will be necessary to include 418 participants (bilateral test, alpha risk of 0.05, power of 0.8, attrition 0.2).\n Considering the risk of lost to follow-up due to our population global condition, we considered an attrition rate of 20% when calculate the sample size.", "id": 1017, "split": "val"} +{"trial_id": "NCT04763291", "pmid": "37726820", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Long-term Consumption of Two Plant-based Dietary Supplements on Cardiovascular Health and Low-grade Inflammation in the Elderly\n\nIncluded conditions:\n- Aging\n- Cardiovascular Diseases\n- Overweight or Obesity\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Continue habitual diet and lifestyle.'}\n- {'label': 'Fruit, Vegetable and Berry (FVB) group', 'type': 'EXPERIMENTAL', 'description': 'Participants have to ingest an encapsulated juice powder concentrate, otherwise continue their habitual diet and lifestyle.', 'interventionNames': ['Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blends']}\n- {'label': 'Omega group', 'type': 'EXPERIMENTAL', 'description': 'Participants have to ingest a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle.', 'interventionNames': ['Dietary Supplement: Juice Plus+ Omega blend']}\n- {'label': 'Fruit, Vegetable, Berry and Omega (FVBO) group', 'type': 'EXPERIMENTAL', 'description': 'Participants have to ingest an encapsulated juice powder concentrate along with a plant-based fatty acid supplement, otherwise continue their habitual diet and lifestyle.', 'interventionNames': ['Dietary Supplement: Juice Plus+ Fruit, Vegetable and Berry blends', 'Dietary Supplement: Juice Plus+ Omega blend']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Juice Plus+ Fruit, Vegetable and Berry blends', 'description': 'Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries.', 'armGroupLabels': ['Fruit, Vegetable and Berry (FVB) group', 'Fruit, Vegetable, Berry and Omega (FVBO) group']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Juice Plus+ Omega blend', 'description': 'Encapsulated plant-based fatty acid supplement.', 'armGroupLabels': ['Fruit, Vegetable, Berry and Omega (FVBO) group', 'Omega group']}\n\nPrimary Outcomes:\n- {'measure': 'Lipid profile markers', 'description': 'Total cholesterol, HDL, LDL, ApoA1, triglycerides, Omega-3-Index', 'timeFrame': '12 months'}\n- {'measure': 'Hemostasis markers', 'description': 'Platelet aggregation, thrombelastometry, coagulation (Quick, PT, PTT)', 'timeFrame': '12 months'}\n- {'measure': 'Oxidative stress markers', 'description': 'oxLDL, MDA, carbonyl proteins, (CP), redox state of albumin, homocysteine', 'timeFrame': '12 months'}\n- {'measure': 'Glucose metabolism', 'description': 'Glucose, insulin, HOMA-IR, HbA1c', 'timeFrame': '12 months'}\n- {'measure': 'Concentration changes in cytokines/ cytokine receptors', 'description': 'TNF-\u03b1, sTNFR1 and sTNFR2, CCL5 = RANTES, IL-1\u03b2, hsCRP, CCL2 = MCP-1, Osteoprotegerin (OPG), IL-5, IL-8', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \ntwo-tailed t-test, 5% significance level (two-sided), 80% power, 30% dropout rate over 24 months", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation was performed according to omega-3 index changes as a key biomarker of cardiovascular health and TNF-\u00ce\u00b1 changes as a key biomarker of low-grade inflammation, following supplementation. Assuming a two-tailed t-test using 5% significance level (two-sided), a sample size of 18 and 19 subjects per group was determined to have 80% power to detect a 30% increase on omega-3 index [32] and a minimum decrease of 0.4 ng/L on TNF-\u00ce\u00b1 [43], respectively. Allowing for a dropout rate of 30% over 24 months, we aim to recruit 112 participants in total (n\u00e2\u0080\u0089=\u00e2\u0080\u008928 control group; n\u00e2\u0080\u0089=\u00e2\u0080\u008928 FVB group; n\u00e2\u0080\u0089=\u00e2\u0080\u008928 Omega group; n\u00e2\u0080\u0089=\u00e2\u0080\u008928 FVBO group).", "id": 1018, "split": "val"} +{"trial_id": "NCT04766866", "pmid": "38458783", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protocol of the PE37 Study: a Multicenter Randomized Trial of Screening with SFlt1/PlGF and Planned Delivery to Prevent Preeclampsia At Term\n\nIncluded conditions:\n- Preeclampsia\n- Intrauterine Growth Restriction\n- Maternal Hypertension\n- Neonatal Outcome\n- Perinatal Death\n\nStudy Armgroups:\n- {'label': 'Non-intervention or non-reveal group', 'type': 'NO_INTERVENTION', 'description': 'Non-intervention or non-reveal (result unknown) group: routine follow-up and spontaneous delivery'}\n- {'label': 'Intervention group or reveal group', 'type': 'EXPERIMENTAL', 'description': 'A ratio cutoff of \\\\>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation', 'interventionNames': ['Diagnostic Test: sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation', 'description': 'A ratio cutoff of \\\\>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation', 'armGroupLabels': ['Intervention group or reveal group']}\n\nPrimary Outcomes:\n- {'measure': 'Rate of term Preeclampsia development', 'description': 'Number of participants with term preeclampsia/total number participants.', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \n90% statistical power, 10% loss, 99% power for non-inferiority hypothesis testing", "answer": 9132, "answer_type": "ESTIMATED", "explanation": "Sample size\n A sample size of 8302 is needed to guarantee a 90% statistical power for demonstrating a 50% reduction (assuming a detection rate of 70% and a 70% risk-reduction by timely induction) in the development of PE (from 1.5%).27 Assuming a 10% loss, the investigators estimated a sample size of 9132\u00e2\u0080\u0089women.\n Under a non-inferiority hypothesis testing design, assuming a composite adverse neonatal outcome incidence of 1% in the revealed group, 0.5% in the concealed risk and a prespecified non-inferiority margin of 0.25%; this sample size (4151 per arm) would result in a power of 99% to reject the null hypothesis that the reveal strategy increases the neonatal complications.27", "id": 1019, "split": "val"} +{"trial_id": "NCT04767087", "pmid": "34526081", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Honey and Nigella Sativa in the Prophylaxis of COVID-19: A Randomized Controlled Trial\n\nIncluded conditions:\n- Covid19\n\nStudy Armgroups:\n- {'label': 'Honey and Nigella sativa Arm', 'type': 'ACTIVE_COMPARATOR', 'description': '0.5 g/kg/day honey 40 mg/Kg/day Nigella sativa seeds', 'interventionNames': ['Drug: Honey', 'Drug: Nigella sativa seed']}\n- {'label': 'Placebo Arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'empty capsule with sugar water', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Honey', 'description': '0.5 gm/Kg/day honey', 'armGroupLabels': ['Honey and Nigella sativa Arm']}\n- {'type': 'DRUG', 'name': 'Nigella sativa seed', 'description': '40 mg/Kg/day', 'armGroupLabels': ['Honey and Nigella sativa Arm']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'empty capsule with sugar water', 'armGroupLabels': ['Placebo Arm']}\n\nPrimary Outcomes:\n- {'measure': 'SARS-CoV-2 infection rate', 'description': 'RT-PCR SARS-CoV-2', 'timeFrame': '14 days'}\n\nPlease estimate the sample size based on the assumption: \nNot specified", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Numbers to be randomised (sample size)\n 1000 participants will be enrolled in the study with 1:1 allocation.", "id": 1020, "split": "val"} +{"trial_id": "NCT04769362", "pmid": "39645270", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Discontinuation of \u0392-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: a Multicenter Randomized Noninferiority Trial\n\nIncluded conditions:\n- Myocardial Infarction\n\nStudy Armgroups:\n- {'label': '\u03b2-blocker discontinuation arm', 'type': 'EXPERIMENTAL', 'description': 'Discontinuation of \u03b2-blocker therapy after at least 1 year of \u03b2-blocker therapy after acute myocardial infarction', 'interventionNames': ['Drug: Discontinuation of \u03b2-blocker']}\n- {'label': '\u03b2-blocker maintenance arm', 'type': 'NO_INTERVENTION', 'description': 'Continuation of \u03b2-blocker therapy after acute myocardial infarction'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Discontinuation of \u03b2-blocker', 'description': 'Discontinuation of \u03b2-blocker after at least 1 year of \u03b2-blocker therapy after acute myocardial infarction', 'armGroupLabels': ['\u03b2-blocker discontinuation arm']}\n\nPrimary Outcomes:\n- {'measure': 'Major adverse cardiac events', 'description': 'a composite of all-cause death, myocardial infarction, hospitalization for heart failure', 'timeFrame': '2.5 years after last patient enrollment'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a one-sided type I error of 2.5%, \u226580% power, and a 2% attrition rate.", "answer": 2540, "answer_type": "ESTIMATED", "explanation": "Sample size calculations\n Originally, we assumed that the recruitment of study patients would occur at a constant rate over 3 years and that study patients would be followed-up with for an additional 2 years after the recruitment of the last patient (median follow-up of 3.5 years; range, 2\u00e2\u0080\u00935 years). However, the enrolment rate has already exceeded our initial expectations (actual accrual period of 2 years), prompting us to perform a revised sample size calculation. To maintain a median follow-up duration of 3.5 years (range, 2.5\u00e2\u0080\u00934.5 years), we have decided to extend the follow-up period to 2.5 years after the recruitment of the last patient. According to data from previous Korean nationwide observational studies, the annual incidence of the primary endpoint is estimated to be 3% in the \u00ce\u00b2-blocker maintenance group.12 The non-inferiority margin of the HR selected was 1.4. With a sampling ratio of 1:1, we estimated that 2540 patients (1270 per group) would result in \u00e2\u0089\u00a580% power at a one-sided type I error of 2.5% and a 2% attrition rate.", "id": 1021, "split": "val"} +{"trial_id": "NCT04770285", "pmid": "39163592", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multi-center, Randomized, Controlled Trial to Evaluate the Effectiveness of a Digital Therapeutic (CT-152) as Adjunctive Therapy in Adult Subjects Diagnosed With Major Depressive Disorder\n\nIncluded conditions:\n- Major Depressive Disorder\n\nStudy Armgroups:\n- {'label': 'Digital Therapeutic A - CT-152', 'type': 'OTHER', 'description': 'Participants received digital treatment session by using the CT-152 mobile application (app) from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of Emotional Faces Memory Task (EFMT) exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.', 'interventionNames': ['Device: CT-152 - Digital Therapeutic']}\n- {'label': 'Digital Therapeutic B - Sham', 'type': 'OTHER', 'description': 'Participants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a Shape and Memory Task (SMT) exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.', 'interventionNames': ['Device: Sham']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'CT-152 - Digital Therapeutic', 'description': 'CT-152 mobile app was used by the participants as per the schedule specified in the respective arm.', 'armGroupLabels': ['Digital Therapeutic A - CT-152']}\n- {'type': 'DEVICE', 'name': 'Sham', 'description': 'Sham mobile app was used by the participants as per the schedule specified in the respective arm.', 'armGroupLabels': ['Digital Therapeutic B - Sham']}\n\nPrimary Outcomes:\n- {'measure': 'Change From Baseline to Week 6 in the MADRS Total Score', 'description': 'The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the \"best\" rating and 6 being the \"worst\" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a more severe level of depression. A negative change from baseline indicates improvement. Least square (LS) mean was estimated using Mixed Model Repeated Measures (MMRM) method.', 'timeFrame': 'Baseline (Day 1) to Week 6'}\n\nPlease estimate the sample size based on the assumption: \n85% power, 2-sided \u03b1=.05, up to 10% missing/dropout rate", "answer": 386, "answer_type": "ACTUAL", "explanation": "Sample Size Calculation\n The initial sample size was calculated to detect a 3-unit difference between the CT-152 plus ADT and sham DTx plus ADT in the change from baseline in MADRS total score, with 85% power at a 2-sided \u00ce\u00b1=.05 level. The resulting sample size was 324 evaluable participants in total (162 in each arm). The full analysis set was defined as all randomized participants who received at least 1 CT-152 or sham DTx session and had at least 2 MADRS total score assessments, 1 of which was at baseline. To compensate for participants who failed to have evaluable assessments of MADRS total score in the full analysis set sample (estimated at up to 10% of all participants), a total of approximately 360 participants (180 in each arm) were planned to be randomized. The trial randomized eligible participants 1:1 across 54 sites. The sample size at any single trial site was capped at approximately 15% of the total number of randomized participants. Randomization was stratified by the trial site.\n Due to the limitations of applying assumptions on the treatment effect size, and to ensure adequate power of the trial, an unmasked interim analysis was conducted by a data monitoring committee, whose members recommended continuing the trial with the planned sample size of 360 participants (actual enrollment included 386 participants).", "id": 1022, "split": "val"} +{"trial_id": "NCT04773639", "pmid": "36384735", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Clinical Trial of a Multi-Modal Palliative Care Intervention\n\nIncluded conditions:\n- Depression, Anxiety\n- Metastatic Cancer\n\nStudy Armgroups:\n- {'label': 'Multi-Modal Acceptance and Commitment Therapy (M-ACT)', 'type': 'EXPERIMENTAL', 'description': 'M-ACT consists of five 2-hour group sessions (plus booster) that alternate with self-paced online modules and check-ins that participants complete on their own, between the group sessions. The intervention addresses distress associated with coping with metastatic cancer and supports engagement in advance care planning. The intervention is based on Acceptance and Commitment Therapy, an intervention model that aims to help people cope with life challenges and difficult thoughts/feelings in a manner that helps them to live fuller and more meaningful lives.', 'interventionNames': ['Behavioral: Multi-Modal Palliative Care Intervention']}\n- {'label': 'Control: Usual Care', 'type': 'OTHER', 'description': 'Patients in the control arm will have access to usual care (UC) at the collaborating clinics, consisting of access to a clinical social worker and nurse practitioners for advance care planning and supportive visits at patient request. After completion of study procedures, including FU, the UC participants will be offered M-ACT free of cost.', 'interventionNames': ['Behavioral: Usual Care Control Condition']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Multi-Modal Palliative Care Intervention', 'description': 'An innovative muli-modal palliative care intervention that addresses the lack of advance care planning and unmet psychosocial needs commonly experienced by patients with metastatic cancer.', 'armGroupLabels': ['Multi-Modal Acceptance and Commitment Therapy (M-ACT)']}\n- {'type': 'BEHAVIORAL', 'name': 'Usual Care Control Condition', 'description': 'The control condition includes usual care (UC) at the collaborating clinics, consisting of access to a clinical social worker and nurse practitioners for advance care planning and supportive visits at patient request.', 'armGroupLabels': ['Control: Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Change in advance care planning', 'description': \"The primary outcome is defined as change in the number of steps taken toward ACP completion from baseline through 2-month follow-up. ACP steps will be assessed with a checklist adapted from the M-ACT pilot study by consulting the Hospice \\\\& Palliative Nurses Association online ACP resources and the study team, and refined by soliciting pilot participants' feedback on item clarity. The checklist describes each ACP step and asks patients to indicate steps taken to date.\", 'timeFrame': 'Assessed four times with parallel timing in the control group: prior to the intervention (Pre), week 3 of the intervention (Mid), within one week after the end of the weekly intervention (Post), at 2-month follow-up (FU)'}\n\nPlease estimate the sample size based on the assumption: \nThe power calculations assume a two-sided alpha of 0.05 and a minimum power of 80%. The analyses consider an intraclass correlation (ICC) ranging from 0.02 to 0.08. The expected sample size accounts for attrition, with an anticipated n = 174 out of a total n = 240 participants contributing data at the final follow-up assessment.", "answer": 240, "answer_type": "ESTIMATED", "explanation": "Power and sample size estimation\n Power calculations to evaluate group differences in outcomes over time Pre thru FU (Study Aim 1) were performed using the Optimal Design For Multilevel and Longitudinal Research Software, Version 3.01 [70], where the effect size estimates consider the number of cohorts/intervention groups, the average sample size per group, and the intraclass correlation (ICC) assessing within-cohort similiarities. Due to expected attrition, power analyses were based on an expected n\u00e2\u0080\u0089=\u00e2\u0080\u0089174 (of total n\u00e2\u0080\u0089=\u00e2\u0080\u0089240) participants contributing data at the final FU assessment, though this number can be considered conservative due to intent to apply modern data techniques to include patients with partial data. Though the M-ACT pilot study showed an average ICC between intervention cohort groups of less than 0.01, we conservatively estimated minimum effect sizes detectable for different power specifications for ICCs ranging from 0.02 to as high as 0.08. These ICC estimates were based on in-person intervention delivery, where cohorts would be similar by clinic and/or geographic area. Given the current switch to the online-only format due to COVID-19, within-cohort similarities are expected to be further attenuated. Power was calculated to detect treatment effects in changes over time, i.e., the condition by time interaction. Assuming two-sided alpha of 0.05 and minimum power of 80%, the proposed sample size will be sufficient to detect an effect size of Cohen\u00e2\u0080\u0099s d\u00e2\u0080\u0089=\u00e2\u0080\u00890.26 (or larger) of the M-ACT intervention over the UC condition on condition differences in change over time across the four time points. For the primary outcome of ACP, assuming a similar standard deviation of \u00c2\u00b1\u00e2\u0080\u00892.29 as observed in the M-ACT pilot trial, this power corresponds to detecting a small but clinically important increase of approximately 0.60 ACP items. If the detectable effect size increases due to higher than anticipated attrition or ICC values, increases as low as 0.80 ACP items completed will still be detectable.\n To evaluate relationships between ACP and anxiety and depression symptoms (Study Aim 2), the expected sample size will provide 80% power to detect an association of anxiety or depression symptoms with ACP as low as r\u00e2\u0080\u0089=\u00e2\u0080\u0089.25, with a multivariable regression model able to detect an R-squared of 0.08, a medium effect size. For the exploratory mediational aim, simulation [71] shows we will have \u00e2\u0089\u00a5\u00e2\u0080\u008980% power to detect mediated effects associated with moderate to large sized path coefficients (e.g., as low as 6-13% of variance explained), which results in an ability to detect mediated effects that are smaller than relationships observed in the M-ACT pilot trial [42].", "id": 1023, "split": "val"} +{"trial_id": "NCT04773691", "pmid": "35022086", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of High-frequency rTMS in Reducing Alcohol Consumption in Non-abstinent Patients With an Alcohol Use Disorder: A Multicentre Randomised Controlled Study\n\nIncluded conditions:\n- Alcoholism\n- rTMS Stimulation\n\nStudy Armgroups:\n- {'label': 'test group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Device: Active rTMS', 'Other: Questionnaires', 'Device: Breathalyzer']}\n- {'label': 'control group', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Device: Placebo rTMS', 'Other: Questionnaires', 'Device: Breathalyzer']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Active rTMS', 'description': 'Two rTMS stimulation sessions spaced 15 minutes apart are delivered daily for 5 consecutive days.\\n\\nA total of 10 sessions. Stimulation parameters: 10 Hz, 1000 pulses per session, 110% of SM, cortical target: right DLPFC', 'armGroupLabels': ['test group']}\n- {'type': 'DEVICE', 'name': 'Placebo rTMS', 'description': 'Two rTMS stimulation sessions spaced 15 minutes apart are delivered daily for 5 consecutive days.\\n\\nA total of 10 sessions. Stimulation parameters: delivering a non-significant current at the beginning and end of the stimulation, simulating active stimulation.', 'armGroupLabels': ['control group']}\n- {'type': 'OTHER', 'name': 'Questionnaires', 'description': 'questionnaires for craving assessment: EVA, OCDS, CGI and ADS and signs of physical withdrawal by CIWA', 'armGroupLabels': ['control group', 'test group']}\n- {'type': 'DEVICE', 'name': 'Breathalyzer', 'description': 'estimation of blood alcohol level', 'armGroupLabels': ['control group', 'test group']}\n\nPrimary Outcomes:\n- {'measure': 'total alcohol consumption (g/d)', 'description': 'total alcohol consumption (g/d), measured by average daily consumption', 'timeFrame': 'through study completion, an average of 1 month'}\n- {'measure': 'number of days of high consumption', 'description': 'reduction in the number of days of high consumption (\u2265 60 g/d for men, \u2265 40 g/d for women)', 'timeFrame': 'through study completion, an average of 1 month'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 1.25% (co-primary outcome), power of 80%, and a 20% rate of premature withdrawal or non-initiation of treatment.", "answer": 144, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size was calculated using PASS software (version 11, Kayesville, UT, USA) [27]. As the primary efficacy outcome, the EMA recommend using both TAC and the number of HDD [1]. Besides, any reduction in total alcohol consumption of at least 10\u00e2\u0080\u0089g/day for patients with alcohol use disorders will reduce the annual and lifetime risk of alcohol-related death [28].\n In this context, the sample size calculation based on an expected difference between the treatment groups of 15\u00e2\u0080\u0089g/day in total alcohol consumption or 3\u00e2\u0080\u0089days per month, with a standard deviation for the TAC of 30\u00e2\u0080\u0089g/day and with an autocorrelation of 0.3 to 0.7 between observations in the same subject, between 82 and 122 patients, would be required.\n Considering a significance level of 1.25% (co-primary outcome) and a power of 80%, and with the hypothesis of a premature withdrawal or a non-initiation of treatment (acute repeated alcoholism) for 20% of individuals, 144 patients (72 per group) should be included to meet the objectives of the study.", "id": 1024, "split": "val"} +{"trial_id": "NCT04773938", "pmid": "35105647", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Endoscopic Third Ventriculostomy for Adults With Hydrocephalus: Creating a Prognostic Model for Success - A Retrospective Multicenter Study\n\nIncluded conditions:\n- Hydrocephalus\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'ETV success', 'description': 'The procedure is considered successful if the patient experience clinical improvement at first follow up and receives no further CSF diversion procedures, within one year of the initial procedure.', 'timeFrame': 'Evaluated 1 year after operation'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation was performed using the 'pmsampsize' package in R. The goal is to achieve the necessary power to create a robust prognostic model.", "answer": 1000, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size was calculated using the \u00e2\u0080\u0098pmsampsize\u00e2\u0080\u0099 package in R by Riley et al.29 The closest analogous predictive model is the ETVSS by Kulkarni et al7 and the estimation was created using prevalence and C-statistic from this model. This resulted in a minimum sample size of 429 patients, for a predictive model using 5 variables. There is no upper limit, as more patients would give a better foundation for the prediction model, especially in patients with aetiologies rarely treated with ETV such as iNPH or hydrocephalus caused by infection or SAH. Approximately 220 adult ETV patients have been identified in Copenhagen 2010\u00e2\u0080\u00932017. Cooperation between several centres should easily provide the minimum required sample size and the necessary power to create a robust prognostic model. An estimate of at least 250 ETV procedures from each of the participating countries would result over 1000 patients.", "id": 1025, "split": "val"} +{"trial_id": "NCT04774770", "pmid": "34548369", "question": "Here is the design of a clinical trial:\n\nOfficial Title: HED-Start: A Randomised Controlled Trial to Evaluate a Positive Skills Intervention for Patients New on Haemodialysis\n\nIncluded conditions:\n- End Stage Renal Disease on Dialysis\n- End Stage Renal Failure on Dialysis\n- End Stage Renal Disease\n- End Stage Kidney Disease\n\nStudy Armgroups:\n- {'label': 'HED-Start Intervention arm', 'type': 'EXPERIMENTAL', 'description': 'Participants assigned to the intervention arm will undergo 4 sessions of the HED-Start program. Each session is 2 hours long and will be conducted fortnightly.', 'interventionNames': ['Behavioral: HED-Start']}\n- {'label': 'Standard care arm', 'type': 'NO_INTERVENTION', 'description': 'Participants assigned to the standard care arm will proceed with routine standard care.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'HED-Start', 'description': 'The HED-Start Program is a cognitive-behavioral intervention based on self-management and motivational interviewing principles.', 'armGroupLabels': ['HED-Start Intervention arm']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Anxiety and Depression (HADS) scores from baseline', 'description': 'Hospital Anxiety and Depression Scale (HADS). The HADS comprises two subscales (anxiety; depression) and can be totaled to produce an overall scale score. Scores range from 0 to 21 for each subscale, and from 0 to 42 for the overall score. Higher scores are indicative of worse anxiety and depression symptoms.', 'timeFrame': 'Participants will be assessed at two time points: [T1] Baseline and [T2] 3 months post-randomization'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed significance level of 5%, power of 80%, and an attrition rate of 30%.", "answer": 148, "answer_type": "ESTIMATED", "explanation": "Sample size\n Sample size calculation was performed using G*Power V.3.19.7. The selected medium effect size (standardised effect size=\u00e2\u0088\u00920.6) was based on the pooled effect estimate obtained from most recent systematic reviews and meta-analyses on psychosocial interventions on reducing depression and anxiety symptoms in those with CKD ranging from d=\u00e2\u0088\u00920.48\u00e2\u0080\u0089to \u00e2\u0088\u00920.60.41\u00e2\u0080\u009343 Assuming a medium effect size of 0.6 and adopting a 1:2 allocation ratio, 34 and 68 participants will be allocated to control and intervention arm, respectively for a (two-tailed) significance level of 5% and a power of 80%. An unequal allocation ratio is to be adopted to account for the potential higher attrition rates in the intervention arm than those of the usual care. Assuming an attrition rate of 30%, a sample size of 148 participants will be sought for the RCT (50 and 98 participants for control and intervention, respectively).", "id": 1026, "split": "val"} +{"trial_id": "NCT04775160", "pmid": "36127081", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Smartphone-based Ecological Momentary Intervention for Secondary Prevention of Suicidal Thoughts and Behavior: a Randomised Clinical Trial\n\nIncluded conditions:\n- Suicide\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'The control group will be monitored using smartphone-based active and passive Ecological Momentary Assessment through the MEmind and eB2 mobile applications, and will receive treatment as usual, which will consist of psychiatric follow-up (scheduled appointments with their psychiatrist) in an outpatient Secondary Suicide Prevention Programme, with predetermined clinical reviews according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks, and 4, 6, 9 and 12 months)'}\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'The intervention group will receive an Ecological Momentary Intervention called SmartSafe, will be monitored using smartphone-based active and passive Ecological Momentary Assessment through the MEmind and eB2 mobile applications, and their treatment as usual, which will consist of psychiatric follow-up (scheduled appointments with their psychiatrist) in an outpatient Secondary Suicide Prevention Programme, with predetermined clinical reviews according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks, and 4, 6, 9 and 12 months)', 'interventionNames': ['Device: SmartSafe']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'SmartSafe', 'description': 'The SmartSafe Ecological Momentary Intervention is contained in the MEmind smartphone application and consists of a Safety plan, an Enhanced contact via app (app-EC) intervention, and a \"mental toolbox\". The Safety plan is a set of personalized coping strategies that the patient can use in a suicidal crisis. Our safety plan was adapted to a digital environment, including the possibility to activate pre-recorded messages, lead to websites with health resources, or put the patient in contact with the emergency services. The Enhanced contact via app (app-EC) intervention is inspired by the SIAM project and consists in messages that will be sent via the MEmind app inquiring patients about their mental well-being and informing them of the means to request preferential or urgent care. The mental toolbox contains videos relaxation techniques videos and behavioral activation and mentalization exercises.', 'armGroupLabels': ['Intervention group'], 'otherNames': ['The SmartSafe Ecological Momentary Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Reduction of suicidal ideation', 'description': 'Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale', 'timeFrame': '6 months'}\n- {'measure': 'Reduction of suicidal ideation', 'description': 'Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nAlpha error set at 5%, power at 80%, dropout rate of 20%, and randomisation imbalance of 10%", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Sample size calculation was performed using G*Power software, V.3.1. Based on previous clinical trials exploring the ability of interventions to reduce SI in the mid-term,36 we estimated a target sample size enough to have 80% power to detect between-group differences of 6\u00e2\u0080\u00937 points on the SI subscale of the CSSRS35 (25% decrease in the intensity of SI in the intervention group). The alpha error was set at 5% and the power at 80%. We assumed a dropout rate of 20% and a randomisation imbalance of 10%. With these settings, we estimated that we needed a total of 220 participants, 110 in each arm.", "id": 1027, "split": "val"} +{"trial_id": "NCT04775953", "pmid": "35578360", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Dalbavancin as an Option for Treatment of S. Aureus Bacteremia (DOTS): A Phase 2b, Multicenter, Randomized, Open-Label, Assessor-Blinded Superiority Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated S. Aureus Bacteremia\n\nIncluded conditions:\n- Staphylococcal Bacteraemia\n\nStudy Armgroups:\n- {'label': 'Arm 1 (Dalbavancin)', 'type': 'EXPERIMENTAL', 'description': 'Dalbavancin 1500 mg will be administrated intravenously (IV) over 30 (-/+10) minutes on Day 1 and 1500 mg IV over 30 (-/+10) minutes on Day 8, renally dose-adjusted to 1125 mg for subjects with Creatinine Clearance (CrCl) \\\\<30 and not on dialysis. N=100', 'interventionNames': ['Drug: Dalbavancin']}\n- {'label': 'Arm 2 (Standard of Care)', 'type': 'ACTIVE_COMPARATOR', 'description': 'For Methicillin-sensitive Staphylococcus aureus (MSSA): nafcillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks) OR oxacillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks OR cefazolin (2 g will be administrated intravenously (IV) every 8 hours for 4-6 weeks) For Methicillin-resistant Staphylococcus aureus (MRSA): vancomycin (dose per local standard of care \u00d7 4-6 weeks) OR daptomycin (6-10 mg/kg will be administrated intravenously (IV) daily for 4-6 weeks). N=100', 'interventionNames': ['Drug: Cefazolin', 'Drug: Daptomycin', 'Drug: Nafcillin', 'Drug: Oxacillin', 'Drug: Vancomycin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Cefazolin', 'description': 'Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. Cefazolin (2 g will be administrated intravenously (IV) every 8 hours for 4-6 weeks)', 'armGroupLabels': ['Arm 2 (Standard of Care)']}\n- {'type': 'DRUG', 'name': 'Dalbavancin', 'description': 'A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species', 'armGroupLabels': ['Arm 1 (Dalbavancin)']}\n- {'type': 'DRUG', 'name': 'Daptomycin', 'description': 'Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria. Daptomycin (6-10 mg/kg will be administrated intravenously (IV) daily for 4-6 weeks', 'armGroupLabels': ['Arm 2 (Standard of Care)']}\n- {'type': 'DRUG', 'name': 'Nafcillin', 'description': 'Nafcillin is a semi-synthetic antibiotic related to penicillin. Nafcillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks)', 'armGroupLabels': ['Arm 2 (Standard of Care)']}\n- {'type': 'DRUG', 'name': 'Oxacillin', 'description': 'Oxacillin is an antibiotic used in resistant staphylococci infections. Oxacillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks', 'armGroupLabels': ['Arm 2 (Standard of Care)']}\n- {'type': 'DRUG', 'name': 'Vancomycin', 'description': 'Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis. Vancomycin (dose per local standard of care \u00d7 4-6 weeks)', 'armGroupLabels': ['Arm 2 (Standard of Care)']}\n\nPrimary Outcomes:\n- {'measure': 'Desirability of Outcome Ranking (DOOR)', 'description': 'DOOR is a composite endpoint assessed by: (1) Clinical Failure: Lack of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated for its treatment; (2) Infectious Complications such as: Endocarditis, New evidence of metastatic foci of infection, relapse - isolation of baseline S. aureus pathogen from a blood culture drawn after randomization, readmission for subsequent care of indication under study, need for additional unplanned source control procedures, or change in antibiotic therapy due to inadequate clinical response; (3) Serious Adverse Events (SAEs); (4) Adverse Events (AEs) Leading to Study Drug Discontinuation; and (5) Death. Clinical failure and infectious complications were assessed by a blinded adjudication committee. Participants missing clinical failure were treated as having clinical failure for calculation of DOOR.', 'timeFrame': 'Day 70'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 2.5% significance level, 12% missing/dropout rate", "answer": 200, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The study is powered for a superiority comparison of the primary objective, a comparison of DOOR. The probability of a subject from the dalbavancin arm having a superior DOOR ranking relative to a subject from the standard of care arm (Wilcoxon-Mann-Whitney U statistic) will be used as a summary measure for the comparison. Assuming a 65% probability the dalbavancin arm will have a better DOOR than the standard of care arm, the number of participants (equally sized groups) needed to reach 90% power at 2.5% significance level for one-sided Wilcoxon-Mann-Whitney U test is 78 participants per arm (nQuery Advisor\u00c2\u00ae, version 8.0). To account for potential loss to follow-up or dropout with approximately 12% missingness, we plan to recruit 100 per arm, i.e., 200 in total. A sample size of 200 results in at least 95.6% power.", "id": 1028, "split": "val"} +{"trial_id": "NCT04776278", "pmid": "38459579", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Diverse Non-student Emerging Adults\n\nIncluded conditions:\n- Alcohol Abuse\n\nStudy Armgroups:\n- {'label': 'Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS)', 'type': 'EXPERIMENTAL', 'description': \"Participants first receive a 50-minute standard brief motivational intervention designed to reduce alcohol use. A week later, they will receive the Substance-free activity session (SFAS), a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use).\", 'interventionNames': ['Behavioral: Brief Alcohol Intervention (BAI)', 'Behavioral: Substance-free Activity Session (SFAS)']}\n- {'label': 'Relaxation Training (RT) + Substance Free Activity Session (SFAS)', 'type': 'EXPERIMENTAL', 'description': \"Participants will complete a relaxation training session that will include a clinician leading them through a diaphragmatic breathing exercise, a progressive muscle relaxation protocol, and then a brief breath-counting (mindfulness) exercise. A week later, the participant will receive the SFAS, a 50-minute counseling session designed to increase the salience of the individual's goals, to highlight the connection between their current patterns of behavior (including drinking and substance-free activities) and the attainment of these goals, and to increase future orientation and engagement in enjoyable and goal-directed activities that are inconsistent with substance use (even if the participant has no desire to change their use).\", 'interventionNames': ['Behavioral: Substance-free Activity Session (SFAS)', 'Behavioral: Relaxation Training (RT)']}\n- {'label': 'Education Control', 'type': 'ACTIVE_COMPARATOR', 'description': 'This minimal contact control condition will include a brief (2-3 minute) discussion where the research assistant (RA) who completed the assessment session will describe the educational handout. This condition is meant to approximate a public health-level approach to providing referral information and some of the content included in the BAI+SFAS condition but without any of the personalized information or motivational interviewing. Participants will receive information on risks associated with alcohol/drug misuse, strategies for reducing alcohol problems, managing stress, and goal-setting. The handout will also include links to hotlines, websites, and apps related to these domains. This condition will not include booster contact', 'interventionNames': ['Other: Education Control']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Brief Alcohol Intervention (BAI)', 'description': \"This session includes a discussion related to harm reduction and the participant's autonomy to make decisions about the information provided in the session; an alcohol use decisional balance exercise; personalized alcohol-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the participant's perception of how much he or she drinks and actual norms, (b) a comparison of the participant's alcohol consumption vs. norms, (c) an estimate of the participant's peak blood alcohol content in the past month, (d) alcohol-related problems experienced, (e) money spent on alcohol, and (f) calories consumed from alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if he or she indicates interest.\", 'armGroupLabels': ['Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS)']}\n- {'type': 'BEHAVIORAL', 'name': 'Substance-free Activity Session (SFAS)', 'description': \"The SFAS session includes : a) discussion of life goals, b) discussion of associations between alcohol and drug use, goals, and substance-free activities; c) a graph depicting the participant's ratings of the relative importance of various aspects of their life and how their actions in the past week have been consistent with these priorities; d) personalized feedback on recent time allocation to activities across life domains, and a discussion of any changes the participant would like to make; e) feedback on symptoms of stress, anxiety and discussion of adaptive coping strategies; f) discussion of enjoyable substance-free activities and hobbies and substance-free recreational activity suggestions tailored to individual's interests and neighborhood; g) a goal setting exercise for specific behavior change plans; h) a Future Thinking Writing Exercise. Participants will receive weekly text-message based booster prompts for four weeks after their SFAS session.\", 'armGroupLabels': ['Brief Alcohol Intervention (BAI) + Substance Free Activity Session (SFAS)', 'Relaxation Training (RT) + Substance Free Activity Session (SFAS)']}\n- {'type': 'BEHAVIORAL', 'name': 'Relaxation Training (RT)', 'description': 'The clinician will begin by establishing the credibility of the session by providing the participant with the rationale that developing relaxation or mindfulness training strategies can reduce stress and enhance wellness. The clinician will then lead the participant through a diaphragmatic breathing exercise, followed by a progressive muscle RT protocol, and then a brief breath-counting (mindfulness) exercise. The session will conclude with a brief discussion of additional stress and anxiety management strategies (e.g., apps to monitor heartrate and breathing). Participants will be asked about their reaction to the techniques and, if interested, encouraged to commit to a specific plan for practicing these techniques.', 'armGroupLabels': ['Relaxation Training (RT) + Substance Free Activity Session (SFAS)']}\n- {'type': 'OTHER', 'name': 'Education Control', 'description': 'This condition will not include any clinical contact other than a brief (2-3 minute) discussion with the research assistant (RA) who completed the assessment session and who will describe the educational handout. This condition is meant to approximate a low-threshold public health-level approach to providing referral information and some of the content included in the BAI+SFAS condition but without any of the personalized information or MI/clinical contact. Thus, participants will receive information on risks associated with alcohol and drug misuse, strategies for reducing use/problems, and strategies for managing stress and setting and follow-through with achievable goals. The handout will also include links to hotlines, websites, and apps related to these domains. This condition will not include booster contact.', 'armGroupLabels': ['Education Control']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline Alcohol Consumption and Drug Use at 1-month', 'description': 'At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.', 'timeFrame': 'Enrollment, 1-month post intervention'}\n- {'measure': 'Change from Baseline Alcohol Consumption and Drug Use at 3-months', 'description': 'At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.', 'timeFrame': 'Enrollment, 3-months post intervention'}\n- {'measure': 'Change from Baseline Alcohol Consumption and Drug Use at 6-months', 'description': 'At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.', 'timeFrame': 'Enrollment, 6-months post-intervention'}\n- {'measure': 'Change from Baseline Alcohol Consumption and Drug Use at 12-months', 'description': 'At each assessment point, participants will complete a computer administered Daily Drinking Questionnaire (DDQ) concerning their daily drinking during a typical week in the past month, an interval found sufficiently long to characterize drinking patterns.', 'timeFrame': 'Enrollment, 12-months post intervention'}\n- {'measure': 'Change from Baseline Alcohol-related Consequences at 1-month', 'description': 'The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.', 'timeFrame': 'Enrollment, 1-month'}\n- {'measure': 'Change from Baseline Alcohol-related Consequences at 3-months', 'description': 'The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.', 'timeFrame': 'Enrollment, 3-months'}\n- {'measure': 'Change from Baseline Alcohol-related Consequences at 6-months', 'description': 'The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.', 'timeFrame': 'Enrollment, 6-months'}\n- {'measure': 'Change from Baseline Alcohol-related Consequences at 12-months', 'description': 'The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) questionnaire asks about negative events over the past month (e.g., neglected obligations, driving after drinking). Research has shown that the BYAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences.', 'timeFrame': 'Enrollment, 12-months'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at alpha=0.05. Power estimates for various effects are: treatment effect of BAI+SFAS vs. control=1.00/1.00; mediation via proportionate substance-free reinforcement=0.90/0.99; mediation via negative affect=0.85/0.93; mediation via alcohol demand=1.00/1.00. The dropout/missing data rates are assumed to be similar to the previous trial: 69% complete cases, 18% missing one data point, 7% missing two data points, 4% missing three data points, and 2% missing four data points.", "answer": 525, "answer_type": "ESTIMATED", "explanation": "Sample size and power\n We have focused our power analysis using Monte Carlo simulations [64] with population estimates and patterns of missingness from our previous trial [24]. These models from our previous trial used generalized mixed models which covaried gender and race/ethnicity, taking into account clustering by individual and therapist. Based on the Monte Carlo estimates comparing BAI\u00e2\u0080\u0089+\u00e2\u0080\u0089SFAS to control (within d\u00e2\u0080\u0089=\u00e2\u0080\u00890.83/0.71, between d\u00e2\u0080\u0089=\u00e2\u0080\u00890.33/0.32), we are proposing to recruit 525 subjects (175 per group) for the study. Assuming a similar pattern of attrition as our previous trial will result in n\u00e2\u0080\u0089=\u00e2\u0080\u0089362 (69%) complete cases, n\u00e2\u0080\u0089=\u00e2\u0080\u008995 (18%) cases missing one data point; n\u00e2\u0080\u0089=\u00e2\u0080\u008937 (7%) cases missing two data points; n\u00e2\u0080\u0089=\u00e2\u0080\u008921 (4%) cases missing three data points; and n\u00e2\u0080\u0089=\u00e2\u0080\u008911 (2%) cases missing four data points. We calculated power via Monte Carlo simulations by determining the proportion of 1000 replications for which the null hypothesis that a parameter was equal to zero was rejected for each parameter at alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 (i.e., probability of rejecting the null hypothesis when it is false). This resulted in the following power estimates for typical drinks/problems: treatment effect of BAI\u00e2\u0080\u0089+\u00e2\u0080\u0089SFAS vs. control\u00e2\u0080\u0089=\u00e2\u0080\u00891.00/1.00; mediation via proportionate substance-free reinforcement\u00e2\u0080\u0089=\u00e2\u0080\u00890.90/0.99; mediation via negative affect\u00e2\u0080\u0089=\u00e2\u0080\u00890.85/0.93; mediation via alcohol demand: 1.00/1.00. While our proposed sample size would not be sufficient to detect very small effects, we believe such small effects are likely to have little clinical meaning in terms of the variables we are assessing in the present trial, and the necessary sample size to detect such effects would be very large (>\u00e2\u0080\u00891000).", "id": 1029, "split": "val"} +{"trial_id": "NCT04776538", "pmid": "37658468", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Single-centre, Double-blinded, Randomised, Placebo-controlled, Phase II Study to Investigate the Safety and Efficacy of Mesenchymal Stem Cell for Radiation-induced Hyposalivation and Xerostomia in Previous Head and Neck Cancer Patients (MESRIX-III)\n\nIncluded conditions:\n- Xerostomia Following Radiotherapy\n\nStudy Armgroups:\n- {'label': 'Stem cell group', 'type': 'EXPERIMENTAL', 'description': '60 patients will be randomized to receive adipose-derived allogeneic stem cells', 'interventionNames': ['Biological: Stem cells']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': '60 patients will receive placebo consisting of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% Dimethyl sulfoxide (DMSO).', 'interventionNames': ['Biological: Placebo']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Stem cells', 'description': 'Each participant will be double-blindly randomized to receive either adipose-derived allogeneic stem cells or placebo consisting of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% Dimethyl sulfoxide (DMSO).', 'armGroupLabels': ['Stem cell group']}\n- {'type': 'BIOLOGICAL', 'name': 'Placebo', 'description': 'Each participant will be double-blindly randomized to receive either adipose-derived allogeneic stem cells or placebo consisting of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% Dimethyl sulfoxide (DMSO).', 'armGroupLabels': ['Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'Salivary gland function', 'description': 'Change in salivary gland function measured by a 4 months change in unstimulated whole saliva flow rate in the group receiving ASCs compared with the group of participants receiving placebo (control group receiving injections of CryoStor10 (BiolifeSolutions), the freeze media for ASCs).', 'timeFrame': '4 month'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, significance level (alpha) of 0.05, and a dropout rate of about 20%", "answer": 120, "answer_type": "ACTUAL", "explanation": "Sample size\n From our previous study MESRIX-I we assess to increase saliva production for whole unstimulated whole saliva flow rate (in ml/min) by about 33% or in absolute numbers from 0.125 to 0.155 after 4\u00c2\u00a0months. The power calculation is based on a power of 0.8 and an alpha of 0.05. This means that the total number of patients included would have to be 100 (50 in each group). We expect a dropout rate of about 20% and therefore aim to include 120 participants in total.", "id": 1030, "split": "val"} +{"trial_id": "NCT04778514", "pmid": "38479746", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Crossover Study Comparing Adherence, Preference + Acceptability of a Dual Prevention Pill (DPP) Capsule Containing PrEP + an Oral Contraceptive Versus Two Separate Pills in Women at Risk of HIV in Harare, Zimbabwe\n\nIncluded conditions:\n- HIV Infections\n- Contraception\n\nStudy Armgroups:\n- {'label': 'Sequence 1', 'type': 'OTHER', 'description': 'This arm is a single, over-encapsulated DPP containing PrEP (200 mg of emtricitabine \\\\[FTC\\\\], 300 mg of tenofovir disoproxil fumarate \\\\[TDF\\\\]) and a COC (30 mcg of ethinyl estradiol \\\\[EE\\\\], 150 mcg of levonorgestrel \\\\[LNG\\\\]) taken once daily for three 28-day cycles followed by PrEP (FTC/TDF) and a COC (EE/LNG) taken daily for three 28-day cycles.', 'interventionNames': ['Drug: Dual Prevention Pill', 'Drug: PrEP and combined oral contraceptive (COC) as two separate tablets']}\n- {'label': 'Sequence 2', 'type': 'OTHER', 'description': 'This arm is two separate tablets (PrEP \\\\[FTC/TDF\\\\] and COC \\\\[EE/LNG\\\\]) taken once daily for three 28-day cycles followed by single, over-encapsulated DPP containing PrEP (FTC/TDF) and a COC (EE/LNG) taken once daily for three 28-day cycles.', 'interventionNames': ['Drug: Dual Prevention Pill', 'Drug: PrEP and combined oral contraceptive (COC) as two separate tablets']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dual Prevention Pill', 'description': 'a single over-encapsulated DPP containing a PrEP tablet and a COC', 'armGroupLabels': ['Sequence 1', 'Sequence 2'], 'otherNames': ['DPP']}\n- {'type': 'DRUG', 'name': 'PrEP and combined oral contraceptive (COC) as two separate tablets', 'description': 'PrEP tablet and a COC as two separate tablets', 'armGroupLabels': ['Sequence 1', 'Sequence 2'], 'otherNames': ['Truvada', 'Zinnia F']}\n\nPrimary Outcomes:\n- {'measure': 'To determine preference for taking a single DPP capsule versus 2 separate tablets (PrEP and COC) once daily among women after using each regimen for three 28-day cycles.', 'description': 'Proportion of women who prefer the DPP (Regimen A) vs 2 separate tablets (Regimen B) after using each regimen for 3 28-day cycles, per self-report on computer-assisted self-interviewing (CASI).', 'timeFrame': 'at study completion (approximately 24 weeks)'}\n- {'measure': 'To assess the acceptability of taking the DPP capsule versus two separate tablets once daily to prevent HIV and unintended pregnancy among women who use each regimen for three 28-day cycles.', 'description': 'Acceptability scores by regimen and overall, per a quantitative acceptability questionnaire via CASI.', 'timeFrame': 'At the 3 and 6 month visits.'}\n\nPlease estimate the sample size based on the assumption: \nIn South Africa, 80% power, 50% correlation between regimens, no period effect, and 10% dropout rate. In Zimbabwe, 94% power with alpha=0.04 and 84% power with alpha=0.02, with a 10% loss to follow-up.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Sample size and power calculations\n \n South Africa\n The sample size calculation was based on comparing adherence between the two regimens. A sample size of 86 has 80% power to detect a difference between the proportion of women who are adherent to each regimen assuming 25% of women are adherent to PrEP alone, 40% are adherent to the DPP, with a correlation between regimens of 50% and no period effect. We estimated 25% of participants would be adherent to the 2-pill regimen based on findings from other PrEP studies among young women in sub-Saharan Africa.5 52 We increased the sample to 96 in case 10% of participants discontinued early while still having 86 participants complete the cross-over period.\n \n \n Zimbabwe\n The sample size was calculated based on detecting a difference in preference for the DPP versus two separate pills. A sample size of 30 has 94% power to detect a preference for one regimen over the other when the true preference for one regimen is at least 80% based on the exact binomial test (alpha=0.04). If only 27 AGYW complete the study (10% loss to follow-up), we have 84% power to detect a preference for one regimen over the other when the true preference for one regimen is at least 80%, based on the exact binomial test (alpha=0.02).", "id": 1031, "split": "val"} +{"trial_id": "NCT04780542", "pmid": "35658942", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Computerized Detection and Internet-based Treatment of Common Mental Disorders Among College Students in Two Latin American LMICs\n\nIncluded conditions:\n- Major Depressive Disorder\n- Generalized Anxiety Disorder\n\nStudy Armgroups:\n- {'label': 'Clinician-Guided iCBT', 'type': 'EXPERIMENTAL', 'description': 'Both help-seeking students recruited from university clinics and non-help-seeking students recruited from needs assessment survey and outreach will receive internet delivered cognitive behavioral therapy guided by clinicians', 'interventionNames': ['Behavioral: Yo Puedo Sentirme Bien- Clinician-Guided version']}\n- {'label': 'Self-guided iCBT', 'type': 'ACTIVE_COMPARATOR', 'description': 'Help-seeking students recruited from university clinics will receive self-guided internet delivered cognitive behavioral therapy while on waitlist. Non-help seeking students recruited from needs assessment survey and outreach will receive the self-guided version of internet delivered cognitive behavioral therapy.', 'interventionNames': ['Behavioral: Yo Puedo Sentirme Bien- Self-Guided version']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Yo Puedo Sentirme Bien- Clinician-Guided version', 'description': 'Internet delivered Cognitive Behavioral Therapy- Guided version', 'armGroupLabels': ['Clinician-Guided iCBT']}\n- {'type': 'BEHAVIORAL', 'name': 'Yo Puedo Sentirme Bien- Self-Guided version', 'description': 'Internet delivered Cognitive Behavioral Therapy- Self-Guided version', 'armGroupLabels': ['Self-guided iCBT']}\n\nPrimary Outcomes:\n- {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'description': 'Self-report measure of depressive symptoms in the prior 2 weeks. Scores range from 0 to 27 with higher scores representing greater depressive symptomatology.', 'timeFrame': '90 days'}\n- {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'description': 'Self-report measure of anxiety symptoms in the prior 2 weeks. Scores range from 0 to 21 with higher scores representing greater anxiety.', 'timeFrame': '90 days'}\n- {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'description': 'Self-report measure of depressive symptoms in the prior 2 weeks. Scores range from 0 to 27 with higher scores representing greater depressive symptomatology.', 'timeFrame': '12 months'}\n- {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'description': 'Self-report measure of anxiety symptoms in the prior 2 weeks. Scores range from 0 to 21 with higher scores representing greater anxiety.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study is powered to detect a 5% difference in remission rates with 0.8 power based on 0.05-level two-sided tests. The study also accounts for loss to follow-up and uses simulation to estimate the required sample sizes.", "answer": 1500, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n \n Expected number of subjects\n We expect to randomize at least 1500 participants in the first year trial and 1000 in each of the second and third year trials.\n \n \n Expected effect size and power calculations\n We powered the study to estimate heterogeneity of treatment effects as defined by the increase in the proportion of patients we would expect to remit from the primary outcomes based on optimized rather than randomized treatment of 5%. We considered this the minimum difference of interest. Although we will be interested both in continuous (i.e., differences in mean scores on symptom rating scales) and categorical (i.e., probabilities of treatment response and remission) outcomes, we evaluated statistical power for a categorical measure of episode remission because this is of greatest clinical importance and because larger samples are required for powerful detection of effects on categorical than continuous outcomes. Meta-analyses of previous iCBT trials for CMDs show that treatment response is approximately 50% and remission is approximately 30%, with rates roughly half these values for control conditions. Closed-form solutions show that samples with fewer than 150 patients per arm provide adequate statistical power (.8 power based on .05-level two-sided tests) to detect effect sizes this large even after making reasonable adjustments for loss to follow-up. However, estimating power to detect heterogeneity of treatment effects is more complex because closed-form solutions do not exist and simulation is needed to determine required sample sizes.\n We carried out such a simulation by building a series of hypothetical population models that assumed that each patient was randomized either to iCBT or a control condition; that the aggregate remission rates after adjusting for loss to follow-up were 27.5% and 17.5% in the two treatment arms, respectively; and that a series of relatively complex nonlinear-interactive multivariate associations existed between 20 predictors and remission. The assumed distributions of predictors and interaction values among predictors were consistent with those found in previous studies. We varied these coefficient values in different models to maintain the same aggregate remission rates but to have the difference between remission rates based on randomized versus optimized treatment vary between 0 and 15%. In each model, the remission rate if intervention assignment was randomized was set at 10% (i.e., 27.5\u00e2\u0080\u009317.5%), but the remission rate if intervention assignment was optimized (i.e., if each student who would have a better outcome if assigned to iCBT was, in fact, assigned to iCBT and all other students were assigned to the control condition, which in some cases could involve these students receiving treatment at the student clinic and having better outcomes than if they received iCBT) was varied between 0 and 15%. We used a state-of-the-art ensemble machine learning method detailed in the proposal to estimate heterogeneity of treatment response. We discovered that adequate statistical power (again defined as .8 power based on .05-level two-sided tests) to detect a difference between the two remission rates of 5%, which we considered the minimum difference of interest, would require a sample of at least 500 patients per treatment arm [59]. A difference of 5% would represent a 50% increase on the 10% aggregate base of the difference in the remission rate between intervention and control groups. Based on a review of previous precision treatment analyses of CMDs, a difference of this magnitude is plausible. Based on this result, we designed the study to have a sample size of 500 per treatment arm. As noted above in the discussion of the sample design, we will have 1500 eligible students to randomize across three arms in the first trial, making it possible for us to estimate a precision treatment model based on data obtained in this trial. However, as noted above in the section on study design, the 12-month follow-up data for these students will not be available until YR2 and it will be possible to use the results of the model for the trial 2 randomization for the first time in YR3. We will replicate the model with follow-up data for students randomized in YR2 and use the harmonized precision treatment model results obtained in YR3 for a final Trial in YR4.", "id": 1032, "split": "val"} +{"trial_id": "NCT04783402", "pmid": "35742400", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Telehealth-based Cognitive-adaptive Training for Women With Breast Cancer in Risk to Suffer Cancer and Chemotherapy-related Cognitive Impairment: a Randomized Controlled Trial.\n\nIncluded conditions:\n- Breast Neoplasms\n\nStudy Armgroups:\n- {'label': 'e-OTCAT', 'type': 'EXPERIMENTAL', 'description': 'The experimental group will receive the e-OTCAT program that consists of a 12-week videoconference-based occupational therapy intervention at the same time women with breast cancer receive chemotherapy.', 'interventionNames': ['Other: e-OTCAT program']}\n- {'label': 'Control Group', 'type': 'OTHER', 'description': 'At the beginning of chemotherapy, the participants allocated to the control group will only receive an educational handbook containing information about most frequent side-effects of cancer and cancer treatments, plus standard care for these patients.', 'interventionNames': ['Other: Educational handbook and standard care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'e-OTCAT program', 'description': 'The e-OTCAT program consists of a combination of cognitive training in terms of attention, memory and processing speed; and adaptive training based on metacognition and cognitive-behavioral strategies (psycho-education, relaxation techniques training, stress management, energy conservation techniques, time management, etc.).\\n\\nThis program also includes homework exercises consisting of a handbook of paper-and-pencil exercises, a cognitive training mobile app, and the practice of strategies seen in adaptive training sessions.', 'armGroupLabels': ['e-OTCAT']}\n- {'type': 'OTHER', 'name': 'Educational handbook and standard care', 'description': 'At the beginning of chemotherapy, the participants will receive an educational handbook containing information about most frequent side-effects of cancer and cancer treatments, plus standard care.', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Subjective cognitive Function:', 'description': 'The primary outcome will be assessed with the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess the subjective cognitive functioning.', 'timeFrame': 'Participants will be followed over 6 months'}\n\nPlease estimate the sample size based on the assumption: \nalpha error of 0.05, a power of 85%, and a 10% dropout rate", "answer": 98, "answer_type": "ESTIMATED", "explanation": "2.6. Sample Size\n The sample size for cognitive function was calculated based on a similar previous study using FACT-Cog version 3.0 [43]. Assuming an alpha error of 0.05, a power of 85% and a medium effect size (d = 0.58) based on the results of the reference study, we need a sample of 44 participants for each group (G*Power v.3.1). In order to compensate for a possible 10% dropout rate [44], we will recruit a total of 98 participants (49 per group).", "id": 1033, "split": "val"} +{"trial_id": "NCT04783675", "pmid": "36223961", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome\n\nIncluded conditions:\n- Steroid-Sensitive Nephrotic Syndrome\n\nStudy Armgroups:\n- {'label': 'Intervention/treatment', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Rituximab']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Rituximab', 'description': 'Rituximab (375 mg/m2) will be given as a single intravenous infusion after remission', 'armGroupLabels': ['Intervention/treatment']}\n\nPrimary Outcomes:\n- {'measure': '1-year relapse-free survival rate', 'description': 'The rate of no relapse within 1 year', 'timeFrame': '1-year period after randomization'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 10% dropout rate, 80% power, and a two-sided alpha level of 0.05.", "answer": 44, "answer_type": "ACTUAL", "explanation": "Sample size\n The present study design is an exploratory single-arm study. The sample size is based on the expected rate of the primary efficacy endpoint and the anticipated size of the effect of RTX treatment. According to previous literature, the 1-year relapse-free survival rate is approximately 30% in children with the first episode of SSNS after standardised prednisone/prednisolone treatment.6 Based on this previous study,6 we estimated that a sample size of 44, with the assumption of a 10% dropout rate, would provide 80% power to detect a 20% increase in the relapse-free rate between the traditional method and RTX treatment at a two-sided alpha level of 0.05.", "id": 1034, "split": "val"} +{"trial_id": "NCT04784598", "pmid": "36343988", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effects of Insoles Adapted in Flip-flop Sandals in People With Heel Pain: a Randomized, Double-blind Clinical, Controlled Study\n\nIncluded conditions:\n- Heel Pain Syndrome\n- Heel\n\nStudy Armgroups:\n- {'label': 'Experimental group', 'type': 'EXPERIMENTAL', 'description': 'Group 1- The intervention group I will receive a customized strip slipper with a 3mm EVA horseshoe piece (Shore A 32). And 2.5mm EVA cover (Shore A 28).', 'interventionNames': ['Other: Insoles adapted in flip-flop sandals']}\n- {'label': 'Sham group', 'type': 'SHAM_COMPARATOR', 'description': 'Group 2- The control group will receive a slipper with a 2.5mm EVA cover (Shore A 32) identical to the one used by the intervention group, but without corrective par', 'interventionNames': ['Other: Insoles adapted in flip-flop sandals']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Insoles adapted in flip-flop sandals', 'description': 'participants of both groups individually received a pair of customized flip-flop sandals, with or without foot pieces, covered with smooth synthetic leather', 'armGroupLabels': ['Experimental group', 'Sham group']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Numerical pain intensity scale - NPS', 'description': 'Pain intensity will be evaluated with the 10-point Numerical Pain Rating Scale, where 0 is \"pain-free\" and 10 is \"maximum pain.', 'timeFrame': 'baseline, 6 weeks after, 12 weeks after, 16 weeks folow up'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, 10% sample loss, estimated SD of 3.2 points", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The sample size was calculated based on the NRPS from a previous study.15 The statistical power of 80% was used to detect a mean difference of 1.8 points in pain, based on a difference found between groups in a study by Costa et al.15 Each group will need 36 individuals considering an estimated SD of 3.2 points and a 5% significance level. However, a sample loss of 10% was added, leading to a sample of 40 individuals per group.", "id": 1035, "split": "val"} +{"trial_id": "NCT04785352", "pmid": "35062907", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Grandi Byen: Supporting Child Growth and Development Through Integrated, Responsive Parenting, Nutrition and Hygiene\n\nIncluded conditions:\n- Malnutrition, Child\n- Development, Child\n- Parenting\n\nStudy Armgroups:\n- {'label': 'Standard well-baby care', 'type': 'NO_INTERVENTION', 'description': \"Children in this arm (control group), as well as children in the two intervention groups, will receive standard care as outlined in the Essential Package of Health Services by Haiti's Ministry of Public Health and Population (MSPP). This includes a World Health Organization (WHO) immunization schedule of vaccines, high dose vitamin A supplements, and growth monitoring and promotion.\"}\n- {'label': 'Nutrition Intervention', 'type': 'EXPERIMENTAL', 'description': 'Children in this arm will receive one egg per day for six months.', 'interventionNames': ['Dietary Supplement: Nutrition Intervention']}\n- {'label': 'Grandi Byen', 'type': 'EXPERIMENTAL', 'description': 'This arm comprises a multicomponent intervention on responsive parenting, nutrition, hygiene, and one egg per day for six months for children.', 'interventionNames': ['Behavioral: Grandi Byen']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Nutrition Intervention', 'description': 'One egg per day for six months', 'armGroupLabels': ['Nutrition Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Grandi Byen', 'description': 'Multicomponent intervention on responsive parenting, nutrition, hygiene + one egg per day for 6 months', 'armGroupLabels': ['Grandi Byen']}\n\nPrimary Outcomes:\n- {'measure': 'Child Growth: Changes in length-for-age Z-score (LAZ)', 'description': 'Child length or height will be measured in centimeters (cm). Length-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months.', 'timeFrame': 'Baseline and months 3, 6, 9, and 12'}\n- {'measure': 'Child Growth: Changes in weight-for-age Z-score (WAZ)', 'description': 'Child weight will be measured in kilograms (kg). Weight-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months.', 'timeFrame': 'Baseline and months 3, 6, 9, and 12'}\n- {'measure': 'Child Growth: Changes in head circumference-for-age Z-score (HCZ)', 'description': 'Child head circumference will be measured in centimeters (cm). Head circumference-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months.', 'timeFrame': 'Baseline and months 3, 6, 9, and 12'}\n- {'measure': 'Child Development: Changes in ASQ- Socio-Emotional (ASQ-SE) score', 'description': 'The Ages \\\\& Stages Questionnaire: Socio-Emotional Questionnaire (ASQ-SE2) will be used to assess and score child socio-emotional development.', 'timeFrame': 'Baseline and months 6 and 12'}\n- {'measure': 'Child Development: Changes in ASQ Communication score', 'description': \"The Ages \\\\& Stages Questionnaire (ASQ-3) will be used to assess and score children's communication skills.\", 'timeFrame': 'Baseline and months 6 and 12'}\n- {'measure': 'Child Development: Changes in ASQ Gross Motor score', 'description': \"The Ages \\\\& Stages Questionnaire (ASQ-3) will be used to assess and score children's gross motor development.\", 'timeFrame': 'Baseline and months 6 and 12'}\n- {'measure': 'Child Development: Changes in ASQ Fine Motor score', 'description': \"The Ages \\\\& Stages Questionnaire (ASQ-3) will be used to assess and score children's fine motor development.\", 'timeFrame': 'Baseline and months 6 and 12'}\n- {'measure': 'Child Development: Changes in ASQ Problem Solving score', 'description': \"The Ages \\\\& Stages Questionnaire (ASQ-3) will be used to assess and score children's problem solving skills.\", 'timeFrame': 'Baseline and months 6 and 12'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an intraclass correlation coefficient (ICC) of 0.7, which is typical for individual\u2019s serial correlation in longitudinal studies. The statistical power is set at 0.80.", "answer": 600, "answer_type": "ACTUAL", "explanation": "Sample size\n The study sample will comprise 600 mother-infant dyads, with 200 eligible pairs each assigned to one of the three study conditions. Using the software Optimal Design (Version 3.01) [64], we determined that a sample of 600 participants will lend our study adequate statistical power which allows us to observe an effect from the study interventions. Using the repeated measures module of the software under the setting of a cluster randomized trial with person-level outcomes and assuming an intraclass correlation coefficient (ICC) of 0.7, we found that the study will have a statistical power of 0.80 to detect an effect size of 0.338, which is slightly above the small effect size defined by Cohen\u00e2\u0080\u0099s d. The ICC of 0.7 is typical for individual\u00e2\u0080\u0099s serial correlation found from most longitudinal studies. If the ICC is reduced to 0.3, the study can detect an even smaller effect size of 0.31.", "id": 1036, "split": "val"} +{"trial_id": "NCT04786145", "pmid": "34011351", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain - a Single-blinded Randomized Controlled Trial\n\nIncluded conditions:\n- Chronic Low-back Pain\n- Facet Joint Pain\n- Degeneration Lumbar Spine\n- Facet Joint Syndrome\n- Back Pain Lower Back Chronic\n\nStudy Armgroups:\n- {'label': 'Cryoneurolysis', 'type': 'ACTIVE_COMPARATOR', 'description': '40 patients are randomized to receive one treatment of cryoneurolysis on the facet joints of three lumbar level corresponding to their facet joint pain generator', 'interventionNames': ['Procedure: Cryoneurolysis']}\n- {'label': 'Radiofrequency ablation', 'type': 'ACTIVE_COMPARATOR', 'description': '40 patients are randomized to receive one treatment of radiofrequency ablation on the facet joints of three lumbar level corresponding to their facet joint pain generator', 'interventionNames': ['Procedure: Radiofrequency ablation']}\n- {'label': 'Placebo', 'type': 'SHAM_COMPARATOR', 'description': '40 patients are randomized to receive sham treatment. Subjected to similar procedures as cryoneurolysis and radiofrequency ablation, but without active treatment.', 'interventionNames': ['Procedure: Placebo']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Cryoneurolysis', 'description': 'This is a medical procedure that temporarily blocks nerve conduction along peripheral nerve pathways by freezing it. Small probe is inserted in order to freeze the target nerve, can facilitate complete regeneration of the structure and function of the affected nerve.', 'armGroupLabels': ['Cryoneurolysis'], 'otherNames': ['cryoanalgesia', 'cryoneuroablation']}\n- {'type': 'PROCEDURE', 'name': 'Radiofrequency ablation', 'description': 'This is a medical procedure that temporarily blocks nerve conduction along peripheral nerve pathways. Small needle with an active heating tip is inserted, to destroy the functionality of the target nerve using heat from radiofrequency energy.', 'armGroupLabels': ['Radiofrequency ablation']}\n- {'type': 'PROCEDURE', 'name': 'Placebo', 'description': 'No active treatment is given.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'The effect of the intervention, assessed by Patient Global Impression of Change (PGIC) at 4 weeks follow-up', 'description': 'The Patient Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall improvement after treatment ranging from 1) very much improved, 2) much improved, 3) minimally improved, 4) no change, 5) minimally worse, 6) much worse, or 7) very much worse', 'timeFrame': '4 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-tailed test, \u03b1 = 0.025, 25% margin for loss to follow-up, overall significance level of 5%.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample Size\n Based on our pilot study (not published), we postulate that 50\u00e2\u0080\u0089% of the participants who receive an active treatment (cryoneurolysis or radiofrequency ablation) and 5\u00e2\u0080\u0089% of the placebo group will report a significant improvement of change in pain after intervention, equivalent to Patient Global Impression of Change (PGIC)\u00e2\u0080\u0089\u00e2\u0089\u00a4\u00e2\u0080\u00892, at 4 weeks\u00e2\u0080\u0099 follow-up. Sample size is calculated by Fisher\u00e2\u0080\u0099s Exact test based on the above-mentioned and with 80\u00e2\u0080\u0089% power (two-tailed) and \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.025, 120 participants (40 per group) are needed in the study, which also includes a 25\u00e2\u0080\u0089% margin for loss to follow-up. The power of the study is the probability that there is a significant difference between each of the two intervention groups, where in each of the two tests a significant level of 2.5\u00e2\u0080\u0089% is used, so that the overall significance level becomes 5\u00e2\u0080\u0089%.", "id": 1037, "split": "val"} +{"trial_id": "NCT04787575", "pmid": "38176866", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Open-label, Multicentre, Randomized, Parallel Group Study to Assess the Efficacy and Safety of Oxygen-ozone Therapy Plus Oral Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices\n\nIncluded conditions:\n- Infection\n\nStudy Armgroups:\n- {'label': 'Arm A', 'type': 'EXPERIMENTAL', 'description': 'Oxygen-ozone therapy plus antibiotic therapy', 'interventionNames': ['Procedure: Oxygen-ozone therapy']}\n- {'label': 'Arm B', 'type': 'OTHER', 'description': 'Antibiotic therapy', 'interventionNames': ['Procedure: Oxygen-ozone therapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Oxygen-ozone therapy', 'description': 'Oxygen-ozone therapy (group a) will be performed by:\\n\\ni) Self-haemoinfusion of 200 cc. with concentrations of 40-50 \u03bcg/ml, to be performed two/three times a week, for a time of 6 weeks (for a maximum of 15 sessions); ii) Subcutaneous injections in the perilesional site at the dose of 5 cc. with concentrations of 4 \u03bcg,/ml, Cleanse wounds with 100 cc of 5-10 ug ozone gas', 'armGroupLabels': ['Arm A', 'Arm B']}\n\nPrimary Outcomes:\n- {'measure': 'Clinical success at Day 14', 'description': 'Resolution/improvement of signs and symptoms of infection of the wound in the target lesion (i.e. a score \u2264 1 for a maximum of two signs/symptoms) from baseline to Day 14. The following symptoms will be evaluated by patients on a 0-4 point Likert scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom; 4 = very severe symptom): pain, burning, redness and malodour.\\n\\nThe following signs will be evaluated by investigators on a 0-4 point Likert scale (0 = no sign; 1 = mild sign; 2 = moderate sign; 3 = severe sign; 4 = very severe sign): erythema, local warmth, swelling, purulent secretion.', 'timeFrame': '2 week'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, significance level of 0.05 (two-sided), dropout rate of 10%, and the statistical test used is the two-sided Z-test with pooled variance.", "answer": 186, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study will include a total of 186 evaluable patients, 93 in each treatment group. Considering a dropout rate of 10%, up to 104 patients in each group will be enrolled. Being a superiority design, the sample size is discussed for the primary efficacy endpoint, defined as the proportion of patients with clinical success on Day 14.\n For the calculations, it has been assumed that:\n \n \n Ffity per cent of patients receiving antibiotic therapy alone and 70% of patients receiving antibiotic oxygen-ozone therapy will experience clinical success, with a difference between group proportions of 20%.\n \n \n With a power of 80% and a significance level of 0.05 (two-sided), 93 patients in each treatment group are required.\n \n \n The statistical test used is the two-sided Z-test with pooled variance.", "id": 1038, "split": "val"} +{"trial_id": "NCT04789863", "pmid": "35987671", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Towards Implementation of an Integrated Model of Care in Long-Term Follow-Up After Allogeneic Hematopoietic SteM Cell TransplantatIon faciLitated by eHealth Technology (The SMILe Project) - An Effectiveness-implementation Science Study\n\nIncluded conditions:\n- Stem Cell Transplantation\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'OTHER', 'description': 'Intervention group (IG) patients will receive usual care plus the SMILe-ICM (see below) when they come to their planned follow-up appointments at the University Hospital Basel. Thus, while IG participants will receive the same number of follow-up appointments as CG participants (depending on their state of health), they will also receive the SMILe-ICM, i.e., tailored self-management and behavioural support delivered by the combination of totally 12 face-to-face meetings with a Care Coordinator (CC) and the SMILeApp. The personal meetings with the CC will last around 40-90 minutes. The first three of them will occur during the initial alloSCT hospitalization, and the other nine will occur in the outpatient setting, beginning with biweekly and expanding to bi-monthly intervals until one year post-alloSCT.', 'interventionNames': ['Device: SMILe-Integrated Care Model']}\n- {'label': 'Control group', 'type': 'OTHER', 'description': 'see \"Intervention\" section', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'SMILe-Integrated Care Model', 'description': \"Four self-management intervention modules will be delivered by human and technology: 1) monitoring \\\\& follow-up; 2) infection prevention; 3) medication adherence; 4) physical activity.\\n\\nHuman. A CC will provide structured and tailored self-management and behavioural support regarding all 4 modules via 12 face-to-face meetings congruent with planned clinic follow-up visits. The CC will be connected with the patients via the SMILe technology, enabling rapid responses to early signs of health deterioration.\\n\\nTechnology. The SMILe technology consists of the SMILeApp and SMILeCare. The latter is the interface of the monitoring component to connect the patient with the CC supporting fast recognition of symptoms and health deterioration. The SMILeApp enables to daily record a set of medical, behavioural and symptom-related data. A lexicon provides self-management and behavioural information. All data will be transferred to the clinic to be monitored, with the patient's consent, via SMILeCare.\", 'armGroupLabels': ['Intervention group']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'The control group (CG) participants will receive usual care, which includes no specific counselling. USB outpatient appointment frequency follows a standard schedule: during the first 3 months post-alloSCT, depending on their health status, most patients (73%) return 1 to 3 times per week for follow-up at the USB outpatient clinic, where they are mainly seen by a junior or senior physician. Depending on health status and recovery, follow-up intervals extend to weekly or monthly within 1 year post-alloSCT. A research assistant (RA) will just contact CG participants for data collection. If participants raise concerns about any symptoms, the RA will encourage them to contact their physicians.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change of re-hospitalization rate from post-alloSCT discharge up to 15 months after allogeneic stem cell transplantation', 'description': 'The number of events after the initial post-alloSCT discharge per patient', 'timeFrame': 'Data will be collected monthly via medical records during the study period, i.e., until one year post-alloSCT and for a further period of 3 months to test for a possible wane out effect.'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes an \u03b1 level of 0.05, a power of 80%, a small effect size, a refusal rate of 10%, and a dropout rate of 15%. The observation period is 15 months (1.25 years).", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size determination for aim 1\n In order to determine an appropriate patient sample size, we considered the USB\u00e2\u0080\u0099s baseline hospitalisation event rate per patient year. As exact patient year data are not available, we assumed that in any given year, each transplant patient year receives roughly 0.5 patient years of care. We based our calculations on Schenkel et al.\u00e2\u0080\u0099s [6] study, which used patient years (number of hospitalisation events per patient year (HEPPY)) as an outcome for an intervention in lung transplantation.\n The hospitalisation rate consists of two elements: the number of hospitalisations and the period (in years) over which patients are followed up. We conducted simulations using the paramtest software package [76], computing 10\u00e2\u0080\u00b2000 iterations of the chosen parameters. Based on the USB\u00e2\u0080\u0099s available data, we set the hospitalization events per patient year to 1.56. The study\u00e2\u0080\u0099s observation period is 15\u00e2\u0080\u0089months (1.25\u00e2\u0080\u0089years). We determined the minimum sample size using the inverse of the effect size in Schenkel et al. [6], i.e., 1.79 [1.31\u00e2\u0080\u00932.43]. Following Olivier et al.\u00e2\u0080\u0099s guidance [77], we aimed for the upper bound of a small effect size. The simulation is based on a binomial distribution with a shape parameter of 4. Assuming an \u00ce\u00b1 level of 0.05, a power of 80% and an effect size of 1.79, a minimum sample size of 52 patients (26 per group) was determined. Based on a refusal rate of 10% and a 15% drop out rate, then, we will aim to recruit a total of 80 patients (40 per group). Considering that approximately 70 adults per year receive both alloSCT and follow-up at USB, recruitment will take a minimum of 16\u00e2\u0080\u0089months.", "id": 1039, "split": "val"} +{"trial_id": "NCT04793217", "pmid": "35982485", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Project Someleze: A Randomized Trial of ImpACT+, a Coping Intervention to Improve Clinical and Mental Health Outcomes Among HIV-infected Women With Sexual Trauma in South Africa\n\nIncluded conditions:\n- HIV\n- Trauma Exposure\n\nStudy Armgroups:\n- {'label': 'Improving AIDS Care after Trauma+', 'type': 'EXPERIMENTAL', 'description': 'ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.', 'interventionNames': ['Behavioral: Improving AIDS Care After Trauma +']}\n- {'label': 'Adapted Problem-Solving Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.', 'interventionNames': ['Behavioral: Adapted Problem-Solving Therapy']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Improving AIDS Care After Trauma +', 'description': 'ImpACT+ integrates skills for HIV treatment adherence and coping with trauma, tailored to the South African context. This includes exploration of values informing care engagement, recognizing the synergistic stress of sexual trauma and HIV, understanding the contribution of stressors to maladaptive coping, and developing adaptive methods for coping as alternatives to avoidance. ImpACT+ will be delivered in private spaces at the primary care clinic and will consist of 6 individual sessions followed by 6 maintenance check-ins. Individual sessions focus on coping, adherence, and care engagement during an early critical period, while maintenance check-ins reinforce positive change and support ongoing implementation of skills. Evidence supports a 6-session format in low-resource settings. Individual sessions will begin within 2 weeks after the baseline survey and be completed by the 4-month assessment. Maintenance check-ins will begin following the 4-month assessment.', 'armGroupLabels': ['Improving AIDS Care after Trauma+']}\n- {'type': 'BEHAVIORAL', 'name': 'Adapted Problem-Solving Therapy', 'description': 'Participants will receive three weekly individual sessions of adapted PST. The goal of PST is to identify problems that interfere with daily activities and address them through problem-orientation work. We anticipate stressors will include (a) relationship difficulties, including family stress, (b) financial stress and unemployment, (c) general impact of HIV infection, and (d) overall chronic stress. Thus, PST may indirectly address stressors that may impact care engagement, but will not address the intersection of HIV and trauma specifically.', 'armGroupLabels': ['Adapted Problem-Solving Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'Viral suppression/viral load', 'description': 'HIV-1 RNA viral load (COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, Roche). Viral suppression defined as \\\\<50 copies/ml. Continuous measures of viral load, modeled using a log10 transformation.', 'timeFrame': 'Up to 12 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-tailed alpha level of 0.05, 80% retention rate", "answer": 350, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Our enrollment target is 350, which will allow detection of intervention effects on viral suppression at 12-month follow-up. Based on data from our preliminary studies [66] and corroborated by national estimates [32], we expect that 57% of women who are newly initiating ART and randomized to the PST condition will be virally suppressed at the 12-month follow-up. With 350 women randomized equally to both conditions, we will have 80% power with a two-tailed alpha level of 0.05 to detect differences between a proportion of 57% in the PST condition and 73% in the ImpACT\u00e2\u0080\u0089+\u00e2\u0080\u0089condition. This power calculation assumes we will retain 80% of participants over the study period. In the pilot, we were able to successfully retain 80% of all participants (83.3% of newly initiating participants) for the duration of the study [45].", "id": 1040, "split": "val"} +{"trial_id": "NCT04794036", "pmid": "35853037", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patients: a Feasibility Study\n\nIncluded conditions:\n- Coronavirus\n- Fatigue\n- Musculoskeletal Complication\n\nStudy Armgroups:\n- {'label': 'Experimental Group', 'type': 'EXPERIMENTAL', 'description': 'Telerehabilitation asynchronous programme at home', 'interventionNames': ['Other: Asynchronous telerehabilitation programme']}\n- {'label': 'Control Group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Rehabilitation programme with an explanatory booklet at home', 'interventionNames': ['Other: Rehabilitation programme']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Asynchronous telerehabilitation programme', 'description': 'Home-based physical rehabilitation programme using a telerehabilitation platform', 'armGroupLabels': ['Experimental Group']}\n- {'type': 'OTHER', 'name': 'Rehabilitation programme', 'description': 'Home-based physical rehabilitation programme by means of an explanatory booklet', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'Fatigue Severity Level', 'description': 'Change in fatigue severity level. Fatigue will be assessed with the Fatigue Severity Scale (FSS). The Fatigue Severity Scale is a self-reported scale composed of 9 items. Each item is rated from 1 to 7 (from 1=strongly disagree to 7=strongly agree). In the FSS, a mean of less than 4 points is considered to be no fatigue and more than 4 is considered to present fatigue. The higher the score, the greater the severity of fatigue.', 'timeFrame': 'Pre-intervention (day 1); after intervention (day 84); follow up 1 (3 months after intervention); follow up 2 (6 months after intervention).'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 50, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n A sample size of 50 subjects will be required, 20 in each group, plus 10 in anticipation of future losses according to the recommendations for RCT pilot studies [95, 96].", "id": 1041, "split": "val"} +{"trial_id": "NCT04794569", "pmid": "37907305", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome Phase IV Pilot Study\n\nIncluded conditions:\n- Deep Vein Thrombosis\n- Post Thrombotic Syndrome\n\nStudy Armgroups:\n- {'label': 'Tinzaparin', 'type': 'EXPERIMENTAL', 'description': 'initial 3-week lead-in course of low molecular weight heparin (tinzaparin 175 units/Kg sc daily) followed by a direct oral anticoagulant (rivaroxaban 20mg po daily) for at least 3 months', 'interventionNames': ['Drug: tinzaparin']}\n- {'label': 'Rivaroxaban', 'type': 'ACTIVE_COMPARATOR', 'description': 'Direct oral anticoagulant only (rivaroxaban 15mg po BID for 3 weeks followed by rivaroxaban 20mg po daily ) for at least 3 months', 'interventionNames': ['Drug: Rivaroxaban']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'tinzaparin', 'description': 'low molecular weight heparin', 'armGroupLabels': ['Tinzaparin']}\n- {'type': 'DRUG', 'name': 'Rivaroxaban', 'description': 'direct oral anticoagulant', 'armGroupLabels': ['Rivaroxaban']}\n\nPrimary Outcomes:\n- {'measure': 'PTS at 6 months', 'description': 'Proportion of patients with PTS at 6 months using the Villalta scale. PTS will be diagnosed using the Villalta scale. This clinical scale is the recommended standard to diagnose PTS.', 'timeFrame': '6 months post randomization'}\n- {'measure': 'Main feasibility', 'description': 'Main feasibility outcomes: a. Proportion of eligible patients, among patients screened b. Proportion of recruited patients, among patients who are eligible c. Proportion of patients who are compliant with tinzaparin, among recruited patients assigned to tinzaparin arm.', 'timeFrame': '3 months post randomization'}\n\nPlease estimate the sample size based on the assumption: \nThe median sample size per arm for pilot studies is 30 participants (range 8-114) and for feasibility studies is 36 (range 15-114). Temporal effects on PTS frequency are considered but not adjusted for in this pilot trial.", "answer": 9, "answer_type": "ACTUAL", "explanation": "Sample size and power calculations\n The objective of this pilot trial is to assess feasibility of the study protocol and to obtain an estimate of the magnitude of difference in effectiveness between tinzaparin followed by rivaroxaban compared with upfront rivaroxaban. This will inform our estimation of the required sample size for a larger, definitive future trial. There are currently no available data to estimate the expected magnitude of this difference, as DOACs have not been directly compared with LMWHs for the prevention of PTS. Other PTS literature has shown effect sizes around 0.25 in terms of the effect of the intervention on the Villalta scale score at 6 months,37 suggesting that a sample size of around 25 patients per treatment arm would be sufficient.38 In an audit of sample sizes for pilot and feasibility trials undertaken in the UK, Billingham et al found that the median sample size per arm for pilot studies was 30 participants (range 8\u00e2\u0080\u0093114) and for feasibility studies was 36 (range 15\u00e2\u0080\u0093114).39 Another factor that may influence the required sample size is the temporal effect on frequency of PTS. While some authors have found that PTS frequency increases with time,40 others have not,41 suggesting that adjusting the sample size for this is premature. We plan to recruit 60 participants in total, which places our pilot trial within the recommended sample size range for pilot studies.", "id": 1042, "split": "val"} +{"trial_id": "NCT04794764", "pmid": "34615684", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room\n\nIncluded conditions:\n- Pulmonary Aspiration of Gastric Contents\n\nStudy Armgroups:\n- {'label': 'McGrath MAC', 'type': 'EXPERIMENTAL', 'description': 'First pass success rate using the McGrath Mac', 'interventionNames': ['Device: McGrath Mac']}\n- {'label': 'Macintosh Laryngoscope', 'type': 'EXPERIMENTAL', 'description': 'First pass success rate using the Macintosh laryngoscope', 'interventionNames': ['Device: Macintosh Laryngoscope']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'McGrath Mac', 'description': 'in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.', 'armGroupLabels': ['McGrath MAC']}\n- {'type': 'DEVICE', 'name': 'Macintosh Laryngoscope', 'description': 'in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.', 'armGroupLabels': ['Macintosh Laryngoscope']}\n\nPrimary Outcomes:\n- {'measure': 'First pass Intubation success rate', 'description': 'successful tracheal intubation at the first attempt, compared to more than one attempt', 'timeFrame': 'at intubation in 60 seconds'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a power of 96% and a significance level of 5%, with a drop-out rate of about 5%.", "answer": 1000, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size calculation was based on achieving successful tracheal intubation on the first attempt. In recent trials, the VL showed a first attempt success rate of 97%. We determined the power of the study by assuming a first-pass success rate of 92% (DL)20 30 and 97% (McG).43 We chose this study for the sample size calculation because the purpose was to compare VL and DL, including anaesthesia trainees in the operating room. On the basis of the current first-pass success rate, we hypothesised that an increase of 5% by skilled laryngoscopists in the McGrath group compared with the DL group would be a relevant improvement in airway management. We determined that the inclusion of 474\u00e2\u0080\u0089patients per group would show relevant differences. Assuming a drop-out rate of about 5%, 500\u00e2\u0080\u0089patients per group will be included. With 1000\u00e2\u0080\u0089patients, an increase from 92% (DL) to 97% (McG) in the first-pass success rate can be observed with a power of 96% at the 5% significance level.", "id": 1043, "split": "val"} +{"trial_id": "NCT04795843", "pmid": "36127096", "question": "Here is the design of a clinical trial:\n\nOfficial Title: MovetheHip-trial: The Effectiveness of Exercise and Patient Education Compared With Usual Care on Self-reported Pain in Patients With Hip Dysplasia\n\nIncluded conditions:\n- Hip Dysplasia\n\nStudy Armgroups:\n- {'label': 'Exercise and patient education', 'type': 'EXPERIMENTAL', 'description': '6-months', 'interventionNames': ['Other: Exercise and patient education']}\n- {'label': 'Usual Care', 'type': 'ACTIVE_COMPARATOR', 'description': '6-months', 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Exercise and patient education', 'description': 'Over a period of 6-months, patients will be offered eight one-to-one supervised training sessions. In these sessions, patients will be instructed in a home-based exercise programme and given patient education. The programme includes four exercises covering strength and stability training. The exercises will be performed in sets of three with a minimum of 5 repetitions, and patients will be instructed to perform a minimum of three training sessions each week. Each of the exercises can be progressed through three levels of difficulty, allowing for individualised treatment with regard to exercise quality and perceived exertion according to the Borg CR10 scale. Exercises will be performed on a perceived exertion level from somewhat hard (level 5) to very hard (level 7). Patient education includes pain management, a focus on exercise adherence and progression, and advice on physical activity.', 'armGroupLabels': ['Exercise and patient education']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': 'Patients will follow usual care, including an individual consultation on self-management of hip symptoms and general advice on exercise and physical activity.', 'armGroupLabels': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)', 'description': 'HAGOS pain sub-item measures degree of hip and/or groin pain through ten individual questions on a score from 0 to 100, higher score indicates lower pain.', 'timeFrame': 'From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)'}\n\nPlease estimate the sample size based on the assumption: \nA common SD of 13 HAGOS pain points for the change in each group, an alpha level of 5%, and a power of 86%. An expected dropout rate of 15% during the 6-month follow-up period, resulting in a power of 80%.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size\n The power calculation was based on a clinical superiority calculation.58 The expected mean difference between groups was 15 points in the change in HAGOS pain over a 6-month follow-up period.15 The superiority margin was a MCID of 10 points in the between-group change in the HAGOS pain over 6\u00e2\u0080\u0089months,37 representing the lower end of the 95% CI of the expected mean difference between groups. Given these assumptions, a sample size of 200 participants (n=100 in each group), a common SD of 13 HAGOS pain points15 for the change in each group and an alpha level of 5%, we will reach a power of 86%. Based on an expected dropout of 15% during the 6-month follow-up period,15 our sample size will be 170 participants (85 in each group), and the power of the trial will be 80%.", "id": 1044, "split": "val"} +{"trial_id": "NCT04796389", "pmid": "34642197", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Result of a Music Intervention on Anxiety in Critically Ill Patients\n\nIncluded conditions:\n- Anxiety\n\nStudy Armgroups:\n- {'label': 'Recorded music', 'type': 'EXPERIMENTAL', 'description': 'Recorded music intervention', 'interventionNames': ['Other: Music']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Standard of care'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Music', 'description': 'Preferred music of the participant administered using headphones.', 'armGroupLabels': ['Recorded music']}\n\nPrimary Outcomes:\n- {'measure': 'Anxiety (VAS-A)', 'description': 'Measured using the Visual Analogue Scale for Anxiety (VAS-A), on a scale of 0 to 10, in which a higher score means a worse outcome.', 'timeFrame': '1.5 year'}\n\nPlease estimate the sample size based on the assumption: \nA global significance level of 5%, a significance level of 1.7% for each of the three VAS-A tests using Bonferroni correction, a power of 80%, two-sided testing, and a dropout rate of 10%.", "answer": 104, "answer_type": "ACTUAL", "explanation": "Sample size\n For the sample size calculation, we assumed a treatment effect based on the study of Chlan et al.16 They report a mean VAS-A of 50.5\u00e2\u0080\u0089mm with a SD of 29.2\u00e2\u0080\u0089mm in the ICU population. They found a reduction of 19.5\u00e2\u0080\u0089mm when music intervention is provided. To achieve a global significance level of 5%, a significance level of 1.7% based on the Bonferroni correction will be used for each of the three VAS-A tests (on day 1, 2 and 3 after inclusion), accounting for multiple testing and to obtain a power of 80%, planning two-sided testing, and a dropout rate of 10%. Consequently, the sample size will be 104, which means 52 in each study arm. (This sample size calculation was performed using https://clincalc.com/stats/samplesize.aspx.)", "id": 1045, "split": "val"} +{"trial_id": "NCT04797286", "pmid": "38689245", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Sildenafil for Early Pulmonary Vascular Disease in Scleroderma\n\nIncluded conditions:\n- Scleroderma\n- Mildly Elevated Pulmonary Pressures\n\nStudy Armgroups:\n- {'label': 'Sildenafil', 'type': 'EXPERIMENTAL', 'description': 'Sildenafil 20 mg by mouth three(3) times each day', 'interventionNames': ['Drug: Sildenafil']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo by mouth three(3) times each day', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Sildenafil', 'description': 'Sildenafil 20 mg three times a day. This is the approved dose for the treatment of pulmonary arterial hypertension. It is being studied in this trial with a population who has mildly elevated pulmonary pressures.', 'armGroupLabels': ['Sildenafil'], 'otherNames': ['Revatio, Viagra']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Oral pill placebo.', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Difference in change in distance walked in 6 minute walk test (6MWT) at 4 months', 'description': 'As assessed by change in 6 minute walk distance (6MWD) in feet (from baseline to 4 months) between the sildenafil group and the placebo group.', 'timeFrame': 'Baseline and 4 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level of 0.05 and a power of >80%. A 10% drop-out rate is accounted for, with the possibility of maintaining adequate power even if the drop-out rate increases to 17%.", "answer": 30, "answer_type": "ESTIMATED", "explanation": "Sample size\n We have based our effect size estimate of 45\u00c2\u00a0m upon our preliminary data (not shown) demonstrating a difference in mean 6MWD between SSc patients with normal mPAP and SSc-MEP of \u00e2\u0088\u00bc\u00e2\u0080\u008950\u00c2\u00a0m with a standard deviation of 75\u00c2\u00a0m. As such, we will have >\u00e2\u0080\u008980% power to detect this difference at significance level of 0.05 with 27 subjects. To account for a 10% drop-out rate, we are enrolling 30 subjects. Even if our actual drop-out rate nearly doubles our expected rate (17% vs. 10%), we maintain adequate power to detect a difference of 45\u00c2\u00a0m with 80% power (Fig.\u00c2\u00a03). While this estimate of change in 6MWD exceeds the MID for the 6MWD in PAH, the MID for this test in SSc-MEP is unknown. Further, if differences in 6MWD observed in the study do not reach the predefined detectable alternative, clinical relevance of the effect on 6MWD may be reflected by comparing the proportion of patients who exceeded the MID for 6MWD between arms. Based upon a sample size of 27 subjects completing the trial, we also have adequate power (80% or greater) to detect differences in the proposed secondary outcome measures. For instance, we have 80% power to detect a mean difference in PAC of 0.6 mL/mmHg (SD 1.1) between treatment arms; this difference was the average difference between these SSc-MEP and SSc-normal pressures found in our preliminary studies (data not shown). Further, we will have sufficient power to detect differences of 0.23\u00c2\u00a0cm (SD 0.5) in TAPSE between groups which is close to the estimated MID for TAPSE in SSc-PAH (0.22\u00c2\u00a0cm) from prior work from our group [28]. For global RV strain measured by STE, we have more than 85% power to detect a difference of 4.8% (SD 8%); this is the difference detected in our ATPAHSS Study of ambrisentan and tadalafil in treatment na\u00c3\u00afve SSc-PAH patients after therapy [28, 32]. Similarly, we have adequate power to detect a difference of 5% (SD 9%) in RVEF between arms; this difference is the MID for RVEF in PAH [35]. For HRQoL outcomes, we also have adequate power to detect clinically relevant changes in SF-36 of 5 units (SD 7 units) and emPHasis-10 of 6 units (SD 10) [36].\n \nFig. 3Power estimates and detectable alternatives by sample size in the SEPVADIS trial", "id": 1046, "split": "val"} +{"trial_id": "NCT04797312", "pmid": "34838109", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery\n\nIncluded conditions:\n- Anesthesia\n- Anesthesia; Adverse Effect\n- Opioid Analgesic Adverse Reaction\n- Post-Op Complication\n\nStudy Armgroups:\n- {'label': 'Opioid free anesthesia (OFA) protocol', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Opioid Free Anaesthesia protocol']}\n- {'label': 'standard practice protocol based on the use of opioids (sufentanil or remifentanil)', 'type': 'SHAM_COMPARATOR', 'interventionNames': ['Drug: standard practice protocol based on the use of opioids (sufentanil or remifentanil)']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Opioid Free Anaesthesia protocol', 'description': 'The OFA protocol begins with a systematic preoperative premedication with clonidine, continues with an adapted intraoperative management without opioid administration, but associating several molecules (clonidine, magnesium, lidocaine, ketamine) and ends with a continued administration of xylocaine up to 1 hour postoperatively in PACU. The use of an opioid in preoperative or intraoperative phases is considered as a deviation from the protocol.\\n\\nTo these different molecules, the use of hypnotic molecules left to the choice of the practitioner and a curare will be systematically associated.', 'armGroupLabels': ['Opioid free anesthesia (OFA) protocol']}\n- {'type': 'DRUG', 'name': 'standard practice protocol based on the use of opioids (sufentanil or remifentanil)', 'description': 'Standard anesthetic practices can be summed up as the combination of a hypnotic, a morphinic (sufentanil or remifentanil) and a curare. The use of ketamine is allowed.', 'armGroupLabels': ['standard practice protocol based on the use of opioids (sufentanil or remifentanil)']}\n\nPrimary Outcomes:\n- {'measure': 'FQoR-15 score at 24 hours', 'description': 'Value of the French Quality of Recovery-15 score (minimum value of 0 and maximum value of 150, with a higher score for a better outcome).\\n\\nThe QoR-15 questionnaires will be completed by the patient himself whenever possible, who could be helped by a nurse blinded to the assignment group, or by phone if the patient has returned home.', 'timeFrame': '24 hours after surgery'}\n\nPlease estimate the sample size based on the assumption: \nType I error risk of 0.05 in a two-sided test, power of 0.8, and a 10% dropout rate.", "answer": 140, "answer_type": "ESTIMATED", "explanation": "Sample size\n According to the database used to assess the French version of the QoR-15 that included 72 patients undergoing gynecologic, digestive, or urologic major surgery, the mean QoR-15 score was 97 at 24\u00e2\u0080\u0089h after the surgery, with a standard deviation of 16. A difference of at least 8.0 points in the score is considered clinically significant [30]. The OFA will thus be superior to the standard of care if the mean QoR-15 is at least 105. Considering a type I error risk of 0.05 in two-sided test and a power of 0.8, the estimated number of patients needed is 126 (63 patients in both groups). Considering that data will not be available for ten percent of the patients (e.g., surgery canceled, lost in follow-up, consent withdrawal) regarding the primary outcome, we plan to include 140 patients.", "id": 1047, "split": "val"} +{"trial_id": "NCT04797871", "pmid": "35945634", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Resistance Training Intervention on the Clinical Status in Patients With Post Discharge Symptoms After Covid-19: The \"EXER-COVID Study\"\n\nIncluded conditions:\n- Covid19\n- SARS-CoV2\n- Fatigue Syndrome, Chronic\n- Stress, Psychological\n- Pain, Chronic\n\nStudy Armgroups:\n- {'label': 'Exercise', 'type': 'EXPERIMENTAL', 'description': 'Resistance training', 'interventionNames': ['Behavioral: Resistance training']}\n- {'label': 'Standard care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Non-supervised ACSM exercise guidelines', 'interventionNames': ['Behavioral: Standard care']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Resistance training', 'description': 'Participants will complete a 2-days-a-week training routine: Resistance training (RT, 50-75% 1RM (one-repetition maximum), 4 sets, 8-12 repetitions, 4 exercises). The warn up include Light Intensity Continuous Training (8-10 min, 65-70% HRR). Progressions will be individualized and consistent with patient tolerance. Sessions will be supervised by Physiotherapists and Graduated in Sports Sciences.', 'armGroupLabels': ['Exercise']}\n- {'type': 'BEHAVIORAL', 'name': 'Standard care', 'description': 'This group will be allocated to standard care and therefore no supervised exercise regimen according to scientific guidelines for general physical activity and return to sport provided by the ACSM guidelines for Chronic Obstructive Pulmonary Disease and Cardiovascular Disease.', 'armGroupLabels': ['Standard care']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in Cardiorespiratory fitness', 'description': 'Measured with an incremental VO2 protocol on exercise bike by COSMED Quark CPET plus OMNIA (COSMED\u00ae, Rome, Italy)', 'timeFrame': 'Baseline, 6 Weeks and 12 Weeks'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80% (1-\u03b2) with a two-tailed alpha <0.05, adjustment for baseline value and other prognostic covariates. Potential dropout rate of <15-20%.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size\n Given the absence of exercise interventions for patients with persistent COVID-19 symptoms [57], in this area, a conservative approach will be used to estimate the sample size. Inspired by a Lau et al. study [58], it is expected that the exercise group will increase cardiorespiratory fitness at least 1-MET (3.5\u00e2\u0080\u0089mL/kg/min) more than the standard care group with an SD of 5.4%. A sample size of 84 participants (42 per group) provides statistical power (1\u00e2\u0088\u0092\u00ce\u00b2) of 80% using a two-tailed alpha <0.05\u00e2\u0080\u0089and adjustment for baseline value and other prognostic covariates [59]. This sample size will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes. Considering a potential dropout rate of <15\u00e2\u0080\u009320% based on our previous exercise trials [60, 61], a total of 100 participants (50 per group) will be randomized. This power will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes if the effects are moderate (i.e., effect size of Cohen\u00e2\u0080\u0099s d \u00e2\u0089\u00a5 0.6). This power is not sufficient for detecting potentially meaningful differences in any of the exploratory clinical outcomes. Given that the purpose of this phase II trial is to inform larger phase II and III trials, the patient-reported and clinical outcomes will also be interpreted for potential clinical significance based on the direction and magnitude of numerical differences. These calculations were performed with the Power and Sample Size Calculations program, Version 2.1.23.", "id": 1048, "split": "val"} +{"trial_id": "NCT04798599", "pmid": "35392886", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Using Information and Communication Technologies (ICTs) to Solve the Repressed Demand for Primary Dental Care in the SUS Due to the COVID-19 Pandemic\n\nIncluded conditions:\n- Dental Caries in Children\n- Dental Diseases\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'In the intervention group there will be the application of the intervention - use of telemonitoring and teleorientation applied to children in primary care in Dentistry.', 'interventionNames': ['Other: Telemonitoring and teleorientation']}\n- {'label': 'Waiting list', 'type': 'ACTIVE_COMPARATOR', 'description': \"In the control group, children waiting to be booked to the intervention (in implementation in the unit because of the pandemic) will be evaluated for the outcomes. Only after the evaluation, the control group's children will be invited to perform the teleconsultation (proposed intervention).\", 'interventionNames': ['Other: Control Group - Waiting list']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Telemonitoring and teleorientation', 'description': 'Teleservice will be performed through a digital platform (Video for Health\" - V4H). The service will consist of: a) recognition of the condition identified in the pandemic period, including updates on medical history, current oral health condition, search for dental care in other units, need for referral, change of hygiene habits, b) realization of diet guidance, hygiene and other necessary habits, made from a situational recognition of such habits, c) targeting the needs presented, in which individualized counselling will be given seeking to meet the demand presented by that family nucleus. A dental form developed on the digital platform Google Forms will serve as a guide for the performance of the service and where the collected data will be formally recorded. The guidelines, although individualized for the needs of each child, will follow a pre-defined and standardized structure and based on the best evidence available in the subject.', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Control Group - Waiting list', 'description': 'No intervention (at least, until the time frame for outcome assessment)', 'armGroupLabels': ['Waiting list']}\n\nPrimary Outcomes:\n- {'measure': 'Family/patient\u00b4s perception about the dental care', 'description': 'Evaluation of the quality of dental care to be measured by the SERVQUAL questionnaire (a multi-dimensional research instrument) - total of 22 items and 5 dimensions, comprising 4 items to capture tangibles, 5 items to capture reliability, 4 items for responsiveness, 4 items for assurance and 5 items to capture empathy.\\n\\nA total of 100 points is allocated among the five dimensions. The participants evaluate the degree to which they perceived the proposed service. To identify participants\\' perceptions, one item asked, \"How do you feel about these service attributes that are already provided?\", which was scored on a 5-point Likert-type scale of \"very bad (1)\" to \"very good (5).\"', 'timeFrame': '2 weeks after intervention (or one week of waiting - in the case of the control group)'}\n\nPlease estimate the sample size based on the assumption: \nA more conservative calculation was used, and an extra 20% was added to compensate for possible losses.", "answer": 368, "answer_type": "ESTIMATED", "explanation": "Sample size and recruitment\n The sample calculation was made using the application sample-size.net and considered the primary outcome for the RCT as a reference. As more than one dimension is considered in evaluating the primary outcome, we consider an average between them. A hypothetical user's difference between the perceived and the expected users' quality appraisal related to a regular health service clinic [27] was used to estimate a minimum difference for this trial, aiming at a more conservative calculation. The minimum difference expected was set, then, as 0,17 (effect size) and a standard deviation of 0,53 assumed (based on the worst case scenario in the referred study) [27]. A minimum sample of 306 users or family representatives in the RCT was estimated. Extra 20% was added to compensate for possible losses, resulting in a final sample of 368 families recruited. Thus, the first 368 families from the unit's care list will be included (randomized). To reach the required number of children, all participants registered at the mobile dental care unit will be invited to participate in this study by telephone\u00c2\u00a0or social media contact or message, as detailed in the before-and-after study.", "id": 1049, "split": "val"} +{"trial_id": "NCT04798755", "pmid": "35318229", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy, Safety and Cost-effectiveness of Methotrexate, Adalimumab, or Their Combination in Non-infectious Non-anterior Uveitis: a Randomized, Parallel 3 Arms, Active-controlled, Phase 3 Open Label With Blinded Outcome Assessment Study\n\nIncluded conditions:\n- Uveitis\n\nStudy Armgroups:\n- {'label': 'Adalimumab', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Adalimumab']}\n- {'label': 'Methotrexate', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Methotrexate']}\n- {'label': 'Adalimumab+Methotrexate', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Adalimumab+Methotrexate']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Methotrexate', 'description': 'Inicial dose 15mg/week increasing up to 25 mg/week', 'armGroupLabels': ['Methotrexate']}\n- {'type': 'DRUG', 'name': 'Adalimumab', 'description': 'At the Baselin visit adalimumab 80 mg subcutaneous loading dose followed a week later by 40 mg every-other-week starting at Week 1.', 'armGroupLabels': ['Adalimumab']}\n- {'type': 'DRUG', 'name': 'Adalimumab+Methotrexate', 'description': 'Adalimumab: at the Baseline visit 80 mg subcutaneous loading dose followed a week later by 40 mg every-other-week starting at Week 1.\\n\\nMethotrexate:Inicial dose 15mg/week increasing up to 25 mg/week', 'armGroupLabels': ['Adalimumab+Methotrexate']}\n\nPrimary Outcomes:\n- {'measure': 'Good Clinical Response', 'description': 'Complete resolution of the ocular inflammatory signs, achieved within the first 16 weeks of the study, and maintained until week 52; no treatment failure due to safety or intolerability.', 'timeFrame': '52 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: 0.05; Power: 80%; Missing/dropout rate: 15%; Superiority or relevant clinical improvement: delta of 5% of the effect.", "answer": 192, "answer_type": "ESTIMATED", "explanation": "Sample size determination\n \nADA arm: after 1\u00e2\u0080\u0089year (50 weeks) of treatment, 20.3% of NIU patients achieved an outcome similar to our primary efficacy outcome.28\n\n \nMTX arm: after 6 months of treatment, 65% of NIU patients achieve also similar outcome;64 we estimate that of those patients, 18%65 and 16%66 will be unable to maintain our outcome due to AEs and inefficacy, respectively; therefore, at 1\u00e2\u0080\u0089year, 43% will achieve our primary efficacy outcome. This figure will be assumed as the percentage of subjects treated with monotherapy achieving the primary efficacy outcome.\n \nMTX+ADA arm: we will assume that combination therapy will increase the percentage of subjects achieving our primary efficacy outcome by 23% compared with the monotherapy arms.\n To detect statistically significant differences between groups with a power of 80% and a significance level of 0.05, it will be necessary to recruit 54 patients per study arm (162 in total). Since the follow-up period is 52 weeks, losses of 15% will be assumed, increasing the sample size to 64 patients per study arm (192 patients in total). In order to test the difference between the treatments, superiority or relevant clinical improvement has been considered from a delta of 5% of the effect.", "id": 1050, "split": "val"} +{"trial_id": "NCT04801004", "pmid": "36600357", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Real-world Study to Evaluate the Primary Patency and Freedom From TLR of Endovascular Treatment in TOSAKA III In-stent Restenosis of Lower Extremity Femoropopliteal Artery.\n\nIncluded conditions:\n- Peripheral Arterial Disease\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Freedom from clinically-driven TLR', 'description': 'CD-TLR was de\ufb01ned as any reintervention within the target lesion(s) because of recurrent symptoms. Freedom form CD-TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nA 10% lost to follow-up rate is assumed. Statistical significance is considered at a two-sided p<0.05. Normal distribution and homogeneous tests of variance will be performed. Continuous data will be presented as mean\u00b1SD, and categorical data as numbers and percentages. Various statistical tests will be used based on data distribution and variance homogeneity.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n Taking into account a 10% lost to follow-up rate and a target enrolment of 300 patients, 270 patients will be included in the effectiveness analysis.\n Statistical analysis will be performed using Stata SE V.15.1 software (StataCorp). Continuous data will be presented as the mean\u00c2\u00b1SD, and categorical data will be presented as numbers (n) and percentages (%). Normal distribution and homogeneous tests of variance will be performed in advance. For the data groups that have a normal distribution and homogeneous variances, comparisons between two groups will be made using unpaired Student\u00e2\u0080\u0099s t-tests and one-way analysis of variance, followed by Bonferroni tests for multiple group comparisons. For the data groups that do not have a normal distribution or homogeneous variances, nonparametric tests will be used. Univariate and multivariate analyses will be performed by logistic analysis. Generally, a two-sided p<0.05\u00e2\u0080\u0089will be considered statistically significant unless otherwise stated.", "id": 1051, "split": "val"} +{"trial_id": "NCT04805554", "pmid": "35190439", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee\n\nIncluded conditions:\n- Osteo Arthritis Knee\n\nStudy Armgroups:\n- {'label': 'Joint Insights Decision Aid', 'type': 'EXPERIMENTAL', 'description': 'Participants view the entire Joint Insights decision aid for knee osteoarthritis including: Education Module with information about knee osteoarthritis and risks and benefits of various treatment options, Preferences and Values elicitation questions, and Personalized Risk/Benefit Report.', 'interventionNames': ['Other: Joint Insights decision aid']}\n- {'label': 'Education Module Only', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants view the Joint Insights Education Module only', 'interventionNames': ['Other: Joint Insights decision aid']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Joint Insights decision aid', 'description': \"The Joint Insights decision aid was developed by Dell Medical School faculty in collaboration with OM1, a health outcomes and predictive analytics company. This decision aid uses patient-report outcome measures (PROMs) - specifically, the PROMIS Global and the KOOS JR - along with patient clinical and demographic information (age, sex, race, ethnicity, chronic narcotic use, body mass index), in machine-learning-based predictive analytic models to provide personalized estimates of likely benefit or harm from total knee replacement surgery. The tool is designed to collect PROMs or pull in PROMs collected through other systems (e.g., an EHR or a third-party PROM platform). It also provides condition-specific education to patients with knee OA and allows a patient to reflect on and document their preferences and goals. The personalized risk/benefit report generated by the decision aid is meant to be discussed with the patient's provider to enhance shared decision making.\", 'armGroupLabels': ['Education Module Only', 'Joint Insights Decision Aid']}\n\nPrimary Outcomes:\n- {'measure': 'Patient perception of decision process and quality as measured by the Knee Decision Quality Instrument (Knee-DQI)', 'description': 'Patients are asked about whether they were offered a choice between treatments (yes/no), to what extent the pros and cons were discussed (a lot/some/a little/not at all), and whether the health care provider asked for their preferences (yes/no). Participants receive 1 point for a response of \"yes\" or \"a lot/some.\" The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicated a more shared decision making process.', 'timeFrame': 'Immediately following enrollment visit'}\n\nPlease estimate the sample size based on the assumption: \nType I error rate of 0.05, power of 0.90, equal sample size in intervention and control groups, 10% loss to follow-up rate", "answer": 200, "answer_type": "ACTUAL", "explanation": "Statistical precision and sample size\n We calculated the sample size for the RCT by treating the decision process score of the DQI as continuous. We aimed to detect a treatment effect size (ie, Cohen\u00e2\u0080\u0099s D) as small as 0.5 (consistent with preliminary data from the first 26 subjects we have studied) with a type I error rate of 0.05 and power of 0.90, assuming equal sample size in intervention and control groups. Given our eight randomisation strata, we estimate a needed sample size of 180 participants, or 90 for each group. With an estimated loss to follow-up rate of 10%, our target enrolment for the RCT is 200 participants, or 100 for each arm.", "id": 1052, "split": "val"} +{"trial_id": "NCT04806191", "pmid": "34996788", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Making Shoulder Pain Simple in General Practice-implementing an Evidenced Based Guideline for Shoulder Pain, a Hybrid Design Cluster Randomised Study\n\nIncluded conditions:\n- Shoulder Pain\n- Frozen Shoulder\n- Rotator Cuff Tendinosis\n- Myalgia\n- Rotator Cuff Impingement Syndrome\n- Rotator Cuff Tear or Rupture, Not Specified as Traumatic\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Patients will be assessed by GPs who have attended an outreach workshop and trained at using an evidence based strategy for shoulder examination and treatment. GPs will have access to a decision support tool and patients is offered a tailored information package for self management.', 'interventionNames': ['Other: Evidence based treatment strategy', 'Other: Targeted patient information package']}\n- {'label': 'Treatment as usual (TAU)', 'type': 'ACTIVE_COMPARATOR', 'description': 'The participants enrolled in the control period will receive treatment as offered in general practice.', 'interventionNames': ['Other: Treatment as usual (TAU)']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Evidence based treatment strategy', 'description': 'Evidence-based clinical examination and treatment plan', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Targeted patient information package', 'description': 'GPs will in cooperation with the patients tailor a information package targeted to the patients needs regarding their clinical shoulder diagnosis and individual implications and needs (Pain, sleep, exercises etc.).', 'armGroupLabels': ['Intervention']}\n- {'type': 'OTHER', 'name': 'Treatment as usual (TAU)', 'description': 'Usual care as provided by the GP', 'armGroupLabels': ['Treatment as usual (TAU)']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Shoulder Pain and Disability Index (SPADI)', 'description': '13 item patient reported questionnaire on shoulder pain and disability. (0 = no pain or shoulder disability, 100 = worst pain and disability).', 'timeFrame': 'Change from 0 to 12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, alpha at 0.05 for a two-sided test, ICC of 0.02, and a possible drop-out rate of 10%.", "answer": 250, "answer_type": "ESTIMATED", "explanation": "Sample size\n The target sample size is 250\u00e2\u0080\u0089patients. The incidence of shoulder pain in general practice has been reported to be 2%\u00e2\u0080\u00934%.1 2 Based on the ICPC-2 codes for shoulder pain, we found that 67\u00e2\u0080\u0089patients were given a primary shoulder diagnosis in a GP surgery with three GPs in \u00c3\u0098stfold County in Norway in 2017. Most GP surgeries have three to four GPs in Norway. Therefore, in estimating the sample size for this study, we used a conservative assumption of 3% as the incidence of shoulder pain. Previous studies guided our choice of estimates for the sample size calculation. We used the computer programme IBM SPSS Sample Power V.3.01 and inflated by the design effect using the formula DE=1+n-1\u00cf\u0081 where n is the number of individuals per clusters and \u00cf\u0081 the intracluster correlation coefficient (ICC).30\u00e2\u0080\u009333 Setting the desired statistical power of the study at 80%, alpha at 0.05 for a two sided test and an ICC of 0.02, we estimated that we needed to recruit 250\u00e2\u0080\u0089patients to detect a clinically important difference of 8 points between the groups in the SPADI score and an SD of 22 points in both groups, taking into account a possible drop-out rate of 10%. Thus, assuming that only one-third of the patients contacting their GP will participate in the study, we will recruit at least 36 GPs in 10 GP-clusters to recruit an adequate sample size in 1\u00e2\u0080\u0089year. We will if necessary, increase the recruitment period to reach an adequate targeted sample size.", "id": 1053, "split": "val"} +{"trial_id": "NCT04806724", "pmid": "36056413", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Opening the Conversation for Couples With Reproductive Health Concerns\n\nIncluded conditions:\n- Breast Cancer\n- Gynecologic Cancer\n\nStudy Armgroups:\n- {'label': 'Program #1', 'type': 'EXPERIMENTAL', 'description': 'Participants attend 5 sessions (1.5 hours each) consisting of education and skills training to address cancer-related reproductive and sexual health concerns. Sessions occur via videoconference.', 'interventionNames': ['Behavioral: Opening the Conversation']}\n- {'label': 'Program #2', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference.', 'interventionNames': ['Behavioral: Side by Side']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Opening the Conversation', 'description': 'The intervention includes 5 weekly sessions (1.5 hours each), plus participant educational materials, and is delivered to couples via videoconference by a trained interventionist. Participants are asked to complete home activities between sessions. Sessions focus on development of communication and coping skills, with a focus on reproductive and sexual health distress.', 'armGroupLabels': ['Program #1']}\n- {'type': 'BEHAVIORAL', 'name': 'Side by Side', 'description': 'The intervention includes 4 weekly sessions (1.5 hours each), plus participant educational materials, and is delivered to couples via videoconference by a trained interventionist. Participants are asked to complete home activities between sessions. Sessions focus on development of communication and coping skills, with a focus on general cancer-related distress.', 'armGroupLabels': ['Program #2']}\n\nPrimary Outcomes:\n- {'measure': 'Change in reproductive distress', 'description': 'Relationship concern domain of the Fertility Problem Inventory (FPI) scale. 10 items. Range 10-60. Higher score indicates more reproductive distress.', 'timeFrame': 'Baseline to 3 months post-intervention'}\n- {'measure': 'Change in sexual distress', 'description': 'Sexual and relationship distress (SaRDS). 30 items. Range 1-30. Higher score indicates more sexual distress.', 'timeFrame': 'Baseline to 3 months post-intervention'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a significance level that provides 90% power without attrition and 80% power with 20% attrition. It also assumes a cross-dyad correlation of r = .4.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size estimate/ power calculations\n A sensitivity power analysis was conducted using the program G*Power and anticipating an initial sample of 100 couples (N = 200 individuals), and an attrition rate of 20% at the final assessment. Given that the design has two levels of the treatment and three assessments, for outcomes that are assessed on only survivors (or only partners), the study has 90% power to detect small to moderate effects (i.e., d = .32) if there is no attrition. With the expected 20% attrition, the study has 80% power to detect effects greater than d = .36. Because both partners will complete most of the same outcomes, for these outcomes the effective sample size is larger than the number of dyads but smaller than the number of individuals. Specifically, assuming a cross-dyad correlation of r = .4 (e.g., the correlation between the two partners\u00e2\u0080\u0099 distress), the effective sample size to test the treatment by time interaction is 142 without attrition and 114 with attrition. Thus, for these outcomes, without attrition the study will have 90% power to detect effects of d > .27 and with attrition it will have 90% power to detect effects of d > .30.", "id": 1054, "split": "val"} +{"trial_id": "NCT04808882", "pmid": "35473740", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ANTIcoagulation in Severe COVID-19 Patients: a Multicenter, Parallel-group, Open-label, Randomized Controlled Trial\n\nIncluded conditions:\n- Severe COVID-19 Pneumonia\n\nStudy Armgroups:\n- {'label': 'Low dose prophylactic anticoagulation', 'type': 'EXPERIMENTAL', 'description': 'LD-PA', 'interventionNames': ['Drug: Tinzaparin, Low dose prophylactic anticoagulation']}\n- {'label': 'High dose prophylactic anticoagulation', 'type': 'EXPERIMENTAL', 'description': 'HD-PA', 'interventionNames': ['Drug: Tinzaparin, High dose prophylactic anticoagulation']}\n- {'label': 'Therapeutic anticoagulation', 'type': 'EXPERIMENTAL', 'description': 'TA', 'interventionNames': ['Drug: Tinzaparin,Therapeutic anticoagulation']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Tinzaparin, Low dose prophylactic anticoagulation', 'description': 'Participants randomized to the LD-PA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: LD-PA : 3500 IU/24h. Depending on the type of tinzaparin pre-filled syringe available in the participating center, the dose of 4000 IU/24h will be allowed in place of 3500 IU/24h.\\n\\nIf tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: LD-PA: 4000 IU/24h.\\n\\nAfter day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians.\\n\\nRecommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data.', 'armGroupLabels': ['Low dose prophylactic anticoagulation'], 'otherNames': ['LD-PA']}\n- {'type': 'DRUG', 'name': 'Tinzaparin, High dose prophylactic anticoagulation', 'description': 'Participants randomized to the HD-PA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: HD-PA : 7000 IU/24h.\\n\\nIf tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: HD-PA: 4000 IU/12h.\\n\\nAfter day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians.\\n\\nRecommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data.', 'armGroupLabels': ['High dose prophylactic anticoagulation'], 'otherNames': ['HD-PA']}\n- {'type': 'DRUG', 'name': 'Tinzaparin,Therapeutic anticoagulation', 'description': 'Participants randomized to the TA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: TA : 175 IU/kg/24h.\\n\\nIf tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: TA: 100 IU/kg/12h.\\n\\nAfter day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians.\\n\\nRecommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data.', 'armGroupLabels': ['Therapeutic anticoagulation'], 'otherNames': ['TA']}\n\nPrimary Outcomes:\n- {'measure': 'All-cause mortality', 'timeFrame': 'Day-28'}\n- {'measure': 'Number of days to clinical improvement', 'description': 'Clinical improvement will be assessed through a seven-category ordinal scale derived from the WHO scale, using the following categories: 1. not hospitalized with resumption of normal activities; 2. not hospitalized, but unable to resume normal activities; 3. hospitalized, not requiring supplemental oxygen; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7. death. As all included patients will at least require oxygen supplementation, live discharge from hospital will represent a minimal 2-points decrease in the 7-points scale, thus a clinical improvement.', 'timeFrame': 'Day-28'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha of 0.017 using Bonferroni correction for multiple testing, 80% power, 5% of patients alive at day 28 without clinical improvement, Weibull distribution for survival curves, normal distribution for time to clinical improvement.", "answer": 353, "answer_type": "ACTUAL", "explanation": "Sample size and its statistical justification\n The required number of participants to be randomised is 300 patients (from 353 included). Estimates, derived from prior studies led in similar populations,16 showed that a sample of at least 300 patients (100 per group) suffices to achieve \u00e2\u0089\u00a580% power that is required to detect a statistically significant difference in the ranked composite primary endpoint. The analyses rely on two-sided alpha of 0.017 using Bonferroni correction for multiple testing considering three pairwise comparisons between the randomised arms. Sample size calculation assumed having day 28 mortality of 24%, 21% and 18%, and time to clinical improvement of 16\u00c2\u00b13 days (SD), 14\u00c2\u00b13 days and 12\u00c2\u00b13 days, with LD-PA, HD-PA and TA, respectively. We hypothesise that the rate of positive CTPA would be 15%.18 19 For such, we aim to include 353 patients in order to randomise 300.\n Sample size calculation also considered the pairwise comparisons between the groups. For each performed comparison, 5000 samples were simulated using R software. For the first component of the hierarchical primary endpoint (mortality), survival curves were simulated based on a Weibull distribution using the R package simsurv. For the second component of the hierarchical primary endpoint (time to clinical improvement) assessed in alive patients, two different approaches, taking into account the distribution of this parameter, were used to test the robustness of results in relation with the retained hypotheses. First, a normal distribution was hypothesised with means\u00c2\u00b1SD of 16\u00c2\u00b13, 14\u00c2\u00b13 and 12\u00c2\u00b13 days in LD-PA, HD-PA and TA, respectively. Second, incidence curves of clinical improvement were simulated based on Weibull distribution using the R package simsurv, with survival medians of 16, 14 and 12 days in LD-PA, HD-PA and TA groups, respectively. With both approaches, 5% of patients were systematically identified through simulation as alive patients at day 28 but without achieving clinical improvement, which is consistent with Cao et al.16 SD and mean number of days to clinical improvement, as well as shape and scale parameters of Weibull survival curves simulations were determined from the study of Cao et al.16 considering median (IQR) survival time and Kaplan-Meier curves. Within each sample/pairwise comparison, an individual score is calculated by comparing each patient in one group with all patients in the second group (23). These scores are then compared between groups using Mann-Whitney/Wilcoxon test in each of the 5000 samples, and the p value of each test is recorded. For each pairwise comparison, the percentage of tests with a p<0.017 is calculated, which gives an estimate of the achieved statistical power.", "id": 1055, "split": "val"} +{"trial_id": "NCT04809402", "pmid": "36717799", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cataract Online Refraction Evaluation: A Multi Center Randomized Controlled Trial\n\nIncluded conditions:\n- Cataract\n\nStudy Armgroups:\n- {'label': 'Telemonitoring', 'type': 'OTHER', 'description': 'Subjects in the telemonitoring group will have post-operative follow-up measurements involving teleconsultations, remote eye exams and health questionnaires.', 'interventionNames': ['Other: remote monitoring after cataract surgery']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Subjects in the usual care group will receive regular post-operative care, mostly involving in-hospital consultations.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'remote monitoring after cataract surgery', 'description': 'remote monitoring after cataract surgery', 'armGroupLabels': ['Telemonitoring']}\n\nPrimary Outcomes:\n- {'measure': 'Cost-effectiveness', 'description': 'The main outcome measure will be Incremental cost-effectiveness ratio (ICER), defined as euros per QALY, and compared between the two groups.', 'timeFrame': 'pre-operative until 3 months after surgery'}\n\nPlease estimate the sample size based on the assumption: \nA standard deviation of 0.30 logMAR, an \u03b1 of 0.05, a power of 90%, 20% loss to follow-up, and using a one-sided, one sample t-test.", "answer": 94, "answer_type": "ACTUAL", "explanation": "Study population and sample size calculation\n Patients planned for bilateral cataract surgery without visual acuity influencing comorbidities are eligible for study participation. The surgical procedures can be performed on the same day (i.e. immediate sequential) or on two different days. Exclusion criteria are: cataract surgeries combined with other procedures (including keratoplasty, vitrectomy, glaucoma filter implants), presence of ocular comorbidities that negatively influence post-operative visual acuity (such as amblyopia, age-related macular degeneration, diabetic retinopathy, glaucoma or uveitis), insufficient command of the Dutch, German or English language, no access to a smartphone and computer/tablet, and inability to successfully perform the demo version of the web-based eye exam.\n The sample size calculation is based on determining the validity of the web-based eye exam since calculations based on cost-effectiveness and safety were not feasible. We aim to assess whether the corrected distance visual acuity obtained with the web-based refraction is not significantly worse than the visual acuity obtained with the manifest refraction. We assume no difference between the measurements and consider a difference up to 0.10 logMAR to be non-inferior. With a standard deviation of 0.30 logMAR (a commonly used SD in power calculations on visual acuity [29\u00e2\u0080\u009331]), an \u00ce\u00b1 of 0.05, a power of 90, 20% loss to follow-up and using a one-sided, one sample t-test, 94 eyes are then required in the telemonitoring group (so 47 participants, as all measurements will be performed bilaterally). This results in a total study population of 94 participants (188 eyes) for both study groups.", "id": 1056, "split": "val"} +{"trial_id": "NCT04809610", "pmid": "36574408", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of the Internet Attachment-Based Compassion Therapy (iABCT) to Improve the Quality of Life and Well-being in a Population With Chronic Medical Illness.\n\nIncluded conditions:\n- Chronic Medical Illness\n\nStudy Armgroups:\n- {'label': 'Intervention group: Internet attachment-based compassion therapy (iABCT).', 'type': 'EXPERIMENTAL', 'description': 'The iABCT is a self-applied program based on the attachment theory and the use of compassion meditations. It is composed of 8 modules that have been reformulated to be completely self-applied and include text, images, illustrations, videos, audio with guided meditations, exercises, and homework. Downloadable PDF files will be made available so that users can review them offline. Each module has been optimized to have a duration of 60 and 90 minutes approximately. The entire intervention is estimated to be completed in eight weeks.', 'interventionNames': ['Behavioral: Internet attachment-based compassion therapy (iABCT).']}\n- {'label': 'Control group: Waiting list control group.', 'type': 'NO_INTERVENTION', 'description': 'Participants in this condition will be informed that they will have access to the intervention at 3 months (after the intervention group).'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Internet attachment-based compassion therapy (iABCT).', 'description': 'The iABCT is a self-applied program based on the attachment theory and the use of compassion meditations. It is composed of 8 modules that have been reformulated to be completely self-applied and include text, images, illustrations, videos, audio with guided meditations, exercises and homework. Downloadable PDF files will be made available so that users can review them offline. Each module has been optimized to have a duration of 60 and 90 minutes approximately. The entire intervention is estimated to be completed in eight weeks.', 'armGroupLabels': ['Intervention group: Internet attachment-based compassion therapy (iABCT).']}\n\nPrimary Outcomes:\n- {'measure': 'Changes in quality of life', 'description': 'EuroQol (EQ-5D; Badia et al., 1999). It is a self-report measures composed by five dimensions of functionality in daily-life and three levels of severity (1-3). A higher score in this scale indicates higher severity on the different areas of functioning in daily life.', 'timeFrame': 'Baseline (week 0), 3-month follow-up, 6-month follow-up'}\n- {'measure': 'Changes in wellbeing', 'description': 'Pemberton Happiness Index (PHI; Herv\u00e1s and V\u00e1zquez, 2013). The scale includes eleven items related to different domains of remembered well-being (general, hedonic, eudaimonic, and social well-being) and ten items related to experienced well-being (i.e., positive and negative emotional events that possibly happened the day before); the sum of these items produces a combined well-being index that range from 0 to 10. Higher levels indicate higher levels of wellbeing.', 'timeFrame': 'Baseline (week 0), 3-month follow-up, 6-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nstatistical power of .80, significance level (\u00ce\u00b1) of .05, dropout rate of 30%", "answer": 68, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample will be composed of 68 participants as minimum. The sample size was calculated using the G*Power 3.1.9.7 for Windows program [68]. Estimated sample size was decided based on medium effect sizes (d = 0.4), statistical power of .80 and \u00ce\u00b1 = .05, indicating a necessary sample of 52 participants [69]. Considering that the dropout rate in Internet-based interventions for the chronic medical ill population is usually around 30%, a target of 34 people per group was set [70\u00e2\u0080\u009372].", "id": 1057, "split": "val"} +{"trial_id": "NCT04812717", "pmid": "36123067", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prevention of Vasoplegia With the Use of CytoSorb.\n\nIncluded conditions:\n- Heart Failure\n- Vasoplegia\n\nStudy Armgroups:\n- {'label': 'CytoSorb-Yes', 'type': 'ACTIVE_COMPARATOR', 'description': 'Heart failure patients that will receive intraoperative treatment with CytoSorb.', 'interventionNames': ['Device: CytoSorb device']}\n- {'label': 'CytoSorb-No', 'type': 'NO_INTERVENTION', 'description': 'Heart failure patients that will not receive intraoperative treatment with CytoSorb.'}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'CytoSorb device', 'description': 'The CytoSorb device will be placed in the CPB circuit in half of the study population during their cardiac operation.', 'armGroupLabels': ['CytoSorb-Yes']}\n\nPrimary Outcomes:\n- {'measure': 'Delta systemic vascular resistance index (SVRi) after CPB.', 'description': 'The change in SVRi after the administration of phenylephrine after cessation of CPB.', 'timeFrame': 'during surgery (2-10 hours)'}\n- {'measure': 'Incidence of vasoplegia.', 'description': 'Vasoplegic syndrome defined as the continuous need of vasopressors (norepinephrine \u22650.2 \u03bcg/kg/min for at least 12 consecutive hours, terlipressin, or methylene blue) in combination with a cardiac index (CI) \u22652.2 l/min/m2 for at least 12 consecutive hours, starting within the first 3 days postoperatively.', 'timeFrame': '72 hours'}\n\nPlease estimate the sample size based on the assumption: \n90% power, 0.05 two-sided significance level, and compensation for possible data loss", "answer": 36, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary endpoint is delta SVRi with phenylephrine challenge after CPB. A sample size of 17 patients in each treatment group will have 90% power to detect a difference in means of 400\u00e2\u0080\u0089dyn s/cm5 assuming that the common SD is 350\u00e2\u0080\u0089dyn s/cm523 and when using a 0.05 two-sided significance level. To compensate for possible loss of data due to failing of the vasoconstriction test, one extra patient will be included in each group, resulting in a total sample size of 36 patients.", "id": 1058, "split": "val"} +{"trial_id": "NCT04815408", "pmid": "39909529", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Phase II Study of PD-1 Antibody Plus Neoadjuvant Chemotherapy for Advanced-stage Ovarian Cancer (Z2HOC-01)\n\nIncluded conditions:\n- Ovarian Cancer\n- Neoadjuvant Chemotherapy\n- Anti-PD-1\n- Neoadjuvant Immunotherapy\n\nStudy Armgroups:\n- {'label': 'NIC', 'type': 'EXPERIMENTAL', 'description': '1. Neoadjuvant treatment BGB-A317 200mg q3 weeks (total 3 dosing) Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 q3 weeks (total 3 dosing)\\n2. Interval debulking surgery and HIPEC\\n3. Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)', 'interventionNames': ['Drug: BGB-A317', 'Drug: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5']}\n- {'label': 'NC', 'type': 'ACTIVE_COMPARATOR', 'description': '1. Neoadjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 q3 weeks (total 3 dosing)\\n2. Interval debulking surgery and HIPEC\\n3. Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)', 'interventionNames': ['Drug: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'BGB-A317', 'description': 'PD-1 antibody\uff0cTislelizumab (BGB-A317)', 'armGroupLabels': ['NIC']}\n- {'type': 'DRUG', 'name': 'albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5', 'description': 'albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5', 'armGroupLabels': ['NC', 'NIC']}\n\nPrimary Outcomes:\n- {'measure': 'Progression-free survival(PFS)', 'description': '12 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.', 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nOne-sided significance level of \u03b1=0.05, 80% power, and a dropout rate of 10%.", "answer": 40, "answer_type": "ESTIMATED", "explanation": "Sample size and randomisation\n This is an exploratory biomarker study, and any statistical comparisons between the two treatment arms will be exploratory in nature. Moreover, the study is structured as a parallel-group randomised trial, with the primary outcome being the 1-year PFS rate. The randomisation ratio is 1:1. Assuming a 1-year PFS rate of 60% in the control group14 15 and 80% rate (a 20% increase) in the treatment group, with a one-sided significance level of \u00ce\u00b1=0.05 and 80% power, the study requires a sample size of 40 subjects (20 in each group), a dropout rate of 10% is assumed. The requisite sample size was calculated using PASS 15. Randomisation will be performed using a computer-generated programme that incorporates a random element, which will ensure a balance of the tumour stage.", "id": 1059, "split": "val"} +{"trial_id": "NCT04817124", "pmid": "35688585", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-based Context\n\nIncluded conditions:\n- Aging\n\nStudy Armgroups:\n- {'label': 'stimulation group', 'type': 'EXPERIMENTAL', 'description': 'Anodal tDCS+ intensive cognitive Training', 'interventionNames': ['Device: Anodal tDCS', 'Behavioral: Intensive cognitive training']}\n- {'label': 'sham group', 'type': 'SHAM_COMPARATOR', 'description': 'Sham tDCS + intensive cognitive Training', 'interventionNames': ['Behavioral: Intensive cognitive training', 'Device: Sham tDCS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Anodal tDCS', 'description': 'Anodal transcranial direct current stimulation (tDCS), 6 sessions with 20 minutes stimulation each (1,5 mA).', 'armGroupLabels': ['stimulation group']}\n- {'type': 'BEHAVIORAL', 'name': 'Intensive cognitive training', 'description': 'Intensive cognitive training of a letter memory updating task, 6 sessions for approximately 20 min', 'armGroupLabels': ['sham group', 'stimulation group']}\n- {'type': 'DEVICE', 'name': 'Sham tDCS', 'description': 'Sham transcranial direct current stimulation (tDCS), 6 sessions with 30 sec stimulation each (1,5 mA) to ensure blinding of participants.', 'armGroupLabels': ['sham group']}\n\nPrimary Outcomes:\n- {'measure': 'Feasibility of conducting the intervention in a home-based context', 'description': 'Feasibility of home-based tDCS as operationalized by at least 2/3 (out of 6 planned sessions) successfully performed interventional sessions per participant. A session is regarded as successful if it is marked as completed in the stimulation system.', 'timeFrame': '2 weeks'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses an independent t-test with a two-sided significance level of 0.05 and a power of 80%. The lower bound of the 95% CI for the proportion of participants meeting the feasibility criterion needs to be at 60%.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Sample size\n As the primary goal of this study will be to assess feasibility, and as it is recommended to employ results of feasibility trials for sample size calculation of a planned subsequent trial,46 we chose a sample size of n=30.47 To infer feasibility, the lower bound of the 95% CI of the proportion of participants who fulfilled the feasibility criterion needs to be at 60%. Thus, 76%, that is, n=23 participants will have to meet the feasibility criterion.\n With 15 participants per stimulation group (anodal vs sham stimulation), we will be able to able to scope the general feasibility of this home-based intervention, and will be able to plan follow-up trails accordingly. Additionally, we will be able to explore descriptively the benefit of anodal tDCS over sham with regard to performance after the training on the trained and untrained working memory tasks to obtain estimates of effect sizes for power calculations of future RCTs.48 49 Using an independent t-test with a two-sided significance level of 0.05 and a power of 80%, we will be able to demonstrate an effect of Cohen\u00e2\u0080\u0099s d=1.06\u00e2\u0080\u0089or higher on behavioural performance.", "id": 1060, "split": "val"} +{"trial_id": "NCT04818359", "pmid": "36814313", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Movement and Health Beyond Care, MoviS: Nutrition and Exercise Educational Programs for Breast Cancer Survivors\n\nIncluded conditions:\n- Breast Cancer Survivors\n\nStudy Armgroups:\n- {'label': 'Interventional Arm', 'type': 'EXPERIMENTAL', 'description': 'Supervised exercise program: MoviS Training. Lifestyle (nutrition and exercise) counseling based on WCRF 2018 recommendations; psychological well-being counseling which comprises evaluation for anxiety and depression.', 'interventionNames': ['Behavioral: MoviS Training']}\n- {'label': 'Control Arm', 'type': 'NO_INTERVENTION', 'description': 'Lifestyle (nutrition and exercise) counseling based on WCRF 2018 recommendations; psychological well-being counseling which comprises evaluation for anxiety and depression.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'MoviS Training', 'description': 'Patients will undergo a supervised exercise program consisting of 3 months of aerobic exercise training (2 d/week of directly supervised exercise and 1 d/week of remotely supervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min).', 'armGroupLabels': ['Interventional Arm']}\n\nPrimary Outcomes:\n- {'measure': 'Quality of life assessed by questionnaire', 'description': 'Change in quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores ranging from 0 to 100; higher scores indicate better quality of life.', 'timeFrame': 'Baseline - after 3, 6, 12, 24 months'}\n\nPlease estimate the sample size based on the assumption: \nUsing a t-test for independent samples, with an alpha of 0.05 and statistical power of 0.80, and considering an expected drop-out rate of 30%.", "answer": 172, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The sample size was calculated with the aim of verifying the differences between the QoL changes in the two groups (i.e., intervention and control arm), after 3 months of intervention.\n The QoL expected improvement in the experimental group at 12 weeks is 15.1 \u00c2\u00b1 17.7, while in the control arm, it is 6.1 \u00c2\u00b1 17.1 [24]. Using a t-test for independent samples, with an alpha of 0.05 and statistical power of 0.80, to find differences in QoL improvements between the two groups at the end of the intervention, 60 participants per group will be needed. Considering an expected drop-out of 30%, a total of 172 patients will be recruited. The sample size was calculated using Stata statistical software (StataCorp. 2013. Stata Statistical Software: Release 13. College Station, TX: StataCorp LP).", "id": 1061, "split": "val"} +{"trial_id": "NCT04819152", "pmid": "35078840", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of Tobacco Cessation Interventions for Different Groups of Users in Sweden: a National Prospective Cohort Study\n\nIncluded conditions:\n- Tobacco Use\n- Smoking\n- Cigarette Use, Electronic\n\nStudy Armgroups:\n- {'label': 'Exposed', 'description': 'Several studies will be performed based on this cohort. I each study the exposed group will be a group of tobacco users evaluatedin the relevant study. This could be a vulnarable group tobacco users such as: users without a job, with short or no education, without permanent housing, diagnosed with mental illness, diagnosed with chronic obstructive pulmonary disease (COPD), undergoing surgery, adolescents, elderly, migrants, or pregnant women.', 'interventionNames': ['Behavioral: Tobacco cessation intervention']}\n- {'label': 'Unexposed', 'description': 'In each study the unexposed group will consist of tobacco user from the study cohort without the condition examined in the relevant study.', 'interventionNames': ['Behavioral: Tobacco cessation intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Tobacco cessation intervention', 'description': 'Already implemented in-person (including online meetings) tobacco cessation interventions in Sweden', 'armGroupLabels': ['Exposed', 'Unexposed']}\n\nPrimary Outcomes:\n- {'measure': '% of patients that are continuously smokefree', 'description': 'Self-reported smoking status, questionnaire completed by telephone interview', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided test, a 5% level of significance, a power of 80%, and an expectation of high acceptance and follow-up rates among patients.", "answer": 8000, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated for the dichotomous main outcome (successful quitting (yes/no) after 6 months) and based on the following assumptions: a two-sided test, a 5% level of significance, a power of 80%, an estimated effect in the control group of 35%, and a minimum relevant difference of 5\u00e2\u0080\u009310\u00e2\u0080\u0089percentage points.\n The online calculator \u00e2\u0080\u0098Inference for Proportions: Comparing Two Independent Samples\u00e2\u0080\u0099 (www.stat.ubc.ca/%7Erollin/stats/ssize/) was used to estimate the necessary sample size of each group. Based on a minimal relevant difference on 10% and 5% each group should include at least 329 and 1377 tobacco users, respectively. As the study groups in this study are not equal-sized, the sample size gives the estimated size of the smallest group (the vulnerable group in question).\n We expect to include 8000 patients. Based on the overall existing interest from the tobacco cessation counsellors, at least 200 of them are each expected to collect data from at least 20\u00e2\u0080\u0089patients/year. The large majority of potential patients are expected to accept inclusion and follow-up.31 To be able to manifest a difference in effect size of 10%, 4% for the included patients would have to belong to each of the given risk factors (vulnerable groups). To show a difference of 5%, this would be the case for 17% of the included patients.", "id": 1062, "split": "val"} +{"trial_id": "NCT04819425", "pmid": "38330026", "question": "Here is the design of a clinical trial:\n\nOfficial Title: \"Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath. A Randomized Multicenter, Cluster and Crossover Controlled Study. FIXATUB\"\n\nIncluded conditions:\n- Intubation Complication\n\nStudy Armgroups:\n- {'label': 'Elastic Adhesive Strips', 'type': 'EXPERIMENTAL', 'description': \"Endotracheal tube fixed by elastic adhesive tape (Tensoplast type adhesive tape):\\n\\nThe adhesive tape will be attached to the patient's face (opposite side to the endotracheal tube) and then two turns around the endotracheal tube will be made. The rest of the adhesive tape will be attached to the other side of the face (side of the endotracheal tube).\\n\\nThe laminated tape will be kept on the adhesive tape until it passes over the neck in order to avoid adhering to the hair.\\n\\nFinally, the end of the adhesive tape will be replaced on the part already attached to the patient.\\n\\nIt will be changed daily and after stain or examinations if necessary.\", 'interventionNames': ['Device: Elastic Adhesive Strips']}\n- {'label': 'Lace in A Protective Sheath', 'type': 'ACTIVE_COMPARATOR', 'description': 'A loop is made with the lace then the endotracheal tube is passed through the loop. The loop is tightened by pulling each side on the remaining cords and a knot is made on one side of the fastener.\\n\\nIt will be changed daily and after stain or examinations if necessary.', 'interventionNames': ['Device: Lace in A Protective Sheath']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Elastic Adhesive Strips', 'description': 'Securement of Endotracheal tube with Elastic Adhesive Strips', 'armGroupLabels': ['Elastic Adhesive Strips']}\n- {'type': 'DEVICE', 'name': 'Lace in A Protective Sheath', 'description': 'Securement of Endotracheal tube with Lace in A Protective Sheath', 'armGroupLabels': ['Lace in A Protective Sheath']}\n\nPrimary Outcomes:\n- {'measure': 'Peribuccal lesion', 'description': 'Appearance of at least one peribuccal lesion during the first 10 days of maintaining the endotracheal tube inserted orally.\\n\\nPresence of peribuccal lesion will be validated on picture by an independent review committee.\\n\\nThe picture will be taken daily without the visible fixing system (blind maintained for the adjudication committee) from J0 to J10 at the site of the endotracheal tube.', 'timeFrame': 'up to 10 days after intubation'}\n\nPlease estimate the sample size based on the assumption: \nModerate intra-class correlation coefficient of 0.1, within-cluster between-period correlation coefficient of 0.05, 90% power, 5% alpha level.", "answer": 768, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The study will take place in 16 centers (clusters) over two 12-month periods.\n According to the IDEFIX study (data not published, but provided during the French Intensive Care Congress in 2012, S1 Appendix), we hypothesize that 35% of patients with a \"cord and sleeve\" fixation system have a peri-oral lesion compared to 20% with the elastic adhesive tape system.\n The calculation of the number of subjects needed must take into account the design of the study and thus the two intra-class and inter-class correlation coefficients [18].\n As we have no data on the estimation of correlation coefficients, we have retained, for the calculation of the number of subjects, a \"moderate\" intra-class correlation coefficient and therefore defined at 0.1, and as recommended, a within-cluster between-period correlation coefficient equal to half of the intra-class correlation coefficient, i.e. 0.05 [19].\n With 90% power and 5% alpha level, we calculated that each of the 16 centers would need to include an average of 24 patients per period.\n A total of 768 patients are to be included.", "id": 1063, "split": "val"} +{"trial_id": "NCT04823104", "pmid": "36797021", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health\n\nIncluded conditions:\n- Pregnancy\n- Living in an Isolated Area\n\nStudy Armgroups:\n- {'label': 'Intervention group with home visitation', 'type': 'EXPERIMENTAL', 'description': 'pregnant women who are included in this group will be assigned an intervention by home visitation for pregnancy follow-up', 'interventionNames': ['Other: Home visitation']}\n- {'label': 'control group without home visitation', 'type': 'NO_INTERVENTION', 'description': 'pregnant women will be free to choose their pregnancy follow-up without home visitation'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Home visitation', 'description': 'Home visitation for pregnancy follow-up', 'armGroupLabels': ['Intervention group with home visitation']}\n\nPrimary Outcomes:\n- {'measure': 'adequate pregnancy follow-up according to the French recommendations', 'description': 'number of consultations, In all, 8 consultations should take place in a pregnancy that goes to term', 'timeFrame': '9 months'}\n- {'measure': 'adequate pregnancy follow-up according to the French recommendations', 'description': 'number of ultrasound exams, Three systematic or screening ultrasound examinations, one per trimester, are recommended', 'timeFrame': '9 months'}\n- {'measure': 'adequate pregnancy follow-up according to the French recommendations', 'description': 'number of biological exams of recommended laboratory tests for antenatal care', 'timeFrame': '9 months'}\n\nPlease estimate the sample size based on the assumption: \nAn alpha risk of 5%, a power of 90%, and a participation rate of 80% are assumed. The level of correlation of behaviors in the same cluster ranges from 0.1 to 0.5.", "answer": 330, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to the national perinatal survey, almost 20% of women have not had the eight antenatal consultations recommended.23 According to the PRECare study, 50.7% of women did not receive adequate antenatal care, that is, care that corresponds to the HAS guidelines.24 The objective of the mobile antenatal care clinic is to improve antenatal care so that it meets the national guidelines. Considering the method of randomisation chosen, two indicators must be taken into account: the inflation factor, specific to the cluster, and the level of correlation of the behaviours of subjects in the same cluster. The perinatal health network data suggest that the mean number of women a year who could be included in a cluster is 2.5. Extrapolating from the literature involving pregnant women in cluster-randomised trials, the level of correlation of behaviours ranges from 0.1 to 0.5.25\n For an alpha risk of 5%, a power of 90% and a success rate for the primary objective of 85% for the intervention group and 70% for the control group, we calculated the number of subjects necessary by considering three correlation coefficient values: 0.1, 0.2 and 0.5. The number of subjects necessary thus ranges between 217 and 330 for an 80% participation rate. Considering previous data in the perinatal health network 300\u00e2\u0080\u0093400 pregnancies occur each year in the municipalities include in the study. Thus, the sample size can be reached considering the time of the study. As it is a new intervention, participation rate may be less than expected, however as the mobile clinic will be as close as possible to women\u00e2\u0080\u0099s living place, access to healthcare will be easier for them.", "id": 1064, "split": "val"} +{"trial_id": "NCT04834427", "pmid": "35870990", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Safety and Efficacy Evaluation of S (+) -Ketamine for Postoperative Acute Pain in Children in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial\n\nIncluded conditions:\n- S-ketamine\n- Esketamine\n- Acute Pain\n- Postoperative Pain\n- Analgesia\n- Hyperalgesia\n- Delirium\n- Depression, Anxiety\n- Children\n\nStudy Armgroups:\n- {'label': 'S (+)-Ketamine group', 'type': 'EXPERIMENTAL', 'description': 'Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction, maintenance or postoperative analgesia.', 'interventionNames': ['Drug: Conventional therapy + S (+)-Ketamine']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients who undergo conventional therapy without S (+)-Ketamine hydrochloride injection during perioperative period.', 'interventionNames': ['Drug: Conventional therapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Conventional therapy + S (+)-Ketamine', 'description': 'In principle, there are no specific restrictions on the dosage, mode of administration, timing, and compatibility of S-ketamine hydrochloride injection, but the recommended dosage is given, which is lower than the dosage specified in the instructions.\\n\\nRecommended use and dosage of S (+)-Ketamine:\\n\\n1. Intravenous injection\uff1aBolus intravenous injection before skin incision, the dose is 0.1\\\\~0.25 mg/kg; Bolus intravenous injection (dose 0.1\\\\~0.25 mg/kg) before skin incision + continuous intravenous infusion (dose of 0.1\\\\~0.25 mg/kg/h) during operation; Continuous intravenous infusion after surgery with a dose of 0.02\\\\~0.1 mg/kg/h for 24\\\\~48 h.\\n2. Intramuscular injection\uff1aThe dose is 2\\\\~4 mg/kg.', 'armGroupLabels': ['S (+)-Ketamine group'], 'otherNames': ['Conventional therapy + S-ketamine', 'Conventional therapy + Esketamine']}\n- {'type': 'DRUG', 'name': 'Conventional therapy', 'description': 'Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine.', 'armGroupLabels': ['Control group'], 'otherNames': ['Routine treatment']}\n\nPrimary Outcomes:\n- {'measure': 'The area under the broken line of FLACC scale score', 'description': 'Only for children aged 0\\\\~7 years. The score of FLACC Scale is 0-10, the higher the score, the more severe the pain.', 'timeFrame': 'Hour 0-48 after surgery'}\n- {'measure': 'The area under the broken line of Numerical Rating Scale score', 'description': 'Only for children aged 8\\\\~17years. The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain.', 'timeFrame': 'Hour 0-48 after surgery'}\n- {'measure': 'Opioid consumption', 'description': 'Total opioid consumption(conversion to equivalent morphine)', 'timeFrame': 'Hour 0-48 after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe assumptions include a power of 80%, a two-sided significance level of 0.025, and a 2:1 ratio of S(+)-ketamine hydrochloride group to the conventional group.", "answer": 3000, "answer_type": "ESTIMATED", "explanation": "Power and sample size determination\n This study hypothesis that S(+)-ketamine hydrochloride could significantly reduce pain scores and/or opioid consumption within 48 h after surgery compared with routine clinical practice. Due to the lack of reference for primary endpoint, the sample size will be evaluated under different effect size assumption. Assuming power is 80%, two-sided significant level 0.025, and the ratio of S(+)-ketamine hydrochloride group to conventional group is 2:1, the sample size under different effect sizes is shown in Table 1. As shown, about 687 patients will be powerful enough to detect an effect size of 0.25. The effect size d is defined as d = (\u00ce\u00bc1\u00e2\u0080\u0093\u00ce\u00bc2)/\u00cf\u0083, and Cohen (1988) gave the interpretation of d=0.25 as 25% of \u00cf\u0083 and defines d = 0.2, 0.5, and 0.8 as small, medium, and large effect size. In our study, the used effect size of 0.25 is a relatively small effect size. By considering 4 types of surgery, we decide to include 3000 patients. Patients will stratify by age and surgical approach, and enrolled in a competitive enrollment way until the total number of research centers reached the expected sample size.Table 1The sample sizes under different effect sizesControl group(N)S(+)-ketamine hydrochloride group (N)Total subjects(N)Effect sizes581161740.5001302603900.3332294586870.25035771410710.200514102815420.167699139820970.143913182627390.1251155231034650.1111426285242780.100Sample size under different effect sizes assuming power is 80%, two-sided significant level of 0.025, and the ratio of S(+)-ketamine hydrochloride group to conventional group is 2:1", "id": 1065, "split": "val"} +{"trial_id": "NCT04835688", "pmid": "36253829", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transmyringeal Ventilation Tube Insertion for Unilateral Meni\u00e8re's Disease: a Prospective, Sham-controlled, Double-blinded, Randomized, Clinical Trial\n\nIncluded conditions:\n- Meniere Disease\n\nStudy Armgroups:\n- {'label': 'Ventilation tube insertion', 'type': 'EXPERIMENTAL', 'description': 'Ventilation tube insertion into the tympanic membrane.', 'interventionNames': ['Procedure: Transmyringeal ventilation tube insertion']}\n- {'label': 'Sham-treatment', 'type': 'SHAM_COMPARATOR', 'description': 'Sham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion.', 'interventionNames': ['Procedure: Sham-treatment']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Transmyringeal ventilation tube insertion', 'description': 'In both groups, the tympanic membrane will be anesthetized by local application of topical prilocaine (EMLA) or phenol or by infiltration anaesthesia of the outer ear canal. The choice of method is left to the discretion of the surgeon.\\n\\nFor the experimental group, insertion of a ventilation tube will be performed. An incision is performed, usually in the lower, anterior quadrant of the tympanic membrane and the transmyringeal tube is inserted.', 'armGroupLabels': ['Ventilation tube insertion'], 'otherNames': ['Ventilation tube insertion, grommet insertion']}\n- {'type': 'PROCEDURE', 'name': 'Sham-treatment', 'description': 'For the control group, the ENT-specialist will touch the tympanic membrane with an alligator ear forceps to simulate getting a paracentesis. In the same procedure, without having made a paracentesis, a ventilation tube is placed on the tympanic membrane and removed again afterwards. The reason for the above-mentioned is to simulate getting a paracentesis and insertion of a ventilation tube.', 'armGroupLabels': ['Sham-treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Number of vertigo attacks lasting more than 20 minutes', 'description': 'Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.', 'timeFrame': '3 months'}\n- {'measure': 'Number of vertigo attacks lasting more than 20 minutes', 'description': 'Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 104, "answer_type": "ESTIMATED", "explanation": "Sample size\n An estimated 104 participants in total or 52 participants in each group will be necessary.\n The primary analysis will be according to the intention-to-treat principle. The trial will be initiated in 2021 and is expected to end in 2025.", "id": 1066, "split": "val"} +{"trial_id": "NCT04835688", "pmid": "36253829", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transmyringeal Ventilation Tube Insertion for Unilateral Meni\u00e8re's Disease: a Prospective, Sham-controlled, Double-blinded, Randomized, Clinical Trial\n\nIncluded conditions:\n- Meniere Disease\n\nStudy Armgroups:\n- {'label': 'Ventilation tube insertion', 'type': 'EXPERIMENTAL', 'description': 'Ventilation tube insertion into the tympanic membrane.', 'interventionNames': ['Procedure: Transmyringeal ventilation tube insertion']}\n- {'label': 'Sham-treatment', 'type': 'SHAM_COMPARATOR', 'description': 'Sham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion.', 'interventionNames': ['Procedure: Sham-treatment']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Transmyringeal ventilation tube insertion', 'description': 'In both groups, the tympanic membrane will be anesthetized by local application of topical prilocaine (EMLA) or phenol or by infiltration anaesthesia of the outer ear canal. The choice of method is left to the discretion of the surgeon.\\n\\nFor the experimental group, insertion of a ventilation tube will be performed. An incision is performed, usually in the lower, anterior quadrant of the tympanic membrane and the transmyringeal tube is inserted.', 'armGroupLabels': ['Ventilation tube insertion'], 'otherNames': ['Ventilation tube insertion, grommet insertion']}\n- {'type': 'PROCEDURE', 'name': 'Sham-treatment', 'description': 'For the control group, the ENT-specialist will touch the tympanic membrane with an alligator ear forceps to simulate getting a paracentesis. In the same procedure, without having made a paracentesis, a ventilation tube is placed on the tympanic membrane and removed again afterwards. The reason for the above-mentioned is to simulate getting a paracentesis and insertion of a ventilation tube.', 'armGroupLabels': ['Sham-treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Number of vertigo attacks lasting more than 20 minutes', 'description': 'Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.', 'timeFrame': '3 months'}\n- {'measure': 'Number of vertigo attacks lasting more than 20 minutes', 'description': 'Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nNot explicitly stated in the provided paragraph.", "answer": 104, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome in the study will be the number of attacks within the first 3 months after ventilation tube insertion. Because this is count data (i.e. an incidence rate) a Poisson distribution is expected, and a Poisson regression model most likely will give the best fit for analysis of the primary outcome.\n The simulation software \u00e2\u0080\u009dPowersim\u00e2\u0080\u009d developed for the used statistical package, STATA, was applied for Power calculations.\n Given the lack of published data concerning the expected effect of ventilation tube insertion, we chose to assume a 50% reduction in the intervention group, which we believe is realistic as well as a necessity. A 50% reduction gives an Incidence Rate Ratio (IRR) of 0.5 and an ln(IRR) of \u00e2\u0088\u00920.69315.\n Using an alpha value of 0.05 and an expected effect size of 0.5 (ln(0.5) = \u00e2\u0088\u00920.69315), and to obtain a power of 0.8, an expected 94 participants in total or 47 participants in each group will be necessary. To adjust for drop-outs, a safety margin of 10% results in 104 participants in total.", "id": 1067, "split": "val"} +{"trial_id": "NCT04836780", "pmid": "36109825", "question": "Here is the design of a clinical trial:\n\nOfficial Title: DEXamethasone EARLY Administration in Hospitalized Patients With Covid-19 Pneumonia and High Risk of Developing Acute Respiratory Distress Syndrome\n\nIncluded conditions:\n- COVID-19\n- Acute Respiratory Distress Syndrome\n- Pneumonia, Viral\n\nStudy Armgroups:\n- {'label': 'Dexamethasone', 'type': 'EXPERIMENTAL', 'description': 'Dexamethasone base 6 mg once daily for seven days', 'interventionNames': ['Drug: Dexamethasone']}\n- {'label': 'Standard of care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard care therapy', 'interventionNames': ['Drug: Dexamethasone']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'Dexamethasone base 6 mg once daily for seven days', 'armGroupLabels': ['Dexamethasone', 'Standard of care'], 'otherNames': ['Dexametasona kern pharma solution for injection 4 mg/ml']}\n\nPrimary Outcomes:\n- {'measure': 'The primary trial outcome is the development of moderate-severe ARDS', 'description': 'Based on the Berlin criteria, moderate ARDS is defined by a PaO2/FiO2 ratio \\\\>100 mmHg and \u2264200 mmHg. According to The American College of Chest Physicians patients with a PaO2/FiO2 ratio around 200 mmHg requiring supplemental oxygen in nasal cannula at 3 L/min (FiO2 0.30) for a SpO2 of 91-92%. The collected data as outcome measure will be general vital sign, Sequential Organ Failure Assessment (SOFA) score, the clinical status of the patient using the ordinal scale of the WHO, SpO2, partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio calculated from SpO2/FiO2, blood routine tests and chest radiography. Concomitant drugs and adverse event monitoring will be collected. Data will measure during admission. Participants will schedule for a follow-up visit on the 30 and 90th day to track their long-term prognosis, clinical status and sequelae.', 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided alpha = 0.05, potential loss to follow-up", "answer": 126, "answer_type": "ESTIMATED", "explanation": "Sample size\n We powered the study to assess whether the intervention would reduce the incidence of ARDS. Based on available evidence, we estimate a 30% risk of ARDS in the control group [2]. We are looking for an ARDS 10% absolute reduction in the intervention group. Assuming 80% power and two-sided alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, 226 participants would be needed to detect the resulting reduction of ARDS from 30% in the control group to 20% in the intervention group. We adopted a sample size of 252 (126 per group) to compensate for the potential loss to follow-up of some participants.", "id": 1068, "split": "val"} +{"trial_id": "NCT04837105", "pmid": "36216413", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy: Randomized Control Trial\n\nIncluded conditions:\n- Cerebral Palsy\n- Gait Disorders, Neurologic\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Classic rehab (physio including strength rehab, fitness, motor activity...) + treadmill gait training 3\\\\*/week/4weeks:\\n\\n5 minutes of warm-up with gradual increase in treadmill speed, max 20 minutes of walking at 80% of maximum speed, 5 minutes of active recovery with gradual decrease in treadmill speed.\\n\\n(protocol from Grecco et al.)', 'interventionNames': ['Other: Treadmill']}\n- {'label': 'Test group', 'type': 'EXPERIMENTAL', 'description': 'Classic rehab - same as control group - (physio including strength rehab, fitness, motor activity...) + overground ARROW CP gait training 3\\\\*/week/4weeks:\\n\\nwalking sprint session at maximal speed with gradual increase in number of repetitions over the weeks.\\n\\n(protocol from Verschuren et al.)', 'interventionNames': ['Other: Serious game ARROW CP']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Serious game ARROW CP', 'description': 'ARROW CP is developed for Microsoft Hololens headset. Feedback on gait performance are delivering to the participant in real time and with delay. Participants have to walk at their maximal speed during \"sprint session\".', 'armGroupLabels': ['Test group']}\n- {'type': 'OTHER', 'name': 'Treadmill', 'description': 'Participant walk on a treadmill at 80% of their maximal speed during maximum 20 minutes (+5 min warm-up / 5 min cool-down)', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': '6 minutes walking test', 'description': 'Aim of the measurement: To quantify changes in the parameters of walking quality (speed, cadence, step length).\\n\\nProcedure: The patient is instructed to walk for 6 minutes in an unobstructed corridor. The distance walked is recorded for the calculation of walking speed. Fatigue is assessed with a Borg scale and heart rate is continuously recorded.', 'timeFrame': '6 minutes'}\n\nPlease estimate the sample size based on the assumption: \nAlpha=0.05, beta=0.20 (power=0.80), and a failure rate of 10%. Statistical significance level of p=0.05 for ANOVA and other tests. All analyses will be performed using R, with the trial statistician blinded to group allocation until the database is locked.", "answer": 14, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n According to a study of Grecco et al an average augmentation of 83% (range 80%\u00e2\u0080\u009385%) in 6MWT was calculated after following 12\u00e2\u0080\u0089weeks of TT in postoperative context.13 The distance travelled during the 6MWT increases from before: 166.4\u00c2\u00b139.1\u00e2\u0080\u0089m to after: 304.7\u00c2\u00b175.8\u00e2\u0080\u0089m. The effect size was calculated: d=2.29. In this previous study, the mean number of training sessions throughout the 12-week period was 11.1 (around 1 session per week) that is, total dose of 6\u00e2\u0080\u0089hours/12\u00e2\u0080\u0089weeks. It has been hypothesised that participants following a more intensive protocol (three sessions/week that is, total dose of 6\u00e2\u0080\u0089hours/4\u00e2\u0080\u0089weeks) will show the same effect on the 6MWT.\n With an alpha=0.05\u00e2\u0080\u0089and beta=0.20 (power=0.80), a sample size of 6 subjects per group will be required. When taking a failure rate of 10% into account, 14 subjects should be included.\n The required sample size was calculated with G Power 3.1.9.7. Parameter was t-tests \u00e2\u0080\u0093 Means; difference between two independent means (two groups) with a priori analysis.\n The effect of the GT protocol will be analysed using a multivariate repeated measures analysis of variance (ANOVA). The possible differences between and within T0, T1 and T2 for the intervention group and control group will be calculated with a statistical significance level of p=0.05. If there is a significant difference, a post hoc test will be executed to further investigate group differences. Quantitative descriptive statistics will be used to present patient characteristics and global results. Data from PACES questionnaire will be analysed using normality test (deciding to use parametric/non-parametric statistics), descriptive statistics, reliability test (Cronbach Alpha/composite reliability), Pearson/Spearman correlational test. All statistical analyses will be performed using R with a statistical significance level of p=0.05. Moreover, the trial statistician will remain blinded to group allocation until the database has been locked.", "id": 1069, "split": "val"} +{"trial_id": "NCT04838496", "pmid": "36068495", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Neo-adjuvant FOLFOXIRI and Chemoradiotherapy for High Risk (\"Ugly\") Locally Advanced Rectal Cancer\n\nIncluded conditions:\n- Rectal Cancer\n\nStudy Armgroups:\n- {'label': 'Single-arm study', 'type': 'EXPERIMENTAL', 'description': 'All patients will receive induction chemotherapy consisting of 4-6 cycles of FOLFOXIRI. Restaging will be performed after 4 cycles with a pelvic MRI and a thoraco-abdominal CT-scan. In case of stable or responsive disease, the remaining 2 cycles of FOLFOXIRI will be provided. In case of progressive, but still resectable disease, chemoradiation will be provided immediately, without the remaining 2 cycles of FOLFOXIRI. Restaging will be performed after chemoradiation. In case of resectable disease, surgery is performed.', 'interventionNames': ['Drug: FOLFOXIRI Protocol']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'FOLFOXIRI Protocol', 'description': \"FOLFOXIRI consists of oxaliplatin, irinotecan, leucovorin and 5-fluorouracil and is administered every 2 weeks:\\n\\nDosing:\\n\\n* Day 1: irinotecan 165 mg/m2 body-surface area (BSA) intravenously (IV), followed by oxaliplatin 85mg/m2 BSA IV in combination with leucovorin 400mg/m2 BSA, followed by:\\n* Day 1-2: 3200 mg/m2 BSA of continuous 5-fluorouracil IV\\n* Day 3-14: rest days.\\n\\nBoth regimen are initially administered for four cycles. In case of responsive or stable disease, a 5th and 6th cycle of FOLFOXIRI will be administered.\\n\\nIn case of unacceptable toxicity, the aforementioned dosages can be reduced or one or more chemotherapeutical agents can be omitted at discretion of the medical oncologist and will be noted in the patient's medical file. At discretion of the medical oncologist, a start dosage of 75% of the advised dosage could be considered in patients above 70 years of age.\", 'armGroupLabels': ['Single-arm study']}\n\nPrimary Outcomes:\n- {'measure': 'The main study parameter is the proportion of patients with a pathological complete response (pCR) and those patients who started a wait and see strategy and have sustained clinical complete response (cCR) at 1 year.', 'description': 'The pCR is evaluated by an experienced pathologist. A pCR is defined as the absence of residual tumour cells in the complete resected specimen including all resected regional lymph nodes (ypT0N0). A cCR is defined as the absence of viable tumour tissue based on MRI, evaluated by an experienced radiologist. There is a cCR in case of a sustained clinical response at 1 year after chemoradiotherapy.', 'timeFrame': 'pCR is determined after surgery directly. There is a cCR in case of a sustained clinical response until at least one year after chemoradiotherapy'}\n\nPlease estimate the sample size based on the assumption: \nA 5% significance level, 90% power, and a 5% dropout rate are assumed.", "answer": 128, "answer_type": "ESTIMATED", "explanation": "Sample size\n A 10% CR rate is assumed in patients diagnosed with hr-LARC, treated with chemoradiotherapy alone prior to surgery [30, 32]. Based on the available literature and a retrospective analysis of patients from our own institution a CR rate of 20% is hypothesised after neoadjuvant chemotherapy and chemoradiotherapy for hr-LARC [30, 32, 33]. A 5% significance level and a 90% power, resulted in a total of 121 required patients. A drop-out of 5% is expected, resulting in a total sample size of 128 patients.", "id": 1070, "split": "val"} +{"trial_id": "NCT04842448", "pmid": "36323462", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Hyperbaric Oxygen for Treatment of Long COVID Syndrome; A Randomized, Placebo-Controlled, Double-Blind, Phase II Clinical Trial\n\nIncluded conditions:\n- COVID-19\n- Post COVID-19 Condition\n- Post COVID-19 Condition, Unspecified\n- Post COVID Condition\n- Post-COVID Syndrome\n- Post-Acute COVID-19 Syndrome\n\nStudy Armgroups:\n- {'label': 'Hyperbaric oxygen treatment', 'type': 'EXPERIMENTAL', 'description': 'HBO2 240 kPa, 90 min, maximum 10 treatments', 'interventionNames': ['Drug: Hyperbaric oxygen']}\n- {'label': 'Sham treatment', 'type': 'PLACEBO_COMPARATOR', 'description': 'Air 134-120 kPa, 90 min, maximum 10 treatments', 'interventionNames': ['Procedure: Sham treatment']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Hyperbaric oxygen', 'description': 'Hyperbaric oxygen 240 kPa for 90 minutes (with 10 min compression time, 2 air bakes and 10 minutes decompression time).', 'armGroupLabels': ['Hyperbaric oxygen treatment'], 'otherNames': ['HBO', 'HBO2', 'HBOT']}\n- {'type': 'PROCEDURE', 'name': 'Sham treatment', 'description': 'Sham treatment 134-120 kPa Air (with 5 min compression time, and 5 min decompression to 120 kPa, two air brakes will be reported to the subjects)', 'armGroupLabels': ['Sham treatment'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'RAND 36 change', 'description': 'Mean change from baseline to 13 weeks in RAND 36 domains role limitations due to physical health (RP) and physical functioning (PF).\\n\\nRAND 36 is a self-reporting questionnaire that contains 36 items that measure eight concepts of health in general terms, at present and past four weeks. Numeric values from the survey are coded so that all items are scored from 0 (lowest score) to 100 (highest possible score). Scores then represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the eight scale scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.', 'timeFrame': 'Baseline and 13 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 0.05 significance level, common SD of 15, t-test for independent groups.", "answer": 80, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n The primary endpoint is mean change from baseline to week 13 in the RAND-36 score. A 10-point higher mean change in the HBOT group compared with the placebo group is considered as a clinically relevant difference. Sample size calculation was performed using t-test for independent groups, with an 80% power), and a type I error rate of 0.05 (5%), assuming a common SD of 15 from prior studies, to detect a 10-unit difference between groups. Power calculations indicate that at least 37 subjects per group are needed. Subsequently, we aim to recruit 80 subjects. nQuery V.7 was used for sample size calculation.", "id": 1071, "split": "val"} +{"trial_id": "NCT04845074", "pmid": "35138410", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis Eligible For Shoulder Arthroplasty: the ProAct Multicenter, Randomized Controlled Trial\n\nIncluded conditions:\n- Glenohumeral Osteoarthritis\n\nStudy Armgroups:\n- {'label': 'TSA-group', 'type': 'EXPERIMENTAL', 'description': 'Surgery', 'interventionNames': ['Procedure: TSA-group']}\n- {'label': 'Exercise-group', 'type': 'EXPERIMENTAL', 'description': 'Exercise', 'interventionNames': ['Other: Exercise-group']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'TSA-group', 'description': 'Anatomical total shoulder arthroplasty followed by standard rehabilitation.', 'armGroupLabels': ['TSA-group']}\n- {'type': 'OTHER', 'name': 'Exercise-group', 'description': 'The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.', 'armGroupLabels': ['Exercise-group']}\n\nPrimary Outcomes:\n- {'measure': 'the Western Ontario Osteoarthritis of the Shoulder index (WOOS)', 'description': 'WOOS consist of 19 items to be answered using a visual analog scale (VAS). Each item has a possible score ranging from 0 to 100, leading to a total WOOS score ranging from 0 to 1900, with 0 being the best. For simplicity reasons, raw scores can be converted to a percentage of the maximum score (0-100, 100 best).', 'timeFrame': 'Measured at 12-month follow-up'}\n\nPlease estimate the sample size based on the assumption: \nThe significance level is set at 5%, the power is 80%, and the dropout rate is assumed to be 30%.", "answer": 102, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size calculation is based on WOOS data from the Danish Shoulder Arthroplasty Register and on end scores obtained from the feasibility study. The median WOOS score 1 year after surgery for patients with glenohumeral OA treated with TSA is 85 points (Danish Shoulder Arthroplasty Registry [DSR] 2020). The assumed SD was 27, calculated from the interquartile range (IQR). After completing the exercise intervention in the feasibility study, the WOOS score was a mean 67 (SD 22). With a 5% level of significance and a sample size of 78 patients, the study will have 80% power to detect an 18-point difference in the end scores between the surgical and exercise group. Assuming a 30% dropout rate, the total number of patients needed is 102.", "id": 1072, "split": "val"} +{"trial_id": "NCT04846972", "pmid": "39237867", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Facilitate and Sustain Return to Work After Breast Cancer: Randomized Controlled Trial\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Control group', 'description': 'After inclusion, patients will receive standard care. Women allocated in this group will have the standard care.'}\n- {'label': 'FASTRACS intervention group', 'description': 'Women allocated in the FASTRACS intervention group will follow a structured care pathway comprising three successive steps (end of chemotherapy interview with a nurse, transitional visit with their GP, pre-RTW visit with their OP), plus one optional step (late visit with an OP- RTW to work coordinator). Four tools will be used during the intervention (RTW guide or checklist for the patient, the GP, the OP and the employer).', 'interventionNames': ['Behavioral: FASTRACS intervention']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'FASTRACS intervention', 'description': 'Intervention (4 steps) :\\n\\n* Penultimate to last chemotherapy : patient will receive tools of the intervention\\n* 1 month after the end of oncological treatment (OT): patient will attend a general medicine consultation with the GP RTW checklist\\n* 2 months after OT: patient will attend a pre RTW visit with the OP RTW checklist\\n* 5 months after the end of OT: if the patient has not returned to work 10 months after inclusion, they will have a visit with an OP-RTW to work coordinator\\n\\nSelf-questionnaires will evaluate quality of life (EORTC QLQC30, BR23, Euroqol (EQ-5D-5L)), anxiety and depression (HAD), employment status, self-efficacy to return to work (RTW-SE11), pre-RTW and RTW visit with the OP, social support, care consumption, physical activity (short IPAQ), perceived performance (WRF), work conditions. The implementation and use of the intervention tools will also be assessed: the patient guide, the employer guide, RTW checklists for the GP and the OP.', 'armGroupLabels': ['FASTRACS intervention group']}\n\nPrimary Outcomes:\n- {'measure': '(a) a sustained return to work between inclusion and 12 months after oncological treatments; and (b) the number of days on sick leave between inclusion and 12 months after oncological treatments .', 'description': 'The main analysis of the primary endpoint will be based on the net benefit of the intervention, estimated using the generalized pairwise comparison method', 'timeFrame': '12 months after oncological treatments (radiation therapy, or chemotherapy for patients without radiation therapy)'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided alpha risk of 5%, power of over 80%, and a 5% attrition rate.", "answer": 420, "answer_type": "ESTIMATED", "explanation": "Sample size\n We assumed that 75% of patients in the control group would return to work permanently [10] and that among these patients, the average number of days off work in the first year would be 60 days. The number of days off work was simulated using a beta distribution. The study was calibrated to detect an improvement in the FASTRACS intervention group, with 85% of patients returning to work permanently, including a reduction in the average number of days off work for medical reasons to 55 days. 5000 trials were simulated with \u00e2\u0080\u009cR\u00e2\u0080\u009d 3.3.1 software to evaluate the expected performance of our study according to these hypotheses. The results showed that an enrolment of 400 patients would make it possible to demonstrate a statistically significant net benefit at a two-sided alpha risk of 5%, with a power of over 80%. Assuming a 5% attrition rate, 420 patients would need to be randomised (210 patients per group).", "id": 1073, "split": "val"} +{"trial_id": "NCT04847310", "pmid": "35139809", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Cost-effectiveness and Cost-Utility Evaluation of the Individual vs. Group Transdiagnostic Psychological Treatment for Emotional Disorders in Primary Care (PsicAP-Costs)\n\nIncluded conditions:\n- Emotional Disorder\n- Depression\n- Somatoform Disorders\n- Anxiety Disorders\n\nStudy Armgroups:\n- {'label': 'Group 1', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Group brief transdiagnostic cognitive-behavioral therapy']}\n- {'label': 'Group 2', 'type': 'EXPERIMENTAL', 'interventionNames': ['Other: Individual brief transdiagnostic cognitive-behavioral therapy']}\n- {'label': 'Group 3', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Treatment as usual']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Group brief transdiagnostic cognitive-behavioral therapy', 'description': 'An adaptation of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) (Barlow et al., 2015) and the IAPT programme (Clark, 2018). It has been developed by Cano-Vindel (Gonz\u00e1lez-Blanch et al., 2018) and consists in seven 90-minute sessions, provided by a non-assessor clinical psychologist in 12-16 weeks, with 8-10 participants per group. Sessions are weekly or biweekly, reducing their frequency as the intervention advances. The activities and homework proposed are supported with materials such as theory documents, a CD for progressive muscle relaxation, self-recording sheets, and a therapy web (www.desordenesemocionales.es).', 'armGroupLabels': ['Group 1'], 'otherNames': ['Group tCBT']}\n- {'type': 'OTHER', 'name': 'Individual brief transdiagnostic cognitive-behavioral therapy', 'description': 'An adaption of the group therapy, with the same phases. However, since it is an individual intervention, it is more flexible than group one and its contents and duration can be personalized. This intervention consists of a minimum of 6 and a maximum of 8 sessions of 30-60 minutes, provided by a clinical psychologist not involved in the assessments.', 'armGroupLabels': ['Group 2'], 'otherNames': ['Individual tCBT']}\n- {'type': 'OTHER', 'name': 'Treatment as usual', 'description': 'Participants in this group will be provided the common primary care treatment by the GP, in a face-to-face consultation that seldom exceeds 10 minutes. TAU usually consists in pharmacological treatment prescribed by the GP, however, it might also consist in practical advice or even non-treatment (Watts et al., 2015). The first consultation will count as part of the recruitment process and, if the patient accepts to participate in the trial, no therapeutic help will be provided to them until they are allocated. Once in the TAU intervention, if the practitioner recommended any psychological treatment as part of it (e.g., referral to specialized care), the participant would be excluded to avoid contamination between clusters. TAU has not a specific amount of sessions; it will finish when the GP considers the patient is recovered.', 'armGroupLabels': ['Group 3'], 'otherNames': ['TAU']}\n\nPrimary Outcomes:\n- {'measure': 'Change in depression symptoms: 9-item Patient Health Questionnaire (PHQ-9)', 'description': 'The PHQ-9 (Kroenke et al., 2001) is the depression module of the PHQ (D\u00edez-Quevedo et al., 2001; Spitzer et al., 1999), that scores the 9 DSM-IV depression criteria present in the last two weeks from 0 (\"not at all\") to 3 (\"nearly every day\"). A score of 10 is usually set as the cut-off point for major depression disorder (MDD): a score of 10-14 indicates minor depression, moderate MDD, or dysthymia; 15-19, moderately severe MDD; and 20-27, severe MDD. This tool has been tested in Spanish primary care centres (McDonald\\'s \u03c9 = .89) (Mu\u00f1oz-Navarro, Cano-Vindel, Medrano et al., 2017), finding 12 as the best cut point for MDD diagnosis (sensitivity of 84% and specificity of 78%) compared with 10 (sensitivity of 95% and specificity of 67%).', 'timeFrame': 'Baseline, immediately after the intervention, and follow-ups (6 and 12 months)'}\n- {'measure': 'Change in anxiety symptoms: 7-item General Anxiety Disorder scale (GAD-7)', 'description': 'The GAD-7 (Spitzer et al., 2006) assesses common anxiety symptoms in the last two weeks, scoring from 0 (\"not at all\") to 3 (\"nearly every day\"). Cut points of 5, 10, and 15 represent mild, moderate, and severe anxiety, respectively. The algorithm sets 8 as the cut point for GAD, however it has been found that a score of 10 is more optimal (Spitzer et al., 2006). We will use the version validated by Garc\u00eda-Campayo et al. (2010), that was recently tested in primary care centres (Cronbach\\'s \u03b1 = .83) (Mu\u00f1oz-Navarro, Cano-Vindel, Moriana et al., 2017), confirming the score of 10 as the best diagnostic criterion (sensitivity of 87% and specificity of 78%).', 'timeFrame': 'Baseline, immediately after the intervention, and follow-ups (6 and 12 months)'}\n- {'measure': 'Change in panic symptoms: Patient Health Questionnaire-Panic Disorder (PHQ-PD)', 'description': 'The PHQ-PD is the specific panic disorder module of the PHQ and scores each DSM-IV criterion as \"yes\" or \"no\" (Wittkampf et al., 2011). Mu\u00f1oz-Navarro et al. (2016) tested it in Spanish primary care settings and modified the original algorithm to increase the sensitivity for PD diagnosis: the most optimal cut-off point for screening purposes was 5 (the first item \\\\[for panic screening\\\\] and one of the following three, plus four somatic symptoms) (sensitivity of 77% and specificity of 72%).', 'timeFrame': 'Baseline, immediately after the intervention, and follow-ups (6 and 12 months)'}\n- {'measure': 'Change in somatoform symptoms: 15-item Patient Health Questionnaire (PHQ-15)', 'description': 'The PHQ-15 (Kroenke et al., 2002) is the somatization module of the PHQ. It includes 13 somatic symptoms plus 2 from the PHQ-9 (sleeping problems and fatigue). Scores of 5, 10, and 15 represent low, medium, and high somatic symptom severity, respectively. To screen a somatization disorder, whereas the original algorithm needs of at least a score of 2 in three or more somatic symptoms (sensitivity of 78% and specificity of 71%) (van Ravesteijn et al., 2009), the cut point usually used is 10; nevertheless, since this can be obtained with ten symptoms of mild severity, we decided to join both criteria to screen the disorder. Furthermore, an absence of biological cause is also often required (since PHQ-15 does not distinguish between medically explained and unexplained symptoms) (Kroenke et al., 2002), but the self-administered nature of the PHQ-15 makes difficult to determine this. The PHQ-15 has been validated with Spanish psychiatric outpatients (\u03b1 = .78) (Ros et al., 2010).', 'timeFrame': 'Baseline, immediately after the intervention, and follow-ups (6 and 12 months)'}\n\nPlease estimate the sample size based on the assumption: \nAn effect size of .3 (f value), a statistical power of .8, a significance level of .05, and a dropout rate of 15% were assumed.", "answer": 128, "answer_type": "ESTIMATED", "explanation": "Sample size\n We used effect sizes from the previous literature to determine the sample size. Corpas et al.\u00e2\u0080\u0099s primary care RCT [41] compared both group and individual brief tCBT with TAU for emotional disorders and found low to medium effect sizes for all outcomes. Individual effects were larger (Cohen\u00e2\u0080\u0099s d ranged from .54 to .74) than group effects (.4 to .63) when compared with TAU; however, there was no significant difference between both transdiagnostic formats, with (very) low effect sizes (.06 to .27). Another primary RCT by Corpas et al. [36] compared tCBT with TAU and found medium to large effect sizes (from .39 for depression to .81 for panic symptoms). Finally, the PsicAP study compared the group tCBT used herein to TAU in primary care. Intention-to-treat analyses showed low to medium effect sizes over time for depression (Morris\u00e2\u0080\u0099 d ranged from .36 to .58), anxiety (.38 to .65), and somatizations (.31 to .4). Subsequently, we decided to assume a medium effect size of .6 (Cohen\u00e2\u0080\u0099s d).\n Since software to determine sample sizes for linear mixed model analyses was not available, we used the f index of G*Power [52]. We assumed an effect size of .3 (the equivalent f value); a statistical power (1 - \u00ce\u00b2) of .8; and a significance level (\u00ce\u00b1) of .05, obtaining a required sample size of 111. However, to control withdrawals and take into account the abandonment rates in other similar trials [36, 41], we assumed a dropout rate of 15%, which brought the required sample size to 128.", "id": 1074, "split": "val"} +{"trial_id": "NCT04848077", "pmid": "37700241", "question": "Here is the design of a clinical trial:\n\nOfficial Title: STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life\n\nIncluded conditions:\n- Movement Disorders\n- Parkinson Disease\n\nStudy Armgroups:\n- {'label': 'Very high dose', 'type': 'EXPERIMENTAL', 'description': 'Very large proportional increase in stepcount relative to baseline stepcount.', 'interventionNames': ['Behavioral: Step count increase with the use of a motivational smartphone application']}\n- {'label': 'High dose', 'type': 'EXPERIMENTAL', 'description': 'Large proportional increase in stepcount relative to baseline stepcount.', 'interventionNames': ['Behavioral: Step count increase with the use of a motivational smartphone application']}\n- {'label': 'Intermediate dose', 'type': 'EXPERIMENTAL', 'description': 'Medium proportional increase in stepcount relative to baseline stepcount.', 'interventionNames': ['Behavioral: Step count increase with the use of a motivational smartphone application']}\n- {'label': 'Active controls', 'type': 'ACTIVE_COMPARATOR', 'description': 'Small proportional increase in stepcount relative to baseline stepcount.', 'interventionNames': ['Behavioral: Step count increase with the use of a motivational smartphone application']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Step count increase with the use of a motivational smartphone application', 'description': \"All participants will be given access to an application installed on the participants' own smartphone: the STEPWISE app. The STEPWISE app will encourage participants to increase their long-term physical activity (1 year). Different treatment arms will receive different physical activity goals. Participants will get feedback and support via the smartphone app, that stimulates them to reach their individual physical activity goal (i.e. target percentage increase in stepcount).\", 'armGroupLabels': ['Active controls', 'High dose', 'Intermediate dose', 'Very high dose']}\n\nPrimary Outcomes:\n- {'measure': 'Mean change in step count per day', 'description': \"Mean change in step count per day as measured continuously with the participant's smartphone from baseline (week -4 to 0) to follow-up (week 49-52). Higher scores indicate more physical activity (steps).\", 'timeFrame': 'Week -4 until 0 and week 49 until 52'}\n\nPlease estimate the sample size based on the assumption: \nAssuming an SD of 2000 steps, allowing for up to 20% loss to follow-up, the study will have greater than 90% power to detect a significant increase in step counts over one year based on a two-tailed test at p < 0.05.", "answer": 452, "answer_type": "ESTIMATED", "explanation": "Sample size\n The planned sample size is 452 participants. This sample size is based on a previous study of one-year change in step counts in a clinical trial evaluating the use of a smartphone application to increase physical activity of patients with chronic obstructive pulmonary disease (COPD) [37]. Vorrink, Kort [37] reported a person-to-person standard deviation (SD) of change in one-year step count of 1957 in the active arm and 1973 in the control arm [38]. With 452 participants randomized 1:1:1:1 to the treatment arms (active control or intermediate, large or very large dose group), assuming an SD of 2000 steps and allowing for up to 20% loss to follow-up, the study will have greater than 90% power to infer a significant increase in step counts over one year if the expected 52-week increase in steps in the very large dose group relative to the active control group is at least 1000 steps based on a two-tailed test at p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05 for this single primary comparison. One thousand steps is within the range of increases associated with exercise interventions among older adults and those with disabilities and chronic illness [39].", "id": 1075, "split": "val"} +{"trial_id": "NCT04848935", "pmid": "37879700", "question": "Here is the design of a clinical trial:\n\nOfficial Title: CURATE.AI Optimised Digital COgnitive Rehabilitation Therapy (COR-Tx) for Post Brain Radiotherapy Patients: CURATE.AI COR-Tx Mixed-methods Feasibility Clinical Trial\n\nIncluded conditions:\n- Cognitive Decline\n\nStudy Armgroups:\n- {'label': 'CURATE.AI', 'type': 'EXPERIMENTAL', 'description': 'A cognitive evaluation and a Digital Diagnostic (DD) session performed anytime before radiotherapy will serve as the baseline. After the radiotherapy treatment, which can last between 1 to 6.5 weeks, patients will have a variable recovery time (0 to 4 weeks). Subsequently, patients will be subject to a cognitive evaluation and a DD session, right before starting the Digital Intervention (DI) training. This training will comprise ten weeks of DI (three 10-15 minute sessions per week). Patients will complete cognitive evaluations and DD sessions at the end of DI, and 16 and 32 weeks after the end of DI.', 'interventionNames': ['Device: CURATE.AI']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'CURATE.AI', 'description': 'CURATE.AI will be utilised to provide personalised training intensity recommendations (low, medium or high) to the patients during the digital cognitive test battery DI session. The difficulty of each task will be modulated by CURATE.AI by adjusting the frequency of critical events that demand evaluation and/or response.', 'armGroupLabels': ['CURATE.AI']}\n\nPrimary Outcomes:\n- {'measure': 'Patient acceptability of the digital cognitive test battery DI/DD obtained during a semi-structured interview', 'description': 'Qualitative summary of patient acceptability of the digital cognitive test battery DI/DD', 'timeFrame': 'One visit 60 minutes (at the end of the 10 week intervention)'}\n- {'measure': 'Patient adherence to the DI/DD', 'description': 'Percentage of completed DI/DD sessions', 'timeFrame': 'up to 12 months'}\n- {'measure': 'Patient attrition rate to the DI/DD', 'description': 'Percentage of patients that drop out of DI/DD', 'timeFrame': 'up to 12 months'}\n- {'measure': 'Percentage of CURATE.AI profiles successfully created and applied', 'timeFrame': 'up to 12 months'}\n- {'measure': 'Timely delivery of DI/DD at indicated time points', 'description': 'Percentage of DI/DD sessions successfully delivered by study team at indicated time points', 'timeFrame': 'up to 12 months'}\n- {'measure': 'Digital intervention limited efficacy', 'description': 'Change in cognitive performance as measured by the standard of care cognitive evaluations pre-post digital intervention', 'timeFrame': 'up to 12 months'}\n- {'measure': 'Digital diagnostic limited efficacy', 'description': 'Correlation between standard of care cognitive evaluations scores and digital diagnostic scores', 'timeFrame': 'up to 12 months'}\n\nPlease estimate the sample size based on the assumption: \nNo formal assumptions on significance level, power, or missing/dropout rate were made.", "answer": 15, "answer_type": "ESTIMATED", "explanation": "Sample size\n We intend to recruit 15 participants for this study. As this is a feasibility clinical trial with no prior data, we did not perform formal sample size calculations. However, this sample size is based on the number of patients who can be practically and logistically recruited within the period of this feasibility trial that will allow for a reasonable signal to expand to a larger RCT.", "id": 1076, "split": "val"} +{"trial_id": "NCT04849130", "pmid": "35818060", "question": "Here is the design of a clinical trial:\n\nOfficial Title: DynMPFL - Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation\n\nIncluded conditions:\n- Patellar Instability\n\nStudy Armgroups:\n- {'label': 'Static reconstruction technique according to Sch\u00f6ttle', 'type': 'ACTIVE_COMPARATOR', 'description': 'Static reconstruction technique according to Sch\u00f6ttle', 'interventionNames': ['Procedure: Static reconstruction technique according to Sch\u00f6ttle']}\n- {'label': 'Dynamic reconstruction technique according to Becher', 'type': 'ACTIVE_COMPARATOR', 'description': 'Dynamic reconstruction technique according to Becher', 'interventionNames': ['Procedure: Dynamic reconstruction technique according to Becher']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Static reconstruction technique according to Sch\u00f6ttle', 'description': 'In static MPFL reconstruction, a graft (harvested autologous gracilis tendon or allogen transplant) is attached to the femoral and patellar bones using tunnels, screws, and/or anchors.', 'armGroupLabels': ['Static reconstruction technique according to Sch\u00f6ttle']}\n- {'type': 'PROCEDURE', 'name': 'Dynamic reconstruction technique according to Becher', 'description': 'Dynamic MPFL procedure by detaching and reinserting only the distal part of a hamstring muscle to the patella and leaving the proximal tendon attached to its muscle. This way the patella position can be adjusted dynamically by hamstring contraction.', 'armGroupLabels': ['Dynamic reconstruction technique according to Becher']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Kujala score', 'description': 'Patient reported knee function and anterior knee pain as assessed with the Kujala score at preoperative screening, at the hospitalization time and four postoperative follow ups . The Kujala scale consists of 13 questions covering a range of physical symptoms and limitations that are presented in a multiple choice answer format, with a different point value assigned to each answer. The maximum score is 100, with higher scores indicating better function.', 'timeFrame': 'up to 24 months'}\n\nPlease estimate the sample size based on the assumption: \n80% power, 5% significance level, and a 10% dropout rate.", "answer": 60, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We based our sample size calculation on the primary outcome, the Kujala score. To date, no high-quality study (randomized trial) on the difference in change in Kujala score between dynamic and static MPFL reconstruction is available. However, in a prospective randomized control trial, Kang et al. [56] compared two different tensioning techniques for static MPFL reconstruction. They reported an effect size of 7.8 for the improvement in the Kujala score for both groups and a group difference in change in Kujala score of 1.9. Based on biomechanical considerations, we expect a larger improvement in patients stabilized using the dynamic MPFL reconstruction. Assuming a 3.8-point improvement in the Kujala score in patients with dynamic MPFL reconstruction compared to patients with static MPFL reconstruction, 54 patients (27 per group) are required to detect a significant difference in change in Kujala score between the two groups with 80% power at a significance level of 5%. We expect a dropout rate of about 10%, and will thus we will target a study cohort of 60 patients (30 per group).", "id": 1077, "split": "val"} +{"trial_id": "NCT04850300", "pmid": "38719321", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses\n\nIncluded conditions:\n- Total Knee Arthroplasty\n\nStudy Armgroups:\n- {'label': 'Total knee prosthesis 1', 'type': 'EXPERIMENTAL', 'description': 'prosthesis with medial condylar stabilization', 'interventionNames': ['Procedure: Total knee prosthesis with medial condylar stabilization']}\n- {'label': 'Total knee prosthesis 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'traditional prosthesis with central pivot stabilization', 'interventionNames': ['Procedure: Total knee prosthesis with central pivot stabilization']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Total knee prosthesis with medial condylar stabilization', 'description': 'Surgery will be done of Total knee prosthesis with medial condylar stabilization', 'armGroupLabels': ['Total knee prosthesis 1']}\n- {'type': 'PROCEDURE', 'name': 'Total knee prosthesis with central pivot stabilization', 'description': 'Surgery will be done of Total knee prosthesis with central pivot stabilization', 'armGroupLabels': ['Total knee prosthesis 2']}\n\nPrimary Outcomes:\n- {'measure': 'Maximum walking speed (MWS)', 'description': 'Maximum distance traveled by the body per unit of time (m\u00b7s-1). It will ask for participants to walk safely and as quickly as possible, without running, in a 10 m, straight and flat walkway. The two first and last stride will be discarded from the analysis in order to avoid the acceleration and deceleration of the star and end of the gait. The gait speed will be measured with the NedAMH/IBV v5.6 (Institute of Biomechanics of Valencia, Spain) software which uses two infrared or red light photocells to measured gait speed. This outcome will be measured in all the assessment times of the study.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nA statistical significance level of 5% (two-tailed) and a power of 90%, with an expected dropout rate of 20%.", "answer": 99, "answer_type": "ESTIMATED", "explanation": "Sample size and recruitment\n The sample size was determined using G*Power V.3.1. Due to the lack of previous studies with a similar methodology to that proposed in this protocol, the sample size estimation was based on the expected differences on gait between two participant groups who received two different prosthetic at 6-month follow-up post-TKA,32 in whose work the medial stabilisation model proposed in this protocol is used. A small-medium effect (f=0.15), a statistical significance of 5% at the two-tailed level and a power of 90% are set, which gives a total of 82 people to be recruited. If 20% of the possible dropouts are considered, the initial recruitment will be of 99 people. From the beginning of the study, the coordinating researcher and head of the Orthopedic Surgery and Traumatology Service has reviewed the scheduled surgeries and asks each patient with scheduled TKA if they are interested in participating. All patients who show interest are informed, and the criteria for participation in their usual pre-surgical trauma appointment are evaluated. The study recruitment period will remain open for 1 year.", "id": 1078, "split": "val"} +{"trial_id": "NCT04851015", "pmid": "35863836", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia\n\nIncluded conditions:\n- Pneumocystis\n- Pneumocystis Pneumonia\n- Pneumocystis Jirovecii Infection\n- Pneumocystis Infections\n- Pneumocystis Carinii Infection\n- Pneumocystosis; Pneumonia (Etiology)\n- Pneumocystis Carinii; Infection, Resulting From HIV Disease\n- Pneumocystosis Associated With AIDS\n\nStudy Armgroups:\n- {'label': 'Reduced dose TMP-SMX', 'type': 'EXPERIMENTAL', 'description': 'Trimethoprim-Sulfamethoxazole at a total dose of 10mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as a dose of 10mg/kg/day open label with additional placebo tablets or intravenous placebo solution given to simulate 15mg/kg/day. All doses will be adjusted for obesity and renal function.', 'interventionNames': ['Drug: trimethoprim-sulfamethoxazole']}\n- {'label': 'Standard dose TMP-SMX', 'type': 'ACTIVE_COMPARATOR', 'description': 'Trimethoprim-Sulfamethoxazole at a total dose of 15mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as 10mg/kg/day open label plus an extra masked 5mg/kg/day of tablets or intravenous solution. All doses will be adjusted for obesity and renal function.', 'interventionNames': ['Drug: trimethoprim-sulfamethoxazole']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'trimethoprim-sulfamethoxazole', 'description': '10mg/kg/day of TMP component', 'armGroupLabels': ['Reduced dose TMP-SMX'], 'otherNames': ['Reduced dose']}\n- {'type': 'DRUG', 'name': 'trimethoprim-sulfamethoxazole', 'description': '15mg/kg/day of TMP component', 'armGroupLabels': ['Standard dose TMP-SMX'], 'otherNames': ['Standard dose']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion with Treatment failure', 'description': 'Composite of death, new mechanical ventilation or treatment change for presumed inefficacy or severe adverse events', 'timeFrame': '21 days'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes 80% power and a two-tailed alpha error probability of 0.05 for superiority. For non-inferiority, a one-sided 95% CI with an upper limit excluding a difference in favor of the high dose group of more than 5% is assumed.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary effectiveness endpoint for this study is a composite of death, new mechanical ventilation or change in treatment by day 21. In accordance with our meta-analysis, 20% of patients on conventional dose of TMP-SMX experienced death.49 Various published studies have shown estimates varying from 14%58 to 30%59 on this dose requiring mechanical ventilation. Conversely, a meta-analysis showed mortality of 9% among the low-dose treatment group.49 Estimates of mechanical ventilation are sparse in the low-dose group; between 0%58 and 34%.60 An observational study of 104 patients reported an Intensive Care Unit admission rate (with and without mechanical ventilation) of 17% in a low-dose group.32 Therefore, based on unpublished data collected at the MUHC, our meta-analysis, and previously published observational studies and RCTs, we estimate that the composite endpoint will occur in approximately 40% of patients administered the standard dose and 20%\u00e2\u0080\u009325% of those taking reduced dose. To detect an absolute difference of 15% in event rate (40% in the standard dose group vs 25% in the reduced dose group) with 80% power and a two-tailed alpha error probability of 0.05, we will require a total sample size of 300 participants (n=150 per arm) to obtain an objective of superiority. We have an interest in establishing non-inferiority should a superiority trial fail to detect a significant difference between dosage groups.61 We will prespecify a prospectively defined margin of 5% for non-inferiority. Assuming there is a true difference in favour of the reduced dose treatment of 9% (eg, 40% vs 31%), a total of 288 (n=144 per arm) patients will be required for 80% power to ensure that the upper limit of a one-sided 95% CI will exclude a difference in favour of the high dose group of more than 5%.", "id": 1079, "split": "val"} +{"trial_id": "NCT04852367", "pmid": "37741968", "question": "Here is the design of a clinical trial:\n\nOfficial Title: PanDox: Feasibility of Enhanced Chemotherapy Delivery to Non-resectable Primary Pancreatic Tumours Using Thermosensitive Liposomal Doxorubicin (ThermoDox\u00ae) and Focused Ultrasound\n\nIncluded conditions:\n- Pancreatic Ductal Adenocarcinoma\n- Pancreatic Cancer Stage IV\n- Pancreatic Cancer Non-resectable\n- Pancreatic Cancer Metastatic\n\nStudy Armgroups:\n- {'label': 'Arm A (Doxorubicin)', 'type': 'ACTIVE_COMPARATOR', 'description': 'a single intravenous dose of Doxorubicin, 50 mg/ m2 in 250 mL of normal saline or 5% dextrose over a 30-min infusion is delivered as per local practice.', 'interventionNames': ['Drug: Doxorubicin']}\n- {'label': 'Arm B (ThermoDox + Focused Ultrasound)', 'type': 'EXPERIMENTAL', 'description': 'under general anaesthetic, patients receive FUS, which is moved through the target tumour volume to raise the bulk tumour temperature above the thermal release threshold. At presumed target temperature, a single intravenous dose of ThermoDox\u00ae, 50 mg/ m2 in 250 mL of normal saline or 5% dextrose over a 30-min infusion is delivered concurrently to FUS, in line with the pharmacy manual provided by the manufacturer. FUS will continue following infusion, for no longer than two hours from infusion commencing.', 'interventionNames': ['Device: Focused Ultrasound', 'Drug: ThermoDox']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Focused Ultrasound', 'description': 'Focused ultrasound targetting the tumour at subablative powers, to facilitate drug release', 'armGroupLabels': ['Arm B (ThermoDox + Focused Ultrasound)']}\n- {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Doxorubicin infusion', 'armGroupLabels': ['Arm A (Doxorubicin)']}\n- {'type': 'DRUG', 'name': 'ThermoDox', 'description': 'ThermoDox infusion', 'armGroupLabels': ['Arm B (ThermoDox + Focused Ultrasound)']}\n\nPrimary Outcomes:\n- {'measure': 'To quantify the enhancement in intratumoural doxorubicin concentration when delivered with ThermoDox\u00ae and mild hyperthermia generated non-invasively by focused ultrasound (FUS) compared to free drug alone', 'description': 'A statistically significant enhancement in concentration of total intra-tumoural doxorubicin from tumour biopsies at the targeted tumour site receiving drug with FUS compared to drug alone. Quantification of inter-tumoural drug release will be achieved using a GLP HPLC (High Pressure Liquid Chromatography) assay', 'timeFrame': 'within 30 hours of intervention'}\n\nPlease estimate the sample size based on the assumption: \nStatistically meaningful enhanced drug delivery will be demonstrated using an unpaired t-test.", "answer": 0, "answer_type": "ACTUAL", "explanation": "Sample size\n The PanDox study is intended to recruit 18 evaluable participants. This sample size reflects that this is a Phase I study and is in line with the available funding resources and likely recruitment rates. Using estimates of mean tissue doxorubicin and standard deviation from the TARDOX trial [10], the participant number is predicted to be large enough to demonstrate statistically meaningful enhanced drug delivery using an unpaired t-test. Additionally, the sample size is small enough to ensure that participants are not unnecessarily recruited and exposed to potential side effects.", "id": 1080, "split": "val"} +{"trial_id": "NCT04855578", "pmid": "35820684", "question": "Here is the design of a clinical trial:\n\nOfficial Title: GABA-WHY Study: Deprescription of Gabapentinoids in Medical Inpatients\n\nIncluded conditions:\n- Polypharmacy\n- Gabapentin\n- Pregabalin\n\nStudy Armgroups:\n- {'label': 'Usual Medical Care', 'type': 'NO_INTERVENTION', 'description': 'During the control period, patients admitted to the study sites who qualify for the trial will receive a pharmacy medication reconciliation as part of usual medical care. Study participants will be informed that the goal of the trial is to evaluate medication use and medication changes after discharge, but they will not be informed that gabapentinoids are specifically being targeted. Medical staff will not receive specific information about the trial, or particular instructions with regards to deprescription during the control period.'}\n- {'label': 'In-Hopsital Patient Educational Brochure and Physician Education about Gabapentinoid Prescription', 'type': 'EXPERIMENTAL', 'description': 'During the intervention period, patients admitted to the study sites who qualify for the trial will receive an in-hospital educational brochure. Additionally, the medical team will attend an educational session about gabapentinoid prescription.', 'interventionNames': ['Other: In-Hopsital Patient Educational Brochure', 'Other: Physician Education about Gabapentinoid Prescription']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'In-Hopsital Patient Educational Brochure', 'description': \"The participant's medication list will be identified from the pharmacy database and validated with the participant's best possible medication history taken at time of admission by a pharmacist. Eligibility will be confirmed by the participant's treating medical team with support from the study investigators. Participants who are enrolled during the intervention phase will receive an educational brochure about the risks of chronic gabapentinoid use, and about how to safely discontinue use. The brochure is written using a sixth-grade vocabulary and has been validated in both English and French for comprehension and readability, including for people with mild cognitive impairment.\", 'armGroupLabels': ['In-Hopsital Patient Educational Brochure and Physician Education about Gabapentinoid Prescription']}\n- {'type': 'OTHER', 'name': 'Physician Education about Gabapentinoid Prescription', 'description': 'An educational session about the purpose of the study and risks of gabapentinoid prescription will be delivered to physicians (staff and medical residents) on each study unit at both sites during the intervention period. The educational session will include a presentation by the chief of the medical service at the monthly teaching rounds, and an electronic message will be sent to all physicians on the medical service. Physicians will also be presented a brief overview of the educational brochure.', 'armGroupLabels': ['In-Hopsital Patient Educational Brochure and Physician Education about Gabapentinoid Prescription']}\n\nPrimary Outcomes:\n- {'measure': 'Gabapentinoid Discontinuation or Dose Reduction With Intention to Stop', 'description': 'Proportion of study participants with a gabapentinoid prescription stopped or decreased with intention to stop at the time of follow-up', 'timeFrame': '8-weeks post-hospital discharge'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation allows for a 2-sided type 1 error of 5%, a type 2 error of 20%, and accounts for a 15% loss to follow-up.", "answer": 160, "answer_type": "ACTUAL", "explanation": "Sample sizeThe estimated sample size is 160 participants, with a 1:1 distribution between the intervention and control groups. The control period event rate (gabapentinoid deprescription at 8 weeks postdischarge) is expected to be 13%.15 We calculated the sample size to detect an absolute increase of 20% in deprescription rates (number needed to treat of 5), allowing for a 2-sided type 1 error of 5% and a type 2 error of 20% (132 subjects), and accounting for 15% loss to follow-up, including death in hospital and after discharge (156 subjects, rounded to 160). Given previous trial results showing that educational brochures for benzodiazepines can lead to an absolute increase of 43% in deprescription rates among medical inpatients (number needed to treat of 3),18 an absolute increase in deprescription rates of 20% was thought to be a reasonable target in this trial.", "id": 1081, "split": "val"} +{"trial_id": "NCT04857632", "pmid": "38908848", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Statin for Neuroprotection in Spontaneous Intracerebral Hemorrhage\n\nIncluded conditions:\n- Intracerebral Hemorrhage\n- Statins\n\nStudy Armgroups:\n- {'label': 'Statins group', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Statin']}\n- {'label': 'Control group', 'type': 'NO_INTERVENTION'}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Statin', 'description': 'atorvastatin 20mg per day for 7 days', 'armGroupLabels': ['Statins group']}\n\nPrimary Outcomes:\n- {'measure': 'Perihemorrhagic edema to hematoma ratio', 'timeFrame': '7 days'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u00ce\u00b1) is set at 0.05, power (1-\u00ce\u00b2) is 90%, the test is two-sided, and the sample size ratio between the two groups is 1:1. A dropout rate of 20% or less is considered.", "answer": 98, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n Applying PASS software for sample size estimation, this study is a randomised controlled study of two independent samples mean comparison, set the test level \u00ce\u00b1=0.05, test efficacy 1\u00e2\u0088\u0092\u00ce\u00b2=90%, \u00ce\u00b2 is two sided, the ratio of the sample size of the two groups is set as 1:1. Referring to the results of a clinical trial study published by our research group,17 the mean rPHE of ICH patients in the control group was 2.02 at 7\u00e2\u0080\u0089days after enrolment, and the variance was 0.27. In this study, assuming that the mean rPHE in the statin treatment group decreased by about 10%, the PASS software estimated N1=39, N2=39 and N=78. As such, the minimum sample size was 78 patients. Considering a dropout rate of 20% or less, the overall sample size was estimated to be 98 cases.", "id": 1082, "split": "val"} +{"trial_id": "NCT04861688", "pmid": "35418437", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Double-blind, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of NeuroAiD II\u2122 (MLC901) to Improve Cognitive Functioning in Non-surgical Mild Traumatic Brain Injury Patients\n\nIncluded conditions:\n- Traumatic Brain Injury\n\nStudy Armgroups:\n- {'label': 'NeuroAiD II\u2122 (MLC901)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Recommended treatment is 2 capsules orally, 3 times a day (i.e. 6 capsules per day). Treatment is 12 weeks.', 'interventionNames': ['Combination Product: Traditional Chinese Medicine (NeuroAiD II\u2122 (MLC901)']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Capsule 2 capsules orally, 3 times a day', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'Traditional Chinese Medicine (NeuroAiD II\u2122 (MLC901)', 'description': \"NeuroAiD II\u2122 (MLC901) contains the extracts of 9 botanical active ingredients blended with commonly used excipients. The 9 botanical active ingredients are traditional herbs well documented in the Pharmacopoeia of the People's Republic of China.\", 'armGroupLabels': ['NeuroAiD II\u2122 (MLC901)']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo with same appearance as active intervention', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Central Nervous System Vital Signs (CNS-VS), Domain score: Complex Attention', 'description': 'Change in complex attention score, determined using Central Nervous System Vital Signs (CNS-VS) computer cognitive testing system, after 6 months of treatment compared to baseline in the group of patients receiving NeuroAiD II\u2122 (MLC901), compared to the placebo group.\\n\\nIn the domain dashboard, above average domain scores indicate a Standard Score (SS) greater than 109 or a Percentile Rank (PR) greater than 74, indicating a high functioning test subject. Average is a SS 90-102 or PR 25-74, indicating normal function. Low average is SS 80-99 or PR 9-24 indicating a slight deficit or impairment. Below average is SS 70-79 or PR 2-8, indicating moderate level of deficit or impairment. Very low is SS less than 70 or a PR less than 2, indicating a deficit and impairment. Lower score is better for Complex Attention.', 'timeFrame': '6 months of treatment compared to baseline'}\n\nPlease estimate the sample size based on the assumption: \nTarget power: 80%. Two-sided significance level: 5%. Hypotheses: H0: MT\u2265MR, H1: MT50 percent central vein diameter reduction (stenosis) using CT venography', 'timeFrame': '1.5-3 months after the catheterization'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level: one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval), Power: 80%, Missing/dropout rate: 50%.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Sample size calculation for the primary outcome was performed using an online calculator (https://www.sealedenvelope.com/power/binary-noninferior/) based on results of a previous study [3] that demonstrated a CVS incidence of 10% after tCDC insertion in the internal jugular vein. The rate of stenosis events in historical data has ranged from 10% for the jugular vein to 42% for the subclavian vein. Given the perceived and shown advantages with subclavian lines (less infections/thrombosis, more comfortable for the patient during insertion and use), we chose a 15% noninferiority margin as this is less than half the absolute difference, is judged to be clinically acceptable and results in a reasonable sample size. Calculations revealed that 50 patients per group are needed to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favour of the standard group. In order to have 100 patients perform the CT venography for the per-protocol analysis, at least 200 patients will probably have to be included in the trial. Important differences found between the treatment groups (in terms of how many that did not complete the protocol) will be reported.", "id": 1085, "split": "val"} +{"trial_id": "NCT04874038", "pmid": "38773653", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)\n\nIncluded conditions:\n- Post-mastectomy Pain Syndrome\n- Breast Cancer\n- Pain, Postoperative\n- Pain, Chronic\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Intraoperative intravenous lidocaine/placebo infusion', 'interventionNames': ['Drug: Lidocaine 20mg/ml']}\n- {'label': 'Control', 'type': 'PLACEBO_COMPARATOR', 'description': 'Intraoperative intravenous lidocaine/placebo infusion', 'interventionNames': ['Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Lidocaine 20mg/ml', 'description': 'Patients in the intervention group will receive an IV lidocaine infusion using a dosage regimen of 1.5 mg/kg bolus of a 2% lidocaine solution with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room).', 'armGroupLabels': ['Intervention'], 'otherNames': ['Lidocaine 2%']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution) until the end of surgery (and up to 30 minutes into recovery room).', 'armGroupLabels': ['Control'], 'otherNames': ['0.9% sodium chloride solution']}\n\nPrimary Outcomes:\n- {'measure': 'Development of persistent pain 3-months after breast cancer surgery', 'description': 'Persistent pain at 3-months', 'timeFrame': '3- months'}\n\nPlease estimate the sample size based on the assumption: \nThe trial aims for 90% power to detect the effect with a two-sided significance level (\u03b1) of 0.05 and accounts for a 10% loss-to-follow-up rate.", "answer": 1602, "answer_type": "ESTIMATED", "explanation": "Sample size\n Only a few prospective studies provide data on the prevalence of persistent pain at 3\u00c2\u00a0months after breast cancer surgery, with estimates ranging from 33 to 82% [32, 34, 49, 73, 74]. The largest study (n\u00e2\u0080\u0089=\u00e2\u0080\u0089150) reported a 33% prevalence at 3 months; however, only 84 (56%) patients provided follow-up data. Our pilot (n\u00e2\u0080\u0089=\u00e2\u0080\u0089100), conducted at two Canadian centers, found a prevalence of persistent pain of 58.3% (95% CI 38.6 to 78.1%) in the control group at 3 months. Furthermore, our pilot found a 32% relative risk reduction (RRR) with the use of IV lidocaine, whereas Grigoras et al. [32] and Kim et al. [34] found a 75 and a 50% RRR at 3 months, respectively. We believe these RRR estimates are likely overestimations of the true treatment effect given the small size of the trials, the multiple pathogenic mechanisms involved, and the rarity of such large effect sizes in the medical literature [75, 76] and within chronic pain prevention trials [77].\n We have therefore chosen to design our trial to identify a plausible, but clinically important, 25% RRR while using 30% as the control group pain prevalence at 3 months. To achieve 90% power to detect in a two-sided comparison with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, and 10% loss-to follow-up, we will need a sample of 1602 participants. For a fixed RRR, power increases as the control group prevalence increases. This sample size also provides adequate power to inform realistic RRRs in important but less common secondary outcomes such as presence of moderate-to-severe pain. For example, based on a control group prevalence of moderate-to-severe pain of 16% in our pilot, we have 80% power to detect a RRR of 31% or greater.", "id": 1086, "split": "val"} +{"trial_id": "NCT04874246", "pmid": "36115677", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Diluted VAsopressin During Robot-assisted Laparoscopic myomEctomy for dimiNishing Blood Loss According To the Dilution Concentration of Normal salINE: a Randomized Controlled Pilot Study\n\nIncluded conditions:\n- Uterine Leiomyoma\n\nStudy Armgroups:\n- {'label': 'Diluted Vasopressin Group 1', 'type': 'ACTIVE_COMPARATOR', 'description': 'During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 50 ml of normal saline to make a total of 100 ml) was injected before uterine serosal incision.', 'interventionNames': ['Drug: Vasopressin']}\n- {'label': 'Diluted Vasopressin Group 2', 'type': 'ACTIVE_COMPARATOR', 'description': 'During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 200 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.', 'interventionNames': ['Drug: Vasopressin']}\n- {'label': 'Diluted Vasopressin Group 3', 'type': 'ACTIVE_COMPARATOR', 'description': 'During robot-assisted laparoscopic myomectomy, diluted vasopressin (a solution prepared by mixing 20 units of vasopressin with 400 ml of normal saline to make a total of 100 m) was injected before uterine serosal incision.', 'interventionNames': ['Drug: Vasopressin']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Vasopressin', 'description': 'During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.', 'armGroupLabels': ['Diluted Vasopressin Group 1', 'Diluted Vasopressin Group 2', 'Diluted Vasopressin Group 3'], 'otherNames': ['Vasopressin 20U']}\n\nPrimary Outcomes:\n- {'measure': 'Estimated blood loss (EBL) during operation', 'description': 'The volume of blood loss will be estimated by using simple visual assessment technique referring to irrigation bottle', 'timeFrame': 'during operation'}\n\nPlease estimate the sample size based on the assumption: \nA 10% drop-out rate is assumed. Statistical analyses will use SPSS software V.25.0. Measurement data will be described in mean and SD or median and IQR, and categorical variables as number and percentage. The Kruskal-Wallis H test will analyze the difference in blood loss between the three groups. The incidence of side effects will be compared using the \u03c72 test or Fisher\u2019s exact test. A p<0.05 is considered statistically significant.", "answer": 39, "answer_type": "ACTUAL", "explanation": "Sample size\n Since this study is conducted as a pilot study, we did not separately calculate the sample size. The present pilot study examines the feasibility of a full randomised clinical trial of proper dilution level of vasopressin for RALM and determines the effect size for further large-scale studies. Based on a previous report, we plan to allocate 12 subjects per group for randomisation, and a total of 36 subjects are required.23 With a 10% drop-out rate and 1 subject per group, we aim to target 39 subjects.\n \n Statistical methods\n For the statistical analyses, we will use SPSS software V.25.0 (SPSS). Measurement data will be described in mean and SD or median and IQR, and categorical variables as number and percentage. The difference in blood loss between the three groups was analysed using the Kruskal-Wallis H test. The incidence of side effects between each group is compared and evaluated using the \u00cf\u00872 test or Fisher\u00e2\u0080\u0099s exact test. A p<0.05 is considered statistically significant.\n \n \n Ethics and dissemination\n The Institutional Review Board has approved this pilot study of the Seoul National University Hospital (No. H-2011-107-1174). The current protocol version is 1.3. Even though vasopressin has already been approved for marketing and is used in clinical practice, the use of vasopressin to reduce bleeding in myomectomy has not been approved up to now. Thus, this clinical trial has been separately approved by the Korean Ministry of Food and Drug Safety (No. 33696).\n The confidentiality of personal information will be protected. All of the personal identification information will be deleted. Each participant is assigned a study identification number at enrolment. Data will be handled by the study identification number. Before participation, patients will receive detailed information about the purpose and possible consequences of the trial. Written informed consent will be obtained from each participant before enrolment by the investigators. Finally, the results of this study will be published in peer-reviewed journals and be presented at academic conferences.\n \n \n Patient and public involvement\n Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.", "id": 1087, "split": "val"} +{"trial_id": "NCT04874688", "pmid": "36585147", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Child Health, Agriculture and Integrated Nutrition (CHAIN): a Randomized Trial to Close the Nutrient Gap in Rural Zimbabwe\n\nIncluded conditions:\n- Stunting\n\nStudy Armgroups:\n- {'label': 'IYCF-Only', 'type': 'ACTIVE_COMPARATOR', 'description': 'Infants in the IYCF-only arm will receive white maize and SQ-LNS daily from 6 months of age, and the primary caregiver will receive a series of behaviour-change modules delivered by village health workers.', 'interventionNames': ['Dietary Supplement: Small-quantity lipid-based nutrient supplement', 'Dietary Supplement: White maize meal']}\n- {'label': 'IYCF-Plus', 'type': 'EXPERIMENTAL', 'description': 'Infants in the IYCF-plus arm will receive orange provitamin A-fortified maize and SQ-LNS daily from 6 months of age, plus powdered NUA-45 sugar beans, moringa leaf powder, and powdered whole egg; and the primary caregiver will receive a series of behaviour-change modules delivered by village health workers.', 'interventionNames': ['Dietary Supplement: Small-quantity lipid-based nutrient supplement', 'Dietary Supplement: Provitamin A biofortified maize', 'Dietary Supplement: NUA-45 biofortified sugar beans', 'Dietary Supplement: Moringa oleifera', 'Dietary Supplement: Whole egg powder']}\n\nInterventions:\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Small-quantity lipid-based nutrient supplement', 'description': 'Small Quantity Lipid-based Nutrient Supplement (SQ-LNS) is a food supplement rich in both macro and micronutrients (calories, proteins, fat and multivitamin mix). SQ-LNS is not considered a regulated drug product in Zimbabwe, or by the United States Food and Drug Administration (FDA). It is commercially available for prevention of chronic malnutrition, produced by Nutriset (https://www.nutriset.fr/products/en/enov-nutributter2). Each child will receive a daily sachet of 20g SQ-LNS between 6-12 months of age, consumed directly from the sachet or mixed with porridge.', 'armGroupLabels': ['IYCF-Only', 'IYCF-Plus']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Provitamin A biofortified maize', 'description': 'Provitamin A Maize Meal is orange maize-meal processed from provitamin A-rich orange maize. PVA maize meal will be sourced from International Maize and Wheat Improvement Centre (CIMMYT). Children in the intervention arm will consume 13g - 128g of pro-vitamin A (PVA) maize meal, with added powders. Each family will receive a monthly ration of 5kg PVA maize and this ration takes into consideration of household sharing. Families with children in the IYCF arm will receive white maize meal.', 'armGroupLabels': ['IYCF-Plus'], 'otherNames': ['Orange maize']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'NUA-45 biofortified sugar beans', 'description': 'NUA 45 bean powder is ground from roasted iron and zinc-rich biofortified sugar beans. NUA 45 bean powder will be sourced from Sky Brands Ltd Company. Children will consume a daily dose of 5g - 15g of NUA 45 bean powder added to complementary foods.', 'armGroupLabels': ['IYCF-Plus']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Moringa oleifera', 'description': 'Moringa oleifera is an edible plant abundant in dry tropic regions including Zimbabwe. It is known to be rich in micronutrients and has been widely used in Zimbabwe and around the world both as a food and a herb. Moringa oleifera leaf powder, is a dried and ground powder produced from Moringa oleifera leaves using traditional methods. It has been widely used to fortify complementary foods in the African region with the aim of improving micronutrient status. Moringa oleifera leaf powder will be sourced from Lemex Products Company. Children will receive a daily dose of 5g - 15g of Moringa leaf powder added to complementary foods.', 'armGroupLabels': ['IYCF-Plus'], 'otherNames': ['Moringa leaf powder']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Whole egg powder', 'description': 'Egg Powder is hydrolysed non-genetically modified organism (GMO), fine and unflavoured whole egg powder. It is processed with no additives, preservatives, lecithin, added sugar, soy or monosodium glutamate. Egg powder will be sourced from France (A \\\\& D Food Ingredients - distributor in South Africa). Children in the IYCF-plus arm will receive a daily dose of 14g egg powder. A 15% extra amount of egg powder will be provided to families taking into consideration of household sharing. Egg powder will be provided in sealed plastic jars similar to that of peanut butter and households will receive promotion messages to store the powder in a cool, dry place and avoiding contact with water or moisture during use.', 'armGroupLabels': ['IYCF-Plus']}\n- {'type': 'DIETARY_SUPPLEMENT', 'name': 'White maize meal', 'description': 'Commercial white maize meal will be provided monthly. Infants age 6-8 months will receive 45g (3 tablespoons) daily; infants aged 9-12 months will receive 71g (4.5 tablespoons) daily.', 'armGroupLabels': ['IYCF-Only']}\n\nPrimary Outcomes:\n- {'measure': 'Energy intake', 'description': 'Percentage of infants meeting daily energy requirements, measured by multi-pass 24-hour dietary recall,', 'timeFrame': '9 months of age (window 9-11 months)'}\n\nPlease estimate the sample size based on the assumption: \n86% power at 5% significance level, with a 10% lost to follow-up rate; 80% power if lost to follow-up is 15%.", "answer": 192, "answer_type": "ACTUAL", "explanation": "Sample size\n The sample size of 192 infants assumes 10% lost to follow-up due to withdrawal and infant deaths, meaning there will be an estimated 86 evaluable infants per group at endline. This sample size provides 86% power at 5% significance to detect a 20% increase in the proportion of infants achieving their recommended energy intake (by 24-hour dietary recall) in the IYCF-plus arm, assuming that only 65% of infants are meeting requirements in the IYCF (standard-of-care) arm based on SHINE data. If lost to follow-up is as high as 15%, we will still have 80% power to detect a 20% increase in the proportion reaching their daily energy intake (study primary outcome).", "id": 1088, "split": "val"} +{"trial_id": "NCT04875325", "pmid": "38902836", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Recurrent Disease Detection After Resection of Pancreatic Adenocarcinoma Using a Standardized Surveillance Strategy: a Nationwide Randomized Controlled Trial\n\nIncluded conditions:\n- Resectable Pancreatic Ductal Adenocarcinoma\n- Recurrent Pancreatic Ductal Adenocarcinoma\n\nStudy Armgroups:\n- {'label': 'Standardized surveillance', 'type': 'EXPERIMENTAL', 'description': 'Standardized surveillance strategy with routine imaging and serum tumor marker testing.', 'interventionNames': ['Other: Standardized surveillance']}\n- {'label': 'Non-standardized surveillance', 'type': 'NO_INTERVENTION', 'description': 'Non-standardized surveillance strategy according to current clinical practice.'}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Standardized surveillance', 'description': 'Standardized 3-monthly surveillance with routine imaging and serum tumor marker testing.', 'armGroupLabels': ['Standardized surveillance']}\n\nPrimary Outcomes:\n- {'measure': 'Overall survival', 'description': 'The interval between the date of PDAC resection and either death from any cause or last follow-up.', 'timeFrame': 'From date of PDAC resection until date of death from any cause or date of last follow-up, whichever came first, assessed up to 24 months'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 80%, a 0.05 two-sided significance level, a drop-out rate of 1%, a baseline event rate of 3.5%, and a follow-up duration of 30 months.", "answer": 306, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n A retrospective study by Elmi et al. demonstrated that the median overall survival after primary tumor resection was 30.4\u00c2\u00a0months in 163 patients who received routine imaging surveillance, as compared with 17.1\u00c2\u00a0months in 66 patients receiving clinical follow-up without imaging [32]. Data from 1580 patients who underwent PDAC resection between 2014 and 2019 within the Netherlands showed a median overall survival of 33.6\u00c2\u00a0months (95% confidence interval (CI) 29.4\u00e2\u0080\u009338.2\u00c2\u00a0months) in 284 patients who received routine follow-up imaging and 20.8\u00c2\u00a0months (95% CI 19.8\u00e2\u0080\u009322.6\u00c2\u00a0months) in 1296 patients undergoing a symptomatic follow-up approach without routine imaging (Fig.\u00c2\u00a02). Combining these outcomes results in an expected median survival of 32.0\u00c2\u00a0months vs. 19.0\u00c2\u00a0months for patients in the intervention and control arm of the RADAR-PANC trial, respectively.Fig.\u00c2\u00a02Kaplan\u00e2\u0080\u0093Meier curve comparing overall survival between patients with routine follow-up imaging and symptomatic follow-up in the Netherlands between 2014\u00e2\u0080\u00932019 (unpublished data)\n As we expect 80% of patients to accept the experimental intervention offered in the intervention arm of the study, an estimated refusal rate of 20% needs to be taken into account. This leads to a decrease of the overall survival to 29.4\u00c2\u00a0months (80%\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u008932.0\u00c2\u00a0months\u00e2\u0080\u0089+\u00e2\u0080\u008920%\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u008919.0\u00c2\u00a0months) for patients in the intervention arm. Moreover, despite that current non-standardized follow-up in daily clinical practice mainly results in a symptomatic follow-up approach without routine imaging, data from our recurrence database showed that 85/1580 patients (5%) did nonetheless receive routine follow-up imaging based on shared-decision making (the remaining 199/284 patients (70%) who received routine follow-up imaging participated in a clinical study with a study-specific follow-up including routine imaging). This results in a slight increase of the suspected overall survival in the control arm to 19.7\u00c2\u00a0months (95%\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u008919.0\u00c2\u00a0months\u00e2\u0080\u0089+\u00e2\u0080\u00895%\u00e2\u0080\u0089\u00c3\u0097\u00e2\u0080\u008932.0\u00c2\u00a0months). The clinically relevant survival difference of 29.4\u00c2\u00a0months vs. 19.7\u00c2\u00a0months for the intervention and control arm, respectively, also approximates the mean survival difference of 9.5\u00c2\u00a0months presented in the meta-analysis from Halle-Smith et al. [33]. These numbers correspond to a relative hazard (RH) of survival of 1.49, which is used to calculate the sample size of the study. Furthermore, as we expect a minimal level of loss to follow-up in this surveillance study, a censoring rate of 1% is expected each month.\n To detect a 49% overall survival improvement (RH of survival 1.49) for patients in the intervention group, as compared with the control group, with a statistical power of 80% and a 0.05 two-sided significance level, a sample size of 306 patients is required. This calculation was based on the assumption of an exponential model, a median overall survival of 19.7\u00c2\u00a0months in the control arm, a follow-up duration of 30\u00c2\u00a0months, a drop-out rate of 1% and a baseline event rate of 3.5%. Following this calculation, we plan to include 306 patients in total: 153 patients in the recurrence-focused follow-up group and 153 patients in the non-standardized, symptomatic follow-up group.", "id": 1089, "split": "val"} +{"trial_id": "NCT04877860", "pmid": "37582097", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effectiveness of an E-Health System Integrated in a Physical Recovery Program for the Treatment of Pain in the Oncological Population. PaiNEd Study.\n\nIncluded conditions:\n- Breast Cancer\n\nStudy Armgroups:\n- {'label': 'Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)', 'type': 'EXPERIMENTAL', 'description': 'Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Access to the PaiNEd system.', 'interventionNames': ['Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)']}\n- {'label': 'Multimodal rehabilitation program + traditional biomedical information', 'type': 'ACTIVE_COMPARATOR', 'description': 'Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Dossier with traditional biomedical recommendations on the management of pain and disability.', 'interventionNames': ['Other: Multimodal rehabilitation program + traditional biomedical information']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Information dossier with recommendations on pain control and dysfunction improvement.', 'interventionNames': ['Other: Control group']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)', 'description': 'The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises.\\n\\n4 sessions of myofascial induction.\\n\\nFinally, patients will have access to the PaiNEd system before the start of the program (to prepare them for treatment sessions) and during the development of the treatment program in which they will introduce their pain levels and their characteristics and also receive a series of educational advice and recommendations for its improvement.', 'armGroupLabels': ['Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)']}\n- {'type': 'OTHER', 'name': 'Multimodal rehabilitation program + traditional biomedical information', 'description': 'The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises.\\n\\n4 sessions of myofascial induction.\\n\\nPatients will receive a dossier with traditional biomedical recommendations on pain management and disability associated with the side effects of cancer treatment.', 'armGroupLabels': ['Multimodal rehabilitation program + traditional biomedical information']}\n- {'type': 'OTHER', 'name': 'Control group', 'description': 'Waiting list of patients who have agreed to participate in the study. They will receive an information dossier with recommendations on pain control and improvement of dysfunction (similar to what was worked on in the experimental group). These recommendations will be distributed at the beginning of the study (initial assessment) and they will be summoned at 8 weeks for the next collection of variables. All patients will be invited to participate in the experimental phase at the end of the control phase.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months.', 'description': \"The Visual Analogue Scale is used to assess the intensity of spontaneous neck, temporomandibular and shoulder pain. The VAS is a 100 mm line anchored with a '0' at one end representing no pain and '100' at the other end representing the worst pain imaginable.\", 'timeFrame': 'Baseline, 2 and 6 months.'}\n\nPlease estimate the sample size based on the assumption: \nDifferences of at least 5% can be detected with a statistical power of 90% and a significance level alpha of 0.05. A maximum monitoring loss of 20% will be allowed.", "answer": 72, "answer_type": "ESTIMATED", "explanation": "Calculation of the sample size\n The estimation of the sample size and statistical power for the trial were determined based on the main variable, pain measured through the VAS. Based on a previous study [26] and estimating that patients in the intervention group would have a difference of 15 mm or more in the VAS compared to the control group, differences of at least 5% can be detected with a statistical power of 90% and a significance level alpha \u00ce\u00b1 of 0.05. This will require a sample of 24 patients per group, which will result in a total of 72 participants. Therefore, a maximum monitoring loss of 20% will be allowed. To carry out this sample calculation, the G*Power v. 3.1 Software was used.", "id": 1090, "split": "val"} +{"trial_id": "NCT04882514", "pmid": "39563457", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized Double Blinded Within Dose, Controlled, Safety and Immunogenicity Study of GAS Vaccine Candidate in Healthy Individuals.\n\nIncluded conditions:\n- Group A Streptococcal Infection\n\nStudy Armgroups:\n- {'label': 'Vaccine p*17-K4S2 (50 \u00b5g/mL) Vaccine', 'type': 'EXPERIMENTAL', 'description': 'To evaluate the safety and immunogenicity of p\\\\*17-CRM197 (25\u00b5g) + K4S2-CRM197 (6.25\u00b5g): TOTAL 31.25 \u00b5g', 'interventionNames': ['Biological: p*17-K4S2']}\n- {'label': 'J8-K4S2 (100 \u00b5g/mL ) Vaccine', 'type': 'EXPERIMENTAL', 'description': 'To evaluate the safety and immunogenicity J8-CRM197 (50\u00b5g) + K4S2-CRM197 (6.25\u00b5g): TOTAL 56.25 \u00b5g', 'interventionNames': ['Biological: J8-K4S2']}\n- {'label': 'Rabavert Vaccine', 'type': 'SHAM_COMPARATOR', 'description': 'Comparator vaccine (RABAVERT)', 'interventionNames': ['Biological: Rabavert vaccine']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'p*17-K4S2', 'description': 'Administer p\\\\*17-K4S2 25 \u03bcg vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly', 'armGroupLabels': ['Vaccine p*17-K4S2 (50 \u00b5g/mL) Vaccine']}\n- {'type': 'BIOLOGICAL', 'name': 'J8-K4S2', 'description': 'Administer a vaccination schedule of J8-K4S2 50\u03bcg vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly', 'armGroupLabels': ['J8-K4S2 (100 \u00b5g/mL ) Vaccine']}\n- {'type': 'BIOLOGICAL', 'name': 'Rabavert vaccine', 'description': 'Administer the standard Rabavert vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly. The Rabavert vaccine will be used as a control comparator as it has a similar approved dosing schedule to the investigational vaccines.', 'armGroupLabels': ['Rabavert Vaccine']}\n\nPrimary Outcomes:\n- {'measure': 'Adverse Events', 'description': 'Safety is the primary outcome, and will be measured by assessing the clinical symptoms and signs at each study visit and completing standard lab parameters (hematological and biochemical) as well as performing echocardiograms to assess for mitral regurgitation', 'timeFrame': '6 months after last dose of vaccine is administered'}\n\nPlease estimate the sample size based on the assumption: \nA t-test with \u03b1 = 0.05 and power = 0.8 was used for the sample size calculation.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n Thirty (30) participants are to be enrolled\u00e2\u0080\u009410 in J8-K4S2 arm, 10 in p*17-K4S2 arm, and 10 in comparator vaccine arm. This includes 10 patients in stage 1, for initial test doses, and 20 patients in stage 2, in a fully randomized, controlled stage (Fig. 1).\n To calculate this sample size, we took the J8-specific antibody titer as the continuous immunogenicity design endpoint and used data from a pilot study of the J8-DT vaccine in 8 healthy volunteers [20]. The mean (SD) titer of antibody to J8 was 1.6 (0.29) \u00ce\u00bcg/mL and 4.5 (2.4) \u00ce\u00bcg/mL at baseline and 28\u00c2\u00a0days after vaccination, respectively. Assuming the immunogenicity of the J8-K4S2 or p*17-K4S2 vaccine will be at least as strong, and using a t-test with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 and power\u00e2\u0080\u0089=\u00e2\u0080\u00890.8, eight subjects per group would be needed to demonstrate an increase in titers after vaccination compared to commercial vaccine (RabAvert, by standard sample size calculations for normally distributed data.", "id": 1091, "split": "val"} +{"trial_id": "NCT04882696", "pmid": "37126507", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Impact of Non-slip Socks on Motor Recovery in the Elderly An Open Label, Single-center, Randomized, Controlled Pilot Study\n\nIncluded conditions:\n- Aging\n- Acute Care Unit\n- Fall Injury\n\nStudy Armgroups:\n- {'label': 'usual care with bare feet', 'type': 'NO_INTERVENTION', 'description': 'patients will be treated barefoot during their stay'}\n- {'label': 'specific care with anti-slip socks', 'type': 'EXPERIMENTAL', 'description': 'Patients in this group will wear non-slip socks', 'interventionNames': ['Other: Non-slip socks']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Non-slip socks', 'description': 'Patients will wear non-slip socks during their hospitalization', 'armGroupLabels': ['specific care with anti-slip socks']}\n\nPrimary Outcomes:\n- {'measure': 'Change from Baseline walking speed (start of physiotherapy treatment) at D8.', 'description': \"Change from Baseline walking speed at the patient's preferred speed over 10m between (start of physiotherapy treatment) at D8.\", 'timeFrame': 'Day 8'}\n\nPlease estimate the sample size based on the assumption: \nAlpha risk set at 5%, power of 90%, using a two sample t-test.", "answer": 1, "answer_type": "ACTUAL", "explanation": "Sample size determination\n The sample size required for this study was estimated at 46. The calculation was based on a difference of 0.10m/s in the ten-meter timed walk (see below) between the two groups, a standard deviation of the difference of 0.10 (an improvement in walking speed of 0.10m/s is considered clinically relevant in an older adults with mobility disabilities, subacute stroke survivors, and community dwelling older people [22]), an alpha risk set at 5% and a power of 90% (two sample t-test). To guarantee the power of the study, we plan to include 50 patients.", "id": 1092, "split": "val"} +{"trial_id": "NCT04889274", "pmid": "37715222", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Effect of Dietary Nitrate and Sex on COVID-19 Vaccine Induced Vascular Dysfunction in Healthy Men and Women\n\nIncluded conditions:\n- Cardiovascular Diseases\n- Endothelial Dysfunction\n\nStudy Armgroups:\n- {'label': 'Part A: Male healthy volunteers', 'type': 'EXPERIMENTAL', 'interventionNames': ['Biological: COVID-19 vaccine']}\n- {'label': 'Part A: Female healthy volunteers', 'type': 'EXPERIMENTAL', 'interventionNames': ['Biological: COVID-19 vaccine']}\n- {'label': 'Part B: Nitrate-rich beetroot juice', 'type': 'ACTIVE_COMPARATOR', 'description': 'Dietary Supplement: Concentrate beetroot Juice (70 ml) containing \\\\~5mmol of inorganic nitrate', 'interventionNames': ['Biological: COVID-19 vaccine', 'Biological: Concentrate beetroot Juice']}\n- {'label': 'Part B: Nitrate-deplete beetroot juice', 'type': 'PLACEBO_COMPARATOR', 'description': 'Dietary Supplement: Concentrate beetroot Juice (70 ml) which is nitrate-depleted', 'interventionNames': ['Biological: COVID-19 vaccine', 'Biological: Nitrate-deplete beetroot juice']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'COVID-19 vaccine', 'description': 'COVID-19 vaccine as offered by NHS England', 'armGroupLabels': ['Part A: Female healthy volunteers', 'Part A: Male healthy volunteers', 'Part B: Nitrate-deplete beetroot juice', 'Part B: Nitrate-rich beetroot juice']}\n- {'type': 'BIOLOGICAL', 'name': 'Concentrate beetroot Juice', 'description': 'Beetroot juice containing approximately 5mmol/l nitrate', 'armGroupLabels': ['Part B: Nitrate-rich beetroot juice']}\n- {'type': 'BIOLOGICAL', 'name': 'Nitrate-deplete beetroot juice', 'description': 'Beetroot juice with nitrate removed', 'armGroupLabels': ['Part B: Nitrate-deplete beetroot juice']}\n\nPrimary Outcomes:\n- {'measure': 'Comparison of change in FMD from baseline between the sexes after COVID-19 vaccination', 'description': 'A measurement of brachial artery diameter using ultrasound (FMD, flow mediated dilatation) will be conducted at visits 2 and 3 (i.e. pre- and post-vaccine). This outcome measure will compare these 2 measurements, and change in FMD will be calculated as subtracting the value collected at visit 3 from visit 2, and expressed as a percentage (%). Comparisons will then be made between the sexes (i.e. males vs females) in Part A.', 'timeFrame': 'Up to 28 days'}\n- {'measure': 'Comparison of change in FMD from baseline after COVID-19 vaccination following inorganic nitrate versus placebo supplementation', 'description': 'A measurement of brachial artery diameter using ultrasound (FMD, flow mediated dilatation) will be conducted at visits 2 and 3 (i.e. pre- and post-vaccine). This outcome measure will compare these 2 measurements, and change in FMD will be calculated as subtracting the value collected at visit 3 from visit 2, and expressed as a percentage (%). Comparisons will then be made between intervention and placebo in Part B.', 'timeFrame': 'Up to 28 days'}\n- {'measure': 'Comparison of change in plasma [NO2-] following inorganic nitrate versus placebo supplementation', 'description': 'Quantification of \\\\[NO2-\\\\] will be made using ozone chemiluminescence. Samples of blood, urine and saliva will be acquired at visit 2 and visit 3 (i.e. pre- and post-vaccine). Measurement of \\\\[NO2-\\\\] will be made in all matrices at both timepoints, and a comparison will be made (for this we plan on using 2-way ANOVA, using GraphPad Prism statistics package) to compare time and intervention.', 'timeFrame': 'Up to 28 days'}\n\nPlease estimate the sample size based on the assumption: \nFor part A: 90% power, 10% dropout rate. For part B: 80% power for primary outcome, 90% power for sex differences, >95% power to detect a rise in [NO2\u2212], 10% dropout rate.", "answer": 98, "answer_type": "ACTUAL", "explanation": "Sample size determination and statistical analysis\n In this study, we aim to recruit 98 participants, with 30 healthy volunteers in part A and 64 in part B. This sample size will empower the study to test the primary endpoint.\n These numbers have been based upon our previous experience with typhoid vaccination which causes a reduction in FMD of ~ 1.5% absolute units which is a reduction of approximately 25% of the response [28]. We have previously identified sex differences in the response to typhoid vaccine, with a change from baseline of FMD of \u00e2\u0088\u0092\u00e2\u0080\u00890.5 (SD = 2.4) in men and 2.4 (SD = 2.5) in women [29]. For part A, using these data, if we use a conservative effect size of 25% less than that achieved in our previously published study, 13 participants are required in each group to provide 90% power for the primary outcome. To account for potential dropouts of ~ 10%, 15 participants will be recruited into each group and thus 30 volunteers in total. For the analysis of part A, a linear regression model will be used to compare changes in vascular dysfunction pre- to post-vaccination between the sexes, unadjusted and adjusted for important risk factors including age, body mass index, and baseline vessel diameter.\n Our unpublished preliminary data investigating the effects of dietary inorganic nitrate on vascular responses (FMD) has identified a decrease in FMD from baseline of 1.4 (SD = 1.5) with typhoid vaccine and with dietary nitrate intervention only 0.08 (SD = 1.7) [20]. Based on these data, for the primary outcome of change in FMD, 25 participants will be required in each group at an 80% power, to observe a difference between the intervention arms. To observe the differences between the sexes, 30 in each group provides a 90% power, which will also offer a > 95% power to detect a rise in [NO2\u00e2\u0088\u0092], as observed in previous studies [30]. To account for potential dropouts of ~ 10%, a total of 68 volunteers will be recruited. For the statistical analysis in part B, analysis of covariance (ANCOVA) will be used to compare the change in vascular dysfunction pre- to post-vaccination, between dietary nitrate and placebo control groups adjusting for pre-vaccination level, and to compare the change in plasma [NO2\u00e2\u0088\u0092] between the dietary nitrate and placebo control groups.\n Personal data will be stored in a secured site file and clinical notes in a paper CRF, which will be security locked and coded. Only the direct research team will have access to the trial CRF. The subject will be given a unique, single identifier which will be used to identify data and samples. Results data will only be stored, shared, analysed, transmitted, and presented in an anonymised form. Participant experience questionnaires will be completed and stored in the secure CRF. Reasons for drop-out or deviation from protocol will be detailed in full. Data quality will be assessed upon completion of the study and stored electronically. Confidentiality will be maintained through these secure measures before, during, and after the trial. Data access will be granted only to direct study members. Upon completion of the study, a fully blinded data analysis will be undertaken by a statistician.", "id": 1093, "split": "val"} +{"trial_id": "NCT04889820", "pmid": "39901122", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Oncologic oUTcomes of Neoadjuvant Chemotherapy for obSTructive Colon cAncer After steNt Decompression (OUTSTAND Trial); Multicenter Randomized Controlled Trial\n\nIncluded conditions:\n- Colon Cancer, Obstruction\n\nStudy Armgroups:\n- {'label': 'The Control group', 'type': 'ACTIVE_COMPARATOR', 'description': '- The patients who are assigned into control group take a curative surgery within 2 weeks after successful SEMS placement. And then, after recovery period, adjuvant FOLFOX chemotherapy will be administered into them. Adjuvnat FOLFOX chemotherapy will be administered every 2week during 6 months (total 12 cycles).', 'interventionNames': ['Drug: Adjuvant chemotherapy', 'Procedure: Curative resection']}\n- {'label': 'The Experimental group', 'type': 'EXPERIMENTAL', 'description': '- The patients who are assigned into the experimental group take a neoadjuvant FOLFOX chemotherapy within 2 weeks after successful SEMS placement. After three cycles of FOLFOX, they will take a curative surgery. And then, after recovery period, adjuvant FOLFOX chemotherapy will be administered into them. Adjuvnat FOLFOX chemotherapy will be administered every 2week during about 4 months (total 9 cycles). The perioperative FOLFOX chemotherapy in the experimetal group will be totally 12 cycles during 6months.', 'interventionNames': ['Drug: Neoadjuvant chemotherapy', 'Drug: Adjuvant chemotherapy', 'Procedure: Curative resection']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Neoadjuvant chemotherapy', 'description': 'In this study, patients with obstructive colon cancer will be divided into two groups; in the control group, curative surgery will be performed within 2 weeks after successful SEMS placement, and in the experimental group, 3 cycles of neoadjuvant chemotherapy will be administered into patients who undergo successful SEMS placement and then curative surgery will be performed after neoadjuvnat chemotherapy. After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles.', 'armGroupLabels': ['The Experimental group'], 'otherNames': ['Curative surgery']}\n- {'type': 'DRUG', 'name': 'Adjuvant chemotherapy', 'description': 'After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles.', 'armGroupLabels': ['The Control group', 'The Experimental group'], 'otherNames': ['curative surgery']}\n- {'type': 'PROCEDURE', 'name': 'Curative resection', 'description': 'After successful SEMS placement, curate resection will be performed for all enrolled patients regardless of neoadjuvant chemotherapy.', 'armGroupLabels': ['The Control group', 'The Experimental group']}\n\nPrimary Outcomes:\n- {'measure': '3-year overall survival', 'description': '3-year overall survival after curative surgery', 'timeFrame': '3 years after surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe study uses a non-inferiority log-rank test with a significance level of 0.050 and 80.1% power to detect an equivalence hazard ratio of 2.29, assuming the actual hazard ratio is 1.00 and the hazard rate of the reference group is 0.0446. The study duration is six years, with uniform subject accrual over the first three years. The dropout rate for both control and experimental groups is 0.0100. The failure rate for stents is 8%, and the failure rate for screening is 15%.", "answer": 204, "answer_type": "ESTIMATED", "explanation": "Sample size and randomization\n Based on our retrospective analysis, the 5-year overall survival (OS) rate for the control group was 84.1%. However, for patients who underwent curative surgery 4 weeks after SEMS placement without neoadjuvant chemotherapy, the OS rate was only 37.5%. The maximum response rate was assumed to be 80.0%, while the minimum response rate was assumed to be 40.0%. The non-inferiority limit for this study was set at 20%, which is half of 40%. Additionally, a non-inferiority margin of 60% was established. We determined the noninferiority margin for our study based on clinical judgment and retrospective data. We have chosen the noninferiority test as a method to minimize the unrealistic overall survival difference resulting from such a significant gap. We have set the non-inferiority limit for this study at 20%, which is relatively large. However, we believed that a 20% increase in OS with neoadjuvant therapy is possible and realistic, even though it is not a small number. Although it is generally advisable to choose a smaller value for the noninferiority margin, the feasibility of study recruitment was another important factor to consider. Therefore, we selected the noninferiority margin equivalent to a 20% increase in the expected OS rate. A non-inferiority log-rank test was conducted with a total sample size of 204 subjects, evenly divided between the control and experimental groups. The test achieved 80.1% power at a significance level of 0.050 to detect an equivalence hazard ratio of 2.29, assuming the actual hazard ratio is 1.00 and the hazard rate of the reference group is 0.0446. The study will last for six years, during which subject accrual (entry) will occur within the first three years. The accrual pattern is uniform across all time periods; all years are equal. The proportion of participants dropping out of the control group is 0.0100. The proportion of participants dropping out of the experimental group is 0.0100. The proportion of individuals switching from the control group to another group with a hazard rate equal to that of the experimental group is 0.0000. The proportion of individuals switching from the experimental group to another group with a hazard rate equal to that of the reference group is 0.0000. The estimated failure rate for stents is 8%. And, the failure rate for screening - indicating synchronous malignancies at other sites or patients requiring emergency operations - is 15%. A total of over 260 patients will be screened for the successful trial.\n After the successful placement of self-expandable metal stents (SEMS), random allocation will be carried out with the consent of patients and their guardians. A total of 204 patients will be evenly distributed between the two groups in a 1:1 ratio. This study is a multicenter, randomized (1:1), parallel-group, open-label, controlled clinical trial. Using a random-number table, assignment codes will be concealed in opaque envelopes. To avoid the issue of tampering with the allocation from the sealed envelopes, the sealed opaque envelopes containing the randomization card, which is not visible through transillumination, are stored at the trial administration center (St. Vincent\u00e2\u0080\u0099s Hospital, Suwon, Korea). They are opened by a third party immediately after receiving a telephone call from the clinician who wishes to enroll a patient, in order to minimize the risk of allocation manipulation. The sealed envelopes will be used but will be open by a centralized system. Half of the patients will be randomly assigned to the control group, while the other half will be assigned to the experimental group through randomization.", "id": 1094, "split": "val"} +{"trial_id": "NCT04891640", "pmid": "36755328", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)\n\nIncluded conditions:\n- Juvenile Spondyloarthritis\n\nStudy Armgroups:\n- {'label': 'TNFi Standard Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Continue fixed standard treatment (i.e., no change from current therapy)', 'interventionNames': ['Other: Standard TNFi Therapy']}\n- {'label': 'TNFi fixed longer dosing intervals', 'type': 'EXPERIMENTAL', 'description': 'Fixed longer dosing intervals of TNFi (i.e., increased time between doses)', 'interventionNames': ['Other: TNFi fixed longer dosing intervals']}\n- {'label': 'TNFi Therapy Withdrawal', 'type': 'EXPERIMENTAL', 'description': 'Stop TNFi treatment', 'interventionNames': ['Other: Stop TNFi treatment']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Standard TNFi Therapy', 'description': 'Participants randomly assigned to this arm will continue taking their TNFi medication as currently prescribed.', 'armGroupLabels': ['TNFi Standard Therapy']}\n- {'type': 'OTHER', 'name': 'TNFi fixed longer dosing intervals', 'description': 'Participants randomly assigned to this arm will increase the time between TNFi medication doses.\\n\\n* Adalimumab- from every 2 to 3 weeks\\n* Certolizumab- from every 2 to 4 weeks\\n* Etanercept- from every 1 to 2 weeks\\n* Golimumab- from every 4 to 6 weeks\\n* Infliximab- from baseline to baseline + 2 weeks', 'armGroupLabels': ['TNFi fixed longer dosing intervals']}\n- {'type': 'OTHER', 'name': 'Stop TNFi treatment', 'description': 'Participants randomly assigned to this arm will stop TNFi medication.', 'armGroupLabels': ['TNFi Therapy Withdrawal']}\n\nPrimary Outcomes:\n- {'measure': 'Juvenile Spondyloarthritis (JSpA) flare', 'description': \"JSpA flare is defined as clinically meaningful worsening in \u22653 of the following: caregiver/patient assessment of well-being, physician assessment of disease activity, caregiver/patient assessment of pain, physical function, and active joint count. Meaningful change for well-being, disease activity, and pain are an increase of \u22652 on visual analogue scale (range 0-10 with higher scores indicating poorer well-being, higher disease activity, and higher magnitude of pain). Meaningful change in function is defined as \u22653 unit change in the PROMIS mobility or upper extremity T-scores. The Patient-Reported Outcomes Measurement Information System (PROMIS) short forms include 8 questions and a T-score of '50' represents the healthy population mean score with standard deviation of 10. Active joint count is defined as the number of joints with swelling or, in the absence of swelling, limitation of motion accompanied by pain or warmth as per the physician examination.\", 'timeFrame': '12 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study aims for 80% power at a 0.05 significance level for the primary hypothesis and 80% power at a 0.025 significance level for the secondary hypothesis. For Objective 2, 92% power at a significance level of 0.02 is assumed, with a within-subject correlation of 0.3 and a clinically meaningful change of 0.5 standard deviation (SD) units.", "answer": 198, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n We aim to recruit 198 subjects in total with 66 randomized to each arm, with an anticipated 10% loss to follow-up. Based on the data in the C-OPTIMISE trial [26], we anticipate the cumulative flare rate in the BACK-OFF JSpA standard dosing group by month 12 (end of the active study) will be approximately 16%. With 60 patients in standard treatment group and 60 in fixed longer dosing group, and a 16% cumulative flare rate in the standard dosing group, a non-inferiority comparison using the logrank test achieves 80% power at a 0.05 significance level when the non-inferiority bound is 2.5 and the hazard ratio (HR) is 1. Stated simply, if the cumulative rate of flare in the standard TNFi dose group is 16%,\n we can declare noninferiority if the HR non-inferiority bound is \u00e2\u0089\u00a42.5 and the cumulative flare rate in the fixed longer dosing arm is no more than 31%. This meets the acceptable noninferiority margin of an absolute difference of 15% in the cumulative flare rate that was determined by consensus of BACK-OFF JSpA site PIs. This non-inferiority margin is also in accordance with other recent published TNFi dose reduction trials [27\u00e2\u0080\u009330]. To test our secondary hypothesis, which is that the TNFi stop arm is inferior to each of other two arms (standard TNFi dose and fixed longer TNFi dosing), the logrank test achieves 80% power at a 0.025 significance level (to adjust for multiple comparisons of the secondary hypotheses) to detect a difference of 3.2 in the hazard ratio.\n For Objective 2, with an evaluable N=60 in each arm we will have 92% power at a significance level of 0.02 to detect a time-average difference of 0.5\u00c3\u0097SD between any two arms in pain interference if we account for repeated measures (3 times on average, ranging from 2 to 4) by assuming a within-subject correlation of 0.3. FDA guidance suggests that 0.5 standard deviation (SD) units is the level of group-level change in PROs that is clinically meaningful, which we will be powered to detect [31].", "id": 1095, "split": "val"} +{"trial_id": "NCT04892199", "pmid": "36720576", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Does the Glucagon-like Peptide-1 Receptor Agonist Semaglutide Prevent Deterioration of Metabolic State in Prediabetic or Diabetic Patients With Schizophrenia Treated With the Antipsychotic Compounds Clozapine or Olanzapine?\n\nIncluded conditions:\n- Metabolic Disturbance\n- Schizophrenia\n- Type 2 Diabetes\n- Clozapine\n- GLP-1\n- Olanzapine\n\nStudy Armgroups:\n- {'label': 'Semaglutide injection once-weekly', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Drug: Semaglutide, 1.34 mg/mL']}\n- {'label': 'Semaglutide-Placebo injection once-weekly', 'type': 'PLACEBO_COMPARATOR', 'interventionNames': ['Drug: Semaglutide-placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Semaglutide, 1.34 mg/mL', 'description': 'Semaglutide 1.34 mg/ml, 1.5 ml pre-filled pen-injector is supplied in pens for injection containing 2.0 mg of the GLP-1RA semaglutide in 1.5 ml sterile water with disodiumphosphate and propylenglycol, and phenol for conservation (pH 8.15). Direction for use will be given together with trial products.The possible doses of semaglutide are 0.25 mg, 0.50 mg and 1.0 mg. The initial weekly dose will be 0.25 mg for four weeks, then 0.5 mg for four weeks and then 1.0 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.0 mg semaglutide will remain on 0.5 mg once-weekly. The injection is administered subcutaneously once-weekly.', 'armGroupLabels': ['Semaglutide injection once-weekly']}\n- {'type': 'DRUG', 'name': 'Semaglutide-placebo', 'description': 'The semaglutide placebo pens contain \"XX-vehicle\" (no active drug) and are administered in the same way and volume as semaglutide. The semaglutide placebo is specially packed for this study and will be used in the study only. The initial weekly dose will be 0.25 mg for four weeks, then 0.5 mg for four weeks and then 1.0 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.0 mg semaglutide placebo will remain on 0.5 mg once-weekly. The injection is administered once-weekly. If the lowest tolerated dose is less than 0.5 mg of semaglutide placebo once-weekly, the patient will be excluded from the study.', 'armGroupLabels': ['Semaglutide-Placebo injection once-weekly']}\n\nPrimary Outcomes:\n- {'measure': 'The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c).', 'timeFrame': '26 weeks'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (\u03b1) of 5%, power (1\u2212\u03b2) of 90%, and an expected dropout rate of 50%.", "answer": 104, "answer_type": "ESTIMATED", "explanation": "Sample size\n The study is an explanatory study and the required patient population size is based on significance level (\u00ce\u00b1) of 5%, a power (1\u00e2\u0088\u0092\u00ce\u00b2) of 90%, where \u00ce\u00b2 (10%) is the risk of accepting a hypothesis that is false. Based on data from a recent study in similar patients,76 we estimated that the minimum relevant difference (MIREDIF) of HbA1c (primary endpoint) after 26 weeks of intervention would be \u00e2\u0088\u00920.26% with an SD of 0.28%. With the aforementioned power, significance level, MIREDIF and SD, the trial requires 26 patients in each of the two arms, that is, a total of 52 patients. Thus, with an expected dropout of 50%, a total of 104 patients will be randomised.", "id": 1096, "split": "val"} +{"trial_id": "NCT04893681", "pmid": "38443989", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Proof-of-concept Randomized Controlled Trial to Evaluate Dental Caries Preventive Effects of Fluoridated Bottled Water\n\nIncluded conditions:\n- Dental Caries in Children\n\nStudy Armgroups:\n- {'label': 'Fluoridated bottle water', 'type': 'EXPERIMENTAL', 'description': \"5-gallon bottles containing water from the New Bern Water Resources Division's Black Creek aquifer which contains naturally-occurring fluoride in a concentration of approximately 0.8 mg/L F\", 'interventionNames': ['Other: Fluoridated bottled drinking water']}\n- {'label': 'Non-fluoridated bottled water', 'type': 'PLACEBO_COMPARATOR', 'description': \"5-gallon bottles containing water from the North Lenoir Water Corporation's Black Creek aquifer which contains a negligible concentration of fluoride.\", 'interventionNames': ['Other: Non-fluoridated drinking water']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Fluoridated bottled drinking water', 'description': 'Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.', 'armGroupLabels': ['Fluoridated bottle water']}\n- {'type': 'OTHER', 'name': 'Non-fluoridated drinking water', 'description': 'Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.', 'armGroupLabels': ['Non-fluoridated bottled water']}\n\nPrimary Outcomes:\n- {'measure': 'dmfs index', 'description': 'The number of primary tooth surfaces that are decayed, missing or filled will be enumerated during dental examinations of children near the time of their 4th birthday. Decay will be assessed clinically at the threshold of macroscopic enamel loss, as per criteria defined by the International Caries Detection and Assessment System. Five surfaces per tooth will be enumerated in all primary teeth (maximum = 20 teeth per child), yielding a count of affected surfaces that can range from 0 (no dental caries experience) to 100 (worst possible extent of dental caries experience). The lower-case abbreviation \"dmfs\" signifies disease in the primary dentition, a convention used to distinguish it from equivalent measures for the permanent dentition, where an uppercase abbreviation is used, as defined for the National Library of Medicine\\'s Medical Subject Heading heading \"DMF Index\".', 'timeFrame': 'Dental examination in year 4'}\n\nPlease estimate the sample size based on the assumption: \nPower of 80%, 1-tailed alpha = 0.2, and a presumed loss to follow-up of 20%.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The power calculation for this phase 2b trial is based on the principle that pilot studies should replicate, in miniature, a definitive trial that would be conducted if justified by findings from the pilot study [17]. By definition, such pilot studies lack the statistical power of a definitive trial. Instead, the goal is to calculate the point estimate of the preventive effect size and plausible range of effect size estimates to make the following three decisions:If the pilot study\u00e2\u0080\u0099s point estimate of effect size is zero or less, and there were no significant flaws in the conduct of the pilot study, a definitive trial is contra-indicated (i.e., a null or harmful finding).If the one-tailed, upper 80% confidence limit of the pilot study effect size is less than the a priori threshold of public-health-significance, then a definitive trial is probably unjustifiable because it would require a very large sample size to estimate a meager health benefit.Otherwise, the definitive trial should go ahead using the point estimate from the pilot study as the effect size when calculating the required sample size for the definitive trial.\n When applied using estimates of the dmfs index for 3\u00e2\u0080\u00934 year-olds living in non-fluoridated areas of the US [4], that approach yields a required sample size of 158 subjects (79 per study group), specifying a clinically significant group difference of 1.1 (s.d. = 7.8), equivalent to 37% reduction in mean dmfs, and power of 80%. (Specifically, using the SAS power procedure with options \u00e2\u0080\u009ctwo sample means ci = diff halfwidth = 1.1, stddev = 7.8,\u00e2\u0080\u009d 1-tailed alpha = 0.2 and probwidth = 0.8.) The required sample size of 158 subjects with 4-year-old dmfs data was increased to 200 randomized subjects to allow for a presumed loss to follow-up of 20% between enrollment and the 4th Birthday Dental Caries Examination.", "id": 1097, "split": "val"} +{"trial_id": "NCT04895852", "pmid": "36797022", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficacy and Safety of Transcutaneous Electrical Acupoints Stimulation for Preoperative Anxiety in Thoracoscopic Surgery: Study Protocol for a Randomized Controlled Trial\n\nIncluded conditions:\n- Acupuncture Therapy\n- Preoperative Period\n- Anxiety\n- Thoracoscopic Surgery\n\nStudy Armgroups:\n- {'label': 'TEAS group', 'type': 'EXPERIMENTAL', 'description': '30 minutes TEAS therapy on DU20, EX-HN3, LI4, LR3 once per day for three days before surgery.', 'interventionNames': ['Device: TEAS']}\n- {'label': 'Control group', 'type': 'SHAM_COMPARATOR', 'description': 'The control group selects the same acupoints as the TEAS group and other intervention measures are the same as the TEAS group except for the current intensity is set to 0-mA.', 'interventionNames': ['Device: Sham TEAS']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'TEAS', 'description': 'The self-adhesive gel electrode pad will be placed at the center of DU20 (Baihui), EX-HN3 (Yintang) and both sides of LI4 (Hegu), LR3 (Taichong) in strict accordance with the World Health Organization Standardized Acupuncture Location. Electric stimulation will be used with a TEAS apparatus (HANS200A Beijing Huawei Co., LTD.) . The frequency of the electrical stimulation will be set as alternating 2/100Hz to relieve anxiety. The current intensity will be adjusted individually, starting at 1 mA and increasing gradually until the patient can perceive and tolerate it (preferably slight twitching of local muscles without pain).', 'armGroupLabels': ['TEAS group']}\n- {'type': 'DEVICE', 'name': 'Sham TEAS', 'description': 'The STEAS group selects the same acupoints as the TEAS group and other intervention measures are the same as the TEAS group except for the current intensity is set to 0-mA. The acupuncturist responsible for the operation will tell patients in STEAS group that this is a type of stimulus without perception.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'Score change of Generalized Anxiety Scale (GAD-7)', 'description': \"Add the scores of each of the 7 items to get the total score; among them, 0-4 points for no anxiety, 5-9 points for possible mild anxiety, 10-14 points for possible moderate anxiety, 15 Scores above are likely to have severe anxiety. The GAD-7 scores' Change between three days before and the day before surgery will be recorded.\", 'timeFrame': 'up to 3 days before surgery'}\n\nPlease estimate the sample size based on the assumption: \nTest level bilateral \u03b1=0.05, test power 1\u2212\u03b2 = 0.9, 15% probability of lost to follow-up", "answer": 92, "answer_type": "ESTIMATED", "explanation": "Sample size\n Primary outcome indicator in this trial is the GAD-7 score variation between the day before VATS with the baseline. The sample size was calculated on the grounds of our preliminary trial (online supplemental material 1). Reference for optimal effectiveness in clinical trials of two sample mean comparison, using formula for calculating sample size of clinical trials as follow.\n \n 10.1136/bmjopen-2022-067082.supp1\n Supplementary data\n \n\n\n \n \n\nn1=n2=2[(u\u00ce\u00b1+u\u00ce\u00b2)\u00ce\u00b4/\u00cf\u0083]2+14u\u00ce\u00b12\n\n\n GAD-7 score change in TEAS group increase the divergence between the STEAS group and the SD by 73%. \u00ce\u00b4/\u00cf\u0083=0.73, test level bilateral \u00ce\u00b1=0.05, test power 1\u00e2\u0088\u0092\u00ce\u00b2 = 0.9. Through calculation, each group required sample size is 40 samples. The submitted trial will demand 92 participants to be divided into two groups of 46 in consideration of the 15% probability of lost to follow-up.", "id": 1098, "split": "val"} +{"trial_id": "NCT04897100", "pmid": "37907927", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method\n\nIncluded conditions:\n- Club Foot\n- Achilles Tendon Surgery\n\nStudy Armgroups:\n- {'label': 'Needle tenotomy', 'type': 'EXPERIMENTAL', 'description': 'Patient will receive an Achilles tendon tenotomy using a 22G needle when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.', 'interventionNames': ['Procedure: Achilles tendon tenotomy']}\n- {'label': 'Blade tenotomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patient will receive an Achilles tendon tenotomy using a 11 blade when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.', 'interventionNames': ['Procedure: Achilles tendon tenotomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Achilles tendon tenotomy', 'description': 'Achilles tendon tenotomy during Ponseti treatment for clubfoot', 'armGroupLabels': ['Blade tenotomy', 'Needle tenotomy']}\n\nPrimary Outcomes:\n- {'measure': 'Dorsiflexion', 'description': 'Ankle dorsiflexion measured in degrees', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha (significance level) is set at 5%, power is set at 95%, and the standard deviation is 9.02. A dropout rate of 10% is expected during the first year of follow-up.", "answer": 244, "answer_type": "ACTUAL", "explanation": "Sample size\n \n Change of sample size after initial protocol creation\n The sample size for this trial has been adapted after submission of the initial protocol. In preparation of submission of the final protocol for publication, it was brought to our attention that a sample size calculation for a non-inferiority trial requires the determination of a non-inferiority margin. The initial sample size, which had been calculated based on an expected difference in success rate between both tenotomy techniques, has been abandoned and replaced by a sample size calculation based on the calculation of an inferiority margin. The full calculation can be found below.\n \n \n Non-inferiority margin determination\n Dorsiflexion was defined as \u00e2\u0080\u009ctrue dorsiflexion\u00e2\u0080\u009d at the ankle joint and not mobility at the midfoot level. True maximal dorsiflexion measures the tibiocalcaneal angle when the foot is put in maximum dorsiflexion. Only a limited number of studies report on the range of dorsiflexion achieved after tenotomy. We identified two studies that used post-tenotomy radiographs to assess for dorsiflexion range [19, 20]. One study assessed evolution of ankle dorsiflexion over time post-tenotomy. The study states that children who still maintained 15\u00c2\u00b0 dorsiflexion at age 12 all had a minimum of 20\u00c2\u00b0 dorsiflexion under the age of 3\u00c2\u00a0years [21]. This raises the question if the ideal dorsiflexion under the age of 3\u00c2\u00a0years should be 20\u00c2\u00b0 instead of 15\u00c2\u00b0 as initially proposed by Ponseti. We identified 17.5\u00c2\u00b0 dorsiflexion, mid-way between both proposed cut-offs, minimally acceptable range of post-operative dorsiflexion in our study.\n The mean range of dorsiflexion and standard deviation including the data of both radiologic studies mentioned above was determined using an inverse-variance model with random effects (Fig.\u00c2\u00a03). The obtained mean range was 21.42\u00c2\u00b0 of dorsiflexion. The mean range of dorsiflexion obtained from the literature is very close to the mean range of dorsiflexion (20.2\u00c2\u00b0) obtained in our pilot study before starting the full RCT.Fig. 3Inverse-variance model with random effects to determine mean dorsiflexion rate using blade tenotomy\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$\\begin{array}{c}\\mathrm{Non}-\\mathrm{inferiority \\,margin}\\\\ =\\mathrm{ mean \\,range \\,of\\, dorsiflexion \\,from\\, literature }-\\mathrm{ minimally\\, acceptable\\, range\\, of\\, post}-\\mathrm{operative\\, dorsiflexion}\\\\ = 21.42^\\circ - 17.5^\\circ \\\\ = 3.92^\\circ \\end{array}$$\\end{document}Non-inferioritymargin=meanrangeofdorsiflexionfromliterature-minimallyacceptablerangeofpost-operativedorsiflexion=21.42\u00e2\u0088\u0098-17.5\u00e2\u0088\u0098=3.92\u00e2\u0088\u0098\n For practical purposes, a non-inferiority margin of 4\u00c2\u00b0 will be applied instead of 3.92.\n \n \n Sample size and power calculation\n Sample sizes are calculated using the WHO sample size determination software [22].\n Sample size calculation for primary outcome:Alpha\u00e2\u0080\u0089=\u00e2\u0080\u00895%Power 95%Non-inferiority margin: 4Standard deviation: 9.02\n Required sample size\u00e2\u0080\u0089=\u00e2\u0080\u0089222 feet (111 in each arm).\n Drop-out from clubfoot programs is a common event in LMICs, especially throughout the bracing phase. In literature, drop-out rates of up to 30% have been reported over the total period of bracing which is about 3\u00c2\u00a0years on average [17, 18, 23]. Internal data from the Pehla Qadam clubfoot program shows similar outcome with about 30% drop-out over the entire course of the treatment. We therefore expect during the first year of follow-up to lose about 10% of our patients. We will therefore increase the sample size by 10% to adjust for the expected drop-out.\n A total sample size of 244 feet (122 per arm) will be recruited for this trial.", "id": 1099, "split": "val"} +{"trial_id": "NCT04897100", "pmid": "37907927", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method\n\nIncluded conditions:\n- Club Foot\n- Achilles Tendon Surgery\n\nStudy Armgroups:\n- {'label': 'Needle tenotomy', 'type': 'EXPERIMENTAL', 'description': 'Patient will receive an Achilles tendon tenotomy using a 22G needle when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.', 'interventionNames': ['Procedure: Achilles tendon tenotomy']}\n- {'label': 'Blade tenotomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patient will receive an Achilles tendon tenotomy using a 11 blade when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.', 'interventionNames': ['Procedure: Achilles tendon tenotomy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Achilles tendon tenotomy', 'description': 'Achilles tendon tenotomy during Ponseti treatment for clubfoot', 'armGroupLabels': ['Blade tenotomy', 'Needle tenotomy']}\n\nPrimary Outcomes:\n- {'measure': 'Dorsiflexion', 'description': 'Ankle dorsiflexion measured in degrees', 'timeFrame': '3 months'}\n\nPlease estimate the sample size based on the assumption: \nAlpha (significance level) is set at 5%, power is set at 95%, and the standard deviation is 9.02. A dropout rate of 10% is expected during the first year of follow-up.", "answer": 244, "answer_type": "ACTUAL", "explanation": "Sample size and power calculation\n Sample sizes are calculated using the WHO sample size determination software [22].\n Sample size calculation for primary outcome:Alpha\u00e2\u0080\u0089=\u00e2\u0080\u00895%Power 95%Non-inferiority margin: 4Standard deviation: 9.02\n Required sample size\u00e2\u0080\u0089=\u00e2\u0080\u0089222 feet (111 in each arm).\n Drop-out from clubfoot programs is a common event in LMICs, especially throughout the bracing phase. In literature, drop-out rates of up to 30% have been reported over the total period of bracing which is about 3\u00c2\u00a0years on average [17, 18, 23]. Internal data from the Pehla Qadam clubfoot program shows similar outcome with about 30% drop-out over the entire course of the treatment. We therefore expect during the first year of follow-up to lose about 10% of our patients. We will therefore increase the sample size by 10% to adjust for the expected drop-out.\n A total sample size of 244 feet (122 per arm) will be recruited for this trial.", "id": 1100, "split": "val"} +{"trial_id": "NCT04897347", "pmid": "37591642", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial\n\nIncluded conditions:\n- Cerebral Palsy\n\nStudy Armgroups:\n- {'label': 'Robotic Trunk-Support-Trainer (TruST)', 'type': 'EXPERIMENTAL', 'description': 'Postural-reaching control intervention with TruST', 'interventionNames': ['Device: Robotic Trunk-Support-Trainer (TruST)']}\n- {'label': 'Static Trunk Support', 'type': 'ACTIVE_COMPARATOR', 'description': 'Postural-reaching control intervention with Rigid Trunk Support', 'interventionNames': ['Device: Static Trunk Support']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Robotic Trunk-Support-Trainer (TruST)', 'description': 'This will involve tailoring the level of postural assistance via force fields and systematically introduce postural task-progression across training sessions. Age-appropriate activities, including toys and games, will be used in training.\\n\\n- Twelve 2hr training sessions (3 times per week for 4 weeks)', 'armGroupLabels': ['Robotic Trunk-Support-Trainer (TruST)']}\n- {'type': 'DEVICE', 'name': 'Static Trunk Support', 'description': 'This will involve static support for the trunk via a trained therapist. Age-appropriate activities, including toys and games, will be used in training.\\n\\n- Twelve 2hr training sessions (3 times per week for 4 weeks)', 'armGroupLabels': ['Static Trunk Support']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Modified Functional Reach Test (mFRT) after intervention', 'description': 'The mFRT measures proactive postural control during maximum reaching distance. It is a valid and reliable tool in CP; and it discriminates GMFCS levels.', 'timeFrame': 'Through study completion, an average of 4 months'}\n- {'measure': 'Change in Postural Star-Sitting Test (PSST) after intervention', 'description': 'The PSST will be performed before and after interventions to monitor sitting control progression in both TruST- and control-intervention groups. The investigators have several motivations that rationalize this customized measurement. It: 1) is age-appropriate, 2) is goal-oriented, 3) directly measures sitting based on trunk control improvements, 4) is responsive to capture sitting workspace area increases, and 5) offers data with a straightforward functional interpretation.', 'timeFrame': 'Through study completion, an average of 4 months'}\n- {'measure': 'Change in Box and Blocks Test (BBT) after intervention', 'description': 'The BBT examines manual dexterity. The child moves the maximum number of blocks (2.5cm2), one at a time, between the compartments of a partitioned box within 60s. B\\\\&B is sensitive to post-intervention changes with the more- and less-affected hand. Arm displacement and grasping will be analyzed with Datavyu. An instruction manual has been created to standardize video-coding procedures and define the reaching variables. Grasping will be defined from the moment the hand contacts the block to the time this is lifted from the surface. Arm displacement will be defined from end of grasping to block release. Reaching performance will be the summation of grasping and arm displacement. Two coders will be used to determine video-coding reliability.', 'timeFrame': 'Through study completion, an average of 4 months'}\n\nPlease estimate the sample size based on the assumption: \npower=0.8, two-tailed \u03b1 rate=1% (p<0.005), mixed ANOVA", "answer": 82, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n We used preliminary data from our previous study and literature to estimate sample and effect sizes.16 25 For this purpose, G-Power (V.3.1.9.4., Dusseldorf University) and SPSS (V.25, IBM) were used. Our primary outcome was upper body balance during seated reaching (Pilot average=30\u00c2\u00b0 \u00c2\u00b1 SD=22\u00c2\u00b0, partial \u00ce\u00b72=0.10, n=11). With a mixed analysis of variance (ANOVA), we estimated 68 subjects to achieve a power=0.8, considering a two-tailed \u00ce\u00b1 rate=1% (p<0.005). We will recruit an additional 20% of participants (82 participants in total) to account for potential group heterogeneity and dropouts.", "id": 1101, "split": "val"} +{"trial_id": "NCT04898699", "pmid": "36332953", "question": "Here is the design of a clinical trial:\n\nOfficial Title: IPrEP: A Combination HIV Prevention Strategy for Young Women at Risk for HIV in Kisumu, Kenya IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya\n\nIncluded conditions:\n- HIV\n\nStudy Armgroups:\n- {'label': 'PrEP+', 'type': 'EXPERIMENTAL', 'description': 'PrEP+ is an experimental pre-exposure prophylaxis (PrEP)-focused prevention strategy providing daily oral tenofovir/emtricitabine (TDF/FTC) in combination with two adherence self-management interventions: (1) real-time feedback from point-of-care urine drug-level assay, (2) HIV self-testing and (3) 2-way text message reminders in addition to standard of care HIV risk-reduction counseling among male clients (MC) of female sex workers in Kisumu, Kenya.', 'interventionNames': ['Device: UrSure Rapid Urine Tenofovir Test', 'Device: OraQuick Rapid HIV Self-test kit', 'Drug: Tenofovir (300mg)/Emtricitabine(200mg) [Truvada\u00ae]', 'Behavioral: 2-way text message reminders', 'Behavioral: HIV risk-reduction counseling']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'UrSure Rapid Urine Tenofovir Test', 'description': 'A point of care urine immunoassay to measure PrEP drug levels for adherence in participant urine samples over the preceding seven days will be done at all follow-up visits. At enrollment, study staff will explain the use of this experimental measurement of PrEP drug level in urine samples. Participants will receive results of the test at the same study visit during which it is performed.', 'armGroupLabels': ['PrEP+']}\n- {'type': 'DEVICE', 'name': 'OraQuick Rapid HIV Self-test kit', 'description': 'Participants will be provided with HIV self-testing kits to use at their discretion and, in case of multi-month dispensing, prior to start of new bottle of PrEP medication, in between study visits. HIV self-testing kits will be provided to confirm their HIV-negative status and make a connection between PrEP use and protection against HIV. Participants will receive detailed, interactive training on HIVST with pictorial elements, including instructions to contact study staff immediately in event of a reactive test for confirmation as per Kenya guidelines.', 'armGroupLabels': ['PrEP+']}\n- {'type': 'DRUG', 'name': 'Tenofovir (300mg)/Emtricitabine(200mg) [Truvada\u00ae]', 'description': 'Information will be provided regarding dosing of PrEP medications, importance of daily adherence, importance of frequent HIV testing, and signs and symptoms of drug toxicity, acute HIV infection and STIs. An initial one-month supply (30 pills) of FTC/TDF will be given to all PrEP study participants. At the one-month study assessment, a two-month supply of daily oral FTC/TDF will be given to each participant, after HIV testing, assessment for acute HIV infection and review of side effects and adherence, following national guidelines and procedures for PrEP services. At Month 3 assessment, a three-month supply of oral FTC/TDF will be given.', 'armGroupLabels': ['PrEP+']}\n- {'type': 'BEHAVIORAL', 'name': '2-way text message reminders', 'description': 'All participants will receive weekly SMS visit reminders to support PrEP adherence. Participants will be asked at study enrollment for a primary contact telephone number and an alternate number for contact. Participants without cell phones will be provided an inexpensive cell phone (although cell phone ownership is very high in Kenya). Participants will receive a discrete weekly SMS text (or voice message if participant is illiterate) to encourage healthy behaviors, use of HIV self-test kit, study engagement and PrEP adherence. Messages will be a general message that the participant has selected and will not have any information identifying the participant as part of the study or describing the purpose of the study. An example text is \"Remember to look after yourself today, See you tomorrow.\" Participants will be requested to respond to the message with any questions, concerns or messages that they have for the study staff.', 'armGroupLabels': ['PrEP+']}\n- {'type': 'BEHAVIORAL', 'name': 'HIV risk-reduction counseling', 'description': 'All study participants will be provided with brief interactive counseling at each study visit, tailored to the results of their urine assay.', 'armGroupLabels': ['PrEP+']}\n\nPrimary Outcomes:\n- {'measure': 'PrEP adherence', 'description': 'Percentage of participants with plasma tenofovir concentration of \\\\>40 ng/mL (consistent with daily adherence)', 'timeFrame': '6-month visit'}\n\nPlease estimate the sample size based on the assumption: \nDesign Effect of 2.40, significance level not explicitly stated, power not explicitly stated, assuming loss-to-follow-up of 10%.", "answer": 120, "answer_type": "ESTIMATED", "explanation": "Sample size justification\n The study sample size was determined to be 120 MCs based on feasibility concerns for conducting a convenience sample of this population. An estimate of the precision of the 95% CI of our primary outcome of 6-month adherence (described below) was obtained using the methodology applied by Cornfield and assuming a Design Effect of 2.40 A Design Effect is a simple number that estimates how much less efficient a non-random sample is compared with a simple random sample; a Design Effect of 2 implies that a non-random sample would need twice the number of individuals as a simple random sample to obtain the same-precision estimates .41\n With 120 participants enrolled, and treating those lost to follow-up as \u00e2\u0080\u0098not adherent\u00e2\u0080\u0099 (as in the primary analysis), this sample size will result in a reasonably precise estimate of adherence at 6\u00e2\u0080\u0089months. For example, assuming 70% adherence at 6\u00e2\u0080\u0089months, our powered 95%\u00e2\u0080\u0089CI will be 58.4%\u00e2\u0080\u009381.6%% (11.6% precision). Similarly, conducting a \u00e2\u0080\u0098complete case\u00e2\u0080\u0099 analysis (as in the secondary analysis) restricted to those with complete outcome ascertainment and assuming loss-to-follow-up of 10%, our powered 95%\u00e2\u0080\u0089CI will be marginally wider at 57.8%\u00e2\u0080\u009382.2% (12.2% precision).41 With 120 participants, our precision will be similar across a range of measured adherence proportions at 6 months (table 2).\n \n Table 2\n \n Width of 95%\u00e2\u0080\u0089CI for estimating adherence at 6 months, assuming a sample size of 120 and a design effect of 2\n \n \n \n \n Proportion adherent at 6\u00e2\u0080\u0089months (%)\n LCL (%)\n UCL (%)\n Precision(1/2 width of 95%\u00e2\u0080\u0089CI) (%)\n \n \n \n \n 30\n 18.4\n 41.6\n 11.6\n \n \n 40\n 27.6\n 52.4\n 12.4\n \n \n 50\n 37.3\n 62.7\n 12.7\n \n \n 60\n 47.6\n 72.4\n 12.4\n \n \n 70\n 58.4\n 81.6\n 11.6\n \n \n 80\n 69.9\n 90.1\n 10.1\n \n \n 90\n 82.4\n 97.6\n 7.6\n \n \n \n \n \n LCL, Lower Confidence Limit; UCL, Upper Confidence Limit.\n \n \n \n Quantitative data analysis will be conducted using SAS V.9.4 (Cary, North Carolina, USA). An overview of primary and secondary outcomes and their definitions follows.", "id": 1102, "split": "val"} +{"trial_id": "NCT04903002", "pmid": "34556520", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluating the Efficacy of Intranasal Oxytocin on Pain and Function Among Individuals Who Experience Chronic Pain: a Multisite, Placebo-controlled, Blinded, Sequential, Within-subjects Crossover Trial\n\nIncluded conditions:\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'Crossover sequence 1: Oxytocin first', 'type': 'OTHER', 'description': 'Patients receive 2-weeks courses of 24-IU oxytocin, placebo, 48-IU oxytocin.', 'interventionNames': ['Drug: 24-IU oxytocin', 'Drug: 48-IU oxytocin', 'Drug: Placebo']}\n- {'label': 'Crossover sequence 2: placebo first', 'type': 'OTHER', 'description': 'Patients receive 2-weeks courses of placebo, 24-IU oxytocin, 48-IU oxytocin.', 'interventionNames': ['Drug: 24-IU oxytocin', 'Drug: 48-IU oxytocin', 'Drug: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': '24-IU oxytocin', 'description': 'Patients will self-administer a 2-week course of 24-IU intranasal oxytocin \\\\[4-IU per puff (12-IU delivered to each nostril); Syntocinon, Novartis, Switzerland\\\\], twice per day (once in the morning and once in the evening).', 'armGroupLabels': ['Crossover sequence 1: Oxytocin first', 'Crossover sequence 2: placebo first']}\n- {'type': 'DRUG', 'name': '48-IU oxytocin', 'description': 'Patients will self-administer a 2-week course of 48-IU intranasal oxytocin \\\\[4-IU per puff (24-IU delivered to each nostril); Syntocinon, Novartis, Switzerland\\\\], twice per day (once in the morning and once in the evening).', 'armGroupLabels': ['Crossover sequence 1: Oxytocin first', 'Crossover sequence 2: placebo first']}\n- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Patients will receive an intranasal placebo containing the same ingredients as the oxytocin nasal spray with the exception of active oxytocin. Administration schedule and procedure will be identical to that described in 24-IU oxytocin.', 'armGroupLabels': ['Crossover sequence 1: Oxytocin first', 'Crossover sequence 2: placebo first']}\n\nPrimary Outcomes:\n- {'measure': 'Pain intensity', 'description': 'Pain severity index on the Brief Pain Inventory - Short Form (BPI-SF). Mean scores range from 0 to 10 with higher scores indicating greater pain.', 'timeFrame': 'Change from Day 1 to Day 14 of nasal spray administration.'}\n- {'measure': 'Pain-related interference', 'description': 'Pain interference index on the Brief Pain Inventory - Short Form (BPI-SF). Mean scores range from 0 to 10 with higher scores indicating greater pain-related interference.', 'timeFrame': 'Change from Day 1 to Day 14 of nasal spray administration.'}\n\nPlease estimate the sample size based on the assumption: \nOverall type I error rate of 0.05, using O'Brien and Fleming's method for interim analysis, Sidak method for multiple comparisons (\u03b1=0.0127), SD of 2.0 for pain intensity and physical function, block-based symmetric correlation matrix, and a potential attrition rate of 20%.", "answer": 336, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n We based our sample size calculation on the number of patients needed to evaluate a clinically significant reduction in pain intensity and improvement in physical function of the primary outcomes: change in pain intensity and physical function from day 1 to day 14 that occurs between conditions (24\u00e2\u0080\u0089IU oxytocin vs placebo; 48\u00e2\u0080\u0089IU oxytocin vs placebo). The hypothesis tests are one sided and the trial is powered using a sequential, repeated-measures crossover design with one interim analysis to monitor the preliminary activity of the 24\u00e2\u0080\u0089IU and 48\u00e2\u0080\u0089IU doses of oxytocin relative to placebo (refer to section 3.2.1 for greater detail on the interim analysis).\n The overall type I error rate will be 0.05 and the O\u00e2\u0080\u0099Brien and Fleming\u00e2\u0080\u0099s method77 will be used to control for the inflation of type I error due to the interim analysis. The interim analysis will be conducted when primary outcomes are available for half of the proposed sample. The Sidak method78 will be used to adjust for multiple comparisons (ie, \u00ce\u00b1=0.0127 after adjusting for 4 comparisons: 24\u00e2\u0080\u0089IU and 48\u00e2\u0080\u0089IU doses of oxytocin compared with placebo for pain intensity and physical function). Based on previous research with chronic pain populations,58 we assume a SD of 2.0 for pain intensity and physical function and a block-based symmetric correlation matrix under which the 2-week correlation within the same arm is assumed to be 0.863; the subcorrelation matrix of day 1 and day 14 pain intensity and physical function across two arms is comparable for any two arms; and the correlation of day 1 and day 1 on two arms equals that of day 14 and day 14. We anticipate that the correlation of day 1 and day 14 cross-arms will be lower than the correlation of the same day pain intensity/physical function. As a conservative measure, we assume the correlation of day 1 and day 14 is comparable to the same day correlation cross two arms and a better power will be achieved if the correlation between day 1 and day 14 is lower. The sample size is determined as the largest for two scenarios on whether the subcorrelation matrix of day 1 and day 14 is stable over phases or not.\n For the scenario of stable subcorrelation matrix of day 1 and day 14, all phases data will be included in the analysis. Target power is 0.9 to detect a 0.5 SD difference in pain intensity/physical function, which corresponds to an effect size of 0.56 for the outcomes of change between day 1 and day 14 under the aforementioned assumptions on the covariance matrix. The required sample size is 41 per province to accommodate one interim analysis. If the subcorrelation matrix of day 1 and day 14 is unstable cross phases, only the first two phases data will be included in the analysis and the size for evaluating the efficacy of the 24\u00e2\u0080\u0089IU and 48\u00e2\u0080\u0089IU over the placebo is reduced to 2/3, where the two samples are independent (\u00ce\u00b1=0.0127 using Sidak). Under this scenario, the power is set as 0.8 for the same effect size and the required sample size is 54, which is increased to 81 accounting for abandoning the phase III data due to instability of the correlation. Therefore, the sample size of 81 per province will be used and this is the robust size to guarantee at least 80% power and an overall type I error of 0.05 with an interim analysis for different scenarios of the correlation matrix of pain intensity/physical function. The covariates of sex and province will be adjusted and the rule of 8 additional cases per covariate will be followed for the combined analysis on the efficacy of 24\u00e2\u0080\u0089IU and 48\u00e2\u0080\u0089IU oxytocin relative to placebo. Accounting for a potential attrition rate of 20% and the balance among the 2 sequences per province, a total sample of 336 patients (112 per province) is required.", "id": 1103, "split": "val"} +{"trial_id": "NCT04903275", "pmid": "35279220", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Caries Inhibition With CO2-Laser During Orthodontic Treatment\n\nIncluded conditions:\n- Caries; Initial\n\nStudy Armgroups:\n- {'label': 'Fluoride and Laser', 'type': 'EXPERIMENTAL', 'description': 'In the split-mouth design, the left maxillary anterior teeth receive topical fluoride application and carbon dioxide (CO2) laser irradiation.', 'interventionNames': ['Procedure: Topical fluoride application and Laser irradiation']}\n- {'label': 'Fluoride', 'type': 'ACTIVE_COMPARATOR', 'description': 'In the split-mouth design, this arm - the contralateral teeth (right maxillary incisors), will receive topical fluoride application.', 'interventionNames': ['Procedure: Topical fluoride application']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Topical fluoride application and Laser irradiation', 'description': 'Topical fluoride varnish application (Clinpro\u2122 White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth followed by laser irradiation with CO2-laser (Ultra Dream Pulse, DS_40U, Daeshin Enterprise, Seoul, South Korea), emission wavelength 10,600 nm, time on-100 \u03bcs, time off-40 ms; average power-0.73 W; peak power-292.73 W; speed of movement-2 mm/s; energy density with movements-5 J/cm2; tip-to-tissue distance-20 mm; tip diameter 700 \u03bcm; irradiation time-30 s.', 'armGroupLabels': ['Fluoride and Laser']}\n- {'type': 'PROCEDURE', 'name': 'Topical fluoride application', 'description': 'Topical fluoride varnish application (Clinpro\u2122 White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth', 'armGroupLabels': ['Fluoride']}\n\nPrimary Outcomes:\n- {'measure': 'Changes into International Caries Detection and Assessment System (ICDAS) codes', 'description': \"The International Caries and Detection System (ICDAS) is a visual scoring system developed for use in clinical assessment and clinical research of caries development and progression. It uses a numbered scoring system with a range from 0 to 6, to grade enamel demineralization and cavitation. Code of '0' represents unaffected/sound enamel, no caries change, '1' - first visual change, represents initial demineralization that is visible only after air drying, '2' represents a distinct visual change in the enamel that is visible when the surface is wet, '3' represents localized enamel loss or breakdown, no visible dentin or underlying shadow, and '4-6' represent larger carious lesions in dentin.\", 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 95% and power of 80%", "answer": 41, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation is based on our primary outcome endpoint of changes in ICDAS score on the vestibular surfaces of the anterior maxillary teeth in the left and the right quadrants per subject, by comparing the proportion of teeth with worsening ICDAS score in experimental in comparison to the control group. To determine the sample size for each group, a priori power analysis was conducted as follows:\n\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$ n=\\frac{\\left(z\\frac{\\upalpha}{2}+\\mathrm{z}\\upbeta \\right)2\\left(p1\\left(1-p1\\right)+p2\\ \\left(1-p2\\ \\right)\\right)}{\\begin{array}{c}\\left(p1-p2\\right)2\\\\ {}\\end{array}} $$\\end{document}n=z\u00ce\u00b12+z\u00ce\u00b22p11\u00e2\u0088\u0092p1+p21\u00e2\u0088\u0092p2p1\u00e2\u0088\u0092p22\n p1: 8.7% of the lesion incidence in the control group\n p2: 3.6% of the lesion incidence in the laser group\n The data for this power analysis were obtained from a previous study.9 The significance level was considered as 95% and power was 80%. By inserting the minimum values in the above formula, the sample size was calculated as 241 teeth (121 teeth per group, i.e., a total number of 41 patients).", "id": 1104, "split": "val"} +{"trial_id": "NCT04904107", "pmid": "39806626", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicentre Randomized Controlled Trial to Improve the accUracy of Referrals to the emerGency departmEnt of patieNts With chesT Pain by Using the Modified HEART Score in Emergency Medical Transport (URGENT 2.0)\n\nIncluded conditions:\n- Chest Pain\n- Acute Coronary Syndrome\n- Myocardial Infarction\n- Myocardial Ischemia\n- Heart Attack\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Chest pain patients in the intervention group will be assessed by EMT personnel by performing the modified HEART score (including POC high sensitive troponin-I measurement (POC HS cTnI)) and the referral policy depends on the result.\\n\\n* In case of a low modified HEART score (modified HEART 0-3) patients will not be referred to the cardiac ED.\\n* Patients with a modified HEART score \\\\>3 are directly referred to the cardiac ED after evaluation. These patients will receive standard care.', 'interventionNames': ['Diagnostic Test: modified HEART score (including POC hs cTnI analysis)']}\n- {'label': 'Control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Chest pain patients in the control group will receive standard triage and standard care according to the local (EMT) protocol.', 'interventionNames': ['Other: Standard care and triage according to the local (EMT)protocol.']}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'modified HEART score (including POC hs cTnI analysis)', 'description': 'The modified HEART score was developed in 2007 and has been validated to stratify the risk of short-term adverse cardiac events in patients with chest pain at the ED. Negative predictive value (NPV) of the modified HEART score for ACS as well as positive predictive value (PPV) for major adverse cardiac events (MACE) within 6 weeks after presentation is high.\\n\\nThe modified HEART score is an acronym for history, ECG, age, risk factors and troponin at arrival.The components can be rated 0,1 or 2 points each and result in a total score between 0 and 10.', 'armGroupLabels': ['Intervention group']}\n- {'type': 'OTHER', 'name': 'Standard care and triage according to the local (EMT)protocol.', 'description': 'Standard care and triage of chest pain patients according to the local (EMT)protocol.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'The incidence of non-cardiac chest pain (NCCP) patients admitted at the cardiac ED (percentage, %)', 'description': 'Evaluation of the percentage of NCCP patients admitted to the cardiac ED by performing the modified HEART score in comparison to our control group (regular triage and care). We aim to detect a reduction of minimal 10% in unnecessarily referred chest pain patients (NCCP patients) but expect an even higher percentage. A lower percentage of NCCP patients indicates improval of the triage of chest pain patients.', 'timeFrame': '30 days'}\n- {'measure': 'The incidence of MACE (percentage, %)', 'description': 'The mortality and major adverse cardiovascular events (MACE) i.e. acute myocardial infarction, non-elective percutaneous coronary intervention, coronary artery bypass grafting or all cause death within 30 days, 6 months and 1 year after initial presentation in the intervention group versus control group.\\n\\nWe aim that the proportion of MACE in the intervention group (modified HEART score) is non-inferior to the control group (regular care and triage). Preliminary results of the second phase of FAMOUS Triage trial showed 15.7% (13.1-18.6) MACE rate.We used the expected incidence of 15.7% as the point estimate (meaning no difference between control and intervention). A higher MACE rate (%) in the intervention group suggests a worst outcome.', 'timeFrame': '30 days, 6 months and 1 year'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% and a two-tailed type I error of 5% for the primary endpoint; 90% power and a one-sided 95% CI (or equivalently a 90% two-sided CI) for the safety endpoint. Correction for loss to follow-up is also considered.", "answer": 852, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n A large sample size is required to adequately power both the efficacy and safety endpoint and for the eventual implementation of the modified HEART score in the prehospital setting.\n A baseline registry performed at our hospital in 2015 showed that 74.5% of the patients who contacted the GPC were unnecessarily referred to the ED with suspected ACS.22 For the sample size calculation based on the primary endpoint, we used the clinical calculator (https://clincalc.com/stats/samplesize.aspx). Aiming at a power of 80% and a two-tailed type I error of 5%, 328 patients need to be enrolled within this study in each study group (the intervention and control group) in order to be able to demonstrate a reduction of 10% in unnecessarily referred patients.\n The sample size calculation for the safety endpoint is based on demonstrating that the proportion of MACE in the intervention group is non-inferior to that in the control group. Preliminary results of the second phase of the FAMOUS Triage trial showed a 15.7% (13.1\u00e2\u0080\u009318.6) MACE rate.23 We used the expected incidence of 15.7% as the point estimate (meaning no difference between the control group and the intervention group). Phase 3 of the FAMOUS Triage trial is a non-inferiority trial, controlled before\u00e2\u0080\u0093after multicentre study with a sequential design with the aim to assess feasibility and safety of prehospital risk assessment by paramedics using the HEART score.24 Based on the study design paper of this trial, we set the non-inferiority margin at 7.5%. For the sample size calculation, we used the clinical calculator (see https://www.sealedenvelope.com/power/binary-noninferior/).\n If there is truly no difference between the standard and experimental treatment (15.7% in both groups), then 808 patients are required to be 90% sure that the upper limit of a one-sided 95% CI (or equivalently a 90% two-sided CI) will exclude a difference in favour of the standard group of more than 7.5%.\n To correct for loss to follow-up, we will include 426 patients in the intervention group and 426 patients in the control group, adding up to a total study population of 852 patients.", "id": 1105, "split": "val"} +{"trial_id": "NCT04907669", "pmid": "34836907", "question": "Here is the design of a clinical trial:\n\nOfficial Title: An Implementation Study of Suicide Risk Management Among Discharged Psychiatric Patients Based on Brief Contact Interventions and Sequential Multiple Assignment Randomized Trial\n\nIncluded conditions:\n- Suicide\n\nStudy Armgroups:\n- {'label': 'Group 1a', 'type': 'EXPERIMENTAL', 'description': \"After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 1, participants will receive brief contact intervention (BCI) monthly. If participants' suicide risk increased at 3 months after discharge, they will be re-randomized into Group 1a and Group 1b to receive BCIs weekly (Group 1a) and bi-weekly (Group 1b).\", 'interventionNames': ['Other: Brief contact intervention']}\n- {'label': 'Group 1b', 'type': 'EXPERIMENTAL', 'description': \"After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 1, participants will receive brief contact intervention (BCI) monthly. If participants' suicide risk increased at 3 months after discharge, they will be re-randomized to receive BCIs weekly (Group 1a) and bi-weekly (Group 1b).\", 'interventionNames': ['Other: Brief contact intervention']}\n- {'label': 'Group 1c', 'type': 'EXPERIMENTAL', 'description': \"After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 1, participants will receive brief contact intervention (BCI) monthly. If participants' suicide risk decreased or did not change, they will remain receiving BCIs monthly as Group 1c.\", 'interventionNames': ['Other: Brief contact intervention']}\n- {'label': 'Group 2a', 'type': 'EXPERIMENTAL', 'description': 'After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 2, participants will receive brief contact intervention (BCI) weekly. If the suicide risk increased or did not change, they will remain receiving BCIs weekly as Group 2a.', 'interventionNames': ['Other: Brief contact intervention']}\n- {'label': 'Group 2b', 'type': 'EXPERIMENTAL', 'description': 'After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 2, participants will receive brief contact intervention (BCI) weekly. If the suicide risk decreased, they will be re-randomized to receive BCIs monthly (Group 2b) and bi-weekly (Group 2c).', 'interventionNames': ['Other: Brief contact intervention']}\n- {'label': 'Group 2c', 'type': 'EXPERIMENTAL', 'description': 'After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 2, participants will receive brief contact intervention (BCI) weekly. If the suicide risk decreased, they will be re-randomized to receive BCIs monthly (Group 2b) and bi-weekly (Group 2c).', 'interventionNames': ['Other: Brief contact intervention']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Brief contact intervention', 'description': \"The BCI in this study is a series of structured messages, and messages will be delivered to participants by pushing feeds through WeChat and an iOS/Android application developed for this study. If participants did not use smartphones, messages will be delivered by mobile text messages or by phone calls. Though the final details are yet to be determined by the CBPR study, the investigators expect to structure messages into six components including introduction, greetings for previous complains, mental health promotion, encouragement, and coping strategies, remind of treatment and subsequent visit, and crisis intervention resource.\\n\\nNoted, the same messages will also be sent to patients' LHSs.\", 'armGroupLabels': ['Group 1a', 'Group 1b', 'Group 1c', 'Group 2a', 'Group 2b', 'Group 2c']}\n\nPrimary Outcomes:\n- {'measure': 'The trajectory of suicide ideation from baseline to three months after discharge', 'description': \"This study will use the Beck Suicide Ideation Scale-Chinese Version (BSI-CV) to assess participants' suicide ideation. The BSI-CV includes 19 items, and each item scores from 0 to 2 with a total score ranging from 0 to 38, and a higher score indicates a higher level of suicide ideation. The total score's trajectory from baseline to three months after discharge will be recorded and compared.\", 'timeFrame': 'It will be evaluated at three months after discharge.'}\n- {'measure': 'The trajectory of suicide ideation from baseline to 12 months after discharge', 'description': \"This study will use the Beck Suicide Ideation Scale-Chinese Version (BSI-CV) to assess participants' suicide ideation. The BSI-CV includes 19 items, and each item scores from 0 to 2 with a total score ranging from 0 to 38, and a higher score indicates a higher level of suicide ideation. The total score's trajectory from baseline to 12 months after discharge will be recorded and compared.\", 'timeFrame': 'It will be evaluated at 12 months after discharge.'}\n\nPlease estimate the sample size based on the assumption: \ntype I error \u03b1 at 0.05, type II error \u03b2 at 0.20, power (1-\u03b2) at 0.80, and a 20% increase in sample size to account for dropout", "answer": 624, "answer_type": "ESTIMATED", "explanation": "Sample size\n The sample size was calculated to estimate the primary effect between group 1 and group 2 in the trial.67 We set the rate of type I error \u00ce\u00b1 at 0.05, the rate of type II error \u00ce\u00b2 at 0.20, the power (1-\u00ce\u00b2) at 0.80, the moderate effect size d at 0.35,68 and the sample size is 130 for each group, 260 in total; considering dropout, we will increase the sample size by 20%, and the final sample size is 312 participants. We will conduct two SMART trials in patients with psychotic symptoms and MDD separately, and the sample size for each trial is 312 (624 patients in total). We aim to recruit participants from 1 January 2022 until the sample size is reached.", "id": 1106, "split": "val"} +{"trial_id": "NCT04908241", "pmid": "37474180", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT): A Randomized Controlled Trial\n\nIncluded conditions:\n- Stroke\n- Stroke, Ischemic\n- Stroke Hemorrhagic\n- Cerebral Injury\n- Cerebral Infarction\n- Brain Diseases\n- Central Nervous System Diseases\n- Cerebral Vascular Accident\n- Cerebral Vascular Disorder\n- Brain Ischemia\n- Brain Infarction\n- Cardiovascular Diseases\n- Infarction\n\nStudy Armgroups:\n- {'label': 'TRAIL', 'type': 'EXPERIMENTAL', 'description': 'TRAIL is a 4-week progressive exercise and self-management intervention for lower extremity recovery delivered by a trained registered physical therapist, in a 2:1 participant-to-therapist ratio. Each participant grouping will receive two telerehabilitation sessions (60-90 minutes) each week for 4 weeks (total 8-12 hours).', 'interventionNames': ['Other: TRAIL']}\n- {'label': 'EDUCATION', 'type': 'ACTIVE_COMPARATOR', 'description': 'The EDUCATION control arm is a 4-week education program focusing on stroke knowledge and risk factors. It will be delivered by health professionals who have experience working with individuals with stroke, knowledge of chronic disease self-management (e.g. physical or occupational therapists, nurses, kinesiologists), and who have completed study-specific training on the EDUCATION program\\n\\nParticipants will receive video conferencing sessions with the same schedule and 2:1 participant-to-coach ratio as TRAIL. Each participant grouping will receive two educational telerehabilitation sessions (60-90 minutes) each week for 4 weeks (total 8-12 hours).', 'interventionNames': ['Other: EDUCATION']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'TRAIL', 'description': 'Each week has a specific focus for lower extremity rehabilitation:\\n\\nWeek 1) Building a base: 8 exercises, 10-15 repetitions x 2-3 sets\\n\\nWeek 2) Increasing repetitions: 8 exercises, 15-20 repetitions x 3 sets\\n\\nWeek 3) Building exercise tolerance:10 exercises, 15-20 repetitions x 3 sets\\n\\nWeek 4) Maximizing repetitions: 10 exercises, 30 seconds as many reps as possible x 2 sets\\n\\nAt the end of the second exercise session each week, the therapist and participants work collaboratively to develop an independent exercise action plan to be completed before the first session of the next week. The self-managed plans includes exercises selected from TRAIL, agreed upon by the participant and therapist, that are safe to perform without therapist oversight. The aims of the exercise action plan are to: i) Add exercise volume without using program resources (e.g., therapist time); and ii) Build capacity for self-management for long-term health and well-being after TRAIL has ended.', 'armGroupLabels': ['TRAIL']}\n- {'type': 'OTHER', 'name': 'EDUCATION', 'description': 'EDUCATION has a specific focus on:\\n\\nWeek 1) What is stroke (e.g., gaining an understanding of the function of the brain, types of stroke and how stroke affects physical function) and introduction to self-management;\\n\\nWeek 2) What is self-management;\\n\\nWeek 3) Self-management for post-stroke complications (e.g., activities of daily living);\\n\\nWeek 4) Self-management for secondary prevention (e.g., blood pressure, diet, medication, stress management).\\n\\nEducation therapists will be provided with lesson plans and manuals to be circulated with the participants, and will facilitate the educational session through interactive Powerpoint presentations. In addition, participants will be asked to complete 30-60 minutes of educational homework, which will be discussed at the commencement of the following session.', 'armGroupLabels': ['EDUCATION']}\n\nPrimary Outcomes:\n- {'measure': 'Change from baseline Timed Up and Go (TUG) at 4 weeks', 'description': 'Performance walking test to assess functional mobility', 'timeFrame': 'Baseline, Post-Intervention (immediately following 4 weeks of intervention), 3-months, 6-months'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level of 0.05 (two-sided), 80% power, and 20% attrition rate.", "answer": 96, "answer_type": "ESTIMATED", "explanation": "Sample size estimate\n Based on our feasibility study with an SD of 9.6\u00e2\u0080\u0089s of the virtual/online TUG as our primary clinical outcome, we require a sample size of 74 participants to detect a clinically important difference of 5 s37 between groups, at a level of significance of 0.05 (two-sided), with 80% power (G*Power, V.3.1.9.7, D\u00c3\u00bcsseldorf GER). To account for 20% attrition, we will recruit 93 participants, plus another 3 participants to ensure the 2:1 participant-to-therapist ratio for each of the TRAIL and EDUCATION groups, for a total of 96 participants (48 per study arm). Our previous work has found very low ICCs (<0.01) for walking and mobility outcomes across six Canadian stroke rehabilitation centres.38 Thus, clustering by site was not considered in the sample size calculation.", "id": 1107, "split": "val"} +{"trial_id": "NCT04909229", "pmid": "35940841", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia\n\nIncluded conditions:\n- Insomnia Chronic\n\nStudy Armgroups:\n- {'label': 'PEAR-003b PDT Intervention', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.', 'interventionNames': ['Device: PEAR-003b PDT Intervention', 'Device: Fitbit', 'Behavioral: Sleep education materials']}\n- {'label': 'Control Arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.', 'interventionNames': ['Device: Fitbit', 'Behavioral: Sleep education materials']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'PEAR-003b PDT Intervention', 'description': 'The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.', 'armGroupLabels': ['PEAR-003b PDT Intervention']}\n- {'type': 'DEVICE', 'name': 'Fitbit', 'description': 'Patients will receive a Fitbit and receive standard of care', 'armGroupLabels': ['Control Arm', 'PEAR-003b PDT Intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Sleep education materials', 'description': 'Patients will receive sleep hygiene and healthy sleep tips.', 'armGroupLabels': ['Control Arm', 'PEAR-003b PDT Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Change in Insomnia Severity', 'description': \"Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)\", 'timeFrame': 'From baseline to 9 weeks post randomization'}\n\nPlease estimate the sample size based on the assumption: \nAlpha 0.05, 25% dropout rate, normally distributed outcomes, and the analysis may draw from outcome values recorded at baseline and each follow-up time.", "answer": 100, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n Our sample size was determined assuming 90% power to detect an effect size of d=0.52\u00e2\u0080\u0089for the main outcome (change in ISI from baseline to 9-week postrandomisation),50 with alpha 0.05 using the PASS software (PASS 15) to detect a clinically meaningful change.53 This effect size is 1/2 to 1/3 of what we have seen previously. Because this effect size is smaller than the levels demonstrated in RCTs, we are adequately powered to detect changes of interest in the main ISI outcome. We further note that this calculation is conservative because the analysis may optionally draw from outcome values recorded at baseline and each follow-up time. Because the models assume that each outcome is normally distributed, the outcome effects represent the average amount each outcome is expected to change with the incremental shift in any explanatory variable. We will recruit a total of 100 participants and will randomly assign them to treatment and control arms based on a 50% probability of assignment. We also assume a 25% rate of dropout between baseline and the end of follow-up, resulting in an effective sample size of N=80. The dropout attrition rate is based on prior research on the SHUTi intervention where study dropout attrition at 1\u00e2\u0080\u0089year has been as high as 50%50 although another study was as low as 4%21 at the end of treatment evaluation. This may be due to the fact that differential dropout is frequently greater in active than control conditions in clinical trials due to the added psychological effort required in the active group and/or to attainment of treatment goals.", "id": 1108, "split": "val"} +{"trial_id": "NCT04909528", "pmid": "37872628", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Premature Ventricular Contractions\n\nIncluded conditions:\n- Premature Ventricular Contraction\n\nStudy Armgroups:\n- {'label': 'Experimental Group', 'type': 'EXPERIMENTAL', 'description': 'Low-level tragus stimulation', 'interventionNames': ['Device: Low-level tragus stimulation']}\n- {'label': 'Control Group', 'type': 'SHAM_COMPARATOR', 'description': 'Sham stimulation', 'interventionNames': ['Device: Sham stimulation']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Low-level tragus stimulation', 'description': 'Frequency: 20Hz; Pulse width: 0.2 ms; Current is based on the following: Determine the perception threshold (feeling tingling) at the time of baseline information assessment. Because of sensory adaptation, ask the patient 5 minutes later to increase the current by 1-5 mA. Try to find the current level below the discomfort level and above the perception threshold; Stimulation spot: ear tragus; Stimulation time: 30 min in the morning (from 6:00 a.m. to 9:00 a.m.) and 30 min in the evening (from 20:00 p.m. to 23:00 p.m.)', 'armGroupLabels': ['Experimental Group']}\n- {'type': 'DEVICE', 'name': 'Sham stimulation', 'description': 'Frequency: 20 Hz; Pulse width: 0.2 ms; Current is based on the following: Determine the perception threshold (feeling tingling) at the time of baseline information assessment. Because of sensory adaptation, ask the patient 5 minutes later to increase the current by 1-5 mA. Try to find the current level below the discomfort level and above the perception threshold; Stimulate spot: ear lobe. Stimulation time: 30 min in the morning (from 6:00 a.m. to 9:00 a.m.) and 30 min in the evening (from 20:00 p.m. to 23:00 p.m.)', 'armGroupLabels': ['Control Group']}\n\nPrimary Outcomes:\n- {'measure': 'PVC burden', 'description': 'Patients underwent noninvasive continuous ECG monitoring using an adhesive continuous ECG patch for 10 days to evaluate their PVC burden which is de\ufb01ned as the percentage of premature ventricular beats in total heart beats.', 'timeFrame': '3 months follow-up'}\n- {'measure': 'PVC burden', 'description': 'Patients underwent noninvasive continuous ECG monitoring using an adhesive continuous ECG patch for 10 days to evaluate their PVC burden which is de\ufb01ned as the percentage of premature ventricular beats in total heart beats.', 'timeFrame': '6 months follow-up'}\n\nPlease estimate the sample size based on the assumption: \n80% power, two-sided significance alpha level of 0.05, and a potential drop-out rate of 10%.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on the 11 patients who underwent 1 month of stimulation, the average burden at baseline was 21.7% and the relative reduction after stimulation was 16.4%. We assume a baseline burden of 15% and expect a reduction of 40% at the end of 6 months. A sample size of 90 patients would provide at least 80% power to detect the specified effect sizes at a two-sided significance alpha level of 0.05. The sample size was calculated by using online statistic system (STATBOX, http://www.cnstat.org/statbox/; last access 9/19/2023). The exact formula used for sample size was as follows.\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$$1-{\\varvec{\\beta}}={\\varvec{P}}{\\varvec{\\upgamma}}[{\\varvec{F}}(1,{\\varvec{N}}-2,{\\varvec{N}}\\{\\left({{\\varvec{\\upomega}}}_{1}{{\\varvec{\\upomega}}}_{2}\\right)[\\frac{{{\\varvec{\\mu}}}_{1}-{{\\varvec{\\mu}}}_{2}}{{\\varvec{\\sigma}}}{]}^{2}\\})\\ge {{\\varvec{F}}}_{\\boldsymbol{\\alpha }}]$$\\end{document}1-\u00ce\u00b2=P\u00ce\u00b3[F(1,N-2,N{\u00cf\u00891\u00cf\u00892[\u00ce\u00bc1-\u00ce\u00bc2\u00cf\u0083]2})\u00e2\u0089\u00a5F\u00ce\u00b1]\\documentclass[12pt]{minimal}\n\t\t\t\t\\usepackage{amsmath}\n\t\t\t\t\\usepackage{wasysym} \n\t\t\t\t\\usepackage{amsfonts} \n\t\t\t\t\\usepackage{amssymb} \n\t\t\t\t\\usepackage{amsbsy}\n\t\t\t\t\\usepackage{mathrsfs}\n\t\t\t\t\\usepackage{upgreek}\n\t\t\t\t\\setlength{\\oddsidemargin}{-69pt}\n\t\t\t\t\\begin{document}$${{\\varvec{n}}}_{1}={{\\varvec{N}}}^{\\boldsymbol{*}}{{\\varvec{\\omega}}}_{1},\\boldsymbol{ }{{\\varvec{n}}}_{2}=\\boldsymbol{ }{{\\varvec{N}}}^{\\boldsymbol{*}}{{\\varvec{\\omega}}}_{2}$$\\end{document}n1=N\u00e2\u0088\u0097\u00cf\u00891,n2=N\u00e2\u0088\u0097\u00cf\u00892\n To account for a potential drop-out rate of 10%, 50 patients in each group and 100 patients in total are planned to be recruited.", "id": 1109, "split": "val"} +{"trial_id": "NCT04911517", "pmid": "35477432", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rationale and Design of a Prospective, Multicenter Phase \u2161 Clinical Trial of Safety and Efficacy Evaluation of Long Course Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.\n\nIncluded conditions:\n- Colorectal Neoplasms\n\nStudy Armgroups:\n- {'label': 'long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations', 'type': 'EXPERIMENTAL', 'description': 'long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer', 'interventionNames': ['Combination Product: long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations']}\n\nInterventions:\n- {'type': 'COMBINATION_PRODUCT', 'name': 'long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations', 'description': 'long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer', 'armGroupLabels': ['long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations']}\n\nPrimary Outcomes:\n- {'measure': 'pathologic complete response\uff08pCR\uff09', 'description': 'All the enrolled patients will receive total mesorectal excision (TME) 7-9 weeks after the end of long course radiotherapy. The rectal specimens will be evaluated by the pathologists who are experienced on the rectal cancer diagnosis according to the 1997 Dworak grading system. The rectal cancer will be classified into 5 grades. Grade 0-3 will be considered as non-pCR while grade 4 represent pCR.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nThe required sample size was calculated with 80% power, 95% confidence intervals, and a 10% loss of follow-up rate. Statistical analyses will use SPSS software (version 22.0), with 2-tailed analyses, 5\u201395% confidence intervals, and p-values < 0.05 considered statistically significant.", "answer": 50, "answer_type": "ESTIMATED", "explanation": "Sample size and statistical analysis\n This study is designed as a multicenter, single-arm phase II clinical trial. The pCR rate of single preoperative NCRT is assumed to be about 15% according to previous studies [14, 15]. On the other hand, the expectant pCR rate in this trail will be 40%. The required sample size was calculated to be 50 patients with 80% power and 95% confidence intervals. Moreover, 10% loss of follow-up rate is also considered. Such sample size was calculated using PASS software (version 15).\n Statistical analyses will be in progress using the SPSS software (version 22.0). All analyses were 2-tailed. The confidence interval was 5\u00e2\u0080\u009395%. p-values\u00e2\u0080\u0089<\u00e2\u0080\u00890.05 were considered as statistically significant. Continuous variables will be presented as means\u00e2\u0080\u0089\u00c2\u00b1\u00e2\u0080\u0089standard deviation and analyzed using an unpaired t-test with Welch\u00e2\u0080\u0099s correction. Categorical variables will be presented as number and percentage and analyzed using chi-square test with Fisher\u00e2\u0080\u0099s exact test. The Kaplan\u00e2\u0080\u0093Meier method and log-rank test were used to calculate the DFS and OS.", "id": 1110, "split": "val"} +{"trial_id": "NCT04912206", "pmid": "36153600", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain, Prospective Randomized Dual Centre Study\n\nIncluded conditions:\n- Abdominal Pain\n\nStudy Armgroups:\n- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Point-of-Care Ultrasound on top of diagnosis work-up', 'interventionNames': ['Diagnostic Test: Point-of-Care Ultrasound']}\n- {'label': 'Control', 'type': 'NO_INTERVENTION', 'description': 'Usual diagnosis work-up without Point-of-Care Ultrasound'}\n\nInterventions:\n- {'type': 'DIAGNOSTIC_TEST', 'name': 'Point-of-Care Ultrasound', 'description': 'Abdominal clinician-performed Ultrasound', 'armGroupLabels': ['Intervention']}\n\nPrimary Outcomes:\n- {'measure': 'Exact diagnostic rate', 'description': 'Comparison of the rate of exact diagnostic after clinical exam and biological results with point-of-care ultrasound (interventional arm) or without (control arm) according to the adjudication committee diagnostic (reference diagnosis).', 'timeFrame': \"The reference diagnosis will be determined by an adjudication committee on the basis of an exhaustive analysis of the patient's file at Day 28\"}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a 0.05 alpha risk, 80% power, and a 5% attrition rate.", "answer": 256, "answer_type": "ACTUAL", "explanation": "Sample size calculation\n According to Lindelius [7], a correct diagnosis has been reached in 56.8% of patients consulting to the ED for acute abdominal pain after the clinical exam and biological results. The hypothesis is based on an improvement of 30% of diagnostic accuracy by POCUS. Jang [10] demonstrated an improvement of diagnostic accuracy by 45% while Lindelius by 8% [7, 8]. A correct diagnostic rate of 57% is expected in the control group and 74% in the intervention group. With a 0.05 alpha risk and a 80% power, 244 patients will be required. A 5% attrition rate (patients randomized but presenting exclusion criteria) is expected; thus, 256 randomized patients are needed for this study.", "id": 1111, "split": "val"} +{"trial_id": "NCT04913649", "pmid": "37885026", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'\n\nIncluded conditions:\n- Iron Deficiency Anemia\n\nStudy Armgroups:\n- {'label': 'Intravenous iron (ferric derisomaltose)', 'type': 'EXPERIMENTAL', 'description': 'The intervention consists of a single dose of ferric derisomaltose (Monofer\u00ae) 100 mg/mL solution for infusion (Monofer\u00ae is a registered product with a marketing authorization in the Netherlands (RVG number: 103070). Manufacturer: Pharmacosmos A/S, Denmark. Dutch marketing authorization holder: Cablon Medical B.V). The method of administration and dosage of the investigational medication are standard treatment. The ferric derisomaltose dose will calculated for each patient depending on body weight (20mg/kg) and diluted in 250 ml NaCl 0.9%. Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards', 'interventionNames': ['Drug: Ferric Derisomaltose 100 MG/ML']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Single dose of sodium chloride 0.9% (250ml). Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards', 'interventionNames': ['Drug: Sodium chloride']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Ferric Derisomaltose 100 MG/ML', 'description': 'Postoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg/kg in approximately 60 minutes.', 'armGroupLabels': ['Intravenous iron (ferric derisomaltose)'], 'otherNames': ['Monofer']}\n- {'type': 'DRUG', 'name': 'Sodium chloride', 'description': 'Postoperative treatment with a single dose NaCl 0.9% in approximately 60 minutes.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Disability', 'description': 'Disability measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12). Based on the answers a disability score can be calculated. 0% is no disability and 100% is fully disabled.', 'timeFrame': '90 days after elective cardiac surgery'}\n\nPlease estimate the sample size based on the assumption: \nTwo-tailed unpaired T-test with a two-sided significance level of 5%, power of 80%, and a loss to follow-up margin of 10%.", "answer": 310, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n In the previously conducted AGE cohort (ClinicalTrials.gov Identifier NCT02535728) studying a similar patient population, the mean WHODAS 2.0 score for CABG and AVR patients after 3\u00c2\u00a0months was 12% points with a standard deviation (SD) of 15% points. For an expected effect size, a mean difference in WHODAS 2.0 score of 5% points or more between the treatment and placebo groups was chosen. This difference in WHODAS 2.0 score is consistent with a clinically relevant change in disability [18]. We based our sample size estimate on the most conservative (largest) standard deviation, which was 15% points. To detect a mean difference in WHODAS 2.0 score of 5% points at 90\u00c2\u00a0days using a two-tailed unpaired T-test with a two-sided significance level of 5% and a power of 80% with equal allocation to two arms would require 142 patients per treatment group. Taking into account a loss to follow-up margin of 10%, we aim to include a total cohort of 310 patients. Calculations were performed using R version 3.6.1\u00e2\u0080\u0094\u00c2\u00a9 2019\u00e2\u0080\u009307-05, R, Inc., for Windows.", "id": 1112, "split": "val"} +{"trial_id": "NCT04915027", "pmid": "37803460", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Rehabkompassen\u00ae - a Novel Digital Tool for Facilitating Patient-tailored Rehabilitation in the Post-acute Continuum of Care After Stroke - A Multicenter Pragmatic Randomized Controlled Trial\n\nIncluded conditions:\n- Stroke\n\nStudy Armgroups:\n- {'label': 'Intervention i.e. with Rehabkompassen\u00ae', 'type': 'EXPERIMENTAL', 'description': 'The participants will use the digital graphic Rehabkompassen\u00ae at follow-up.', 'interventionNames': ['Other: a usual follow-up with Rehabkompassen\u00ae']}\n- {'label': 'Control exposure i.e. without Rehabkompassen\u00ae', 'type': 'ACTIVE_COMPARATOR', 'description': 'The participants will use Post-Stroke Checklist at follow-up as recommended by \"Socialstyrelsen\".', 'interventionNames': ['Other: a usual follow-up with Post-Stroke Checklist, i.e. without Rehabkompassen\u00ae']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'a usual follow-up with Rehabkompassen\u00ae', 'description': \"Rehabkompassen\u00ae is a patient-centered digital graphic tool for capturing the patient's rehabilitation needs in the follow-up after stroke.\", 'armGroupLabels': ['Intervention i.e. with Rehabkompassen\u00ae']}\n- {'type': 'OTHER', 'name': 'a usual follow-up with Post-Stroke Checklist, i.e. without Rehabkompassen\u00ae', 'description': 'Post-Stroke Checklist consists of eleven questions concerning common and treatable post-stroke problems affecting quality of life.', 'armGroupLabels': ['Control exposure i.e. without Rehabkompassen\u00ae']}\n\nPrimary Outcomes:\n- {'measure': 'Daily activities', 'description': 'The simplified modified Rankin Scale questionnaire (smRSq) will be used to measure daily activities and functional status. The smRSq is based on the yes/no responses to five questions, which in turn results an ordinal data of seven categories (0-6) of the modified Rankin Scale. A favorable outcome will be defined as mRS score of 0-2 (no symptoms to independent but with minor disability). A poor outcome will be defined as mRS score of 3-5 (disability but able to walk to bed-bound and in need of full nursing care) or 6 (death).', 'timeFrame': '12 months follow-up after stroke'}\n- {'measure': 'Social activities', 'description': 'Stroke Impact Scale 3.0 (SIS)-participation (SIS-p) will be used to measure social activities. SIS-p is the dominant problem among persons after stroke reported in previous Swedish stroke RCTs; but not covered by smRSq. The SIS-p score ranges from 0-100 and the higher the score the less impact of stroke.', 'timeFrame': '12 months follow-up after stroke'}\n\nPlease estimate the sample size based on the assumption: \n90% power, significance level of 2.5% for each test, target familywise error rate of 5%, and a 15% loss to follow-up rate.", "answer": 1106, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n The study is predicted to have 90% power in the analysis of both primary outcomes at a significance level of 2.5% for each individual test to account for planned correction for multiple comparisons with a target familywise error rate of 5%.\n Sample size calculations were performed assuming a mean difference of 4 points in the SIS-p score between the groups at the 12-month follow-up. There is uncertainty regarding the minimum clinically important difference in the SIS-p, but differences in sizes between 10 and 15 points have previously been suggested [29]. A power analysis was conducted using Monte Carlo simulations, in which SIS-p data for the control group were generated from a beta distribution with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00891.1 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.5, while Rehabkompassen\u00c2\u00ae data were generated under the assumption of \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00891.1 and \u00ce\u00b2\u00e2\u0080\u0089=\u00e2\u0080\u00890.385. This corresponds approximately to a mean value of 70 and a standard deviation of 28 for the control group, in line with what Guidetti et al. [25] reported for a population of stroke patients at 12 months after stroke. Under these assumptions, the results showed that we need to include 940 patients to detect a statistically significant difference in the SIS-p score when using an ordinal proportional odds model to compare the groups at the 12-month follow-up. The average odds ratio across all simulations was 1.5, as estimated using the function orm from the R package rms for comparing the intervention group to the control group [40].\n The sample size calculation for the mRS score was based on aggregated unpublished data from the Swedish Stroke Register (Riksstroke). The marginal distribution of mRS scores collected 12\u00c2\u00a0months after stroke among Swedish patients was 0: 22.4%, 1: 18.0%, 2: 18.0%, 3: 16.8%, 4: 11.1%, 5: 4.3% and 6: 9.4%. The function popower from the package Hmisc [41] in the statistical software R was used to determine that a sample size of 940 patients (470 in each group) is sufficient to detect a true odds ratio of 0.67 at 90% power when using an ordinal proportional odds model to compare groups.\n Thus, 940 patients should be sufficient for both primary outcomes. To account for a 15% loss to follow-up rate, we plan to recruit 1106 patients for the study (Fig.\u00c2\u00a03).", "id": 1113, "split": "val"} +{"trial_id": "NCT04915339", "pmid": "35777867", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Pilot Study Among Type 2 Diabetes Patients Investigating Effects of Computerized Cognitive and Physical Activity Programs Combined or Single.\n\nIncluded conditions:\n- Diabetes Mellitus, Type 2\n\nStudy Armgroups:\n- {'label': 'Group 1: physical activity then cognitive training', 'type': 'EXPERIMENTAL', 'description': 'Using an online-computerized application, physical activities will be prescribed for one month. After a 15 days break, cognitive training activities will be prescribed the same way. A feedback by the patient will be asked fallowing each activity to control the observance.', 'interventionNames': ['Behavioral: Physical activity', 'Behavioral: cognitive training']}\n- {'label': 'Group 2: Cognitive training then physical activity', 'type': 'EXPERIMENTAL', 'description': 'Contrary to the first group, the second one starts with cognitive training intervention then engages in physical activity in same way as the first group. A feedback by the patient will also be asked fallowing each activity to control the observance', 'interventionNames': ['Behavioral: Physical activity', 'Behavioral: cognitive training']}\n- {'label': 'Group 3 : resonance frequency breathing then combined physical activity and cognitive training', 'type': 'EXPERIMENTAL', 'description': 'The third group takes part in a 1 month breathing exercise program. After a 15 days break (as the groups 1 and 2), a combined physical activity and cognitive training program is administrated for 1 month. As the others arms, a feedback by the patient will be asked fallowing each activity to control the observance', 'interventionNames': ['Behavioral: combined physical and cognitive training']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Physical activity', 'description': 'The intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables...) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation...).', 'armGroupLabels': ['Group 1: physical activity then cognitive training', 'Group 2: Cognitive training then physical activity']}\n- {'type': 'BEHAVIORAL', 'name': 'cognitive training', 'description': 'The intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables...) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation...).', 'armGroupLabels': ['Group 1: physical activity then cognitive training', 'Group 2: Cognitive training then physical activity']}\n- {'type': 'BEHAVIORAL', 'name': 'combined physical and cognitive training', 'description': 'The intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables...) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation...).', 'armGroupLabels': ['Group 3 : resonance frequency breathing then combined physical activity and cognitive training']}\n\nPrimary Outcomes:\n- {'measure': 'Episodic memory performances', 'description': 'Scores are obtained from delayed memory recall tests from the logical memory subtest of the Wechsler memory scale. It consists of two short narrative stories with an immediate recall phase after each story and a delayed recall phase after 10 minutes. During the delayed recall, each correct detail was awarded with one score point. On a scale of 0 to 50, a higher score means a better detailed recall.', 'timeFrame': 'Month 1 (Between 1 day and a week before and after the first intervention)'}\n- {'measure': 'Episodic memory performances', 'description': 'Scores are obtained from delayed memory recall tests from the logical memory subtest of the Wechsler memory scale. It consists of two short narrative stories with an immediate recall phase after each story and a delayed recall phase after 10 minutes. During the delayed recall, each correct detail was awarded with one score point. On a scale of 0 to 50, a higher score means a better detailed recall.', 'timeFrame': 'Month 2 (a week after the second intervention)'}\n- {'measure': 'Episodic memory performances', 'description': 'Scores are obtained from delayed memory recall tests from the logical memory subtest of the Wechsler memory scale. It consists of two short narrative stories with an immediate recall phase after each story and a delayed recall phase after 10 minutes. During the delayed recall, each correct detail was awarded with one score point. On a scale of 0 to 50, a higher score means a better detailed recall.', 'timeFrame': 'Month 3'}\n\nPlease estimate the sample size based on the assumption: \nThree predictors, significance level of 0.05, statistical power of 0.95, and using the 'pwr' package in R software.", "answer": 81, "answer_type": "ESTIMATED", "explanation": "Sample size\n The main objective will be to verify whether the improvements in physiological parameters predict the improvement of different psychological variables. This hypothesis will be tested by performing a multiple linear regression with three physiological variables (score composite of fitness level, HRV and stress biomarkers) as predictors. To conduct a power analysis, data obtained using a physical exercise intervention assessing the association between improved HRV and executive performance was used as a reference.64 The authors reported a correlation of r=.44,p\u00c2\u00a7amp;lt;.05 between cardiac functioning and the number of errors on a battery of cognitive tests. To obtain Cohen\u00e2\u0080\u0099s f2,69 the following formula was applied f2=R21-R2. With R2=.19, a result of f2=.24 was obtained. On the R software,70 power analyses was performed using the \u00e2\u0080\u009cpwr\u00e2\u0080\u009d package,71 with three predictors, a cut-off at 0.05, and a statistical power of 0.95, revealed a total sample size of 72 participants (24 participants per group). To ensure sufficient statistical power for secondary objectives as well, a total sample size of at least 81 individuals will be targeted (27 individuals per group).", "id": 1114, "split": "val"} +{"trial_id": "NCT04916197", "pmid": "38439027", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Postoperative Prolonged Sedation With Dexmedetomidine After Successful Reperfusion With Endovascular Thrombectomy on Long-term Prognosis in Patients With Acute Ischemic Stroke (PPDET)\n\nIncluded conditions:\n- Acute Ischemic Stroke\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Dexmedetomidine 0.1\\\\~1.0 \u03bcg/kg/h for 24h after patients finished endovascular thrombectomy and returned to ICU. Maintain Ramsay score 2-3.', 'interventionNames': ['Drug: Dexmedetomidine prolonged sedation']}\n- {'label': 'Control group', 'type': 'PLACEBO_COMPARATOR', 'description': 'An equal dose of saline 24h after patients finished endovascular thrombectomy and returned to ICU. If the Ramsay sedation score is 1, propofol will be administrated to maintain the Ramsay sedation score at 2 to 3.', 'interventionNames': ['Drug: 0.9% saline']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexmedetomidine prolonged sedation', 'description': 'Dexmedetomidine for 24h after patients finished endovascular thrombectomy and returned to ICU.', 'armGroupLabels': ['Intervention group']}\n- {'type': 'DRUG', 'name': '0.9% saline', 'description': 'An equal dose of 0.9% saline 24h after patients finished endovascular thrombectomy and returned to ICU.', 'armGroupLabels': ['Control group']}\n\nPrimary Outcomes:\n- {'measure': 'The favorable functional outcome of stroke-related disability rate', 'description': 'Modified Rankin Scale \u2264 2 points. mRS range from 0 to 6, higher scores mean a worse outcome.', 'timeFrame': '90 \u00b1 14 days after thrombectomy'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80%, a two-sided significance level (alpha) of 0.05, and a 10% dropout rate were assumed.", "answer": 368, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n According to previous studies, the functional independence rate at 90 days after EVT for AIS is about 40 to 55% [7, 8]. Given the risk and benefit of infusion with DEX after EVT, at least an increase of 15% in the proportion of mRS 0\u00e2\u0080\u00932 in the AIS patients with postoperative prolonged sedation is considered clinically meaningful. Thus, we assume 50% of participants in the control group could achieve mRS 0\u00e2\u0080\u00932 and an increase of 15% in the intervention group. With a power of 80% and 2-side \u00ce\u00b1 = .05, 167 patients per group are required. Considering a 10% dropout rate and random block length, the total sample size is 368 (184 patients per group). The sample size calculation was conducted on PASS software, version 14.0 (Number Cruncher Statistical Software).", "id": 1115, "split": "val"} +{"trial_id": "NCT04918745", "pmid": "38547135", "question": "Here is the design of a clinical trial:\n\nOfficial Title: VertiGO! - Get up and GO! With the Vestibular Implant\n\nIncluded conditions:\n- Bilateral Vestibular Loss\n\nStudy Armgroups:\n- {'label': 'ABC', 'type': 'OTHER', 'description': 'A = Baseline stimulation, no modulation\\n\\nB = Baseline stimulation, modulation stimulation\\n\\nC = Reduced baseline stimulation, modulation stimulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}\n- {'label': 'ACB', 'type': 'OTHER', 'description': 'A = Baseline stimulation, no modulation\\n\\nC = Reduced baseline stimulation, modulation stimulation\\n\\nB = Baseline stimulation, modulation stimulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}\n- {'label': 'BAC', 'type': 'OTHER', 'description': 'B = Baseline stimulation, modulation stimulation\\n\\nA = Baseline stimulation, no modulation\\n\\nC = Reduced baseline stimulation, modulation stimulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}\n- {'label': 'BCA', 'type': 'OTHER', 'description': 'B = Baseline stimulation, modulation stimulation\\n\\nC = Reduced baseline stimulation, modulation stimulation\\n\\nA = Baseline stimulation, no modulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}\n- {'label': 'CAB', 'type': 'OTHER', 'description': 'C = Reduced baseline stimulation, modulation stimulation\\n\\nA = Baseline stimulation, no modulation\\n\\nB = Baseline stimulation, modulation stimulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}\n- {'label': 'CBA', 'type': 'OTHER', 'description': 'C = Reduced baseline stimulation, modulation stimulation\\n\\nB = Baseline stimulation, modulation stimulation\\n\\nA = Baseline stimulation, no modulation', 'interventionNames': ['Device: Cochlear Vestibular Implant (CVI)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Cochlear Vestibular Implant (CVI)', 'description': 'The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:\\n\\n* A - Baseline stimulation, no modulation stimulation\\n* B - Baseline stimulation, modulated stimulation\\n* C - Reduced baseline stimulation, modulated stimulation', 'armGroupLabels': ['ABC', 'ACB', 'BAC', 'BCA', 'CAB', 'CBA']}\n\nPrimary Outcomes:\n- {'measure': 'Safety of vestibular stimulation via the CVI', 'description': \"Amount of (S)AE's after implantation to determine safety of the device\", 'timeFrame': 'Through full trial period, up to 5 years postoperatively'}\n- {'measure': 'The feasibility of vestibular stimulation improving Dynamic Visual Acuity during walking', 'description': 'Quantifying vestibulo-ocular reflex restoration on a functional level by evaluating the capacity of vestibular stimulation (via the CVI) to improve dynamic visual acuity while walking. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}\n- {'measure': 'The feasibility of vestibular stimulation improving Dynamic Visual Acuity during passive head movements', 'description': 'Quantifying vestibulo-ocular reflex restoration on a functional level by evaluating the capacity of vestibular stimulation (via the CVI) to improve dynamic visual acuity during fast passive head movements measured with the functional Head Impulse Test. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}\n- {'measure': 'The feasibility of vestibular stimulation restoring the high-frequency vestibulo-ocular reflex', 'description': 'Evaluating the capacity of vestibular stimulation (via the CVI) to increase vestibulo-ocular reflex gain during fast passive head movements in the LHRH, RALP and LARP planes measured with the video Head Impulse Test. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}\n- {'measure': 'The feasibility of vestibular stimulation restoring the low-frequency vestibulo-ocular reflex', 'description': 'Evaluating the capacity of vestibular stimulation (via the CVI) to increase vestibulo-ocular reflex gain during slow, passive, full body rotations measured with the Torsion Swing test. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}\n- {'measure': 'The feasibility of vestibular stimulation improving the self-movement perception in dark', 'description': 'Evaluating whether vestibular stimulation (via the CVI) can improve self-motion perception measured by controlled motion stimuli delivered by a moving platform. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}\n- {'measure': 'The feasibility of vestibular stimulation improving gait stability and balance based on motion capture data', 'description': 'Evaluating the influence of vestibular stimulation (via the CVI) on walking patterns and stability based on motion capture data. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}\n- {'measure': 'The feasibility of vestibular stimulation improving balance based on clinical evaluation', 'description': 'Clinical evaluation of the influence of vestibular stimulation (via the CVI) on balance measured with the MiniBESTest. Adaptation to stimulation will be evaluated through each 4-day stimulation period with each stimulation algorithm being evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}\n- {'measure': 'Speech perception with CVI in quiet without simultaneous vestibular stimulation', 'description': 'Evaluating hearing performance with the CVI based on speech perception in quiet measured with an aided consonant-nucleus-consonant word test, without simultaneous vestibular stimulation', 'timeFrame': 'Through the full trial period, until 5 years after implantation'}\n- {'measure': 'Interaction between vestibular and cochlear stimulation on speech perception in quiet', 'description': 'Evaluating hearing performance with the CVI based on speech perception in quiet while simultaneously providing vestibular stimulation, measured with an aided consonant-nucleus-consonant word test. The influence of each vestibular stimulation algorithm will be evaluated separately.', 'timeFrame': 'Through each 4-day VI stimulation period, within 2 years after implantation'}\n- {'measure': 'Speech perception with CVI in noise without simultaneous vestibular stimulation', 'description': 'Evaluating hearing performance with the CVI based on speech perception in noise measured with a sentence speech In noise test, without simultaneous vestibular stimulation', 'timeFrame': 'Through the full trial period, until 5 years after implantation'}\n- {'measure': 'Change in otolith function due to CVI implantation', 'description': 'Evaluating the influence of CVI implantation on otolith function based on cVEMP and oVEMP responses post-operatively, comparing with the pre-operative situation.', 'timeFrame': 'preoperatively and 1 month postoperatively'}\n- {'measure': 'Vestibular and cochlear electrode location', 'description': 'Evaluating the location and potential migration of the vestibular and cochlear electrodes of the CVI with cone-beam CT scans- of the mastoid.', 'timeFrame': 'Through the full trial period, until 5 years after implantation'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level (alpha) set at 0.05, power set at 0.80, and a two-sided Wilcoxon signed-rank test used for sample size calculation.", "answer": 13, "answer_type": "ESTIMATED", "explanation": "2.5 Sample size calculation\n Sample size calculation is based on the primary study outcome: DVA score (see 2.4.1). Visual acuity (VA) can be expressed in several different units. However, for data analysis it is important to use the logarithm of the minimum angle of resolution (logMAR), since this unit scales linearly with the geometric progression of the visual acuity chart [73]. Data from previous measurements on the influence of vestibular stimulation on DVA was used for the sample size calculation [19]. Although this data was obtained with a different version of VCI (which did not yet allow simultaneous VI and CI stimulation), it is the closest analog available to approximate the results of this trial. To account for the between-patient difference in VA, the data from the previous experiment, expressed in logMAR, were normalized to the static VA measured for each patient. This yields mean logMAR values of 0.065 (SD 0.061) and 0.205 (SD 0.066) for VI active and VI inactive, respectively. Since the size of the dataset is too small to determine whether or not the data is normally distributed, the sample size was calculated for a two-sided Wilcoxon signed-rank test. Significance level (alpha) was set at 0.05 and power was set at 0.80 [74, 75]. Both effect size and minimal sample size were calculated with G*Power 3.1.9.7 [76]. Effect size was determined to be 2.20, which resulted in a minimum sample size of five. Given the available resources (e.g. prototype hardware and software, budget limitations due to high (surgical) costs of the procedures) and to provide this statistical background with a safety margin, this trial will aim to include a minimum of eight, with a maximum of 13, patients. Although this is still a relatively small number, both safety and efficacy of the new prototype VCI is believed to be investigated thoroughly with this sample size due to the high frequency of measurements and a total follow-up duration of 5 years.", "id": 1116, "split": "val"} +{"trial_id": "NCT04920643", "pmid": "39209495", "question": "Here is the design of a clinical trial:\n\nOfficial Title: High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery (ULTRA): A Canadian Randomized Controlled Trial\n\nIncluded conditions:\n- Congenital Heart Disease\n\nStudy Armgroups:\n- {'label': 'High-Exchange Ultrafiltration', 'type': 'EXPERIMENTAL', 'description': 'Subzero-Balance Simple Modified Ultrafiltration (60ml/kg/hour)', 'interventionNames': ['Procedure: Ultrafiltration']}\n- {'label': 'Low-Exchange Ultrafiltration', 'type': 'ACTIVE_COMPARATOR', 'description': 'Subzero-Balance Simple Modified Ultrafiltration (6ml/kg/hour)', 'interventionNames': ['Procedure: Ultrafiltration']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Ultrafiltration', 'description': \"Ultrafiltration is used during cardiac surgery with cardiopulmonary bypass to remove both fluid and small molecules such as inflammatory cytokines from the patient's circulation.\", 'armGroupLabels': ['High-Exchange Ultrafiltration', 'Low-Exchange Ultrafiltration']}\n\nPrimary Outcomes:\n- {'measure': 'Peak Vasoactive-Ventilation Renal Score', 'timeFrame': 'Up to 5 days'}\n\nPlease estimate the sample size based on the assumption: \nTwo-way ANOVA with stratification by STAT score (STAT 1 and STAT 2-5), alpha=0.05, beta=0.2.", "answer": 96, "answer_type": "ESTIMATED", "explanation": "Sample size\n The primary outcome of ULTRA is the peak postoperative VVR score. The sample size calculation was based on a minimal clinically important relative reduction in the primary outcome of 25%. This threshold was identified by consultation with clinical experts and represents a significant improvement in cardiopulmonary and vasomotor function. A two-way analysis of variance (ANOVA)which considered the stratification by STAT score (STAT 1 and STAT 2\u00e2\u0080\u00935) with alpha=0.05 and beta=0.2. The decision to stratify by surgical risk STAT score was crucial to ensure this variable is balanced for comparison between treatment groups, as STAT score is strongly correlated with morbidity and mortality after paediatric cardiac surgery.21 The sample size calculation used peak VVR data from the pilot study for patients that matched ULTRA\u00e2\u0080\u0099s inclusion criteria. According to these parameters, 48 patients in each group are required, yielding a total of 96 patients.", "id": 1117, "split": "val"} +{"trial_id": "NCT04921449", "pmid": "35613820", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Cluster-Randomized Trial of the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) Protocol for Acute Low Back Pain\n\nIncluded conditions:\n- Low Back Pain\n\nStudy Armgroups:\n- {'label': 'Embedded ED Physical Therapy (NEED-PT)', 'type': 'EXPERIMENTAL', 'description': \"An ED physical therapist will be embedded with the primary treatment team to evaluate patients presenting with low back pain at the beginning of the overall treatment course. The physical therapist will utilize a clinical protocol (NEED-PT) that matches the patient's history and exam findings to an appropriate treatment classification consisting of directional preference exercises, manual traction, stabilization exercises, non-thrust manipulation/mobilization, and/or psychologically informed rehabilitation. The NEED-PT intervention will supplement any usual care performed by the treating physician.\", 'interventionNames': ['Other: ED Physical Therapy']}\n- {'label': 'Usual Care', 'type': 'OTHER', 'description': \"Usual care consists of any ED testing or treatment not involving an ED physical therapist in accordance with the treating physician's usual and customary practice. This could include diagnostic imaging, patient education and reassurance, and administration and/or prescribing of analgesic medications.\", 'interventionNames': ['Other: Usual Care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'ED Physical Therapy', 'description': 'All ED Physical Therapy treatment classifications involve a combination of exercise, range of motion, education, prognostic guidance, and reassurance. Patients are provided with an individualized home exercise plan based on their matched treatment classification and/or active rest.', 'armGroupLabels': ['Embedded ED Physical Therapy (NEED-PT)']}\n- {'type': 'OTHER', 'name': 'Usual Care', 'description': \"Includes any diagnostic imaging, patient education and reassurance, and administration or prescribing of analgesic medications, as per the treating physician's usual and customary practice.\", 'armGroupLabels': ['Usual Care']}\n\nPrimary Outcomes:\n- {'measure': 'PROMIS Pain Interference (PROMIS-PI)', 'description': 'PROMIS-PI measures the self-reported consequences of pain on relevant aspects of a person\\'s life, including social, cognitive, emotional, physical, and recreational activities. We will use the computer-adaptive format to minimize respondent burden. Scores are standardized to the general U.S. population, with a score of 50 representing the population mean. The time frame of interest for the PROMIS-PI is \"in the past 7 days,\" meaning that participants provide responses based on their symptoms over the last week.', 'timeFrame': 'Three months after the index ED visit.'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided 5% level of significance, 84% power, 20% dropout rate, correlation of approximately 0.50 between baseline and follow-up.", "answer": 360, "answer_type": "ACTUAL", "explanation": "Power and sample size\n We used \u00e2\u0080\u0098The Shiny CRT Calculator\u00e2\u0080\u0099 to explore varying assumptions on cluster size (ie, average number of participants per physician), number of clusters (or physicians) and intracluster correlation (ICC). Under the parallel-arm, \u00e2\u0080\u0098cohort\u00e2\u0080\u0099 design, with baseline measurement of the primary outcome, the calculator also allows for an assumption on correlation between baseline and follow-up. The table in the Statistical Analysis Plan (SAP, online supplemental appendix file 1) illustrates power to detect at least a 3.5 mean difference across study arms if we assume just two time points (baseline and 3\u00e2\u0080\u0089months, which we deem conservative as we will have up to seven time points of observation, including baseline) per participant with a correlation of approximately 0.50. We conservatively estimate that we will need to enrol up to 360 total participants to account for worst-case (20%) scenario dropout for both physicians and participants. Thus, after accounting for physician and participant dropout, a final sample size of 16 physicians per arm and 7 participants per physician (n=224 total or 112 per arm) achieves 84% power to detect a mean between-arm difference of 3.5 PROMIS-PI points assuming SD of 10 points, ICC coefficient of 0.10, and a two-sided 5% level of significance.\n \n 10.1136/bmjopen-2022-061283.supp1\n Supplementary data\n \n\n\n \n In our pilot work, we found a small ICC (0.01\u00e2\u0080\u00930.04),13 indicating minimal within-physician effects that were not significant; however, we use a more conservative estimate of the ICC at 0.10 in the event that greater than anticipated within-physician effects are encountered. In the event that ICC is lower than expected or dropout rate is lower than 20%, we anticipate often over 90% power to detect a meaningful difference across arms. Since our target final analytic sample size is 224 total participants, if we can reach our target with fewer participants enrolled than 360, we will consider stopping enrolment under the guidance of the Data Safety and Monitoring Board (DSMB). We will plan to monitor dropout rates, ICC, SD, and within-participant correlation throughout the course of the trial and will formally present these data to the DSMB at regular intervals.", "id": 1118, "split": "val"} +{"trial_id": "NCT04922749", "pmid": "35361168", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Evaluation of the Implementation and Effectiveness of a Multidisciplinary Lifestyle Treatment for Inpatients With Mental Illness (MULTI+)\n\nIncluded conditions:\n- Mental Illness\n- Lifestyle\n\nStudy Armgroups:\n- {'label': 'TAU', 'type': 'NO_INTERVENTION', 'description': 'Treatment as usual (TAU); consist mainly of pharmacological treatment and psychotherapy.'}\n- {'label': 'MULTI+', 'type': 'EXPERIMENTAL', 'description': 'Lifestyle treatment', 'interventionNames': ['Behavioral: MULTI+']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'MULTI+', 'description': 'MULTI+ is a multidisciplinary, multicomponent treatment which aims to improve lifestyle factors through a holistic lifestyle approach, by focusing on 10 core components. The MULTI+ will be integrated into daily treatment to promote uptake and sustainability.', 'armGroupLabels': ['MULTI+']}\n\nPrimary Outcomes:\n- {'measure': 'QRISK3 score', 'description': 'Algorithm that estimates the probability of developing cardiovascular disease over the next 10 years by taking multiple risk factors into account.', 'timeFrame': '4 measurements semi-annually over a period of 24 months'}\n\nPlease estimate the sample size based on the assumption: \nA conservative dropout rate of 10%, a correlation of 0.1 between clusters, a power of 80%, and a significance level of 5% (p < 0.05).", "answer": 846, "answer_type": "ESTIMATED", "explanation": "Sample size\n Our sample size considerations are based on demonstrating a difference in body weight between conditions. The reason is that we did not have any relevant data on changes in QRISK3 for this population, whereas body weight has been used in our previous research [32]. Furthermore, body weight is a key component of the QRISK3 and, given the nature of MULTI\u00e2\u0080\u0089+\u00e2\u0080\u0089, it is likely that other components of the QRISK3 will change in the same direction. Therefore, using body weight can be seen as a more robust and more conservative approach than using uncertain assumptions about changes in QRISK3.\n Our research showed that 53.8% of the patients who participated in MULTI lost\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00895% of their initial bodyweight, as opposed to 16.3% of the patients who followed TAU. Given the broader implementation of MULTI\u00e2\u0080\u0089+\u00e2\u0080\u0089, with patients who spend less time in healthcare than those in the earlier study, we expect to find effects in a relative smaller number of patients in this study. Based on a small-scale follow-up, we will assume 32% of patients will lose\u00e2\u0080\u0089\u00e2\u0089\u00a5\u00e2\u0080\u00895% of their initial bodyweight instead of 53.8%. Because metabolic risk factors are a routinely measured outcome, we expect a conservative dropout rate of 10%. Because there is insufficient knowledge about the correlations between clusters, we will assume a correlation of 0.1. Based on these data, a power of 80%, a significance level of 5% (p\u00e2\u0080\u0089<\u00e2\u0080\u00890.05), three clusters, the minimal sample size should consist of 846 patients. Given the high patient turnover (n\u00e2\u0089\u00882000), this seems feasible.", "id": 1119, "split": "val"} +{"trial_id": "NCT04922827", "pmid": "36056419", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Randomized, Controlled, Multicenter, Open Label Phase II Clinical Study to Evaluate Infliximab in the Treatment of Patients With Severe COVID-19 Disease\n\nIncluded conditions:\n- COVID-19\n\nStudy Armgroups:\n- {'label': 'Infliximab + Standard of Care', 'type': 'EXPERIMENTAL', 'interventionNames': ['Drug: Infliximab', 'Other: Standard of Care']}\n- {'label': 'Standard of Care', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Other: Standard of Care']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Infliximab', 'description': 'single intravenous administration of 5 milligrams/kilogram', 'armGroupLabels': ['Infliximab + Standard of Care']}\n- {'type': 'OTHER', 'name': 'Standard of Care', 'description': 'Standard of Care', 'armGroupLabels': ['Infliximab + Standard of Care', 'Standard of Care']}\n\nPrimary Outcomes:\n- {'measure': '28-day mortality', 'description': 'differences in mortality-rates between both study arms (Infliximab + Standard of Care vs. Standard of Care) 28 days after randomisation', 'timeFrame': '28 days after randomization'}\n\nPlease estimate the sample size based on the assumption: \nTwo-sided Fisher\u2019s exact test, significance level alpha = 0.05, power = 95%, dropout rate = 10%", "answer": 9, "answer_type": "ACTUAL", "explanation": "Sample size and statistical analysis\n Sample size planning was based on unpublished retrospective data from Jena University Hospital (April 2020\u00e2\u0080\u0093January 2021, part of the data set in [29]). In 31 patients, the 28-day mortality was 50% in SOC and 12.2% in patients with SOC + infliximab. Under these assumptions, a two-sided Fisher\u00e2\u0080\u0099s exact test at significance level alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05 has a power of 95%, if 40 patients are included in each of the two groups. Allowing for a dropout rate of 10%, the total number of patients to be randomised is 88 (2 \u00c3\u0097 44). We used nQuery 7.0 (Statistical Solutions Ltd, Cork, Ireland) for sample size planning. The full analysis set population (FAS) includes all patients enrolled and randomised to the study with at least one observation after randomisation. Patients will be analysed as randomised (intention-to-treat principle). The primary efficacy analysis will be conducted in the FAS. All variables collected will be analysed in the FAS. The per-protocol collective includes all patients in the intention-to-treat collective who do not have major protocol deviations. In sensitivity analysis, the primary efficacy analysis will be repeated in the per-protocol collective. If there are differences between randomised and actual treatment, an additional \u00e2\u0080\u0098as treated\u00e2\u0080\u0099 sensitivity analysis will be performed. An interim-analysis is not planned. Data analysts will be blinded.", "id": 1120, "split": "val"} +{"trial_id": "NCT04922840", "pmid": "35177467", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Improved Cardiovascular Health for Patients With Inflammatory Joint Diseases\n\nIncluded conditions:\n- Spondyloarthritis\n- Rheumatoid Arthritis\n- Psoriatic Arthritis\n\nStudy Armgroups:\n- {'label': 'High-intensity exercise (HIIT)', 'type': 'EXPERIMENTAL', 'description': 'Usual care; CVD risk assessment, lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication.\\n\\nThe 12-week intervention is carried out as individual or group sessions with maximal 4 patients, supervised by physiotherapists in primary health care. The HIIT group complete two weekly HIIT sessions and a third weekly session with exercise at moderate intensity. Exercise is tailored to each individual to provide the same relative exercise stress and to ensure progression. Target exercise intensity is tracked by a heart rate monitor.\\n\\nIndividual exercise session are recorded in a training diary. Succeeding the intervention, a questionnaire will be distributed to patients in the HIIT group. Semi-structured interviews will target physiotherapists supervising HIIT and 5-7 patients in the HIIT group.', 'interventionNames': ['Behavioral: High-intensity exercise (HIIT)']}\n- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Control group participants receive the same treatment as usual care; CVD risk assessment including lifestyle advice (heart-healthy diet, regular exercise, weight management and non-smoking) and relevant medication. Control group participants are invited to a physiotherapist-led theoretical and practical HIIT session following study completion.'}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'High-intensity exercise (HIIT)', 'description': '12 week intervention: Two weekly sessions of 35-40 min exercise: 10 min warm-up, followed by 4x4 min at 90-95% peak heart rate (HRpeak) interspaced by 2-3 min active breaks at 60-70% HRpeak and a third weekly session with continuous exercise for a minimum of 40 min at moderate intensity.', 'armGroupLabels': ['High-intensity exercise (HIIT)']}\n\nPrimary Outcomes:\n- {'measure': 'Peak oxygen uptake - VO2peak ml/kg/min', 'description': 'VO2peak, expressed in milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). VO2peak will be measured by a Cardiopulmonary Exercise test (CPET) on a treadmill, using electrocardiogram (ECG), breath-by-breath gas analyzing system, blood pressure (BP) monitor, pulse oximetry, and Borg rating of perceived exertion', 'timeFrame': '3 months post baseline'}\n\nPlease estimate the sample size based on the assumption: \nUsing a reported upper bound of 4.5 on the SD of change in VO2peak and 80% power to detect this difference, with a 20% drop-out rate.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size\n Sample size is calculated on the basis of the primary outcome variable, where a between-group difference in peak oxygen uptake (VO2peak) of 3.5 mL/kg/min is considered to be of clinical relevance.20 Using a reported upper bound of 4.5 on the SD of change in VO2peak34 and 80% power to detect this difference, approximately 25 participants are required in each group. To allow for a possible 20% drop-out rate, we plan to randomise 60 patients in total (ie, 30 per group).", "id": 1121, "split": "val"} +{"trial_id": "NCT04922853", "pmid": "37312165", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer\uff1aa Prospective, Non-inferior, Randomized, Controlled Trial\n\nIncluded conditions:\n- Rectal Cancer\n- Neoadjuvant Chemotherapy\n\nStudy Armgroups:\n- {'label': '2 cycles group', 'type': 'EXPERIMENTAL', 'description': 'patients which recruited have 2 cycles Capox regimen (oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals), then those patients with no sever chemotheraputic AE, have TME operation after reevaluation and randomization.', 'interventionNames': ['Drug: Capox chemotherapy']}\n- {'label': '4 cycles group', 'type': 'OTHER', 'description': 'patients which recruited have 2 cycles Capox regimen (oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals), then those patients with no sever chemotheraputic AE, have two more cycles chemotherapy and TME operation after reevaluation and randomization.', 'interventionNames': ['Drug: Capox chemotherapy']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Capox chemotherapy', 'description': 'oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals', 'armGroupLabels': ['2 cycles group', '4 cycles group']}\n\nPrimary Outcomes:\n- {'measure': 'pathological Tumor Regression Grade evaluation', 'description': 'pTRG', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \nNon-inferiority test with \u03b1 = 0.05, power (1-\u03b2) = 0.8, non-inferiority margin (hazard ratio) \u03b4 = 0.05, Pearson chi-square test, 10% withdrawal/lost to follow-up rate, 6% dropout rate in the 4 cycles CAPOX group.", "answer": 554, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n According to phase II trial [16], the proportion of patients who had poor pathological remission (pTRG 3) after 4 cycles of CAPOX was 27.9%. The proportion of pTRG3 after 2 cycles of CAPOX is expected to increase by no more than 10%. The non-inferiority test is used with \u00ce\u00b1\u00e2\u0080\u0089=\u00e2\u0080\u00890.05, (1-\u00ce\u00b2)\u00e2\u0080\u0089=\u00e2\u0080\u00890.8, and the non-inferiority margin (hazard ratio) value \u00ce\u00b4 is set as 0.05. Pearson chi-square test is used to calculate the sample size required for the experiment, and 249 samples are required for each group calculated by a normal approximation algorithm [25]. Ten percent of patients are estimated to withdraw from the group or lost to follow-up; 277 patients are needed in each group. The planned enrollment time is 2.5\u00c2\u00a0years, and the total number of patients is about 554 cases. Meanwhile, it is assumed that the dropout rate of patients in the 4 cycles of the CAPOX group is about 6% due to intolerance of chemotherapy. Therefore, it is estimated that 294 patients would be included in the 2 cycles of the CAPOX group and 260 patients in the 4 cycles of the CAPOX group.", "id": 1122, "split": "val"} +{"trial_id": "NCT04923334", "pmid": "36351735", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Nonpharmacologic Pain Management in FQHC Primary Care Clinics\n\nIncluded conditions:\n- Low Back Pain\n- Chronic Pain\n\nStudy Armgroups:\n- {'label': 'Brief Pain Teleconsult', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to Brief Pain Teleconsult will receive the brief teleconsult intervention in Phase 1 (1-12 weeks) Responder status to the Phase 1 treatment will be examined at the 12 week assessment. Participants determined to be non-responders will receive the Telehealth Physical Therapy intervention. Responders receive no additional treatment.', 'interventionNames': ['Behavioral: Brief Pain Teleconsult', 'Behavioral: Telehealth Physical Therapy']}\n- {'label': 'Brief Pain Teleconsult plus Telehealth Physical Therapy', 'type': 'EXPERIMENTAL', 'description': 'Participants randomized to Brief Pain Teleconsult plus Telehealth Physical Therapy will receive the brief teleconsult intervention in Phase 1 followed by the 10-week physical therapy intervention. No additional treatment is provided after the 12 week assessment.', 'interventionNames': ['Behavioral: Brief Pain Teleconsult', 'Behavioral: Telehealth Physical Therapy']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Brief Pain Teleconsult', 'description': 'The Brief Pain Teleconsult intervention includes 2 sessions provided by a licensed physical therapist over about 1 week. The sessions focus on pain education from a biopsychosocial perspective that is designed to address negative pain appraisals and catastrophizing thoughts, providing advice to be active and engage in exercise and physical activity, and reassurance that activity is beneficial and safe.', 'armGroupLabels': ['Brief Pain Teleconsult', 'Brief Pain Teleconsult plus Telehealth Physical Therapy']}\n- {'type': 'BEHAVIORAL', 'name': 'Telehealth Physical Therapy', 'description': 'The Telehealth Physical Therapy intervention involves weekly telehealth sessions provided over 10 weeks. Telehealth Physical Therapy is provided by a licensed physical therapist. Key components of the intervention include reinforcing biopsychosocial education messages and developing an exercise and physical activity program using cognitive behavioral principles such as goal setting and positive reinforcement. Pain coping strategies including mindful breathing and progressive relaxation techniques will be included.', 'armGroupLabels': ['Brief Pain Teleconsult', 'Brief Pain Teleconsult plus Telehealth Physical Therapy']}\n\nPrimary Outcomes:\n- {'measure': 'PEG-3', 'description': 'The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores with higher scores indicating greater pain impact', 'timeFrame': '12 weeks'}\n\nPlease estimate the sample size based on the assumption: \n80% retention across follow-ups, significance level (two-sided \u03b1) = 0.05, power = 80% or 90%, serial correlations R=0 for repeated PEG assessments, intraclass correlation coefficients (ICCs) for outcomes across therapists with a mean around 0.08, and a denominator df of 7 for statistical inference.", "answer": 500, "answer_type": "ESTIMATED", "explanation": "Sample size Justification\n We based power calculations on the following assumptions: (1) 80% retention across follow-ups, based on our experience in prior trials,46 85 (2) minimum important difference (MID) for the PEG is 1.0 (SD=2.5),68 86 which translates to 40% of 1 SD change, (3) A projected sample size of 500 participants or 250 per group and (4) a conservative assumption of serial correlations R=0 for repeated PEG assessments. For exploratory analyses of treatment effects across therapists as random effects, we assume there will be a total of eight therapists who will see similar numbers of patients and we conservatively assume a denominator df of 7 (8\u00e2\u0080\u00931) for statistical inference. Previous studies have noted variable intraclass correlation coefficients (ICCs) for outcomes across therapists providing psychological interventions with a mean around 0.08.87\u00e2\u0080\u009389 We note that the ICC in this study may be lower because the same therapists will treat subjects in both arms, but we are not aware of previous data that would confirm this conjecture. With these assumptions, table 6 provides conservative estimates of the minimum treatment effects in the full cohort that are detectable with the fixed and random effects approaches with 80% or 90% power and two-sided \u00ce\u00b1=0.05. These calculations indicate excellent power to detect the MID for the PEG under a fixed effects approach. Adequate power to detect the MID is possible under a random effects approach, but is not assured with high confidence.\n \n Table 6\n \n Minimum detectable treatment effects on the primary PEG outcome\u00e2\u0080\u0094analyses of the full study cohort\n \n \n \n \n Power\n Fixed effects approach\n Random effects approach\n \n \n ICC=0.04\n ICC=0.08\n ICC=0.12\n \n \n \n \n 80%\n 0.70\n 0.99\n 1.14\n 1.27\n \n \n 90%\n 0.81\n 1.15\n 1.32\n 1.48\n \n \n \n \n \n ICC, intraclass correlation coefficient; PEG, pain, enjoyment and general activity.", "id": 1123, "split": "val"} +{"trial_id": "NCT04924010", "pmid": "35062997", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Perioperative Cognitive Behavioural Therapy on Chronic Persistent Postsurgical Pain Among Breast Cancer Patients With High Pain Catastrophising Characteristics: A Randomised, Double-blind Clinical Trial\n\nIncluded conditions:\n- Breast Cancer\n- Chronic Pain\n- Chronic Postsurgical Pain\n- Quality of Life\n\nStudy Armgroups:\n- {'label': 'Cognitive Behavioural Therapy (CBT)', 'type': 'ACTIVE_COMPARATOR', 'description': \"Cognitive behavioural therapy (CBT) is a talking therapy that can help patients manage problems by changing the way they think and behave. It's most commonly used to treat anxiety, depression and chronic pain conditions.\", 'interventionNames': ['Behavioral: Cognitive Behavioural Therapy (CBT)']}\n- {'label': 'Education and Mindfulness', 'type': 'PLACEBO_COMPARATOR', 'description': 'Education and mindfulness therapy refers to lessons on techniques to calm the mind and body - can reduce the negative effects of stress', 'interventionNames': ['Behavioral: Education and Mindfulness']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Cognitive Behavioural Therapy (CBT)', 'description': 'The CBT intervention will be delivered by a Senior Psychologist with seventeen years of hospital psychology experience, six in the treatment of chronic pain patients. Sessions are delivered in one hour, individual therapy appointments to patients, and there is an emphasis on relaxation training, cognitive restructuring, exercise and pacing, behavioral activation, improving sleep, and anger management. Standardized worksheets and homework assignments are an important part of CBT-CP and these will be given (post or email) to patients who will be asked to read and complete in terms of complementing the consultations. This intervention has been developed with reference to two sources: A successful national implementation of CBT for chronic pain (CBT-CP) using video teleconferencing format \\\\[Connolly KS et al\\\\] AND an evidence-based CBT manual specifically designed to treat chronic pain \\\\[Murphy JL et al\\\\].', 'armGroupLabels': ['Cognitive Behavioural Therapy (CBT)']}\n- {'type': 'BEHAVIORAL', 'name': 'Education and Mindfulness', 'description': 'To control for differences in attention between the two interventions, patients in the mindfulness group will also have two meetings before the surgery and two meetings afterward. As the same person will be providing the CBT-CP and educational interventions, this confounding factor will be controlled for. The control intervention consists of discussing pain education, as derived from the self-management section of the chronic pain Ireland website (https://www.chronicpain.ie/our-services/self-management) and the persistent pain section of the pain toolkit website (https://www.paintoolkit.org/persistent-pain). Four mindfulness-based stress reduction exercises will be completed including an introductory session on mindful breathing, a guided meditation, progressive muscle relaxation, and a body scan. These sessions will last about half an hour.', 'armGroupLabels': ['Education and Mindfulness']}\n\nPrimary Outcomes:\n- {'measure': 'Brief Pain Inventory (BPI) Short-form: average pain severity', 'description': \"BPI Short-form is a 9 item questionnaire used to evaluate the severity of a patient's cancer or non cancer pain \\\\[Tan G et al\\\\]. Brief Pain Inventory short-form scale is measured between 0 - 10, where '0' indicates no pain and '10' indicates severe pain. A decrease in the Brief Pain Inventory score of 2 or more from the baseline score is considered significant and indicates an improvement in severity of the patient's cancer and non-cancer pain.\", 'timeFrame': '3 months post-operative'}\n\nPlease estimate the sample size based on the assumption: \nType I error = 0.05, Type II error = 0.2 (power 80%), and a dropout rate of approximately 10%.", "answer": 48, "answer_type": "ACTUAL", "explanation": "Sample size {14}\n The primary outcome is the difference in the BPI average pain severity score between the study groups, three months after surgery. A clinically important difference on the BPI is 2 raw score reduction on the 11-point Numerical Pain Rating Scale (NRS) [22\u00e2\u0080\u009324]. The standard deviation (SD) of BPI scores after breast surgery is in the order of 2.3 [25] on this scale. Taking a BPI score reduction of 2 as the minimal clinically relevant difference, then n = 21 patients would be required each arm if type I error = 0.05 and type II error is 0.2 (power 80%). This calculation was verified by using an online power calculator (https://www.sealedenvelope.com/power/continuous-superiority/). The screening process for potential eligible participants will be a very thorough methodological process. As mentioned in the exclusion criteria, any suspected non-compliant participants will not be enrolled or randomised to either of the study\u00e2\u0080\u0099s intervention. By taking this approach, we endeavour to limit the number of dropouts to approximately 10%, and therefore, we propose to enrol 24 eligible patients in each group (N = 48 total).", "id": 1124, "split": "val"} +{"trial_id": "NCT04924452", "pmid": "36691137", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Efficiency of Er:YAG Laser Therapy in Combination With Behaviour Management Technique in Reducing Anxiety Among Paediatric Dental Patients\n\nIncluded conditions:\n- Dental Caries\n- Dental Anxiety\n- Behavior\n\nStudy Armgroups:\n- {'label': 'Er:YAG laser therapy', 'type': 'EXPERIMENTAL', 'description': 'Er:YAG laser will be used for enamel conditioning of the occlusal surfaces of the permanent molars before sealant application as well as the standardized caries treatment.', 'interventionNames': ['Procedure: Laser conditioning and Sealant application', 'Device: Er:YAG laser therapy']}\n- {'label': 'Conventional therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Conventional rotary instruments will be used for caries treatment.', 'interventionNames': ['Procedure: Sealant application', 'Procedure: Conventional therapy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Laser conditioning and Sealant application', 'description': 'Sealant application protocol includes: a low-speed rubber cup and pumice paste (CleanPolish, Kerr) will be used for 30 seconds for cleaning and polishing of the occlusal surface of the chosen permanent molar; tooth surface will be washed for debris and organic residue removal and dried with air spray; isolation; laser conditioning of the occlusal enamel surface. The parameter settings used will be: tip-to-tissue distance 1.5mm from the tooth surface; tip diameter 600 \u00b5m; laser energy 70 mJ; pulse frequency 10 Hz; water spray level 8; average power 0.7 W; energy density 67 J/cm2; tooth surface will be etched with 35% phosphoric acid gel (Etching gel, DMP Ltd) for 30 seconds and rinsed for the same time; reisolation; tooth surface will be dried with air spray for 15s; fissure sealant application (Pit\\\\&Fissure Sealant, DMP Ltd); light cured for 20 seconds.', 'armGroupLabels': ['Er:YAG laser therapy']}\n- {'type': 'PROCEDURE', 'name': 'Sealant application', 'description': 'Sealant application protocol includes: a low-speed rubber cup and pumice paste (CleanPolish, Kerr) will be used for 30 seconds for cleaning and polishing of the occlusal surface of the chosen permanent molar; tooth surface will be washed for debris and organic residue removal and dried with air spray; isolation; tooth surface will be etched with 35% phosphoric acid gel (Etching gel, DMP Ltd) for 30 seconds and rinsed for the same time; reisolation; tooth surface will be dried with air spray for 15s; fissure sealant application (Pit\\\\&Fissure Sealant, DMP Ltd); light cured for 20 seconds.', 'armGroupLabels': ['Conventional therapy']}\n- {'type': 'DEVICE', 'name': 'Er:YAG laser therapy', 'description': 'Er:YAG laser (LiteTouch, Light Instruments LTD), emission wavelength 2940 nm will be used for caries removal - parameters: enamel removal - energy 100-200mJ; density 9.84-13.03 J/cm2, pulse frequency 20Hz; tip diameter 800 \u03bcm; water spray level 8; tip-to-tissue distance 0.5\u00f71 mm form the tooth surface; dentin removal - energy 100mJ; density 9.84 J/cm2, pulse frequency 20Hz; tip diameter 800 \u03bcm; water spray level 8; tip-to-tissue distance 0.5\u00f71 mm form the tooth surface. Restoration with compomer.', 'armGroupLabels': ['Er:YAG laser therapy']}\n- {'type': 'PROCEDURE', 'name': 'Conventional therapy', 'description': 'Conventional rotary instruments will be used for caries removal - high-speed and low-speed dental handpieces. Restoration with compomer.', 'armGroupLabels': ['Conventional therapy']}\n\nPrimary Outcomes:\n- {'measure': 'self-report dental anxiety on a modified version of the self-report Faces Scale by LeBaron', 'description': \"The scale comprises a row of five faces ranging from 'relaxed' to 'very worried' in combination with a visual analog scale of 0 - 10. Each child was asked to point to the face or choose the number which most closely depicted its state of anxiety.\", 'timeFrame': 'Immediately after the dental treatment'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation assumes a test power greater than 95% and a significance level of \u03b1 = 0.05.", "answer": 82, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation is performed based on data from a pilot study with 20 subjects. To estimate sample size for the primary outcome\u00e2\u0080\u0094self-reported anxiety felt, according to the Faces Scale by LeBaron\u00e2\u0080\u0094a t-test for paired groups has been used (G* Power software V.3.1,6 since we have two groups). The effect size was determined using the formula\n ES=Control\u00e2\u0088\u0092TreatedSDpooled=2.33\u00e2\u0088\u00920.333.25=0.62,\n where SD is the pooled SD, an average of the SD of the experimental and control groups. The sample size is calculated to assure a test power greater than 95% and a significant level of \u00ce\u00b1=0.05. We estimated a sample size of 41 patients per group to detect significant differences. Thus, the final sample size for this study will be 82 patients.", "id": 1125, "split": "val"} +{"trial_id": "NCT04930159", "pmid": "38348827", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence\n\nIncluded conditions:\n- Endometrial Cancer\n\nStudy Armgroups:\n- {'label': 'Enhanced usual care', 'type': 'NO_INTERVENTION', 'description': 'Written materials in an appealing package.'}\n- {'label': 'Facilitated group support', 'type': 'ACTIVE_COMPARATOR', 'description': 'Weekly group gatherings.', 'interventionNames': ['Behavioral: Facilitated group support']}\n- {'label': '1:1 Peer Support', 'type': 'ACTIVE_COMPARATOR', 'description': 'Individual peer support calls.', 'interventionNames': ['Behavioral: 1:1 Peer Support']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Facilitated group support', 'description': 'Weekly group gatherings where content will alternate between group conversation and focused topics (e.g., treatment side-effects, mental health, family dynamics, nutrition, financial hardship) with facilitated discussion by a trained professional in nutrition, psychotherapy, cognitive behavioral therapy, or medicine. Each group will cycle through the same order of topics.', 'armGroupLabels': ['Facilitated group support']}\n- {'type': 'BEHAVIORAL', 'name': '1:1 Peer Support', 'description': '1:1 peer support via telephone or video either during or near a treatment visit. Call content will be focused on social support and driven by the needs of the participant.', 'armGroupLabels': ['1:1 Peer Support']}\n\nPrimary Outcomes:\n- {'measure': 'Treatment completion (relative dose)', 'description': 'Relative dose is the ratio of actual-to-expected total dose of treatment received. The calculation of expected total dose will be made from the baseline treatment recommendation data collected at enrollment.', 'timeFrame': '6 months'}\n\nPlease estimate the sample size based on the assumption: \nThe study assumes a type 1 error rate of 0.025 with a conservative Bonferroni correction for two statistical tests. Covariate adjustment for SPS-24 measured at baseline is planned, assuming a correlation of 0.3 between baseline and 6-month SPS-24. The sample size for the Facilitated Support Group is increased by 30% due to potential correlation among participants, assuming an intraclass correlation coefficient of 0.12 and an average group size of 4. The study also accounts for a 7-8% loss to follow-up and missing data.", "answer": 252, "answer_type": "ESTIMATED", "explanation": "Sample size\n A study sample size of n\u00c2\u00a0=\u00c2\u00a0252 was established to provide a minimum of 80% statistical power for the secondary outcome of SPS-24 social isolation, and >80% power for the primary outcome of treatment completion. Sample size estimation accounted for a type 1 error rate of 0.025 to accommodate a conservative Bonferroni correction for two statistical tests of the primary end point (enhanced usual care vs 1:1 peer support, enhanced usual care vs facilitated support group). We plan to use covariate adjustment for SPS-24 measured at baseline as one would do in a traditional analysis of covariance (ANCOVA) model and conservatively assumed a correlation between baseline and 6-month SPS-24 of 0.3. A minimum of n\u00c2\u00a0=\u00c2\u00a070 participants are required in each intervention arm to detect an effect size 4.0 points (standard deviation of 8.0) with 80% power, a change that represents the total absence or presence of one aspect of each of the subscales. Due to the group nature of the Facilitated Support Group intervention, outcomes among participants randomized to this intervention may be correlated with one another. We therefore increased the sample size for the Facilitated Support Group by 30% (variance inflation factor\u00c2\u00a0=\u00c2\u00a01.30), assuming an intraclass correlation coefficient of 0.12 and average anticipated group size of 4. Finally, we accounted for possible loss to follow-up and missing data of 7\u00e2\u0080\u00938% [41]. These calculations resulted in a total sample size of 252 participants (76 enhanced usual care, 100 facilitated support group, and 76 1:1 peer support). With this sample size, the study has 84% power to detect an absolute improvement in relative dose of 6.5% or larger, which represents a small but meaningful improvement in treatment completion relative to improvements observed in other studies (8\u00e2\u0080\u009316%) [30].", "id": 1126, "split": "val"} +{"trial_id": "NCT04931485", "pmid": "37734896", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Protocolised Early De-Resuscitation in Septic Shock (REDUCE) - a Randomised Controlled Multi-centre Feasibility Study\n\nIncluded conditions:\n- Septic Shock\n\nStudy Armgroups:\n- {'label': 'Intervention: REDUCE Protocol', 'type': 'EXPERIMENTAL', 'description': 'Fluid resuscitation and de-resuscitation is based on the REDUCE fluid management protocol.', 'interventionNames': ['Other: Fluid management according to the REDUCE Fluid Protocol']}\n- {'label': 'Standard of Care', 'type': 'ACTIVE_COMPARATOR', 'description': 'Fluid resuscitation and de-resuscitation according to the standard of care', 'interventionNames': ['Other: Standard of care']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Fluid management according to the REDUCE Fluid Protocol', 'description': 'Fluid management according to the protocol will be guided by pre-defined clinical signs for impaired perfusion and fluid overload.', 'armGroupLabels': ['Intervention: REDUCE Protocol'], 'otherNames': ['REDUCE protocol']}\n- {'type': 'OTHER', 'name': 'Standard of care', 'description': 'Fluid resuscitation and de-resuscitation will be managed according to the standard of care', 'armGroupLabels': ['Standard of Care']}\n\nPrimary Outcomes:\n- {'measure': 'Proportion of patient with a negative fluid balance on day 3', 'description': 'Proportion of patients with a negative cumulative fluid balance on day 3', 'timeFrame': 'Up to day 3 after ICU admission'}\n\nPlease estimate the sample size based on the assumption: \nPower of 0.8, 15% dropout rate, Pearson's \u03c72 test, significance level not explicitly stated", "answer": 170, "answer_type": "ESTIMATED", "explanation": "Determination of sample size\n We intend to enrol 170 patients to show an increase in the proportion of patients with a negative fluid balance on day 3 after ICU admission from 30% to 50% (power of 0.8), including a 15% dropout rate. The estimation is based on previous trials, as well as data from our ICU, which has shown that about one-third of patients with septic shock achieve a negative cumulative fluid balance on day 3.18 41 We have chosen day 3, as previous studies have shown a better survival in patients with septic shock with achieving a negative cumulative fluid balance on day 3 after ICU admission.18 42 The sample size calculation was performed by the CTU of the University of Bern and was computed using Stata, V.16.1, applying Pearson\u00e2\u0080\u0099s \u00cf\u00872 test.", "id": 1127, "split": "val"} +{"trial_id": "NCT04932473", "pmid": "36585141", "question": "Here is the design of a clinical trial:\n\nOfficial Title: ALFAsleep: Exploring Cognitive and Biological Correlates of Sleep Quality and Their Potential Links With Alzheimer's Disease\n\nIncluded conditions:\n- Cognitively Unimpaied\n\nStudy Armgroups:\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Sleep quality', 'description': 'Actigraphy-derived sleep quality measures', 'timeFrame': 'up to 2 weeks'}\n\nPlease estimate the sample size based on the assumption: \nStatistical power of 90%, 5% type I error probability (two tails), and consideration of missing/dropout rate.", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size has been computed with G*Power V.3.1.9.4,96 taking into account the estimated effect size (ES) of a previous study using a similar methodology for the detection of differences in sleep efficiency between cognitively unimpaired individuals with normal versus abnormal A\u00ce\u00b2 biomarkers.24 For this ES (ES=0.49), we calculate that a sample size of n=178 (89 cases/89 controls) would be enough to achieve a statistical power of 90%, assuming a 5% type I error probability (two tails) (figure 2).\n \n Figure 2\n \n Estimation of statistical power as a function of sample size.\n \n \n \n Based on these estimations, we plan to recruit 200 subjects: 100 with altered A\u00ce\u00b2 biomarkers and 100 with normal biomarkers. The sample size for the exploratory PSG substudy (n=90) is based on previous literature.44", "id": 1128, "split": "val"} +{"trial_id": "NCT04932577", "pmid": "39938959", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis\n\nIncluded conditions:\n- Liver Cirrhosis\n\nStudy Armgroups:\n- {'label': 'Faecal microbiota transplantation', 'type': 'EXPERIMENTAL', 'description': 'The patients will receive three applications of FMT consisting of 50 g cryopreserved, homogenized faeces from healthy donors. The faecal material will be dispensed into double-coated, acid-resistant enterocapsules or cryobags. Faeces will be screened according to international guidelines.', 'interventionNames': ['Biological: Faecal microbiota transplantation']}\n- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo products is produced from a suspension of glycerol, saline and food colouring and cannot be distinguished from the active FMT products.', 'interventionNames': ['Biological: Placebo']}\n\nInterventions:\n- {'type': 'BIOLOGICAL', 'name': 'Faecal microbiota transplantation', 'description': 'All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year.', 'armGroupLabels': ['Faecal microbiota transplantation'], 'otherNames': ['FMT']}\n- {'type': 'BIOLOGICAL', 'name': 'Placebo', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}\n\nPrimary Outcomes:\n- {'measure': 'Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients.', 'description': 'Using data from the patient journals, we will be able to examine the exact time to event in each of the patients. To compare the two groups, hazard ratios will be calculated.', 'timeFrame': '1 year'}\n\nPlease estimate the sample size based on the assumption: \nStatistical significance level of 0.05, power of 80%, 1-year risk of new decompensation or death is 60%", "answer": 220, "answer_type": "ESTIMATED", "explanation": "Sample size estimation\n We will use a statistical significance level of 0.05 and aim for a power of 80%. In patients with decompensated liver cirrhosis, the 1-year risk of new decompensation or death is predicted to be 60%.33 47 Previous studies found a strong effect of rifaximin on the recurrence of HE (HR 0.42),48 and an effect of beta-blockers on decompensation (HR 0.51)49 in patients with compensated liver cirrhosis. To be able to detect an effect of FMT with an HR of at least 0.60 (a conservative presumption of a weaker treatment response than reported in the other studies), we need to randomise 220 patients with 110 in each arm.", "id": 1129, "split": "val"} +{"trial_id": "NCT04934462", "pmid": "35361185", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Prospective Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability\n\nIncluded conditions:\n- Musculoskeletal Abnormalities\n- Hip Injuries\n\nStudy Armgroups:\n- {'label': 'non-surgical treatment', 'type': 'OTHER', 'description': 'All participants will undergo 6 months of non-surgical treatment.', 'interventionNames': ['Procedure: physiotherapy']}\n- {'label': 'arthroscopic treatment', 'type': 'OTHER', 'description': 'Those participants with failed non-surgical treatment at 6 months will undergo arthroscopic treatment.', 'interventionNames': ['Procedure: physiotherapy', 'Procedure: arthroscopy']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'physiotherapy', 'description': 'Six months physiotherapy aimed at hip stability.', 'armGroupLabels': ['arthroscopic treatment', 'non-surgical treatment']}\n- {'type': 'PROCEDURE', 'name': 'arthroscopy', 'description': 'Arthroscopic plication of hip joint capsule.', 'armGroupLabels': ['arthroscopic treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Mean Change from Baseline in Hip Function on the International Hip Outcome Tool (iHOT-12) at 24 Months', 'description': 'Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).', 'timeFrame': '24 Months'}\n- {'measure': 'Mean Change from Baseline in Hip Function on the Copenhagen Hip and Groin Outcome Score (HAGOS) at 24 Months', 'description': 'Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).', 'timeFrame': '24 Months'}\n- {'measure': 'Mean Change from Baseline in Maximal Isometric Hip Muscle Force in Newton at 24 Months', 'description': 'Maximal hip isometric muscle force will be assessed using a dynamometer (Hoggan MicroFET2, Hoggan, Scientific L.L.C., Salt Lake City, USA) for hip flexion, adduction, abduction, and extension. The maximal developed force in Newton will be recorded. Higher Newton value means a better outcome.', 'timeFrame': '24 Months'}\n- {'measure': 'Mean Change from Baseline in Hop Performance at 24 Months', 'description': 'Hop performance will be measured with 3 single-leg hops: vertical hop (Muscle lab, Ergotest Technology, Oslo, Norway), hop for distance and a 30-second side-hop test. Each hop test is performed with the patients holding their hands behind their back. For the vertical hop, the time from take-off to landing is converted into hop height in centimeters. In the hop for distance test, the distance between top of the toes at take-off to heel at landing is measured in centimeters. For the 30 second side hop test, one trial per leg is allowed, where the patient is instructed to hop as many times as possible over 2 lines 40 centimeters apart. The number of hops is recorded. Higher height, longer distance and higher number of hops means a better outcome.', 'timeFrame': '24 Months'}\n\nPlease estimate the sample size based on the assumption: \npower 80%, significance level (alpha) 0.05, standard deviation (sigma) 25.5", "answer": 26, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n Based on previous results of arthroscopic hip preservation surgery, for the comparison of pre- and post-treatment hip function, a minimum sample size of 26 patients for each treatment group is needed to reach a power of 80% with the iHOT-12 (sigma 25.5, alpha 0.05, effect size 20) [30].", "id": 1130, "split": "val"} +{"trial_id": "NCT04934982", "pmid": "35397576", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer (Stage IA1 With LVSI, IA2)\n\nIncluded conditions:\n- Cervical Cancer\n\nStudy Armgroups:\n- {'label': '1', 'type': 'EXPERIMENTAL', 'description': 'the group of LRH', 'interventionNames': ['Other: Total Laparoscopic or Robotic Radical Hysterectomy']}\n- {'label': '2', 'type': 'ACTIVE_COMPARATOR', 'description': 'the group of ARH', 'interventionNames': ['Other: Total Abdominal Radical Hysterectomy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Total Laparoscopic or Robotic Radical Hysterectomy', 'description': 'Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1\\\\~2 cm of the parametrium and 1\\\\~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).', 'armGroupLabels': ['1']}\n- {'type': 'OTHER', 'name': 'Total Abdominal Radical Hysterectomy', 'description': 'Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1\\\\~2 cm of the parametrium and 1\\\\~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).', 'armGroupLabels': ['2']}\n\nPrimary Outcomes:\n- {'measure': 'the rate of PFS at 5 years', 'description': 'The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated.', 'timeFrame': '5 years from surgery'}\n\nPlease estimate the sample size based on the assumption: \n80% power, a one-sided alpha of 0.025, and a 10% drop-out rate.", "answer": 690, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This study uses a non-inferiority trial design, and the primary outcome is the 5-year PFS rate. The sample size is calculated based on the difference between the two groups of 5-year PFS rate. The 5-year OS rate of the patients in the open surgery group is estimated to be 96% based on clinical data from our hospital, and the 5-year PFS rate is lacking. To infer the relationship between 5-year PFS rate and 5-year OS rate in patients undergoing open surgery, we refer to previous studies and construct a linear regression equation with 5-year OS rate as the independent variable X and 5-year PFS rate as the dependent variable Y (Y\u00e2\u0080\u0089=\u00e2\u0080\u00891.199 X-0.219). Therefore, the 5-year PFS rate of the open surgery group is estimated to be 93%, when the 5-year OS rate is 96%. Based on the assumptions of (i) a 5-year PFS rate of 93% in the open surgery group, (ii) a non-inferiority margin of 6%, (iii) 80% power, and (iv) a one-sided alpha of 0.025, the sample size estimation resulted in 308 subjects per group (calculated with SAS software, version 9.4). Considering a 10% drop-out rate and the randomization scheme with block size of 6, a total of 690 subjects should be randomized (345 per group).", "id": 1131, "split": "val"} +{"trial_id": "NCT04936074", "pmid": "36765352", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Comparison of Posterior Muscle-preserving Selective Laminectomy and Laminectomy With Fusion for Treating Degenerative Cervical Myelopathy: Myelopathy Randomized Controlled Trial (MyRanC)\n\nIncluded conditions:\n- Cervical Spondylotic Myelopathy\n\nStudy Armgroups:\n- {'label': 'Muscle preserving selective laminectomy (L-group)', 'type': 'EXPERIMENTAL', 'description': 'Muscle-preserving selective laminectomy with a posterior midline incision and dissection through the nuchal fascia. The spinous processes are split in the midline using a high-speed burr/ultrasound knife and without disturbing the deep extensor muscles on either side. Angulating away from the midline, the spinous processes are divided at their bases. Laminectomy is performed with a width no more than 2-3 mm wider than the dural borders. The facet joints are not exposed. Finally, the split spionous processes are sutured together. No collar or restrictions will be used in either group.', 'interventionNames': ['Procedure: Muscle preserving selective laminectomy']}\n- {'label': 'Laminectomy with instrumented fusion (LF-group)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Laminectomy with instrumented fusion with a midline incision over the appropriate levels defined as the same levels as the extension of laminectomy plus one level above and below but not extending beyond C3-C7. Soft tissue dissection and retraction is performed to identify osseous landmarks. Special care is taken to spare muscle attachments on C2 and C7. Spinal instrumentation is performed with lateral mass or pedicle screws (C3-C7) combined with rod fixation. Laminectomy is performed with a width not extending more than 2 mm outside the dural borders. Facet joint injury should be avoided. Special care is taken to spare the C7 spinous process and distal half of C7 lamina. The sagittal alignment is corrected before spinal fixation. No collar or restrictions will be used in either group.', 'interventionNames': ['Procedure: Laminectomy with instrumented fusion']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Muscle preserving selective laminectomy', 'description': 'Muscle-preserving selective laminectomy differ from traditional laminectomy by the spinous process split that preserves the deep extensor muscles. The bilateral facet joints are not exposed. After the laminectomy is finished the split fragments of the spinous process are sutured together so that the deep extensor muscles are restored.', 'armGroupLabels': ['Muscle preserving selective laminectomy (L-group)']}\n- {'type': 'PROCEDURE', 'name': 'Laminectomy with instrumented fusion', 'description': 'A traditional laminectomy is complemented with lateral mass and/or pedicle screws connected with rods.', 'armGroupLabels': ['Laminectomy with instrumented fusion (LF-group)']}\n\nPrimary Outcomes:\n- {'measure': 'The primary endpoint will be reoperation for any reason to reflect whether laminectomy alone or laminectomy with instrumented fusion results in fewer reoperations without increasing the frequency of complications.', 'description': 'Reoperation will be considered in case of:\\n\\n* Postoperative hematoma or reperfusion injury with neurologic deterioration within hours/days after the primary surgery.\\n* Change in sagittal alignment (kyphosis, DJK of more than 40 mm cSVA and/or C2-C7 Cobb \\\\< -10\u00b0) with corresponding symptoms of camptocormia/increased pain/neurological deterioration.\\n* ASP defined as degenerative changes on an adjacent level diagnosed with MRI and concomitant symptoms of myelopathy and/or radiculopathy.\\n* Implant failure (clear radiolucency around \\\\>1 screw or rod breakage with increased neck pain and/or neurologic deterioration).\\n* Postoperative infection that requires revision surgery.', 'timeFrame': 'Recorded at 5 years of follow-up'}\n\nPlease estimate the sample size based on the assumption: \nSignificance level not explicitly stated; power of 86% based on simulation; 5% loss due to dropout and emigration.", "answer": 300, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Based on data from the national Swedish spine registry on patients with CSM, reoperation was estimated to be 3.5% after stand-alone laminectomy and 7.4% after laminectomy and fusion. Five-year mortality was estimated to be 16.3% in the same population [31].\n We further determined that excluding a 5% excess rate of reoperation in the laminectomy group vs laminectomy and fusion was a clinically relevant target for the study and therefore set the non-inferiority margin at 5 percentage points (pp).\n With a planned sample size of 300 participants and with regard to mortality and an additional 5% loss due to dropout and emigration, we end up with 236 analyzable patients. This results in a power of 86% based on simulation using rerandomization. The reason for stopping at 300 patients was made on the calculation on how many patients it is reasonable for the four sites to include in 4\u00e2\u0080\u00935 years. Ideally, we would have reached for 90% power but have agreed to compromise with a power over 85% if that means that we will finish the study in due time.\n All statistical analyses were performed in R [32], version 4.0.5 (R Foundation for Statistical Computing, Vienna, Austria), and the R code used in the sample size calculation may be received upon request.", "id": 1132, "split": "val"} +{"trial_id": "NCT04936282", "pmid": "36344929", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients: a Spanish Multicenter, Randomized, Controlled Parallel-group Trial: The TRAINING Study\n\nIncluded conditions:\n- Kidney Transplant Failure and Rejection\n\nStudy Armgroups:\n- {'label': 'Experimental', 'type': 'EXPERIMENTAL', 'description': 'Normal treatment (Steroids, tacrolimus and mycophenolate) for first 90 days, then add Grafalon single-dose if borderline lesions are present in protocol biopsy (performed at third month post-transplantation).', 'interventionNames': ['Drug: Grafalon']}\n- {'label': 'Normal treatment', 'type': 'ACTIVE_COMPARATOR', 'description': 'Normal treatment (Steroids, tacrolimus and mycophenolate) arm', 'interventionNames': ['Drug: Normal Treatment']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Grafalon', 'description': 'When Borderline lesions are present in protocol biopsy, administer Grafalon \u00ae 6 mg/kg/day in a single day. Then continue with the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day).', 'armGroupLabels': ['Experimental']}\n- {'type': 'DRUG', 'name': 'Normal Treatment', 'description': 'When Borderline lesions are present in protocol biopsy, administer the normal treatment: Steroids (5 mg/day), tacrolimus (0.1 mg/kg/day) and mycophenolate (1000 mg/day)', 'armGroupLabels': ['Normal treatment']}\n\nPrimary Outcomes:\n- {'measure': 'Presence of interstitial fibrosis/tubular atrophy (IFTA)', 'description': 'Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant.', 'timeFrame': '24 months'}\n- {'measure': 'Renal function measured with CKD-EPI', 'description': 'Renal function after kidney transplant in both groups at 24 months measured according to glomerular filtration rate determined by CKD-EPI formula', 'timeFrame': '24 months'}\n\nPlease estimate the sample size based on the assumption: \nA power of 80% (Beta = 0.20), a statistical risk of 5% (alpha = 0.05), and a 15% loss to follow-up.", "answer": 80, "answer_type": "ESTIMATED", "explanation": "Sample size\n Data analyzed in previous studies where renal function is compared in patients with BL versus those without inflammation have been used as reference points [32, 33]. To detect a difference in GFR of 10\u00e2\u0080\u0089ml/min at 24\u00e2\u0080\u0089months post-KT in both groups with an estimated standard deviation in one of the groups of 15\u00e2\u0080\u0089ml/min, a power of 80% (Beta\u00e2\u0080\u0089=\u00e2\u0080\u00890.20), and a statistical risk of 5% (alpha\u00e2\u0080\u0089=\u00e2\u0080\u00890.05), a total of 70 patients with BL (35 in each therapeutic arm) is required. Assuming a 15% loss to follow-up, 80 patients (40 in each group) are needed for the evaluation of efficacy (Epidat 3.1).", "id": 1133, "split": "val"} +{"trial_id": "NCT04936620", "pmid": "37550727", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling\n\nIncluded conditions:\n- Spinal Cord Injuries\n\nStudy Armgroups:\n- {'label': 'Duroplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'Duroplasty (includes Surgery with Laminectomy)', 'interventionNames': ['Procedure: Duroplasty', 'Procedure: Spinal surgery']}\n- {'label': 'No duroplasty', 'type': 'ACTIVE_COMPARATOR', 'description': 'No duroplasty (but includes surgery with Laminectomy)', 'interventionNames': ['Procedure: Spinal surgery']}\n\nInterventions:\n- {'type': 'PROCEDURE', 'name': 'Duroplasty', 'description': 'Expansion Duroplasty', 'armGroupLabels': ['Duroplasty']}\n- {'type': 'PROCEDURE', 'name': 'Spinal surgery', 'description': 'Spinal surgery including laminectomy', 'armGroupLabels': ['Duroplasty', 'No duroplasty']}\n\nPrimary Outcomes:\n- {'measure': 'Change in AIS motor score', 'description': 'Change in American Spinal Injury Association Impairment Scale total limb motor score at 6 months', 'timeFrame': '6 months versus baseline'}\n\nPlease estimate the sample size based on the assumption: \n15% patient loss to follow-up by 6 months, statistical power of 85%, 2-sided significance level of 5%. Statistical power may be revised to 90% if recruitment figure of 260 is achievable.", "answer": 222, "answer_type": "ESTIMATED", "explanation": "Sample size {14}\n Assuming a 6-month improvement in change in AIS motor score (\u00ce\u0094AMS) from a mean (SD) of 17 (25) in the control arm to 28 (25) in the intervention arm, allowing for 15% patient loss to follow-up by 6 months (including patient death which is estimated to be around 2\u00e2\u0080\u00933% by 6 months), a total sample size of 222 patients is required with statistical power of 85% and 2-sided significance level of 5%. The assumed difference in \u00ce\u0094AMS and SD are based on our exploratory study [7] and are supported by data from the European Multicenter Study about Spinal Cord Injury (EMSCI) database and other published series [16, 17] in which \u00ce\u0094AMS is between 15 and 18 with SD ranging from 15 to 25. While recruitment is in progress, the statistical power will be revised from 85 to 90% if it becomes clear that the new recruitment figure (N = 260) is achievable. The final decision to increase recruitment will be made by the TSC.\n \n Mechanistic study\n Since the proposed mechanistic studies are intended to be hypothesis-generating, no formal sample size calculation has been performed.", "id": 1134, "split": "val"} +{"trial_id": "NCT04938570", "pmid": "34936689", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Wearables in Rugby Union: A Protocol for Multimodal Digital Sports-related Concussion Assessment\n\nIncluded conditions:\n- Concussion, Brain\n- Sports Injury\n\nStudy Armgroups:\n- {'label': 'University-level and amateur rugby players', 'description': 'University-level and amateur rugby players will be recruited and assessed (motor, visual and symptom assessment) over one season ( June 2021 to August 2022).\\n\\nParticipants will be stratified according to gender (males n\u2248100, and females n\u2248100). Although the number of SRC that will be observed during the season is not known, the investigators will compare a number of head injuries/SRC to the results from cohort baseline testing. Participants that do not sustain a concussion will also have follow up testing at the end of the season.'}\n\nInterventions:\n\nPrimary Outcomes:\n- {'measure': 'Step time (mean \u00b1 standard deviation)', 'description': 'Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable', 'timeFrame': 'Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months'}\n- {'measure': 'Stance time (seconds, mean \u00b1 standard deviation)', 'description': 'Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable', 'timeFrame': 'Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months'}\n- {'measure': 'Stride time (seconds, mean \u00b1 standard deviation)', 'description': 'Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable', 'timeFrame': 'Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months'}\n- {'measure': 'Swing time (seconds, mean \u00b1 standard deviation)', 'description': 'Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable', 'timeFrame': 'Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months'}\n- {'measure': 'Stride length (cm, mean \u00b1 standard deviation)', 'description': 'Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable', 'timeFrame': 'Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months'}\n- {'measure': 'Stride velocity (cms-1), mean \u00b1 standard deviation)', 'description': 'Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable', 'timeFrame': 'Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months'}\n\nPlease estimate the sample size based on the assumption: \nConfidence level of 95% (\u03b1 = 0.05, Z-value = 1.96), margin of error of 0.075 (7.5%).", "answer": 200, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size calculation is based sample sizes from previous paper examining multimodal assessment, ~200 [18,35]. To determine the appropriate sample size (SS) for estimating the proportion of players we used the following formula (Eq 1) as previously described.\n \nSS=(Z\u00e2\u0088\u0092score)2\u00c3\u0097proportion\u00c3\u0097(1\u00e2\u0080\u0093proportion)/(marginoferror)2\n(1)\n\n For a confidence level of 95%, \u00ce\u00b1 is 0.05 and the corresponding Z-value is 1.96. The sample proportion is unknown. We chose the number 0.50 (50%) because it takes the maximum spread into account. Consensus about the margin of error was achieved by joint discussion of the research group; a margin error of 0.075 (7.5%) was accepted. For a population size of 200 and a confidence level of 95%, \u00ce\u00b1 is 0.05 and the corresponding z-value is 1.96. Therefore, in total, 200 patients will be enrolled in the study to reach the necessary sample size.", "id": 1135, "split": "val"} +{"trial_id": "NCT04939831", "pmid": "37592299", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)\n\nIncluded conditions:\n- Cervical Cancer\n\nStudy Armgroups:\n- {'label': '1', 'type': 'EXPERIMENTAL', 'description': 'the group of LRH', 'interventionNames': ['Other: Total Laparoscopic or Robotic Radical Hysterectomy']}\n- {'label': '2', 'type': 'ACTIVE_COMPARATOR', 'description': 'the group of ARH', 'interventionNames': ['Other: Total Abdominal Radical Hysterectomy']}\n\nInterventions:\n- {'type': 'OTHER', 'name': 'Total Laparoscopic or Robotic Radical Hysterectomy', 'description': 'Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.', 'armGroupLabels': ['1']}\n- {'type': 'OTHER', 'name': 'Total Abdominal Radical Hysterectomy', 'description': 'Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.', 'armGroupLabels': ['2']}\n\nPrimary Outcomes:\n- {'measure': 'the rate of OS at 5 years', 'description': 'Compare between groups(Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.)', 'timeFrame': '5 years from surgery'}\n\nPlease estimate the sample size based on the assumption: \n80% power, a one-sided alpha of 0.025, and a 10% drop-out rate.", "answer": 1104, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n This study is a non-inferiority trial, with the primary outcome of 5-year OS rate. The sample size is calculated based on the difference between the two groups of 5-year OS rate. According to clinical data from our hospital, the 5-year OS rate of the open surgery group is estimated to be 72%. Based on the assumptions of (i) the 5-year OS rate of 72% in the open surgery group, (ii) a non-inferiority margin of 8%, (iii) 80% power, and (iv) a one-sided alpha of 0.025, the sample size estimation resulted in 495 subjects per group (SAS software, version 9.4). Assuming a 10% drop-out rate and considering the randomization scheme with a block size of 6, the final sample size is 1104 patients (552 for each group).", "id": 1136, "split": "val"} +{"trial_id": "NCT04940689", "pmid": "38830745", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Opioid-Free Anesthesia in Cardiac Surgery\n\nIncluded conditions:\n- Anesthesia\n\nStudy Armgroups:\n- {'label': 'Standard arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'General anesthesia strategy with morphine:\\n\\n* Within 10 minutes before the induction of general anesthesia: administration of a placebo of 50 mL of 0.9% NaCl by slow IV\\n* The anesthetic induction will be carried out by an intravenous hypnotic (propofol or etomidate) combined with IV curare and remifentanil (morphine derivative) IV for a concentration target of 4 ng / mL.\\n* Maintenance of anesthesia will be carried out with propofol or a halogenated gas (sevoflurane or desflurane) in continuous administration (qs bispectral index 40-60) and remifentanil (target concentration 1-10 ng / mL). The administration of curare will be carried out as needed. In order to anticipate the sudden end of the analgesia, an administration of morphine 0.15 mg / kg IV will be carried out 30 minutes before the end of the intervention as recommended', 'interventionNames': ['Drug: Remifentanil']}\n- {'label': 'OFA arm', 'type': 'EXPERIMENTAL', 'description': 'General anesthesia strategy without morphine\\n\\n* Within 10 minutes before the induction of general anesthesia: pre-induction dose of dexmedetomidine 0.5 g / kg and lidocaine 1.5 mg / kg by slow IV.\\n* The anesthetic induction will be carried out by an intravenous hypnotic (propofol or etomidate) combined with an IV curare\\n* The maintenance of the anesthesia will be carried out by propofol or a halogenated gas (sevoflurane or desflurane) in continuous administration (qsp bispectral index 40-60), dexmedetomidine 0.5-1.0 g / kg / h, lidocaine 2 mg / kg / h. The administration of curare will be carried out as needed.', 'interventionNames': ['Drug: Dexm\u00e9d\u00e9tomidine 0.5 g/kg + lidocaine 1.5 mg/kg']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexm\u00e9d\u00e9tomidine 0.5 g/kg + lidocaine 1.5 mg/kg', 'description': 'The patient will be anesthetized with Dexmedetomidine 0.5 g / kg + lidocaine 1.5 mg / kg for the induction instead of morphin.', 'armGroupLabels': ['OFA arm'], 'otherNames': ['experimental']}\n- {'type': 'DRUG', 'name': 'Remifentanil', 'description': 'The patient will be anesthetized with morphin.', 'armGroupLabels': ['Standard arm'], 'otherNames': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'To assess the impact of general anesthesia strategy without the use of opioids (OFA) on the incidence of major postoperative complications related to opioids compared to the reference strategy using opioids.', 'description': 'Composite criterion consisting of the appearance 48 hours after the surgery of an intestinal ileus, and / or of an alteration of the neurological state, and / or of an acute respiratory failure, and / or of a death', 'timeFrame': '48 hours post-surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a one-sided Pearson's \u03c72 test at a 0.05 significance level, with 80% power. The analysis will follow the intention-to-treat principle, and missing values for the primary endpoint will be imputed according to the maximal bias assumption. All statistical tests are two-sided with a 0.05 level required for statistical significance.", "answer": 268, "answer_type": "ESTIMATED", "explanation": "Sample size calculation, statistics and allocation\n \n Sample size calculation\n The primary endpoint of this study is a composite endpoint defined by the occurrence of at least one of the four major opioid-related complications within 48 hours after cardiac surgery. The sample size was calculated with respect to Pearson\u00e2\u0080\u0099s \u00cf\u00872 test at a one-sided 0.05 level, to compare the occurrence of complication between the two groups. In a recent French national survey, 50% of patients presented at least one complication among POCD, ileus or respiratory distress (data not published). In order to obtain 80% power for the difference given by the respective composite endpoint probabilities of 35% and 50% in the OFA and OBA arms, respectively, with one-sided type I error of 5% (reduction in complications of at least 30%), 134 patients will have to be included in each group, hence 268 patients overall. The unilateral characteristic of the test is justified by a previous retrospective study from Guinot et al, where OFA showed a reduction in postoperative outcomes. These data have been recently confirmed by another cohort study from the same authors.32 33\n\n \n \n Statistics\n The main analysis will be carried out on all randomised patients according to the treatment group drawn at random (intention-to-treat principle).\n Patient characteristics will be described using standard parameters: mean, SD, median, IQR and extreme values for quantitative variables and frequencies and percentages for categorical variables.\n The proportion of patients experiencing the main outcome and its 95% CI will be estimated in each group and compared by means of Pearson\u00e2\u0080\u0099s \u00cf\u00872 test.\n This analysis will be complemented by a comparison using the logistic regression model with the main outcome (patients meeting the primary endpoint within 48 hours after cardiac surgery) as the response and the treatment group (OFA or OBA) and potential factors associated with the response as explanatory variables such as age, body mass index, Euroscore 2, type of surgery (CABG or combined surgery) and duration of CPB.\n The same general approach as outlined above will be used to compare the secondary qualitative outcomes (nausea\u00e2\u0080\u0093vomiting, pain, arrhythmia, shock, relative adrenal insufficiency, acute kidney injury, mortality) and Student\u00e2\u0080\u0099s t-test will be used to compare quantitative parameters (length of stay).\n No interim analysis will be performed.\n Since this is an intention-to-treat analysis, in cases of missing value for the primary endpoint, imputation will be used according to the maximal bias assumption for incomplete observations. Namely, patients will be considered to experience the main outcome in the OFA group, and conversely in the OBA group.\n All statistical tests are two sided, with a two-sided 0.05 level required for statistical significance.\n \n \n Allocation and blinding\n Patients who give written informed consent to participate in the study will be randomly assigned to the control (OBA) and experimental (OFA) groups. Inclusion and randomisation will be performed using the Ennov Clinical trial online software (Ennov, France), and a unique and anonymous number will be attributed to each patient. Randomisation will be stratified by centre in a 1:1 ratio using balanced blocks. All data will be collected and anonymised in an electronic case report form on the Ennov Clinical trial platform by a dedicated clinical research technician. Data will be monitored by a clinical research assistant in the presence of the clinical research technician and the main investigator of the site. Data will be stored for 15 years after the end of the trial in a dedicated secure server by the Clinical Research Department of the Rouen University Hospital.\n Patients will be blinded to the allocated group and a 50 mL vial of 0.9% NaCl will be administrated before induction of anaesthesia in the OBA group to reinforce the blindness. The anaesthesia team will not be blinded to the allocation, but the postoperative care team in ICU will be blinded.\n \n \n Safety concerns\n In accordance with French regulations, every serious adverse event related to the investigational medicinal products or not, expected or unexpected, will be immediately reported to the sponsor (Clinical Research Department of the Rouen University Hospital) by the investigator, with the exception of those that are identified as not requiring immediate reporting in the protocol. A serious adverse event is defined as one that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, causes significant disability or prolonged incapacity, is a congenital anomaly or birth defect or is a medical event. The investigator will have to complete a \u00e2\u0080\u0098serious adverse event\u00e2\u0080\u0099 form on which will be indicated the date of onset, criterion of seriousness, intensity, treatment dates, causality relationship with the investigational medicinal products and the outcome. The period in which serious adverse events should be reported begins from the date of the authorisation of the study until 48 hours after the end of the anaesthetic of the patient included in the study or without a time limit if it is possibly related to the investigational medicinal product and/or to the clinical trial.\n As mentioned in the protocol, the following events will not require immediate reporting: complications associated with cardiac surgery and unrelated to investigational medicinal products will not require immediate reporting but will be collected in the case report form.\n Moreover, in order to avoid collection duplication in the case report form, the events POI, acute respiratory failure and POCD will be recorded as the primary endpoint in the case report form but not reported on the \u00e2\u0080\u0098adverse event\u00e2\u0080\u0099 page. In the same way, nausea and vomiting and bradycardia will be recorded as secondary endpoints in the case report form, with the exception of bradycardia meeting one of the following definitions, which will be reported on the adverse event page and subject to immediate reporting: (1) appearance of profound bradycardia in relation to investigational medicinal products (heart rate below 35 bpm lasting more than 120 s or below 40 bpm with haemodynamic repercussions) will be considered as a serious adverse event; (2) episodes of atropine-refractory bradycardia, defined as failure to normalise heart rate (heart rate greater than or equal to 50 bpm), despite at least two administrations of 1 mg atropine.\n In the case of profound and severe bradycardia (heart rate below 40 bpm), if there is no response to two doses of 1 mg atropine, the treatment will be stopped prematurely, and an alternative anaesthetic technique used to ensure the surgical procedure.\n In addition, serious adverse events will be submitted to the data and safety monitoring board (DSMB). The DSMB is independent of the trial investigators and will perform an ongoing review of safety parameters and overall study conduct.\n This is justified in view of the study population at risk of mortality (independently of this trial), the off-label use of anaesthesia drugs in the OFA group and the high rate of complications associated with cardiac surgery. The DSMB will comprise three experts: an anaesthetist, a drug safety expert and a methodologist. The members will meet before the start of the trial, then on a regular basis (after 10% and half of the patients included, at the end of the study after the database lock), and if necessary, at any time at the sponsor\u00e2\u0080\u0099s request in the case of a significant event. The DSMB will have to assess the benefit/risk ratio of the trial and to give recommendations on whether the study should be discontinued or not. All serious adverse events for which the investigator or the sponsor considers that a causal relationship with the investigational medicinal products can be reasonably considered will be considered as suspected serious adverse reactions (SARs). If they are unexpected, they are qualified as being suspected unexpected SARs and will be notified in a report by the sponsor to EudraVigilance (European pharmacovigilance database) and to the local regulatory agency within the regulatory time periods for reporting: immediate reporting if seriousness criteria are death or life threatening, and reporting within 15 days for other seriousness criteria.", "id": 1137, "split": "val"} +{"trial_id": "NCT04940689", "pmid": "38830745", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Opioid-Free Anesthesia in Cardiac Surgery\n\nIncluded conditions:\n- Anesthesia\n\nStudy Armgroups:\n- {'label': 'Standard arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'General anesthesia strategy with morphine:\\n\\n* Within 10 minutes before the induction of general anesthesia: administration of a placebo of 50 mL of 0.9% NaCl by slow IV\\n* The anesthetic induction will be carried out by an intravenous hypnotic (propofol or etomidate) combined with IV curare and remifentanil (morphine derivative) IV for a concentration target of 4 ng / mL.\\n* Maintenance of anesthesia will be carried out with propofol or a halogenated gas (sevoflurane or desflurane) in continuous administration (qs bispectral index 40-60) and remifentanil (target concentration 1-10 ng / mL). The administration of curare will be carried out as needed. In order to anticipate the sudden end of the analgesia, an administration of morphine 0.15 mg / kg IV will be carried out 30 minutes before the end of the intervention as recommended', 'interventionNames': ['Drug: Remifentanil']}\n- {'label': 'OFA arm', 'type': 'EXPERIMENTAL', 'description': 'General anesthesia strategy without morphine\\n\\n* Within 10 minutes before the induction of general anesthesia: pre-induction dose of dexmedetomidine 0.5 g / kg and lidocaine 1.5 mg / kg by slow IV.\\n* The anesthetic induction will be carried out by an intravenous hypnotic (propofol or etomidate) combined with an IV curare\\n* The maintenance of the anesthesia will be carried out by propofol or a halogenated gas (sevoflurane or desflurane) in continuous administration (qsp bispectral index 40-60), dexmedetomidine 0.5-1.0 g / kg / h, lidocaine 2 mg / kg / h. The administration of curare will be carried out as needed.', 'interventionNames': ['Drug: Dexm\u00e9d\u00e9tomidine 0.5 g/kg + lidocaine 1.5 mg/kg']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Dexm\u00e9d\u00e9tomidine 0.5 g/kg + lidocaine 1.5 mg/kg', 'description': 'The patient will be anesthetized with Dexmedetomidine 0.5 g / kg + lidocaine 1.5 mg / kg for the induction instead of morphin.', 'armGroupLabels': ['OFA arm'], 'otherNames': ['experimental']}\n- {'type': 'DRUG', 'name': 'Remifentanil', 'description': 'The patient will be anesthetized with morphin.', 'armGroupLabels': ['Standard arm'], 'otherNames': ['Control']}\n\nPrimary Outcomes:\n- {'measure': 'To assess the impact of general anesthesia strategy without the use of opioids (OFA) on the incidence of major postoperative complications related to opioids compared to the reference strategy using opioids.', 'description': 'Composite criterion consisting of the appearance 48 hours after the surgery of an intestinal ileus, and / or of an alteration of the neurological state, and / or of an acute respiratory failure, and / or of a death', 'timeFrame': '48 hours post-surgery'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size calculation is based on a one-sided Pearson's \u03c72 test at a 0.05 significance level, with 80% power. The analysis will follow the intention-to-treat principle, and missing values for the primary endpoint will be imputed according to the maximal bias assumption. All statistical tests are two-sided with a 0.05 level required for statistical significance.", "answer": 268, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary endpoint of this study is a composite endpoint defined by the occurrence of at least one of the four major opioid-related complications within 48 hours after cardiac surgery. The sample size was calculated with respect to Pearson\u00e2\u0080\u0099s \u00cf\u00872 test at a one-sided 0.05 level, to compare the occurrence of complication between the two groups. In a recent French national survey, 50% of patients presented at least one complication among POCD, ileus or respiratory distress (data not published). In order to obtain 80% power for the difference given by the respective composite endpoint probabilities of 35% and 50% in the OFA and OBA arms, respectively, with one-sided type I error of 5% (reduction in complications of at least 30%), 134 patients will have to be included in each group, hence 268 patients overall. The unilateral characteristic of the test is justified by a previous retrospective study from Guinot et al, where OFA showed a reduction in postoperative outcomes. These data have been recently confirmed by another cohort study from the same authors.32 33", "id": 1138, "split": "val"} +{"trial_id": "NCT04941911", "pmid": "34857585", "question": "Here is the design of a clinical trial:\n\nOfficial Title: A Double-blind Randomised Placebo-controlled Feasibility Study to Assess the Impact of Octreotide Infusion During Liver Transplantation on Post-operative Renal Failure.\n\nIncluded conditions:\n- Liver Transplantation\n- Renal Failure\n\nStudy Armgroups:\n- {'label': 'Intervention group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Octreotide intravenous infusion, 100mcg bolus with a subsequent infusion of 100mcg per hour during surgery.', 'interventionNames': ['Drug: Octreotide Acetate']}\n- {'label': 'Placebo group', 'type': 'PLACEBO_COMPARATOR', 'description': 'Sodium chloride 0.9% w/v', 'interventionNames': ['Other: Placebo']}\n\nInterventions:\n- {'type': 'DRUG', 'name': 'Octreotide Acetate', 'description': 'Octreotide syringes will contain 50ml of octreotide acetate at 20mcg/ml in 0.9% w/v sodium chloride in water.', 'armGroupLabels': ['Intervention group']}\n- {'type': 'OTHER', 'name': 'Placebo', 'description': 'Sodium chloride 0.9% w/v', 'armGroupLabels': ['Placebo group']}\n\nPrimary Outcomes:\n- {'measure': 'Ability to recruit patients.', 'description': 'This will be assessed by:\\n\\n\u2022 Ability to recruit patients (target: \u2265 30% consent rate of eligible patients admitted for transplant)', 'timeFrame': 'Approximately 180 days.'}\n- {'measure': 'Completion of the study intervention.', 'description': 'This will be assessed by:\\n\\n\u2022 The percentage of patients successfully completing the study intervention. Defined as eligible patients who receive the entire study drug infusion in a blinded manner.', 'timeFrame': 'Approximately 9.5 hours.'}\n\nPlease estimate the sample size based on the assumption: \nThe sample size will allow estimation of patient consent rate with a 95% CI of \u00b1 10% based on 100 participants approached. Survival to discharge is above 96% for both study sites, indicating that ninety-day follow-up data collection will be achieved for the majority of patients.", "answer": 30, "answer_type": "ACTUAL", "explanation": "Sample size\n Thirty patients will be recruited from two sites, with 20 in the study drug (octreotide) arm and 10 in the placebo. This sample will allow us to demonstrate the feasibility of conducting a full-scale randomised trial. This study is not powered to detect differences in treatment effect but will obtain estimates of an effect and its variance.30 This sample size will allow us to estimate patient consent rate with a 95% CI of \u00c2\u00b1 10% (based on 100 participants approached). The secondary outcome data will provide the required information for a sample size calculation for the primary end point of a subsequent trial.31 Survival to discharge is above 96% for both study sites and hence it is likely that the ninety day follow data collection will be achieved for the majority of patients.\n \n Recruitment rate\n Over 275 patients per year will be eligible for study inclusion across the two study sites. With a 10 month recruitment period, this requires a 13% recruitment rate. A recent interventional trial in liver transplantation at the RFH achieved a 53% recruitment rate.32 Staff involvement and recruitment strategies will be similar in this study indicating this is a deliverable recruitment target.", "id": 1139, "split": "val"} +{"trial_id": "NCT04944147", "pmid": "35410927", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-COVID-19 Cognitive Impairment\n\nIncluded conditions:\n- COVID-19\n- Post-COVID-19\n\nStudy Armgroups:\n- {'label': 'Anodal tDCS + cognitive training', 'type': 'EXPERIMENTAL', 'description': 'device: anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA) over left dorsolateral prefrontal cortex\\n\\nbehavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions', 'interventionNames': ['Device: Anodal tDCS', 'Behavioral: Intensive cognitive training']}\n- {'label': 'Sham tDCS + cognitive training', 'type': 'PLACEBO_COMPARATOR', 'description': 'device: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex\\n\\nbehavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions', 'interventionNames': ['Device: Sham tDCS', 'Behavioral: Intensive cognitive training']}\n- {'label': 'Sham tDCS + Progressive Muscle Relaxation training', 'type': 'ACTIVE_COMPARATOR', 'description': 'device: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex\\n\\nbehavioral: progressive muscle relaxation (PMR) standardized instructed PMR (20 minutes), 9 sessions', 'interventionNames': ['Device: Sham tDCS', 'Behavioral: Progressive muscle relaxation (PMR)']}\n\nInterventions:\n- {'type': 'DEVICE', 'name': 'Anodal tDCS', 'description': 'Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA)', 'armGroupLabels': ['Anodal tDCS + cognitive training']}\n- {'type': 'DEVICE', 'name': 'Sham tDCS', 'description': 'Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants', 'armGroupLabels': ['Sham tDCS + Progressive Muscle Relaxation training', 'Sham tDCS + cognitive training']}\n- {'type': 'BEHAVIORAL', 'name': 'Intensive cognitive training', 'description': 'Intensive cognitive training of a letter memory updating task, 9 sessions', 'armGroupLabels': ['Anodal tDCS + cognitive training', 'Sham tDCS + cognitive training']}\n- {'type': 'BEHAVIORAL', 'name': 'Progressive muscle relaxation (PMR)', 'description': 'Standardized instructed PMR training, 9 sessions', 'armGroupLabels': ['Sham tDCS + Progressive Muscle Relaxation training']}\n\nPrimary Outcomes:\n- {'measure': 'Working memory performance at post-assessment', 'description': 'Percent change of correct responses in the n-back task compared to the pre-training assessment.', 'timeFrame': '3 weeks'}\n\nPlease estimate the sample size based on the assumption: \nA two-sided significance level of \u03b1=0.05 and a power of at least 80%.", "answer": 60, "answer_type": "ACTUAL", "explanation": "Sample size\n Power calculation is based on recent studies using multisession application of cognitive training compared with a control training on immediate performance in the trained task (primary outcome).49\u00e2\u0080\u009351 Based on these data, we estimated an effect size of 0.8 (Cohen\u00e2\u0080\u0099s d). To demonstrate an effect in the primary outcome between cognitive training groups and control (% correct in the n-back task for training groups vs PMR group) with an independent t-test using a two-sided significance level of \u00ce\u00b1=0.05\u00e2\u0080\u0089and a power of at least 80%, 60 participants (40 for cognitive training groups (for secondary comparison of training plus anodal vs sham tDCS groups), 20 for PMR group) need to be included. This conservative approach using a t-test was chosen, even though we intend to analyse the primary outcome conducting analysis of covariance models.52 This monocentric clinical trial will serve to calculate the sample size for a subsequent multicentre clinical trial. Sample size estimation was conducted using R software (http://www.R-project.org) and the pwr package (https://cran.r-project.org/package=pwr).", "id": 1140, "split": "val"} +{"trial_id": "NCT04945876", "pmid": "36864377", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Effect of Mobile Health Technology (mHealth), Exercise Adherence and Optimal Nutrition Post Rehabilitation Among People With Parkinson's Disease\n\nIncluded conditions:\n- Parkinson Disease\n\nStudy Armgroups:\n- {'label': 'Control group', 'type': 'NO_INTERVENTION', 'description': 'Participants is encouraged to follow the home-based rehabilitation plan based on the recommendations from the rehabilitation center. No further follow up except for testing at 12 weeks and six months.\\n\\nAfter the completion of the study the control group will be offered a session of individual exercise and diet guidance as well as a period of digital follow-up as needed.'}\n- {'label': 'Intervention group', 'type': 'EXPERIMENTAL', 'description': 'Participants will receive a session of individual exercise and diet guidance with focus on goals and motivation for diet and exercise and help to overcome any barriers for self-efficacy. They will also receive an activity tracker and an introduction on how to use it. Further they will receive a monthly digital follow-up to provide support and address questions and goals regarding nutrition, daily energy expenditure and exercise. The participants can also send sms if they have questions during the follow-up period. They will be encouraged to continue to follow the home-based rehabilitation plan based on the recommendations from the rehabilitation center. If needed they can get help to find suitable exercise groups in their own municipality. The Garmin wristband will be used to facilitate daily activity and continuing exercise at recommended intensity level at home. Participants who are malnourished, or at risk of malnutrition, will receive specific guidance session on nutrition.', 'interventionNames': ['Behavioral: Digital follow-up']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Digital follow-up', 'description': 'Participants will receive:\\n\\nOne session of individual exercise and diet guidance focusing on goals and motivation.\\n\\nAn activity tracker and instructions on how to use it both for motivation, daily activity tracking, logging of specific exercise and using the wristbands heart rate monitor to control intensity level during exercise.\\n\\nMonthly digital follow-up to provide support and address questions and goals regarding nutrition, daily energy expenditure and exercise.\\n\\nOpportunity to send sms with questions regarding nutrition and exercise. Participants who are malnourished, or at risk of malnutrition will be offered a total of two hours of additional individualized, digital guidance on nutrition as needed.', 'armGroupLabels': ['Intervention group']}\n\nPrimary Outcomes:\n- {'measure': 'Six minute walk test (6MWT)', 'description': 'A sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. It evaluates the functional capacity of the individual.', 'timeFrame': 'measured at baseline, 12 weeks and 6 months'}\n\nPlease estimate the sample size based on the assumption: \nA significance level of 0.05 and 80% power is assumed. The sample size is expanded by 20% to account for possible losses during follow-up.", "answer": 100, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The primary outcome\u00c2\u00a0of the current study is the difference between groups in physical capacity, measured by the 6MWT. Previous studies among older adults have defined a substantial, meaningful change between groups in the 6MWT to be a mean (SD) of 50 (80) meters. This estimate requires 82 participants, 41 in each group, and a clinical trial with an independent comparison of two groups at a significance level of 0.05 and 80% power is assumed. Considering possible losses during follow-up, the sample will be expanded by 20% (20 participants). Thus, 100 participants will be included in total [113].", "id": 1141, "split": "val"} +{"trial_id": "NCT04946292", "pmid": "36523250", "question": "Here is the design of a clinical trial:\n\nOfficial Title: Developing and Evaluating a Theory-derived Intervention to Improve Oral Health of Community-dwelling Elderly\n\nIncluded conditions:\n- Periodontal Diseases\n- Dental Caries\n\nStudy Armgroups:\n- {'label': 'Theory-derived intervention', 'type': 'EXPERIMENTAL', 'description': 'Questionnaire will be used including the scales for three dominant theoretical models, Health Belief Model (HBM), Theory of planned behaviour (TPB) and Social Cognitive Theory (SCT). The theoretical model that best explains the health behaviours of the selected participants will be selected for designing oral health intervention.The theory-derived intervention will address the constructs/domains of the selected model(s) in the context of the three target behaviours (diet, toothbrushing and dental flossing).', 'interventionNames': ['Behavioral: Theory-derived intervention']}\n- {'label': 'Conventional health education', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants will be randomly assigned to the control group, stratified by gender and education level. Allocation concealment will be ensured by using sealed opaque envelopes.', 'interventionNames': ['Behavioral: Conventional health education']}\n\nInterventions:\n- {'type': 'BEHAVIORAL', 'name': 'Theory-derived intervention', 'description': 'The intervention will be delivered through multimedia materials and group activities, as appropriate. Participants will spend approximately 30-45 minutes for the intervention. Intervention materials and activities will be carefully designed to address all the constructs/ domains of the selected theoretical model(s). The effectiveness of the interventions will be evaluated using behavioural outcomes (diet, brushing, flossing) and clinical outcomes (oral hygiene, caries and periodontal conditions).', 'armGroupLabels': ['Theory-derived intervention']}\n- {'type': 'BEHAVIORAL', 'name': 'Conventional health education', 'description': 'The conventional health education will be delivered through an oral health talk and oral health booklet. Topics covered are: (i) common oral diseases and its consequences; (ii) common dental problems among older adults; (iii) importance of oral health measures (healthy diet, toothbrushing and dental flossing); and (iv) proper techniques for toothbrushing and dental flossing.', 'armGroupLabels': ['Conventional health education']}\n\nPrimary Outcomes:\n- {'measure': 'Increment of coronal caries', 'description': 'Number of new surfaces with coronal caries', 'timeFrame': 'From baseline to 2 years post-intervention'}\n- {'measure': 'Increment of root caries', 'description': 'Number of new surfaces with root caries', 'timeFrame': 'From baseline to 2 years post-intervention'}\n\nPlease estimate the sample size based on the assumption: \nBased on a significance level of 5% and a power of 80%, with an estimated 25% attrition rate.", "answer": 440, "answer_type": "ESTIMATED", "explanation": "Sample size calculation\n The sample size needed for this study was calculated by using the software G*Power V.3.1.9.2 (Franz Faul, University of Kiel, Germany). The sample size calculation was based on the primary outcomes, namely increment of coronal caries (\u00ce\u0094DFS \u00e2\u0080\u0093 coronal) and increment of root caries (\u00ce\u0094DFS \u00e2\u0080\u0093 root), and independent t-tests for comparing means of two independent groups. A caries incidence study among the elderly reported that the mean (SD) 5\u00e2\u0080\u0089years caries incidence were 2.65 (3.14) for coronal caries and 2.21 (2.83) for root caries.17 The 2-year incidence of coronal caries and root caries were therefore estimated to be 1.06 (1.26) and 0.88 (1.13), respectively, in the control group. The effect of an intervention is considered clinically significant if it reduces the caries incidence by 40%. Based on a significance level of 5% and a power of 80%, 140 subjects per group are needed for coronal caries and 165 subjects are needed for root caries outcome measures. To take both outcome measures into account, the higher number (ie, n=165) will be adopted. Allowing for a 25% attrition rate, 220 elderly persons will need to be recruited into each group, giving a total sample size of 440.", "id": 1142, "split": "val"}